In vitro diagnostic medical devices

Code EMDN W

1 558 fabricants, 31 626 modèles dont 31 133 en vente, 51 pays. Présents sur le marché en France : 258

Présent sur le marché en Seulement les modèles en vente Inclure accessoires et consommables Pays du fabricant

Fabricants enregistrés en Europe (EUDAMED) 1 558

En vente
Plus commercialisé
93/42 Ancienne directive, pas encore certifié selon le règlement MDR
Cliquez sur un fabricant pour voir toute sa gamme, sur un modèle pour ouvrir sa fiche EUDAMED.

Fabricant	Pays	Modèles enregistrés	Classe	Contact
Bio SB FDA Mandataire UE : QAdvis EAR AB (Suède)	États-Unis	A-1-Antichymotrypsin, EP384, RMab BSB 350098/79 A-1-Antichymotrypsin, EP384, RMab BSB 350198/79 A-1-Antichymotrypsin, EP384, RMab BSB 350298/79 A-1-Antitrypsin, Polyclonal, RPab BSB 501198/79 A-1-Antitrypsin, Polyclonal, RPab BSB 501298/79 3 061 autres A-1-Antitrypsin, Polyclonal, RPab BSB 501398/79 ACE2, BSB-135, MMab BSB-3702-0198/79 ACE2, BSB-135, MMab BSB-3702-0598/79 ACE2, BSB-135, MMab BSB-3702-198/79 ACTH, BSB-25, MMab BSB 501898/79 ACTH, BSB-25, MMab BSB 501998/79 ACTH, BSB-25, MMab BSB 502098/79 Actin Muscle Specific, HHF35, MMab BSB 502598/79 Actin Muscle Specific, HHF35, MMab BSB 502698/79 Actin Muscle Specific, HHF35, MMab BSB 502798/79 Actin Smooth Muscle, BSB-15, MMab BSB 503298/79 Actin Smooth Muscle, BSB-15, MMab BSB 503398/79 Actin Smooth Muscle, BSB-15, MMab BSB 503498/79 Adipophilin\|ADRP, BSB-91, MMab BSB 324998/79 Adipophilin\|ADRP, BSB-91, MMab BSB 325098/79 Adipophilin\|ADRP, BSB-91, MMab BSB 325198/79 Albumin, polyclonal, RPab BSB 301598/79 Albumin, polyclonal, RPab BSB 301698/79 Albumin, polyclonal, RPab BSB 301798/79 Albumin\|FITC, polyclonal, RPab BSB-3000-0598/79 Albumin\|FITC, polyclonal, RPab BSB-3000-198/79 ALK-1\|CD246, EP302, RMab BSB 279998/79 ALK-1\|CD246, EP302, RMab BSB 280098/79 ALK-1\|CD246, EP302, RMab BSB 280198/79 ALK-1\|CD246, RBT-ALK1, RMab BSB 504698/79 ALK-1\|CD246, RBT-ALK1, RMab BSB 504798/79 ALK-1\|CD246, RBT-ALK1, RMab BSB 504898/79 Alpha Synuclein, BSB-114, MMab BSB 328998/79 Alpha Synuclein, BSB-114, MMab BSB 329098/79 Alpha Synuclein, BSB-114, MMab BSB 329198/79 Alpha-Fetoprotein, BSB-23, MMab BSB 505398/79 Alpha-Fetoprotein, BSB-23, MMab BSB 505498/79 Alpha-Fetoprotein, BSB-23, MMab BSB 505598/79 AMACRacemase\|P504S, 13H4, RMab BSB 506098/79 AMACRacemase\|P504S, 13H4, RMab BSB 506198/79 AMACRacemase\|P504S, 13H4, RMab BSB 506298/79 Amyloid A, EP335, RMab BSB 280698/79 Amyloid A, EP335, RMab BSB 280798/79 Amyloid A, EP335, RMab BSB 280898/79 Amyloid Beta, RBT-A4, RMab BSB 344498/79 Amyloid Beta, RBT-A4, RMab BSB 344598/79 Amyloid Beta, RBT-A4, RMab BSB 344698/79 Androgen Receptor, BSB-4, MMab BSB 607498/79 Androgen Receptor, BSB-4, MMab BSB 607598/79 Androgen Receptor, BSB-4, MMab BSB 607698/79 Annexin A1, BSB-95, MMab BSB 636298/79 Annexin A1, BSB-95, MMab BSB 636398/79 Annexin A1, BSB-95, MMab BSB 636498/79 Annexin VII, EP367, RMab BSB-3709-0198/79 Annexin VII, EP367, RMab BSB-3709-0598/79 Annexin VII, EP367, RMab BSB-3709-198/79 APOE4, BSB-170, MMab BSB-3798-0198/79 APOE4, BSB-170, MMab BSB-3798-0598/79 APOE4, BSB-170, MMab BSB-3798-198/79 Arginase-1, EP261, RMab BSB 245098/79 Arginase-1, EP261, RMab BSB 245198/79 Arginase-1, EP261, RMab BSB 245298/79 ARID1A, EP303, RMab BSB-3749-0198/79 ARID1A, EP303, RMab BSB-3749-0598/79 ARID1A, EP303, RMab BSB-3749-198/79 Aspergillus, RBT-A.fumi, RMab BSB-3804-0198/79 Aspergillus, RBT-A.fumi, RMab BSB-3804-0598/79 Aspergillus, RBT-A.fumi, RMab BSB-3804-198/79 ATM, EP327, RMab BSB-3710-0198/79 ATM, EP327, RMab BSB-3710-0598/79 ATM, EP327, RMab BSB-3710-198/79 ATRX, BSB-108, MMab BSB 329698/79 ATRX, BSB-108, MMab BSB 329798/79 ATRX, BSB-108, MMab BSB 329898/79 ATRX, RBT-ATRX, RMab BSB-3711-0198/79 ATRX, RBT-ATRX, RMab BSB-3711-0598/79 ATRX, RBT-ATRX, RMab BSB-3711-198/79 Aurora B, RM278, RMab BSB-3712-0198/79 Aurora B, RM278, RMab BSB-3712-0598/79 Aurora B, RM278, RMab BSB-3712-198/79 B7H3\|CD276, RBT-B7H3, RMab BSB 281398/79 B7H3\|CD276, RBT-B7H3, RMab BSB 281498/79 B7H3\|CD276, RBT-B7H3, RMab BSB 281598/79 BAP1, BSB-109, MMab BSB 330398/79 BAP1, BSB-109, MMab BSB 330498/79 BAP1, BSB-109, MMab BSB 330598/79 Bax, E63, RMab BSB 608198/79 Bax, E63, RMab BSB 608298/79 Bax, E63, RMab BSB 608398/79 BCA-225, Cu-18, MMab BSB 506798/79 BCA-225, Cu-18, MMab BSB 506898/79 BCA-225, Cu-18, MMab BSB 506998/79 bcl-10, BSB-22, MMab BSB 270198/79 bcl-10, BSB-22, MMab BSB 270298/79 bcl-10, BSB-22, MMab BSB 270398/79 bcl-2, BSB-5, MMab BSB 507498/79 bcl-2, BSB-5, MMab BSB 507598/79 bcl-2, BSB-5, MMab BSB 507698/79 bcl-2, EP36, RMab BSB 654498/79 bcl-2, EP36, RMab BSB 654598/79 bcl-2, EP36, RMab BSB 654698/79 bcl-6, BSB-26, MMab BSB 343798/79 bcl-6, BSB-26, MMab BSB 343898/79 bcl-6, BSB-26, MMab BSB 343998/79 bcl-6, EP278, RMab BSB 282098/79 bcl-6, EP278, RMab BSB 282198/79 bcl-6, EP278, RMab BSB 282298/79 bcl-6, RBT-bcl6, RMab BSB 508198/79 bcl-6, RBT-bcl6, RMab BSB 508298/79 bcl-6, RBT-bcl6, RMab BSB 508398/79 BCOR, BSB-128, MMab BSB-2370-0198/79 BCOR, BSB-128, MMab BSB-2370-0598/79 BCOR, BSB-128, MMab BSB-2370-198/79 Beta-Catenin, 14, MMab BSB 508898/79 Beta-Catenin, 14, MMab BSB 508998/79 Beta-Catenin, 14, MMab BSB 509098/79 Beta-Catenin, RM276, RMab BSB-3756-0198/79 Beta-Catenin, RM276, RMab BSB-3756-0598/79 Beta-Catenin, RM276, RMab BSB-3756-198/79 BG8 LewisY, F3, MMab BSB 637698/79 BG8 LewisY, F3, MMab BSB 637798/79 BG8 LewisY, F3, MMab BSB 637898/79 BOB.1, RBT BOB.1, RMab BSB-3700-0198/79 BOB.1, RBT BOB.1, RMab BSB-3700-0598/79 BOB.1, RBT BOB.1, RMab BSB-3700-198/79 Brachyury, RBT-TBXT, RMab BSB 349398/79 Brachyury, RBT-TBXT, RMab BSB 349498/79 Brachyury, RBT-TBXT, RMab BSB 349598/79 BRAF V600E, RM8, RMab BSB 282798/79 BRAF V600E, RM8, RMab BSB 282898/79 BRAF V600E, RM8, RMab BSB 282998/79 BRG-1\|SMARCA4, BSB-154, MMab BSB-3714-0198/79 BRG-1\|SMARCA4, BSB-154, MMab BSB-3714-0598/79 BRG-1\|SMARCA4, BSB-154, MMab BSB-3714-198/79 c-Met\|HGFR, EP1454Y, RMab BSB 658698/79 c-Met\|HGFR, EP1454Y, RMab BSB 658798/79 c-Met\|HGFR, EP1454Y, RMab BSB 658898/79 c-Myc, EP121, RMab BSB 657998/79 c-Myc, EP121, RMab BSB 658098/79 c-Myc, EP121, RMab BSB 658198/79 C1q, Polyclonal, RPab BSB 302298/79 C1q, Polyclonal, RPab BSB 302398/79 C1q, Polyclonal, RPab BSB 302498/79 C1q\|FITC, Polyclonal, RPab BSB-3001-0598/79 C1q\|FITC, Polyclonal, RPab BSB-3001-198/79 C3c, Polyclonal, RPab BSB 302998/79 C3c, Polyclonal, RPab BSB 303098/79 C3c, Polyclonal, RPab BSB 303198/79 C3c\|FITC, Polyclonal, RPab BSB-3002-0598/79 C3c\|FITC, Polyclonal, RPab BSB-3002-198/79 C3d, Polyclonal, RPab BSB 639098/79 C3d, Polyclonal, RPab BSB 639198/79 C3d, Polyclonal, RPab BSB 639298/79 C4c, Polyclonal, RPab BSB 303698/79 C4c, Polyclonal, RPab BSB 303798/79 C4c, Polyclonal, RPab BSB 303898/79 C4c\|FITC, Polyclonal, RPab BSB-3003-0598/79 C4c\|FITC, Polyclonal, RPab BSB-3003-198/79 C4d, EP272, RMab BSB 283498/79 C4d, EP272, RMab BSB 283598/79 C4d, EP272, RMab BSB 283698/79 CA-125, OC125, MMab BSB 509598/79 CA-125, OC125, MMab BSB 509698/79 CA-125, OC125, MMab BSB 509798/79 CA15-3, DF3, MMab BSB 510298/79 CA15-3, DF3, MMab BSB 510398/79 CA15-3, DF3, MMab BSB 510498/79 CA19-9, 121SLE, MMab BSB 510998/79 CA19-9, 121SLE, MMab BSB 511098/79 CA19-9, 121SLE, MMab BSB 511198/79 Cadherin17\|LI-Cadherin, EP86, RMab BSB 685298/79 Cadherin17\|LI-Cadherin, EP86, RMab BSB 685398/79 Cadherin17\|LI-Cadherin, EP86, RMab BSB 685498/79 Calcitonin, EP92, RMab BSB 641198/79 Calcitonin, EP92, RMab BSB 641298/79 Calcitonin, EP92, RMab BSB 641398/79 Caldesmon, BSB-19, MMab BSB 610298/79 Caldesmon, BSB-19, MMab BSB 610398/79 Caldesmon, BSB-19, MMab BSB 610498/79 Calponin, BSB-20, MMab BSB 512398/79 Calponin, BSB-20, MMab BSB 512498/79 Calponin, BSB-20, MMab BSB 512598/79 Calretinin, RM324, RMab BSB-3757-0198/79 Calretinin, RM324, RMab BSB-3757-0598/79 Calretinin, RM324, RMab BSB-3757-198/79 Candida Albicans, RBT-C.alb, RMab BSB-3803-0198/79 Candida Albicans, RBT-C.alb, RMab BSB-3803-0598/79 Candida Albicans, RBT-C.alb, RMab BSB-3803-198/79 Carbonic Anhydrase 9, EP161, RMab BSB 641898/79 Carbonic Anhydrase 9, EP161, RMab BSB 641998/79 Carbonic Anhydrase 9, EP161, RMab BSB 642098/79 Caspase-3, RM250, RMab BSB-3715-0198/79 Caspase-3, RM250, RMab BSB-3715-0598/79 Caspase-3, RM250, RMab BSB-3715-198/79 Cathepsin K, BSB-172, MMab BSB-3800-0198/79 Cathepsin K, BSB-172, MMab BSB-3800-0598/79 Cathepsin K, BSB-172, MMab BSB-3800-198/79 Caveolin-1, EP353, RMab BSB 331798/79 Caveolin-1, EP353, RMab BSB 331898/79 Caveolin-1, EP353, RMab BSB 331998/79 CD10, 56C6, MMab BSB 517998/79 CD10, 56C6, MMab BSB 518098/79 CD10, 56C6, MMab BSB 518198/79 CD103\|ITGAE, EP206, RMab BSB 286298/79 CD103\|ITGAE, EP206, RMab BSB 286398/79 CD103\|ITGAE, EP206, RMab BSB 286498/79 CD105\|Endoglin, EP274, RMab BSB 286998/79 CD105\|Endoglin, EP274, RMab BSB 287098/79 CD105\|Endoglin, EP274, RMab BSB 287198/79 CD117, EP10, RMab BSB 531998/79 CD117, EP10, RMab BSB 532098/79 CD117, EP10, RMab BSB 532198/79 CD117, RM359, RMab BSB-3758-0198/79 CD117, RM359, RMab BSB-3758-0598/79 CD117, RM359, RMab BSB-3758-198/79 CD11b, EP45, RMab BSB 643998/79 CD11b, EP45, RMab BSB 644098/79 CD11b, EP45, RMab BSB 644198/79 CD11c, EP157, RMab BSB 644698/79 CD11c, EP157, RMab BSB 644798/79 CD11c, EP157, RMab BSB 644898/79 CD123 IL-3Ra, BSB-59, MMab BSB 532698/79 CD123 IL-3Ra, BSB-59, MMab BSB 532798/79 CD123 IL-3Ra, BSB-59, MMab BSB 532898/79 CD13, 38C12, MMab BSB 632798/79 CD13, 38C12, MMab BSB 632898/79 CD13, 38C12, MMab BSB 632998/79 CD137\|TNFRSF9, BSB-159, MMab BSB-3717-0198/79 CD137\|TNFRSF9, BSB-159, MMab BSB-3717-0598/79 CD137\|TNFRSF9, BSB-159, MMab BSB-3717-198/79 CD138, B-A38, MMab BSB 533398/79 CD138, B-A38, MMab BSB 533498/79 CD138, B-A38, MMab BSB 533598/79 CD138, EP201, RMab BSB 653098/79 CD138, EP201, RMab BSB 653198/79 CD138, EP201, RMab BSB 653298/79 CD14, 7, MMab BSB 631398/79 CD14, 7, MMab BSB 631498/79 CD14, 7, MMab BSB 631598/79 CD14, EP128, RMab BSB 646098/79 CD14, EP128, RMab BSB 646198/79 CD14, EP128, RMab BSB 646298/79 CD142\|TF\|Coagulation Factor III, BSB-143, MMab BSB-3718-0198/79 CD142\|TF\|Coagulation Factor III, BSB-143, MMab BSB-3718-0598/79 CD142\|TF\|Coagulation Factor III, BSB-143, MMab BSB-3718-198/79 CD147, BSB-137, MMab BSB-3704-0198/79 CD147, BSB-137, MMab BSB-3704-0598/79 CD147, BSB-137, MMab BSB-3704-198/79 CD15, BSB-119, MMab BSB 518698/79 CD15, BSB-119, MMab BSB 518798/79 CD15, BSB-119, MMab BSB 518898/79 CD16, EP364, RMab BSB 332498/79 CD16, EP364, RMab BSB 332598/79 CD16, EP364, RMab BSB 332698/79 CD163, 10D6, MMab BSB 630698/79 CD163, 10D6, MMab BSB 630798/79 CD163, 10D6, MMab BSB 630898/79 CD19, BSB-97, MMab BSB 622998/79 CD19, BSB-97, MMab BSB 623098/79 CD19, BSB-97, MMab BSB 623198/79 CD1a, EP80, RMab BSB 513798/79 CD1a, EP80, RMab BSB 513898/79 CD1a, EP80, RMab BSB 513998/79 CD2, AB75, MMab BSB 620898/79 CD2, AB75, MMab BSB 620998/79 CD2, AB75, MMab BSB 621098/79 CD20, L26, MMab BSB 519398/79 CD20, L26, MMab BSB 519498/79 CD20, L26, MMab BSB 519598/79 CD21, EP64, RMab BSB 520098/79 CD21, EP64, RMab BSB 520198/79 CD21, EP64, RMab BSB 520298/79 CD23, 1B12, MMab BSB 520798/79 CD23, 1B12, MMab BSB 520898/79 CD23, 1B12, MMab BSB 520998/79 CD23, EP75, RMab BSB 647498/79 CD23, EP75, RMab BSB 647598/79 CD23, EP75, RMab BSB 647698/79 CD25, 4C9, MMab BSB 632098/79 CD25, 4C9, MMab BSB 632198/79 CD25, 4C9, MMab BSB 632298/79 CD25, RBT-CD25, RMab BSB 245798/79 CD25, RBT-CD25, RMab BSB 245898/79 CD25, RBT-CD25, RMab BSB 245998/79 CD3 Epsilon, RBT-CD3e, RMab BSB 514498/79 CD3 Epsilon, RBT-CD3e, RMab BSB 514598/79 CD3 Epsilon, RBT-CD3e, RMab BSB 514698/79 CD3, RBT-CD3, RMab BSB 642598/79 CD3, RBT-CD3, RMab BSB 642698/79 CD3, RBT-CD3, RMab BSB 642798/79 CD30, Ber-H2, MMab BSB 521498/79 CD30, Ber-H2, MMab BSB 521598/79 CD30, Ber-H2, MMab BSB 521698/79 CD31, 1A10, MMab BSB 522198/79 CD31, 1A10, MMab BSB 522298/79 CD31, 1A10, MMab BSB 522398/79 CD33, RBT-CD33, RMab BSB 345198/79 CD33, RBT-CD33, RMab BSB 345298/79 CD33, RBT-CD33, RMab BSB 345398/79 CD34, EP88, RMab BSB 648898/79 CD34, EP88, RMab BSB 648998/79 CD34, EP88, RMab BSB 649098/79 CD34, QBEnd\|10, MMab BSB 522898/79 CD34, QBEnd\|10, MMab BSB 522998/79 CD34, QBEnd\|10, MMab BSB 523098/79 CD35, EP197, RMab BSB 649598/79 CD35, EP197, RMab BSB 649698/79 CD35, EP197, RMab BSB 649798/79 CD35, RLB25, MMab BSB 523598/79 CD35, RLB25, MMab BSB 523698/79 CD35, RLB25, MMab BSB 523798/79 CD38, EP135, RMab BSB 650298/79 CD38, EP135, RMab BSB 650398/79 CD38, EP135, RMab BSB 650498/79 CD38, SPC32, MMab BSB 620198/79 CD38, SPC32, MMab BSB 620298/79 CD38, SPC32, MMab BSB 620398/79 CD4, RBT-CD4, RMab BSB 515198/79 CD4, RBT-CD4, RMab BSB 515298/79 CD4, RBT-CD4, RMab BSB 515398/79 CD41\| Integrin alpha IIb, EP178, RMab BSB 650998/79 CD41\| Integrin alpha IIb, EP178, RMab BSB 651098/79 CD41\| Integrin alpha IIb, EP178, RMab BSB 651198/79 CD42b, EP409, RMab BSB 350798/79 CD42b, EP409, RMab BSB 350898/79 CD42b, EP409, RMab BSB 350998/79 CD43, MT1, MMab BSB 524298/79 CD43, MT1, MMab BSB 524398/79 CD43, MT1, MMab BSB 524498/79 CD44, BSB-12, MMab BSB 623698/79 CD44, BSB-12, MMab BSB 623798/79 CD44, BSB-12, MMab BSB 623898/79 CD45, 2B11 and PD7\|26, MMab BSB 524998/79 CD45, 2B11 and PD7\|26, MMab BSB 525098/79 CD45, 2B11 and PD7\|26, MMab BSB 525198/79 CD45RA, 4KB5, MMab BSB 525698/79 CD45RA, 4KB5, MMab BSB 525798/79 CD45RA, 4KB5, MMab BSB 525898/79 CD45RO, UCHL-1, MMab BSB 526398/79 CD45RO, UCHL-1, MMab BSB 526498/79 CD45RO, UCHL-1, MMab BSB 526598/79 CD5, RBT-CD5, RMab BSB 515898/79 CD5, RBT-CD5, RMab BSB 515998/79 CD5, RBT-CD5, RMab BSB 516098/79 CD5, RM314, RMab BSB-3759-0198/79 CD5, RM314, RMab BSB-3759-0598/79 CD5, RM314, RMab BSB-3759-198/79 CD56, 123C3.D5, MMab BSB 527098/79 CD56, 123C3.D5, MMab BSB 527198/79 CD56, 123C3.D5, MMab BSB 527298/79 CD57, BSB-10, MMab BSB 527798/79 CD57, BSB-10, MMab BSB 527898/79 CD57, BSB-10, MMab BSB 527998/79 CD6, BSB-54, MMab BSB 270898/79 CD6, BSB-54, MMab BSB 270998/79 CD6, BSB-54, MMab BSB 271098/79 CD61, 2f2, MMab BSB 528498/79 CD61, 2f2, MMab BSB 528598/79 CD61, 2f2, MMab BSB 528698/79 CD61, EP65, RMab BSB 351498/79 CD61, EP65, RMab BSB 351598/79 CD61, EP65, RMab BSB 351698/79 CD63, NKI\|C3, MMab BSB 629998/79 CD63, NKI\|C3, MMab BSB 630098/79 CD63, NKI\|C3, MMab BSB 630198/79 CD68, BSB-8, MMab BSB 529198/79 CD68, BSB-8, MMab BSB 529298/79 CD68, BSB-8, MMab BSB 529398/79 CD68, KP-1, MMab BSB 271598/79 CD68, KP-1, MMab BSB 271698/79 CD68, KP-1, MMab BSB 271798/79 CD7, EP132, RMab BSB 232498/79 CD7, EP132, RMab BSB 232598/79 CD7, EP132, RMab BSB 232698/79 CD7, LP15, MMab BSB 516598/79 CD7, LP15, MMab BSB 516698/79 CD7, LP15, MMab BSB 516798/79 CD71, 10F11, MMab BSB 652398/79 CD71, 10F11, MMab BSB 652498/79 CD71, 10F11, MMab BSB 652598/79 CD73\|NT5E, RM431, RMab BSB-3716-0198/79 CD73\|NT5E, RM431, RMab BSB-3716-0598/79 CD73\|NT5E, RM431, RMab BSB-3716-198/79 CD74, LN2, MMab BSB 529898/79 CD74, LN2, MMab BSB 529998/79 CD74, LN2, MMab BSB 530098/79 CD75, LN-1, MMab BSB 272298/79 CD75, LN-1, MMab BSB 272398/79 CD75, LN-1, MMab BSB 272498/79 CD79a, JCB117, MMab BSB 530598/79 CD79a, JCB117, MMab BSB 530698/79 CD79a, JCB117, MMab BSB 530798/79 CD8, C8\|144B, MMab BSB 517298/79 CD8, C8\|144B, MMab BSB 517398/79 CD8, C8\|144B, MMab BSB 517498/79 CD8, EP334, RMab BSB 284898/79 CD8, EP334, RMab BSB 284998/79 CD8, EP334, RMab BSB 285098/79 CD99, BSB-9, MMab BSB 531298/79 CD99, BSB-9, MMab BSB 531398/79 CD99, BSB-9, MMab BSB 531498/79 CDK2, RBT-CDK2, RMab BSB 263998/79 CDK2, RBT-CDK2, RMab BSB 264098/79 CDK2, RBT-CDK2, RMab BSB 264198/79 CDK4, EP180, RMab BSB 246498/79 CDK4, EP180, RMab BSB 246598/79 CDK4, EP180, RMab BSB 246698/79 CDX2, EP25, RMab BSB 606098/79 CDX2, EP25, RMab BSB 606198/79 CDX2, EP25, RMab BSB 606298/79 CEA, BSB-13, MMab BSB 534098/79 CEA, BSB-13, MMab BSB 534198/79 CEA, BSB-13, MMab BSB 534298/79 CEA, Polyclonal, RPab BSB 653798/79 CEA, Polyclonal, RPab BSB 653898/79 CEA, Polyclonal, RPab BSB 653998/79 CEACAM7, BSB-168, MMab BSB-3791-0198/79 CEACAM7, BSB-168, MMab BSB-3791-0598/79 CEACAM7, BSB-168, MMab BSB-3791-198/79 Chromogranin A, LK2H10, MMab BSB 534798/79 Chromogranin A, LK2H10, MMab BSB 534898/79 Chromogranin A, LK2H10, MMab BSB 534998/79 CITED1, BSB-177, MMab BSB-3808-0198/79 CITED1, BSB-177, MMab BSB-3808-0598/79 CITED1, BSB-177, MMab BSB-3808-198/79 Claudin-1, Polyclonal, RPab BSB 656598/79 Claudin-1, Polyclonal, RPab BSB 656698/79 Claudin-1, Polyclonal, RPab BSB 656798/79 Claudin-4, EP417, RMab BSB-3792-0198/79 Claudin-4, EP417, RMab BSB-3792-0598/79 Claudin-4, EP417, RMab BSB-3792-198/79 Claudin-5, EP224, RMab BSB 240198/79 Claudin-5, EP224, RMab BSB 240298/79 Claudin-5, EP224, RMab BSB 240398/79 Claudin-7, EP399, RMab BSB-3719-0198/79 Claudin-7, EP399, RMab BSB-3719-0598/79 Claudin-7, EP399, RMab BSB-3719-198/79 Collagen Type IV, CIV22, MMab BSB 535498/79 Collagen Type IV, CIV22, MMab BSB 535598/79 Collagen Type IV, CIV22, MMab BSB 535698/79 Collagen Type IV, RBT-COL4, RMab BSB-3777-0198/79 Collagen Type IV, RBT-COL4, RMab BSB-3777-0598/79 Collagen Type IV, RBT-COL4, RMab BSB-3777-198/79 COX-2, RBT-COX2, RMab BSB 536198/79 COX-2, RBT-COX2, RMab BSB 536298/79 COX-2, RBT-COX2, RMab BSB 536398/79 CTLA-4\|CD152, BSB-88, MMab BSB 288398/79 CTLA-4\|CD152, BSB-88, MMab BSB 288498/79 CTLA-4\|CD152, BSB-88, MMab BSB 288598/79 CTLA-4\|CD152, RBT-CTLA-4, RMab BSB 348698/79 CTLA-4\|CD152, RBT-CTLA-4, RMab BSB 348798/79 CTLA-4\|CD152, RBT-CTLA-4, RMab BSB 348898/79 CXCL12\|SDF-1, BSB-165, MMab BSB-3713-0198/79 CXCL12\|SDF-1, BSB-165, MMab BSB-3713-0598/79 CXCL12\|SDF-1, BSB-165, MMab BSB-3713-198/79 CXCR4\|CD184\|Fusin, EP394, RMab BSB-3720-0198/79 CXCR4\|CD184\|Fusin, EP394, RMab BSB-3720-0598/79 CXCR4\|CD184\|Fusin, EP394, RMab BSB-3720-198/79 CXCR5\|CD185, Polyclonal, RPab BSB-3721-0198/79 CXCR5\|CD185, Polyclonal, RPab BSB-3721-0598/79 CXCR5\|CD185, Polyclonal, RPab BSB-3721-198/79 Cyclin B1, RM281, RMab BSB-3760-0198/79 Cyclin B1, RM281, RMab BSB-3760-0598/79 Cyclin B1, RM281, RMab BSB-3760-198/79 Cyclin D1, RBT-14, RMab BSB 536898/79 Cyclin D1, RBT-14, RMab BSB 536998/79 Cyclin D1, RBT-14, RMab BSB 537098/79 Cyclin D1, RM241, RMab BSB-3761-0198/79 Cyclin D1, RM241, RMab BSB-3761-0598/79 Cyclin D1, RM241, RMab BSB-3761-198/79 Cyclin D3, BSB-171, MMab BSB-3799-0198/79 Cyclin D3, BSB-171, MMab BSB-3799-0598/79 Cyclin D3, BSB-171, MMab BSB-3799-198/79 Cyclin E1, EP126, RMab BSB 655898/79 Cyclin E1, EP126, RMab BSB 655998/79 Cyclin E1, EP126, RMab BSB 656098/79 Cytokeratin 14, LL002, MMab BSB 622298/79 Cytokeratin 14, LL002, MMab BSB 622398/79 Cytokeratin 14, LL002, MMab BSB 622498/79 Cytokeratin 14, RM328, RMab BSB-3762-0198/79 Cytokeratin 14, RM328, RMab BSB-3762-0598/79 Cytokeratin 14, RM328, RMab BSB-3762-198/79 Cytokeratin 17, BSB-33, MMab BSB 272998/79 Cytokeratin 17, BSB-33, MMab BSB 273098/79 Cytokeratin 17, BSB-33, MMab BSB 273198/79 Cytokeratin 18, EP30, RMab BSB 669898/79 Cytokeratin 18, EP30, RMab BSB 669998/79 Cytokeratin 18, EP30, RMab BSB 670098/79 Cytokeratin 19, BSB-34, MMab BSB 273698/79 Cytokeratin 19, BSB-34, MMab BSB 273798/79 Cytokeratin 19, BSB-34, MMab BSB 273898/79 Cytokeratin 19, EP72, RMab BSB 538298/79 Cytokeratin 19, EP72, RMab BSB 538398/79 Cytokeratin 19, EP72, RMab BSB 538498/79 Cytokeratin 19, RM364, RMab BSB-3763-0198/79 Cytokeratin 19, RM364, RMab BSB-3763-0598/79 Cytokeratin 19, RM364, RMab BSB-3763-198/79 Cytokeratin 20, EP23, RMab BSB 670598/79 Cytokeratin 20, EP23, RMab BSB 670698/79 Cytokeratin 20, EP23, RMab BSB 670798/79 Cytokeratin 20, Ks20.8, MMab BSB 538998/79 Cytokeratin 20, Ks20.8, MMab BSB 539098/79 Cytokeratin 20, Ks20.8, MMab BSB 539198/79 Cytokeratin 35BH11, 35BetaH11, MMab BSB 542498/79 Cytokeratin 35BH11, 35BetaH11, MMab BSB 542598/79 Cytokeratin 35BH11, 35BetaH11, MMab BSB 542698/79 Cytokeratin 4, EP4, RMab BSB 659398/79 Cytokeratin 4, EP4, RMab BSB 659498/79 Cytokeratin 4, EP4, RMab BSB 659598/79 Cytokeratin 5 and 6, D5 and 16B4, MMab BSB 540398/79 Cytokeratin 5 and 6, D5 and 16B4, MMab BSB 540498/79 Cytokeratin 5 and 6, D5 and 16B4, MMab BSB 540598/79 Cytokeratin 7, OV-TL 12\|30, MMab BSB 541098/79 Cytokeratin 7, OV-TL 12\|30, MMab BSB 541198/79 Cytokeratin 7, OV-TL 12\|30, MMab BSB 541298/79 Cytokeratin 7, RM284, RMab BSB-3764-0198/79 Cytokeratin 7, RM284, RMab BSB-3764-0598/79 Cytokeratin 7, RM284, RMab BSB-3764-198/79 Cytokeratin 8 and 18, B22.1 and B23.1, MMab BSB 541798/79 Cytokeratin 8 and 18, B22.1 and B23.1, MMab BSB 541898/79 Cytokeratin 8 and 18, B22.1 and B23.1, MMab BSB 541998/79 Cytokeratin 8, EP17, RMab BSB 666398/79 Cytokeratin 8, EP17, RMab BSB 666498/79 Cytokeratin 8, EP17, RMab BSB 666598/79 Cytokeratin Cocktail AE1 and AE3, AE1 and AE3, MMab BSB 543198/79 Cytokeratin Cocktail AE1 and AE3, AE1 and AE3, MMab BSB 543298/79 Cytokeratin Cocktail AE1 and AE3, AE1 and AE3, MMab BSB 543398/79 Cytokeratin HMW 34BE12, 34BetaE12, MMab BSB 539698/79 Cytokeratin HMW 34BE12, 34BetaE12, MMab BSB 539798/79 Cytokeratin HMW 34BE12, 34BetaE12, MMab BSB 539898/79 Cytokeratin LMW CAM5.2, CAM5.2, MMab BSB 205998/79 Cytokeratin LMW CAM5.2, CAM5.2, MMab BSB 206098/79 Cytokeratin LMW CAM5.2, CAM5.2, MMab BSB 206198/79 Cytokeratin MNF116, MNF116, MMab BSB 353598/79 Cytokeratin MNF116, MNF116, MMab BSB 353698/79 Cytokeratin MNF116, MNF116, MMab BSB 353798/79 Cytokeratin OSCAR, OSCAR, MMab BSB 618098/79 Cytokeratin OSCAR, OSCAR, MMab BSB 618198/79 Cytokeratin OSCAR, OSCAR, MMab BSB 618298/79 DDR1, BSB-173, MMab BSB-3801-0198/79 DDR1, BSB-173, MMab BSB-3801-0598/79 DDR1, BSB-173, MMab BSB-3801-198/79 Desmin, D33, MMab BSB 545998/79 Desmin, D33, MMab BSB 546098/79 Desmin, D33, MMab BSB 546198/79 Desmoglein-3, EP306, RMab BSB 289798/79 Desmoglein-3, EP306, RMab BSB 289898/79 Desmoglein-3, EP306, RMab BSB 289998/79 DOG-1, EP332, RMab BSB 290498/79 DOG-1, EP332, RMab BSB 290598/79 DOG-1, EP332, RMab BSB 290698/79 DOG-1, RBT-DOG1, RMab BSB 627198/79 DOG-1, RBT-DOG1, RMab BSB 627298/79 DOG-1, RBT-DOG1, RMab BSB 627398/79 E-Cadherin, EP6, RMab BSB 546698/79 E-Cadherin, EP6, RMab BSB 546798/79 E-Cadherin, EP6, RMab BSB 546898/79 EGFR Phospho, EP11, RMab BSB 671998/79 EGFR Phospho, EP11, RMab BSB 672098/79 EGFR Phospho, EP11, RMab BSB 672198/79 EGFR, 31G7, MMab BSB 547398/79 EGFR, 31G7, MMab BSB 547498/79 EGFR, 31G7, MMab BSB 547598/79 EMA, E29, MMab BSB 548098/79 EMA, E29, MMab BSB 548198/79 EMA, E29, MMab BSB 548298/79 EpCAM\|Epithelial Specific Antigen, Ber-EP4, MMab BSB 627898/79 EpCAM\|Epithelial Specific Antigen, Ber-EP4, MMab BSB 627998/79 EpCAM\|Epithelial Specific Antigen, Ber-EP4, MMab BSB 628098/79 EpCAM\|Epithelial Specific Antigen, MOC-31, MMab BSB 672698/79 EpCAM\|Epithelial Specific Antigen, MOC-31, MMab BSB 672798/79 EpCAM\|Epithelial Specific Antigen, MOC-31, MMab BSB 672898/79 Epstein Barr Virus LMP-1, CS1-4, MMab BSB 548798/79 Epstein Barr Virus LMP-1, CS1-4, MMab BSB 548898/79 Epstein Barr Virus LMP-1, CS1-4, MMab BSB 548998/79 ERCC1, EP219, RMab BSB 248598/79 ERCC1, EP219, RMab BSB 248698/79 ERCC1, EP219, RMab BSB 248798/79 ERG, EP111, RMab BSB 674098/79 ERG, EP111, RMab BSB 674198/79 ERG, EP111, RMab BSB 674298/79 Estrogen Receptor, BSB-1, MMab BSB 274398/79 Estrogen Receptor, BSB-1, MMab BSB 274498/79 Estrogen Receptor, BSB-1, MMab BSB 274598/79 Estrogen Receptor, EP1, RMab BSB 249298/79 Estrogen Receptor, EP1, RMab BSB 249398/79 Estrogen Receptor, EP1, RMab BSB 249498/79 Estrogen Receptor, RBT-11, RMab BSB 549498/79 Estrogen Receptor, RBT-11, RMab BSB 549598/79 Estrogen Receptor, RBT-11, RMab BSB 549698/79 Estrogen Receptor, RM292, RMab BSB-3765-0198/79 Estrogen Receptor, RM292, RMab BSB-3765-0598/79 Estrogen Receptor, RM292, RMab BSB-3765-198/79 Factor H\|Complement Factor H, BSB-164, MMab BSB-3723-0198/79 Factor H\|Complement Factor H, BSB-164, MMab BSB-3723-0598/79 Factor H\|Complement Factor H, BSB-164, MMab BSB-3723-198/79 Factor VIII-Related Antigen, Polyclonal, RPab BSB 550198/79 Factor VIII-Related Antigen, Polyclonal, RPab BSB 550298/79 Factor VIII-Related Antigen, Polyclonal, RPab BSB 550398/79 Factor XIIIa, EP292, RMab BSB 550898/79 Factor XIIIa, EP292, RMab BSB 550998/79 Factor XIIIa, EP292, RMab BSB 551098/79 Fascin, BSB-36, MMab BSB 551598/79 Fascin, BSB-36, MMab BSB 551698/79 Fascin, BSB-36, MMab BSB 551798/79 FGFR-3, BSB-150, MMab BSB-3724-0198/79 FGFR-3, BSB-150, MMab BSB-3724-0598/79 FGFR-3, BSB-150, MMab BSB-3724-198/79 Fibrinogen, Polyclonal, RPab BSB 305098/79 Fibrinogen, Polyclonal, RPab BSB 305198/79 Fibrinogen, Polyclonal, RPab BSB 305298/79 Fibrinogen\|FITC, Polyclonal, RPab BSB-3004-0598/79 Fibrinogen\|FITC, Polyclonal, RPab BSB-3004-198/79 Fli-1, G146-222, MMab BSB 552298/79 Fli-1, G146-222, MMab BSB 552398/79 Fli-1, G146-222, MMab BSB 552498/79 FOXL2, Polyclonal, RPab BSB-3725-0198/79 FOXL2, Polyclonal, RPab BSB-3725-0598/79 FOXL2, Polyclonal, RPab BSB-3725-198/79 FOXP1, EP137, RMab BSB 675498/79 FOXP1, EP137, RMab BSB 675598/79 FOXP1, EP137, RMab BSB 675698/79 FOXP3, EP340, RMab BSB 292598/79 FOXP3, EP340, RMab BSB 292698/79 FOXP3, EP340, RMab BSB 292798/79 FOXP3, Polyclonal, RPab BSB 676198/79 FOXP3, Polyclonal, RPab BSB 676298/79 FOXP3, Polyclonal, RPab BSB 676398/79 FSH, BSB-55, MMab BSB 553698/79 FSH, BSB-55, MMab BSB 553798/79 FSH, BSB-55, MMab BSB 553898/79 FSH, EP257, RMab BSB 354298/79 FSH, EP257, RMab BSB 354398/79 FSH, EP257, RMab BSB 354498/79 Fumarate Hydratase\|Fumarase, BSB-151, MMab BSB-3726-0198/79 Fumarate Hydratase\|Fumarase, BSB-151, MMab BSB-3726-0598/79 Fumarate Hydratase\|Fumarase, BSB-151, MMab BSB-3726-198/79 GAB1\|GRB2-associated-binding protein 1, BSB-155, MMab BSB-3727-0198/79 GAB1\|GRB2-associated-binding protein 1, BSB-155, MMab BSB-3727-0598/79 GAB1\|GRB2-associated-binding protein 1, BSB-155, MMab BSB-3727-198/79 Galectin-3, 9C4, MMab BSB 554398/79 Galectin-3, 9C4, MMab BSB 554498/79 Galectin-3, 9C4, MMab BSB 554598/79 Gastrin, Polyclonal, RPab BSB 555098/79 Gastrin, Polyclonal, RPab BSB 555198/79 Gastrin, Polyclonal, RPab BSB 555298/79 GATA3, EP368, RMab BSB 333198/79 GATA3, EP368, RMab BSB 333298/79 GATA3, EP368, RMab BSB 333398/79 GATA3, L50-823, MMab BSB 267398/79 GATA3, L50-823, MMab BSB 267498/79 GATA3, L50-823, MMab BSB 267598/79 GCDFP-15, 23A3, MMab BSB 555798/79 GCDFP-15, 23A3, MMab BSB 555898/79 GCDFP-15, 23A3, MMab BSB 555998/79 GFAP, G-A-5, MMab BSB 556498/79 GFAP, G-A-5, MMab BSB 556598/79 GFAP, G-A-5, MMab BSB 556698/79 GFAP, RM246, RMab BSB-3766-0198/79 GFAP, RM246, RMab BSB-3766-0598/79 GFAP, RM246, RMab BSB-3766-198/79 GH, BSB-99, MMab BSB 333898/79 GH, BSB-99, MMab BSB 333998/79 GH, BSB-99, MMab BSB 334098/79 GH, EP267, RMab BSB 249998/79 GH, EP267, RMab BSB 250098/79 GH, EP267, RMab BSB 250198/79 Glucagon, BSB-111, MMab BSB 334598/79 Glucagon, BSB-111, MMab BSB 334698/79 Glucagon, BSB-111, MMab BSB 334798/79 Glucagon, EP74, RMab BSB 233198/79 Glucagon, EP74, RMab BSB 233298/79 Glucagon, EP74, RMab BSB 233398/79 GLUT1, EP141, RMab BSB 678298/79 GLUT1, EP141, RMab BSB 678398/79 GLUT1, EP141, RMab BSB 678498/79 Glutamine Synthetase, GS-6, MMab BSB 293298/79 Glutamine Synthetase, GS-6, MMab BSB 293398/79 Glutamine Synthetase, GS-6, MMab BSB 293498/79 Glycophorin A, GA-R2 (HIR2), MMab BSB 558598/79 Glycophorin A, GA-R2 (HIR2), MMab BSB 558698/79 Glycophorin A, GA-R2 (HIR2), MMab BSB 558798/79 Glypican-3, 1G12, MMab BSB 624398/79 Glypican-3, 1G12, MMab BSB 624498/79 Glypican-3, 1G12, MMab BSB 624598/79 Granzyme B, EP230, RMab BSB 240898/79 Granzyme B, EP230, RMab BSB 240998/79 Granzyme B, EP230, RMab BSB 241098/79 hCG, BSB-38, MMab BSB 559998/79 hCG, BSB-38, MMab BSB 560098/79 hCG, BSB-38, MMab BSB 560198/79 HE4, EP370, RMab BSB 335298/79 HE4, EP370, RMab BSB 335398/79 HE4, EP370, RMab BSB 335498/79 HEG1, SKM9-2, MMab BSB-3728-0198/79 HEG1, SKM9-2, MMab BSB-3728-0598/79 HEG1, SKM9-2, MMab BSB-3728-198/79 Helicobacter Pylori, BSB-37, MMab BSB 268098/79 Helicobacter Pylori, BSB-37, MMab BSB 268198/79 Helicobacter Pylori, BSB-37, MMab BSB 268298/79 Helicobacter Pylori, EP279, RMab BSB 328298/79 Helicobacter Pylori, EP279, RMab BSB 328398/79 Helicobacter Pylori, EP279, RMab BSB 328498/79 Helicobacter pylori, Polyclonal, RPab BSB 560698/79 Helicobacter pylori, Polyclonal, RPab BSB 560798/79 Helicobacter pylori, Polyclonal, RPab BSB 560898/79 Hepatocyte Specific Antigen\Hep-Par1, OCH1E5, MMab BSB 562798/79 Hepatocyte Specific Antigen\Hep-Par1, OCH1E5, MMab BSB 562898/79 Hepatocyte Specific Antigen\Hep-Par1, OCH1E5, MMab BSB 562998/79 HER-2 neu, BSB-3, MMab BSB 563498/79 HER-2 neu, BSB-3, MMab BSB 563598/79 HER-2 neu, BSB-3, MMab BSB 563698/79 HER-2 neu, RBT-HER2, RMab BSB 203898/79 HER-2 neu, RBT-HER2, RMab BSB 203998/79 HER-2 neu, RBT-HER2, RMab BSB 204098/79 HER-3\|c-erbB-3, RBT-HER3, RMab BSB 263298/79 HER-3\|c-erbB-3, RBT-HER3, RMab BSB 263398/79 HER-3\|c-erbB-3, RBT-HER3, RMab BSB 263498/79 HER2 neu, EP3, RMab BSB 251398/79 HER2 neu, EP3, RMab BSB 251498/79 HER2 neu, EP3, RMab BSB 251598/79 Herpes Simplex Virus I and II, 10A3 and BSB-116, MMab BSB 347298/79 Herpes Simplex Virus I and II, 10A3 and BSB-116, MMab BSB 347398/79 Herpes Simplex Virus I and II, 10A3 and BSB-116, MMab BSB 347498/79 Herpes Simplex Virus I, 10A3, MMab BSB 268798/79 Herpes Simplex Virus I, 10A3, MMab BSB 268898/79 Herpes Simplex Virus I, 10A3, MMab BSB 268998/79 Herpes Simplex Virus II, BSB-116, MMab BSB 346598/79 Herpes Simplex Virus II, BSB-116, MMab BSB 346698/79 Herpes Simplex Virus II, BSB-116, MMab BSB 346798/79 hGAL\|GCET2, EP316, RMab BSB 293998/79 hGAL\|GCET2, EP316, RMab BSB 294098/79 hGAL\|GCET2, EP316, RMab BSB 294198/79 HHV-8, 13B10, MMab BSB 564898/79 HHV-8, 13B10, MMab BSB 564998/79 HHV-8, 13B10, MMab BSB 565098/79 HHV-8, RBT-HHV8, RMab BSB-3778-0198/79 HHV-8, RBT-HHV8, RMab BSB-3778-0598/79 HHV-8, RBT-HHV8, RMab BSB-3778-198/79 HIF-1alpha, EP118, RMab BSB 252098/79 HIF-1alpha, EP118, RMab BSB 252198/79 HIF-1alpha, EP118, RMab BSB 252298/79 Histone H3 Phospho, EP233, RMab BSB 252798/79 Histone H3 Phospho, EP233, RMab BSB 252898/79 Histone H3 Phospho, EP233, RMab BSB 252998/79 HMGA2, EP398, RMab BSB-3729-0198/79 HMGA2, EP398, RMab BSB-3729-0598/79 HMGA2, EP398, RMab BSB-3729-198/79 hPL, EP241, RMab BSB 241598/79 hPL, EP241, RMab BSB 241698/79 hPL, EP241, RMab BSB 241798/79 hPL, Polyclonal, RPab BSB 680398/79 hPL, Polyclonal, RPab BSB 680498/79 hPL, Polyclonal, RPab BSB 680598/79 HPV, BSB-66, MMab BSB 565598/79 HPV, BSB-66, MMab BSB 565698/79 HPV, BSB-66, MMab BSB 565798/79 HPV16, CAMVIR-1, MMab BSB 294698/79 HPV16, CAMVIR-1, MMab BSB 294798/79 HPV16, CAMVIR-1, MMab BSB 294898/79 HSP70, RM432, RMab BSB-3730-0198/79 HSP70, RM432, RMab BSB-3730-0598/79 HSP70, RM432, RMab BSB-3730-198/79 ICOS\|CD278, RM417, RMab BSB-3731-0198/79 ICOS\|CD278, RM417, RMab BSB-3731-0598/79 ICOS\|CD278, RM417, RMab BSB-3731-198/79 IDH1 R132H, IHC132, MMab BSB 354998/79 IDH1 R132H, IHC132, MMab BSB 355098/79 IDH1 R132H, IHC132, MMab BSB 355198/79 IDH1 R132H, RBT-IDH1, RMab BSB-3732-0198/79 IDH1 R132H, RBT-IDH1, RMab BSB-3732-0598/79 IDH1 R132H, RBT-IDH1, RMab BSB-3732-198/79 IFN-Alpha, BSB-158, MMab BSB-3733-0198/79 IFN-Alpha, BSB-158, MMab BSB-3733-0598/79 IFN-Alpha, BSB-158, MMab BSB-3733-198/79 IFN-Gamma, BSB-161, MMab BSB-3734-0198/79 IFN-Gamma, BSB-161, MMab BSB-3734-0598/79 IFN-Gamma, BSB-161, MMab BSB-3734-198/79 IgA, BSB-39, MMab BSB 566298/79 IgA, BSB-39, MMab BSB 566398/79 IgA, BSB-39, MMab BSB 566498/79 IgA, Polyclonal, RPab BSB 305798/79 IgA, Polyclonal, RPab BSB 305898/79 IgA, Polyclonal, RPab BSB 305998/79 IgA\|FITC, Polyclonal, GPab BSB-3005-0598/79 IgA\|FITC, Polyclonal, GPab BSB-3005-198/79 IgD, EP173, RMab BSB 296098/79 IgD, EP173, RMab BSB 296198/79 IgD, EP173, RMab BSB 296298/79 IgD\|FITC, Polyclonal, GPab BSB-3006-0598/79 IgD\|FITC, Polyclonal, GPab BSB-3006-198/79 IgE, Polyclonal, RPab BSB 307098/79 IgE, Polyclonal, RPab BSB 307198/79 IgE, Polyclonal, RPab BSB 307298/79 IgE\|FITC, Polyclonal, GPab BSB-3011-0598/79 IgE\|FITC, Polyclonal, GPab BSB-3011-198/79 IgG, BSB-40, MMab BSB 567698/79 IgG, BSB-40, MMab BSB 567798/79 IgG, BSB-40, MMab BSB 567898/79 IgG4, BSB-96, MMab BSB 681098/79 IgG4, BSB-96, MMab BSB 681198/79 IgG4, BSB-96, MMab BSB 681298/79 IgG4, EP138, RMab BSB 681798/79 IgG4, EP138, RMab BSB 681898/79 IgG4, EP138, RMab BSB 681998/79 IgG\|FITC, Polyclonal, GPab BSB-3007-0598/79 IgG\|FITC, Polyclonal, GPab BSB-3007-198/79 IgM, BSB-41, MMab BSB 568398/79 IgM, BSB-41, MMab BSB 568498/79 IgM, BSB-41, MMab BSB 568598/79 IgM, Polyclonal, RPab BSB 308398/79 IgM, Polyclonal, RPab BSB 308498/79 IgM, Polyclonal, RPab BSB 308598/79 IgM\| FITC, Polyclonal, RPab BSB-3008-0598/79 IgM\| FITC, Polyclonal, RPab BSB-3008-198/79 IL-1a, BSB-138, MMab BSB-3705-0198/79 IL-1a, BSB-138, MMab BSB-3705-0598/79 IL-1a, BSB-138, MMab BSB-3705-198/79 IL-1b, BSB-139, MMab BSB-3706-0198/79 IL-1b, BSB-139, MMab BSB-3706-0598/79 IL-1b, BSB-139, MMab BSB-3706-198/79 IL-6, BSB-140, MMab BSB-3707-0198/79 IL-6, BSB-140, MMab BSB-3707-0598/79 IL-6, BSB-140, MMab BSB-3707-198/79 IMP-3\|1GF2BP3, EP286, RMab BSB 296798/79 IMP-3\|1GF2BP3, EP286, RMab BSB 296898/79 IMP-3\|1GF2BP3, EP286, RMab BSB 296998/79 Inhibin alpha, EP378, RMab BSB 335998/79 Inhibin alpha, EP378, RMab BSB 336098/79 Inhibin alpha, EP378, RMab BSB 336198/79 Inhibin Alpha, R1, MMab BSB 569098/79 Inhibin Alpha, R1, MMab BSB 569198/79 Inhibin Alpha, R1, MMab BSB 569298/79 INI-1, 25, MMab BSB 683198/79 INI-1, 25, MMab BSB 683298/79 INI-1, 25, MMab BSB 683398/79 INI-1, RBT-INI1, RMab BSB-3779-0198/79 INI-1, RBT-INI1, RMab BSB-3779-0598/79 INI-1, RBT-INI1, RMab BSB-3779-198/79 iNOS, RBT-iNOS, RMab BSB 265998/79 iNOS, RBT-iNOS, RMab BSB 266098/79 iNOS, RBT-iNOS, RMab BSB 266198/79 INSM1, BSB-123, MMab BSB 355698/79 INSM1, BSB-123, MMab BSB 355798/79 INSM1, BSB-123, MMab BSB 355898/79 INSM1, RBT-INSM1, RMab BSB-3780-0198/79 INSM1, RBT-INSM1, RMab BSB-3780-0598/79 INSM1, RBT-INSM1, RMab BSB-3780-198/79 Insulin, BSB-42, MMab BSB 569798/79 Insulin, BSB-42, MMab BSB 569898/79 Insulin, BSB-42, MMab BSB 569998/79 Islet 1\|ISL1, EP283, RMab BSB 297498/79 Islet 1\|ISL1, EP283, RMab BSB 297598/79 Islet 1\|ISL1, EP283, RMab BSB 297698/79 Kappa Light Chains, BSB-58, MMab BSB 570498/79 Kappa Light Chains, BSB-58, MMab BSB 570598/79 Kappa Light Chains, BSB-58, MMab BSB 570698/79 Kappa\|FITC, Polyclonal, GPab BSB-3009-0598/79 Kappa\|FITC, Polyclonal, GPab BSB-3009-198/79 Ki-67, EP5, RMab BSB 571198/79 Ki-67, EP5, RMab BSB 571298/79 Ki-67, EP5, RMab BSB 571398/79 Ki-67, RM360, RMab BSB-3767-0198/79 Ki-67, RM360, RMab BSB-3767-0598/79 Ki-67, RM360, RMab BSB-3767-198/79 Ksp-Cadherin, 4H6\|F9, MMab BSB 628598/79 Ksp-Cadherin, 4H6\|F9, MMab BSB 628698/79 Ksp-Cadherin, 4H6\|F9, MMab BSB 628798/79 LAG-3\|CD223, EP294, RMab BSB 336698/79 LAG-3\|CD223, EP294, RMab BSB 336798/79 LAG-3\|CD223, EP294, RMab BSB 336898/79 Lambda, BSB-16, MMab BSB 571898/79 Lambda, BSB-16, MMab BSB 571998/79 Lambda, BSB-16, MMab BSB 572098/79 Lambda\|FITC, Polyclonal, GPab BSB-3010-0598/79 Lambda\|FITC, Polyclonal, GPab BSB-3010-198/79 Lamin-B1, RBT-LMNB1, RMab BSB-3735-0198/79 Lamin-B1, RBT-LMNB1, RMab BSB-3735-0598/79 Lamin-B1, RBT-LMNB1, RMab BSB-3735-198/79 Laminin-R\|RPSA, BSB-144, MMab BSB-3736-0198/79 Laminin-R\|RPSA, BSB-144, MMab BSB-3736-0598/79 Laminin-R\|RPSA, BSB-144, MMab BSB-3736-198/79 Langerin, 12D6, MMab BSB 684598/79 Langerin, 12D6, MMab BSB 684698/79 Langerin, 12D6, MMab BSB 684798/79 LEF-1, EP310, RMab BSB 338098/79 LEF-1, EP310, RMab BSB 338198/79 LEF-1, EP310, RMab BSB 338298/79 LH, BSB-53, MMab BSB 572598/79 LH, BSB-53, MMab BSB 572698/79 LH, BSB-53, MMab BSB 572798/79 LIN28, EP150, RMab BSB 356398/79 LIN28, EP150, RMab BSB 356498/79 LIN28, EP150, RMab BSB 356598/79 LMO2, RBT-LM02, RMab BSB 357798/79 LMO2, RBT-LM02, RMab BSB 357898/79 LMO2, RBT-LM02, RMab BSB 357998/79 LRG1, BSB-174, MMab BSB-3802-0198/79 LRG1, BSB-174, MMab BSB-3802-0598/79 LRG1, BSB-174, MMab BSB-3802-198/79 Lysozyme, EP134, RMab BSB 685998/79 Lysozyme, EP134, RMab BSB 686098/79 Lysozyme, EP134, RMab BSB 686198/79 Macrophage HAM-56, HAM-56, MMab BSB 573998/79 Macrophage HAM-56, HAM-56, MMab BSB 574098/79 Macrophage HAM-56, HAM-56, MMab BSB 574198/79 MAGEC2, EP405, RMab BSB-3795-0198/79 MAGEC2, EP405, RMab BSB-3795-0598/79 MAGEC2, EP405, RMab BSB-3795-198/79 Mammaglobin, EP249, RMab BSB 574698/79 Mammaglobin, EP249, RMab BSB 574798/79 Mammaglobin, EP249, RMab BSB 574898/79 Mart-1\|Melan-A, A103, MMab BSB 687398/79 Mart-1\|Melan-A, A103, MMab BSB 687498/79 Mart-1\|Melan-A, A103, MMab BSB 687598/79 Mart-1\|Melan-A, M2-7C10, MMab BSB 575398/79 Mart-1\|Melan-A, M2-7C10, MMab BSB 575498/79 Mart-1\|Melan-A, M2-7C10, MMab BSB 575598/79 Maspin, BSB-92, MMab BSB 326898/79 Maspin, BSB-92, MMab BSB 326998/79 Maspin, BSB-92, MMab BSB 327098/79 MCM2, RBT-MCM2, RMab BSB 633498/79 MCM2, RBT-MCM2, RMab BSB 633598/79 MCM2, RBT-MCM2, RMab BSB 633698/79 MCM3, EP202, RMab BSB 688798/79 MCM3, EP202, RMab BSB 688898/79 MCM3, EP202, RMab BSB 688998/79 MDM2, BSB-64, MMab BSB 298198/79 MDM2, BSB-64, MMab BSB 298298/79 MDM2, BSB-64, MMab BSB 298398/79 MDR-1, JSB-1, MMab BSB 690198/79 MDR-1, JSB-1, MMab BSB 690298/79 MDR-1, JSB-1, MMab BSB 690398/79 Melanoma Cocktail: HMB-45, MART-1 and Tyrosinase, HMB-45, A103 and BSB-6, MMab BSB 688098/79 Melanoma Cocktail: HMB-45, MART-1 and Tyrosinase, HMB-45, A103 and BSB-6, MMab BSB 688198/79 Melanoma Cocktail: HMB-45, MART-1 and Tyrosinase, HMB-45, A103 and BSB-6, MMab BSB 688298/79 Melanoma KBA.62, KBA.62, MMab BSB 690898/79 Melanoma KBA.62, KBA.62, MMab BSB 690998/79 Melanoma KBA.62, KBA.62, MMab BSB 691098/79 Melanoma PNL2, PNL2, MMab BSB 691598/79 Melanoma PNL2, PNL2, MMab BSB 691698/79 Melanoma PNL2, PNL2, MMab BSB 691798/79 Melanosome HMB45, HMB-45, MMab BSB 576098/79 Melanosome HMB45, HMB-45, MMab BSB 576198/79 Melanosome HMB45, HMB-45, MMab BSB 576298/79 Mesothelial Cell, HBME-1, MMab BSB 345898/79 Mesothelial Cell, HBME-1, MMab BSB 345998/79 Mesothelial Cell, HBME-1, MMab BSB 346098/79 MGMT\|AGAT, EP337, RMab BSB-3737-0198/79 MGMT\|AGAT, EP337, RMab BSB-3737-0598/79 MGMT\|AGAT, EP337, RMab BSB-3737-198/79 MiTF, C5 and D5, MMab BSB 625098/79 MiTF, C5 and D5, MMab BSB 625198/79 MiTF, C5 and D5, MMab BSB 625298/79 MLH1, G168-728, MMab BSB 576798/79 MLH1, G168-728, MMab BSB 576898/79 MLH1, G168-728, MMab BSB 576998/79 MLH1, RBT-MLH1, RMab BSB-3787-0198/79 MLH1, RBT-MLH1, RMab BSB-3787-0598/79 MLH1, RBT-MLH1, RMab BSB-3787-198/79 MMP-9, EP127, RMab BSB 254198/79 MMP-9, EP127, RMab BSB 254298/79 MMP-9, EP127, RMab BSB 254398/79 MNDA, BSB-157, MMab BSB-3738-0198/79 MNDA, BSB-157, MMab BSB-3738-0598/79 MNDA, BSB-157, MMab BSB-3738-198/79 MSH2, BSB-147, MMab BSB-3722-0198/79 MSH2, BSB-147, MMab BSB-3722-0598/79 MSH2, BSB-147, MMab BSB-3722-198/79 MSH2, RBT-MSH2, RMab BSB 692998/79 MSH2, RBT-MSH2, RMab BSB 693098/79 MSH2, RBT-MSH2, RMab BSB 693198/79 MSH6, 44, MMab BSB 614598/79 MSH6, 44, MMab BSB 614698/79 MSH6, 44, MMab BSB 614798/79 MSH6, EP49, RMab BSB 693598/79 MSH6, EP49, RMab BSB 693698/79 MSH6, EP49, RMab BSB 693798/79 MTAP, RBT-MTAP, RMab BSB-3739-0198/79 MTAP, RBT-MTAP, RMab BSB-3739-0598/79 MTAP, RBT-MTAP, RMab BSB-3739-198/79 MUC-4, EP256, RMab BSB 255598/79 MUC-4, EP256, RMab BSB 255698/79 MUC-4, EP256, RMab BSB 255798/79 MUC1, BSB-44, MMab BSB 615298/79 MUC1, BSB-44, MMab BSB 615398/79 MUC1, BSB-44, MMab BSB 615498/79 MUC1, EP85, RMab BSB 694298/79 MUC1, EP85, RMab BSB 694398/79 MUC1, EP85, RMab BSB 694498/79 MUC1, RBT-MUC1, RMab BSB-3788-0198/79 MUC1, RBT-MUC1, RMab BSB-3788-0598/79 MUC1, RBT-MUC1, RMab BSB-3788-198/79 MUC2, BSB-45, MMab BSB 615998/79 MUC2, BSB-45, MMab BSB 616098/79 MUC2, BSB-45, MMab BSB 616198/79 MUC2, EP187, RMab BSB 694998/79 MUC2, EP187, RMab BSB 695098/79 MUC2, EP187, RMab BSB 695198/79 MUC4, 8G7, MMab BSB 298898/79 MUC4, 8G7, MMab BSB 298998/79 MUC4, 8G7, MMab BSB 299098/79 MUC5AC, CLH2, MMab BSB 616698/79 MUC5AC, CLH2, MMab BSB 616798/79 MUC5AC, CLH2, MMab BSB 616898/79 MUC6, CLH5, MMab BSB 617398/79 MUC6, CLH5, MMab BSB 617498/79 MUC6, CLH5, MMab BSB 617598/79 MUM1, EP190, RMab BSB 695698/79 MUM1, EP190, RMab BSB 695798/79 MUM1, EP190, RMab BSB 695898/79 Musashi 2, RM422, RMab BSB-3740-0198/79 Musashi 2, RM422, RMab BSB-3740-0598/79 Musashi 2, RM422, RMab BSB-3740-198/79 Mycobacterium tuberculosis, Polyclonal, RPab BSB 299598/79 Mycobacterium tuberculosis, Polyclonal, RPab BSB 299698/79 Mycobacterium tuberculosis, Polyclonal, RPab BSB 299798/79 Myelin Basic Protein, EP207, RMab BSB 696398/79 Myelin Basic Protein, EP207, RMab BSB 696498/79 Myelin Basic Protein, EP207, RMab BSB 696598/79 Myeloperoxidase, EP151, RMab BSB 697098/79 Myeloperoxidase, EP151, RMab BSB 697198/79 Myeloperoxidase, EP151, RMab BSB 697298/79 Myeloperoxidase, Polyclonal, RPab BSB 578898/79 Myeloperoxidase, Polyclonal, RPab BSB 578998/79 Myeloperoxidase, Polyclonal, RPab BSB 579098/79 MyoD1, EP212, RMab BSB 697798/79 MyoD1, EP212, RMab BSB 697898/79 MyoD1, EP212, RMab BSB 697998/79 Myogenin, F5D, MMab BSB 579598/79 Myogenin, F5D, MMab BSB 579698/79 Myogenin, F5D, MMab BSB 579798/79 Myoglobin, BSB-104, MMab BSB 338798/79 Myoglobin, BSB-104, MMab BSB 338898/79 Myoglobin, BSB-104, MMab BSB 338998/79 Myoglobin, EP87, RMab BSB 698498/79 Myoglobin, EP87, RMab BSB 698598/79 Myoglobin, EP87, RMab BSB 698698/79 Myosin Smooth Muscle, BSB-17, MMab BSB 592798/79 Myosin Smooth Muscle, BSB-17, MMab BSB 592898/79 Myosin Smooth Muscle, BSB-17, MMab BSB 592998/79 Nanog, EP225, RMab BSB 358498/79 Nanog, EP225, RMab BSB 358598/79 Nanog, EP225, RMab BSB 358698/79 Napsin A, BSB-112, MMab BSB 339598/79 Napsin A, BSB-112, MMab BSB 339698/79 Napsin A, BSB-112, MMab BSB 339798/79 Napsin A, EP205, RMab BSB 699198/79 Napsin A, EP205, RMab BSB 699298/79 Napsin A, EP205, RMab BSB 699398/79 Napsin A, RBT-NAPSA, RMab BSB-3789-0198/79 Napsin A, RBT-NAPSA, RMab BSB-3789-0598/79 Napsin A, RBT-NAPSA, RMab BSB-3789-198/79 Nestin, EP287, RMab BSB 200398/79 Nestin, EP287, RMab BSB 200498/79 Nestin, EP287, RMab BSB 200598/79 NeuN, A60, MMab BSB 201098/79 NeuN, A60, MMab BSB 201198/79 NeuN, A60, MMab BSB 201298/79 NeuN, RBT-NeuN, RMab BSB-3781-0198/79 NeuN, RBT-NeuN, RMab BSB-3781-0598/79 NeuN, RBT-NeuN, RMab BSB-3781-198/79 Neurofilament, 2F11, MMab BSB 581698/79 Neurofilament, 2F11, MMab BSB 581798/79 Neurofilament, 2F11, MMab BSB 581898/79 Neurofilament, EP79, RMab BSB 201798/79 Neurofilament, EP79, RMab BSB 201898/79 Neurofilament, EP79, RMab BSB 201998/79 NGFR, BSB-18, MMab BSB 629298/79 NGFR, BSB-18, MMab BSB 629398/79 NGFR, BSB-18, MMab BSB 629498/79 NKX2.2, EP336, RMab BSB 310998/79 NKX2.2, EP336, RMab BSB 311098/79 NKX2.2, EP336, RMab BSB 311198/79 NKX3.1, EP356, RMab BSB 311698/79 NKX3.1, EP356, RMab BSB 311798/79 NKX3.1, EP356, RMab BSB 311898/79 NKX3.1, RM430, RMab BSB-3785-0198/79 NKX3.1, RM430, RMab BSB-3785-0598/79 NKX3.1, RM430, RMab BSB-3785-198/79 NRAS, RBT-NRAS, RMab BSB 266698/79 NRAS, RBT-NRAS, RMab BSB 266798/79 NRAS, RBT-NRAS, RMab BSB 266898/79 NSE, BSB-94, MMab BSB 582398/79 NSE, BSB-94, MMab BSB 582498/79 NSE, BSB-94, MMab BSB 582598/79 NUT\|NUTM1, RBT-NUTM1, RMab BSB-3793-0198/79 NUT\|NUTM1, RBT-NUTM1, RMab BSB-3793-0598/79 NUT\|NUTM1, RBT-NUTM1, RMab BSB-3793-198/79 OCT-2, EP115, RMab BSB 202498/79 OCT-2, EP115, RMab BSB 202598/79 OCT-2, EP115, RMab BSB 202698/79 OCT-4, EP143, RMab BSB 203198/79 OCT-4, EP143, RMab BSB 203298/79 OCT-4, EP143, RMab BSB 203398/79 OLIG2, EP112, RMab BSB 256298/79 OLIG2, EP112, RMab BSB 256398/79 OLIG2, EP112, RMab BSB 256498/79 Osteonectin\|SPARC, BSB-93, MMab BSB 326198/79 Osteonectin\|SPARC, BSB-93, MMab BSB 326298/79 Osteonectin\|SPARC, BSB-93, MMab BSB 326398/79 OX-40\|CD134, BSB-90, MMab BSB 312398/79 OX-40\|CD134, BSB-90, MMab BSB 312498/79 OX-40\|CD134, BSB-90, MMab BSB 312598/79 p120 Catenin, EP66, RMab BSB 208098/79 p120 Catenin, EP66, RMab BSB 208198/79 p120 Catenin, EP66, RMab BSB 208298/79 p14 ARF, RBT-p14, RMab BSB 359898/79 p14 ARF, RBT-p14, RMab BSB 359998/79 p14 ARF, RBT-p14, RMab BSB 360098/79 p16, 16P04, JC2, MMab BSB 583098/79 p16, 16P04, JC2, MMab BSB 583198/79 p16, 16P04, JC2, MMab BSB 583298/79 p16, RBT-p16, RMab BSB 347998/79 p16, RBT-p16, RMab BSB 348098/79 p16, RBT-p16, RMab BSB 348198/79 p16, RM267, RMab BSB-3768-0198/79 p16, RM267, RMab BSB-3768-0598/79 p16, RM267, RMab BSB-3768-198/79 p21, DCS-60.2, MMab BSB 206698/79 p21, DCS-60.2, MMab BSB 206798/79 p21, DCS-60.2, MMab BSB 206898/79 p27, SX53G8, MMab BSB 583798/79 p27, SX53G8, MMab BSB 583898/79 p27, SX53G8, MMab BSB 583998/79 p40, ZR8, RMab BSB 207398/79 p40, ZR8, RMab BSB 207498/79 p40, ZR8, RMab BSB 207598/79 p53, DO7, MMab BSB 584498/79 p53, DO7, MMab BSB 584598/79 p53, DO7, MMab BSB 584698/79 p57, Kp10, MMab BSB 619498/79 p57, Kp10, MMab BSB 619598/79 p57, Kp10, MMab BSB 619698/79 p63, 4A4, MMab BSB 360598/79 p63, 4A4, MMab BSB 360698/79 p63, 4A4, MMab BSB 360798/79 p63, EP174, RMab BSB 585198/79 p63, EP174, RMab BSB 585298/79 p63, EP174, RMab BSB 585398/79 pan-TRK, RBT-TRK, RMab BSB-2376-0198/79 pan-TRK, RBT-TRK, RMab BSB-2376-0598/79 pan-TRK, RBT-TRK, RMab BSB-2376-198/79 pan-TRK, RM423, RMab BSB-3742-0198/79 pan-TRK, RM423, RMab BSB-3742-0598/79 pan-TRK, RM423, RMab BSB-3742-198/79 Parafibromin, BSB-50, MMab BSB 275098/79 Parafibromin, BSB-50, MMab BSB 275198/79 Parafibromin, BSB-50, MMab BSB 275298/79 Parathyroid Hormone\|PTH, BSB-24, MMab BSB 208798/79 Parathyroid Hormone\|PTH, BSB-24, MMab BSB 208898/79 Parathyroid Hormone\|PTH, BSB-24, MMab BSB 208998/79 Parvalbumin, EP300, RMab BSB 340998/79 Parvalbumin, EP300, RMab BSB 341098/79 Parvalbumin, EP300, RMab BSB 341198/79 Parvovirus, R92F6, MMab BSB 585798/79 Parvovirus, R92F6, MMab BSB 585898/79 Parvovirus, R92F6, MMab BSB 585998/79 PAX-2, EP235, RMab BSB 256998/79 PAX-2, EP235, RMab BSB 257098/79 PAX-2, EP235, RMab BSB 257198/79 PAX-5, RBT-PAX5, RMab BSB 586498/79 PAX-5, RBT-PAX5, RMab BSB 586598/79 PAX-5, RBT-PAX5, RMab BSB 586698/79 PAX-7, BSB-145, MMab BSB-3743-0198/79 PAX-7, BSB-145, MMab BSB-3743-0598/79 PAX-7, BSB-145, MMab BSB-3743-198/79 PAX-8, RM436, RMab BSB-3786-0198/79 PAX-8, RM436, RMab BSB-3786-0598/79 PAX-8, RM436, RMab BSB-3786-198/79 PAX-8, ZR-1, RMab BSB 210198/79 PAX-8, ZR-1, RMab BSB 210298/79 PAX-8, ZR-1, RMab BSB 210398/79 PD-1\|CD279, EP239, RMab BSB 315198/79 PD-1\|CD279, EP239, RMab BSB 315298/79 PD-1\|CD279, EP239, RMab BSB 315398/79 PD-1\|CD279, NAT-105, MMab BSB 621598/79 PD-1\|CD279, NAT-105, MMab BSB 621698/79 PD-1\|CD279, NAT-105, MMab BSB 621798/79 PD-L1\|CD274, 28-8, RMab BSB-2371-0198/79 PD-L1\|CD274, 28-8, RMab BSB-2371-0598/79 PD-L1\|CD274, 28-8, RMab BSB-2371-198/79 PD-L1\|CD274, RBT-PDL1, RMab BSB 265298/79 PD-L1\|CD274, RBT-PDL1, RMab BSB 265398/79 PD-L1\|CD274, RBT-PDL1, RMab BSB 265498/79 PDGFR-B, RBT-PDGFRB, RMab BSB 235298/79 PDGFR-B, RBT-PDGFRB, RMab BSB 235398/79 PDGFR-B, RBT-PDGFRB, RMab BSB 235498/79 PDX1, EP139, RMab BSB 315898/79 PDX1, EP139, RMab BSB 315998/79 PDX1, EP139, RMab BSB 316098/79 PELP1, RBT-PELP1, RMab BSB-3744-0198/79 PELP1, RBT-PELP1, RMab BSB-3744-0598/79 PELP1, RBT-PELP1, RMab BSB-3744-198/79 Perforin, 5B10, MMab BSB 210898/79 Perforin, 5B10, MMab BSB 210998/79 Perforin, 5B10, MMab BSB 211098/79 PGP 9.5, BSB-46, MMab BSB 211598/79 PGP 9.5, BSB-46, MMab BSB 211698/79 PGP 9.5, BSB-46, MMab BSB 211798/79 PHOX2B, EP312, RMab BSB 361298/79 PHOX2B, EP312, RMab BSB 361398/79 PHOX2B, EP312, RMab BSB 361498/79 PLA2R1, BSB-129, MMab BSB-2372-0198/79 PLA2R1, BSB-129, MMab BSB-2372-0598/79 PLA2R1, BSB-129, MMab BSB-2372-198/79 PLAP, BSB-47, MMab BSB 275798/79 PLAP, BSB-47, MMab BSB 275898/79 PLAP, BSB-47, MMab BSB 275998/79 PLAP, EP194, RMab BSB 587198/79 PLAP, EP194, RMab BSB 587298/79 PLAP, EP194, RMab BSB 587398/79 PMS2, EP51, RMab BSB 212298/79 PMS2, EP51, RMab BSB 212398/79 PMS2, EP51, RMab BSB 212498/79 Pneumocystis jirovecii, 3F6, MMab BSB 587898/79 Pneumocystis jirovecii, 3F6, MMab BSB 587998/79 Pneumocystis jirovecii, 3F6, MMab BSB 588098/79 Podoplanin\|D2-40, D2-40, MMab BSB 606798/79 Podoplanin\|D2-40, D2-40, MMab BSB 606898/79 Podoplanin\|D2-40, D2-40, MMab BSB 606998/79 PRAME, RBT-PRAME, RMab BSB-2374-0198/79 PRAME, RBT-PRAME, RMab BSB-2374-0598/79 PRAME, RBT-PRAME, RMab BSB-2374-198/79 Prealbumin\|Transthyretin, BSB-125, MMab BSB 361998/79 Prealbumin\|Transthyretin, BSB-125, MMab BSB 362098/79 Prealbumin\|Transthyretin, BSB-125, MMab BSB 362198/79 Progesterone Receptor, BSB-2, MMab BSB 212998/79 Progesterone Receptor, BSB-2, MMab BSB 213098/79 Progesterone Receptor, BSB-2, MMab BSB 213198/79 Progesterone Receptor, EP2, RMab BSB 257698/79 Progesterone Receptor, EP2, RMab BSB 257798/79 Progesterone Receptor, EP2, RMab BSB 257898/79 Progesterone Receptor, RBT-22, RMab BSB 588598/79 Progesterone Receptor, RBT-22, RMab BSB 588698/79 Progesterone Receptor, RBT-22, RMab BSB 588798/79 Prolactin, EP193, RMab BSB 213698/79 Prolactin, EP193, RMab BSB 213798/79 Prolactin, EP193, RMab BSB 213898/79 Prolactin, PRL02, MMab BSB 589298/79 Prolactin, PRL02, MMab BSB 589398/79 Prolactin, PRL02, MMab BSB 589498/79 Prostein\|P501S, EP381, RMab BSB 316598/79 Prostein\|P501S, EP381, RMab BSB 316698/79 Prostein\|P501S, EP381, RMab BSB 316798/79 PSAP, PASE\|4LJ, MMab BSB 590698/79 PSAP, PASE\|4LJ, MMab BSB 590798/79 PSAP, PASE\|4LJ, MMab BSB 590898/79 PSMA, EP192, RMab BSB 634898/79 PSMA, EP192, RMab BSB 634998/79 PSMA, EP192, RMab BSB 635098/79 pTau Phospho\|Thr 181, BSB-176, MMab BSB-3807-0198/79 pTau Phospho\|Thr 181, BSB-176, MMab BSB-3807-0598/79 pTau Phospho\|Thr 181, BSB-176, MMab BSB-3807-198/79 PTEN, RBT-PTEN, RMab BSB 264698/79 PTEN, RBT-PTEN, RMab BSB 264798/79 PTEN, RBT-PTEN, RMab BSB 264898/79 PTEN, RM265, RMab BSB-3769-0198/79 PTEN, RM265, RMab BSB-3769-0598/79 PTEN, RM265, RMab BSB-3769-198/79 PU.1, EP18, RMab BSB 215798/79 PU.1, EP18, RMab BSB 215898/79 PU.1, EP18, RMab BSB 215998/79 Pygopus 2\|Pygo 2, BSB-156, MMab BSB-3745-0198/79 Pygopus 2\|Pygo 2, BSB-156, MMab BSB-3745-0598/79 Pygopus 2\|Pygo 2, BSB-156, MMab BSB-3745-198/79 Renal Cell Carcinoma, PN-15, MMab BSB 591398/79 Renal Cell Carcinoma, PN-15, MMab BSB 591498/79 Renal Cell Carcinoma, PN-15, MMab BSB 591598/79 Retinoblastoma\| Rb, 1F8, MMab BSB 613098/79 Retinoblastoma\| Rb, 1F8, MMab BSB 613198/79 Retinoblastoma\| Rb, 1F8, MMab BSB 613298/79 ROS-1, EP282, RMab BSB 362698/79 ROS-1, EP282, RMab BSB 362798/79 ROS-1, EP282, RMab BSB 362898/79 S-100, 4C4.9, MMab BSB 592098/79 S-100, 4C4.9, MMab BSB 592198/79 S-100, 4C4.9, MMab BSB 592298/79 S100A1, EP184, RMab BSB 216498/79 S100A1, EP184, RMab BSB 216598/79 S100A1, EP184, RMab BSB 216698/79 S100P, EP186, RMab BSB 218598/79 S100P, EP186, RMab BSB 218698/79 S100P, EP186, RMab BSB 218798/79 SALL4, 6E3, MMab BSB 318698/79 SALL4, 6E3, MMab BSB 318798/79 SALL4, 6E3, MMab BSB 318898/79 SALL4, EP299, RMab BSB 319398/79 SALL4, EP299, RMab BSB 319498/79 SALL4, EP299, RMab BSB 319598/79 SATB2, EP281, RMab BSB 320098/79 SATB2, EP281, RMab BSB 320198/79 SATB2, EP281, RMab BSB 320298/79 SDHB, BSB-131, MMab BSB-2375-0198/79 SDHB, BSB-131, MMab BSB-2375-0598/79 SDHB, BSB-131, MMab BSB-2375-198/79 SF-1\|Steroidogenic Factor 1, BSB-149, MMab BSB-3746-0198/79 SF-1\|Steroidogenic Factor 1, BSB-149, MMab BSB-3746-0598/79 SF-1\|Steroidogenic Factor 1, BSB-149, MMab BSB-3746-198/79 SMAD4\|DPC4, BSB-63, MMab BSB 320798/79 SMAD4\|DPC4, BSB-63, MMab BSB 320898/79 SMAD4\|DPC4, BSB-63, MMab BSB 320998/79 SMAD4\|DPC4, RBT-SMAD4, RMab BSB 340298/79 SMAD4\|DPC4, RBT-SMAD4, RMab BSB 340398/79 SMAD4\|DPC4, RBT-SMAD4, RMab BSB 340498/79 Somatostatin Receptor 2\|SSTR2, EP149, RMab BSB-3748-0198/79 Somatostatin Receptor 2\|SSTR2, EP149, RMab BSB-3748-0598/79 Somatostatin Receptor 2\|SSTR2, EP149, RMab BSB-3748-198/79 Somatostatin, BSB-113, MMab BSB 341698/79 Somatostatin, BSB-113, MMab BSB 341798/79 Somatostatin, BSB-113, MMab BSB 341898/79 SOX-10, BSB-62, MMab BSB 221298/79 SOX-10, BSB-62, MMab BSB 221398/79 SOX-10, BSB-62, MMab BSB 221498/79 SOX-10, EP268, RMab BSB 258398/79 SOX-10, EP268, RMab BSB 258498/79 SOX-10, EP268, RMab BSB 258598/79 SOX-11, CL0142, MMab BSB 221998/79 SOX-11, CL0142, MMab BSB 222098/79 SOX-11, CL0142, MMab BSB 222198/79 SOX-2, RM427, RMab BSB-3770-0198/79 SOX-2, RM427, RMab BSB-3770-0598/79 SOX-2, RM427, RMab BSB-3770-198/79 SOX-9, EP317, RMab BSB 321498/79 SOX-9, EP317, RMab BSB 321598/79 SOX-9, EP317, RMab BSB 321698/79 Spectrin, RBC2\|3D5, MMab BSB 594198/79 Spectrin, RBC2\|3D5, MMab BSB 594298/79 Spectrin, RBC2\|3D5, MMab BSB 594398/79 SS18-SSX, RBT-SS18-SSX, RMab BSB-3796-0198/79 SS18-SSX, RBT-SS18-SSX, RMab BSB-3796-0598/79 SS18-SSX, RBT-SS18-SSX, RMab BSB-3796-198/79 STAR, EP226, RMab BSB 363398/79 STAR, EP226, RMab BSB 363498/79 STAR, EP226, RMab BSB 363598/79 STAT6, EP325, RMab BSB 342398/79 STAT6, EP325, RMab BSB 342498/79 STAT6, EP325, RMab BSB 342598/79 Stathmin, EP247, RMab BSB 259798/79 Stathmin, EP247, RMab BSB 259898/79 Stathmin, EP247, RMab BSB 259998/79 Surfactant protein D\|SP-D, BSB-162, MMab BSB-3747-0198/79 Surfactant protein D\|SP-D, BSB-162, MMab BSB-3747-0598/79 Surfactant protein D\|SP-D, BSB-162, MMab BSB-3747-198/79 Survivin, EP119, RMab BSB 222698/79 Survivin, EP119, RMab BSB 222798/79 Survivin, EP119, RMab BSB 222898/79 SV40, Pab101, MMab BSB 223398/79 SV40, Pab101, MMab BSB 223498/79 SV40, Pab101, MMab BSB 223598/79 Synaptophysin, EP158, RMab BSB 224098/79 Synaptophysin, EP158, RMab BSB 224198/79 Synaptophysin, EP158, RMab BSB 224298/79 Synaptophysin, Polyclonal, RPab BSB 594898/79 Synaptophysin, Polyclonal, RPab BSB 594998/79 Synaptophysin, Polyclonal, RPab BSB 595098/79 T-Bet\|TBX-2, EP263, RMab BSB 260498/79 T-Bet\|TBX-2, EP263, RMab BSB 260598/79 T-Bet\|TBX-2, EP263, RMab BSB 260698/79 TAG-72, BSB-21, MMab BSB 595598/79 TAG-72, BSB-21, MMab BSB 595698/79 TAG-72, BSB-21, MMab BSB 595798/79 Tau, BSB-115, MMab BSB 343098/79 Tau, BSB-115, MMab BSB 343198/79 Tau, BSB-115, MMab BSB 343298/79 TCL1, EP105, RMab BSB 225498/79 TCL1, EP105, RMab BSB 225598/79 TCL1, EP105, RMab BSB 225698/79 TCR Alpha, BSB-126, MMab BSB 364098/79 TCR Alpha, BSB-126, MMab BSB 364198/79 TCR Alpha, BSB-126, MMab BSB 364298/79 TCR Beta, BSB-117, MMab BSB 226198/79 TCR Beta, BSB-117, MMab BSB 226298/79 TCR Beta, BSB-117, MMab BSB 226398/79 TCR Delta, BSB-127, MMab BSB 364798/79 TCR Delta, BSB-127, MMab BSB 364898/79 TCR Delta, BSB-127, MMab BSB 364998/79 TDP-43\|TARDBP, BSB-166, MMab BSB-3776-0198/79 TDP-43\|TARDBP, BSB-166, MMab BSB-3776-0598/79 TDP-43\|TARDBP, BSB-166, MMab BSB-3776-198/79 TdT, EP266, RMab BSB 261198/79 TdT, EP266, RMab BSB 261298/79 TdT, EP266, RMab BSB 261398/79 TdT, RBT-TdT, RMab BSB 226898/79 TdT, RBT-TdT, RMab BSB 226998/79 TdT, RBT-TdT, RMab BSB 227098/79 TFE3, EP285, RMab BSB 322898/79 TFE3, EP285, RMab BSB 322998/79 TFE3, EP285, RMab BSB 323098/79 Thymidylate synthase\|TS, BSB-160, MMab BSB-3750-0198/79 Thymidylate synthase\|TS, BSB-160, MMab BSB-3750-0598/79 Thymidylate synthase\|TS, BSB-160, MMab BSB-3750-198/79 Thyroglobulin, 2H11 and 6E1, MMab BSB 276498/79 Thyroglobulin, 2H11 and 6E1, MMab BSB 276598/79 Thyroglobulin, 2H11 and 6E1, MMab BSB 276698/79 Thyroglobulin, BSB-49, MMab BSB 597698/79 Thyroglobulin, BSB-49, MMab BSB 597798/79 Thyroglobulin, BSB-49, MMab BSB 597898/79 Thyroid Peroxidase, EP159, RMab BSB 261898/79 Thyroid Peroxidase, EP159, RMab BSB 261998/79 Thyroid Peroxidase, EP159, RMab BSB 262098/79 TIA-1, RBT-TIA1, RMab BSB-3782-0198/79 TIA-1, RBT-TIA1, RMab BSB-3782-0598/79 TIA-1, RBT-TIA1, RMab BSB-3782-198/79 TIA-1, TIA-1, MMab BSB 635598/79 TIA-1, TIA-1, MMab BSB 635698/79 TIA-1, TIA-1, MMab BSB 635798/79 TIGIT, BSB-152, MMab BSB-3751-0198/79 TIGIT, BSB-152, MMab BSB-3751-0598/79 TIGIT, BSB-152, MMab BSB-3751-198/79 TIM-3\|HAVCR2\|CD366, BSB-163, MMab BSB-3752-0198/79 TIM-3\|HAVCR2\|CD366, BSB-163, MMab BSB-3752-0598/79 TIM-3\|HAVCR2\|CD366, BSB-163, MMab BSB-3752-198/79 Tinto A-1-Antichymotrypsin, EP384, RMab BSB 349798/79 Tinto A-1-Antichymotrypsin, EP384, RMab BSB 349898/79 Tinto A-1-Antichymotrypsin, EP384, RMab BSB 349998/79 Tinto A-1-Antitrypsin, Polyclonal, RPab BSB 500898/79 Tinto A-1-Antitrypsin, Polyclonal, RPab BSB 500998/79 Tinto A-1-Antitrypsin, Polyclonal, RPab BSB 501098/79 Tinto ACE2, BSB-135, MMab BSB-3702-1598/79 Tinto ACE2, BSB-135, MMab BSB-3702-398/79 Tinto ACE2, BSB-135, MMab BSB-3702-798/79 Tinto ACTH, BSB-25, MMab BSB 501598/79 Tinto ACTH, BSB-25, MMab BSB 501698/79 Tinto ACTH, BSB-25, MMab BSB 501798/79 Tinto Actin Muscle Specific, HHF35, MMab BSB 502298/79 Tinto Actin Muscle Specific, HHF35, MMab BSB 502398/79 Tinto Actin Muscle Specific, HHF35, MMab BSB 502498/79 Tinto Actin Smooth Muscle, BSB-15, MMab BSB 502998/79 Tinto Actin Smooth Muscle, BSB-15, MMab BSB 503098/79 Tinto Actin Smooth Muscle, BSB-15, MMab BSB 503198/79 Tinto Adipophilin\|ADRP, BSB-91, MMab BSB 324698/79 Tinto Adipophilin\|ADRP, BSB-91, MMab BSB 324798/79 Tinto Adipophilin\|ADRP, BSB-91, MMab BSB 324898/79 Tinto Albumin, polyclonal, RPab BSB 301298/79 Tinto Albumin, polyclonal, RPab BSB 301398/79 Tinto Albumin, polyclonal, RPab BSB 301498/79 Tinto Albumin\|FITC, polyclonal, RPab BSB-3000-1598/79 Tinto Albumin\|FITC, polyclonal, RPab BSB-3000-398/79 Tinto Albumin\|FITC, polyclonal, RPab BSB-3000-798/79 Tinto ALK-1\|CD246, EP302, RMab BSB 279698/79 Tinto ALK-1\|CD246, EP302, RMab BSB 279798/79 Tinto ALK-1\|CD246, EP302, RMab BSB 279898/79 Tinto ALK-1\|CD246, RBT-ALK1, RMab BSB 504398/79 Tinto ALK-1\|CD246, RBT-ALK1, RMab BSB 504498/79 Tinto ALK-1\|CD246, RBT-ALK1, RMab BSB 504598/79 Tinto Alpha Synuclein, BSB-114, MMab BSB 328698/79 Tinto Alpha Synuclein, BSB-114, MMab BSB 328798/79 Tinto Alpha Synuclein, BSB-114, MMab BSB 328898/79 Tinto Alpha-Fetoprotein, BSB-23, MMab BSB 505098/79 Tinto Alpha-Fetoprotein, BSB-23, MMab BSB 505198/79 Tinto Alpha-Fetoprotein, BSB-23, MMab BSB 505298/79 Tinto AMACRacemase\|P504S, 13H4, RMab BSB 505798/79 Tinto AMACRacemase\|P504S, 13H4, RMab BSB 505898/79 Tinto AMACRacemase\|P504S, 13H4, RMab BSB 505998/79 Tinto Amyloid A, EP335, RMab BSB 280398/79 Tinto Amyloid A, EP335, RMab BSB 280498/79 Tinto Amyloid A, EP335, RMab BSB 280598/79 Tinto Amyloid Beta, RBT-A4, RMab BSB 344198/79 Tinto Amyloid Beta, RBT-A4, RMab BSB 344298/79 Tinto Amyloid Beta, RBT-A4, RMab BSB 344398/79 Tinto Androgen Receptor, BSB-4, MMab BSB 607198/79 Tinto Androgen Receptor, BSB-4, MMab BSB 607298/79 Tinto Androgen Receptor, BSB-4, MMab BSB 607398/79 Tinto Annexin A1, BSB-95, MMab BSB 635998/79 Tinto Annexin A1, BSB-95, MMab BSB 636098/79 Tinto Annexin A1, BSB-95, MMab BSB 636198/79 Tinto Annexin VII, EP367, RMab BSB-3709-1598/79 Tinto Annexin VII, EP367, RMab BSB-3709-398/79 Tinto Annexin VII, EP367, RMab BSB-3709-798/79 Tinto APOE4, BSB-170, MMab BSB-3798-1598/79 Tinto APOE4, BSB-170, MMab BSB-3798-398/79 Tinto APOE4, BSB-170, MMab BSB-3798-798/79 Tinto Arginase-1, EP261, RMab BSB 244798/79 Tinto Arginase-1, EP261, RMab BSB 244898/79 Tinto Arginase-1, EP261, RMab BSB 244998/79 Tinto ARID1A, EP303, RMab BSB-3749-1598/79 Tinto ARID1A, EP303, RMab BSB-3749-398/79 Tinto ARID1A, EP303, RMab BSB-3749-798/79 Tinto Aspergillus, RBT-A.fumi, RMab BSB-3804-1598/79 Tinto Aspergillus, RBT-A.fumi, RMab BSB-3804-398/79 Tinto Aspergillus, RBT-A.fumi, RMab BSB-3804-798/79 Tinto ATM, EP327, RMab BSB-3710-1598/79 Tinto ATM, EP327, RMab BSB-3710-398/79 Tinto ATM, EP327, RMab BSB-3710-798/79 Tinto ATRX, BSB-108, MMab BSB 329398/79 Tinto ATRX, BSB-108, MMab BSB 329498/79 Tinto ATRX, BSB-108, MMab BSB 329598/79 Tinto ATRX, RBT-ATRX, RMab BSB-3711-1598/79 Tinto ATRX, RBT-ATRX, RMab BSB-3711-398/79 Tinto ATRX, RBT-ATRX, RMab BSB-3711-798/79 Tinto Aurora B, RM278, RMab BSB-3712-1598/79 Tinto Aurora B, RM278, RMab BSB-3712-398/79 Tinto Aurora B, RM278, RMab BSB-3712-798/79 Tinto B7H3\|CD276, RBT-B7H3, RMab BSB 281098/79 Tinto B7H3\|CD276, RBT-B7H3, RMab BSB 281198/79 Tinto B7H3\|CD276, RBT-B7H3, RMab BSB 281298/79 Tinto BAP1, BSB-109, MMab BSB 330098/79 Tinto BAP1, BSB-109, MMab BSB 330198/79 Tinto BAP1, BSB-109, MMab BSB 330298/79 Tinto Bax, E63, RMab BSB 607898/79 Tinto Bax, E63, RMab BSB 607998/79 Tinto Bax, E63, RMab BSB 608098/79 Tinto BCA-225, Cu-18, MMab BSB 506498/79 Tinto BCA-225, Cu-18, MMab BSB 506598/79 Tinto BCA-225, Cu-18, MMab BSB 506698/79 Tinto bcl-10, BSB-22, MMab BSB 269898/79 Tinto bcl-10, BSB-22, MMab BSB 269998/79 Tinto bcl-10, BSB-22, MMab BSB 270098/79 Tinto bcl-2, BSB-5, MMab BSB 507198/79 Tinto bcl-2, BSB-5, MMab BSB 507298/79 Tinto bcl-2, BSB-5, MMab BSB 507398/79 Tinto bcl-2, EP36, RMab BSB 654198/79 Tinto bcl-2, EP36, RMab BSB 654298/79 Tinto bcl-2, EP36, RMab BSB 654398/79 Tinto bcl-6, BSB-26, MMab BSB 343498/79 Tinto bcl-6, BSB-26, MMab BSB 343598/79 Tinto bcl-6, BSB-26, MMab BSB 343698/79 Tinto bcl-6, EP278, RMab BSB 281798/79 Tinto bcl-6, EP278, RMab BSB 281898/79 Tinto bcl-6, EP278, RMab BSB 281998/79 Tinto bcl-6, RBT-bcl6, RMab BSB 507898/79 Tinto bcl-6, RBT-bcl6, RMab BSB 507998/79 Tinto bcl-6, RBT-bcl6, RMab BSB 508098/79 Tinto BCOR, BSB-128, MMab BSB-2370-1598/79 Tinto BCOR, BSB-128, MMab BSB-2370-398/79 Tinto BCOR, BSB-128, MMab BSB-2370-798/79 Tinto Beta-Catenin, 14, MMab BSB 508598/79 Tinto Beta-Catenin, 14, MMab BSB 508698/79 Tinto Beta-Catenin, 14, MMab BSB 508798/79 Tinto Beta-Catenin, RM276, RMab BSB-3756-1598/79 Tinto Beta-Catenin, RM276, RMab BSB-3756-398/79 Tinto Beta-Catenin, RM276, RMab BSB-3756-798/79 Tinto BG8 LewisY, F3, MMab BSB 637398/79 Tinto BG8 LewisY, F3, MMab BSB 637498/79 Tinto BG8 LewisY, F3, MMab BSB 637598/79 Tinto BOB.1, RBT BOB.1, RMab BSB-3700-1598/79 Tinto BOB.1, RBT BOB.1, RMab BSB-3700-398/79 Tinto BOB.1, RBT BOB.1, RMab BSB-3700-798/79 Tinto Brachyury, RBT-TBXT, RMab BSB 349098/79 Tinto Brachyury, RBT-TBXT, RMab BSB 349198/79 Tinto Brachyury, RBT-TBXT, RMab BSB 349298/79 Tinto BRAF V600E, RM8, RMab BSB 282498/79 Tinto BRAF V600E, RM8, RMab BSB 282598/79 Tinto BRAF V600E, RM8, RMab BSB 282698/79 Tinto BRG-1\|SMARCA4, BSB-154, MMab BSB-3714-1598/79 Tinto BRG-1\|SMARCA4, BSB-154, MMab BSB-3714-398/79 Tinto BRG-1\|SMARCA4, BSB-154, MMab BSB-3714-798/79 Tinto c-Met\|HGFR, EP1454Y, RMab BSB 658398/79 Tinto c-Met\|HGFR, EP1454Y, RMab BSB 658498/79 Tinto c-Met\|HGFR, EP1454Y, RMab BSB 658598/79 Tinto c-Myc, EP121, RMab BSB 657698/79 Tinto c-Myc, EP121, RMab BSB 657798/79 Tinto c-Myc, EP121, RMab BSB 657898/79 Tinto C1q, Polyclonal, RPab BSB 301998/79 Tinto C1q, Polyclonal, RPab BSB 302098/79 Tinto C1q, Polyclonal, RPab BSB 302198/79 Tinto C1q\|FITC, Polyclonal, RPab BSB-3001-1598/79 Tinto C1q\|FITC, Polyclonal, RPab BSB-3001-398/79 Tinto C1q\|FITC, Polyclonal, RPab BSB-3001-798/79 Tinto C3c, Polyclonal, RPab BSB 302698/79 Tinto C3c, Polyclonal, RPab BSB 302798/79 Tinto C3c, Polyclonal, RPab BSB 302898/79 Tinto C3c\|FITC, Polyclonal, RPab BSB-3002-1598/79 Tinto C3c\|FITC, Polyclonal, RPab BSB-3002-398/79 Tinto C3c\|FITC, Polyclonal, RPab BSB-3002-798/79 Tinto C3d, Polyclonal, RPab BSB 638798/79 Tinto C3d, Polyclonal, RPab BSB 638898/79 Tinto C3d, Polyclonal, RPab BSB 638998/79 Tinto C4c, Polyclonal, RPab BSB 303398/79 Tinto C4c, Polyclonal, RPab BSB 303498/79 Tinto C4c, Polyclonal, RPab BSB 303598/79 Tinto C4c\|FITC, Polyclonal, RPab BSB-3003-1598/79 Tinto C4c\|FITC, Polyclonal, RPab BSB-3003-398/79 Tinto C4c\|FITC, Polyclonal, RPab BSB-3003-798/79 Tinto C4d, EP272, RMab BSB 283198/79 Tinto C4d, EP272, RMab BSB 283298/79 Tinto C4d, EP272, RMab BSB 283398/79 Tinto CA-125, OC125, MMab BSB 509298/79 Tinto CA-125, OC125, MMab BSB 509398/79 Tinto CA-125, OC125, MMab BSB 509498/79 Tinto CA15-3, DF3, MMab BSB 509998/79 Tinto CA15-3, DF3, MMab BSB 510098/79 Tinto CA15-3, DF3, MMab BSB 510198/79 Tinto CA19-9, 121SLE, MMab BSB 510698/79 Tinto CA19-9, 121SLE, MMab BSB 510798/79 Tinto CA19-9, 121SLE, MMab BSB 510898/79 Tinto Cadherin17\|LI-Cadherin, EP86, RMab BSB 684998/79 Tinto Cadherin17\|LI-Cadherin, EP86, RMab BSB 685098/79 Tinto Cadherin17\|LI-Cadherin, EP86, RMab BSB 685198/79 Tinto Calcitonin, EP92, RMab BSB 640898/79 Tinto Calcitonin, EP92, RMab BSB 640998/79 Tinto Calcitonin, EP92, RMab BSB 641098/79 Tinto Caldesmon, BSB-19, MMab BSB 609998/79 Tinto Caldesmon, BSB-19, MMab BSB 610098/79 Tinto Caldesmon, BSB-19, MMab BSB 610198/79 Tinto Calponin, BSB-20, MMab BSB 512098/79 Tinto Calponin, BSB-20, MMab BSB 512198/79 Tinto Calponin, BSB-20, MMab BSB 512298/79 Tinto Calretinin, RM324, RMab BSB-3757-1598/79 Tinto Calretinin, RM324, RMab BSB-3757-398/79 Tinto Calretinin, RM324, RMab BSB-3757-798/79 Tinto Candida Albicans, RBT-C.alb, RMab BSB-3803-1598/79 Tinto Candida Albicans, RBT-C.alb, RMab BSB-3803-398/79 Tinto Candida Albicans, RBT-C.alb, RMab BSB-3803-798/79 Tinto Carbonic Anhydrase 9, EP161, RMab BSB 641598/79 Tinto Carbonic Anhydrase 9, EP161, RMab BSB 641698/79 Tinto Carbonic Anhydrase 9, EP161, RMab BSB 641798/79 Tinto Caspase-3, RM250, RMab BSB-3715-1598/79 Tinto Caspase-3, RM250, RMab BSB-3715-398/79 Tinto Caspase-3, RM250, RMab BSB-3715-798/79 Tinto Cathepsin K, BSB-172, MMab BSB-3800-1598/79 Tinto Cathepsin K, BSB-172, MMab BSB-3800-398/79 Tinto Cathepsin K, BSB-172, MMab BSB-3800-798/79 Tinto Caveolin-1, EP353, RMab BSB 331498/79 Tinto Caveolin-1, EP353, RMab BSB 331598/79 Tinto Caveolin-1, EP353, RMab BSB 331698/79 Tinto CD10, 56C6, MMab BSB 517698/79 Tinto CD10, 56C6, MMab BSB 517798/79 Tinto CD10, 56C6, MMab BSB 517898/79 Tinto CD103\|ITGAE, EP206, RMab BSB 285998/79 Tinto CD103\|ITGAE, EP206, RMab BSB 286098/79 Tinto CD103\|ITGAE, EP206, RMab BSB 286198/79 Tinto CD105\|Endoglin, EP274, RMab BSB 286698/79 Tinto CD105\|Endoglin, EP274, RMab BSB 286798/79 Tinto CD105\|Endoglin, EP274, RMab BSB 286898/79 Tinto CD117, EP10, RMab BSB 531698/79 Tinto CD117, EP10, RMab BSB 531798/79 Tinto CD117, EP10, RMab BSB 531898/79 Tinto CD117, RM359, RMab BSB-3758-1598/79 Tinto CD117, RM359, RMab BSB-3758-398/79 Tinto CD117, RM359, RMab BSB-3758-798/79 Tinto CD11b, EP45, RMab BSB 643698/79 Tinto CD11b, EP45, RMab BSB 643798/79 Tinto CD11b, EP45, RMab BSB 643898/79 Tinto CD11c, EP157, RMab BSB 644398/79 Tinto CD11c, EP157, RMab BSB 644498/79 Tinto CD11c, EP157, RMab BSB 644598/79 Tinto CD123 IL-3Ra, BSB-59, MMab BSB 532398/79 Tinto CD123 IL-3Ra, BSB-59, MMab BSB 532498/79 Tinto CD123 IL-3Ra, BSB-59, MMab BSB 532598/79 Tinto CD13, 38C12, MMab BSB 632498/79 Tinto CD13, 38C12, MMab BSB 632598/79 Tinto CD13, 38C12, MMab BSB 632698/79 Tinto CD137\|TNFRSF9, BSB-159, MMab BSB-3717-1598/79 Tinto CD137\|TNFRSF9, BSB-159, MMab BSB-3717-398/79 Tinto CD137\|TNFRSF9, BSB-159, MMab BSB-3717-798/79 Tinto CD138, B-A38, MMab BSB 533098/79 Tinto CD138, B-A38, MMab BSB 533198/79 Tinto CD138, B-A38, MMab BSB 533298/79 Tinto CD138, EP201, RMab BSB 652798/79 Tinto CD138, EP201, RMab BSB 652898/79 Tinto CD138, EP201, RMab BSB 652998/79 Tinto CD14, 7, MMab BSB 631098/79 Tinto CD14, 7, MMab BSB 631198/79 Tinto CD14, 7, MMab BSB 631298/79 Tinto CD14, EP128, RMab BSB 645798/79 Tinto CD14, EP128, RMab BSB 645898/79 Tinto CD14, EP128, RMab BSB 645998/79 Tinto CD142\|TF\|Coagulation Factor III, BSB-143, MMab BSB-3718-1598/79 Tinto CD142\|TF\|Coagulation Factor III, BSB-143, MMab BSB-3718-398/79 Tinto CD142\|TF\|Coagulation Factor III, BSB-143, MMab BSB-3718-798/79 Tinto CD147, BSB-137, MMab BSB-3704-1598/79 Tinto CD147, BSB-137, MMab BSB-3704-398/79 Tinto CD147, BSB-137, MMab BSB-3704-798/79 Tinto CD15, BSB-119, MMab BSB 518398/79 Tinto CD15, BSB-119, MMab BSB 518498/79 Tinto CD15, BSB-119, MMab BSB 518598/79 Tinto CD16, EP364, RMab BSB 332198/79 Tinto CD16, EP364, RMab BSB 332298/79 Tinto CD16, EP364, RMab BSB 332398/79 Tinto CD163, 10D6, MMab BSB 630398/79 Tinto CD163, 10D6, MMab BSB 630498/79 Tinto CD163, 10D6, MMab BSB 630598/79 Tinto CD19, BSB-97, MMab BSB 622698/79 Tinto CD19, BSB-97, MMab BSB 622798/79 Tinto CD19, BSB-97, MMab BSB 622898/79 Tinto CD1a, EP80, RMab BSB 513498/79 Tinto CD1a, EP80, RMab BSB 513598/79 Tinto CD1a, EP80, RMab BSB 513698/79 Tinto CD2, AB75, MMab BSB 620598/79 Tinto CD2, AB75, MMab BSB 620698/79 Tinto CD2, AB75, MMab BSB 620798/79 Tinto CD20, L26, MMab BSB 519098/79 Tinto CD20, L26, MMab BSB 519198/79 Tinto CD20, L26, MMab BSB 519298/79 Tinto CD21, EP64, RMab BSB 519798/79 Tinto CD21, EP64, RMab BSB 519898/79 Tinto CD21, EP64, RMab BSB 519998/79 Tinto CD23, 1B12, MMab BSB 520498/79 Tinto CD23, 1B12, MMab BSB 520598/79 Tinto CD23, 1B12, MMab BSB 520698/79 Tinto CD23, EP75, RMab BSB 647198/79 Tinto CD23, EP75, RMab BSB 647298/79 Tinto CD23, EP75, RMab BSB 647398/79 Tinto CD25, 4C9, MMab BSB 631798/79 Tinto CD25, 4C9, MMab BSB 631898/79 Tinto CD25, 4C9, MMab BSB 631998/79 Tinto CD25, RBT-CD25, RMab BSB 245498/79 Tinto CD25, RBT-CD25, RMab BSB 245598/79 Tinto CD25, RBT-CD25, RMab BSB 245698/79 Tinto CD3 Epsilon, RBT-CD3e, RMab BSB 514198/79 Tinto CD3 Epsilon, RBT-CD3e, RMab BSB 514298/79 Tinto CD3 Epsilon, RBT-CD3e, RMab BSB 514398/79 Tinto CD3, RBT-CD3, RMab BSB 642298/79 Tinto CD3, RBT-CD3, RMab BSB 642398/79 Tinto CD3, RBT-CD3, RMab BSB 642498/79 Tinto CD30, Ber-H2, MMab BSB 521198/79 Tinto CD30, Ber-H2, MMab BSB 521298/79 Tinto CD30, Ber-H2, MMab BSB 521398/79 Tinto CD31, 1A10, MMab BSB 521898/79 Tinto CD31, 1A10, MMab BSB 521998/79 Tinto CD31, 1A10, MMab BSB 522098/79 Tinto CD33, RBT-CD33, RMab BSB 344898/79 Tinto CD33, RBT-CD33, RMab BSB 344998/79 Tinto CD33, RBT-CD33, RMab BSB 345098/79 Tinto CD34, EP88, RMab BSB 648598/79 Tinto CD34, EP88, RMab BSB 648698/79 Tinto CD34, EP88, RMab BSB 648798/79 Tinto CD34, QBEnd\|10, MMab BSB 522598/79 Tinto CD34, QBEnd\|10, MMab BSB 522698/79 Tinto CD34, QBEnd\|10, MMab BSB 522798/79 Tinto CD35, EP197, RMab BSB 649298/79 Tinto CD35, EP197, RMab BSB 649398/79 Tinto CD35, EP197, RMab BSB 649498/79 Tinto CD35, RLB25, MMab BSB 523298/79 Tinto CD35, RLB25, MMab BSB 523398/79 Tinto CD35, RLB25, MMab BSB 523498/79 Tinto CD38, EP135, RMab BSB 649998/79 Tinto CD38, EP135, RMab BSB 650098/79 Tinto CD38, EP135, RMab BSB 650198/79 Tinto CD38, SPC32, MMab BSB 619898/79 Tinto CD38, SPC32, MMab BSB 619998/79 Tinto CD38, SPC32, MMab BSB 620098/79 Tinto CD4, RBT-CD4, RMab BSB 514898/79 Tinto CD4, RBT-CD4, RMab BSB 514998/79 Tinto CD4, RBT-CD4, RMab BSB 515098/79 Tinto CD41\| Integrin alpha IIb, EP178, RMab BSB 650698/79 Tinto CD41\| Integrin alpha IIb, EP178, RMab BSB 650798/79 Tinto CD41\| Integrin alpha IIb, EP178, RMab BSB 650898/79 Tinto CD42b, EP409, RMab BSB 350498/79 Tinto CD42b, EP409, RMab BSB 350598/79 Tinto CD42b, EP409, RMab BSB 350698/79 Tinto CD43, MT1, MMab BSB 523998/79 Tinto CD43, MT1, MMab BSB 524098/79 Tinto CD43, MT1, MMab BSB 524198/79 Tinto CD44, BSB-12, MMab BSB 623398/79 Tinto CD44, BSB-12, MMab BSB 623498/79 Tinto CD44, BSB-12, MMab BSB 623598/79 Tinto CD45, 2B11 and PD7\|26, MMab BSB 524698/79 Tinto CD45, 2B11 and PD7\|26, MMab BSB 524798/79 Tinto CD45, 2B11 and PD7\|26, MMab BSB 524898/79 Tinto CD45RA, 4KB5, MMab BSB 525398/79 Tinto CD45RA, 4KB5, MMab BSB 525498/79 Tinto CD45RA, 4KB5, MMab BSB 525598/79 Tinto CD45RO, UCHL-1, MMab BSB 526098/79 Tinto CD45RO, UCHL-1, MMab BSB 526198/79 Tinto CD45RO, UCHL-1, MMab BSB 526298/79 Tinto CD5, RBT-CD5, RMab BSB 515598/79 Tinto CD5, RBT-CD5, RMab BSB 515698/79 Tinto CD5, RBT-CD5, RMab BSB 515798/79 Tinto CD5, RM314, RMab BSB-3759-1598/79 Tinto CD5, RM314, RMab BSB-3759-398/79 Tinto CD5, RM314, RMab BSB-3759-798/79 Tinto CD56, 123C3.D5, MMab BSB 526798/79 Tinto CD56, 123C3.D5, MMab BSB 526898/79 Tinto CD56, 123C3.D5, MMab BSB 526998/79 Tinto CD57, BSB-10, MMab BSB 527498/79 Tinto CD57, BSB-10, MMab BSB 527598/79 Tinto CD57, BSB-10, MMab BSB 527698/79 Tinto CD6, BSB-54, MMab BSB 270598/79 Tinto CD6, BSB-54, MMab BSB 270698/79 Tinto CD6, BSB-54, MMab BSB 270798/79 Tinto CD61, 2f2, MMab BSB 528198/79 Tinto CD61, 2f2, MMab BSB 528298/79 Tinto CD61, 2f2, MMab BSB 528398/79 Tinto CD61, EP65, RMab BSB 351198/79 Tinto CD61, EP65, RMab BSB 351298/79 Tinto CD61, EP65, RMab BSB 351398/79 Tinto CD63, NKI\|C3, MMab BSB 629698/79 Tinto CD63, NKI\|C3, MMab BSB 629798/79 Tinto CD63, NKI\|C3, MMab BSB 629898/79 Tinto CD68, BSB-8, MMab BSB 528898/79 Tinto CD68, BSB-8, MMab BSB 528998/79 Tinto CD68, BSB-8, MMab BSB 529098/79 Tinto CD68, KP-1, MMab BSB 271298/79 Tinto CD68, KP-1, MMab BSB 271398/79 Tinto CD68, KP-1, MMab BSB 271498/79 Tinto CD7, EP132, RMab BSB 232198/79 Tinto CD7, EP132, RMab BSB 232298/79 Tinto CD7, EP132, RMab BSB 232398/79 Tinto CD7, LP15, MMab BSB 516298/79 Tinto CD7, LP15, MMab BSB 516398/79 Tinto CD7, LP15, MMab BSB 516498/79 Tinto CD71, 10F11, MMab BSB 652098/79 Tinto CD71, 10F11, MMab BSB 652198/79 Tinto CD71, 10F11, MMab BSB 652298/79 Tinto CD73\|NT5E, RM431, RMab BSB-3716-1598/79 Tinto CD73\|NT5E, RM431, RMab BSB-3716-398/79 Tinto CD73\|NT5E, RM431, RMab BSB-3716-798/79 Tinto CD74, LN2, MMab BSB 529598/79 Tinto CD74, LN2, MMab BSB 529698/79 Tinto CD74, LN2, MMab BSB 529798/79 Tinto CD75, LN-1, MMab BSB 271998/79 Tinto CD75, LN-1, MMab BSB 272098/79 Tinto CD75, LN-1, MMab BSB 272198/79 Tinto CD79a, JCB117, MMab BSB 530298/79 Tinto CD79a, JCB117, MMab BSB 530398/79 Tinto CD79a, JCB117, MMab BSB 530498/79 Tinto CD8, C8\|144B, MMab BSB 516998/79 Tinto CD8, C8\|144B, MMab BSB 517098/79 Tinto CD8, C8\|144B, MMab BSB 517198/79 Tinto CD8, EP334, RMab BSB 284598/79 Tinto CD8, EP334, RMab BSB 284698/79 Tinto CD8, EP334, RMab BSB 284798/79 Tinto CD99, BSB-9, MMab BSB 530998/79 Tinto CD99, BSB-9, MMab BSB 531098/79 Tinto CD99, BSB-9, MMab BSB 531198/79 Tinto CDK2, RBT-CDK2, RMab BSB 263698/79 Tinto CDK2, RBT-CDK2, RMab BSB 263798/79 Tinto CDK2, RBT-CDK2, RMab BSB 263898/79 Tinto CDK4, EP180, RMab BSB 246198/79 Tinto CDK4, EP180, RMab BSB 246298/79 Tinto CDK4, EP180, RMab BSB 246398/79 Tinto CDX2, EP25, RMab BSB 605798/79 Tinto CDX2, EP25, RMab BSB 605898/79 Tinto CDX2, EP25, RMab BSB 605998/79 Tinto CEA, BSB-13, MMab BSB 533798/79 Tinto CEA, BSB-13, MMab BSB 533898/79 Tinto CEA, BSB-13, MMab BSB 533998/79 Tinto CEA, Polyclonal, RPab BSB 653498/79 Tinto CEA, Polyclonal, RPab BSB 653598/79 Tinto CEA, Polyclonal, RPab BSB 653698/79 Tinto CEACAM7, BSB-168, MMab BSB-3791-1598/79 Tinto CEACAM7, BSB-168, MMab BSB-3791-398/79 Tinto CEACAM7, BSB-168, MMab BSB-3791-798/79 Tinto Chromogranin A, LK2H10, MMab BSB 534498/79 Tinto Chromogranin A, LK2H10, MMab BSB 534598/79 Tinto Chromogranin A, LK2H10, MMab BSB 534698/79 Tinto CITED1, BSB-177, MMab BSB-3808-1598/79 Tinto CITED1, BSB-177, MMab BSB-3808-398/79 Tinto CITED1, BSB-177, MMab BSB-3808-798/79 Tinto Claudin-1, Polyclonal, RPab BSB 656298/79 Tinto Claudin-1, Polyclonal, RPab BSB 656398/79 Tinto Claudin-1, Polyclonal, RPab BSB 656498/79 Tinto Claudin-4, EP417, RMab BSB-3792-1598/79 Tinto Claudin-4, EP417, RMab BSB-3792-398/79 Tinto Claudin-4, EP417, RMab BSB-3792-798/79 Tinto Claudin-5, EP224, RMab BSB 239898/79 Tinto Claudin-5, EP224, RMab BSB 239998/79 Tinto Claudin-5, EP224, RMab BSB 240098/79 Tinto Claudin-7, EP399, RMab BSB-3719-1598/79 Tinto Claudin-7, EP399, RMab BSB-3719-398/79 Tinto Claudin-7, EP399, RMab BSB-3719-798/79 Tinto Collagen Type IV, CIV22, MMab BSB 535198/79 Tinto Collagen Type IV, CIV22, MMab BSB 535298/79 Tinto Collagen Type IV, CIV22, MMab BSB 535398/79 Tinto Collagen Type IV, RBT-COL4, RMab BSB-3777-1598/79 Tinto Collagen Type IV, RBT-COL4, RMab BSB-3777-398/79 Tinto Collagen Type IV, RBT-COL4, RMab BSB-3777-798/79 Tinto COX-2, RBT-COX2, RMab BSB 535898/79 Tinto COX-2, RBT-COX2, RMab BSB 535998/79 Tinto COX-2, RBT-COX2, RMab BSB 536098/79 Tinto CTLA-4\|CD152, BSB-88, MMab BSB 288098/79 Tinto CTLA-4\|CD152, BSB-88, MMab BSB 288198/79 Tinto CTLA-4\|CD152, BSB-88, MMab BSB 288298/79 Tinto CTLA-4\|CD152, RBT-CTLA-4, RMab BSB 348398/79 Tinto CTLA-4\|CD152, RBT-CTLA-4, RMab BSB 348498/79 Tinto CTLA-4\|CD152, RBT-CTLA-4, RMab BSB 348598/79 Tinto CXCL12\|SDF-1, BSB-165, MMab BSB-3713-1598/79 Tinto CXCL12\|SDF-1, BSB-165, MMab BSB-3713-398/79 Tinto CXCL12\|SDF-1, BSB-165, MMab BSB-3713-798/79 Tinto CXCR4\|CD184\|Fusin, EP394, RMab BSB-3720-1598/79 Tinto CXCR4\|CD184\|Fusin, EP394, RMab BSB-3720-398/79 Tinto CXCR4\|CD184\|Fusin, EP394, RMab BSB-3720-798/79 Tinto CXCR5\|CD185, Polyclonal, RPab BSB-3721-1598/79 Tinto CXCR5\|CD185, Polyclonal, RPab BSB-3721-398/79 Tinto CXCR5\|CD185, Polyclonal, RPab BSB-3721-798/79 Tinto Cyclin B1, RM281, RMab BSB-3760-1598/79 Tinto Cyclin B1, RM281, RMab BSB-3760-398/79 Tinto Cyclin B1, RM281, RMab BSB-3760-798/79 Tinto Cyclin D1, RBT-14, RMab BSB 536598/79 Tinto Cyclin D1, RBT-14, RMab BSB 536698/79 Tinto Cyclin D1, RBT-14, RMab BSB 536798/79 Tinto Cyclin D1, RM241, RMab BSB-3761-1598/79 Tinto Cyclin D1, RM241, RMab BSB-3761-398/79 Tinto Cyclin D1, RM241, RMab BSB-3761-798/79 Tinto Cyclin D3, BSB-171, MMab BSB-3799-1598/79 Tinto Cyclin D3, BSB-171, MMab BSB-3799-398/79 Tinto Cyclin D3, BSB-171, MMab BSB-3799-798/79 Tinto Cyclin E1, EP126, RMab BSB 655598/79 Tinto Cyclin E1, EP126, RMab BSB 655698/79 Tinto Cyclin E1, EP126, RMab BSB 655798/79 Tinto Cytokeratin 14, LL002, MMab BSB 621998/79 Tinto Cytokeratin 14, LL002, MMab BSB 622098/79 Tinto Cytokeratin 14, LL002, MMab BSB 622198/79 Tinto Cytokeratin 14, RM328, RMab BSB-3762-1598/79 Tinto Cytokeratin 14, RM328, RMab BSB-3762-398/79 Tinto Cytokeratin 14, RM328, RMab BSB-3762-798/79 Tinto Cytokeratin 17, BSB-33, MMab BSB 272698/79 Tinto Cytokeratin 17, BSB-33, MMab BSB 272798/79 Tinto Cytokeratin 17, BSB-33, MMab BSB 272898/79 Tinto Cytokeratin 18, EP30, RMab BSB 669598/79 Tinto Cytokeratin 18, EP30, RMab BSB 669698/79 Tinto Cytokeratin 18, EP30, RMab BSB 669798/79 Tinto Cytokeratin 19, BSB-34, MMab BSB 273398/79 Tinto Cytokeratin 19, BSB-34, MMab BSB 273498/79 Tinto Cytokeratin 19, BSB-34, MMab BSB 273598/79 Tinto Cytokeratin 19, EP72, RMab BSB 537998/79 Tinto Cytokeratin 19, EP72, RMab BSB 538098/79 Tinto Cytokeratin 19, EP72, RMab BSB 538198/79 Tinto Cytokeratin 19, RM364, RMab BSB-3763-1598/79 Tinto Cytokeratin 19, RM364, RMab BSB-3763-398/79 Tinto Cytokeratin 19, RM364, RMab BSB-3763-798/79 Tinto Cytokeratin 20, EP23, RMab BSB 670298/79 Tinto Cytokeratin 20, EP23, RMab BSB 670398/79 Tinto Cytokeratin 20, EP23, RMab BSB 670498/79 Tinto Cytokeratin 20, Ks20.8, MMab BSB 538698/79 Tinto Cytokeratin 20, Ks20.8, MMab BSB 538798/79 Tinto Cytokeratin 20, Ks20.8, MMab BSB 538898/79 Tinto Cytokeratin 35BH11, 35BetaH11, MMab BSB 542198/79 Tinto Cytokeratin 35BH11, 35BetaH11, MMab BSB 542298/79 Tinto Cytokeratin 35BH11, 35BetaH11, MMab BSB 542398/79 Tinto Cytokeratin 4, EP4, RMab BSB 659098/79 Tinto Cytokeratin 4, EP4, RMab BSB 659198/79 Tinto Cytokeratin 4, EP4, RMab BSB 659298/79 Tinto Cytokeratin 5 and 6, D5 and 16B4, MMab BSB 540098/79 Tinto Cytokeratin 5 and 6, D5 and 16B4, MMab BSB 540198/79 Tinto Cytokeratin 5 and 6, D5 and 16B4, MMab BSB 540298/79 Tinto Cytokeratin 7, OV-TL 12\|30, MMab BSB 540798/79 Tinto Cytokeratin 7, OV-TL 12\|30, MMab BSB 540898/79 Tinto Cytokeratin 7, OV-TL 12\|30, MMab BSB 540998/79 Tinto Cytokeratin 7, RM284, RMab BSB-3764-1598/79 Tinto Cytokeratin 7, RM284, RMab BSB-3764-398/79 Tinto Cytokeratin 7, RM284, RMab BSB-3764-798/79 Tinto Cytokeratin 8 and 18, B22.1 and B23.1, MMab BSB 541498/79 Tinto Cytokeratin 8 and 18, B22.1 and B23.1, MMab BSB 541598/79 Tinto Cytokeratin 8 and 18, B22.1 and B23.1, MMab BSB 541698/79 Tinto Cytokeratin 8, EP17, RMab BSB 666098/79 Tinto Cytokeratin 8, EP17, RMab BSB 666198/79 Tinto Cytokeratin 8, EP17, RMab BSB 666298/79 Tinto Cytokeratin Cocktail AE1 and AE3, AE1 and AE3, MMab BSB 542898/79 Tinto Cytokeratin Cocktail AE1 and AE3, AE1 and AE3, MMab BSB 542998/79 Tinto Cytokeratin Cocktail AE1 and AE3, AE1 and AE3, MMab BSB 543098/79 Tinto Cytokeratin HMW 34BE12, 34BetaE12, MMab BSB 539398/79 Tinto Cytokeratin HMW 34BE12, 34BetaE12, MMab BSB 539498/79 Tinto Cytokeratin HMW 34BE12, 34BetaE12, MMab BSB 539598/79 Tinto Cytokeratin LMW CAM5.2, CAM5.2, MMab BSB 205698/79 Tinto Cytokeratin LMW CAM5.2, CAM5.2, MMab BSB 205798/79 Tinto Cytokeratin LMW CAM5.2, CAM5.2, MMab BSB 205898/79 Tinto Cytokeratin MNF116, MNF116, MMab BSB 353298/79 Tinto Cytokeratin MNF116, MNF116, MMab BSB 353398/79 Tinto Cytokeratin MNF116, MNF116, MMab BSB 353498/79 Tinto Cytokeratin OSCAR, OSCAR, MMab BSB 617798/79 Tinto Cytokeratin OSCAR, OSCAR, MMab BSB 617898/79 Tinto Cytokeratin OSCAR, OSCAR, MMab BSB 617998/79 Tinto DDR1, BSB-173, MMab BSB-3801-1598/79 Tinto DDR1, BSB-173, MMab BSB-3801-398/79 Tinto DDR1, BSB-173, MMab BSB-3801-798/79 Tinto Desmin, D33, MMab BSB 545698/79 Tinto Desmin, D33, MMab BSB 545798/79 Tinto Desmin, D33, MMab BSB 545898/79 Tinto Desmoglein-3, EP306, RMab BSB 289498/79 Tinto Desmoglein-3, EP306, RMab BSB 289598/79 Tinto Desmoglein-3, EP306, RMab BSB 289698/79 Tinto DOG-1, EP332, RMab BSB 290198/79 Tinto DOG-1, EP332, RMab BSB 290298/79 Tinto DOG-1, EP332, RMab BSB 290398/79 Tinto DOG-1, RBT-DOG1, RMab BSB 626898/79 Tinto DOG-1, RBT-DOG1, RMab BSB 626998/79 Tinto DOG-1, RBT-DOG1, RMab BSB 627098/79 Tinto E-Cadherin, EP6, RMab BSB 546398/79 Tinto E-Cadherin, EP6, RMab BSB 546498/79 Tinto E-Cadherin, EP6, RMab BSB 546598/79 Tinto EGFR Phospho, EP11, RMab BSB 671698/79 Tinto EGFR Phospho, EP11, RMab BSB 671798/79 Tinto EGFR Phospho, EP11, RMab BSB 671898/79 Tinto EGFR, 31G7, MMab BSB 547098/79 Tinto EGFR, 31G7, MMab BSB 547198/79 Tinto EGFR, 31G7, MMab BSB 547298/79 Tinto EMA, E29, MMab BSB 547798/79 Tinto EMA, E29, MMab BSB 547898/79 Tinto EMA, E29, MMab BSB 547998/79 Tinto EpCAM\|Epithelial Specific Antigen, Ber-EP4, MMab BSB 627598/79 Tinto EpCAM\|Epithelial Specific Antigen, Ber-EP4, MMab BSB 627698/79 Tinto EpCAM\|Epithelial Specific Antigen, Ber-EP4, MMab BSB 627798/79 Tinto EpCAM\|Epithelial Specific Antigen, MOC-31, MMab BSB 672398/79 Tinto EpCAM\|Epithelial Specific Antigen, MOC-31, MMab BSB 672498/79 Tinto EpCAM\|Epithelial Specific Antigen, MOC-31, MMab BSB 672598/79 Tinto Epstein Barr Virus LMP-1, CS1-4, MMab BSB 548498/79 Tinto Epstein Barr Virus LMP-1, CS1-4, MMab BSB 548598/79 Tinto Epstein Barr Virus LMP-1, CS1-4, MMab BSB 548698/79 Tinto ERCC1, EP219, RMab BSB 248298/79 Tinto ERCC1, EP219, RMab BSB 248398/79 Tinto ERCC1, EP219, RMab BSB 248498/79 Tinto ERG, EP111, RMab BSB 673798/79 Tinto ERG, EP111, RMab BSB 673898/79 Tinto ERG, EP111, RMab BSB 673998/79 Tinto Estrogen Receptor, BSB-1, MMab BSB 274098/79 Tinto Estrogen Receptor, BSB-1, MMab BSB 274198/79 Tinto Estrogen Receptor, BSB-1, MMab BSB 274298/79 Tinto Estrogen Receptor, EP1, RMab BSB 248998/79 Tinto Estrogen Receptor, EP1, RMab BSB 249098/79 Tinto Estrogen Receptor, EP1, RMab BSB 249198/79 Tinto Estrogen Receptor, RBT-11, RMab BSB 549198/79 Tinto Estrogen Receptor, RBT-11, RMab BSB 549298/79 Tinto Estrogen Receptor, RBT-11, RMab BSB 549398/79 Tinto Estrogen Receptor, RM292, RMab BSB-3765-1598/79 Tinto Estrogen Receptor, RM292, RMab BSB-3765-398/79 Tinto Estrogen Receptor, RM292, RMab BSB-3765-798/79 Tinto Factor H\|Complement Factor H, BSB-164, MMab BSB-3723-1598/79 Tinto Factor H\|Complement Factor H, BSB-164, MMab BSB-3723-398/79 Tinto Factor H\|Complement Factor H, BSB-164, MMab BSB-3723-798/79 Tinto Factor VIII-Related Antigen, Polyclonal, RPab BSB 549898/79 Tinto Factor VIII-Related Antigen, Polyclonal, RPab BSB 549998/79 Tinto Factor VIII-Related Antigen, Polyclonal, RPab BSB 550098/79 Tinto Factor XIIIa, EP292, RMab BSB 550598/79 Tinto Factor XIIIa, EP292, RMab BSB 550698/79 Tinto Factor XIIIa, EP292, RMab BSB 550798/79 Tinto Fascin, BSB-36, MMab BSB 551298/79 Tinto Fascin, BSB-36, MMab BSB 551398/79 Tinto Fascin, BSB-36, MMab BSB 551498/79 Tinto FGFR-3, BSB-150, MMab BSB-3724-1598/79 Tinto FGFR-3, BSB-150, MMab BSB-3724-398/79 Tinto FGFR-3, BSB-150, MMab BSB-3724-798/79 Tinto Fibrinogen, Polyclonal, RPab BSB 304798/79 Tinto Fibrinogen, Polyclonal, RPab BSB 304898/79 Tinto Fibrinogen, Polyclonal, RPab BSB 304998/79 Tinto Fibrinogen\|FITC, Polyclonal, RPab BSB-3004-1598/79 Tinto Fibrinogen\|FITC, Polyclonal, RPab BSB-3004-398/79 Tinto Fibrinogen\|FITC, Polyclonal, RPab BSB-3004-798/79 Tinto Fli-1, G146-222, MMab BSB 551998/79 Tinto Fli-1, G146-222, MMab BSB 552098/79 Tinto Fli-1, G146-222, MMab BSB 552198/79 Tinto FOXL2, Polyclonal, RPab BSB-3725-1598/79 Tinto FOXL2, Polyclonal, RPab BSB-3725-398/79 Tinto FOXL2, Polyclonal, RPab BSB-3725-798/79 Tinto FOXP1, EP137, RMab BSB 675198/79 Tinto FOXP1, EP137, RMab BSB 675298/79 Tinto FOXP1, EP137, RMab BSB 675398/79 Tinto FOXP3, EP340, RMab BSB 292298/79 Tinto FOXP3, EP340, RMab BSB 292398/79 Tinto FOXP3, EP340, RMab BSB 292498/79 Tinto FOXP3, Polyclonal, RPab BSB 675898/79 Tinto FOXP3, Polyclonal, RPab BSB 675998/79 Tinto FOXP3, Polyclonal, RPab BSB 676098/79 Tinto FSH, BSB-55, MMab BSB 553398/79 Tinto FSH, BSB-55, MMab BSB 553498/79 Tinto FSH, BSB-55, MMab BSB 553598/79 Tinto FSH, EP257, RMab BSB 353998/79 Tinto FSH, EP257, RMab BSB 354098/79 Tinto FSH, EP257, RMab BSB 354198/79 Tinto Fumarate Hydratase\|Fumarase, BSB-151, MMab BSB-3726-1598/79 Tinto Fumarate Hydratase\|Fumarase, BSB-151, MMab BSB-3726-398/79 Tinto Fumarate Hydratase\|Fumarase, BSB-151, MMab BSB-3726-798/79 Tinto GAB1\|GRB2-associated-binding protein 1, BSB-155, MMab BSB-3727-1598/79 Tinto GAB1\|GRB2-associated-binding protein 1, BSB-155, MMab BSB-3727-398/79 Tinto GAB1\|GRB2-associated-binding protein 1, BSB-155, MMab BSB-3727-798/79 Tinto Galectin-3, 9C4, MMab BSB 554098/79 Tinto Galectin-3, 9C4, MMab BSB 554198/79 Tinto Galectin-3, 9C4, MMab BSB 554298/79 Tinto Gastrin, Polyclonal, RPab BSB 554798/79 Tinto Gastrin, Polyclonal, RPab BSB 554898/79 Tinto Gastrin, Polyclonal, RPab BSB 554998/79 Tinto GATA3, EP368, RMab BSB 332898/79 Tinto GATA3, EP368, RMab BSB 332998/79 Tinto GATA3, EP368, RMab BSB 333098/79 Tinto GATA3, L50-823, MMab BSB 267098/79 Tinto GATA3, L50-823, MMab BSB 267198/79 Tinto GATA3, L50-823, MMab BSB 267298/79 Tinto GCDFP-15, 23A3, MMab BSB 555498/79 Tinto GCDFP-15, 23A3, MMab BSB 555598/79 Tinto GCDFP-15, 23A3, MMab BSB 555698/79 Tinto GFAP, G-A-5, MMab BSB 556198/79 Tinto GFAP, G-A-5, MMab BSB 556298/79 Tinto GFAP, G-A-5, MMab BSB 556398/79 Tinto GFAP, RM246, RMab BSB-3766-1598/79 Tinto GFAP, RM246, RMab BSB-3766-398/79 Tinto GFAP, RM246, RMab BSB-3766-798/79 Tinto GH, BSB-99, MMab BSB 333598/79 Tinto GH, BSB-99, MMab BSB 333698/79 Tinto GH, BSB-99, MMab BSB 333798/79 Tinto GH, EP267, RMab BSB 249698/79 Tinto GH, EP267, RMab BSB 249798/79 Tinto GH, EP267, RMab BSB 249898/79 Tinto Glucagon, BSB-111, MMab BSB 334298/79 Tinto Glucagon, BSB-111, MMab BSB 334398/79 Tinto Glucagon, BSB-111, MMab BSB 334498/79 Tinto Glucagon, EP74, RMab BSB 232898/79 Tinto Glucagon, EP74, RMab BSB 232998/79 Tinto Glucagon, EP74, RMab BSB 233098/79 Tinto GLUT1, EP141, RMab BSB 677998/79 Tinto GLUT1, EP141, RMab BSB 678098/79 Tinto GLUT1, EP141, RMab BSB 678198/79 Tinto Glutamine Synthetase, GS-6, MMab BSB 292998/79 Tinto Glutamine Synthetase, GS-6, MMab BSB 293098/79 Tinto Glutamine Synthetase, GS-6, MMab BSB 293198/79 Tinto Glycophorin A, GA-R2 (HIR2), MMab BSB 558298/79 Tinto Glycophorin A, GA-R2 (HIR2), MMab BSB 558398/79 Tinto Glycophorin A, GA-R2 (HIR2), MMab BSB 558498/79 Tinto Glypican-3, 1G12, MMab BSB 624098/79 Tinto Glypican-3, 1G12, MMab BSB 624198/79 Tinto Glypican-3, 1G12, MMab BSB 624298/79 Tinto Granzyme B, EP230, RMab BSB 240598/79 Tinto Granzyme B, EP230, RMab BSB 240698/79 Tinto Granzyme B, EP230, RMab BSB 240798/79 Tinto hCG, BSB-38, MMab BSB 559698/79 Tinto hCG, BSB-38, MMab BSB 559798/79 Tinto hCG, BSB-38, MMab BSB 559898/79 Tinto HE4, EP370, RMab BSB 334998/79 Tinto HE4, EP370, RMab BSB 335098/79 Tinto HE4, EP370, RMab BSB 335198/79 Tinto HEG1, SKM9-2, MMab BSB-3728-1598/79 Tinto HEG1, SKM9-2, MMab BSB-3728-398/79 Tinto HEG1, SKM9-2, MMab BSB-3728-798/79 Tinto Helicobacter Pylori, BSB-37, MMab BSB 267798/79 Tinto Helicobacter Pylori, BSB-37, MMab BSB 267898/79 Tinto Helicobacter Pylori, BSB-37, MMab BSB 267998/79 Tinto Helicobacter Pylori, EP279, RMab BSB 327998/79 Tinto Helicobacter Pylori, EP279, RMab BSB 328098/79 Tinto Helicobacter Pylori, EP279, RMab BSB 328198/79 Tinto Helicobacter pylori, Polyclonal, RPab BSB 560398/79 Tinto Helicobacter pylori, Polyclonal, RPab BSB 560498/79 Tinto Helicobacter pylori, Polyclonal, RPab BSB 560598/79 Tinto Hepatocyte Specific Antigen\Hep-Par1, OCH1E5, MMab BSB 562498/79 Tinto Hepatocyte Specific Antigen\Hep-Par1, OCH1E5, MMab BSB 562598/79 Tinto Hepatocyte Specific Antigen\Hep-Par1, OCH1E5, MMab BSB 562698/79 Tinto HER-2 neu, BSB-3, MMab BSB 563198/79 Tinto HER-2 neu, BSB-3, MMab BSB 563298/79 Tinto HER-2 neu, BSB-3, MMab BSB 563398/79 Tinto HER-2 neu, RBT-HER2, RMab BSB 203598/79 Tinto HER-2 neu, RBT-HER2, RMab BSB 203698/79 Tinto HER-2 neu, RBT-HER2, RMab BSB 203798/79 Tinto HER-3\|c-erbB-3, RBT-HER3, RMab BSB 262998/79 Tinto HER-3\|c-erbB-3, RBT-HER3, RMab BSB 263098/79 Tinto HER-3\|c-erbB-3, RBT-HER3, RMab BSB 263198/79 Tinto HER2 neu, EP3, RMab BSB 251098/79 Tinto HER2 neu, EP3, RMab BSB 251198/79 Tinto HER2 neu, EP3, RMab BSB 251298/79 Tinto Herpes Simplex Virus I and II, 10A3 and BSB-116, MMab BSB 346998/79 Tinto Herpes Simplex Virus I and II, 10A3 and BSB-116, MMab BSB 347098/79 Tinto Herpes Simplex Virus I and II, 10A3 and BSB-116, MMab BSB 347198/79 Tinto Herpes Simplex Virus I, 10A3, MMab BSB 268498/79 Tinto Herpes Simplex Virus I, 10A3, MMab BSB 268598/79 Tinto Herpes Simplex Virus I, 10A3, MMab BSB 268698/79 Tinto Herpes Simplex Virus II, BSB-116, MMab BSB 346298/79 Tinto Herpes Simplex Virus II, BSB-116, MMab BSB 346398/79 Tinto Herpes Simplex Virus II, BSB-116, MMab BSB 346498/79 Tinto hGAL\|GCET2, EP316, RMab BSB 293698/79 Tinto hGAL\|GCET2, EP316, RMab BSB 293798/79 Tinto hGAL\|GCET2, EP316, RMab BSB 293898/79 Tinto HHV-8, 13B10, MMab BSB 564598/79 Tinto HHV-8, 13B10, MMab BSB 564698/79 Tinto HHV-8, 13B10, MMab BSB 564798/79 Tinto HHV-8, RBT-HHV8, RMab BSB-3778-1598/79 Tinto HHV-8, RBT-HHV8, RMab BSB-3778-398/79 Tinto HHV-8, RBT-HHV8, RMab BSB-3778-798/79 Tinto HIF-1alpha, EP118, RMab BSB 251798/79 Tinto HIF-1alpha, EP118, RMab BSB 251898/79 Tinto HIF-1alpha, EP118, RMab BSB 251998/79 Tinto Histone H3 Phospho, EP233, RMab BSB 252498/79 Tinto Histone H3 Phospho, EP233, RMab BSB 252598/79 Tinto Histone H3 Phospho, EP233, RMab BSB 252698/79 Tinto HMGA2, EP398, RMab BSB-3729-1598/79 Tinto HMGA2, EP398, RMab BSB-3729-398/79 Tinto HMGA2, EP398, RMab BSB-3729-798/79 Tinto hPL, EP241, RMab BSB 241298/79 Tinto hPL, EP241, RMab BSB 241398/79 Tinto hPL, EP241, RMab BSB 241498/79 Tinto hPL, Polyclonal, RPab BSB 680098/79 Tinto hPL, Polyclonal, RPab BSB 680198/79 Tinto hPL, Polyclonal, RPab BSB 680298/79 Tinto HPV, BSB-66, MMab BSB 565298/79 Tinto HPV, BSB-66, MMab BSB 565398/79 Tinto HPV, BSB-66, MMab BSB 565498/79 Tinto HPV16, CAMVIR-1, MMab BSB 294398/79 Tinto HPV16, CAMVIR-1, MMab BSB 294498/79 Tinto HPV16, CAMVIR-1, MMab BSB 294598/79 Tinto HSP70, RM432, RMab BSB-3730-1598/79 Tinto HSP70, RM432, RMab BSB-3730-398/79 Tinto HSP70, RM432, RMab BSB-3730-798/79 Tinto ICOS\|CD278, RM417, RMab BSB-3731-1598/79 Tinto ICOS\|CD278, RM417, RMab BSB-3731-398/79 Tinto ICOS\|CD278, RM417, RMab BSB-3731-798/79 Tinto IDH1 R132H, IHC132, MMab BSB 354698/79 Tinto IDH1 R132H, IHC132, MMab BSB 354798/79 Tinto IDH1 R132H, IHC132, MMab BSB 354898/79 Tinto IDH1 R132H, RBT-IDH1, RMab BSB-3732-1598/79 Tinto IDH1 R132H, RBT-IDH1, RMab BSB-3732-398/79 Tinto IDH1 R132H, RBT-IDH1, RMab BSB-3732-798/79 Tinto IFN-Alpha, BSB-158, MMab BSB-3733-1598/79 Tinto IFN-Alpha, BSB-158, MMab BSB-3733-398/79 Tinto IFN-Alpha, BSB-158, MMab BSB-3733-798/79 Tinto IFN-Gamma, BSB-161, MMab BSB-3734-1598/79 Tinto IFN-Gamma, BSB-161, MMab BSB-3734-398/79 Tinto IFN-Gamma, BSB-161, MMab BSB-3734-798/79 Tinto IgA, BSB-39, MMab BSB 565998/79 Tinto IgA, BSB-39, MMab BSB 566098/79 Tinto IgA, BSB-39, MMab BSB 566198/79 Tinto IgA, Polyclonal, RPab BSB 305498/79 Tinto IgA, Polyclonal, RPab BSB 305598/79 Tinto IgA, Polyclonal, RPab BSB 305698/79 Tinto IgA\|FITC, Polyclonal, GPab BSB-3005-1598/79 Tinto IgA\|FITC, Polyclonal, GPab BSB-3005-398/79 Tinto IgA\|FITC, Polyclonal, GPab BSB-3005-798/79 Tinto IgD, EP173, RMab BSB 295798/79 Tinto IgD, EP173, RMab BSB 295898/79 Tinto IgD, EP173, RMab BSB 295998/79 Tinto IgD\|FITC, Polyclonal, GPab BSB-3006-1598/79 Tinto IgD\|FITC, Polyclonal, GPab BSB-3006-398/79 Tinto IgD\|FITC, Polyclonal, GPab BSB-3006-798/79 Tinto IgE, Polyclonal, RPab BSB 306798/79 Tinto IgE, Polyclonal, RPab BSB 306898/79 Tinto IgE, Polyclonal, RPab BSB 306998/79 Tinto IgE\|FITC, Polyclonal, GPab BSB-3011-1598/79 Tinto IgE\|FITC, Polyclonal, GPab BSB-3011-398/79 Tinto IgE\|FITC, Polyclonal, GPab BSB-3011-798/79 Tinto IgG, BSB-40, MMab BSB 567398/79 Tinto IgG, BSB-40, MMab BSB 567498/79 Tinto IgG, BSB-40, MMab BSB 567598/79 Tinto IgG4, BSB-96, MMab BSB 680798/79 Tinto IgG4, BSB-96, MMab BSB 680898/79 Tinto IgG4, BSB-96, MMab BSB 680998/79 Tinto IgG4, EP138, RMab BSB 681498/79 Tinto IgG4, EP138, RMab BSB 681598/79 Tinto IgG4, EP138, RMab BSB 681698/79 Tinto IgG\|FITC, Polyclonal, GPab BSB-3007-1598/79 Tinto IgG\|FITC, Polyclonal, GPab BSB-3007-398/79 Tinto IgG\|FITC, Polyclonal, GPab BSB-3007-798/79 Tinto IgM, BSB-41, MMab BSB 568098/79 Tinto IgM, BSB-41, MMab BSB 568198/79 Tinto IgM, BSB-41, MMab BSB 568298/79 Tinto IgM, Polyclonal, RPab BSB 308098/79 Tinto IgM, Polyclonal, RPab BSB 308198/79 Tinto IgM, Polyclonal, RPab BSB 308298/79 Tinto IgM\| FITC, Polyclonal, RPab BSB-3008-1598/79 Tinto IgM\| FITC, Polyclonal, RPab BSB-3008-398/79 Tinto IgM\| FITC, Polyclonal, RPab BSB-3008-798/79 Tinto IL-1a, BSB-138, MMab BSB-3705-1598/79 Tinto IL-1a, BSB-138, MMab BSB-3705-398/79 Tinto IL-1a, BSB-138, MMab BSB-3705-798/79 Tinto IL-1b, BSB-139, MMab BSB-3706-1598/79 Tinto IL-1b, BSB-139, MMab BSB-3706-398/79 Tinto IL-1b, BSB-139, MMab BSB-3706-798/79 Tinto IL-6, BSB-140, MMab BSB-3707-1598/79 Tinto IL-6, BSB-140, MMab BSB-3707-398/79 Tinto IL-6, BSB-140, MMab BSB-3707-798/79 Tinto IMP-3\|1GF2BP3, EP286, RMab BSB 296498/79 Tinto IMP-3\|1GF2BP3, EP286, RMab BSB 296598/79 Tinto IMP-3\|1GF2BP3, EP286, RMab BSB 296698/79 Tinto Inhibin alpha, EP378, RMab BSB 335698/79 Tinto Inhibin alpha, EP378, RMab BSB 335798/79 Tinto Inhibin alpha, EP378, RMab BSB 335898/79 Tinto Inhibin Alpha, R1, MMab BSB 568798/79 Tinto Inhibin Alpha, R1, MMab BSB 568898/79 Tinto Inhibin Alpha, R1, MMab BSB 568998/79 Tinto INI-1, 25, MMab BSB 682898/79 Tinto INI-1, 25, MMab BSB 682998/79 Tinto INI-1, 25, MMab BSB 683098/79 Tinto INI-1, RBT-INI1, RMab BSB-3779-1598/79 Tinto INI-1, RBT-INI1, RMab BSB-3779-398/79 Tinto INI-1, RBT-INI1, RMab BSB-3779-798/79 Tinto iNOS, RBT-iNOS, RMab BSB 265698/79 Tinto iNOS, RBT-iNOS, RMab BSB 265798/79 Tinto iNOS, RBT-iNOS, RMab BSB 265898/79 Tinto INSM1, BSB-123, MMab BSB 355398/79 Tinto INSM1, BSB-123, MMab BSB 355498/79 Tinto INSM1, BSB-123, MMab BSB 355598/79 Tinto INSM1, RBT-INSM1, RMab BSB-3780-1598/79 Tinto INSM1, RBT-INSM1, RMab BSB-3780-398/79 Tinto INSM1, RBT-INSM1, RMab BSB-3780-798/79 Tinto Insulin, BSB-42, MMab BSB 569498/79 Tinto Insulin, BSB-42, MMab BSB 569598/79 Tinto Insulin, BSB-42, MMab BSB 569698/79 Tinto Islet 1\|ISL1, EP283, RMab BSB 297198/79 Tinto Islet 1\|ISL1, EP283, RMab BSB 297298/79 Tinto Islet 1\|ISL1, EP283, RMab BSB 297398/79 Tinto Kappa Light Chains, BSB-58, MMab BSB 570198/79 Tinto Kappa Light Chains, BSB-58, MMab BSB 570298/79 Tinto Kappa Light Chains, BSB-58, MMab BSB 570398/79 Tinto Kappa\|FITC, Polyclonal, GPab BSB-3009-1598/79 Tinto Kappa\|FITC, Polyclonal, GPab BSB-3009-398/79 Tinto Kappa\|FITC, Polyclonal, GPab BSB-3009-798/79 Tinto Ki-67, EP5, RMab BSB 570898/79 Tinto Ki-67, EP5, RMab BSB 570998/79 Tinto Ki-67, EP5, RMab BSB 571098/79 Tinto Ki-67, RM360, RMab BSB-3767-1598/79 Tinto Ki-67, RM360, RMab BSB-3767-398/79 Tinto Ki-67, RM360, RMab BSB-3767-798/79 Tinto Ksp-Cadherin, 4H6\|F9, MMab BSB 628298/79 Tinto Ksp-Cadherin, 4H6\|F9, MMab BSB 628398/79 Tinto Ksp-Cadherin, 4H6\|F9, MMab BSB 628498/79 Tinto LAG-3\|CD223, EP294, RMab BSB 336398/79 Tinto LAG-3\|CD223, EP294, RMab BSB 336498/79 Tinto LAG-3\|CD223, EP294, RMab BSB 336598/79 Tinto Lambda, BSB-16, MMab BSB 571598/79 Tinto Lambda, BSB-16, MMab BSB 571698/79 Tinto Lambda, BSB-16, MMab BSB 571798/79 Tinto Lambda\|FITC, Polyclonal, GPab BSB-3010-1598/79 Tinto Lambda\|FITC, Polyclonal, GPab BSB-3010-398/79 Tinto Lambda\|FITC, Polyclonal, GPab BSB-3010-798/79 Tinto Lamin-B1, RBT-LMNB1, RMab BSB-3735-1598/79 Tinto Lamin-B1, RBT-LMNB1, RMab BSB-3735-398/79 Tinto Lamin-B1, RBT-LMNB1, RMab BSB-3735-798/79 Tinto Laminin-R\|RPSA, BSB-144, MMab BSB-3736-1598/79 Tinto Laminin-R\|RPSA, BSB-144, MMab BSB-3736-398/79 Tinto Laminin-R\|RPSA, BSB-144, MMab BSB-3736-798/79 Tinto Langerin, 12D6, MMab BSB 684298/79 Tinto Langerin, 12D6, MMab BSB 684398/79 Tinto Langerin, 12D6, MMab BSB 684498/79 Tinto LEF-1, EP310, RMab BSB 337798/79 Tinto LEF-1, EP310, RMab BSB 337898/79 Tinto LEF-1, EP310, RMab BSB 337998/79 Tinto LH, BSB-53, MMab BSB 572298/79 Tinto LH, BSB-53, MMab BSB 572398/79 Tinto LH, BSB-53, MMab BSB 572498/79 Tinto LIN28, EP150, RMab BSB 356098/79 Tinto LIN28, EP150, RMab BSB 356198/79 Tinto LIN28, EP150, RMab BSB 356298/79 Tinto LMO2, RBT-LM02, RMab BSB 357498/79 Tinto LMO2, RBT-LM02, RMab BSB 357598/79 Tinto LMO2, RBT-LM02, RMab BSB 357698/79 Tinto LRG1, BSB-174, MMab BSB-3802-1598/79 Tinto LRG1, BSB-174, MMab BSB-3802-398/79 Tinto LRG1, BSB-174, MMab BSB-3802-798/79 Tinto Lysozyme, EP134, RMab BSB 685698/79 Tinto Lysozyme, EP134, RMab BSB 685798/79 Tinto Lysozyme, EP134, RMab BSB 685898/79 Tinto Macrophage HAM-56, HAM-56, MMab BSB 573698/79 Tinto Macrophage HAM-56, HAM-56, MMab BSB 573798/79 Tinto Macrophage HAM-56, HAM-56, MMab BSB 573898/79 Tinto MAGEC2, EP405, RMab BSB-3795-1598/79 Tinto MAGEC2, EP405, RMab BSB-3795-398/79 Tinto MAGEC2, EP405, RMab BSB-3795-798/79 Tinto Mammaglobin, EP249, RMab BSB 574398/79 Tinto Mammaglobin, EP249, RMab BSB 574498/79 Tinto Mammaglobin, EP249, RMab BSB 574598/79 Tinto Mart-1\|Melan-A, A103, MMab BSB 687098/79 Tinto Mart-1\|Melan-A, A103, MMab BSB 687198/79 Tinto Mart-1\|Melan-A, A103, MMab BSB 687298/79 Tinto Mart-1\|Melan-A, M2-7C10, MMab BSB 575098/79 Tinto Mart-1\|Melan-A, M2-7C10, MMab BSB 575198/79 Tinto Mart-1\|Melan-A, M2-7C10, MMab BSB 575298/79 Tinto Maspin, BSB-92, MMab BSB 326598/79 Tinto Maspin, BSB-92, MMab BSB 326698/79 Tinto Maspin, BSB-92, MMab BSB 326798/79 Tinto MCM2, RBT-MCM2, RMab BSB 633198/79 Tinto MCM2, RBT-MCM2, RMab BSB 633298/79 Tinto MCM2, RBT-MCM2, RMab BSB 633398/79 Tinto MCM3, EP202, RMab BSB 688498/79 Tinto MCM3, EP202, RMab BSB 688598/79 Tinto MCM3, EP202, RMab BSB 688698/79 Tinto MDM2, BSB-64, MMab BSB 297898/79 Tinto MDM2, BSB-64, MMab BSB 297998/79 Tinto MDM2, BSB-64, MMab BSB 298098/79 Tinto MDR-1, JSB-1, MMab BSB 689898/79 Tinto MDR-1, JSB-1, MMab BSB 689998/79 Tinto MDR-1, JSB-1, MMab BSB 690098/79 Tinto Melanoma Cocktail: HMB-45, MART-1 and Tyrosinase, HMB-45, A103 and BSB-6, MMab BSB 687798/79 Tinto Melanoma Cocktail: HMB-45, MART-1 and Tyrosinase, HMB-45, A103 and BSB-6, MMab BSB 687898/79 Tinto Melanoma Cocktail: HMB-45, MART-1 and Tyrosinase, HMB-45, A103 and BSB-6, MMab BSB 687998/79 Tinto Melanoma KBA.62, KBA.62, MMab BSB 690598/79 Tinto Melanoma KBA.62, KBA.62, MMab BSB 690698/79 Tinto Melanoma KBA.62, KBA.62, MMab BSB 690798/79 Tinto Melanoma PNL2, PNL2, MMab BSB 691298/79 Tinto Melanoma PNL2, PNL2, MMab BSB 691398/79 Tinto Melanoma PNL2, PNL2, MMab BSB 691498/79 Tinto Melanosome HMB45, HMB-45, MMab BSB 575798/79 Tinto Melanosome HMB45, HMB-45, MMab BSB 575898/79 Tinto Melanosome HMB45, HMB-45, MMab BSB 575998/79 Tinto Mesothelial Cell, HBME-1, MMab BSB 345598/79 Tinto Mesothelial Cell, HBME-1, MMab BSB 345698/79 Tinto Mesothelial Cell, HBME-1, MMab BSB 345798/79 Tinto MGMT\|AGAT, EP337, RMab BSB-3737-1598/79 Tinto MGMT\|AGAT, EP337, RMab BSB-3737-398/79 Tinto MGMT\|AGAT, EP337, RMab BSB-3737-798/79 Tinto MiTF, C5 and D5, MMab BSB 624798/79 Tinto MiTF, C5 and D5, MMab BSB 624898/79 Tinto MiTF, C5 and D5, MMab BSB 624998/79 Tinto MLH1, G168-728, MMab BSB 576498/79 Tinto MLH1, G168-728, MMab BSB 576598/79 Tinto MLH1, G168-728, MMab BSB 576698/79 Tinto MLH1, RBT-MLH1, RMab BSB-3787-1598/79 Tinto MLH1, RBT-MLH1, RMab BSB-3787-398/79 Tinto MLH1, RBT-MLH1, RMab BSB-3787-798/79 Tinto MMP-9, EP127, RMab BSB 253898/79 Tinto MMP-9, EP127, RMab BSB 253998/79 Tinto MMP-9, EP127, RMab BSB 254098/79 Tinto MNDA, BSB-157, MMab BSB-3738-1598/79 Tinto MNDA, BSB-157, MMab BSB-3738-398/79 Tinto MNDA, BSB-157, MMab BSB-3738-798/79 Tinto MSH2, BSB-147, MMab BSB-3722-1598/79 Tinto MSH2, BSB-147, MMab BSB-3722-398/79 Tinto MSH2, BSB-147, MMab BSB-3722-798/79 Tinto MSH2, RBT-MSH2, RMab BSB 692698/79 Tinto MSH2, RBT-MSH2, RMab BSB 692798/79 Tinto MSH2, RBT-MSH2, RMab BSB 692898/79 Tinto MSH6, 44, MMab BSB 614298/79 Tinto MSH6, 44, MMab BSB 614398/79 Tinto MSH6, 44, MMab BSB 614498/79 Tinto MSH6, EP49, RMab BSB 693298/79 Tinto MSH6, EP49, RMab BSB 693398/79 Tinto MSH6, EP49, RMab BSB 693498/79 Tinto MTAP, RBT-MTAP, RMab BSB-3739-1598/79 Tinto MTAP, RBT-MTAP, RMab BSB-3739-398/79 Tinto MTAP, RBT-MTAP, RMab BSB-3739-798/79 Tinto MUC-4, EP256, RMab BSB 255298/79 Tinto MUC-4, EP256, RMab BSB 255398/79 Tinto MUC-4, EP256, RMab BSB 255498/79 Tinto MUC1, BSB-44, MMab BSB 614998/79 Tinto MUC1, BSB-44, MMab BSB 615098/79 Tinto MUC1, BSB-44, MMab BSB 615198/79 Tinto MUC1, EP85, RMab BSB 693998/79 Tinto MUC1, EP85, RMab BSB 694098/79 Tinto MUC1, EP85, RMab BSB 694198/79 Tinto MUC1, RBT-MUC1, RMab BSB-3788-1598/79 Tinto MUC1, RBT-MUC1, RMab BSB-3788-398/79 Tinto MUC1, RBT-MUC1, RMab BSB-3788-798/79 Tinto MUC2, BSB-45, MMab BSB 615698/79 Tinto MUC2, BSB-45, MMab BSB 615798/79 Tinto MUC2, BSB-45, MMab BSB 615898/79 Tinto MUC2, EP187, RMab BSB 694698/79 Tinto MUC2, EP187, RMab BSB 694798/79 Tinto MUC2, EP187, RMab BSB 694898/79 Tinto MUC4, 8G7, MMab BSB 298598/79 Tinto MUC4, 8G7, MMab BSB 298698/79 Tinto MUC4, 8G7, MMab BSB 298798/79 Tinto MUC5AC, CLH2, MMab BSB 616398/79 Tinto MUC5AC, CLH2, MMab BSB 616498/79 Tinto MUC5AC, CLH2, MMab BSB 616598/79 Tinto MUC6, CLH5, MMab BSB 617098/79 Tinto MUC6, CLH5, MMab BSB 617198/79 Tinto MUC6, CLH5, MMab BSB 617298/79 Tinto MUM1, EP190, RMab BSB 695398/79 Tinto MUM1, EP190, RMab BSB 695498/79 Tinto MUM1, EP190, RMab BSB 695598/79 Tinto Musashi 2, RM422, RMab BSB-3740-1598/79 Tinto Musashi 2, RM422, RMab BSB-3740-398/79 Tinto Musashi 2, RM422, RMab BSB-3740-798/79 Tinto Mycobacterium tuberculosis, Polyclonal, RPab BSB 299298/79 Tinto Mycobacterium tuberculosis, Polyclonal, RPab BSB 299398/79 Tinto Mycobacterium tuberculosis, Polyclonal, RPab BSB 299498/79 Tinto Myelin Basic Protein, EP207, RMab BSB 696098/79 Tinto Myelin Basic Protein, EP207, RMab BSB 696198/79 Tinto Myelin Basic Protein, EP207, RMab BSB 696298/79 Tinto Myeloperoxidase, EP151, RMab BSB 696798/79 Tinto Myeloperoxidase, EP151, RMab BSB 696898/79 Tinto Myeloperoxidase, EP151, RMab BSB 696998/79 Tinto Myeloperoxidase, Polyclonal, RPab BSB 578598/79 Tinto Myeloperoxidase, Polyclonal, RPab BSB 578698/79 Tinto Myeloperoxidase, Polyclonal, RPab BSB 578798/79 Tinto MyoD1, EP212, RMab BSB 697498/79 Tinto MyoD1, EP212, RMab BSB 697598/79 Tinto MyoD1, EP212, RMab BSB 697698/79 Tinto Myogenin, F5D, MMab BSB 579298/79 Tinto Myogenin, F5D, MMab BSB 579398/79 Tinto Myogenin, F5D, MMab BSB 579498/79 Tinto Myoglobin, BSB-104, MMab BSB 338498/79 Tinto Myoglobin, BSB-104, MMab BSB 338598/79 Tinto Myoglobin, BSB-104, MMab BSB 338698/79 Tinto Myoglobin, EP87, RMab BSB 698198/79 Tinto Myoglobin, EP87, RMab BSB 698298/79 Tinto Myoglobin, EP87, RMab BSB 698398/79 Tinto Myosin Smooth Muscle, BSB-17, MMab BSB 592498/79 Tinto Myosin Smooth Muscle, BSB-17, MMab BSB 592598/79 Tinto Myosin Smooth Muscle, BSB-17, MMab BSB 592698/79 Tinto Nanog, EP225, RMab BSB 358198/79 Tinto Nanog, EP225, RMab BSB 358298/79 Tinto Nanog, EP225, RMab BSB 358398/79 Tinto Napsin A, BSB-112, MMab BSB 339298/79 Tinto Napsin A, BSB-112, MMab BSB 339398/79 Tinto Napsin A, BSB-112, MMab BSB 339498/79 Tinto Napsin A, EP205, RMab BSB 698898/79 Tinto Napsin A, EP205, RMab BSB 698998/79 Tinto Napsin A, EP205, RMab BSB 699098/79 Tinto Napsin A, RBT-NAPSA, RMab BSB-3789-1598/79 Tinto Napsin A, RBT-NAPSA, RMab BSB-3789-398/79 Tinto Napsin A, RBT-NAPSA, RMab BSB-3789-798/79 Tinto Nestin, EP287, RMab BSB 200098/79 Tinto Nestin, EP287, RMab BSB 200198/79 Tinto Nestin, EP287, RMab BSB 200298/79 Tinto NeuN, A60, MMab BSB 200798/79 Tinto NeuN, A60, MMab BSB 200898/79 Tinto NeuN, A60, MMab BSB 200998/79 Tinto NeuN, RBT-NeuN, RMab BSB-3781-1598/79 Tinto NeuN, RBT-NeuN, RMab BSB-3781-398/79 Tinto NeuN, RBT-NeuN, RMab BSB-3781-798/79 Tinto Neurofilament, 2F11, MMab BSB 581398/79 Tinto Neurofilament, 2F11, MMab BSB 581498/79 Tinto Neurofilament, 2F11, MMab BSB 581598/79 Tinto Neurofilament, EP79, RMab BSB 201498/79 Tinto Neurofilament, EP79, RMab BSB 201598/79 Tinto Neurofilament, EP79, RMab BSB 201698/79 Tinto NGFR, BSB-18, MMab BSB 628998/79 Tinto NGFR, BSB-18, MMab BSB 629098/79 Tinto NGFR, BSB-18, MMab BSB 629198/79 Tinto NKX2.2, EP336, RMab BSB 310698/79 Tinto NKX2.2, EP336, RMab BSB 310798/79 Tinto NKX2.2, EP336, RMab BSB 310898/79 Tinto NKX3.1, EP356, RMab BSB 311398/79 Tinto NKX3.1, EP356, RMab BSB 311498/79 Tinto NKX3.1, EP356, RMab BSB 311598/79 Tinto NKX3.1, RM430, RMab BSB-3785-1598/79 Tinto NKX3.1, RM430, RMab BSB-3785-398/79 Tinto NKX3.1, RM430, RMab BSB-3785-798/79 Tinto NRAS, RBT-NRAS, RMab BSB 266398/79 Tinto NRAS, RBT-NRAS, RMab BSB 266498/79 Tinto NRAS, RBT-NRAS, RMab BSB 266598/79 Tinto NSE, BSB-94, MMab BSB 582098/79 Tinto NSE, BSB-94, MMab BSB 582198/79 Tinto NSE, BSB-94, MMab BSB 582298/79 Tinto NUT\|NUTM1, RBT-NUTM1, RMab BSB-3793-1598/79 Tinto NUT\|NUTM1, RBT-NUTM1, RMab BSB-3793-398/79 Tinto NUT\|NUTM1, RBT-NUTM1, RMab BSB-3793-798/79 Tinto OCT-2, EP115, RMab BSB 202198/79 Tinto OCT-2, EP115, RMab BSB 202298/79 Tinto OCT-2, EP115, RMab BSB 202398/79 Tinto OCT-4, EP143, RMab BSB 202898/79 Tinto OCT-4, EP143, RMab BSB 202998/79 Tinto OCT-4, EP143, RMab BSB 203098/79 Tinto OLIG2, EP112, RMab BSB 255998/79 Tinto OLIG2, EP112, RMab BSB 256098/79 Tinto OLIG2, EP112, RMab BSB 256198/79 Tinto Osteonectin\|SPARC, BSB-93, MMab BSB 325898/79 Tinto Osteonectin\|SPARC, BSB-93, MMab BSB 325998/79 Tinto Osteonectin\|SPARC, BSB-93, MMab BSB 326098/79 Tinto OX-40\|CD134, BSB-90, MMab BSB 312098/79 Tinto OX-40\|CD134, BSB-90, MMab BSB 312198/79 Tinto OX-40\|CD134, BSB-90, MMab BSB 312298/79 Tinto p120 Catenin, EP66, RMab BSB 207798/79 Tinto p120 Catenin, EP66, RMab BSB 207898/79 Tinto p120 Catenin, EP66, RMab BSB 207998/79 Tinto p14 ARF, RBT-p14, RMab BSB 359598/79 Tinto p14 ARF, RBT-p14, RMab BSB 359698/79 Tinto p14 ARF, RBT-p14, RMab BSB 359798/79 Tinto p16, 16P04, JC2, MMab BSB 582798/79 Tinto p16, 16P04, JC2, MMab BSB 582898/79 Tinto p16, 16P04, JC2, MMab BSB 582998/79 Tinto p16, RBT-p16, RMab BSB 347698/79 Tinto p16, RBT-p16, RMab BSB 347798/79 Tinto p16, RBT-p16, RMab BSB 347898/79 Tinto p16, RM267, RMab BSB-3768-1598/79 Tinto p16, RM267, RMab BSB-3768-398/79 Tinto p16, RM267, RMab BSB-3768-798/79 Tinto p21, DCS-60.2, MMab BSB 206398/79 Tinto p21, DCS-60.2, MMab BSB 206498/79 Tinto p21, DCS-60.2, MMab BSB 206598/79 Tinto p27, SX53G8, MMab BSB 583498/79 Tinto p27, SX53G8, MMab BSB 583598/79 Tinto p27, SX53G8, MMab BSB 583698/79 Tinto p40, ZR8, RMab BSB 207098/79 Tinto p40, ZR8, RMab BSB 207198/79 Tinto p40, ZR8, RMab BSB 207298/79 Tinto p53, DO7, MMab BSB 584198/79 Tinto p53, DO7, MMab BSB 584298/79 Tinto p53, DO7, MMab BSB 584398/79 Tinto p57, Kp10, MMab BSB 619198/79 Tinto p57, Kp10, MMab BSB 619298/79 Tinto p57, Kp10, MMab BSB 619398/79 Tinto p63, 4A4, MMab BSB 360298/79 Tinto p63, 4A4, MMab BSB 360398/79 Tinto p63, 4A4, MMab BSB 360498/79 Tinto p63, EP174, RMab BSB 584898/79 Tinto p63, EP174, RMab BSB 584998/79 Tinto p63, EP174, RMab BSB 585098/79 Tinto pan-TRK, RBT-TRK, RMab BSB-2376-1598/79 Tinto pan-TRK, RBT-TRK, RMab BSB-2376-398/79 Tinto pan-TRK, RBT-TRK, RMab BSB-2376-798/79 Tinto pan-TRK, RM423, RMab BSB-3742-1598/79 Tinto pan-TRK, RM423, RMab BSB-3742-398/79 Tinto pan-TRK, RM423, RMab BSB-3742-798/79 Tinto Parafibromin, BSB-50, MMab BSB 274798/79 Tinto Parafibromin, BSB-50, MMab BSB 274898/79 Tinto Parafibromin, BSB-50, MMab BSB 274998/79 Tinto Parathyroid Hormone\| PTH, BSB-24, MMab BSB 208498/79 Tinto Parathyroid Hormone\| PTH, BSB-24, MMab BSB 208598/79 Tinto Parathyroid Hormone\| PTH, BSB-24, MMab BSB 208698/79 Tinto Parvalbumin, EP300, RMab BSB 340698/79 Tinto Parvalbumin, EP300, RMab BSB 340798/79 Tinto Parvalbumin, EP300, RMab BSB 340898/79 Tinto Parvovirus, R92F6, MMab BSB 585498/79 Tinto Parvovirus, R92F6, MMab BSB 585598/79 Tinto Parvovirus, R92F6, MMab BSB 585698/79 Tinto PAX-2, EP235, RMab BSB 256698/79 Tinto PAX-2, EP235, RMab BSB 256798/79 Tinto PAX-2, EP235, RMab BSB 256898/79 Tinto PAX-5, RBT-PAX5, RMab BSB 586198/79 Tinto PAX-5, RBT-PAX5, RMab BSB 586298/79 Tinto PAX-5, RBT-PAX5, RMab BSB 586398/79 Tinto PAX-7, BSB-145, MMab BSB-3743-1598/79 Tinto PAX-7, BSB-145, MMab BSB-3743-398/79 Tinto PAX-7, BSB-145, MMab BSB-3743-798/79 Tinto PAX-8, RM436, RMab BSB-3786-1598/79 Tinto PAX-8, RM436, RMab BSB-3786-398/79 Tinto PAX-8, RM436, RMab BSB-3786-798/79 Tinto PAX-8, ZR-1, RMab BSB 209898/79 Tinto PAX-8, ZR-1, RMab BSB 209998/79 Tinto PAX-8, ZR-1, RMab BSB 210098/79 Tinto PD-1\|CD279, EP239, RMab BSB 314898/79 Tinto PD-1\|CD279, EP239, RMab BSB 314998/79 Tinto PD-1\|CD279, EP239, RMab BSB 315098/79 Tinto PD-1\|CD279, NAT-105, MMab BSB 621298/79 Tinto PD-1\|CD279, NAT-105, MMab BSB 621398/79 Tinto PD-1\|CD279, NAT-105, MMab BSB 621498/79 Tinto PD-L1\|CD274, 28-8, RMab BSB-2371-1598/79 Tinto PD-L1\|CD274, 28-8, RMab BSB-2371-398/79 Tinto PD-L1\|CD274, 28-8, RMab BSB-2371-798/79 Tinto PD-L1\|CD274, RBT-PDL1, RMab BSB 264998/79 Tinto PD-L1\|CD274, RBT-PDL1, RMab BSB 265098/79 Tinto PD-L1\|CD274, RBT-PDL1, RMab BSB 265198/79 Tinto PDGFR-B, RBT-PDGFRB, RMab BSB 234998/79 Tinto PDGFR-B, RBT-PDGFRB, RMab BSB 235098/79 Tinto PDGFR-B, RBT-PDGFRB, RMab BSB 235198/79 Tinto PDX1, EP139, RMab BSB 315598/79 Tinto PDX1, EP139, RMab BSB 315698/79 Tinto PDX1, EP139, RMab BSB 315798/79 Tinto PELP1, RBT-PELP1, RMab BSB-3744-1598/79 Tinto PELP1, RBT-PELP1, RMab BSB-3744-398/79 Tinto PELP1, RBT-PELP1, RMab BSB-3744-798/79 Tinto Perforin, 5B10, MMab BSB 210598/79 Tinto Perforin, 5B10, MMab BSB 210698/79 Tinto Perforin, 5B10, MMab BSB 210798/79 Tinto PGP 9.5, BSB-46, MMab BSB 211298/79 Tinto PGP 9.5, BSB-46, MMab BSB 211398/79 Tinto PGP 9.5, BSB-46, MMab BSB 211498/79 Tinto PHOX2B, EP312, RMab BSB 360998/79 Tinto PHOX2B, EP312, RMab BSB 361098/79 Tinto PHOX2B, EP312, RMab BSB 361198/79 Tinto PLA2R1, BSB-129, MMab BSB-2372-1598/79 Tinto PLA2R1, BSB-129, MMab BSB-2372-398/79 Tinto PLA2R1, BSB-129, MMab BSB-2372-798/79 Tinto PLAP, BSB-47, MMab BSB 275498/79 Tinto PLAP, BSB-47, MMab BSB 275598/79 Tinto PLAP, BSB-47, MMab BSB 275698/79 Tinto PLAP, EP194, RMab BSB 586898/79 Tinto PLAP, EP194, RMab BSB 586998/79 Tinto PLAP, EP194, RMab BSB 587098/79 Tinto PMS2, EP51, RMab BSB 211998/79 Tinto PMS2, EP51, RMab BSB 212098/79 Tinto PMS2, EP51, RMab BSB 212198/79 Tinto Pneumocystis jirovecii, 3F6, MMab BSB 587598/79 Tinto Pneumocystis jirovecii, 3F6, MMab BSB 587698/79 Tinto Pneumocystis jirovecii, 3F6, MMab BSB 587798/79 Tinto Podoplanin\|D2-40, D2-40, MMab BSB 606498/79 Tinto Podoplanin\|D2-40, D2-40, MMab BSB 606598/79 Tinto Podoplanin\|D2-40, D2-40, MMab BSB 606698/79 Tinto PRAME, RBT-PRAME, RMab BSB-2374-1598/79 Tinto PRAME, RBT-PRAME, RMab BSB-2374-398/79 Tinto PRAME, RBT-PRAME, RMab BSB-2374-798/79 Tinto Prealbumin\|Transthyretin, BSB-125, MMab BSB 361698/79 Tinto Prealbumin\|Transthyretin, BSB-125, MMab BSB 361798/79 Tinto Prealbumin\|Transthyretin, BSB-125, MMab BSB 361898/79 Tinto Progesterone Receptor, BSB-2, MMab BSB 212698/79 Tinto Progesterone Receptor, BSB-2, MMab BSB 212798/79 Tinto Progesterone Receptor, BSB-2, MMab BSB 212898/79 Tinto Progesterone Receptor, EP2, RMab BSB 257398/79 Tinto Progesterone Receptor, EP2, RMab BSB 257498/79 Tinto Progesterone Receptor, EP2, RMab BSB 257598/79 Tinto Progesterone Receptor, RBT-22, RMab BSB 588298/79 Tinto Progesterone Receptor, RBT-22, RMab BSB 588398/79 Tinto Progesterone Receptor, RBT-22, RMab BSB 588498/79 Tinto Prolactin, EP193, RMab BSB 213398/79 Tinto Prolactin, EP193, RMab BSB 213498/79 Tinto Prolactin, EP193, RMab BSB 213598/79 Tinto Prolactin, PRL02, MMab BSB 588998/79 Tinto Prolactin, PRL02, MMab BSB 589098/79 Tinto Prolactin, PRL02, MMab BSB 589198/79 Tinto Prostein\|P501S, EP381, RMab BSB 316298/79 Tinto Prostein\|P501S, EP381, RMab BSB 316398/79 Tinto Prostein\|P501S, EP381, RMab BSB 316498/79 Tinto PSAP, PASE\|4LJ, MMab BSB 590398/79 Tinto PSAP, PASE\|4LJ, MMab BSB 590498/79 Tinto PSAP, PASE\|4LJ, MMab BSB 590598/79 Tinto PSMA, EP192, RMab BSB 634598/79 Tinto PSMA, EP192, RMab BSB 634698/79 Tinto PSMA, EP192, RMab BSB 634798/79 Tinto pTau Phospho\|Thr 181, BSB-176, MMab BSB-3807-1598/79 Tinto pTau Phospho\|Thr 181, BSB-176, MMab BSB-3807-398/79 Tinto pTau Phospho\|Thr 181, BSB-176, MMab BSB-3807-798/79 Tinto PTEN, RBT-PTEN, RMab BSB 264398/79 Tinto PTEN, RBT-PTEN, RMab BSB 264498/79 Tinto PTEN, RBT-PTEN, RMab BSB 264598/79 Tinto PTEN, RM265, RMab BSB-3769-1598/79 Tinto PTEN, RM265, RMab BSB-3769-398/79 Tinto PTEN, RM265, RMab BSB-3769-798/79 Tinto PU.1, EP18, RMab BSB 215498/79 Tinto PU.1, EP18, RMab BSB 215598/79 Tinto PU.1, EP18, RMab BSB 215698/79 Tinto Pygopus 2\|Pygo 2, BSB-156, MMab BSB-3745-1598/79 Tinto Pygopus 2\|Pygo 2, BSB-156, MMab BSB-3745-398/79 Tinto Pygopus 2\|Pygo 2, BSB-156, MMab BSB-3745-798/79 Tinto Renal Cell Carcinoma, PN-15, MMab BSB 591098/79 Tinto Renal Cell Carcinoma, PN-15, MMab BSB 591198/79 Tinto Renal Cell Carcinoma, PN-15, MMab BSB 591298/79 Tinto Retinoblastoma\| Rb, 1F8, MMab BSB 612798/79 Tinto Retinoblastoma\| Rb, 1F8, MMab BSB 612898/79 Tinto Retinoblastoma\| Rb, 1F8, MMab BSB 612998/79 Tinto ROS-1, EP282, RMab BSB 362398/79 Tinto ROS-1, EP282, RMab BSB 362498/79 Tinto ROS-1, EP282, RMab BSB 362598/79 Tinto S-100, 4C4.9, MMab BSB 591798/79 Tinto S-100, 4C4.9, MMab BSB 591898/79 Tinto S-100, 4C4.9, MMab BSB 591998/79 Tinto S100A1, EP184, RMab BSB 216198/79 Tinto S100A1, EP184, RMab BSB 216298/79 Tinto S100A1, EP184, RMab BSB 216398/79 Tinto S100P, EP186, RMab BSB 218298/79 Tinto S100P, EP186, RMab BSB 218398/79 Tinto S100P, EP186, RMab BSB 218498/79 Tinto SALL4, 6E3, MMab BSB 318398/79 Tinto SALL4, 6E3, MMab BSB 318498/79 Tinto SALL4, 6E3, MMab BSB 318598/79 Tinto SALL4, EP299, RMab BSB 319098/79 Tinto SALL4, EP299, RMab BSB 319198/79 Tinto SALL4, EP299, RMab BSB 319298/79 Tinto SATB2, EP281, RMab BSB 319798/79 Tinto SATB2, EP281, RMab BSB 319898/79 Tinto SATB2, EP281, RMab BSB 319998/79 Tinto SDHB, BSB-131, MMab BSB-2375-1598/79 Tinto SDHB, BSB-131, MMab BSB-2375-398/79 Tinto SDHB, BSB-131, MMab BSB-2375-798/79 Tinto SF-1\|Steroidogenic Factor 1, BSB-149, MMab BSB-3746-1598/79 Tinto SF-1\|Steroidogenic Factor 1, BSB-149, MMab BSB-3746-398/79 Tinto SF-1\|Steroidogenic Factor 1, BSB-149, MMab BSB-3746-798/79 Tinto SMAD4\|DPC4, BSB-63, MMab BSB 320498/79 Tinto SMAD4\|DPC4, BSB-63, MMab BSB 320598/79 Tinto SMAD4\|DPC4, BSB-63, MMab BSB 320698/79 Tinto SMAD4\|DPC4, RBT-SMAD4, RMab BSB 339998/79 Tinto SMAD4\|DPC4, RBT-SMAD4, RMab BSB 340098/79 Tinto SMAD4\|DPC4, RBT-SMAD4, RMab BSB 340198/79 Tinto Somatostatin Receptor 2\|SSTR2, EP149, RMab BSB-3748-1598/79 Tinto Somatostatin Receptor 2\|SSTR2, EP149, RMab BSB-3748-398/79 Tinto Somatostatin Receptor 2\|SSTR2, EP149, RMab BSB-3748-798/79 Tinto Somatostatin, BSB-113, MMab BSB 341398/79 Tinto Somatostatin, BSB-113, MMab BSB 341498/79 Tinto Somatostatin, BSB-113, MMab BSB 341598/79 Tinto SOX-10, BSB-62, MMab BSB 220998/79 Tinto SOX-10, BSB-62, MMab BSB 221098/79 Tinto SOX-10, BSB-62, MMab BSB 221198/79 Tinto SOX-10, EP268, RMab BSB 258098/79 Tinto SOX-10, EP268, RMab BSB 258198/79 Tinto SOX-10, EP268, RMab BSB 258298/79 Tinto SOX-11, CL0142, MMab BSB 221698/79 Tinto SOX-11, CL0142, MMab BSB 221798/79 Tinto SOX-11, CL0142, MMab BSB 221898/79 Tinto SOX-2, RM427, RMab BSB-3770-1598/79 Tinto SOX-2, RM427, RMab BSB-3770-398/79 Tinto SOX-2, RM427, RMab BSB-3770-798/79 Tinto SOX-9, EP317, RMab BSB 321198/79 Tinto SOX-9, EP317, RMab BSB 321298/79 Tinto SOX-9, EP317, RMab BSB 321398/79 Tinto Spectrin, RBC2\|3D5, MMab BSB 593898/79 Tinto Spectrin, RBC2\|3D5, MMab BSB 593998/79 Tinto Spectrin, RBC2\|3D5, MMab BSB 594098/79 Tinto SS18-SSX, RBT-SS18-SSX, RMab BSB-3796-1598/79 Tinto SS18-SSX, RBT-SS18-SSX, RMab BSB-3796-398/79 Tinto SS18-SSX, RBT-SS18-SSX, RMab BSB-3796-798/79 Tinto STAR, EP226, RMab BSB 363098/79 Tinto STAR, EP226, RMab BSB 363198/79 Tinto STAR, EP226, RMab BSB 363298/79 Tinto STAT6, EP325, RMab BSB 342098/79 Tinto STAT6, EP325, RMab BSB 342198/79 Tinto STAT6, EP325, RMab BSB 342298/79 Tinto Stathmin, EP247, RMab BSB 259498/79 Tinto Stathmin, EP247, RMab BSB 259598/79 Tinto Stathmin, EP247, RMab BSB 259698/79 Tinto Surfactant protein D\|SP-D, BSB-162, MMab BSB-3747-1598/79 Tinto Surfactant protein D\|SP-D, BSB-162, MMab BSB-3747-398/79 Tinto Surfactant protein D\|SP-D, BSB-162, MMab BSB-3747-798/79 Tinto Survivin, EP119, RMab BSB 222398/79 Tinto Survivin, EP119, RMab BSB 222498/79 Tinto Survivin, EP119, RMab BSB 222598/79 Tinto SV40, Pab101, MMab BSB 223098/79 Tinto SV40, Pab101, MMab BSB 223198/79 Tinto SV40, Pab101, MMab BSB 223298/79 Tinto Synaptophysin, EP158, RMab BSB 223798/79 Tinto Synaptophysin, EP158, RMab BSB 223898/79 Tinto Synaptophysin, EP158, RMab BSB 223998/79 Tinto Synaptophysin, Polyclonal, RPab BSB 594598/79 Tinto Synaptophysin, Polyclonal, RPab BSB 594698/79 Tinto Synaptophysin, Polyclonal, RPab BSB 594798/79 Tinto T-Bet\|TBX-2, EP263, RMab BSB 260198/79 Tinto T-Bet\|TBX-2, EP263, RMab BSB 260298/79 Tinto T-Bet\|TBX-2, EP263, RMab BSB 260398/79 Tinto TAG-72, BSB-21, MMab BSB 595298/79 Tinto TAG-72, BSB-21, MMab BSB 595398/79 Tinto TAG-72, BSB-21, MMab BSB 595498/79 Tinto Tau, BSB-115, MMab BSB 342798/79 Tinto Tau, BSB-115, MMab BSB 342898/79 Tinto Tau, BSB-115, MMab BSB 342998/79 Tinto TCL1, EP105, RMab BSB 225198/79 Tinto TCL1, EP105, RMab BSB 225298/79 Tinto TCL1, EP105, RMab BSB 225398/79 Tinto TCR Alpha, BSB-126, MMab BSB 363798/79 Tinto TCR Alpha, BSB-126, MMab BSB 363898/79 Tinto TCR Alpha, BSB-126, MMab BSB 363998/79 Tinto TCR Beta, BSB-117, MMab BSB 225898/79 Tinto TCR Beta, BSB-117, MMab BSB 225998/79 Tinto TCR Beta, BSB-117, MMab BSB 226098/79 Tinto TCR Delta, BSB-127, MMab BSB 364498/79 Tinto TCR Delta, BSB-127, MMab BSB 364598/79 Tinto TCR Delta, BSB-127, MMab BSB 364698/79 Tinto TDP-43\|TARDBP, BSB-166, MMab BSB-3776-1598/79 Tinto TDP-43\|TARDBP, BSB-166, MMab BSB-3776-398/79 Tinto TDP-43\|TARDBP, BSB-166, MMab BSB-3776-798/79 Tinto TdT, EP266, RMab BSB 260898/79 Tinto TdT, EP266, RMab BSB 260998/79 Tinto TdT, EP266, RMab BSB 261098/79 Tinto TdT, RBT-TdT, RMab BSB 226598/79 Tinto TdT, RBT-TdT, RMab BSB 226698/79 Tinto TdT, RBT-TdT, RMab BSB 226798/79 Tinto TFE3, EP285, RMab BSB 322598/79 Tinto TFE3, EP285, RMab BSB 322698/79 Tinto TFE3, EP285, RMab BSB 322798/79 Tinto Thymidylate synthase\|TS, BSB-160, MMab BSB-3750-1598/79 Tinto Thymidylate synthase\|TS, BSB-160, MMab BSB-3750-398/79 Tinto Thymidylate synthase\|TS, BSB-160, MMab BSB-3750-798/79 Tinto Thyroglobulin, 2H11 and 6E1, MMab BSB 276198/79 Tinto Thyroglobulin, 2H11 and 6E1, MMab BSB 276298/79 Tinto Thyroglobulin, 2H11 and 6E1, MMab BSB 276398/79 Tinto Thyroglobulin, BSB-49, MMab BSB 597398/79 Tinto Thyroglobulin, BSB-49, MMab BSB 597498/79 Tinto Thyroglobulin, BSB-49, MMab BSB 597598/79 Tinto Thyroid Peroxidase, EP159, RMab BSB 261598/79 Tinto Thyroid Peroxidase, EP159, RMab BSB 261698/79 Tinto Thyroid Peroxidase, EP159, RMab BSB 261798/79 Tinto TIA-1, RBT-TIA1, RMab BSB-3782-1598/79 Tinto TIA-1, RBT-TIA1, RMab BSB-3782-398/79 Tinto TIA-1, RBT-TIA1, RMab BSB-3782-798/79 Tinto TIA-1, TIA-1, MMab BSB 635298/79 Tinto TIA-1, TIA-1, MMab BSB 635398/79 Tinto TIA-1, TIA-1, MMab BSB 635498/79 Tinto TIGIT, BSB-152, MMab BSB-3751-1598/79 Tinto TIGIT, BSB-152, MMab BSB-3751-398/79 Tinto TIGIT, BSB-152, MMab BSB-3751-798/79 Tinto TIM-3\|HAVCR2\|CD366, BSB-163, MMab BSB-3752-1598/79 Tinto TIM-3\|HAVCR2\|CD366, BSB-163, MMab BSB-3752-398/79 Tinto TIM-3\|HAVCR2\|CD366, BSB-163, MMab BSB-3752-798/79 Tinto TLE1, 1F5, MMab BSB 231498/79 Tinto TLE1, 1F5, MMab BSB 231598/79 Tinto TLE1, 1F5, MMab BSB 231698/79 Tinto TLE1, BSB-142, MMab BSB-3784-1598/79 Tinto TLE1, BSB-142, MMab BSB-3784-398/79 Tinto TLE1, BSB-142, MMab BSB-3784-798/79 Tinto TLE1, RBT-TLE1, RMab BSB-3794-1598/79 Tinto TLE1, RBT-TLE1, RMab BSB-3794-398/79 Tinto TLE1, RBT-TLE1, RMab BSB-3794-798/79 Tinto TMPRSS2, BSB-136, MMab BSB-3703-1598/79 Tinto TMPRSS2, BSB-136, MMab BSB-3703-398/79 Tinto TMPRSS2, BSB-136, MMab BSB-3703-798/79 Tinto TNFa-IP2, BSB-141, MMab BSB-3708-1598/79 Tinto TNFa-IP2, BSB-141, MMab BSB-3708-398/79 Tinto TNFa-IP2, BSB-141, MMab BSB-3708-798/79 Tinto Topoisomerase IIa, RBT-Topo2a, RMab BSB 633898/79 Tinto Topoisomerase IIa, RBT-Topo2a, RMab BSB 633998/79 Tinto Topoisomerase IIa, RBT-Topo2a, RMab BSB 634098/79 Tinto TORC3\|CRTC3, BSB-175, MMab BSB-3805-1598/79 Tinto TORC3\|CRTC3, BSB-175, MMab BSB-3805-398/79 Tinto TORC3\|CRTC3, BSB-175, MMab BSB-3805-798/79 Tinto TRAcP, 9C5, MMab BSB 598098/79 Tinto TRAcP, 9C5, MMab BSB 598198/79 Tinto TRAcP, 9C5, MMab BSB 598298/79 Tinto Treponema pallidum, Polyclonal, RPab BSB 323298/79 Tinto Treponema pallidum, Polyclonal, RPab BSB 323398/79 Tinto Treponema pallidum, Polyclonal, RPab BSB 323498/79 Tinto Tri-Methyl-Histone H3(Lys27)\|H3K27Me3, RBT-H3K27Me3, RMab BSB-3806-1598/79 Tinto Tri-Methyl-Histone H3(Lys27)\|H3K27Me3, RBT-H3K27Me3, RMab BSB-3806-398/79 Tinto Tri-Methyl-Histone H3(Lys27)\|H3K27Me3, RBT-H3K27Me3, RMab BSB-3806-798/79 Tinto Trop-2\|EGP-1, BSB-148, MMab BSB-3754-1598/79 Tinto Trop-2\|EGP-1, BSB-148, MMab BSB-3754-398/79 Tinto Trop-2\|EGP-1, BSB-148, MMab BSB-3754-798/79 Tinto TRPS1, EP392, RMab BSB-3790-1598/79 Tinto TRPS1, EP392, RMab BSB-3790-398/79 Tinto TRPS1, EP392, RMab BSB-3790-798/79 Tinto Tryptase, G3, MMab BSB 598798/79 Tinto Tryptase, G3, MMab BSB 598898/79 Tinto Tryptase, G3, MMab BSB 598998/79 Tinto TSH, BSB-56, MMab BSB 599498/79 Tinto TSH, BSB-56, MMab BSB 599598/79 Tinto TSH, BSB-56, MMab BSB 599698/79 Tinto TSH, EP254, RMab BSB 262298/79 Tinto TSH, EP254, RMab BSB 262398/79 Tinto TSH, EP254, RMab BSB 262498/79 Tinto TTF-1, 8G7G3\|1, MMab BSB 600198/79 Tinto TTF-1, 8G7G3\|1, MMab BSB 600298/79 Tinto TTF-1, 8G7G3\|1, MMab BSB 600398/79 Tinto Tyrosinase, BSB-6, MMab BSB 600898/79 Tinto Tyrosinase, BSB-6, MMab BSB 600998/79 Tinto Tyrosinase, BSB-6, MMab BSB 601098/79 Tinto Uroplakin III, EP321, RMab BSB 323998/79 Tinto Uroplakin III, EP321, RMab BSB 324098/79 Tinto Uroplakin III, EP321, RMab BSB 324198/79 Tinto Uroplakin III, Polyclonal, RPab BSB 228698/79 Tinto Uroplakin III, Polyclonal, RPab BSB 228798/79 Tinto Uroplakin III, Polyclonal, RPab BSB 228898/79 Tinto Villin, CWWB1, MMab BSB 601598/79 Tinto Villin, CWWB1, MMab BSB 601698/79 Tinto Villin, CWWB1, MMab BSB 601798/79 Tinto Villin, EP163, RMab BSB 230098/79 Tinto Villin, EP163, RMab BSB 230198/79 Tinto Villin, EP163, RMab BSB 230298/79 Tinto Vimentin, EP21, RMab BSB 230798/79 Tinto Vimentin, EP21, RMab BSB 230898/79 Tinto Vimentin, EP21, RMab BSB 230998/79 Tinto Vimentin, V9, MMab BSB 602298/79 Tinto Vimentin, V9, MMab BSB 602398/79 Tinto Vimentin, V9, MMab BSB 602498/79 Tinto WT1, 6F-H2, MMab BSB 602998/79 Tinto WT1, 6F-H2, MMab BSB 603098/79 Tinto WT1, 6F-H2, MMab BSB 603198/79 Tinto YAP1, BSB-146, MMab BSB-3755-1598/79 Tinto YAP1, BSB-146, MMab BSB-3755-398/79 Tinto YAP1, BSB-146, MMab BSB-3755-798/79 Tinto Zap-70, 2F3.2, MMab BSB 603698/79 Tinto Zap-70, 2F3.2, MMab BSB 603798/79 Tinto Zap-70, 2F3.2, MMab BSB 603898/79 Tinto ZFAND3, BSB-169, MMab BSB-3797-1598/79 Tinto ZFAND3, BSB-169, MMab BSB-3797-398/79 Tinto ZFAND3, BSB-169, MMab BSB-3797-798/79 TintoFast Adipophilin, BSB-91, MMab BSB-3772-1598/79 TintoFast Adipophilin, BSB-91, MMab BSB-3772-398/79 TintoFast Adipophilin, BSB-91, MMab BSB-3772-798/79 TintoFast Androgen Receptor, BSB-4, MMab BSB-3690-1598/79 TintoFast Androgen Receptor, BSB-4, MMab BSB-3690-398/79 TintoFast Androgen Receptor, BSB-4, MMab BSB-3690-798/79 TintoFast CD31, 1A10, MMab BSB-3691-1598/79 TintoFast CD31, 1A10, MMab BSB-3691-398/79 TintoFast CD31, 1A10, MMab BSB-3691-798/79 TintoFast CD34, QBEnd\|10, MMab BSB 368198/79 TintoFast CD34, QBEnd\|10, MMab BSB 368298/79 TintoFast CD34, QBEnd\|10, MMab BSB 368398/79 TintoFast Chromogranin A, LK2H10, MMab BSB-3773-1598/79 TintoFast Chromogranin A, LK2H10, MMab BSB-3773-398/79 TintoFast Chromogranin A, LK2H10, MMab BSB-3773-798/79 TintoFast CK 5 and 6, D5 and 16B4, MMab BSB 366698/79 TintoFast CK 5 and 6, D5 and 16B4, MMab BSB 366798/79 TintoFast CK 5 and 6, D5 and 16B4, MMab BSB 366898/79 TintoFast CK AE1 and AE3, AE1 and AE3, MMab BSB 366398/79 TintoFast CK AE1 and AE3, AE1 and AE3, MMab BSB 366498/79 TintoFast CK AE1 and AE3, AE1 and AE3, MMab BSB 366598/79 TintoFast CK7, OV-TL 12\|30, MMab BSB 366998/79 TintoFast CK7, OV-TL 12\|30, MMab BSB 367098/79 TintoFast CK7, OV-TL 12\|30, MMab BSB 367198/79 TintoFast EMA, E29, MMab BSB-3692-1598/79 TintoFast EMA, E29, MMab BSB-3692-398/79 TintoFast EMA, E29, MMab BSB-3692-798/79 TintoFast EpCAM, Ber-EP4, MMab BSB 367898/79 TintoFast EpCAM, Ber-EP4, MMab BSB 367998/79 TintoFast EpCAM, Ber-EP4, MMab BSB 368098/79 TintoFast HMB-45, HMB-45, MMab BSB-3693-1598/79 TintoFast HMB-45, HMB-45, MMab BSB-3693-398/79 TintoFast HMB-45, HMB-45, MMab BSB-3693-798/79 TintoFast Ki-67, RM360, RMab BSB-3771-1598/79 TintoFast Ki-67, RM360, RMab BSB-3771-398/79 TintoFast Ki-67, RM360, RMab BSB-3771-798/79 TintoFast MART-1, A103, MMab BSB 365198/79 TintoFast MART-1, A103, MMab BSB 365298/79 TintoFast MART-1, A103, MMab BSB 365398/79 TintoFast Melanoma Cocktail: HMB-45, Mart-1 and Tyrosinase, HMB-45, A103 and BSB-6, MMab BSB-3695-1598/79 TintoFast Melanoma Cocktail: HMB-45, Mart-1 and Tyrosinase, HMB-45, A103 and BSB-6, MMab BSB-3695-398/79 TintoFast Melanoma Cocktail: HMB-45, Mart-1 and Tyrosinase, HMB-45, A103 and BSB-6, MMab BSB-3695-798/79 TintoFast MiTF, C5 and D5, MMab BSB 365798/79 TintoFast MiTF, C5 and D5, MMab BSB 365898/79 TintoFast MiTF, C5 and D5, MMab BSB 365998/79 TintoFast NGFR, BSB-18, MMab BSB-3696-1598/79 TintoFast NGFR, BSB-18, MMab BSB-3696-398/79 TintoFast NGFR, BSB-18, MMab BSB-3696-798/79 TintoFast p40, ZR8, RMab BSB-3697-1598/79 TintoFast p40, ZR8, RMab BSB-3697-398/79 TintoFast p40, ZR8, RMab BSB-3697-798/79 TintoFast p63, 4A4, MMab BSB-3698-1598/79 TintoFast p63, 4A4, MMab BSB-3698-398/79 TintoFast p63, 4A4, MMab BSB-3698-798/79 TintoFast Podoplanin, D2-40, MMab BSB-3699-1598/79 TintoFast Podoplanin, D2-40, MMab BSB-3699-398/79 TintoFast Podoplanin, D2-40, MMab BSB-3699-798/79 TintoFast Prame, RBT-PRAME, RMab BSB-3774-1598/79 TintoFast Prame, RBT-PRAME, RMab BSB-3774-398/79 TintoFast Prame, RBT-PRAME, RMab BSB-3774-798/79 TintoFast SOX-10, BSB-62, MMab BSB 365498/79 TintoFast SOX-10, BSB-62, MMab BSB 365598/79 TintoFast SOX-10, BSB-62, MMab BSB 365698/79 TintoFast Synaptophysin, Polyclonal, RPab BSB-3775-1598/79 TintoFast Synaptophysin, Polyclonal, RPab BSB-3775-398/79 TintoFast Synaptophysin, Polyclonal, RPab BSB-3775-798/79 TLE1, 1F5, MMab BSB 231798/79 TLE1, 1F5, MMab BSB 231898/79 TLE1, 1F5, MMab BSB 231998/79 TLE1, BSB-142, MMab BSB-3784-0198/79 TLE1, BSB-142, MMab BSB-3784-0598/79 TLE1, BSB-142, MMab BSB-3784-198/79 TLE1, RBT-TLE1, RMab BSB-3794-0198/79 TLE1, RBT-TLE1, RMab BSB-3794-0598/79 TLE1, RBT-TLE1, RMab BSB-3794-198/79 TMPRSS2, BSB-136, MMab BSB-3703-0198/79 TMPRSS2, BSB-136, MMab BSB-3703-0598/79 TMPRSS2, BSB-136, MMab BSB-3703-198/79 TNFa-IP2, BSB-141, MMab BSB-3708-0198/79 TNFa-IP2, BSB-141, MMab BSB-3708-0598/79 TNFa-IP2, BSB-141, MMab BSB-3708-198/79 Topoisomerase IIa, RBT-Topo2a, RMab BSB 634198/79 Topoisomerase IIa, RBT-Topo2a, RMab BSB 634298/79 Topoisomerase IIa, RBT-Topo2a, RMab BSB 634398/79 TORC3\|CRTC3, BSB-175, MMab BSB-3805-0198/79 TORC3\|CRTC3, BSB-175, MMab BSB-3805-0598/79 TORC3\|CRTC3, BSB-175, MMab BSB-3805-198/79 TRAcP, 9C5, MMab BSB 598398/79 TRAcP, 9C5, MMab BSB 598498/79 TRAcP, 9C5, MMab BSB 598598/79 Treponema pallidum, Polyclonal, RPab BSB 323598/79 Treponema pallidum, Polyclonal, RPab BSB 323698/79 Treponema pallidum, Polyclonal, RPab BSB 323798/79 Tri-Methyl-Histone H3(Lys27)\|H3K27Me3, RBT-H3K27Me3, RMab BSB-3806-0198/79 Tri-Methyl-Histone H3(Lys27)\|H3K27Me3, RBT-H3K27Me3, RMab BSB-3806-0598/79 Tri-Methyl-Histone H3(Lys27)\|H3K27Me3, RBT-H3K27Me3, RMab BSB-3806-198/79 Trop-2\|EGP-1, BSB-148, MMab BSB-3754-0198/79 Trop-2\|EGP-1, BSB-148, MMab BSB-3754-0598/79 Trop-2\|EGP-1, BSB-148, MMab BSB-3754-198/79 TRPS1, EP392, RMab BSB-3790-0198/79 TRPS1, EP392, RMab BSB-3790-0598/79 TRPS1, EP392, RMab BSB-3790-198/79 Tryptase, G3, MMab BSB 599098/79 Tryptase, G3, MMab BSB 599198/79 Tryptase, G3, MMab BSB 599298/79 TSH, BSB-56, MMab BSB 599798/79 TSH, BSB-56, MMab BSB 599898/79 TSH, BSB-56, MMab BSB 599998/79 TSH, EP254, RMab BSB 262598/79 TSH, EP254, RMab BSB 262698/79 TSH, EP254, RMab BSB 262798/79 TTF-1, 8G7G3\|1, MMab BSB 600498/79 TTF-1, 8G7G3\|1, MMab BSB 600598/79 TTF-1, 8G7G3\|1, MMab BSB 600698/79 Tyrosinase, BSB-6, MMab BSB 601198/79 Tyrosinase, BSB-6, MMab BSB 601298/79 Tyrosinase, BSB-6, MMab BSB 601398/79 Uroplakin III, EP321, RMab BSB 324298/79 Uroplakin III, EP321, RMab BSB 324398/79 Uroplakin III, EP321, RMab BSB 324498/79 Uroplakin III, Polyclonal, RPab BSB 228998/79 Uroplakin III, Polyclonal, RPab BSB 229098/79 Uroplakin III, Polyclonal, RPab BSB 229198/79 Villin, CWWB1, MMab BSB 601898/79 Villin, CWWB1, MMab BSB 601998/79 Villin, CWWB1, MMab BSB 602098/79 Villin, EP163, RMab BSB 230398/79 Villin, EP163, RMab BSB 230498/79 Villin, EP163, RMab BSB 230598/79 Vimentin, EP21, RMab BSB 231098/79 Vimentin, EP21, RMab BSB 231198/79 Vimentin, EP21, RMab BSB 231298/79 Vimentin, V9, MMab BSB 602598/79 Vimentin, V9, MMab BSB 602698/79 Vimentin, V9, MMab BSB 602798/79 WT1, 6F-H2, MMab BSB 603298/79 WT1, 6F-H2, MMab BSB 603398/79 WT1, 6F-H2, MMab BSB 603498/79 YAP1, BSB-146, MMab BSB-3755-0198/79 YAP1, BSB-146, MMab BSB-3755-0598/79 YAP1, BSB-146, MMab BSB-3755-198/79 Zap-70, 2F3.2, MMab BSB 603998/79 Zap-70, 2F3.2, MMab BSB 604098/79 Zap-70, 2F3.2, MMab BSB 604198/79 ZFAND3, BSB-169, MMab BSB-3797-0198/79 ZFAND3, BSB-169, MMab BSB-3797-0598/79 ZFAND3, BSB-169, MMab BSB-3797-198/79	– 98/79	Site web ra@biosb.com Fiche EUDAMED Signaler une erreur
Vitrosens	Turquie	ChainFor Adenovirus Detection qPCR Kit CFP3898/79 ChainFor Astrovirus Detection qPCR Kit CFP3998/79 ChainFor Candida Albicans Detection qPCR Kit CFP11098/79 ChainFor CCHFV Detection qPCR Kit CFP10598/79 ChainFor Clostridium diﬀicile Detection qPCR Kit CFP3498/79 646 autres ChainFor CNS & Tick Bourne Infection ID-32 Genotyping qPCR Kit CFP2498/79 ChainFor Cryptosporidium Detection qPCR Kit CFP4598/79 ChainFor EHEC + EPEC + EIEC Detection qPCR Kit CFP5198/79 ChainFor Entamoeba histolytica Detection qPCR Kit CFP4698/79 ChainFor ETEC + EIEC Detection qPCR Kit CFP5298/79 ChainFor Gastroenteritis Parasitic Pathogen Detection qPCR Kit CFP2298/79 ChainFor Gastroenteritis Viral Pathogen Detection qPCR Kit CFP2098/79 ChainFor Giardia lamblia Detection qPCR Kit CFP4798/79 ChainFor HDV Detection qPCR Kit CFP7298/79 ChainFor HPV Screening ID-15 qPCR Kit CFP0798/79 ChainFor HPV Screening ID-26 qPCR Kit CFP0898/79 ChainFor HSV-6 Detection qPCR Kit CFP11598/79 ChainFor Human Metapneumovirus (hMPV) Detection qPCR Kit CFP7798/79 ChainFor Influenza A/B Detection qPCR Kit CFP6498/79 ChainFor Influenza ID-2 Genotyping Detection qPCR Kit CFP6798/79 ChainFor Influenza ID-3 Genotyping Detection qPCR Kit CFP6698/79 ChainFor Malaria Detection qPCR Kit CFP9898/79 ChainFor Norovirus GI + GII Detection qPCR Kit CFP5798/79 ChainFor Norovirus GI Detection qPCR Kit CFP4098/79 ChainFor Norovirus GII Detection RT-qPCR Kit CFP4198/79 ChainFor Parechovirus Detection qPCR Kit CFP7898/79 ChainFor Respiratory ID-4 Genotyping qPCR Kit CFP1398/79 ChainFor Rhinovirus Detection qPCR Kit CFP7998/79 ChainFor Rotavirus Detection qPCR Kit CFP4298/79 ChainFor UTI ID-27 Genotyping qPCR Kit CFP1698/79 ChainFor West Nile Virus Detection qPCR Kit CFP10198/79 ChainFor Wound ID-30 Genotyping qPCR Kit CFP1798/79 ChainFor Yersinia enterocolitica Detection qPCR Kit CFP3298/79 ChainFor™170 réf. ChainFor™ CFP05P2598/79 ChainFor™ CFP05P5098/79 ChainFor™ CFP07P2598/79 ChainFor™ CFP07P5098/79 ChainFor™ CFP09P2598/79 ChainFor™ CFP102P2598/79 ChainFor™ CFP103P10098/79 ChainFor™ CFP103P2598/79 ChainFor™ CFP105P5098/79 ChainFor™ CFP109P2598/79 ChainFor™ CFP109P5098/79 ChainFor™ CFP10P2598/79 ChainFor™ CFP10P5098/79 ChainFor™ CFP110P5098/79 ChainFor™ CFP111P10098/79 ChainFor™ CFP111P5098/79 ChainFor™ CFP112P2598/79 ChainFor™ CFP112P5098/79 ChainFor™ CFP113P2598/79 ChainFor™ CFP115P10098/79 ChainFor™ CFP115P2598/79 ChainFor™ CFP116P2598/79 ChainFor™ CFP116P5098/79 ChainFor™ CFP117P10098/79 ChainFor™ CFP117P2598/79 ChainFor™ CFP118P2598/79 ChainFor™ CFP118P5098/79 ChainFor™ CFP120P2598/79 ChainFor™ CFP129P10098/79 ChainFor™ CFP131P10098/79 ChainFor™ CFP133P2598/79 ChainFor™ CFP134P10098/79 ChainFor™ CFP137P2598/79 ChainFor™ CFP139P10098/79 ChainFor™ CFP139P2598/79 ChainFor™ CFP140P5098/79 ChainFor™ CFP141P10098/79 ChainFor™ CFP141P5098/79 ChainFor™ CFP151P10098/79 ChainFor™ CFP151P2598/79 ChainFor™ CFP151P5098/79 ChainFor™ CFP152P5098/79 ChainFor™ CFP155P10098/79 ChainFor™ CFP157P2598/79 ChainFor™ CFP157P5098/79 ChainFor™ CFP158P10098/79 ChainFor™ CFP158P5098/79 ChainFor™ CFP159P10098/79 ChainFor™ CFP159P5098/79 ChainFor™ CFP160P10098/79 ChainFor™ CFP160P2598/79 ChainFor™ CFP160P5098/79 ChainFor™ CFP161P2598/79 ChainFor™ CFP162P2598/79 ChainFor™ CFP163P2598/79 ChainFor™ CFP163P5098/79 ChainFor™ CFP164P2598/79 ChainFor™ CFP167P10098/79 ChainFor™ CFP167P2598/79 ChainFor™ CFP167P5098/79 ChainFor™ CFP169P5098/79 ChainFor™ CFP171P2598/79 ChainFor™ CFP171P5098/79 ChainFor™ CFP172P10098/79 ChainFor™ CFP172P2598/79 ChainFor™ CFP172P5098/79 ChainFor™ CFP175P2598/79 ChainFor™ CFP176P10098/79 ChainFor™ CFP177P10098/79 ChainFor™ CFP177P5098/79 ChainFor™ CFP179P10098/79 ChainFor™ CFP179P2598/79 ChainFor™ CFP179P5098/79 ChainFor™ CFP180P5098/79 ChainFor™ CFP182P5098/79 ChainFor™ CFP185P10098/79 ChainFor™ CFP186P10098/79 ChainFor™ CFP186P2598/79 ChainFor™ CFP192P10098/79 ChainFor™ CFP192P2598/79 ChainFor™ CFP192P5098/79 ChainFor™ CFP194P5098/79 ChainFor™ CFP195P10098/79 ChainFor™ CFP196P10098/79 ChainFor™ CFP196P2598/79 ChainFor™ CFP197P5098/79 ChainFor™ CFP200P10098/79 ChainFor™ CFP200P5098/79 ChainFor™ CFP206P2598/79 ChainFor™ CFP28P2598/79 ChainFor™ CFP28P5098/79 ChainFor™ CFP35P10098/79 ChainFor™ CFP35P5098/79 ChainFor™ CFP36P2598/79 ChainFor™ CFP36P5098/79 ChainFor™ CFP43P2598/79 ChainFor™ CFP44P2598/79 ChainFor™ CFP46P2598/79 ChainFor™ CFP47P10098/79 ChainFor™ CFP48P10098/79 ChainFor™ CFP48P5098/79 ChainFor™ CFP52P10098/79 ChainFor™ CFP52P2598/79 ChainFor™ CFP54P2598/79 ChainFor™ CFP54P5098/79 ChainFor™ CFP55P5098/79 ChainFor™ CFP56P2598/79 ChainFor™ CFP56P5098/79 ChainFor™ CFP57P2598/79 ChainFor™ CFP57P5098/79 ChainFor™ CFP58P5098/79 ChainFor™ CFP59P10098/79 ChainFor™ CFP59P2598/79 ChainFor™ CFP60P10098/79 ChainFor™ CFP61P10098/79 ChainFor™ CFP61P5098/79 ChainFor™ CFP62P5098/79 ChainFor™ CFP63P10098/79 ChainFor™ CFP64P10098/79 ChainFor™ CFP64P2598/79 ChainFor™ CFP66P10098/79 ChainFor™ CFP66P2598/79 ChainFor™ CFP66P5098/79 ChainFor™ CFP67P10098/79 ChainFor™ CFP67P5098/79 ChainFor™ CFP68P10098/79 ChainFor™ CFP69P10098/79 ChainFor™ CFP73P10098/79 ChainFor™ CFP73P2598/79 ChainFor™ CFP82P10098/79 ChainFor™ CFP82P2598/79 ChainFor™ CFP82P5098/79 ChainFor™ CFP83P2598/79 ChainFor™ CFP87P10098/79 ChainFor™ CFP88P2598/79 ChainFor™ CFP88P5098/79 ChainFor™ CFP94P5098/79 ChainFor™ CFP95P10098/79 ChainFor™ CFP96P2598/79 ChainFor™ CFP96P5098/79 ChainFor™ CFP98P2598/79 ChainFor™ CFP99P10098/79 ChainFor™ CNS v1.0 Genotyping qPCR Kit2 réf. ChainFor™ Gastroenteritis Bacterial ID-14 Genotyping qPCR Kit3 réf. ChainFor™ Gastroenteritis v1.0 Genotyping qPCR Kit3 réf. ChainFor™ Gastroenteritis ID-23 Genotyping qPCR Kit3 réf. ChainFor™ H1N1 Detection qPCR Kit CFP6098/79 ChainFor™ HHV-6/HHV-7 Genotyping qPCR Kit2 réf. ChainFor™ HHV-8 qPCR Kit3 réf. ChainFor™ HPV 16/18 Genotyping qPCR Kit3 réf. ChainFor™ HPV 16/18/45 Genotyping qPCR Kit3 réf. ChainFor™ HPV ID-14 Genotyping qPCR Kit3 réf. ChainFor™ HPV ID-14 Screening qPCR Kit3 réf. ChainFor™ HPV ID-16 Genotyping qPCR Kit3 réf. ChainFor™ HSV-1 qPCR Kit3 réf. ChainFor™ HSV-1/HSV-2 Genotyping qPCR Kit2 réf. ChainFor™ HSV-1/HSV-2/TP Genotyping qPCR Kit3 réf. ChainFor™ HSV-1/HSV-2/VZV Genotyping qPCR Kit3 réf. ChainFor™ HSV-2 qPCR Kit3 réf. ChainFor™ Influenza A ID-4 Genotyping Detection qPCR Kit CFP6598/79 ChainFor™ LYO04WS243 réf. ChainFor™ LYO185WS243 réf. ChainFor™ LYO190WS243 réf. ChainFor™ Parvovirus B19 qPCR Kit3 réf. ChainFor™ Respiratory ID-28 Genotyping qPCR Kit2 réf. ChainFor™ Respiratory v1.0 Genotyping qPCR Kit3 réf. ChainFor™ Respiratory v2.0 Genotyping qPCR Kit3 réf. ChainFor™ Respiratory v3.0 Genotyping qPCR Kit3 réf. ChainFor™ Respiratory v5.0 Genotyping qPCR Kit3 réf. ChainFor™ Respiratory ID-7 Genotyping qPCR Kit3 réf. ChainFor™ SARS-CoV-2/FLU/RSV Genotyping qPCR Kit3 réf. ChainFor™ Sepsis v1.0 Genotyping qPCR Kit3 réf. ChainFor™ Sepsis v2.0 Genotyping qPCR Kit3 réf. ChainFor™ STI ID-12 Genotyping qPCR Kit3 réf. ChainFor™ UTI v1.0 Genotyping qPCR Kit3 réf. ChainFor™ UTI ID-27 Genotyping qPCR Kit3 réf. ChainFor™ Vaginosis v1.0 Genotyping qPCR Kit2 réf. ChainFor™ Vaginosis ID-20 Genotyping qPCR Kit2 réf. ChainFor™ Women’s Health v1.0 Genotyping qPCR Kit3 réf. FIAPro™ Automatic Immunofluorescence Analyzer VMFIA05 LyoSens FLU A qPCR Kit LYO146WS9698/79 LyoSens FLU B qPCR Kit LYO147WS9698/79 LyoSens JCV qPCR Kit LYO100WS9698/79 LyoSens SARS-CoV-2 qPCR Kit LYO106WS9698/79 LyoSens Adenovirus Detection qPCR Kit LYO1298/79 LyoSens ADV Quantitative qPCR Kit LYO130WS9698/79 LyoSens Astrovirus Detection qPCR Kit LYO1398/79 LyoSens BKV qPCR Kit LYO97WS9698/79 LyoSens Campylobacter spp. Detection qPCR Kit LYO0598/79 LyoSens CCHFV Detection qPCR Kit LYO7698/79 LyoSens Chikungunya Virus Detection qPCR Kit LYO6598/79 LyoSens Chlamydia pneumoniae qPCR Kit LYO27WS9698/79 LyoSens Chlamydia Trachomatis Detection qPCR Kit LYO4898/79 LyoSens Clostridium difficile toxins A+B Detection qPCR Kit LYO2398/79 LyoSens Clostridium diﬀicile Detection qPCR Kit LYO0898/79 LyoSens Clostridium diﬀicile toxin A/B Genotyping qPCR Kit LYO11WS9698/79 LyoSens CMV Detection qPCR Kit LYO4298/79 LyoSens Cryptosporidium Detection qPCR Kit LYO1898/79 LyoSens Dengue Virus Detection qPCR Kit LYO6698/79 LyoSens E. coli EHEC, EPEC & EIEC Detection qPCR Kit LYO2498/79 LyoSens E. coli ETEC + EIEC Detection qPCR Kit LYO2598/79 LyoSens EBV qPCR Kit LYO41WS9698/79 LyoSens Entamoeba histolytica Detection qPCR Kit LYO1998/79 LyoSens FLU A + B qPCR Kit LYO37WS9698/79 LyoSens Gardnerella vaginalis Detection qPCR Kit LYO5798/79 LyoSens Genital Ulcer Genotyping qPCR Kit LYO5598/79 LyoSens Giardia lamblia Detection qPCR Kit LYO2098/79 LyoSens H1N1 Detection qPCR Kit LYO3398/79 LyoSens Haemophilus Ducreyi Detection qPCR Kit LYO8198/79 LyoSens HAV Detection qPCR Kit LYO4498/79 LyoSens HDV Detection qPCR Kit LYO4598/79 LyoSens HEV Detection qPCR Kit LYO4398/79 LyoSens hMPV Detection qPCR Kit LYO4998/79 LyoSens HPV 16/18 Genotyping qPCR Kit LYO4698/79 LyoSens HSV-1/HSV-2/TP qPCR Kit LYO128WS9698/79 LyoSens Influenza A ID-4 Genotyping qPCR Kit LYO3898/79 LyoSens Influenza ID-2 Genotyping qPCR Kit LYO4098/79 LyoSens Influenza ID-3 Genotyping qPCR Kit LYO3998/79 LyoSens Lyme Disease Detection qPCR Kit LYO6798/79 LyoSens Malaria Detection qPCR Kit LYO6998/79 LyoSens Measles Detection qPCR Kit LYO6298/79 LyoSens Mumps Detection qPCR Kit LYO7498/79 LyoSens Norovirus GI + GII Detection qPCR Kit LYO3098/79 LyoSens Norovirus GI LYO1498/79 LyoSens Norovirus GII Detection qPCR Kit LYO1598/79 LyoSens Parechovirus Detection qPCR Kit LYO5098/79 LyoSens Parvovirus B19 Detection qPCR Kit LYO6498/79 LyoSens Rhinovirus Detection qPCR Kit LYO5198/79 LyoSens Rotavirus Detection qPCR Kit LYO1698/79 LyoSens RSV A + B qPCR Kit LYO148WS9698/79 LyoSens Salmonella spp. Detection qPCR Kit LYO0498/79 LyoSens Shigella/Enteroinvasive E. coli (EIEC) Detection qPCR Kit LYO0798/79 LyoSens Toxoplasma Detection qPCR Kit LYO6398/79 LyoSens Toxoplasma gondii qPCR Kit LYO149WS9698/79 LyoSens West Nile Virus Detection qPCR Kit LYO7298/79 LyoSens Yersinia enterocolitica Detection qPCR Kit LYO0698/79 LyoSens Zika Virus Detection qPCR Kit LYO7398/79 LyoSense Salmonella spp. Detection qPCR Kit LYO0498/79 LyoSens™9 réf. LyoSens™ LY010WS4898/79 LyoSens™ LYO04WS4898/79 LyoSens™ LYO04WS9698/79 LyoSens™ LYO07WS4898/79 LyoSens™ LYO101WS2498/79 LyoSens™ LYO101WS4898/79 LyoSens™ LYO101WS9698/79 LyoSens™ LYO103WS9698/79 LyoSens™ LYO105WS2498/79 LyoSens™ LYO105WS4898/79 LyoSens™ LYO109WS4898/79 LyoSens™ LYO10WS9698/79 LyoSens™ LYO110WS9698/79 LyoSens™ LYO111WS2498/79 LyoSens™ LYO111WS4898/79 LyoSens™ LYO112WS4898/79 LyoSens™ LYO112WS9698/79 LyoSens™ LYO113WS2498/79 LyoSens™ LYO113WS9698/79 LyoSens™ LYO116WS2498/79 LyoSens™ LYO116WS9698/79 LyoSens™ LYO118WS2498/79 LyoSens™ LYO118WS4898/79 LyoSens™ LYO120WS2498/79 LyoSens™ LYO120WS4898/79 LyoSens™ LYO129WS2498/79 LyoSens™ LYO131WS4898/79 LyoSens™ LYO131WS9698/79 LyoSens™ LYO133WS2498/79 LyoSens™ LYO134WS2498/79 LyoSens™ LYO137WS2498/79 LyoSens™ LYO137WS9698/79 LyoSens™ LYO139WS2498/79 LyoSens™ LYO139WS4898/79 LyoSens™ LYO140WS4898/79 LyoSens™ LYO140WS9698/79 LyoSens™ LYO141WS4898/79 LyoSens™ LYO151WS2498/79 LyoSens™ LYO151WS4898/79 LyoSens™ LYO155WS4898/79 LyoSens™ LYO157WS9698/79 LyoSens™ LYO159WS4898/79 LyoSens™ LYO159WS9698/79 LyoSens™ LYO160WS2498/79 LyoSens™ LYO160WS4898/79 LyoSens™ LYO160WS9698/79 LyoSens™ LYO161WS2498/79 LyoSens™ LYO161WS4898/79 LyoSens™ LYO161WS9698/79 LyoSens™ LYO162WS4898/79 LyoSens™ LYO162WS9698/79 LyoSens™ LYO163WS2498/79 LyoSens™ LYO163WS4898/79 LyoSens™ LYO163WS9698/79 LyoSens™ LYO164WS2498/79 LyoSens™ LYO164WS4898/79 LyoSens™ LYO166WS2498/79 LyoSens™ LYO166WS9698/79 LyoSens™ LYO167WS9698/79 LyoSens™ LYO169WS2498/79 LyoSens™ LYO171WS2498/79 LyoSens™ LYO174WS2498/79 LyoSens™ LYO176WS2498/79 LyoSens™ LYO176WS9698/79 LyoSens™ LYO177WS9698/79 LyoSens™ LYO178WS9698/79 LyoSens™ LYO179WS243 réf. LyoSens™ LYO182WS2498/79 LyoSens™ LYO182WS4898/79 LyoSens™ LYO182WS9698/79 LyoSens™ LYO185WS4898/79 LyoSens™ LYO186WS2498/79 LyoSens™ LYO186WS9698/79 LyoSens™ LYO192WS9698/79 LyoSens™ LYO194WS2498/79 LyoSens™ LYO194WS4898/79 LyoSens™ LYO194WS9698/79 LyoSens™ LYO195WS4898/79 LyoSens™ LYO196WS4898/79 LyoSens™ LYO196WS9698/79 LyoSens™ LYO197WS2498/79 LyoSens™ LYO197WS9698/79 LyoSens™ LYO199WS4898/79 LyoSens™ LYO199WS9698/79 LyoSens™ LYO200WS9698/79 LyoSens™ LYO206WS4898/79 LyoSens™ LYO28WS2498/79 LyoSens™ LYO34WS2498/79 LyoSens™ LYO34WS4898/79 LyoSens™ LYO34WS9698/79 LyoSens™ LYO35WS9698/79 LyoSens™ LYO36WS2498/79 LyoSens™ LYO43WS2498/79 LyoSens™ LYO43WS4898/79 LyoSens™ LYO43WS9698/79 LyoSens™ LYO44WS2498/79 LyoSens™ LYO47WS4898/79 LyoSens™ LYO47WS9698/79 LyoSens™ LYO48WS2498/79 LyoSens™ LYO52WS4898/79 LyoSens™ LYO52WS9698/79 LyoSens™ LYO54WS2498/79 LyoSens™ LYO54WS9698/79 LyoSens™ LYO55WS2498/79 LyoSens™ LYO55WS9698/79 LyoSens™ LYO56WS4898/79 LyoSens™ LYO57WS9698/79 LyoSens™ LYO58WS9698/79 LyoSens™ LYO59WS4898/79 LyoSens™ LYO59WS9698/79 LyoSens™ LYO61WS9698/79 LyoSens™ LYO62WS2498/79 LyoSens™ LYO62WS9698/79 LyoSens™ LYO63WS4898/79 LyoSens™ LYO64WS4898/79 LyoSens™ LYO65WS2498/79 LyoSens™ LYO65WS9698/79 LyoSens™ LYO66WS4898/79 LyoSens™ LYO66WS9698/79 LyoSens™ LYO67WS2498/79 LyoSens™ LYO67WS4898/79 LyoSens™ LYO67WS9698/79 LyoSens™ LYO68WS2498/79 LyoSens™ LYO69WS2498/79 LyoSens™ LYO73WS9698/79 LyoSens™ LYO815WS2498/79 LyoSens™ LYO81WS9698/79 LyoSens™ LYO82WS4898/79 LyoSens™ LYO82WS9698/79 LyoSens™ LYO83WS9698/79 LyoSens™ LYO87WS2498/79 LyoSens™ LYO87WS4898/79 LyoSens™ LYO88WS2498/79 LyoSens™ LYO88WS4898/79 LyoSens™ LYO88WS9698/79 LyoSens™ LYO92WS4898/79 LyoSens™ LYO94WS2498/79 LyoSens™ LYO94WS9698/79 LyoSens™ LYO95WS4898/79 LyoSens™ LYO98WS4898/79 LyoSens™ LYO99WS2498/79 LyoSens™ Respiratory v4.0 Genotyping qPCR Kit LyoSens™ SARS-CoV-2 qPCR Kit2 réf. MagFast 16 Genomic DNA Purification Kit from Bacteria MGF11P96 MagFast 16 Genomic DNA Purification Kit From Blood MGF07P48 MagFast 16-Flex Genomic DNA Purification Kit From Blood MGF08P48 MagFast Single-Cartridge Genomic DNA Purification Kit From Bacteria MGF10P48 MagFast Single-Cartridge Genomic DNA Purification Kit From Blood MGF06P48 MagFast Single-Cartridge Genomic DNA Purification Kit From Blood MGF06P96 MagFast 16 Genomic DNA Purification Kit from Bacteria MGF11P48 MagFast 16 Genomic DNA Purification Kit From Blood MGF07P96 MagFast 16 Total Nucleic Acid Purification Kit MGF03P48 MagFast 16 Total Nucleic Acid Purification Kit MGF03P96 MagFast 16-Flex Genomic DNA Purification Kit From Bacteria MGF12P48 MagFast 16-Flex Genomic DNA Purification Kit From Bacteria MGF12P96 MagFast 16-Flex Genomic DNA Purification Kit From Blood MGF08P96 MagFast 16-Flex Total Nucleic Acid Purification Kit MGF04P48 MagFast 16-Flex Total Nucleic Acid Purification Kit MGF04P96 MagFast Genomic DNA Purification Kit From Bacteria MGF09P100 MagFast Genomic DNA Purification Kit From Blood MGF05P100 MagFast Genomic DNA Purification Kit From Blood MGF05P96 MagFast Single-Cartridge Genomic DNA Purification Kit From Bacteria MGF10P96 MagFast Single-Cartridge Nucleic Acid Purification Kit MGF02P48 MagFast Single-Cartridge Nucleic Acid Purification Kit MGF02P96 MagFast Total Nucleic Acid Purification Kit MGF01P100 PCPO07-01 PCPO27-01 PCPO28-01 PCPO29-01 PCPO30-01 PCPO31-01 PCPO32-01 PCPO33-01 PCPO34-01 PCPO35-01 PCPO44-01 RapidFor™82 réf. RapidFor™ Adenovirus Rapid Test Kit (FIA) VMPO6598/79 RapidFor™ C.difficile GDH v2.0 Test Kit RapidFor™ Chikungunya IgM Rapid Test Kit VMD0598/79 RapidFor™ CMV Rapid Test Kit VMD12498/79 RapidFor™ Crypto + Giardia + Entamoeba v2.0 Test Kit RapidFor™ Cryptosporidium v2.0 Test Kit RapidFor™ CT + NG v2.0 Test Kit RapidFor™ Dengue IgG/IgM Rapid Test Kit (FIA) VMPO7298/79 RapidFor™ Dengue NS1 Ag Rapid Test Kit (FIA) VMPO7198/79 RapidFor™ Dengue NS1 Test Kit2 réf. RapidFor™ E.coli O157:H7 Test Kit2 réf. RapidFor™ Enterovirus 71 IgM Rapid Test Kit VMD10898/79 RapidFor™ Enterovirus Ag Rapid Test Kit VMD12298/79 RapidFor™ Giardia Lamblia v2.0 Test Kit RapidFor™ Giardia lamblia (FIA) VMPO107GAD98/79 RapidFor™ H.pylori Ag Rapid Test Kit (FIA) VMPO6798/79 RapidFor™ H.Pylori v2.0 Test Kit RapidFor™ HBsAb Rapid Test Kit (FIA) VMPO8898/79 RapidFor™ HPV 16/18 Test Kit RapidFor™ HSV (1/2) IgG/IgM Test Kit RapidFor™ HSV-1 IgG/IgM Test Kit RapidFor™ HSV-2 IgG/IgM Test Kit RapidFor™ IL-6 (FIA)2 réf. RapidFor™ Influenza A H5 Test Kit2 réf. RapidFor™ Leishmenia Ab Rapid Test Kit VMD11398/79 RapidFor™ Malaria P.f. (HRP2) Rapid Test Kit VMD2098/79 RapidFor™ Malaria P.f. (pLDH) Rapid Test Kit VMD12798/79 RapidFor™ Malaria P.f. pLDH/HRP2 Test Kit RapidFor™ Monkeypox Virus Ag Rapid Test Kit VMD7398/79 RapidFor™ Mycoplasma pneumoniae Ab Rapid Test Kit VMD6598/79 RapidFor™ Norovirus Rapid Test Kit (FIA) VMPO6698/79 RapidFor™ Norovirus v2.0 Test Kit RapidFor™ PCT/IL-6 (FIA) RapidFor™ Rotavirus Rapid Test Kit (FIA) VMPO642 réf.98/79 RapidFor™ Salmonella spp. Test Kit VMD131TD98/79 RapidFor™ SARS-CoV-2 + FLU A/B + HPIV + RSV + ADV Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + MP + hMPV + HPIV + RhV Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + MP Test Kit3 réf. RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + hMPV + HPIV Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + hMPV Test Kit3 réf. RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + RhV + hMPV Test Kit3 réf. RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV Test Kit5 réf. RapidFor™ SARS-CoV-2 + FLU A/B + RSV + MP + HPIV Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + RSV + hMPV Test Kit2 réf. RapidFor™ SARS-CoV-2 + FLU A/B + RSV Test Kit3 réf. RapidFor™ SARS-CoV-2 + FLU A/B Test Kit6 réf. RapidFor™ SARS-CoV-2 + RSV + ADV Test Kit3 réf. RapidFor™ SARS-CoV-2 + RSV Test Kit2 réf. RapidFor™ SARS-CoV-2 Test Kit2 réf. RapidFor™ VMD04BD98/79 RapidFor™ VMD04BD50LA98/79 RapidFor™ VMD06BD98/79 RapidFor™ VMD06BDLA98/79 RapidFor™ VMD101BC98/79 RapidFor™ VMD101FD98/79 RapidFor™ VMD109STS RapidFor™ VMD110D98/79 RapidFor™ VMD112FD98/79 RapidFor™ VMD135FD98/79 RapidFor™ VMD136FD98/79 RapidFor™ VMD138BC98/79 RapidFor™ VMD138FD98/79 RapidFor™ VMD140FD98/79 RapidFor™ VMD140SC98/79 RapidFor™ VMD141SC98/79 RapidFor™ VMD146BC98/79 RapidFor™ VMD146TD98/79 RapidFor™ VMD147TD98/79 RapidFor™ VMD148FD98/79 RapidFor™ VMD148SC98/79 RapidFor™ VMD150FD98/79 RapidFor™ VMD150SC98/79 RapidFor™ VMD151FD98/79 RapidFor™ VMD151SC98/79 RapidFor™ VMD151SC0198/79 RapidFor™ VMD152FD98/79 RapidFor™ VMD152SC98/79 RapidFor™ VMD154SC98/79 RapidFor™ VMD155FD98/79 RapidFor™ VMD155SC2098/79 RapidFor™ VMD157FD98/79 RapidFor™ VMD157SC98/79 RapidFor™ VMD158FD98/79 RapidFor™ VMD158SC98/79 RapidFor™ VMD159FD98/79 RapidFor™ VMD159SC98/79 RapidFor™ VMD161SC98/79 RapidFor™ VMD162TD98/79 RapidFor™ VMD168TD98/79 RapidFor™ VMD169TD98/79 RapidFor™ VMD16TD98/79 RapidFor™ VMD16TD0198/79 RapidFor™ VMD172TD98/79 RapidFor™ VMD174TD98/79 RapidFor™ VMD175FD98/79 RapidFor™ VMD176STS98/79 RapidFor™ VMD17BC98/79 RapidFor™ VMD17BC2098/79 RapidFor™ VMD17SC98/79 RapidFor™ VMD17TD98/79 RapidFor™ VMD17TD2098/79 RapidFor™ VMD181SC98/79 RapidFor™ VMD187FD98/79 RapidFor™ VMD188SC98/79 RapidFor™ VMD191FD98/79 RapidFor™ VMD191TD98/79 RapidFor™ VMD192SC98/79 RapidFor™ VMD21BD98/79 RapidFor™ VMD22BDLA98/79 RapidFor™ VMD26BDLA98/79 RapidFor™ VMD27TD98/79 RapidFor™ VMD28BD98/79 RapidFor™ VMD28BDLA98/79 RapidFor™ VMD29BD98/79 RapidFor™ VMD36DTS98/79 RapidFor™ VMD36STS98/79 RapidFor™ VMD37BDLA98/79 RapidFor™ VMD38BDLA98/79 RapidFor™ VMD40FD98/79 RapidFor™ VMD40TD98/79 RapidFor™ VMD41FD98/79 RapidFor™ VMD41TD98/79 RapidFor™ VMD42TD98/79 RapidFor™ VMD52BD98/79 RapidFor™ VMD56BDLA98/79 RapidFor™ VMD66FD98/79 RapidFor™ VMD66SC98/79 RapidFor™ VMD66TD98/79 RapidFor™ VMD67TD98/79 RapidFor™ VMD68TD98/79 RapidFor™ VMD69TD98/79 RapidFor™ VMD71BC98/79 RapidFor™ VMD71FD98/79 RapidFor™ VMD71SC98/79 RapidFor™ VMD71SD0198/79 RapidFor™ VMD78FD98/79 RapidFor™ VMD78SC98/79 RapidFor™ VMD79FD98/79 RapidFor™ VMD79SC0198/79 RapidFor™ VMD79TD0198/79 RapidFor™ VMD80BC98/79 RapidFor™ VMD80FD98/79 RapidFor™ VMD81SC98/79 RapidFor™ VMD82FD98/79 RapidFor™ VMD82SC98/79 RapidFor™ VMD83BC98/79 RapidFor™ VMD83TD98/79 RapidFor™ VMD84TD98/79 RapidFor™ VMD88FD98/79 RapidFor™ VMD88TD98/79 RapidFor™ VMD89TD98/79 RapidFor™ VMD95FD98/79 RapidFor™ VMD95SC98/79 RapidFor™ VMD95TD98/79 RapidFor™ VMPO08ED98/79 RapidFor™ VMPO103TD98/79 RapidFor™ VMPO104STS98/79 RapidFor™ VMPO107GD98/79 RapidFor™ VMPO119STS98/79 RapidFor™ VMPO123SC98/79 RapidFor™ VMPO126ED98/79 RapidFor™ VMPO126UP98/79 RapidFor™ VMPO143GD98/79 RapidFor™ VMPO47ED98/79 RapidFor™ VMPO63TD98/79 RapidFor™ VMPO64GD98/79 RapidFor™ VMPO65GD98/79 RapidFor™ VMPO66GD98/79 RapidFor™ VMPO67GD98/79 RapidFor™ VMPO73EP98/79 RapidFor™ VMPO74ED98/79 RapidFor™ VMPO74EP98/79 RapidFor™ VMPO75ED98/79 RapidFor™ VMPO75EP98/79 RapidFor™ VSCD02SC98/79 RapidFor™ VSCD02SC0198/79 RapidFor™ VSCD02ST0198/79 RapidFor™ VSCD08ST0198/79 RapidFor™ Zika IgG/IgM Rapid Test Kit (FIA) VMPO7698/79 RapidFor™ Zika IgM Rapid Test Kit VMD4398/79 RapidFor™Monkeypox Virus Ab Rapid Test Kit VMD7498/79 ViraSens Gel Nucleic Acid Purification Kit VIRA08P100 ViraSens Gel Nucleic Acid Purification Kit VIRA08P50 ViraSens Genomic DNA Purification From Bacteria VIRA0450 ViraSens Genomic DNA Purification From Bacteria VIRA04P100 ViraSens Genomic DNA Purification From Blood VIRA02P100 ViraSens Genomic DNA Purification From Blood VIRA02P50 ViraSens Genomic DNA Purification From Tissue VIRA05P100 ViraSens Genomic DNA Purification From Tissue VIRA05P50 ViraSens Plasmid DNA Purification Kit VIRA07P100 ViraSens Plasmid DNA Purification Kit VIRA07P50 ViraSens Total Nucleic Acid Purification Kit VIRA09P100 ViraSens Total Nucleic Acid Purification Kit VIRA09P50 ViraSens Viral DNA Purification Kit VIRA06P100 ViraSens Viral DNA Purification Kit VIRA06P50 ViraSens Viral Nucleic Acid Purification Kit VIRA01P100 ViraSens Viral Nucleic Acid Purification Kit VIRA01P50 ViraSens Viral RNA Purification Kit VIRA03P100 ViraSens Viral RNA Purification Kit VIRA03P50 WellFor Strep A v2.0 Test Kit VMD150ST0198/79 WellFor VSCD10ST0198/79	A, B, C IVDR, 98/79	Site web info@vitrosens.com Fiche EUDAMED Signaler une erreur
Hangzhou Alltest Biotech FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne) et 1 autre	Chine	16-Channel Fluorescence Immunoassay Analyzer2 réf. 2019-CoV IgG/IgM Rapid Test Cassette2 réf.98/79 ABO and RhD Blood Grouping Rapid Test Cassette98/79 ABO and RhD Blood Grouping Rapid Test Cassette (Whole Blood)98/79 Adenovirus Antigen Rapid Test Cassette (Swab) IAD-50298/79 595 autres Adenovirus Antigen Rapid Test Cassette IAD-50298/79 Adenovirus Antigen Rapid Test Cassette IAD-R50298/79 Adenovirus antigen Test Cassette IAD-60298/79 Adenovirus pneumoniae and RSV Combo Test Cassette FI-AR-50298/79 Adenovirus pneumoniae and RSV Combo Test Cassette(Swab)98/79 Adenovirus pneumoniae/RSV/Influenza A+B ComboTest Cassette98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Cassette98/79 Adenovirus Rapid Test Cassette IAD-60298/79 Adenovirus Rapid Test Cassette IAD-R60298/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Control98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Control98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 Astrovirus Rapid Test Cassette IAS-60298/79 Astrovirus Rapid Test Cassette IAS-R60298/79 AUR-600 Semi-Quantitative Urine Analyzer98/79 Automatic Chemiluminescence Immunoassay Analyzer2 réf. AUTOTESTE COVID-19 Ag(SALIVA)98/79 Bacterial Diarrhea (Shigella/Salmonella/C.diff) Control98/79 berkeleyhealth Easy Check Strep A rapid test (Professional)98/79 Berkeleyhealth Easy Check Strep A rapid test cassette98/79 Blood Grouping Reagents-Lectin Anti-N2 réf.98/79 Bordetella pertussis Antigen Control SCBP-S98/79 Brucella Abortus Antigen Rapid Test Cassette2 réf.98/79 Brucella Abortus Control98/79 Candida albicans Rapid Test Cassette ICA-50298/79 Candida albicans Rapid Test Cassette ICA-R50298/79 Candida albicans Rapid Test ICA-50298/79 Candida albicans Rapid Test(Swab) ICA-50298/79 CARBA-5 Rapid Test98/79 Casete de prueba rápida de antígenos de Salmonella typhi y paratyphi98/79 Casete de Prueba Rápida de Legionella pneumophila98/79 Casete de Test Rápido de VHS 1/2 IgM98/79 Cassette Test Rapide Strep A98/79 Chagas Control SCCHA-D98/79 Chagas Rapid Test Cassette ICHA-30298/79 Chagas Rapid Test Cassette ICHA-40298/79 Chagas Rapid Test Cassette ICHA-R30298/79 Chagas Rapid Test Cassette ICHA-R40298/79 Chikungumya lgG&lgM/Dengue lgG&lgM/Dengue NS1 Combo Rapid Test98/79 Chikungunya IgG/IgM Antibody Control SCCHI-D-L98/79 Chikungunya IgG/IgM Rapid Test Cassette ICHI-30298/79 Chikungunya IgG/IgM Rapid Test Cassette ICHI-40298/79 Chikungunya IgG/IgM Rapid Test Cassette ICHI-R30298/79 Chikungunya IgG/IgM Rapid Test Cassette ICHI-R40298/79 Chikungunya IgG/IgM Test Cassette FI-CHI-40298/79 Chikungunya/Zika Combo Rapid Test ICZ-42598/79 Chlamydia Rapid Test Cassette ICH-50298/79 Chlamydia Rapid Test ICH-50298/79 Chlamydia Rapid Test ICH-N502FH-013 réf. Clostridium difficile GDH + Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICD-635B98/79 Clostridium difficile GDH + Toxin A + Toxin B Control SCCD-D-L98/79 Clostridium difficile GDH Control SCCDG-D-L98/79 Clostridium difficile GDH Rapid Test Cassette (Feces) ICDG-60298/79 Clostridium difficile GDH Rapid Test Cassette ICDG-R60298/79 Clostridium difficile GDH Rapid Test Cassette with LF READER PLUS98/79 Clostridium difficile GDH Test Cassette FI-CDG-60298/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette ICD-63598/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette ICD-635B98/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette ICD-R635B98/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette with LF READER PLUS98/79 Clostridium difficile GDH+Toxin A/B Test Cassette FI-CD-60298/79 Clostridium difficile GDH/Toxin A/Toxin B Test Cassette FI-CD-602B98/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-62598/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-625B98/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-R625B98/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette ICDT-R625B98/79 Clostridium difficile Toxin A/ toxin B Combo Test Cassette FI-CDT-62598/79 Clostridium difficileToxin A+Toxin B Combo Rapid Test Cassette2 réf.98/79 CMV IgM Rapid Test Cassette (Serum/Plasma) ICM-30298/79 CMV IgM Rapid Test Cassette ICM-30298/79 Combo Prueba Rápida Clostridium difficile GDH+Toxina A+Toxina B en Casete98/79 COVID-19 and Influenza A+B Antigen Combo Control98/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test98/79 COVID-19 Antigen Rapid Test8 réf.98/79 COVID-19 Antigen Rapid Test (Corona Lollipop Rapid Test)98/79 COVID-19 Antigen Rapid Test (Oral Fluid)98/79 COVID-19 Antigen Rapid Test Cassette(Oral Fluid)98/79 COVID-19 Antigen Rapid Test(Nasopharyngeal Swab)98/79 COVID-19 Antigen Rapid Test-ITA98/79 COVID-19 Antigen Test Cassette2 réf.98/79 COVID-19 Antigen Test Cassette(Swab)2 réf.98/79 COVID-19 IgG Control98/79 COVID-19 IgG Rapid Test3 réf.98/79 COVID-19 IgG/IgM Rapid Test4 réf.98/79 COVID-19 IgG/IgM Rapid Test Dipstick2 réf.98/79 COVID-19 IgG/IgM Test Cassette98/79 COVID-19 Nucleocapsid Protein IgG Antibody Rapid Test98/79 COVID-19 S-RBD IgG Antibody Test Cassette98/79 COVID-19 S-RBD IgG Quantitative Test Cassette98/79 Cryptococcus Antigen Control SCCRG-D-L98/79 Cryptococcus Antigen Rapid Test Cassette ICRG-40298/79 Cryptococcus Antigen Rapid Test Cassette ICRG-R40298/79 Cryptococcus Antigen Rapid Test Cassette(Whole Blood/Serum/Plasma/Cerebral Spinal Fluid (CSF)) ICRG-40298/79 Cryptosporidium Antigen Control SCCRY-D-L98/79 Cryptosporidium Antigen Rapid Test Cassette ICR-60298/79 Cryptosporidium Antigen Rapid Test Cassette ICR-R60298/79 Cryptosporidium Antigen Rapid Test Cassette(Feces) ICR-60298/79 Cryptosporidium Control SCCRY-L98/79 Cup Reader ACR-100 D-dimer Rapid Test Cassette (WB / P)98/79 D-dimer Rapid Test Cassette CDM-40298/79 D-dimer Rapid Test Cassette CDM-R40298/79 D-dimer Rapid Test Cassette CDM-R402SQ98/79 D-Dimer Test Cassette (Whole Blood/Plasma) FI-DDM-40298/79 D-Dimer Test Cassette FI-DDM-40298/79 D-Dimer Test Cassette(WB/P)98/79 D-Dimer Test Kit (CLIA)98/79 Dengue IgG/IgM Rapid Test Cassette IDEN-40298/79 Dengue IgG/IgM Rapid Test Cassette with LF READER PLUS98/79 Dengue Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IDEC-42598/79 Dengue Combo Rapid Test Cassette IDEC-42598/79 Dengue Combo Rapid Test Cassette IDEC-R42598/79 Dengue Combo Rapid Test IDEC-N425-103 réf. Dengue IgG&IgM/Zika IgG&IgM/Chikungunya IgG/Chikungunya IgM Combo Rapid Test Cassette (Serum/Plasma/Whole blood) 25T/kit98/79 Dengue IgG&IgM/Zika IgG&IgM/Chikungunya IgG/Chikungunya IgM Combo Rapid Test Cassette (Serum/Plasma/Whole blood) IDZC-44598/79 Dengue IgG, IgM and NS1 Combo Test Cassette98/79 Dengue IgG/IgM And NS1 Combo Rapid Test Cassette98/79 Dengue IgG/IgM Control SCDEGM-L98/79 Dengue IgG/IgM Rapid Test Cassette IDEN-R40298/79 Dengue IgG/IgM Rapid Test IDEN-N402-103 réf. Dengue IgG/IgM Test Cassette FI-DEN-40298/79 Dengue NS1 and Zika NS1 Combo Rapid Test98/79 Dengue NS1 Rapid Test3 réf. Dengue NS1 Rapid Test Cassette2 réf.98/79 Dengue NS1 Rapid Test Cassette with LF READER PLUS98/79 Dengue NS1 Test Cassette98/79 Dengue NS1 Test Cassette (Whole Blood/Serum/Plasma)98/79 Dengue Ns1/Dengue lgG&lgM/Chikungunya lgG&lgM/West Nile Virus lgG&lgM Combo Rapid Test98/79 Dengue Ns1/Dengue lgG&lgM/Chikungunya lgG&lgM/zika lgG&lgM Combo Rapid Test98/79 Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) IDEN-40298/79 Dry-type Fluorescent Immunoassay Analyzer (Single channel)2 réf. E.coli O157: H7 Antigen Rapid Test98/79 EBNA IgG Rapid Test Cassette IENG-40298/79 EBNA IgG Rapid Test Cassette IENG-R40298/79 EBV VCA and EBNA IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IECNG-42598/79 EBV VCA IgG Rapid Test Cassette IECG-40298/79 EBV VCA IgG Rapid Test Cassette IECG-R40298/79 Entamoeba histolytica Rapid Test Cassette IEH-60298/79 Entamoeba histolytica Rapid Test Cassette IEH-R60298/79 Entamoeba/Giardia/Crypto Control2 réf.98/79 EV71 IgM Rapid Test Cassette98/79 Family Health Self Test Helicobacter Pylori IHP-N602H-013 réf. FIA Control-(Clostridium difficile GDH)98/79 FIA Control-(Clostridium difficile GDH+Toxin A/B)98/79 FIA Control-(Rotavirus and Adenovirus Combo)98/79 FIA Control-COVID-19 Ag/Influenza A+B98/79 FIA Control-COVID-19 Antigen98/79 FIA Control-Dengue IgG/IgM98/79 FIA Control-Dengue NS198/79 FIA Control-FLU A+B98/79 FIA Control-H. pylori Antigen98/79 FIA Control-Legionella pneumophila98/79 FIA Control-RSV98/79 FIA Control-Strep A98/79 FIA Control-Streptococcus pneumoniae98/79 FIA Control-Syphilis98/79 FLU A+B Test Cassette98/79 FLU A+B Test Cassette(Swab)98/79 Fluorescence Immunoassay Analyzer98/79 Fluorescence Immunoassay Analyzer Instrument7 réf. Fuorescence lmmunoassay Analyzer98/79 Gesunder Magen2 réf.98/79 Giardia Lamblia Control SCGL-D-L98/79 Giardia Lamblia Rapid Test Cassette IGL-60298/79 Giardia Lamblia Rapid Test Cassette IGL-R60298/79 Gonorrhea Control98/79 Gonorrhea Rapid Test Cassette2 réf.98/79 H pylori Antigen Rapid Test Dipstick98/79 H. pylori Antibody Rapid Test Cassette (Serum /Plasma) IHP-30298/79 H. pylori Antibody Rapid Test Cassette IHP-30298/79 H. pylori Antibody Rapid Test Cassette IHP-40298/79 H. pylori Antibody Rapid Test Cassette IHP-R30298/79 H. pylori Antibody Rapid Test Cassette IHP-R40298/79 H. pylori Antibody Rapid Test Dipstick98/79 H. pylori Antibody Rapid Test IHP-N4023 réf. H. pylori Antigen Rapid Test (Feces) IHP-60798/79 H. pylori Antigen Rapid Test Cassette (Feces) IHP-60298/79 H. pylori Antigen Rapid Test Cassette IHP-602H98/79 H. pylori Antigen Rapid Test Cassette(Feces) IHP-602H98/79 H. pylori Antigen Rapid Test IHP-602H98/79 H. pylori Antigen Rapid Test IHP-N601-253 réf. H. pylori Rapid Test IHP-90298/79 H.pylori Antibody Rapid Test IHP-40298/79 H.pylori Antibody Rapid Test IHP-N402B98/79 H.pylori Antibody Rapid Test IHP-N402J98/79 H.pylori Antigen Rapid Test Cassette IHP-60298/79 H.pylori Antigen Rapid Test Cassette IHP-R60298/79 H.pylori Antigen Rapid Test IHP-60198/79 H.pylori Antigen Rapid Test IHP-60298/79 H.pylori Antigen Rapid Test IHP-60798/79 H.pylori Antigen Test Cassette FI-HP-60298/79 H.pylori Antigen Test Cassette(Feces)98/79 H1N1 Antigen Rapid Test Cassette2 réf.98/79 H1N1 Antigen Rapid Test Dipstick98/79 Hantavirus lgG/lgM Rapid Test Cassette98/79 HAV IgG/IgM Combo Rapid Test Cassette IHA-40298/79 HAV IgG/IgM&Syphilis Combo Rapid Test IHAS-43598/79 HAV IgM Rapid Test Cassette IHA-40298/79 HAV IgM Rapid Test Cassette IHA-R40298/79 HAV IgM&Syphilis Combo Rapid Test IHAS-42598/79 Hb Hemoglobin Test Strip OHBS-41198/79 HBsAg Rapid Test Cassette (Whole Blood/Serum/Plasma) IHBSG-40298/79 HBsAg Rapid Test Cassette IHBSG-40298/79 HCV Rapid Test Cassette IHC-40298/79 HCV Rapid Test IHC-40298/79 Helicobacter pylori(HP) IgG Test Kit(CLIA)98/79 HEV IgG/IgM Rapid Test Cassette IHE-30298/79 HEV IgG/IgM Rapid Test Cassette IHE-R30298/79 HEV IgM Rapid Test IHEM-30298/79 Hexagon HbsAg98/79 Hexagon HCV98/79 Hexagon HIV98/79 HIV 1.2 Rapid Test Cassette2 réf.98/79 HIV 1.2 Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HIV 1.2.O Rapid Test Cassette(WB/S/P)98/79 HMPV Rapid Test98/79 HPIV Control98/79 HPIV Rapid Test98/79 HPV 16/18 qPCR Kit98/79 HPV Antigen Control SCHPV-S98/79 HPV Antigen Rapid Test Cassette THPV-50298/79 HPV Antigen Rapid Test Cassette THPV-R50298/79 HSV 1 IgG/IgM Rapid Test Cassette98/79 HSV 1/2 IgG Rapid Test Cassette3 réf.98/79 HSV 1/2 IgG/IgM Combo Rapid Test98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette4 réf.98/79 HSV 1/2 IgG/IgM Rapid Test Cassette3 réf.98/79 HSV 1/2 IgM Rapid Test Cassette3 réf.98/79 HSV 1/2 IgM Rapid Test Cassette(Serum/Plasma)98/79 HSV 2 IgG/IgM Rapid Test Cassette98/79 HSV 2 IgG/IgM Rapid Test Cassette(WB/S/P)98/79 Human Metapneumovirus Antigen Control SCHMPV-D-L98/79 IL-6 Rapid Test98/79 IL-6 Test Cassette98/79 Influenza A Rapid Test Cassette IFLA-50298/79 Influenza A Rapid Test Cassette IFLA-R50298/79 Influenza A Rapid Test Cassette with LF READER PLUS98/79 Influenza A Rapid Test Dipstick98/79 Influenza A+B Rapid Test3 réf. Influenza A+B Rapid Test Cassette IIN-50298/79 Influenza A+B Rapid Test Cassette IIN-R50298/79 Influenza A+B Rapid Test Cassette(Swab / Nasal Aspirate)98/79 Influenza A+B Rapid Test Dipstick98/79 Influenza A+B Rapid Test IIN-R50298/79 Influenza A+B Test Cassette FI-FLU-50298/79 Influenza A/B + H5N1 Antigen Combo Rapid Test98/79 Influenza A/B +H1N1 Combo Rapid Test Cassette with LF READER PLUS98/79 Influenza A/B and RSV RT-qPCR Kit98/79 Influenza A/B+H1N1 Combo Rapid Test Cassette2 réf.98/79 Influenza A/B+H1N1 Control98/79 Influenza A/B+H1N1+H5N1 Antigen Combo Rapid Test98/79 Interleukin-6 (IL-6) Test Kit (CLIA)98/79 Lateral Flow (LF) Portable Reader Plus Instrument2 réf. Lateral Flow (LF) Reader98/79 Lateral Flow (LF) Reader Instrument Lateral Flow (LF) Reader Plus98/79 Lateral Flow (LF) Reader Plus Instrument Legionella pneumophila Control3 réf.98/79 Legionella pneumophila Rapid Test3 réf. Legionella pneumophila Rapid Test Cassette98/79 Legionella pneumophila Rapid Test Cassette (Urine)98/79 Legionella pneumophila Test Cassette98/79 Legionella pneumophila Test Cassette (Urine)98/79 Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) ILEI-40298/79 Leishmania IgG/IgM Rapid Test Cassette ILEI-40298/79 Leishmania IgG/IgM Rapid Test Cassette ILEI-R40298/79 Leptospira IgG/IgM Antibody Control SCLEP-L98/79 Leptospira IgG/IgM Rapid Test Cassette ILEP-R40298/79 Leptospira IgG/IgM Rapid Test Cassette(WB/S/P)98/79 Leptospira IgG/IgM Rapid Test ILEP-40298/79 LF Reader98/79 Lyme IgG/IgM Rapid Test Cassette ILY-R40298/79 Magsår H. Pylori98/79 Malaria Antibody Rapid Test IMAB-40298/79 Malaria P.f. /P.v. Rapid Test Cassette (Whole Blood) IMPV-40298/79 Malaria P.f. /P.v. Rapid Test Cassette IMPV-R40298/79 Malaria P.f. /P.v. Rapid Test IMPV-N402-203 réf. Malaria P.f. /Pan Control SCMPN-D98/79 Malaria P.f. /Pan Rapid Test Cassette (Whole Blood) IMPN-40298/79 Malaria P.f. /Pan Rapid Test IMPN-N402-203 réf. Malaria P.f. Rapid Test Cassette98/79 Malaria P.f. Rapid Test Cassette (Whole Blood) IMA-40298/79 Malaria P.f. Rapid Test Cassette IMA-40298/79 Malaria P.f. Rapid Test Dipstick98/79 Malaria P.f./P.v. /Pan Rapid Test Cassette IMPVF-40298/79 Malaria P.f./P.v. /Pan Test Cassette FI-MAL-43598/79 Malaria P.f./P.v. Control SCMPV-D98/79 Malaria P.f./P.v. Rapid Test Cassette IMPV-40298/79 Malaria P.f./P.v. Rapid Test Dipstick98/79 Malaria P.f./P.v. Rapid Test IMPV-40198/79 Malaria P.f./P.v./Pan Rapid Test Cassette IMPVF-R40298/79 Malaria P.f./P.v./Pan Rapid Test Malaria Test Cassette IMPVF-40298/79 Malaria P.f./P.v./Pan Rapid Test Malaria Test IMPVF-40298/79 Malaria P.f./Pan Rapid Test Cassette IMPN-40298/79 Malaria P.f./Pan Rapid Test Cassette IMPN-R40298/79 Malaria P.f./Pan Rapid Test Dipstick98/79 Malaria P.f./Pan Rapid Test IMPN-40198/79 Measles IgG Antibody Rapid Test Cassette IMEG-40298/79 Measles IgG/IgM Rapid Test IME-R40298/79 Methicillin-resistant Staphylococcus Aureus qPCR Kit98/79 Mivolis H. pylori Antigen Rapid Test Cassette98/79 Mivolis Schnelltest Gesunder Magen2 réf.98/79 Monkeypox Virus Antibody Control SCMXB-L98/79 Monkeypox Virus Antibody Rapid Test IMXB-40298/79 Monkeypox Virus Antibody Rapid Test IMXB-R40298/79 Monkeypox Virus Antibody Test Cassette FI-MXB-40298/79 Monkeypox Virus Antigen Control SCMXG-D-L98/79 Monkeypox Virus Antigen Rapid Test IMXG-40298/79 Monkeypox Virus Antigen Rapid Test IMXG-R40298/79 Monkeypox Virus Antigen Test Cassette FI-MXG-40298/79 Monkeypox Virus Detection qPCR Kit98/79 MONO Rapid Test Cassette IMO-40298/79 MONO Rapid Test Cassette IMO-R40298/79 MONO Rapid Test IMO-40298/79 MONO Rapid Test IMO-N402-253 réf. Multiplex Respiratory Antigen Control SCRTC-S98/79 Multiplex Respiratory Antigen Rapid Test (Flu B/Flu A/HPIV 1/3/HPIV 2/HMPV/Adeno/MP/RSV/COVID-19)98/79 Multiplex Respiratory Antigen Rapid Test IRT9-55598/79 Multiplex Respiratory Antigen Rapid Test IRT9-R55598/79 Multiplex Respiratory Antigen Rapid Test IRTC-510598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5105(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5105(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5105(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-511598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5115(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5115(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-512598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5125(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5125(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-513598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5135(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5135(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-514598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5145(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5145(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-515598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5155(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5155(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5165(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5165(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5175(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5175(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5185(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5185(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5195(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5195(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5205(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5205(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5215(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-52598/79 Multiplex Respiratory Antigen Rapid Test IRTC-525(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-525(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-525(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-53598/79 Multiplex Respiratory Antigen Rapid Test IRTC-535(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-535(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-535(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-54598/79 Multiplex Respiratory Antigen Rapid Test IRTC-545(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-545(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-545(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-55598/79 Multiplex Respiratory Antigen Rapid Test IRTC-555(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-555(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-555(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-56598/79 Multiplex Respiratory Antigen Rapid Test IRTC-565(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-565(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-57598/79 Multiplex Respiratory Antigen Rapid Test IRTC-575(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-575(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-58598/79 Multiplex Respiratory Antigen Rapid Test IRTC-585(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-585(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-585(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-59598/79 Multiplex Respiratory Antigen Rapid Test IRTC-595(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-595(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5X598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5X5(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5X5(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5X5(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-R510598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R511598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R512598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R513598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R514598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R515598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R52598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R53598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R54598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R55598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R56598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R57598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R58598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R59598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R5X598/79 Mycoplasma pneumoniae Antigen Rapid Test Cassette IMP-R50298/79 Mycoplasma pneumoniae Antigen Rapid Test Cassette (Throat Swab)98/79 Mycoplasma pneumoniae Antigen Rapid Test Cassette IMP-50298/79 Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Cassette IMP-42598/79 Mycoplasma pneumoniae IgG/IgM Control SCMPGM-L98/79 Mycoplasma pneumoniae IgM Control SCMPM-L98/79 Mycoplasma pneumoniae IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IMPM-40298/79 Mycoplasma Pneumoniae IgM Rapid Test Cassette IMPM-40298/79 Norovirus Rapid Test Cassette (Feces) INO-60298/79 Norovirus Rapid Test Cassette INO-R60298/79 Norovirus+Rotavirus+Adenovirus+Astrovirus Combo Rapid Test IMVD-R64598/79 Norovirus+Rotavirus/Adenovirus+Astrovirus+Enterovirus Combo Rapid Test IMVD-65598/79 Norovirus/Astorvirus/Enterovirus Combo Control98/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test INRA-63798/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test INRA-RT63598/79 Norovirus/Rotavirus/Adenovirus Combo Test Cassette FI-NRA-63598/79 One Step SARS-CoV-2 (COVID-19) Antigen Rapid Test98/79 Prueba Rápida de antígeno de H. Pylori en casete98/79 Prueba Rápida de HBsAg en Casete98/79 Prueba Rápida de Mononucleosis en Casete98/79 Prueba Rápida de S. pneumoniae Antígeno en Casete98/79 Respiratory Infectious Diseases Rapid Test IRT-510798/79 Respiratory Infectious Diseases Rapid Test IRT-511798/79 Respiratory Infectious Diseases Rapid Test IRT-512798/79 Respiratory Infectious Diseases Rapid Test IRT-513798/79 Respiratory Infectious Diseases Rapid Test IRT-514798/79 Respiratory Infectious Diseases Rapid Test IRT-515798/79 Respiratory Infectious Diseases Rapid Test IRT-52798/79 Respiratory Infectious Diseases Rapid Test IRT-53798/79 Respiratory Infectious Diseases Rapid Test IRT-54798/79 Respiratory Infectious Diseases Rapid Test IRT-55798/79 Respiratory Infectious Diseases Rapid Test IRT-56798/79 Respiratory Infectious Diseases Rapid Test IRT-57798/79 Respiratory Infectious Diseases Rapid Test IRT-58798/79 Respiratory Infectious Diseases Rapid Test IRT-59798/79 Respiratory Infectious Diseases Rapid Test IRT-5X798/79 Rhinovirus Control SCRHV-S98/79 Rhinovirus Rapid Test IRHV-R50298/79 Rotavirus Group A and Norovirus GI/GII RT-qPCR Kit2 réf.98/79 Rotavirus Rapid Test Cassette IRO-60298/79 Rotavirus Rapid Test Cassette IRO-R60298/79 Rotavirus/Adenovirus+Astrovirus Combo Rapid Test IRAA-62598/79 RPR Reagents5 réf.98/79 RSV &Influenza A+B Combo Rapid Test Cassette IRIC-R52598/79 RSV and SARS-CoV-2 Antigen Combo Rapid Test98/79 RSV Rapid Test Cassette IRS-50298/79 RSV Rapid Test Cassette IRS-R50298/79 RSV RapidTest Cassette98/79 RSV Test Cassette (Nasopharyngeal Swab/Nasal Aspirate)98/79 RSV Test Cassette FI-RSV-50298/79 RSV Test Cassette(Swab)98/79 RSV&Influenza A+B Combo Rapid Test Cassette IRIC-52598/79 RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 Rubella IgM Rapid Test Cassette (Serum/Plasma) IRM-30298/79 Rubella IgM Rapid Test Cassette IRM-30298/79 S. pneumoniae and L. pneumophila Control98/79 S. pneumoniae Antigen Rapid Test Cassette ISP-10298/79 S. pneumoniae Antigen Rapid Test Cassette ISP-R10298/79 S. pneumoniae Antigen Rapid Test ISP-N102-103 réf. S. pneumoniae/ L. pneumophila Control98/79 S.pneumoniae Antigen Rapid Test Cassette (Urine) ISP-10298/79 Salmonella paratyphi Antigen Control98/79 Salmonella paratyphi Antigen Rapid Test98/79 Salmonella paratyphi Antigen Rapid Test Cassette98/79 Salmonella paratyphi Antigen Rapid Test Cassette (Feces)98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test Cassette2 réf.98/79 Salmonella typhi and paratyphi Antigen Control98/79 Salmonella typhi and paratyphi B Antigen Combo Rapid Test98/79 Salmonella typhi Antigen Control98/79 Salmonella typhi Antigen Rapid Test98/79 Salmonella typhi Antigen Rapid Test Cassette98/79 SARS-CoV-2 (COVID-19) Antigen Rapid Test3 réf.98/79 SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva)2 réf.98/79 SARS-CoV-2 a chřipka A+B Antigen Combo Rychly test (Vytěr z nosu)98/79 SARS-COV-2 and Influenza A+B Antigen Combo Rapid Test3 réf.98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab)98/79 SARS-CoV-2 and Variant Delta Virus RT-qPCR Kit98/79 SARS-CoV-2 Antigen Control2 réf.98/79 SARS-CoV-2 Antigen Rapid Test4 réf.98/79 SARS-CoV-2 Antigen Rapid Test (Swab)98/79 SARS-CoV-2 Neutralization Antibody Rapid Test2 réf.98/79 SARS-COV-2 RT-qPCR Assay98/79 SARS-CoV-2 S-RBD Antibody Rapid Test98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test3 réf.98/79 SARS-CoV-2 Variant Omicron Virus RT-qPCR Kit98/79 SARS-CoV-2, Influenza A/B and RSV RT-qPCR Kit98/79 SARS-CoV-2-Antigen-Schnelltest (Nasenabstrich)98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Control98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/ Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/ Adenovirus/ M.pneumoniae Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/ Adenovirus/M. pneumoniae Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 Schnelltest Gesunder Magen98/79 Schnelltest Vitamin D98/79 SCREEN® Strep A Test3 réf. Scrub Typhus IgG/IgM Control98/79 Shigella Flexneri Antigen Rapid Test Cassette98/79 Shigella Flexneri Control98/79 Shigella Rapid Test Cassette ISH-62598/79 Shigella Rapid Test Cassette ISH-R62598/79 Shigella Sonnei Antigen Rapid Test Cassette98/79 Shigella Sonnei Control98/79 Sickle cell Rapid Test OSCD-40298/79 Strep A Rapid Test Cassette (Control Line in Blue)(Throat Swab)98/79 Strep A Rapid Test Cassette (Control Line in Red) IST-50298/79 Strep A Rapid Test Cassette (Throat Swab)2 réf.98/79 Strep A Rapid Test Cassette IST-50298/79 Strep A Rapid Test Cassette IST-N50298/79 Strep A Rapid Test Cassette IST-R50298/79 Strep A Rapid Test Cassette ISTB-50298/79 Strep A Rapid Test Cassette ISTB-R50298/79 Strep A Rapid Test Dipstick98/79 Strep A Rapid Test Dipstick (Throat Swab)98/79 Strep A Rapid Test IST-50198/79 Strep A Rapid Test IST-N5013 réf. Strep A Rapid Test ISTB-N501-253 réf. Strep A Test Cassette FI-STA-50298/79 Strep A Test Cassette(Swab)98/79 Strep B Rapid Test Cassette (Swab) ISB-50298/79 Strep B Rapid Test Cassette ISB-50298/79 Strep B Rapid Test Cassette ISB-R50298/79 Strep B Rapid Test Dipstick98/79 Streptococcus pneumoniae Antigen Rapid Test Cassette2 réf.98/79 Streptococcus pneumoniae Antigen Rapid Test Cassette with LF READER ATR-001,10 T/kit98/79 Streptococcus Pneumoniae Antigen Test Cassette98/79 Streptococcus pneumoniae Control2 réf.98/79 Streptococcus pneumoniae Test Cassette98/79 Streptococcus pneumoniae Test Cassette (Urine)98/79 SYP Test Cassette98/79 Syphilis Control98/79 Syphilis Rapid Test (Oral Fluid) ISY-80398/79 Syphilis Rapid Test Cassette ISY-30298/79 Syphilis Rapid Test Cassette ISY-40298/79 Syphilis Rapid Test Cassette ISY-402H98/79 Syphilis Rapid Test Cassette ISY-R30298/79 Syphilis Rapid Test Cassette ISY-R40298/79 Syphilis Rapid Test Dipstick2 réf.98/79 Syphilis Rapid Test Dipstick (Whole Blood /Serum/Plasma)98/79 Syphilis Rapid Test ISY-40298/79 Syphilis Rapid Test ISY-80398/79 Syphilis Rapid Test ISY-N4013 réf. Syphilis Test Cassette FI-SYP-40298/79 Syphilis Test Kit (CLIA)98/79 Szybki test kasetkowy do wykrywania Helicobacter pylori w kale98/79 Test Rapide de l’antigène SARS-CoV-2 (écouvillon nasal)98/79 Teste rápido em cassete de HIV 1.2(Sangue Total/Soro/Plasma)98/79 Tetanus Control SCTET-D-L98/79 Tetanus IgG Test Cassette FI-TET-40298/79 Tetanus Rapid Test Cassette ITE-40298/79 Tetanus Rapid Test Cassette ITE-R40298/79 Tetanus Rapid Test Cassette ITE-R402SQ98/79 Toxo IgG/IgM Rapid Test Cassette2 réf.98/79 Toxo IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 TPHA Reagents3 réf.98/79 Trichomonas Vaginalis Control SCTV-D-L98/79 Trichomonas Vaginalis Rapid Test Cassette (Vaginal Swab) ITV-50298/79 Trichomonas Vaginalis Rapid Test Cassette ITV-50298/79 Trichomonas Vaginalis Rapid Test Cassette ITV-R50298/79 Trichomonas Vaginalis Rapid Test Cassettet(Vaginal Swab)98/79 Trichomonas vaginalis/Gardnerella vaginalis/Candida albicans Combo Rapid Test98/79 TropiDetect Triple Test98/79 Tuberculosis (TB) Rapid Test Cassette98/79 Tuberculosis (TB) Rapid Test Cassette(WB/S/P)98/79 Tuberculosis Rapid Test Cassette98/79 Typhoid IgG/IgM Rapid Test Cassette98/79 Typhoid IgG Rapid Test Cassette98/79 Typhoid IgM Rapid Test Cassette98/79 Typhoid Rapid Test Cassette3 réf.98/79 Typhoid Rapid Test Cassette (Serum/Plasma)2 réf.98/79 Typhoid Rapid Test Dipstick98/79 Typhoid Test Cassette98/79 Urine Analyzer AUR-1003 réf. Urine Analyzer AUR-20098/79 Urine Analyzer AUR-30098/79 Urine Analyzer AUR-4013 réf. Varicella Zoster Virus IgM Rapid Test Cassette IVZM-40298/79 Vibrio cholerae O1/O139 Control98/79 Vitamin D Rapid Test OVD-402H98/79 Vitamin D Rapid Test Cassette OVD-40298/79 Vitamin D Rapid Test Cassette OVD-402H98/79 Zika antigen Test Cassette FI-ZI-40298/79 ZIKA IgG Control SCZIBG-D98/79 Zika IgG/IgM and NS1 Combo Rapid Test Cassette2 réf.98/79 Zika IgG/IgM and NS1 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Zika IgG/IgM Control SCZIB-L98/79 Zika IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IZIB-40298/79 Zika IgG/IgM Rapid Test Cassette IZIB-40298/79 Zika IgG/IgM Rapid Test Cassette IZIB-R40298/79 Zika IgM Test Cassette FI-ZIM-40298/79 Zika NS1 Rapid Test Cassette2 réf.98/79 Zika NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 ZuhauseTEST Gesunder Magen2 réf.98/79	A, B, C IVDR, 98/79	Présent sur le marché en France info@alltests.com.cn Fiche EUDAMED Signaler une erreur
Intervactechnology	Estonie	Euro-Vac AE140298/79 Euro-Vac AE240298/79 Euro-Vac AE250298/79 Euro-Vac AE260298/79 Euro-Vac AE270298/79 588 autres Euro-Vac AE310298/79 Euro-Vac AE390298/79 Euro-Vac AG130298/79 Euro-Vac AG135298/79 Euro-Vac AG250298/79 Euro-Vac AG385298/79 Euro-Vac BE250298/79 Euro-Vac BG250298/79 Euro-Vac CE390298/79 Euro-Vac EE110298/79 Euro-Vac EE120298/79 Euro-Vac EE130298/79 Euro-Vac EE140298/79 Euro-Vac EE260298/79 Euro-Vac EE390298/79 Euro-Vac EE395298/79 Euro-Vac FE120298/79 Euro-Vac FE230298/79 Euro-Vac KE118298/79 Euro-Vac KE127298/79 Euro-Vac KE136298/79 Euro-Vac KE145298/79 Euro-Vac KE390298/79 Euro-Vac LE140298/79 Euro-Vac LE240298/79 Euro-Vac LE250298/79 Euro-Vac LE260298/79 Euro-Vac RE116298/79 Euro-Vac RE120298/79 Euro-Vac SE127298/79 Euro-Vac SE136298/79 Euro-Vac TE105298/79 Euro-Vac TE110298/79 Euro-Vac TE120298/79 Euro-Vac TE130298/79 Euro-Vac TE140298/79 Euro-Vac TE260298/79 Euro-Vac TE390298/79 Lind-Vac AE109098/79 Lind-Vac AE110098/79 Lind-Vac AE110298/79 Lind-Vac AE112098/79 Lind-Vac AE113098/79 Lind-Vac AE120098/79 Lind-Vac AE120298/79 Lind-Vac AE125098/79 Lind-Vac AE130098/79 Lind-Vac AE130298/79 Lind-Vac AE135298/79 Lind-Vac AE140098/79 Lind-Vac AE140298/79 Lind-Vac AE145098/79 Lind-Vac AE150098/79 Lind-Vac AE150298/79 Lind-Vac AE220098/79 Lind-Vac AE230098/79 Lind-Vac AE230298/79 Lind-Vac AE235298/79 Lind-Vac AE240098/79 Lind-Vac AE240298/79 Lind-Vac AE245098/79 Lind-Vac AE250098/79 Lind-Vac AE250298/79 Lind-Vac AE255098/79 Lind-Vac AE260098/79 Lind-Vac AE260298/79 Lind-Vac AE270098/79 Lind-Vac AE270298/79 Lind-Vac AE310098/79 Lind-Vac AE310298/79 Lind-Vac AE370098/79 Lind-Vac AE380098/79 Lind-Vac AE380298/79 Lind-Vac AE390098/79 Lind-Vac AE390298/79 Lind-Vac AE410098/79 Lind-Vac AE411098/79 Lind-Vac AE412098/79 Lind-Vac AG105298/79 Lind-Vac AG110098/79 Lind-Vac AG110298/79 Lind-Vac AG120098/79 Lind-Vac AG120298/79 Lind-Vac AG125098/79 Lind-Vac AG125298/79 Lind-Vac AG127298/79 Lind-Vac AG130098/79 Lind-Vac AG130298/79 Lind-Vac AG135098/79 Lind-Vac AG135298/79 Lind-Vac AG140098/79 Lind-Vac AG140298/79 Lind-Vac AG230098/79 Lind-Vac AG230298/79 Lind-Vac AG235298/79 Lind-Vac AG240098/79 Lind-Vac AG240298/79 Lind-Vac AG250098/79 Lind-Vac AG250298/79 Lind-Vac AG260098/79 Lind-Vac AG260298/79 Lind-Vac AG350298/79 Lind-Vac AG370098/79 Lind-Vac AG370298/79 Lind-Vac AG380098/79 Lind-Vac AG380298/79 Lind-Vac AG385098/79 Lind-Vac AG385298/79 Lind-Vac AG390098/79 Lind-Vac AG390298/79 Lind-Vac AG410098/79 Lind-Vac AG411098/79 Lind-Vac AP130298/79 Lind-Vac BE110298/79 Lind-Vac BE120298/79 Lind-Vac BE130298/79 Lind-Vac BE140298/79 Lind-Vac BE250098/79 Lind-Vac BE250298/79 Lind-Vac BE260098/79 Lind-Vac BE270098/79 Lind-Vac BE310098/79 Lind-Vac BE310298/79 Lind-Vac BE360098/79 Lind-Vac BE370098/79 Lind-Vac BE380098/79 Lind-Vac BE380298/79 Lind-Vac BE390098/79 Lind-Vac BE390298/79 Lind-Vac BE411098/79 Lind-Vac BG120098/79 Lind-Vac BG120298/79 Lind-Vac BG130098/79 Lind-Vac BG130298/79 Lind-Vac BG135098/79 Lind-Vac BG140298/79 Lind-Vac BG250098/79 Lind-Vac BG250298/79 Lind-Vac BG260298/79 Lind-Vac BG370098/79 Lind-Vac BG380098/79 Lind-Vac BG380298/79 Lind-Vac BG390098/79 Lind-Vac BG390298/79 Lind-Vac BG410098/79 Lind-Vac BG411098/79 Lind-Vac CE110298/79 Lind-Vac CE120098/79 Lind-Vac CE120298/79 Lind-Vac CE130298/79 Lind-Vac CE140298/79 Lind-Vac CE240298/79 Lind-Vac CE250098/79 Lind-Vac CE250298/79 Lind-Vac CE260098/79 Lind-Vac CE260298/79 Lind-Vac CE310298/79 Lind-Vac CE380298/79 Lind-Vac CE385298/79 Lind-Vac CE390098/79 Lind-Vac CE390298/79 Lind-Vac CE411098/79 Lind-Vac CE490098/79 Lind-Vac CG250298/79 Lind-Vac CG380298/79 Lind-Vac CG390298/79 Lind-Vac DE120298/79 Lind-Vac DE140298/79 Lind-Vac DE240298/79 Lind-Vac DE250298/79 Lind-Vac DE260298/79 Lind-Vac DE310298/79 Lind-Vac DE380298/79 Lind-Vac DE390298/79 Lind-Vac EE105298/79 Lind-Vac EE110098/79 Lind-Vac EE110298/79 Lind-Vac EE120098/79 Lind-Vac EE120298/79 Lind-Vac EE130098/79 Lind-Vac EE130298/79 Lind-Vac EE140098/79 Lind-Vac EE140298/79 Lind-Vac EE150098/79 Lind-Vac EE150298/79 Lind-Vac EE220098/79 Lind-Vac EE230098/79 Lind-Vac EE230298/79 Lind-Vac EE235098/79 Lind-Vac EE240098/79 Lind-Vac EE240298/79 Lind-Vac EE250098/79 Lind-Vac EE250298/79 Lind-Vac EE260098/79 Lind-Vac EE260298/79 Lind-Vac EE270098/79 Lind-Vac EE270298/79 Lind-Vac EE310098/79 Lind-Vac EE310298/79 Lind-Vac EE380098/79 Lind-Vac EE380298/79 Lind-Vac EE390098/79 Lind-Vac EE390298/79 Lind-Vac EE395098/79 Lind-Vac EE395298/79 Lind-Vac EE411098/79 Lind-Vac EG110098/79 Lind-Vac EG110298/79 Lind-Vac EG120098/79 Lind-Vac EG120298/79 Lind-Vac EG130098/79 Lind-Vac EG130298/79 Lind-Vac EG135098/79 Lind-Vac EG135298/79 Lind-Vac EG140098/79 Lind-Vac EG140298/79 Lind-Vac EG230298/79 Lind-Vac EG240098/79 Lind-Vac EG240298/79 Lind-Vac EG250098/79 Lind-Vac EG250298/79 Lind-Vac EG260098/79 Lind-Vac EG380098/79 Lind-Vac EG380298/79 Lind-Vac EG385098/79 Lind-Vac EG385298/79 Lind-Vac EG390098/79 Lind-Vac EG390298/79 Lind-Vac EG395098/79 Lind-Vac EG495098/79 Lind-Vac FE110098/79 Lind-Vac FE110298/79 Lind-Vac FE120098/79 Lind-Vac FE120298/79 Lind-Vac FE130098/79 Lind-Vac FE130298/79 Lind-Vac FE140098/79 Lind-Vac FE140298/79 Lind-Vac FE150098/79 Lind-Vac FE150298/79 Lind-Vac FE220098/79 Lind-Vac FE220298/79 Lind-Vac FE230098/79 Lind-Vac FE230298/79 Lind-Vac FE240098/79 Lind-Vac FE240298/79 Lind-Vac FE250098/79 Lind-Vac FE250298/79 Lind-Vac FE260098/79 Lind-Vac FE260298/79 Lind-Vac FE270298/79 Lind-Vac FE310098/79 Lind-Vac FE370098/79 Lind-Vac FE380098/79 Lind-Vac FE380298/79 Lind-Vac FE390098/79 Lind-Vac FE390298/79 Lind-Vac FE411098/79 Lind-Vac FG110098/79 Lind-Vac FG110298/79 Lind-Vac FG120098/79 Lind-Vac FG120298/79 Lind-Vac FG130098/79 Lind-Vac FG130298/79 Lind-Vac FG135098/79 Lind-Vac FG140098/79 Lind-Vac FG240098/79 Lind-Vac FG250098/79 Lind-Vac FG260098/79 Lind-Vac FG320098/79 Lind-Vac FG370098/79 Lind-Vac FG390098/79 Lind-Vac HE120098/79 Lind-Vac HE120298/79 Lind-Vac HE130098/79 Lind-Vac HE130298/79 Lind-Vac HE140098/79 Lind-Vac HE140298/79 Lind-Vac HE150298/79 Lind-Vac HE230098/79 Lind-Vac HE230298/79 Lind-Vac HE240098/79 Lind-Vac HE240298/79 Lind-Vac HE250098/79 Lind-Vac HE250298/79 Lind-Vac HE260098/79 Lind-Vac HE260298/79 Lind-Vac HE270298/79 Lind-Vac HE310098/79 Lind-Vac HE310298/79 Lind-Vac HE350098/79 Lind-Vac HE380098/79 Lind-Vac HE380298/79 Lind-Vac HE390098/79 Lind-Vac HE390298/79 Lind-Vac HE411098/79 Lind-Vac HG130098/79 Lind-Vac HG130298/79 Lind-Vac HG140098/79 Lind-Vac HG140298/79 Lind-Vac HG230298/79 Lind-Vac HG240298/79 Lind-Vac HG250098/79 Lind-Vac HG250298/79 Lind-Vac HG260098/79 Lind-Vac HG380098/79 Lind-Vac HG380298/79 Lind-Vac HG390098/79 Lind-Vac HG390298/79 Lind-Vac IE110298/79 Lind-Vac IE120298/79 Lind-Vac IE130098/79 Lind-Vac IE130298/79 Lind-Vac IE260098/79 Lind-Vac IE370098/79 Lind-Vac IG105298/79 Lind-Vac IG110298/79 Lind-Vac IG130298/79 Lind-Vac IG240298/79 Lind-Vac IG250298/79 Lind-Vac IG380298/79 Lind-Vac IG390298/79 Lind-Vac JE140298/79 Lind-Vac JE260098/79 Lind-Vac JE370098/79 Lind-Vac JE390298/79 Lind-Vac JG220298/79 Lind-Vac KE109098/79 Lind-Vac KE109298/79 Lind-Vac KE110298/79 Lind-Vac KE116298/79 Lind-Vac KE118098/79 Lind-Vac KE118298/79 Lind-Vac KE127098/79 Lind-Vac KE127298/79 Lind-Vac KE130298/79 Lind-Vac KE131598/79 Lind-Vac KE135298/79 Lind-Vac KE136098/79 Lind-Vac KE136298/79 Lind-Vac KE140298/79 Lind-Vac KE140598/79 Lind-Vac KE145098/79 Lind-Vac KE145298/79 Lind-Vac KE209098/79 Lind-Vac KE218098/79 Lind-Vac KE218298/79 Lind-Vac KE227098/79 Lind-Vac KE227298/79 Lind-Vac KE236098/79 Lind-Vac KE236298/79 Lind-Vac KE245098/79 Lind-Vac KE245298/79 Lind-Vac KE254098/79 Lind-Vac KE254298/79 Lind-Vac KE263098/79 Lind-Vac KE263298/79 Lind-Vac KE381098/79 Lind-Vac KE381298/79 Lind-Vac KE390098/79 Lind-Vac KE390298/79 Lind-Vac KE410098/79 Lind-Vac KE518298/79 Lind-Vac KE527298/79 Lind-Vac KE530298/79 Lind-Vac KG136298/79 Lind-Vac KG245298/79 Lind-Vac KG381298/79 Lind-Vac KG390298/79 Lind-Vac LE105098/79 Lind-Vac LE105298/79 Lind-Vac LE110098/79 Lind-Vac LE110298/79 Lind-Vac LE115098/79 Lind-Vac LE120098/79 Lind-Vac LE120298/79 Lind-Vac LE125098/79 Lind-Vac LE130098/79 Lind-Vac LE130298/79 Lind-Vac LE140098/79 Lind-Vac LE140298/79 Lind-Vac LE145298/79 Lind-Vac LE150098/79 Lind-Vac LE150298/79 Lind-Vac LE230098/79 Lind-Vac LE230298/79 Lind-Vac LE240098/79 Lind-Vac LE240298/79 Lind-Vac LE250098/79 Lind-Vac LE250298/79 Lind-Vac LE260098/79 Lind-Vac LE260298/79 Lind-Vac LE270098/79 Lind-Vac LE270298/79 Lind-Vac LE310098/79 Lind-Vac LE310298/79 Lind-Vac LE380098/79 Lind-Vac LE380298/79 Lind-Vac LE390098/79 Lind-Vac LE390298/79 Lind-Vac LE410098/79 Lind-Vac LG110098/79 Lind-Vac LG110298/79 Lind-Vac LG120098/79 Lind-Vac LG120298/79 Lind-Vac LG125098/79 Lind-Vac LG130098/79 Lind-Vac LG130298/79 Lind-Vac LG135298/79 Lind-Vac LG140098/79 Lind-Vac LG140298/79 Lind-Vac LG230298/79 Lind-Vac LG240098/79 Lind-Vac LG240298/79 Lind-Vac LG245298/79 Lind-Vac LG250098/79 Lind-Vac LG250298/79 Lind-Vac LG260098/79 Lind-Vac LG260298/79 Lind-Vac LG310298/79 Lind-Vac LG360098/79 Lind-Vac LG370098/79 Lind-Vac LG380098/79 Lind-Vac LG380298/79 Lind-Vac LG390098/79 Lind-Vac LG390298/79 Lind-Vac LG410098/79 Lind-Vac NE110098/79 Lind-Vac NE110298/79 Lind-Vac NE120098/79 Lind-Vac NE120298/79 Lind-Vac NE130098/79 Lind-Vac NE130298/79 Lind-Vac NE140098/79 Lind-Vac NE140298/79 Lind-Vac NE150098/79 Lind-Vac NE150298/79 Lind-Vac NE230098/79 Lind-Vac NE230298/79 Lind-Vac NE240098/79 Lind-Vac NE240298/79 Lind-Vac NE250098/79 Lind-Vac NE250298/79 Lind-Vac NE260098/79 Lind-Vac NE260298/79 Lind-Vac NE270098/79 Lind-Vac NE270298/79 Lind-Vac NE310098/79 Lind-Vac NE310298/79 Lind-Vac NE380098/79 Lind-Vac NE380298/79 Lind-Vac NE390098/79 Lind-Vac NE390298/79 Lind-Vac NE410098/79 Lind-Vac NE411098/79 Lind-Vac PE120098/79 Lind-Vac PE140298/79 Lind-Vac QE105298/79 Lind-Vac QE120098/79 Lind-Vac QG240298/79 Lind-Vac RE116098/79 Lind-Vac RE116298/79 Lind-Vac RE120098/79 Lind-Vac RE120298/79 Lind-Vac RE124098/79 Lind-Vac RE124298/79 Lind-Vac RE130298/79 Lind-Vac RE140098/79 Lind-Vac RE140298/79 Lind-Vac RE150298/79 Lind-Vac RE224098/79 Lind-Vac RE224298/79 Lind-Vac RE230098/79 Lind-Vac RE260098/79 Lind-Vac SE109098/79 Lind-Vac SE109298/79 Lind-Vac SE118098/79 Lind-Vac SE118298/79 Lind-Vac SE120298/79 Lind-Vac SE127098/79 Lind-Vac SE127298/79 Lind-Vac SE128298/79 Lind-Vac SE130298/79 Lind-Vac SE131598/79 Lind-Vac SE135098/79 Lind-Vac SE135298/79 Lind-Vac SE136098/79 Lind-Vac SE136298/79 Lind-Vac SE140598/79 Lind-Vac SE145098/79 Lind-Vac SE145298/79 Lind-Vac SE218098/79 Lind-Vac SE218298/79 Lind-Vac SE227098/79 Lind-Vac SE227298/79 Lind-Vac SE236098/79 Lind-Vac SE236298/79 Lind-Vac SE245098/79 Lind-Vac SE245298/79 Lind-Vac SE254098/79 Lind-Vac SE254298/79 Lind-Vac SE263098/79 Lind-Vac SE263298/79 Lind-Vac SE381098/79 Lind-Vac SE381298/79 Lind-Vac SE390098/79 Lind-Vac SE390298/79 Lind-Vac SE518298/79 Lind-Vac SE520298/79 Lind-Vac SE527098/79 Lind-Vac SE527298/79 Lind-Vac SE530298/79 Lind-Vac SE545298/79 Lind-Vac SG136298/79 Lind-Vac SG245298/79 Lind-Vac SG380298/79 Lind-Vac SG381098/79 Lind-Vac SG381298/79 Lind-Vac SG390298/79 Lind-Vac TE105098/79 Lind-Vac TE105298/79 Lind-Vac TE110098/79 Lind-Vac TE110298/79 Lind-Vac TE120098/79 Lind-Vac TE120298/79 Lind-Vac TE130098/79 Lind-Vac TE130298/79 Lind-Vac TE140098/79 Lind-Vac TE140298/79 Lind-Vac TE145098/79 Lind-Vac TE150098/79 Lind-Vac TE150298/79 Lind-Vac TE230098/79 Lind-Vac TE230298/79 Lind-Vac TE240098/79 Lind-Vac TE240298/79 Lind-Vac TE250098/79 Lind-Vac TE250298/79 Lind-Vac TE260098/79 Lind-Vac TE260298/79 Lind-Vac TE264298/79 Lind-Vac TE270098/79 Lind-Vac TE310098/79 Lind-Vac TE310298/79 Lind-Vac TE370098/79 Lind-Vac TE380098/79 Lind-Vac TE385298/79 Lind-Vac TE390098/79 Lind-Vac TE390298/79 Lind-Vac TE395098/79 Lind-Vac TE395298/79 Lind-Vac TG110098/79 Lind-Vac TG110298/79 Lind-Vac TG120098/79 Lind-Vac TG120298/79 Lind-Vac TG130098/79 Lind-Vac TG135098/79 Lind-Vac TG135298/79 Lind-Vac TG140098/79 Lind-Vac TG140298/79 Lind-Vac TG230298/79 Lind-Vac TG240098/79 Lind-Vac TG240298/79 Lind-Vac TG250098/79 Lind-Vac TG250298/79 Lind-Vac TG260098/79 Lind-Vac TG260298/79 Lind-Vac TG270098/79 Lind-Vac TG370098/79 Lind-Vac TG380098/79 Lind-Vac TG380298/79 Lind-Vac TG385098/79 Lind-Vac TG385298/79 Lind-Vac TG390098/79 Lind-Vac TG390298/79 Lind-Vac TG410098/79 Lind-Vac TG411098/79 Lind-Vac UE390298/79 Lind-Vac VE120298/79 Lind-Vac VE140298/79 Lind-Vac WE120298/79 Lind-Vac WE130298/79 Lind-Vac WE140298/79 Lind-Vac WE240298/79 Lind-Vac WE250298/79 Lind-Vac WE260298/79 Lind-Vac WE380298/79 Lind-Vac WE390298/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Cell Marque Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	<p>Somatostatin Receptor 2A (EP149) Rabbit Monoclonal Primary Antibody</p> 486R-1X series5 réf.98/79 A-1-Antitrypsin Rabbit Polyclonal Antibody98/79 A-1-Antitrypsin Rabbit Polyclonal Antibody 223A-1X series5 réf.98/79 ACTH Rabbit Polyclonal Antibody98/79 ACTH Rabbit Polyclonal Antibody 206A-7X series5 réf.98/79 430 autres Actin, Muscle Specific (HHF35) Mouse Monoclonal Antibody Actin, Muscle Specific (HHF35) Mouse Monoclonal Antibody 201M-9X series6 réf.98/79 Actin, Smooth Muscle (1A4) Mouse Monoclonal Antibody Actin, Smooth Muscle (1A4) Mouse Monoclonal Antibody 202M-9X series3 réf. Adenovirus (2/6 & 20/11) Mouse Monoclonal Primary Antibody98/79 Adenovirus (20/11 & 2/6) Mouse Monoclonal Antibody 212M-1X series5 réf.98/79 Adipophilin Rabbit Polyclonal Antibody 393A-1X series3 réf. ALK Protein (ALK-1) Mouse Monoclonal Antibody 204M-1X series5 réf.98/79 Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary Antibody 203R-1X series5 réf.98/79 Alpha-Fetoprotein Rabbit Polyclonal Antibody Androgen Receptor (SP107) Rabbit Monoclonal Antibody 200R-1X series3 réf. Annexin A1 (MRQ-3) Mouse Monoclonal Antibody 221M-1X series5 réf.98/79 anti-Androgen Receptor (SP107) Rabbit Monoclonal Primary Antibody anti-Arginase-1 (SP156) Rabbit Monoclonal Primary Antibody Anti-C4d (SP91) Rabbit Monoclonal Primary Antibody Anti-Calcitonin (SP17) Rabbit Monoclonal Primary Antibody anti-CD38 (SP149) Rabbit Monoclonal Primary Antibody anti-CMV Blend (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Primary Antibody anti-Cytokeratin 14 (SP53) Rabbit Monoclonal Primary Antibody anti-IgG4 (MRQ-44) Mouse Monoclonal Primary Antibody anti-INI-1 (MRQ-27) Mouse Monoclonal Primary Antibody anti-NSE (MRQ-55) Mouse Monoclonal Primary Antibody98/79 anti-p57Kip2 (Kp10) Mouse Monoclonal Primary Antibody anti-PAX8 (MRQ-50) Mouse Monoclonal Primary Antibody anti-SOX-2 (SP76) Rabbit Monoclonal Primary Antibody98/79 anti-TFE3 (MRQ-37) Rabbit Monoclonal Primary Antibody Arginase-1 (SP156) Rabbit Monoclonal Antibody 380R-1X series3 réf. ARID1A (EP303) Rabbit Monoclonal Primary Antibody 407R-1X series5 réf.98/79 ATRX Rabbit Polyclonal Antibody ATRX Rabbit Polyclonal Antibody 485A-1X series3 réf. BCA-225 (Cu-18) Mouse Monoclonal Antibody 225M-1X series5 réf.98/79 BCL-6 (GI191E/A8) Mouse Monoclonal Antibody BCL2 (124) Mouse Monoclonal Antibody 226M-9X series3 réf. BCL2 (E17) Rabbit Monoclonal Primary Antibody 226R-1X series3 réf. BCL6 (GI191E/A8) Mouse Monoclonal Antibody 227M-9X series3 réf. Beta-Catenin (14) Mouse Monoclonal Antibody Beta-Catenin (14) Mouse Monoclonal Antibody 224M-1X series3 réf. BG8, Lewis<sup>Y</sup> (F3) Mouse Monoclonal Antibody 228M-1X series5 réf.98/79 BOB.1 (SP92) Rabbit Monoclonal Antibody98/79 BOB.1 (SP92) Rabbit Monoclonal Antibody 294R-1X series5 réf.98/79 c-Myc (EP121) Rabbit Monoclonal Primary Antibody 395R-1X series3 réf. C3d Rabbit Polyclonal Antibody98/79 C3d Rabbit Polyclonal Antibody 403A-7X series5 réf.98/79 C4d (SP91) Rabbit Monoclonal Antibody 404R-1X series3 réf. CA-125 (OC125) Mouse Monoclonal Antibody CA-125 (OC125) Mouse Monoclonal Antibody 325M-1X series5 réf.98/79 CA19-9 (121SLE) Mouse Monoclonal Antibody CA19-9 (121SLE) Mouse Monoclonal Antibody 399M-1X series3 réf. Cadherin-17 (SP183) Rabbit Monoclonal Antibody 378R-1X series5 réf.98/79 Calcitonin (SP17) Rabbit Monoclonal Antibody 229R-1X series5 réf.98/79 Caldesmon (E89) Rabbit Monoclonal Antibody Caldesmon (E89) Rabbit Monoclonal Primary Antibody 230R-1X series3 réf. Calponin (CALP) Mouse Monoclonal Antibody 231M-1X series5 réf.98/79 Calponin-1 (EP798Y) Rabbit Monoclonal Antibody Calponin-1 (EP798Y) Rabbit Monoclonal Primary Antibody 231R-1X series3 réf. Calretinin (SP13) Rabbit Monoclonal Antibody 232R-1X series3 réf. Carbonic Anhydrase IX (CA IX) (EP161) Rabbit Monoclonal Primary Antibody 379R-1X series3 réf. Carbonic Anhydrase IX (EP161) Rabbit Monoclonal Primary Antibody Cathepsin K (3F9) Mouse Monoclonal Antibody 402M-1X series5 réf.98/79 CD10 (56C6) Mouse Monoclonal Antibody 110M-1X series3 réf. CD103 (EP206) Rabbit Monoclonal Primary Antibody 437R-1X series5 réf.98/79 CD117, c-kit (YR145) Rabbit Monoclonal Primary Antibody 117R-1X series3 réf. CD11c (5D11) Mouse Monoclonal Antibody 111M-1X series5 réf.98/79 CD123 (6H6) Mouse Monoclonal Antibody 198M-1X series5 réf.98/79 CD13 (SP187) Rabbit Monoclonal Antibody 113R-1X series5 réf.98/79 CD138 (EP201) Rabbit Monoclonal Primary Antibody 138R-2X series5 réf.98/79 CD138/syndecan-1 (B-A38) Mouse Monoclonal Antibody CD138/syndecan-1 (B-A38) Mouse Monoclonal Antibody 138M-1X series3 réf. CD14 (EPR3653) Rabbit Monoclonal Primary Antibody 114R-1X series3 réf. CD15 (MMA) Mouse Monoclonal Antibody 115M-1X series5 réf.98/79 CD16 (SP175) Rabbit Monoclonal Antibody 116R-1X series5 réf.98/79 CD16 (SP175) Rabbit Monoclonal Primary Antibody CD163 (MRQ-26) Mouse Monoclonal Antibody CD163 (MRQ-26) Mouse Monoclonal Antibody 163M-1X series3 réf. CD19 (MRQ-36) Mouse Monoclonal Antibody 119M-1X series5 réf.98/79 CD1a (EP3622) Rabbit Monoclonal Antibody CD1a (EP3622) Rabbit Monoclonal Primary Antibody 101R-1X series3 réf. CD2 (MRQ-11) Mouse Monoclonal Antibody CD2 (MRQ-11) Mouse Monoclonal Antibody 102M-1X series5 réf.98/79 CD20 (L26) Mouse Monoclonal Antibody 120M-8X series6 réf.98/79 CD21 (2G9) Mouse Monoclonal Antibody CD21 (2G9) Mouse Monoclonal Antibody 121M-1X series3 réf. CD21 (EP3093) Rabbit Monoclonal Antibody CD21 (EP3093) Rabbit Monoclonal Primary Antibody 121R-1X series3 réf. CD23 (1B12) Mouse Monoclonal Antibody 123M-1X series5 réf.98/79 CD25 (4C9) Mouse Monoclonal Antibody98/79 CD25 (4C9) Mouse Monoclonal Antibody 125M-1X series5 réf.98/79 CD3 (MRQ-39) Rabbit Monoclonal Antibody 103R-9X series5 réf.98/79 CD30 (Ber-H2) Mouse Monoclonal Antibody 130M-9X series5 réf.98/79 CD31 (JC70) Mouse Monoclonal Antibody CD31 (JC70) Mouse Monoclonal Antibody 131M-9X series3 réf. CD33 (PWS44) Mouse Monoclonal Antibody 133M-1X series5 réf.98/79 CD33 (SP266) Rabbit Monoclonal Primary Antibody98/79 CD34 (QBEnd/10) Mouse Monoclonal Antibody98/79 CD34 (QBEnd/10) Mouse Monoclonal Antibody 134M-1X series3 réf. CD35 (EP197) Rabbit Monoclonal Primary Antibody 135R-1X series5 réf.98/79 CD38 (SP149) Rabbit Monoclonal Antibody 118R-1X series3 réf. CD4 (EP204) Rabbit Monoclonal Primary Antibody 104R-2X series5 réf.98/79 CD4 (SP35) Rabbit Monoclonal Antibody 104R-1X series3 réf. CD43 (MT1) Mouse Monoclonal Antibody 143M-1X series5 réf.98/79 CD44 (MRQ-13) Mouse Monoclonal Antibody 144M-9X series5 réf.98/79 CD45 (LCA) (2B11 & PD7/26) Mouse Monoclonal Antibody CD45 (LCA) (2B11 & PD7/26) Mouse Monoclonal Antibody 145M-9X series3 réf. CD45RO (UCHL-1) Mouse Monoclonal Antibody 147M-9X series5 réf.98/79 CD5 (4C7) Mouse Monoclonal Antibody 205M-1X series5 réf.98/79 CD5 (SP19) Rabbit Monoclonal Antibody 205R-1X series5 réf.98/79 CD56 (123C3.D5) Mouse Monoclonal Antibody 156M-8X series5 réf.98/79 CD56 (MRQ-42) Rabbit Monoclonal Antibody CD56 (MRQ-42) Rabbit Monoclonal Antibody 156R-9X series3 réf. CD57 (NK-1) Mouse Monoclonal Antibody98/79 CD57 (NK-1) Mouse Monoclonal Antibody 157M-9X series5 réf.98/79 CD61 (2F2) Mouse Monoclonal Antibody CD61 (2f2) Mouse Monoclonal Antibody 161M-1X series3 réf. CD63 (NKI/C3) Mouse Monoclonal Antibody 263M-1X series5 réf.98/79 CD68 (Kp-1) Mouse Monoclonal Antibody 168M-9X series5 réf.98/79 CD7 (MRQ-56) Mouse Monoclonal Antibody 107M-2X series5 réf.98/79 CD71 (MRQ-48) Mouse Monoclonal Antibody CD71 (MRQ-48) Mouse Monoclonal Antibody 171M-9X series3 réf. CD79a (JCB117) Mouse Monoclonal Antibody 179M-9X series5 réf.98/79 CD8 (C8/144B) Mouse Monoclonal Antibody 108M-9X series5 réf.98/79 CD99 (EPR3097Y) Rabbit Monoclonal Primary Antibody 199R-1X series5 réf.98/79 CDK4 (DCS-31) Mouse Monoclonal Antibody 478M-9X series3 réf. CDX-2 (EPR2764Y) Rabbit Monoclonal Antibody CDX-2 (EPR2764Y) Rabbit Monoclonal Primary Antibody 235R-1X series3 réf. CEA (CEA31) Mouse Monoclonal Antibody CEA (CEA31) Mouse Monoclonal Antibody 236M-9X series3 réf. CEA Rabbit Polyclonal Antibody 236A-1X series3 réf. Chromogranin A (LK2H10) Mouse Monoclonal Antibody 238M-9X series3 réf. CITED1 (5H6) Mouse Monoclonal Antibody 424M-1X series5 réf.98/79 Claudin 1 Rabbit Polyclonal Antibody 359A-1X series5 réf.98/79 Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody 468R-1X series3 réf. CMV (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Antibody 213M-2X series3 réf. CMV (DDG9/CCH2) Mouse Monoclonal Antibody 213M-1X series3 réf. Collagen Type IV (CIV22) Mouse Monoclonal Antibody 239M-1X series5 réf.98/79 COX-2 (SP21) Rabbit Monoclonal Antibody 240R-1X series5 réf.98/79 Cyclin D1 (SP4) Rabbit Monoclonal Antibody 241R-1X series3 réf. Cytokeratin (34betaE12) Mouse Monoclonal Antibody 334M-8X series6 réf.98/79 Cytokeratin (35betaH11) Mouse Monoclonal Antibody98/79 Cytokeratin (35betaH11) Mouse Monoclonal Antibody 335M-9X series5 réf.98/79 Cytokeratin (CAM 5.2) Mouse Monoclonal Antibody 452M-9X series3 réf. Cytokeratin (OSCAR) Mouse Monoclonal Antibody Cytokeratin (OSCAR) Mouse Monoclonal Antibody 300M-1X series3 réf. Cytokeratin 14 (LL002) Mouse Monoclonal Antibody 314M-1X series5 réf.98/79 Cytokeratin 17 (EP98) Rabbit Monoclonal Primary Antibody 317R-1X series5 réf.98/79 Cytokeratin 19 (A53-B/A2.26) Mouse Monoclonal Antibody Cytokeratin 19 (A53-B/A2.26) Mouse Monoclonal Antibody 319M-1X series3 réf. Cytokeratin 19 (EP72) Rabbit Monoclonal Primary Antibody 319R-2X series5 réf.98/79 Cytokeratin 20 (Ks20.8) Mouse Monoclonal Antibody 320M-1X series3 réf. Cytokeratin 5 & 6 (D5 & 16B4) Mouse Monoclonal Antibody 356M-1X series3 réf. Cytokeratin 5 & 6 (D5/16B4) + TTF-1 (8G7G3/1) Mouse Monoclonal Antibody 902H-0X series2 réf.98/79 Cytokeratin 5 & 6 (EP24 & EP67) Rabbit Monoclonal Primary Antibody 356R-1X series5 réf.98/79 Cytokeratin 5 (EP1601Y) + Cytokeratin 14 (LL002) Mouse/Rabbit Monoclonal Antibodies 905H-0X series2 réf.98/79 Cytokeratin 5 (EP1601Y) Rabbit Monoclonal Primary Antibody 305R-1X series5 réf.98/79 Cytokeratin 5 (SP27) Rabbit Monoclonal Primary Antibody Cytokeratin 7 (OV-TL 12/30) Mouse Monoclonal Antibody 307M-9X series3 réf. Cytokeratin 8 & 18 (B22.1 & B23.1) Mouse Monoclonal Antibody Cytokeratin 8 & 18 (B22.1 & B23.1) Mouse Monoclonal Antibody 818M-9X series3 réf. Cytokeratin Cocktail (AE1 & AE3) Mouse Monoclonal Antibody 313M-1X series3 réf. Cytokeratin, HMW (AE3) Mouse Monoclonal Antibody 303M-1X series5 réf.98/79 Cytokeratin, LMW (AE1) Mouse Monoclonal Antibody 301M-1X series5 réf.98/79 DAB Substrate Kit 957D-X series3 réf. Desmin (D33) Mouse Monoclonal Antibody 243M-1X series5 réf.98/79 DOG1 (SP31) Rabbit Monoclonal Antibody 244R-1X series3 réf. DOG1 (SP31) Rabbit Monoclonal Primary Antibody E-Cadherin (EP700Y) Rabbit Monoclonal Antibody E-cadherin (EP700Y) Rabbit Monoclonal Primary Antibody 246R-1X series3 réf. EGFR (EP22) Rabbit Monoclonal Primary Antibody 414R-2X series5 réf.98/79 EGFR (SP84) Rabbit Monoclonal Antibody 414R-1X series5 réf.98/79 EMA (E29) Mouse Monoclonal Antibody 247M-9X series6 réf.98/79 Ep-CAM/Epithelial Specific Antigen (BER-EP4) 248M-9X series3 réf. Ep-CAM/Epithelial Specific Antigen (BER-EP4) Mouse Monoclonal Antibody Ep-CAM/Epithelial Specific Antigen (MOC-31) Mouse Monoclonal Antibody 248M-1X series3 réf. Epstein Barr Virus (CS1-4) Mouse Monoclonal Antibody98/79 Epstein-Barr Virus (CS1-4) Mouse Monoclonal Antibody 245M-1X series5 réf.98/79 ERG (EP111) Rabbit Monoclonal Primary Antibody 434R-1X series6 réf.98/79 Estrogen Receptor (EP1) Rabbit Monoclonal Primary Antibody 249R-2X series6 réf.98/79 Estrogen Receptor (SP1) Rabbit Monoclonal Antibody 249R-1X series5 réf.98/79 EZH2 (11) Mouse Monoclonal Antibody 415M-1X series5 réf.98/79 Factor VIII-R Ag. Rabbit Polyclonal Antibody98/79 Factor VIII-R Ag. Rabbit Polyclonal Antibody 250A-1X series5 réf.98/79 Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody 251M-1X series3 réf. Factor XIIIa (EP3372) Rabbit Monoclonal Antibody Factor XIIIa (EP3372) Rabbit Monoclonal Primary Antibody 251R-1X series3 réf. FLI-1 (MRQ-1) Mouse Monoclonal Antibody 254M-1X series5 réf.98/79 FOXA1 (2F83) Mouse Monoclonal Antibody 405M-1X series5 réf.98/79 FoxP1 (SP133) Rabbit Monoclonal Antibody 350R-1X series5 réf.98/79 FSH (EP257) Rabbit Monoclonal Primary Antibody 207R-1X series5 réf.98/79 FSH Rabbit Polyclonal Antibody98/79 Galectin-3 (9C4) Mouse Monoclonal Antibody98/79 Galectin-3 (9C4) Mouse Monoclonal Antibody 255M-1X series5 réf.98/79 Gastrin Rabbit Polyclonal Antibody Gastrin Rabbit Polyclonal Antibody 256A-1X series5 réf.98/79 GATA3 (L50-823) Mouse Monoclonal Antibody 390M-1X series3 réf. GATA3 (L50-823) Mouse Monoclonal Primary Antibody GCDFP-15 (23A3) + Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal Antibodies 906H-0X series2 réf.98/79 GCDFP-15 (23A3) Mouse Monoclonal Antibody 257M-1X series6 réf.98/79 GCDFP-15 (EP1582Y) Rabbit Monoclonal Antibody GH (EP267) Rabbit Monoclonal Primary Antibody 208R-1X series5 réf.98/79 GH (Growth Hormone) Rabbit Polyclonal Antibody98/79 Glial Fibrillary Acidic Protein (EP672Y) Rabbit Monoclonal Antibody Glial Fibrillary Acidic Protein (EP672Y) Rabbit Monoclonal Primary Antibody 258R-1X series3 réf. Glucagon (EP74) Rabbit Monoclonal Primary Antibody 259R-1X series5 réf.98/79 GLUT1 Rabbit Polyclonal Antibody98/79 GLUT1 Rabbit Polyclonal Antibody 355A-1X series5 réf.98/79 GLUT3 Rabbit Polyclonal Antibody 413A-1X series5 réf.98/79 Glutamine Synthetase (GS-6) Mouse Monoclonal Antibody 389M-1X series3 réf. Glutamine Synthetase (GS-6) Mouse Monoclonal Primary Antibody Glycophorin A (GA-R2) Mouse Monoclonal Antibody98/79 Glycophorin A (GA-R2) Mouse Monoclonal Antibody 260M-1X series5 réf.98/79 Glypican-3 (1G12) Mouse Monoclonal Antibody Glypican-3 (1G12) Mouse Monoclonal Antibody 261M-9X series3 réf. Granzyme B (EP230) Rabbit Monoclonal Primary Antibody 262R-1X series5 réf.98/79 Granzyme B Rabbit Polyclonal Antibody98/79 h-Caldesmon (hHCD) Mouse Monoclonal Antibody 451M-1X series5 réf.98/79 HBME-1 (HBME-1) Mouse Monoclonal Antibody 283M-1X series3 réf. hCG Rabbit Polyclonal Antibody98/79 hCG Rabbit Polyclonal Antibody 234A-1X series5 réf.98/79 Heat Shock Protein 70 (EP377) Rabbit Monoclonal Primary Antibody 460R-1X series5 réf.98/79 Helicobacter pylori Rabbit Polyclonal Antibody 215A-7X series3 réf. Hemoglobin A (EPR3608) Rabbit Monoclonal Primary Antibody 360R-1X series5 réf.98/79 Hemoglobin A (SP212) Rabbit Monoclonal Primary Antibody98/79 Hepatocyte Specific Antigen (Hep Par-1) (OCH1E5) Mouse Monoclonal Antibody 264M-9X series3 réf. Hepatocyte Specific Antigen (OCH1E5) Mouse Monoclonal Antibody Her2/Neu (EP3) Rabbit Monoclonal Primary Antibody 237R-2X series6 réf.98/79 Her2/Neu (SP3) Rabbit Monoclonal Antibody 237R-1X series5 réf.98/79 Herpes Simplex Virus 1 (10A3) Mouse Monoclonal Primary Antibody Herpes Simplex Virus I (10A3) Mouse Monoclonal Antibody 361M-1X series3 réf. Herpes Simplex Virus I Rabbit Polyclonal Antibody 361A-1X series3 réf. Herpes Simplex Virus II (3C5.2) Mouse Monoclonal Antibody 362M-1X series3 réf. HGAL (MRQ-49) Mouse Monoclonal Antibody 375M-9X series5 réf.98/79 HHV-8 (13B10) Mouse Monoclonal Antibody HHV-8 (13B10) Mouse Monoclonal Antibody 265M-1X series3 réf. HiDef Detection Alk Phos Polymer System 962D-X Series3 réf. HiDef Detection HRP Polymer System 954D-X Series3 réf. HMB-45 (HMB-45) Mouse Monoclonal Antibody 282M-9X series3 réf. HMB-45 + MART-1 (Melan A) + Tyrosinase (HMB-45 + A103 + T311) Mouse Monoclonal Antibody 904H-0X series3 réf.98/79 Human Placental Lactogen (hPL) Rabbit Polyclonal Antibody 266A-1X series5 réf.98/79 IDH1 R132H (MRQ-67) Rabbit Monoclonal Antibody IDH1 R132H (MRQ-67) Rabbit Monoclonal Antibody 456R-3X series3 réf. IgA (EP170) Rabbit Monoclonal Primary Antibody 267R-1X series5 réf.98/79 IgD (EP173) Rabbit Monoclonal Primary Antibody 268R-1X series5 réf.98/79 IgD Rabbit Polyclonal Antibody98/79 IgG Rabbit Polyclonal Antibody98/79 IgG Rabbit Polyclonal Antibody 269A-1X series5 réf.98/79 IgG4 (MRQ-44) Mouse Monoclonal Antibody 367M-1X series3 réf. IgM Rabbit Polyclonal Antibody98/79 IgM Rabbit Polyclonal Antibody 270A-1X series5 réf.98/79 IMP3 (EP286) Rabbit Monoclonal Primary Antibody 433R-1X series5 réf.98/79 Inhibin, alpha (MRQ-63) Rabbit Monoclonal Antibody 271R-2X series5 réf.98/79 Inhibin, alpha (MRQ-63) Rabbit Monoclonal Primary Antibody INI-1 (MRQ-27) Mouse Monoclonal Antibody 272M-1X series3 réf. INSM1 (MRQ-70) Rabbit Monoclonal Antibody 475R-9X series3 réf. Islet-1 (EP283) Rabbit Monoclonal Primary Antibody 431R-1X series5 réf.98/79 Kappa (L1C1) Mouse Monoclonal Antibody 274M-9X series6 réf.98/79 KBA.62 (KBA.62) Mouse Monoclonal Antibody 366M-9X series5 réf.98/79 Ki-67 (MRQ-64) Rabbit Monoclonal Antibody 275R-3X series6 réf.98/79 Ki-67 (SP6) Rabbit Monoclonal Antibody 275R-1X series3 réf. Lambda (Lamb14) Mouse Monoclonal Antibody 277M-9X series6 réf.98/79 Langerin (12D6) Mouse Monoclonal Antibody 392M-1X series5 réf.98/79 LEF1 (EP310) Rabbit Monoclonal Primary Antibody 442R-1X series3 réf. LH Rabbit Polyclonal Antibody98/79 LH Rabbit Polyclonal Antibody 209A-1X series5 réf.98/79 LMO2 (SP51) Rabbit Monoclonal Antibody 370R-1X series5 réf.98/79 Lysozyme Rabbit Polyclonal Antibody98/79 Lysozyme Rabbit Polyclonal Antibody 278A-1X series5 réf.98/79 MAGEC2 (EP405) Rabbit Monoclonal Primary Antibody 477R-1X series5 réf.98/79 Mammaglobin (31A5) Rabbit Monoclonal Antibody Mammaglobin (31A5) Rabbit Monoclonal Antibody 280R-1X series3 réf. Mammaglobin Cocktail (304-1A5 & 31A5) Mouse & Rabbit Cocktail Antibody 280C-1X series5 réf.98/79 MART-1 (M2-7C10) + Tyrosinase (T311) Mouse Monoclonal Antibody 903H-0X series2 réf.98/79 MART-1 (Melan A) (A103) Mouse Monoclonal Antibody 281M-8X series3 réf. MART-1 (Melan A) (M2-7C10) Mouse Monoclonal Antibody 281M-9X series3 réf. MDM2 (IF2) Mouse Monoclonal Antibody 479M-9X series3 réf. Mesothelial Cell (HBME-1) Mouse Monoclonal Antibody Mesothelin (EP140) Rabbit Monoclonal Primary Antibody 439R-1X series5 réf.98/79 Microphthalmia Transcription Factor (MiTF) (C5/D5) Mouse Monoclonal Antibody 284M-9X series3 réf. MLH1 (G168-728) Mouse Monoclonal Antibody 285M-1X series6 réf.98/79 MLH1 (M1) Mouse Monoclonal Antibody 285M-2X series6 réf.98/79 MSH2 (G219-1129) Mouse Monoclonal Antibody 286M-1X series6 réf.98/79 MSH6 (44) Mouse Monoclonal Antibody 287M-1X series6 réf.98/79 MSH6 (SP93) Rabbit Monoclonal Antibody 287R-2X series5 réf.98/79 MUC1 (MRQ-17) Mouse Monoclonal Antibody 290M-1X series5 réf.98/79 MUC2 (MRQ-18) Mouse Monoclonal Antibody MUC2 (MRQ-18) Mouse Monoclonal Antibody 291M-1X series3 réf. MUC4 (8G7) Mouse Monoclonal Antibody 406M-1X series3 réf. MUC5AC (MRQ-19) Mouse Monoclonal Antibody98/79 MUC5AC (MRQ-19) Mouse Monoclonal Antibody 292M-9X series5 réf.98/79 MUC6 (MRQ-20) Mouse Monoclonal Antibody MUC6 (MRQ-20) Mouse Monoclonal Antibody 293M-9X series5 réf.98/79 MUM1 (EP190) Rabbit Monoclonal Primary Antibody MUM1 (EP190) Rabbit Monoclonal Primary Antibody 358R-1X series3 réf. MUM1 (MRQ-8) Mouse Monoclonal Antibody 358M-1X series3 réf. Myeloperoxidase (SP72) Rabbit Monoclonal Antibody 289R-1X series5 réf.98/79 Myeloperoxidase Rabbit Polyclonal Antibody MyoD1 (EP212) Rabbit Monoclonal Primary Antibody MyoD1 (EP212) Rabbit Monoclonal Primary Antibody 386R-1X series3 réf. Myogenin (F5D) Mouse Monoclonal Antibody Myogenin (F5D) Mouse Monoclonal Antibody 296M-1X series3 réf. Myoglobin Rabbit Polyclonal Antibody 297A-7X series5 réf.98/79 Myosin, Smooth Muscle (SMMS-1) Mouse Monoclonal Antibody Myosin, Smooth Muscle (SMMS-1) Mouse Monoclonal Antibody 298M-1X series3 réf. Napsin A (MRQ-60) Mouse Monoclonal Antibody 352M-9X series3 réf. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody Napsin A Rabbit Polyclonal Antibody 352A-7X series3 réf. Nerve Growth Factor Receptor (NGFR) (MRQ-21) Mouse Monoclonal Antibody 304M-1X series5 réf.98/79 Nestin (10C2) Mouse Monoclonal Antibody 388M-1X series5 réf.98/79 Neurofilament (2F11) Mouse Monoclonal Antibody98/79 Neurofilament (2F11) Mouse Monoclonal Antibody 302M-1X series5 réf.98/79 NGFR (Nerve Growth Factor Receptor) (MRQ-21) Mouse Monoclonal Antibody NKX2.2 (EP336) Rabbit Monoclonal Primary Antibody 445R-1X series5 réf.98/79 NKX3.1 (EP356) Rabbit Monoclonal Primary Antibody NKX3.1 (EP356) Rabbit Monoclonal Primary Antibody 441R-1X series3 réf. NSE (MRQ-55) Mouse Monoclonal Antibody 306M-2X series5 réf.98/79 Oct-2 (MRQ-2) Mouse Monoclonal Antibody Oct-2 (MRQ-2) Mouse Monoclonal Antibody 308M-1X series3 réf. Oct-4 (MRQ-10) Mouse Monoclonal Antibody Oct-4 (MRQ-10) Mouse Monoclonal Antibody 309M-1X series3 réf. Olig2 (211F1.1) Mouse Monoclonal Antibody 387M-1X series5 réf.98/79 Olig2 (EP112) Rabbit Monoclonal Primary Antibody98/79 p120 Catenin (MRQ-5) Mouse Monoclonal Antibody 420M-1X series6 réf.98/79 p16INK4A (JC2) Mouse Monoclonal Antibody 416M-1X series3 réf. p21<sup>WAF1</sup> (DCS-60.2) Mouse Monoclonal Antibody 421M-1X series5 réf.98/79 p27<sup>Kip1</sup> (SX53G8) Mouse Monoclonal Antibody 427M-9X series5 réf.98/79 p40 (ZR8) Rabbit Monoclonal Antibody 483R-1X series6 réf.98/79 P504s (13H4) Rabbit Monoclonal Antibody 504R-1X series3 réf. p53 (DO7) Mouse Monoclonal Antibody 453M-9X series5 réf.98/79 p57Kip2 (Kp10) Mouse Monoclonal Antibody 457M-9X series3 réf. p63 (EP174) Rabbit Monoclonal Primary Antibody 482R-1X series6 réf.98/79 Parathyroid Hormone (PTH) (MRQ-31) Mouse Monoclonal Antibody Parathyroid Hormone (PTH) (MRQ-31) Mouse Monoclonal Antibody 310M-2X series3 réf. Parvovirus B19 (R92F6) Mouse Monoclonal Antibody 218M-1X series5 réf.98/79 PAX-2 (EP235) Rabbit Monoclonal Primary Antibody 311R-1X series5 réf.98/79 PAX-5 (24) Mouse Monoclonal Antibody 312M-1X series5 réf.98/79 PAX-5 (SP34) Rabbit Monoclonal Antibody 312R-1X series5 réf.98/79 PAX-7 (MRQ-69) Mouse Monoclonal Antibody 481M-9X series5 réf.98/79 PAX-8 (EP331) Rabbit Monoclonal Primary Antibody PAX-8 (MRQ-50) Mouse Monoclonal Antibody 363M-1X series3 réf. PAX-8 (SP348) Rabbit Monoclonal Antibody 363R-3X series3 réf. PAX-8 Rabbit Polyclonal Antibody 363A-1X series3 réf. PD-1 (NAT105) Mouse Monoclonal Antibody PD-1 (NAT105) Mouse Monoclonal Antibody 315M-9X series3 réf. PD-L1 (28-8) Rabbit Monoclonal Primary Antibody 438R-1X series5 réf.98/79 PD-L1 (ZR3) Rabbit Monoclonal Antibody 438R-2X series5 réf.98/79 Perforin (MRQ-23) Mouse Monoclonal Antibody 316M-1X series5 réf.98/79 Peripherin (8G2) Mouse Monoclonal Antibody 476M-1X series5 réf.98/79 Permanent Red Chromogen Kit 960D-X series2 réf. PGP 9.5 Rabbit Polyclonal Antibody PGP 9.5 Rabbit Polyclonal Antibody 318A-1X series3 réf. Phosphohistone H3 (PHH3) Rabbit Polyclonal Antibody 369A-1X series3 réf. Phosphohistone H3 Rabbit Polyclonal Antibody PHOX2B (EP312) Rabbit Monoclonal Primary Antibody 422R-1X series5 réf.98/79 PLAP (NB10) Mouse Monoclonal Antibody PLAP (NB10) Mouse Monoclonal Antibody 321M-1X series5 réf.98/79 PMS2 (EPR3947) Rabbit Monoclonal Primary Antibody 288R-1X series3 réf.98/79 PMS2 (MRQ-28) Mouse Monoclonal Antibody 288M-1X series5 réf.98/79 Pneumocystis jiroveci (carinii) (3F6) Mouse Monoclonal Antibody 219M-1X series5 réf.98/79 PNL2 (PNL2) Mouse Monoclonal Antibody 365M-9X series5 réf.98/79 Podoplanin (D2-40) Mouse Monoclonal Antibody Podoplanin (D2-40) Mouse Monoclonal Antibody 322M-1X series3 réf. PRAME (EP461) Rabbit Monoclonal Primary Antibody 484R-1X series3 réf. Progesterone Receptor (SP42) Rabbit Monoclonal Antibody 323R-3X series5 réf.98/79 Progesterone Receptor (Y85) Rabbit Monoclonal Primary Antibody 323R-1X series6 réf.98/79 Prolactin (EP193) Rabbit Monoclonal Primary Antibody 210R-1X series5 réf.98/79 Prolactin Rabbit Polyclonal Antibody98/79 Prolactin Rabbit Polyclonal Antibody 210A-1X series5 réf.98/79 Prostein (EP381) Rabbit Monoclonal Primary Antibody 450R-1X series5 réf.98/79 PSAP (PASE/4LJ) Mouse Monoclonal Antibody98/79 PSAP (PASE/4LJ) Mouse Monoclonal Antibody 326M-1X series5 réf.98/79 PSMA (EP192) Rabbit Monoclonal Primary Antibody98/79 PSMA (EP192) Rabbit Monoclonal Primary Antibody 327R-1X series5 réf.98/79 PU.1 (EPR3158Y) Rabbit Monoclonal Primary Antibody 328R-1X series5 réf.98/79 Renal Cell Carcinoma (PN-15) Mouse Monoclonal Antibody Renal Cell Carcinoma (PN-15) Mouse Monoclonal Antibody 329M-9X series3 réf. ROS1 (MRQ-68) Rabbit Monoclonal Antibody 469R-9X series5 réf.98/79 S-100 (4C4.9) Mouse Monoclonal Antibody 330M-1X series3 réf. S100 beta (EP32) Rabbit Monoclonal Primary Antibody 449R-1X series5 réf.98/79 S100A1 (EP184) Rabbit Monoclonal Primary Antibody 408R-1X series5 réf.98/79 S100P (16/f5) Mouse Monoclonal Antibody 376M-9X series5 réf.98/79 SALL4 (6E3) Mouse Monoclonal Antibody 385M-1X series3 réf. SALL4 (6E3) Mouse Monoclonal Primary Antibody SATB2 (EP281) Rabbit Monoclonal Primary Antibody SATB2 (EP281) Rabbit Monoclonal Primary Antibody 384R-1X series3 réf. SDHB (EP288) Rabbit Monoclonal Primary Antibody 466R-1X series5 réf.98/79 SF-1 (EP434) Rabbit Monoclonal Primary Antibody SF-1 (EP434) Rabbit Monoclonal Primary Antibody 462R-1X series3 réf. SMAD4 (MRQ-72) Rabbit Monoclonal Antibody 487R-9X series5 réf.98/79 Smoothelin (R4A) Mouse Monoclonal Antibody 377M-1X series5 réf.98/79 Somatostatin (EP130) Rabbit Monoclonal Primary Antibody 332R-1X series5 réf.98/79 SOX-10 (EP268) Rabbit Monoclonal Primary Antibody 383R-1X series3 réf. SOX-10 (SP267) Rabbit Monoclonal Primary Antibody SOX-11 (MRQ-58) Mouse Monoclonal Antibody 382M-1X series3 réf. SOX-11 (MRQ-58) Mouse Monoclonal Primary Antibody SOX-2 (SP76) Rabbit Monoclonal Antibody 371R-1X series6 réf.98/79 Spectrin (RBC2/3D5) Mouse Monoclonal Antibody 333M-1X series5 réf.98/79 STAT6 (EP325) Rabbit Monoclonal Primary Antibody 426R-1X series3 réf. Stathmin (SP49) Rabbit Monoclonal Antibody 394R-1X series5 réf.98/79 SV40 (MRQ-4) Mouse Monoclonal Antibody SV40 (MRQ-4) Mouse Monoclonal Antibody 351M-1X series3 réf. Synaptophysin (MRQ-40) Rabbit Monoclonal Antibody 336R-9X series3 réf. Synaptophysin (MRQ-40) Rabbit MonoclonalAntibody T-bet (MRQ-46) Rabbit Monoclonal Antibody 368R-7X series5 réf.98/79 TAG-72 (B72.3) Mouse Monoclonal Antibody98/79 TAG-72 (B72.3) Mouse Monoclonal Antibody 337M-8X series5 réf.98/79 TCL1 (MRQ-7) Mouse Monoclonal Antibody 357M-1X series5 réf.98/79 TdT Rabbit Polyclonal Antibody TdT Rabbit Polyclonal Antibody 338A-7X series3 réf. TFE3 (MRQ-37) Rabbit Monoclonal Antibody 354R-1X series3 réf. Thrombomodulin (1009) Mouse Monoclonal Antibody 339M-1X series5 réf.98/79 Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody 340M-1X series5 réf.98/79 TLE1 (1F5) Mouse Monoclonal Antibody 401M-1X series3 réf. Treponema pallidum Rabbit Polyclonal Antibody 397A-1X series5 réf.98/79 TROP2 (EP431) Rabbit Monoclonal Primary Antibody 465R-1X series5 réf.98/79 Tryptase (G3) Mouse Monoclonal Antibody98/79 Tryptase (G3) Mouse Monoclonal Antibody 342M-1X series5 réf.98/79 TSH (EP254) Rabbit Monoclonal Primary Antibody 211R-1X series5 réf.98/79 TSH Rabbit Polyclonal Antibody98/79 TTF-1 (8G7G3/1) Mouse Monoclonal Antibody 343M-9X series3 réf. Tyrosinase (T311) Mouse Monoclonal Antibody 344M-9X series5 réf.98/79 Tyrosine Hydroxylase (LNC1) Mouse Monoclonal Antibody 490M-1X series5 réf.98/79 Uroplakin III (AU-1) Mouse Monoclonal Antibody 345M-1X series5 réf.98/79 Uroplakin III (SP73) Rabbit Monoclonal Antibody98/79 Varicella Zoster Virus (SG1-1, SG1-SG4, NCP-1 & IE-62) Mouse Monoclonal Antibody 364M-1X series3 réf. Villin (CWWB1) Mouse Monoclonal Antibody98/79 Villin (CWWB1) Mouse Monoclonal Antibody 346M-1X series5 réf.98/79 Vimentin (V9) Mouse Monoclonal Antibody 347M-1X series6 réf.98/79 WT1 (6F-H2) Mouse Monoclonal Antibody WT1 (6F-H2) Mouse Monoclonal Antibody 348M-9X series3 réf.	A, B, C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Greiner Bio-One	Autriche	ESR Rack with graduation for 729070 / 7290902 réf. MiniCollect® Complete 0.25 / 0.5 ml K2E K2EDTA lavender cap, paper label, pre-assembled with Carrier Tube 13x75 MiniCollect® K2E K2EDTA TUBE3 réf. MiniCollect® Complete 0.25 / 0.5 ml K3E K3EDTA lavender cap, G-barcode label, pre-assembled with Carrier Tube 13x75 MiniCollect® K3E K3EDTA TUBE3 réf. MiniCollect® Complete 0.25 ml FX Sodium Fluoride / Potassium Oxalate grey cap, G-barcode label, pre-assembled with Carri3 réf. MiniCollect® Complete 0.5 / 0.8 ml CAT Serum Separator Clot Activator gold cap, G-barcode label, pre-assembled with Carr3 réf. 390 autres MiniCollect® Complete 0.5 / 1 ml CAT Serum Clot Activator red cap, G-barcode label, pre-assembled with Carrier Tube 13x73 réf. MiniCollect® Complete 0.5 ml LH Lithium Heparin green cap, G-barcode label, pre-assembled with Carrier Tube 13x753 réf. MiniCollect® Complete 0.8 ml LH Lithium Heparin Separator light-green cap, paper label, pre-assembled with Carrier Tube3 réf. MiniCollect® TUBE 1 ml 9NC Coagulation sodium citrate 3.2% light blue cap MiniCollect® 9NC Coagulation TUBE2 réf. Urine Beaker with integrated Transfer Device 100 ml, yellow lid bulk-packed, non-sterile2 réf. Urine Cup with integrated Transfer Device 100 ml 10 pcs./bag, sterile98/79 Urine Cup with integrated Transfer Device 100 ml bulk-packed, sterile98/79 VACUETTE® FC Mix TUBE 2 ml 13x75 grey cap-white ring, transparent label, non-ridged98/79 VACUETTE® FC Mix TUBE 2 ml 13x75 pink cap-white ring, transparent label, non-ridged98/79 VACUETTE® FC Mix TUBE 3 ml 13x75 grey cap-black ring, non-ridged98/79 VACUETTE® FC Mix TUBE 3 ml 13x75 grey cap-black ring, transparent label, non-ridged98/79 VACUETTE® FC Mix TUBE 3 ml 13x75 pink cap-black ring, transparent label, non-ridged98/79 VACUETTE® SECONDARY Tube MULTIPLEX PET 13x75 mm without cap, PREMIUM3 réf. VACUETTE® TUBE 1 ml CAT Serum Clot Activator 13x75 red cap-white ring, PREMIUM98/79 VACUETTE® TUBE 1 ml K2E K2EDTA 13x75 lavender cap-white ring, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 1 ml K3E K3EDTA 13x75 lavender cap-white ring, G-barcode label, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 1 ml K3E K3EDTA 13x75 lavender cap-white ring, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 1 ml LH Lithium Heparin 13x75 green cap-white ring, PREMIUM98/79 VACUETTE® TUBE 1.5 ml 4NC ESR sodium citrate 3.2% 9x120 black cap, PP VACUETTE® TUBE 4NC ESR sodium citrate 3.2%98/79 VACUETTE® TUBE 1.5 ml 4NC ESR sodium citrate 3.2% 9x120 black cap, PP, G-barcode label VACUETTE® TUBE 4NC ESR sodium citrate 3.2%98/79 VACUETTE® TUBE 1.5 ml 4NC ESR sodium citrate 3.2% 9x120 black cap, PP, High Altitude VACUETTE® TUBE 4NC ESR sodium citrate 3.2%98/79 VACUETTE® TUBE 1.6 ml 4NC ESR sodium citrate 3.2% 9x120 black cap, G-barcode label, glass VACUETTE® TUBE 4NC ESR sodium citrate 3.2%98/79 VACUETTE® TUBE 1.6 ml 4NC ESR sodium citrate 3.2% 9x120 black cap, glass VACUETTE® TUBE 4NC ESR sodium citrate 3.2%98/79 VACUETTE® TUBE 10 ml Urine CCM 16x100 yellow cap-black ring, G-barcode label, Round Base, non-ridged98/79 VACUETTE® TUBE 10 ml Urine CCM 16x100 yellow cap-black ring, Round Base, non-ridged98/79 VACUETTE® TUBE 10 ml Urine Stabilur 16x100 yellow cap-red ring, Round Base, non-ridged98/79 VACUETTE® TUBE 10 ml Z Urine No Additive 16x100 black cap-black ring, round base, non-ridged98/79 VACUETTE® TUBE 10 ml Z Urine No Additive 16x100 yellow cap-yellow ring, Round Base, G-barcode label, non- ridged98/79 VACUETTE® TUBE 10 ml Z Urine No Additive 16x100 yellow cap-yellow ring, Round Base, G-Bi-Barcode label, non- ridged98/79 VACUETTE® TUBE 10 ml Z Urine No Additive 16x100 yellow cap-yellow ring, Round Base, non-ridged98/79 VACUETTE® TUBE 2 ml 9NC Coagulation sodium citrate 3,8% 13x75 blue cap-white ring98/79 VACUETTE® TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring8 réf.98/79 VACUETTE® TUBE 2 ml CAT Serum Clot Activator 13x75 red cap-white ring, G-barcode label, PREMIUM98/79 VACUETTE® TUBE 2 ml CAT Serum Clot Activator 13x75 red cap-white ring, non-ridged98/79 VACUETTE® TUBE 2 ml CAT Serum Clot Activator 13x75 red cap-white ring, PREMIUM98/79 VACUETTE® TUBE 2 ml CAT Serum Clot Activator 13x75 red cap-white ring, transparent label, non-ridged98/79 VACUETTE® TUBE 2 ml CTAD 13x75 blue cap-yellow ring, sandwich tube, transparent label, PREMIUM98/79 VACUETTE® TUBE 2 ml FE Glucose Test only 13x75 grey cap-white ring, non-ridged98/79 VACUETTE® TUBE 2 ml FE Sodium Fluoride / K3EDTA 13x75 grey cap-white ring, G-barcode label, PREMIUM VACUETTE® TUBE FE Sodium Fluoride / K3EDTA98/79 VACUETTE® TUBE 2 ml FE Sodium Fluoride / K3EDTA 13x75 grey cap-white ring, non-ridged VACUETTE® TUBE FE Sodium Fluoride / K3EDTA98/79 VACUETTE® TUBE 2 ml FE Sodium Fluoride / K3EDTA 13x75 grey cap-white ring, PREMIUM VACUETTE® TUBE FE Sodium Fluoride / K3EDTA98/79 VACUETTE® TUBE 2 ml FE Sodium Fluoride / K3EDTA 13x75 grey cap-white ring, transparent label, PREMIUM VACUETTE® TUBE FE Sodium Fluoride / K3EDTA98/79 VACUETTE® TUBE 2 ml FX Sodium Fluoride / Potassium Oxalate 13x75 grey cap-white ring, G-barcode label, PREMIUM98/79 VACUETTE® TUBE 2 ml FX Sodium Fluoride / Potassium Oxalate 13x75 grey cap-white ring, non-ridged98/79 VACUETTE® TUBE 2 ml FX Sodium Fluoride / Potassium Oxalate 13x75 grey cap-white ring, PREMIUM98/79 VACUETTE® TUBE 2 ml FX Sodium Fluoride / Potassium Oxalate 13x75 grey cap-white ring, transparent label, non-ridged98/79 VACUETTE® TUBE 2 ml Homocysteine Detection 13x75 white cap-red ring, sandwich tube, PREMIUM98/79 VACUETTE® TUBE 2 ml K2E K2EDTA 13x75 lavender cap-white ring, G-barcode label, PREMIUM VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 2 ml K2E K2EDTA 13x75 lavender cap-white ring, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 2 ml K2E K2EDTA 13x75 lavender cap-white ring, PREMIUM VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 2 ml K2E K2EDTA 13x75 lavender cap-white ring, transparent label, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 2 ml K2E K2EDTA 13x75 yellow cap-white ring, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 2 ml K3E K3EDTA 13x75 black cap-black ring, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 2 ml K3E K3EDTA 13x75 lavender cap-white ring, G-barcode label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 2 ml K3E K3EDTA 13x75 lavender cap-white ring, G-barcode label, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 2 ml K3E K3EDTA 13x75 lavender cap-white ring, G-bi-barcode label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 2 ml K3E K3EDTA 13x75 lavender cap-white ring, KOH barcode label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 2 ml K3E K3EDTA 13x75 lavender cap-white ring, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 2 ml K3E K3EDTA 13x75 lavender cap-white ring, non-ridged, High Altitude VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 2 ml K3E K3EDTA 13x75 lavender cap-white ring, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 2 ml K3E K3EDTA 13x75 lavender cap-white ring, transparent label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 2 ml K3E K3EDTA 13x75 lavender cap-white ring, transparent label, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 2 ml LH Lithium Heparin 13x75 green cap-white ring, G-barcode label, PREMIUM98/79 VACUETTE® TUBE 2 ml LH Lithium Heparin 13x75 green cap-white ring, non-ridged98/79 VACUETTE® TUBE 2 ml LH Lithium Heparin 13x75 green cap-white ring, PREMIUM98/79 VACUETTE® TUBE 2 ml NH Sodium Heparin 13x75 green cap-green ring, non-ridged98/79 VACUETTE® TUBE 2 ml Z No Additive 13x75 black cap-black ring, non-ridged98/79 VACUETTE® TUBE 2 ml Z No Additive 13x75 black cap-yellow ring, non-ridged, High Altitude98/79 VACUETTE® TUBE 2 ml Z No Additive 13x75 blue cap-black ring, non-ridged98/79 VACUETTE® TUBE 2 ml Z No Additive 13x75 lavender cap-black ring, non-ridged98/79 VACUETTE® TUBE 2 ml Z No Additive 13x75 lavender cap-yellow ring, non-ridged, High Altitude98/79 VACUETTE® TUBE 2 ml Z No Additive 13x75 light blue cap-black ring, non-ridged98/79 VACUETTE® TUBE 2 ml Z No Additive 13x75 light blue cap-yellow ring, non-ridged, High Altitude98/79 VACUETTE® TUBE 2 ml Z No Additive 13x75 pink cap-black ring, non-ridged98/79 VACUETTE® TUBE 2 ml Z No Additive 13x75 pink cap-yellow ring, non-ridged, High Altitude98/79 VACUETTE® TUBE 2 ml Z No Additive 13x75 white cap-white ring, PREMIUM98/79 VACUETTE® TUBE 2.5 ml CAT Serum Separator Clot Activator 13x75 red cap-white ring, non-ridged2 réf.98/79 VACUETTE® TUBE 2.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, G-barcode label, PREMIUM2 réf.98/79 VACUETTE® TUBE 2.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, PREMIUM2 réf.98/79 VACUETTE® TUBE 2.5 ml CAT Serum Separator Clot Activator 13x75 yellow cap-white ring, black KOH barcode label, non-ridge2 réf.98/79 VACUETTE® TUBE 2.5 ml CAT Serum Separator Clot Activator 13x75 yellow cap-white ring, black label, non-ridged2 réf.98/79 VACUETTE® TUBE 2.5 ml LH Lithium Heparin Separator 13x75 green cap-yellow ring, PREMIUM2 réf.98/79 VACUETTE® TUBE 2.75 ml 4NC ESR sodium citrate 3.2% 9x120 black cap, PP VACUETTE® TUBE 4NC ESR sodium citrate 3.2%98/79 VACUETTE® TUBE 2.9 ml 4NC ESR sodium citrate 3.2% 9x120 black cap, glass VACUETTE® TUBE 4NC ESR sodium citrate 3.2%98/79 VACUETTE® TUBE 3 ml 9NC Coagulation sodium citrate 3,8% 13x75 blue cap-black ring98/79 VACUETTE® TUBE 3 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-black ring5 réf.98/79 VACUETTE® TUBE 3 ml 9NC Coagulation sodium citrate 3.2% 13x75 light blue cap-black ring98/79 VACUETTE® TUBE 3 ml CAT Serum Clot Activator 13x75 red cap-black ring, PREMIUM98/79 VACUETTE® TUBE 3 ml CTAD 13x75 blue cap-yellow ring, sandwich tube, transparent label, PREMIUM98/79 VACUETTE® TUBE 3 ml K2E K2EDTA 13x75 lavender cap-black ring, barcode label, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 3 ml K2E K2EDTA 13x75 lavender cap-black ring, G-barcode label, PREMIUM VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 3 ml K2E K2EDTA 13x75 lavender cap-black ring, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 3 ml K2E K2EDTA 13x75 lavender cap-black ring, PREMIUM VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 3 ml K2E K2EDTA 13x75 lavender cap-black ring, transparent label, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-black ring, G-barcode label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-black ring, G-barcode label, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-black ring, G-bi-barcode label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-black ring, KOH barcode label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-black ring, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-black ring, non-ridged, High Altitude VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-black ring, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-black ring, transparent label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-black ring, transparent label, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-red ring, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-red ring, transparent label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-white ring, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-white ring, transparent label, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 orange cap-black ring, KOH barcode label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 orange cap-black ring, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 red cap-black ring, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 3 ml LH Lithium Heparin 13x75 green cap-black ring, non-ridged98/79 VACUETTE® TUBE 3 ml LH Lithium Heparin 13x75 green cap-black ring, PREMIUM98/79 VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 gold cap-white ring, non-ridged98/79 VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 green cap-yellow ring, non-ridged3 réf.98/79 VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 green cap-yellow ring, transparent label, non-ridged2 réf.98/79 VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 green cap-yellow ring, transparent label, PREMIUM98/79 VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 mint green cap-yellow ring, transparent label, non-ridged2 réf.98/79 VACUETTE® TUBE 3 ml Z No Additive 13x75 gold cap-gold ring, red G-barcode label, non-ridged98/79 VACUETTE® TUBE 3 ml Z No Additive 13x75 gold cap-gold ring, red label, non-ridged98/79 VACUETTE® TUBE 3 ml Z No Additive 13x75 red cap-white ring, transparent label, non-ridged98/79 VACUETTE® TUBE 3 ml Z No Additive 13x75 white cap-black ring, non-ridged98/79 VACUETTE® TUBE 3 ml Z Urine No Additive 13x75 yellow cap-yellow ring, Round Base, PREMIUM98/79 VACUETTE® TUBE 3.5 ml 9NC Coagulation sodium citrate 3,8% 13x75 blue cap-black ring2 réf.98/79 VACUETTE® TUBE 3.5 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-black ring6 réf.98/79 VACUETTE® TUBE 3.5 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring98/79 VACUETTE® TUBE 3.5 ml 9NC Coagulation sodium citrate 3.2% 13x75 light blue cap-black ring98/79 VACUETTE® TUBE 3.5 ml CAT Serum Fast Separator 13x75 orange cap-yellow ring, non-ridged98/79 VACUETTE® TUBE 3.5 ml CAT Serum Fast Separator 13x75 orange cap-yellow ring, PREMIUM98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x100 red cap-yellow ring, non-ridged98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 gold cap-black ring, non-ridged2 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 gold cap-gold ring, black label, non-ridged2 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 gold cap-gold ring, PREMIUM2 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 gold cap-gold ring, transparent label, non-ridged2 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 gold cap-gold ring, transparent label, PREMIUM2 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 gold cap-white ring, black label, non-ridged2 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, G-barcode label, non-ridged2 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, G-barcode label, PREMIUM2 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, non-ridged4 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, PREMIUM2 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, transparent label, non-ridged2 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, transparent label, PREMIUM2 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 royal blue cap-yellow ring, non-ridged2 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 white cap-yellow ring, PREMIUM2 réf.98/79 VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 yellow cap-yellow ring, non-ridged98/79 VACUETTE® TUBE 3.5 ml CTAD 13x75 blue cap-yellow ring, sandwich tube, PREMIUM98/79 VACUETTE® TUBE 3.5 ml CTAD 13x75 blue cap-yellow ring, sandwich tube, transparent label, non-ridged98/79 VACUETTE® TUBE 3.5 ml CTAD 13x75 blue cap-yellow ring, sandwich tube, transparent label, PREMIUM98/79 VACUETTE® TUBE 3.5 ml K2E K2EDTA Separator 13x75 lavender cap-yellow ring, PREMIUM VACUETTE® TUBE K2E K2EDTA Separator2 réf.98/79 VACUETTE® TUBE 3.5 ml LH Lithium Heparin Separator 13x100 green cap-yellow ring, non-ridged2 réf.98/79 VACUETTE® TUBE 3.5 ml LH Lithium Heparin Separator 13x75 green cap-red ring, barcode label, non-ridged2 réf.98/79 VACUETTE® TUBE 3.5 ml LH Lithium Heparin Separator 13x75 green cap-yellow ring, barcode label, non-ridged2 réf.98/79 VACUETTE® TUBE 3.5 ml LH Lithium Heparin Separator 13x75 green cap-yellow ring, G-barcode label, PREMIUM2 réf.98/79 VACUETTE® TUBE 3.5 ml LH Lithium Heparin Separator 13x75 green cap-yellow ring, G-bi-barcode label, non-ridged98/79 VACUETTE® TUBE 3.5 ml LH Lithium Heparin Separator 13x75 green cap-yellow ring, non-ridged2 réf.98/79 VACUETTE® TUBE 3.5 ml LH Lithium Heparin Separator 13x75 green cap-yellow ring, PREMIUM2 réf.98/79 VACUETTE® TUBE 3.5 ml LH Lithium Heparin Separator 13x75 green cap-yellow ring, special label, non-ridged2 réf.98/79 VACUETTE® TUBE 3.5 ml LH Lithium Heparin Separator 13x75 green cap-yellow ring, transparent label, PREMIUM2 réf.98/79 VACUETTE® TUBE 3.5 ml LH Lithium Heparin Separator 13x75 mint green cap-yellow ring, transparent label, non-ridged2 réf.98/79 VACUETTE® TUBE 3.5 ml Z No Additive 13x75 white cap-black ring, non-ridged98/79 VACUETTE® TUBE 4 ml CAT Serum Clot Activator 13x75 pink cap-black ring, non-ridged98/79 VACUETTE® TUBE 4 ml CAT Serum Clot Activator 13x75 pink cap-black ring, PREMIUM98/79 VACUETTE® TUBE 4 ml CAT Serum Clot Activator 13x75 red cap-black ring, G-barcode label, PREMIUM98/79 VACUETTE® TUBE 4 ml CAT Serum Clot Activator 13x75 red cap-black ring, non-ridged98/79 VACUETTE® TUBE 4 ml CAT Serum Clot Activator 13x75 red cap-black ring, non-ridged, High Altitude98/79 VACUETTE® TUBE 4 ml CAT Serum Clot Activator 13x75 red cap-black ring, PREMIUM98/79 VACUETTE® TUBE 4 ml CAT Serum Clot Activator 13x75 red cap-black ring, transparent label, non-ridged98/79 VACUETTE® TUBE 4 ml CAT Serum Clot Activator 13x75 red cap-black ring, transparent label, PREMIUM98/79 VACUETTE® TUBE 4 ml CAT Serum Clot Activator 13x75 white cap-black ring, PREMIUM98/79 VACUETTE® TUBE 4 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, G-barcode label, non-ridged2 réf.98/79 VACUETTE® TUBE 4 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged2 réf.98/79 VACUETTE® TUBE 4 ml EDTA Aprotinin 13x75 pink cap-black ring, PREMIUM98/79 VACUETTE® TUBE 4 ml FE Sodium Fluoride / K3EDTA 13x75 grey cap-black ring, G-barcode label, PREMIUM VACUETTE® TUBE FE Sodium Fluoride / K3EDTA98/79 VACUETTE® TUBE 4 ml FE Sodium Fluoride / K3EDTA 13x75 grey cap-black ring, KOH barcode label, non-ridged VACUETTE® TUBE FE Sodium Fluoride / K3EDTA98/79 VACUETTE® TUBE 4 ml FE Sodium Fluoride / K3EDTA 13x75 grey cap-black ring, non-ridged VACUETTE® TUBE FE Sodium Fluoride / K3EDTA98/79 VACUETTE® TUBE 4 ml FE Sodium Fluoride / K3EDTA 13x75 grey cap-black ring, PREMIUM VACUETTE® TUBE FE Sodium Fluoride / K3EDTA98/79 VACUETTE® TUBE 4 ml FX Sodium Fluoride / Potassium Oxalate 13x75 grey cap-black ring, non-ridged98/79 VACUETTE® TUBE 4 ml FX Sodium Fluoride / Potassium Oxalate 13x75 grey cap-black ring, PREMIUM98/79 VACUETTE® TUBE 4 ml FX Sodium Fluoride / Potassium Oxalate 13x75 grey cap-black ring, transparent label, non-ridged98/79 VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 lavender cap-black ring, G-barcode label, PREMIUM VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 lavender cap-black ring, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 lavender cap-black ring, non-ridged, High Altitude VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 lavender cap-black ring, PREMIUM VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 lavender cap-black ring, transparent label, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 lavender cap-white ring, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 lavender cap-white ring, PREMIUM VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 lavender cap-yellow ring, PREMIUM VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 pink cap-black ring, G-barcode label, PREMIUM VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 pink cap-black ring, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 4 ml K3E K3EDTA 13x75 lavender cap-black ring, amber tube, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 4 ml K3E K3EDTA 13x75 lavender cap-black ring, G-barcode label, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 4 ml K3E K3EDTA 13x75 lavender cap-black ring, non-ridged 100/Box VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 4 ml K3E K3EDTA 13x75 lavender cap-black ring, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 4 ml K3E K3EDTA 13x75 lavender cap-black ring, non-ridged, High Altitude VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 4 ml K3E K3EDTA 13x75 lavender cap-black ring, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 4 ml K3E K3EDTA 13x75 lavender cap-black ring, transparent label, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 4 ml K3E K3EDTA 13x75 lavender cap-red ring, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 4 ml K3E K3EDTA 13x75 ping cap-black ring, pink label, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 4 ml LH Lithium Heparin 13x75 green cap-black ring, G-barcode label, PREMIUM98/79 VACUETTE® TUBE 4 ml LH Lithium Heparin 13x75 green cap-black ring, KOH barcode label, non-ridged98/79 VACUETTE® TUBE 4 ml LH Lithium Heparin 13x75 green cap-black ring, non-ridged98/79 VACUETTE® TUBE 4 ml LH Lithium Heparin 13x75 green cap-black ring, non-ridged, High Altitude98/79 VACUETTE® TUBE 4 ml LH Lithium Heparin 13x75 green cap-black ring, PREMIUM98/79 VACUETTE® TUBE 4 ml LH Lithium Heparin 13x75 green cap-black ring, transparent label, non-ridged98/79 VACUETTE® TUBE 4 ml LH Lithium Heparin 13x75 green cap-black ring, transparent label, PREMIUM98/79 VACUETTE® TUBE 4 ml LH Lithium Heparin 16x100 green cap-black ring, G-barcode label, non-ridged98/79 VACUETTE® TUBE 4 ml LH Lithium Heparin 16x100 green cap-black ring, non-ridged98/79 VACUETTE® TUBE 4 ml LH Lithium Heparin Separator 16x100 green cap-yellow ring, G-barcode label, non-ridged98/79 VACUETTE® TUBE 4 ml LH Lithium Heparin Separator 16x100 green cap-yellow ring, non-ridged2 réf.98/79 VACUETTE® TUBE 4 ml NH Sodium Heparin 13x75 green cap-green ring, G-barcode label, PREMIUM98/79 VACUETTE® TUBE 4 ml NH Sodium Heparin 13x75 green cap-green ring, non-ridged98/79 VACUETTE® TUBE 4 ml NH Sodium Heparin 13x75 green cap-green ring, non-ridged, High Altitude98/79 VACUETTE® TUBE 4 ml NH Sodium Heparin 13x75 green cap-green ring, PREMIUM98/79 VACUETTE® TUBE 4 ml NH Sodium Heparin 13x75 royal blue cap-black ring, transparent label, non-ridged98/79 VACUETTE® TUBE 4 ml Urine CCM 13x75 yellow cap-black ring, G-barcode label, Round base, non-ridged98/79 VACUETTE® TUBE 4 ml Urine CCM 13x75 yellow cap-black ring, Round Base, non-ridged98/79 VACUETTE® TUBE 4 ml Z No Additive 13x100 lavender cap-black ring98/79 VACUETTE® TUBE 4 ml Z No Additive 13x75 white cap-black ring, G-barcode label, PREMIUM2 réf.98/79 VACUETTE® TUBE 4 ml Z No Additive 13x75 white cap-black ring, PREMIUM98/79 VACUETTE® TUBE 4 ml Z Urine No Additive 13x75 black cap-black ring, round base, non-ridged98/79 VACUETTE® TUBE 4 ml Z Urine No Additive 13x75 yellow cap-yellow ring, Round Base, G-barcode label, PREMIUM98/79 VACUETTE® TUBE 4.5 ml CAT Serum Clot Activator 13x75 red cap-black ring, PREMIUM98/79 VACUETTE® TUBE 4.5 ml CAT Serum Clot Activator 13x75 red cap-black ring, transparent label, PREMIUM98/79 VACUETTE® TUBE 5 ml 9NC Coagulation sodium citrate 3.2% 13x100 blue cap-black ring98/79 VACUETTE® TUBE 5 ml CAT Serum Fast Separator 13x100 orange cap-yellow ring, G-barcode label, PREMIUM98/79 VACUETTE® TUBE 5 ml CAT Serum Fast Separator 13x100 orange cap-yellow ring, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Fast Separator 13x100 orange cap-yellow ring, PREMIUM98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 gold cap-gold ring, black G-barcode label, PREMIUM2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 gold cap-gold ring, black KOH barcode label, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 gold cap-gold ring, black label, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 gold cap-gold ring, PREMIUM2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 gold cap-gold ring, transparent label, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 gold cap-gold ring, transparent label, PREMIUM2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 orange cap-black ring, black label, PREMIUM98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 pink cap-black ring, special label, non-ridged98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 pink cap-yellow ring, KOH barcode label, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 pink cap-yellow ring, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 red cap-black ring, special label, non-ridged98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 red cap-yellow ring, G-barcode label, PREMIUM2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 red cap-yellow ring, G-bi-barcode label, PREMIUM98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 red cap-yellow ring, KOH barcode label, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 red cap-yellow ring, non-ridged3 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 red cap-yellow ring, PREMIUM2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 red cap-yellow ring, transparent label, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 red cap-yellow ring, transparent label, PREMIUM2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 royal blue cap-yellow ring, blue label, non-ridged98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 royal blue cap-yellow ring, KOH barcode label, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 royal blue cap-yellow ring, non-ridged98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 white cap-black ring, black label, PREMIUM98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 white cap-yellow ring, black label, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 white cap-yellow ring, KOH barcode label, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 yellow cap-black ring, special label, non-ridged98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 yellow cap-yellow ring, black label, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 yellow cap-yellow ring, KOH barcode label, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml K2E K2EDTA Separator 13x100 lavender cap-yellow ring, non-ridged VACUETTE® TUBE K2E K2EDTA Separator98/79 VACUETTE® TUBE 5 ml K2E K2EDTA Separator 13x100 lavender cap-yellow ring, PREMIUM VACUETTE® TUBE K2E K2EDTA Separator98/79 VACUETTE® TUBE 5 ml K2E K2EDTA Separator 13x100 white cap-yellow ring, non-ridged VACUETTE® TUBE K2E K2EDTA Separator98/79 VACUETTE® TUBE 5 ml K2E K2EDTA Separator 13x100 white cap-yellow ring, PREMIUM VACUETTE® TUBE K2E K2EDTA Separator98/79 VACUETTE® TUBE 5 ml K2E K2EDTA Separator 13x100 white cap-yellow ring, special label, non-ridged VACUETTE® TUBE K2E K2EDTA Separator98/79 VACUETTE® TUBE 5 ml LH Lithium Heparin Separator 13x100 green cap-white ring, non-ridged98/79 VACUETTE® TUBE 5 ml LH Lithium Heparin Separator 13x100 green cap-yellow ring, G-barcode label, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml LH Lithium Heparin Separator 13x100 green cap-yellow ring, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml LH Lithium Heparin Separator 13x100 green cap-yellow ring, PREMIUM2 réf.98/79 VACUETTE® TUBE 5 ml LH Lithium Heparin Separator 13x100 green cap-yellow ring, transparent label, non-ridged2 réf.98/79 VACUETTE® TUBE 5 ml LH Lithium Heparin Separator 13x100 green cap-yellow ring, transparent label, PREMIUM98/79 VACUETTE® TUBE 5 ml LH Lithium Heparin Separator 13x100 mint green cap-yellow ring, non-ridged98/79 VACUETTE® TUBE 5 ml LH Lithium Heparin Separator 13x100 mint green cap-yellow ring, transparent label, non-ridged98/79 VACUETTE® TUBE 5 ml Z Discard Tube 13x100 black cap-red ring, non-ridged98/79 VACUETTE® TUBE 5 ml Z No Additive 13x100 white cap-black ring98/79 VACUETTE® TUBE 5,5 ml FX Sodium Fluoride / Potassium Oxalate 13x100 grey cap-black ring, non-ridged98/79 VACUETTE® TUBE 6 ml ACD-A 13x100 yellow cap-black ring, PREMIUM98/79 VACUETTE® TUBE 6 ml ACD-B 13x100 yellow cap-black ring, PREMIUM98/79 VACUETTE® TUBE 6 ml CAT Crossmatch Serum Clot Activator 13x100 pink cap-black ring, special label non-ridged98/79 VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 gold cap-black ring, black label, PREMIUM98/79 VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 orange cap-black ring, non-ridged98/79 VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 pink cap-black ring, pink label, PREMIUM98/79 VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 red cap-black ring, G-barcode label, PREMIUM98/79 VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 red cap-black ring, ISLAB barcode label, non-ridged98/79 VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 red cap-black ring, non-ridged98/79 VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 red cap-black ring, non-ridged, High Altitude98/79 VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 red cap-black ring, PREMIUM98/79 VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 red cap-black ring, transparent label, non-ridged98/79 VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 red cap-black ring, transparent label, PREMIUM98/79 VACUETTE® TUBE 6 ml CPDA 13x100 yellow cap-black ring, non-ridged98/79 VACUETTE® TUBE 6 ml CPDA 13x100 yellow cap-black ring, PREMIUM98/79 VACUETTE® TUBE 6 ml FX Sodium Fluoride / Potassium Oxalate 13x100 grey cap-black ring, PREMIUM98/79 VACUETTE® TUBE 6 ml K2E K2EDTA 13x100 lavender cap-black ring, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 6 ml K2E K2EDTA 13x100 lavender cap-black ring, PREMIUM VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 6 ml K2E K2EDTA 13x100 lavender cap-black ring, transparent label, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 6 ml K2E K2EDTA 13x100 pink cap-black ring, transparent special label, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 6 ml K2E K2EDTA 13x100 red cap-black ring, PREMIUM VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 6 ml K3E Crossmatch K3EDTA 13x100 pink cap-black ring, special label, non-ridged VACUETTE® TUBE K3E Crossmatch K3EDTA4 réf.98/79 VACUETTE® TUBE 6 ml K3E Crossmatch K3EDTA 13x100 pink cap-black ring, special label, PREMIUM VACUETTE® TUBE K3E Crossmatch K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 lavender cap-black ring, G-barcode label, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 lavender cap-black ring, G-bi-barcode label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 lavender cap-black ring, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 lavender cap-black ring, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 lavender cap-black ring, transparent label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 lavender cap-red ring, special label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 orange cap-black ring, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 pink cap-black ring, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 pink cap-black ring, transparent label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 pink cap-red ring, special label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 pink cap-yellow ring, special label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 red cap-red ring, special label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 red cap-yellow ring, special label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 royal blue cap-black ring, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 white cap-black ring, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 yellow cap-black ring, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 yellow cap-red ring, special label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml K3E K3EDTA 13x100 yellow cap-yellow ring, special label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 6 ml LH Lithium Heparin 13x100 green cap-black ring, G-barcode label, PREMIUM98/79 VACUETTE® TUBE 6 ml LH Lithium Heparin 13x100 green cap-black ring, non-ridged98/79 VACUETTE® TUBE 6 ml LH Lithium Heparin 13x100 green cap-black ring, PREMIUM98/79 VACUETTE® TUBE 6 ml LH Lithium Heparin 13x100 green cap-black ring, transparent label, non-ridged98/79 VACUETTE® TUBE 6 ml LH Lithium Heparin 13x100 green cap-black ring, transparent label, PREMIUM98/79 VACUETTE® TUBE 6 ml NH Sodium Heparin 13x100 green cap-green ring, non-ridged98/79 VACUETTE® TUBE 6 ml NH Trace Elements Sodium Heparin 13x100 royalblue cap-black ring, non-ridged98/79 VACUETTE® TUBE 6 ml Urine CCM 13x100 yellow cap-black ring, Round Base, G-bi-barcode label, non-ridged98/79 VACUETTE® TUBE 6 ml Urine CCM 13x100 yellow cap-black ring, Round Base, non-ridged98/79 VACUETTE® TUBE 6 ml Z No Additive 13x100 white cap-black ring, non-ridged98/79 VACUETTE® TUBE 6 ml Z No Additive 13x100 white cap-black ring, PREMIUM98/79 VACUETTE® TUBE 6 ml Z Trace Elements No Additive 13x100 royal blue cap-black ring, non-ridged98/79 VACUETTE® TUBE 6 ml Z Urine No Additive 13x100 yellow cap-yellow ring, Round Base, G-barcode label, PREMIUM98/79 VACUETTE® TUBE 6 ml Z Urine No Additive 13x100 yellow cap-yellow ring, Round Base, non-ridged98/79 VACUETTE® TUBE 6 ml Z Urine No Additive 13x100 yellow cap-yellow ring, Round Base, PREMIUM2 réf.98/79 VACUETTE® TUBE 6 ml Z Urine No Additive 13x100 yellow cap-yellow ring, transparent label, Round Base, PREMIUM98/79 VACUETTE® TUBE 6ml NH Trace Elements Sodium Heparin 13x100 royal blue cap-black ring, PREMIUM98/79 VACUETTE® TUBE 7 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged, double gel2 réf.98/79 VACUETTE® TUBE 7 ml Z Urine No Additive 16x100 yellow cap-yellow ring, Round Base, G-barcode label, non-ridged98/79 VACUETTE® TUBE 7 ml Z Urine No Additive 16x100 yellow cap-yellow ring, Round Base, non-ridged98/79 VACUETTE® TUBE 8 ml CAT Serum Separator 16x100 red cap-yellow ring, G-barcode label, non-ridged98/79 VACUETTE® TUBE 8 ml CAT Serum Separator Clot Activator 16x100 gold cap-gold ring, non-ridged2 réf.98/79 VACUETTE® TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, G-barcode label, non-ridged98/79 VACUETTE® TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, G-bi-barcode label, non-ridged98/79 VACUETTE® TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged3 réf.98/79 VACUETTE® TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged, Gamma98/79 VACUETTE® TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, transparent label, non-ridged98/79 VACUETTE® TUBE 8 ml CAT Serum Separator Clot Activator 16x100 white cap-black ring, black label, non-ridged98/79 VACUETTE® TUBE 8 ml K2E K2EDTA Separator 16x100 lavender cap-yellow ring, non-ridged VACUETTE® TUBE K2E K2EDTA Separator98/79 VACUETTE® TUBE 8 ml K2E K2EDTA Separator 16x100 white cap-yellow ring, non-ridged VACUETTE® TUBE K2E K2EDTA Separator98/79 VACUETTE® TUBE 8 ml K2E K2EDTA Separator 16x100 white cap-yellow ring, transparent label, non-ridged VACUETTE® TUBE K2E K2EDTA Separator98/79 VACUETTE® TUBE 8 ml LH Lithium Heparin Separator 16x100 green cap-yellow ring, G-Bi-Barcode label, non-ridged98/79 VACUETTE® TUBE 8 ml LH Lithium Heparin Separator 16x100 green cap-yellow ring, non-ridged2 réf.98/79 VACUETTE® TUBE 8 ml Urine CCM 16x100 yellow cap-black ring, Round Base, non-ridged98/79 VACUETTE® TUBE 8 ml Z Urine No Additive 16x100 yellow cap-black ring, Round Base, non-ridged98/79 VACUETTE® TUBE 9 ml 9NC Coagulation sodium citrate 3,2% 16x100 blue cap-black ring98/79 VACUETTE® TUBE 9 ml 9NC Coagulation sodium citrate 3,8% 16x100 blue cap-black ring98/79 VACUETTE® TUBE 9 ml ACD-A 16x100 yellow cap-black ring, non-ridged98/79 VACUETTE® TUBE 9 ml ACD-B 16x100 yellow cap-black ring, non-ridged98/79 VACUETTE® TUBE 9 ml CAT Serum Clot Activator 16x100 gold cap-gold ring, non-ridged98/79 VACUETTE® TUBE 9 ml CAT Serum Clot Activator 16x100 red cap-black ring, G-barcode label, non-ridged98/79 VACUETTE® TUBE 9 ml CAT Serum Clot Activator 16x100 red cap-black ring, non-ridged98/79 VACUETTE® TUBE 9 ml CAT Serum Clot Activator 16x100 red cap-black ring, non-ridged, High Altitude98/79 VACUETTE® TUBE 9 ml CAT Serum Clot Activator 16x100 red cap-black ring, transparent label, non-ridged98/79 VACUETTE® TUBE 9 ml CPDA 16x100 yellow cap-black ring, non-ridged98/79 VACUETTE® TUBE 9 ml K2E K2EDTA 16x100 black cap-black ring, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 9 ml K2E K2EDTA 16x100 lavender cap-black ring, G-Bi-Barcode label, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 9 ml K2E K2EDTA 16x100 lavender cap-black ring, non-ridged VACUETTE® TUBE K2E K2EDTA98/79 VACUETTE® TUBE 9 ml K3E K3EDTA 16x100 lavender cap-black ring, barcode label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 9 ml K3E K3EDTA 16x100 lavender cap-black ring, G-barcode label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 9 ml K3E K3EDTA 16x100 lavender cap-black ring, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 9 ml K3E K3EDTA 16x100 lavender cap-black ring, transparent label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 9 ml K3E K3EDTA 16x100 orange cap-black ring, G-barcode label, non-ridged VACUETTE® TUBE K3E K3EDTA98/79 VACUETTE® TUBE 9 ml LH Lithium Heparin 16x100 green cap-black ring, non-ridged98/79 VACUETTE® TUBE 9 ml NH Sodium Heparin 16x100 green cap-black ring, G-barcode label, non-ridged98/79 VACUETTE® TUBE 9 ml NH Sodium Heparin 16x100 green cap-green ring, non-ridged98/79 VACUETTE® TUBE 9 ml Urine CCM 16x100 yellow cap-black ring, Conical Base, non-ridged98/79 VACUETTE® TUBE 9 ml Urine Stabilur 16x100 yellow cap-red ring, Conical Base, non-ridged98/79 VACUETTE® TUBE 9 ml Z No Additive 16x100 white cap-black ring, G-barcode label, non-ridged98/79 VACUETTE® TUBE 9 ml Z No Additive 16x100 white cap-black ring, non-ridged98/79 VACUETTE® TUBE 9 ml Z Urine No Additive 16x100 red cap-red ring, red KOH barcode label, Round Base, non-ridged98/79 VACUETTE® TUBE 9 ml Z Urine No Additive 16x100 royal blue cap-red ring, blue KOH barcode label, Round Base, non- ridged98/79 VACUETTE® TUBE 9 ml Z Urine No Additive 16x100 white cap-red ring, KOH barcode label, Round Base, non-ridged98/79 VACUETTE® TUBE 9 ml Z Urine No Additive 16x100 yellow cap-red ring, KOH barcode label, Conical Base, non-ridged98/79 VACUETTE® TUBE 9 ml Z Urine No Additive 16x100 yellow cap-yellow ring, Conical Base, non-ridged98/79 VACUETTE® TUBE 9 ml Z Urine No Additive 16x100 yellow cap-yellow ring, G-barcode label, Conical Base, non- ridged98/79 VACUETTE® TUBE 9 ml Z Urine No Additive 16x100 yellow cap-yellow ring, G-bi-barcode label, Conical Base, non- ridged98/79 VACUETTE® URI-PLUS 24h urine container with integrated transfer device ESR pipette with adapter, graduated 200 mm for 454073 (plus commercialisé) ESR Rack without graduation for 454073 (plus commercialisé) Urine Beaker with integrated Transfer Device 100 ml, yellow lid 5 pcs./bag, sterile98/79 (plus commercialisé) Urine Beaker with integrated Transfer Device 100 ml, yellow lid single-packed, sterile98/79 (plus commercialisé) VACUETTE® TUBE 10 ml Z Urine No Additive 16x100 yellow cap-red ring, Round Base, non-ridged98/79 (plus commercialisé) VACUETTE® TUBE 2 ml 4NC ESR sodium citrate 3.2% 13x75 black cap-black ring, G-barcode label, PREMIUM VACUETTE® TUBE 4NC ESR sodium citrate 3.2%98/79 (plus commercialisé) VACUETTE® TUBE 4 ml Z Urine No Additive 13x75 black cap-black ring, Round Base, transparent label, non-ridged98/79 (plus commercialisé) VACUETTE® TUBE 4.5 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-black ring98/79 (plus commercialisé) VACUETTE® TUBE 5 ml K2E K2EDTA Separator 13x100 white cap-yellow ring, transparent label, non-ridged VACUETTE® TUBE K2E K2EDTA Separator98/79 (plus commercialisé) VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 red cap-red ring, non-ridged98/79 (plus commercialisé) VACUETTE® TUBE 6 ml K3E K3EDTA Liquid 13x100 lavender cap-black ring, PREMIUM VACUETTE® TUBE K3E K3EDTA98/79 (plus commercialisé)	A IVDR, 98/79	Présent sur le marché en France Site web regulatory-affairs.at@gbo.com Fiche EUDAMED Signaler une erreur
Zytomed Systems	Allemagne	Mouse anti- Actin (Smooth Muscle) BMS00198/79 Mouse anti- Actin (Smooth Muscle) MSG03098/79 Mouse anti- Actin (Smooth Muscle) MSK03098/79 Mouse anti- Actin (Smooth Muscle) MSK030-0598/79 Mouse anti- Actin (Smooth Muscle) NOA-BMS00198/79 334 autres Mouse anti- p16 INK4a MSG12398/79 Mouse anti- p16 INK4a MSK123-0598/79 Mouse anti-ALK/p80 (Anaplastic Lymphoma Kinase) MSK096-0598/79 Mouse anti-CA 19-9 Antigen MSG09498/79 Mouse anti-CA 19-9 Antigen MSK094-0598/79 Mouse anti-Cadherin 17 MSG10598/79 Mouse anti-Cadherin 17 MSK105-0598/79 Mouse anti-CD10 (CALLA) BMS04398/79 Mouse anti-CD10 (CALLA) MSG07098/79 Mouse anti-CD10 (CALLA) MSK07098/79 Mouse anti-CD10 (CALLA) MSK070-0598/79 Mouse anti-CD11c MSG09398/79 Mouse anti-CD11c MSK093-0598/79 Mouse anti-CD138 (Syndecan-1) MSG06398/79 Mouse anti-CD138 (Syndecan-1) MSK06398/79 Mouse anti-CD138 (Syndecan-1) MSK063-0598/79 Mouse anti-CD138 (Syndecan-1) NOA-MSG06398/79 Mouse anti-CD20 BMS00398/79 Mouse anti-CD20 MSG00898/79 Mouse anti-CD20 MSK00898/79 Mouse anti-CD20 MSK008-0598/79 Mouse anti-CD20 NOA-BMS00398/79 Mouse anti-CD30 (Ki-1) MSG06198/79 Mouse anti-CD30 (Ki-1) MSK06198/79 Mouse anti-CD30 (Ki-1) MSK061-0598/79 Mouse anti-CD31 (PECAM-1) BMS04498/79 Mouse anti-CD31 (PECAM-1) NOA-BMS04498/79 Mouse anti-CD34 BMS04598/79 Mouse anti-CD34 NOA-BMS04598/79 Mouse anti-CD45 (LCA) BMS04698/79 Mouse anti-CD45 (LCA) MSG05498/79 Mouse anti-CD45 (LCA) MSK05498/79 Mouse anti-CD45 (LCA) MSK054-0598/79 Mouse anti-CD45 (LCA) NOA-BMS04698/79 Mouse anti-CD5 MSG12098/79 Mouse anti-CD5 MSK120-0598/79 Mouse anti-CD61 MSG08698/79 Mouse anti-CD61 MSK08698/79 Mouse anti-CD61 MSK086-0598/79 Mouse anti-CD61 NOA-MSG08698/79 Mouse anti-CD68 MSG05598/79 Mouse anti-CD68 MSK05598/79 Mouse anti-CD68 MSK055-0598/79 Mouse anti-CD79a BMS00598/79 Mouse anti-CD79a MSG03698/79 Mouse anti-CD79a MSK03698/79 Mouse anti-CD79a MSK036-0598/79 Mouse anti-CD79a NOA-BMS00598/79 Mouse anti-CD8 MSG01198/79 Mouse anti-CD8 MSK01198/79 Mouse anti-CD8 MSK011-0598/79 Mouse anti-CEA [COL-1] BMS02998/79 Mouse anti-CEA [COL-1] MSG02298/79 Mouse anti-CEA [Col-1] MSK02298/79 Mouse anti-CEA [Col-1] MSK022-0598/79 Mouse anti-CEA [Col-1] NOA-BMS02998/79 Mouse anti-Chromogranin A BMS01898/79 Mouse anti-Chromogranin A MSG06298/79 Mouse anti-Chromogranin A MSK06298/79 Mouse anti-Chromogranin A MSK062-0598/79 Mouse anti-Chromogranin A NOA-BMS01898/79 Mouse anti-CTLA4 MSG11698/79 Mouse anti-CTLA4 MSK116-0598/79 Mouse anti-Cytokeratin (HMW) BMS01598/79 Mouse anti-Cytokeratin (HMW) MSG02798/79 Mouse anti-Cytokeratin (HMW) MSK02798/79 Mouse anti-Cytokeratin (HMW) MSK027-0598/79 Mouse anti-Cytokeratin (HMW) NOA-BMS01598/79 Mouse anti-Cytokeratin 19 MSG01798/79 Mouse anti-Cytokeratin 19 MSK01798/79 Mouse anti-Cytokeratin 19 MSK017-0598/79 Mouse anti-Cytokeratin 20 BMS03798/79 Mouse anti-Cytokeratin 20 MSG11998/79 Mouse anti-Cytokeratin 20 MSK11998/79 Mouse anti-Cytokeratin 20 MSK119-0598/79 Mouse anti-Cytokeratin 20 NOA-BMS03798/79 Mouse anti-Cytokeratin 5 & 14 BMS02398/79 Mouse anti-Cytokeratin 5 & 14 MSG10698/79 Mouse anti-Cytokeratin 5 & 14 MSK10698/79 Mouse anti-Cytokeratin 5 & 14 MSK106-0598/79 Mouse anti-Cytokeratin 5 & 14 NOA-BMS02398/79 Mouse anti-Cytokeratin 5 & 6 BMS01798/79 Mouse anti-Cytokeratin 5 & 6 MSG03498/79 Mouse anti-Cytokeratin 5 & 6 MSK03498/79 Mouse anti-Cytokeratin 5 & 6 MSK034-0598/79 Mouse anti-Cytokeratin 5 & 6 NOA-BMS01798/79 Mouse anti-Cytokeratin 7 BMS03098/79 Mouse anti-Cytokeratin 7 MSG03298/79 Mouse anti-Cytokeratin 7 MSK03298/79 Mouse anti-Cytokeratin 7 MSK032-0598/79 Mouse anti-Cytokeratin 7 NOA-BMS03098/79 Mouse anti-Cytokeratin Broad Spectrum BMS00698/79 Mouse anti-Cytokeratin Broad Spectrum MSG01998/79 Mouse anti-Cytokeratin Broad Spectrum MSK01998/79 Mouse anti-Cytokeratin Broad Spectrum MSK019-0598/79 Mouse anti-Cytokeratin Pan BMS05698/79 Mouse anti-Cytokeratin Pan MSG11398/79 Mouse anti-Cytokeratin Pan MSK11398/79 Mouse anti-Cytokeratin Pan MSK113-0598/79 Mouse anti-Cytokeratin Pan Plus (AE1 & AE3 & 5D3) BMS05798/79 Mouse anti-Cytokeratin Pan Plus (AE1 & AE3 & 5D3) MSG09898/79 Mouse anti-Cytokeratin Pan Plus (AE1 & AE3 & 5D3) MSK098-0598/79 Mouse anti-Cytokeratin Pan Plus (AE1 & AE3 & 5D3) NOA-BMS05798/79 Mouse anti-Desmin BMS00798/79 Mouse anti-Desmin MSG05398/79 Mouse anti-Desmin MSK05398/79 Mouse anti-Desmin MSK053-0598/79 Mouse anti-Desmin NOA-BMS00798/79 Mouse anti-E-Cadherin MSG03398/79 Mouse anti-E-Cadherin MSK03398/79 Mouse anti-E-Cadherin MSK033-0598/79 Mouse anti-EMA (Epithelial Membrane Antigen) MSG05998/79 Mouse anti-EMA (Epithelial Membrane Antigen) MSK05998/79 Mouse anti-EMA (Epithelial Membrane Antigen) MSK059-0598/79 Mouse anti-EMA (Epithelial Membrane Antigen) NOA-MSG05998/79 Mouse anti-Epithelial Specific Antigen (ESA, Ep-CAM) BMS04898/79 Mouse anti-Epithelial Specific Antigen (ESA, Ep-CAM) MSG06698/79 Mouse anti-Epithelial Specific Antigen (ESA, Ep-CAM) MSK06698/79 Mouse anti-Epithelial Specific Antigen (ESA, Ep-CAM) MSK066-0598/79 Mouse anti-Epithelial Specific Antigen (ESA, Ep-CAM) MSK10998/79 Mouse anti-Epithelial Specific Antigen (ESA, Ep-CAM) MSK109-0598/79 Mouse anti-Epstein-Barr Virus Cocktail MSG11498/79 Mouse anti-Epstein-Barr Virus Cocktail MSK114-0598/79 Mouse anti-Epstein-Barr Virus Cocktail NOA-MSG11498/79 Mouse anti-ERG MSG09098/79 Mouse anti-ERG MSK090-0598/79 Mouse anti-GATA3 BMS05498/79 Mouse anti-GATA3 MSG10098/79 Mouse anti-GATA3 MSK100-0598/79 Mouse anti-GATA3 NOA-BMS05498/79 Mouse anti-Glypican-3 MSG06798/79 Mouse anti-Glypican-3 MSK067-0598/79 Mouse anti-Glypican-3 NOA-MSG06798/79 Mouse anti-HER2 (c-erbB-2) BMS01498/79 Mouse anti-HER2 (c-erbB-2) MSK04498/79 Mouse anti-HER2 (c-erbB-2) MSK044-0598/79 Mouse anti-HGAL MSG08898/79 Mouse anti-HGAL MSK088-0598/79 Mouse anti-HHV-8 (Human Herpes Virus 8) MSG08598/79 Mouse anti-HHV-8 (Human Herpes Virus 8) MSK085-0598/79 Mouse anti-HHV-8 (Human Herpes Virus 8) NOA-MSG08598/79 Mouse anti-IgG4 MSG08498/79 Mouse anti-IgG4 MSK084-0598/79 Mouse anti-INI-1 MSK078-0598/79 Mouse anti-Ki-67 BMS00998/79 Mouse anti-Ki-67 MSG01898/79 Mouse anti-Ki-67 MSK01898/79 Mouse anti-Ki-67 MSK018-0598/79 Mouse anti-Langerin MSG10398/79 Mouse anti-Langerin MSK103-0598/79 Mouse anti-MART-1 (Melan-A) MSG05698/79 Mouse anti-MART-1 (Melan-A) MSK05698/79 Mouse anti-MART-1 (Melan-A) MSK056-0598/79 Mouse anti-MART-1 (Melan-A) NOA-MSG05698/79 Mouse anti-Melanoma Associated Antigen PNL2 MSG08298/79 Mouse anti-Melanoma Associated Antigen PNL2 MSK082-0598/79 Mouse anti-Melanosome (HMB45) BMS01098/79 Mouse anti-Melanosome (HMB45) MSG00798/79 Mouse anti-Melanosome (HMB45) MSK00798/79 Mouse anti-Melanosome (HMB45) MSK007-0598/79 Mouse anti-Melanosome (HMB45) NOA-BMS01098/79 Mouse anti-MLH1 BMS03398/79 Mouse anti-MLH1 MSK045-0598/79 Mouse anti-MSH2 BMS03498/79 Mouse anti-MSH2 MSG03198/79 Mouse anti-MSH2 MSK031-0598/79 Mouse anti-Myogenin MSG11298/79 Mouse anti-Myogenin MSK112-0598/79 Mouse anti-Myosin SM Heavy Chain MSG08198/79 Mouse anti-Myosin SM Heavy Chain MSK081-0598/79 Mouse anti-Neurofilament L + H (70/200kD) MSG06098/79 Mouse anti-Neurofilament L + H (70/200kD) MSK06098/79 Mouse anti-Neurofilament L + H (70/200kD) MSK060-0598/79 Mouse anti-OCT-2 MSG07398/79 Mouse anti-OCT-2 MSK073-0598/79 Mouse anti-Olig2 MSG11598/79 Mouse anti-Olig2 MSK115-0598/79 Mouse anti-p40 (ΔNp63) BMS05098/79 Mouse anti-p40 (ΔNp63) MSG09798/79 Mouse anti-p40 (ΔNp63) MSK09798/79 Mouse anti-p40 (ΔNp63) MSK097-0598/79 Mouse anti-p40 (ΔNp63) NOA-BMS05098/79 Mouse anti-Parathyroid Hormone (PTH) MSG07298/79 Mouse anti-Parathyroid Hormone (PTH) MSK07298/79 Mouse anti-Parathyroid Hormone (PTH) MSK072-0598/79 Mouse anti-PAX-8 MSG10798/79 Mouse anti-PAX-8 MSK107-0598/79 Mouse anti-Podoplanin MSG05798/79 Mouse anti-Podoplanin MSK05798/79 Mouse anti-Podoplanin MSK057-0598/79 Mouse anti-Podoplanin NOA-MSG05798/79 Mouse anti-S100 BMS01398/79 Mouse anti-S100 MSG05098/79 Mouse anti-S100 MSK05098/79 Mouse anti-S100 MSK050-0598/79 Mouse anti-S100 NOA-BMS01398/79 Mouse anti-S100P (placental S100) MSG08998/79 Mouse anti-S100P (placental S100) MSK089-0598/79 Mouse anti-SOX10 MSG11798/79 Mouse anti-SOX10 MSK117-0598/79 Mouse anti-SOX10 NOA-MSG11798/79 Mouse anti-SOX11 MSG09598/79 Mouse anti-SOX11 MSK095-0598/79 Mouse anti-Thyroglobulin MSG03998/79 Mouse anti-Thyroglobulin MSK03998/79 Mouse anti-Thyroglobulin MSK039-0598/79 Mouse anti-TTF-1 BMS01698/79 Mouse anti-TTF-1 MSG00498/79 Mouse anti-TTF-1 MSG11198/79 Mouse anti-TTF-1 MSK00498/79 Mouse anti-TTF-1 MSK004-0598/79 Mouse anti-TTF-1 MSK111-0598/79 Mouse anti-TTF-1 NOA-MSG11198/79 Mouse anti-Uroplakin II MSG10298/79 Mouse anti-Uroplakin II MSK102-0598/79 Mouse anti-Vimentin BMS01298/79 Mouse anti-Vimentin MSG02398/79 Mouse anti-Vimentin MSK02398/79 Mouse anti-Vimentin MSK023-0598/79 PIN Cocktail (P504S+p63) CO001K98/79 PIN Cocktail (P504S+p63) CO001K-0598/79 PIN Cocktail (P504S+p63) COG00198/79 PIN Cocktail (P504S+p63) NOA-COG00198/79 Rabbit + Mouse HSV Cocktail COG00698/79 Rabbit anti-BCL2 BRB05598/79 Rabbit anti-BCL2 RBG01698/79 Rabbit anti-BCL2 RBK01698/79 Rabbit anti-BCL2 RBK016-0598/79 Rabbit anti-C3d RBG03498/79 Rabbit anti-C3d RBK034-0598/79 Rabbit anti-Caldesmon NOA-RBG04098/79 Rabbit anti-Caldesmon RBG04098/79 Rabbit anti-Caldesmon RBK040-0598/79 Rabbit anti-Calponin-1 RBG04198/79 Rabbit anti-Calponin-1 RBK041-0598/79 Rabbit anti-Calretinin BRB02298/79 Rabbit anti-Calretinin RBG00398/79 Rabbit anti-Calretinin RBK00398/79 Rabbit anti-Calretinin RBK003-0598/79 Rabbit anti-CD14 RBK033-0598/79 Rabbit anti-CD1a RBG04598/79 Rabbit anti-CD1a RBK045-0598/79 Rabbit anti-CD21 RBG03698/79 Rabbit anti-CD21 RBK036-0598/79 Rabbit anti-CD3 BRB04198/79 Rabbit anti-CD3 BRB06398/79 Rabbit anti-CD3 NOA-BRB04198/79 Rabbit anti-CD3 RBG01598/79 Rabbit anti-CD3 RBK01598/79 Rabbit anti-CD3 RBK015-0598/79 Rabbit anti-CD4 BRB04298/79 Rabbit anti-CD4 NOA-BRB04298/79 Rabbit anti-CD56 BRB03998/79 Rabbit anti-CD56 NOA-BRB03998/79 Rabbit anti-CD56 RBG05098/79 Rabbit anti-CD56 RBK05098/79 Rabbit anti-CD56 RBK050-0598/79 Rabbit anti-CD8 BRB03698/79 Rabbit anti-CD8 NOA-BRB03698/79 Rabbit anti-CDX2 BRB02898/79 Rabbit anti-CDX2 NOA-BRB02898/79 Rabbit anti-CDX2 RBG01998/79 Rabbit anti-CDX2 RBK01998/79 Rabbit anti-CDX2 RBK019-0598/79 Rabbit anti-E-Cadherin BRB04798/79 Rabbit anti-E-Cadherin NOA-BRB04798/79 Rabbit anti-E-Cadherin RBG04398/79 Rabbit anti-E-Cadherin RBK04398/79 Rabbit anti-E-Cadherin RBK043-0598/79 Rabbit anti-Estrogen Receptor BRB05398/79 Rabbit anti-Estrogen Receptor NOA-BRB05398/79 Rabbit anti-Factor XIIIa RBG04498/79 Rabbit anti-Factor XIIIa RBK04498/79 Rabbit anti-Factor XIIIa RBK044-0598/79 Rabbit anti-GCDFP-15 RBG03298/79 Rabbit anti-GCDFP-15 RBK032-0598/79 Rabbit anti-GFAP RBG03798/79 Rabbit anti-GFAP RBK03798/79 Rabbit anti-GFAP RBK037-0598/79 Rabbit anti-GLUT-1 BRB04998/79 Rabbit anti-Helicobacter pylori BRB03298/79 Rabbit anti-Helicobacter pylori NOA-BRB03298/79 Rabbit anti-Helicobacter pylori RBG01298/79 Rabbit anti-Helicobacter pylori RBK01298/79 Rabbit anti-Helicobacter pylori RBK012-0598/79 Rabbit anti-Hemoglobin A RBK035-0598/79 Rabbit anti-HER2 (c-erbB-2) NOA-RBG02698/79 Rabbit anti-HER2 (c-erbB-2) RBG02698/79 Rabbit anti-HER2 (c-erbB-2) RBK02698/79 Rabbit anti-HER2 (c-erbB-2) RBK026-0598/79 Rabbit anti-Ki-67 BRB04098/79 Rabbit anti-Ki-67 NOA-BRB04098/79 Rabbit anti-Ki-67 RBG02798/79 Rabbit anti-Ki-67 RBK02798/79 Rabbit anti-Ki-67 RBK027-0598/79 Rabbit anti-Mammaglobin RBG02298/79 Rabbit anti-Mammaglobin RBK022-0598/79 Rabbit anti-Napsin A RBG05998/79 Rabbit anti-Napsin A RBK059-0598/79 Rabbit anti-NKX3-1 RBG06298/79 Rabbit anti-NKX3-1 RBK062-0598/79 Rabbit anti-p40 (ΔNp63) RBG05498/79 Rabbit anti-p40 (ΔNp63) RBK054-0598/79 Rabbit anti-PAX-5 BRB02798/79 Rabbit anti-PAX-8 NOA-RBG04798/79 Rabbit anti-PAX-8 RBG04798/79 Rabbit anti-PAX-8 RBK047-0598/79 Rabbit anti-PD-L1 (CD274) NOA-RBG06398/79 Rabbit anti-PD-L1 (CD274) RBG06398/79 Rabbit anti-PD-L1 (CD274) RBK063-0598/79 Rabbit anti-PGP9.5 (UCHL1) RBG06498/79 Rabbit anti-PGP9.5 (UCHL1) RBK064-0598/79 Rabbit anti-PMS2 RBG04898/79 Rabbit anti-Progesterone Receptor BRB03898/79 Rabbit anti-Progesterone Receptor NOA-BRB03898/79 Rabbit anti-Progesterone Receptor RBG02098/79 Rabbit anti-Progesterone Receptor RBK02098/79 Rabbit anti-Progesterone Receptor RBK020-0598/79 Rabbit anti-PU.1 RBG04298/79 Rabbit anti-PU.1 RBK042-0598/79 Rabbit anti-SOX10 RBG05798/79 Rabbit anti-SOX10 RBK057-0598/79 Rabbit anti-Spirochete (Treponema pallidum) NOA-RBG06598/79 Rabbit anti-Spirochete (Treponema pallidum) RBG06598/79 Rabbit anti-Spirochete (Treponema pallidum) RBK065-0598/79 Rabbit anti-Synaptophysin RBG01198/79 Rabbit anti-Synaptophysin RBK01198/79 Rabbit anti-Synaptophysin RBK011-0598/79 Rabbit anti-T-bet RBG04998/79 Rabbit anti-T-bet RBK049-0598/79 Rabbit anti-TdT RBG05298/79 Rabbit anti-TdT RBK05298/79 Rabbit anti-TdT RBK052-0598/79 Rabbit anti-TFE3 RBK066-0198/79	– 98/79	Site web info@zytomed-systems.de Fiche EUDAMED Signaler une erreur
Acro Biotech FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne) et 1 autre	États-Unis	2019-nCoV IgG/IgM Rapid Test Cassette (Single use kit)98/79 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)2 réf.98/79 Adenovirus / RSV / Influenza A+B Combo Rapid Test Cassette IARI-R53598/79 Adenovirus and RSV Combo Rapid Test Cassette (Nasopharyngeal Swab) IARC-R52598/79 Adenovirus Antigen Rapid Test Cassette (Swab) IAD-50298/79 325 autres Adenovirus antigen Test Cassette (Feces) ACO-AD-60298/79 Adenovirus Control SCADE-D-L98/79 Adenovirus pneumoniae/RSV/Influenza A+B Combo Test Cassette acrARF535F98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Cassette98/79 Adenovirus Rapid Test Cassette (Feces) IAD-60298/79 Adenovirus Rapid Test Cassette ADE2F98/79 Adenovirus+RSV Control SCARC-S98/79 Adenovirus/Rotavirus Control SCRAC-D-L98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Control98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Control98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Control98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Adenovirus/RSV/Influenza A+B Control SCARI-S98/79 Astrovirus Control SCAS-D-L98/79 Astrovirus Rapid Test Cassette IAS-60298/79 Automatic Chemiluminescence Immunoassay Analyzer,Brand:Asterlith Automatic Chemiluminescence Immunoassay Analyzer,Brand:Oupirou3 réf. Bordetella pertussis Antigen Control98/79 Brucella Abortus Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Brucella Abortus Control2 réf.98/79 Campylobacter Control SCCAM-D-L98/79 Candida Albicans Control SCCA-D-L98/79 Candida albicans Rapid Test Cassette (Vaginal Swab) ICA-50298/79 Chagas Control SCCHA-D98/79 Chagas Rapid Test Cassette (Serum/Plasma) ICHA-30298/79 Chagas Rapid Test Cassette (Whole Blood/Serum/Plasma) ICHA-40298/79 Chagas Rapid Test Cassette CHA2C98/79 Chikungunya and Dengue Combo Rapid Test acrCKDE43598/79 Chikungunya control98/79 Chikungunya Ig G/Ig MRapid Test Cassette98/79 Chikungunya IgG/IgM Antibody Control SCCHI-D-L98/79 Chikungunya IgG/IgM Control98/79 Chikungunya IgG/IgM Rapid Test Cassette (Serum/Plasma) ICHI-30298/79 Chikungunya IgG/IgM Rapid Test Cassette CHI2D98/79 Chikungunya IgG/IgM Test Cassette (Whole Blood/ Serum/ Plasma) ACO-CHI-40298/79 Chikungunya/Zika Combo Rapid Test ICZ-ACO42598/79 Clostridium difficile GDH + Toxin A + Toxin B Control SCCD-D-L98/79 Clostridium difficile GDH Control SCCDG-D-L98/79 Clostridium difficile GDH Rapid Test Cassette ICDG-R60298/79 Clostridium difficile GDH Test Cassette (Feces) ACO-CDG-60298/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICD-63598/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test ICD-ACO63798/79 Clostridium difficile GDH+Toxin A+Toxin B Combo Rapid Test Cassette ICD-R635B98/79 Clostridium difficile GDH+Toxin A/B Test Cassette ACO-CD-60298/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-R625B98/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICDT-62598/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICDT-625B98/79 Clostridium difficile Toxin A +Toxin B Control SCCDT-D-L98/79 Clostridium difficile Toxin A/ toxin B Combo Test Cassette (Feces) ACO-CDT-62598/79 Clostridiumdifficile GDH+Toxin A+Toxin BCombo Rapid Test Cassette98/79 Clostridiumdifficile GDHRapid Test Cassette98/79 COVID-19 and Influenza A+B Antigen Combo Control98/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test2 réf.98/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 COVID-19 Antigen Control2 réf.98/79 COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)2 réf.98/79 COVID-19 Antigen Rapid Test (Oral Fluid)2 réf.98/79 COVID-19 Antigen Rapid Test Strip (Nasopharyngeal Swab)98/79 COVID-19 Antigen Test Cassette (Nasopharyngeal Swab)98/79 COVID-19 Antigen Test Cassette (Oral Fluid)98/79 COVID-19 IgG Control98/79 COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma)3 réf.98/79 COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)2 réf.98/79 COVID-19 IgG/IgM Rapid Test Dipstick (Whole Blood/Serum/Plasma)2 réf.98/79 COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)98/79 COVID-19 Nab Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 Nucleocapsid Protein IgG Antibody Rapid Test(Whole Blood/Serum/Plasma)98/79 COVID-19 S-RBD Ab Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 S-RBD IgG Antibody Test Cassette (Whole Blood/Serum/Plasma)98/79 COVID-19 S-RBD IgG Quantitative Test Cassette (Whole Blood /Serum /Plasma)98/79 Cryptococcus Antigen Control98/79 Cryptococcus Antigen Rapid Test Cassette (Whole Blood/ Serum/ Plasma/ Cerebral Spinal Fluid (CSF)) ICRG-40298/79 Cryptosporidium Antigen Control SCCRY-D-L98/79 Cryptosporidium Antigen Rapid Test Cassette (Feces) ICR-60298/79 Cryptosporidium Control SCCRY-L98/79 Cup Reader ACR-ACO100 D-dimer Rapid Test Cassette (Whole Blood /Plasma) CDM-R402SQ98/79 D-dimer Rapid Test Cassette (Whole Blood/Plasma) CDM-40298/79 D-dimer Rapid Test Cassette DDM2D98/79 D-Dimer Test Cassette (Whole Blood /Plasma) ACO-DDM-40298/79 D-Dimer Test Kit(CLIA)98/79 Dengue Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IDEC-42598/79 Dengue Combo Rapid Test Cassette DEC5D98/79 Dengue IgG/IgM Control SCDEGM-L98/79 Dengue IgG/IgM Test Cassette (Whole Blood/ Serum/ Plasma) ACO-DEN-40298/79 Dengue NS1 and Zika NS1 Combo Rapid Test98/79 Dengue NS1 Control3 réf.98/79 Dengue NS1 Rapid Test Cassette (Whole Blood/ Serum/ Plasma)2 réf.98/79 Dengue NS1 Test Cassette (Whole Blood/ Serum/ Plasma)98/79 Dengue/Chikungunya/West Nile Virus Combo Rapid Test acrDCW44598/79 Dengue/Chikungunya/Zika Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IDCZ-R43598/79 Dengue/Chikungunya/Zika Combo Rapid Test Cassette IDCZ-ACO43598/79 Dengue/Zika/Chikungunya Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IDZC-R44598/79 Dengue/Zika/Chikungunya Combo Rapid Test Cassette IDZC-ACO44598/79 Dry-type Fluorescent Immunoassay Analyzer EBNA IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) IENG-40298/79 EBNA IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) IENG-R40298/79 EBV VCA and EBNA IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IECNG-R42598/79 EBV VCA IgA Rapid Test Cassette (Whole Blood/ Serum/ Plasma) IECA-ACO40298/79 EBV VCA IgG Rapid Test (Whole Blood/Serum/Plasma) IECG-R40298/79 EBV VCA IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) IECG-40298/79 Entamoeba Histolytica Control SCEH-D-L98/79 Entamoeba/Giardia/Crypto Control2 réf.98/79 Entamoebahistolytica Rapid Test Cassette98/79 FIA Control50 réf.98/79 FIA Control CA125 Control98/79 FIA Control CA19-9 Control98/79 FIA Control SARS-CoV-2/Influenza A+B/RSV Antigen Control98/79 FIA Control Vibrio cholerae O1/O139 Control98/79 Fluorescence Immunoassay Analyzer4 réf. Giardia Lamblia Control SCGL-D-L98/79 Giardia Lamblia Rapid Test Cassette (Feces) IGL-60298/79 Gonorrhea Control98/79 Gonorrhea Rapid Test Cassette (Swab)98/79 H. pylori Antibody Rapid Test Cassette (Serum/Plasma) IHP-30298/79 H. pylori Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) IHP-40298/79 H. pylori Antibody Rapid Test Cassette HPB2C98/79 H. pylori Antibody Rapid Test Cassette HPB2D98/79 H. pylori Antibody Rapid Test Dipstick (Whole Blood/Serum/Plasma)98/79 H. pylori Antigen Control SCHPG-D-L98/79 H. pylori Antigen Rapid Test Cassette HPG2F98/79 H. pylori Antigen Rapid Test Dipstick (Feces)98/79 H.pylori Ag Control SCHPG-S98/79 H.pylori Antigen Rapid Test Cassette IHP-60298/79 H.pylori Antigen Rapid Test Cassette(Feces) IHP-R60298/79 H.pylori Antigen Test Cassette (Feces) ACO-HP-60298/79 H1N1 Antigen Rapid Test Cassette (Swab)2 réf.98/79 H1N1 Antigen Rapid Test Dipstick (Swab)98/79 Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/ Serum/ Plasma) IHVGM-ACO40298/79 HAV IgG/IgM Combo Rapid Test Cassette HAV5D98/79 HAV IgG/IgM&Syphilis Combo Rapid Test IHAS-ACO43598/79 HAV IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IHA-40298/79 HAV IgM&Syphilis Combo Rapid Test IHAS-ACO42598/79 Hb Hemoglobin Test Strip (Whole Blood) OHBS-ACO41198/79 Helicobacter pylori (HP) IgG Test Kit (CLIA)98/79 HEV IgG/IgM Rapid Test Cassette (Serum/Plasma) IHE-30298/79 HPIV Control98/79 HPV Control SCHPV-S98/79 HSV 1 IgG/IgM Rapid Test Cassette (Whole Blood/ Serum/ Plasma)98/79 HSV 1/2 IgG/IgM Rapid Test Cassette (Serum/Plasma)98/79 HSV 1/2 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)2 réf.98/79 HSV 1/2 IgG Rapid Test Cassette (Serum/Plasma)98/79 HSV 1/2 IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)2 réf.98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Serum/Plasma)98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)2 réf.98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette98/79 HSV 1/2 IgM Rapid Test Cassette (Serum/Plasma)98/79 HSV 1/2 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)2 réf.98/79 HSV 2 IgG/IgM Rapid Test Cassette (Whole Blood/ Serum/ Plasma)98/79 Human Metapneumovirus Antigen Control SCHMPV-D-L98/79 IL-6 Rapid Test (Whole Blood/Serum/Plasma)98/79 Influenza A Control SCFLA-S98/79 Influenza A Rapid Test Cassette (Swab/Nasal Aspirate)2 réf.98/79 Influenza A Rapid Test Dipstick (Swab/Nasal Aspirate)98/79 Influenza A+B Rapid Test Cassette FLU2E98/79 Influenza A+B Rapid Test Cassette(Swab/Nasal Aspirate)98/79 Influenza A+B Rapid Test Dipstick (Swab/Nasal Aspirate)98/79 Influenza A+B Test Cassette (Swab/ Nasal Aspirate)98/79 Influenza A+BRapid Test Cassette98/79 Influenza A/B +H1N1 Combo Rapid Test Cassette (Swab)98/79 Influenza A/B+H1N1 Combo Control98/79 Interleukin-6 (IL-6) Test Kit (CLIA)98/79 Lateral Flow (LF) Portable Reader Legionella pneumophila Control2 réf.98/79 Legionella Pneumophila Rapid Test Cassette (Urine)98/79 Legionella pneumophila Test Cassette (Urine)98/79 Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) ILEI-40298/79 Leptospira Ig G/Ig MRapid Test Cassette98/79 Leptospira IgG/IgM Antibody Control SCLEP-L98/79 LF Reader LF Reader Plus Malaria Antibody Rapid Test IMAB-ACO40298/79 Malaria P.f. /P.v. Rapid Test Cassette (Whole Blood) IMPV-R40298/79 Malaria P.f. /Pan Control SCMPN-D98/79 Malaria P.f. Control SCMPF-D98/79 Malaria P.f. Rapid Test Cassette (Whole Blood) IMA-40298/79 Malaria P.f. Rapid Test Cassette (Whole Blood) IMA-R40298/79 Malaria P.f. Rapid Test Dipstick (Whole Blood)98/79 Malaria P.f./ Pan Rapid Test Cassette (Whole Blood) IMPN-40298/79 Malaria P.f./P.v. /Pan Rapid Test Cassette MFVP2D98/79 Malaria P.f./P.v. Control SCMPV-D98/79 Malaria P.f./P.v. Rapid Test Cassette (Whole Blood) IMPV-40298/79 Malaria P.f./P.v./Pan Control SCMPVF-D98/79 Malaria P.f./P.v./Pan Rapid Test Cassette acrMPVF402R98/79 Malaria P.f./P.v./Pan Rapid Test Cassette IMPVF-40298/79 Malaria P.f./P.v./Pan Test Cassette (Whole Blood) ACO-MAL-43598/79 Malaria P.f./Pan Rapid Test Cassette (Whole Blood) IMPN-R40298/79 Measles IgG Antibody Rapid Test (Whole Blood/ Serum/ Plasma) IMEG-ACO40298/79 Monkeypox Virus Antibody control SCMXB-L98/79 Monkeypox Virus Antibody Rapid Test (Whole Blood/Serum/Plasma) IMXB-ACOR40298/79 Monkeypox Virus Antibody Rapid Test IMXB-ACO40298/79 Monkeypox Virus Antibody Test Cassette acrMXB402F98/79 Monkeypox Virus Antigen control SCMXG-D-L98/79 Monkeypox Virus Antigen Rapid Test IMXG-ACO40298/79 Monkeypox Virus Antigen Rapid Test IMXG-ACOR40298/79 Monkeypox Virus Antigen Test Cassette ACO-MXG-40298/79 MONO Control SCMONO-L98/79 MONO Rapid Test Cassette (Whole Blood/ Serum/ Plasma) IMO-R40298/79 Mononucleosis(MONO)Latex Reagents acrMONO001A98/79 MONORapid Test Cassette98/79 Multiplex Respiratory Antigen Control SCRTC-S98/79 Multiplex Respiratory Antigen Rapid Test (Swab) acrRTC595R98/79 Mycoplasma Pneumoniae Antigen Control SCMP-S98/79 Mycoplasma pneumoniae Antigen Rapid Test Cassette (Throat Swab)98/79 Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IMP-42598/79 Mycoplasma pneumoniae IgG/IgM Control SCMPGM-L98/79 Mycoplasma pneumoniae IgM Control SCMPM-L98/79 Mycoplasma Pneumoniae IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IMPM-40298/79 Mycoplasma pneumoniae/Adenovirus pneumoniae/ RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Cassette98/79 Norovirus Control SCNOR-D-L98/79 Norovirus Rapid Test Cassette (Feces) INO-60298/79 Norovirus+Rotavirus+Adenovirus+Astrovirus Combo Rapid Test IMVD-R64598/79 Norovirus+Rotavirus/Adenovirus+Astrovirus+Enterovirus Combo Rapid Test IMVD-ACO65598/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test IMVD-ACO64798/79 Norovirus/Astorvirus/Enterovirus Combo Control98/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test (Feces) INRA-R63798/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test Cassette INRA-RT63598/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test INRA-ACO63798/79 Norovirus/Rotavirus/Adenovirus Combo Test Cassette ACO-NRA-63598/79 Norovirus/Rotavirus/Adenovirus Control SCNRA-D-L98/79 Respiratory Antigen Rapid Combo Test (Swab) RTC5E98/79 Respiratory Antigen Rapid Combo Test acrMRA585R98/79 Respiratory Antigen Rapid Combo Test acrMRA595R98/79 Respiratory Antigen Rapid Combo Test IRTC-ACO58598/79 Respiratory Antigen Rapid Combo Test IRTC-ACO59598/79 Respiratory Infectious Diseases Rapid Test I(Analytes)-ACO5X798/79 Respiratory Infectious Diseases Rapid Test IAD-ACO50798/79 Respiratory Infectious Diseases Rapid Test IHMPV-ACO50798/79 Respiratory Infectious Diseases Rapid Test IIN-ACO50798/79 Respiratory Infectious Diseases Rapid Test IMP-ACO50798/79 Respiratory Infectious Diseases Rapid Test IMR-ACO50798/79 Respiratory Infectious Diseases Rapid Test INCP-ACO50798/79 Respiratory Infectious Diseases Rapid Test IPIV-ACO50798/79 Respiratory Infectious Diseases Rapid Test IRHV-ACO50798/79 Respiratory Infectious Diseases Rapid Test IRS-ACO50798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO52798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO53798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO54798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO55798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO56798/79 Rotavirus and Adenovirus Combo Rapid Test IRAC-ACO62798/79 Rotavirus Control SCROT-D-L98/79 Rotavirus Rapid Test Cassette (Feces) IRO-60298/79 Rotavirus Rapid Test Cassette ROT2F98/79 Rotavirus/Adenovirus+Astrovirus Combo Rapid Test IRAA-ACO62598/79 RPR Reagents5 réf.98/79 RSV and SARS-CoV-2 Antigen Combo Rapid Test98/79 RSV Control SCRSV-S98/79 RSV Rapid Test Cassette (Nasopharyngeal swab/Nasal Aspirate)98/79 RSV Test Cassette (Nasopharyngeal Swab/Nasal Aspirate)98/79 RSV/Influenza A+B Control SCRI-S98/79 RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 RSVRapid Test Cassette98/79 S. pneumoniae/L. pneumophila Control2 réf.98/79 Salmonella paratyphi Antigen Rapid Test Cassette (Feces)98/79 Salmonella paratyphi Control98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test Cassette (Feces)98/79 Salmonella typhi Antigen Control98/79 Salmonella Typhi Antigen Rapid Test Cassette (Feces)98/79 SARS-CoV-2 (COVID-19) Antigen Rapid Test (Swab)98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Control98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test2 réf.98/79 SARS-CoV-2 Antigen Rapid Test (Nasal Swab)98/79 SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma)98/79 SARS-COV-2 RT-qPCR Assay98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma)98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Contro98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test2 réf.98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Control98/79 Scrub Typhus IgG/IgM Control2 réf.98/79 Shigella Rapid Test Cassette (Feces) ISH-ACO62598/79 Sickle Cell Rapid Test OSCD-ACO40298/79 Strep A Rapid Test Cassette (Throat Swab)2 réf.98/79 Strep A Rapid Test Cassette ISTB-R50298/79 Strep A Rapid Test Dipstick (Throat Swab)2 réf.98/79 Strep A Test Cassette (Throat Swab)98/79 Strep ARapid Test Cassette (Control Linein Red)98/79 Strep B Rapid Test Cassette (Swab) ISB-R50298/79 Strep B Rapid Test Cassette (Swab) ISB-50298/79 Strep B Rapid Test Dipstick (Swab)98/79 Streptococcus pneumoniae Control2 réf.98/79 Streptococcus pneumoniae Test Cassette (Urine)98/79 Streptococcuspneumoniae Antigen Rapid Test Cassette98/79 Syphilis Control SCSYP-L98/79 Syphilis Rapid Test Cassette (Whole Blood/Serum/Plasma) ISY-R40298/79 Syphilis Rapid Test Cassette (Serum/Plasma) ISY-R30298/79 Syphilis Rapid Test Cassette ISY-30298/79 Syphilis Rapid Test Cassette ISY-40298/79 Syphilis Rapid Test Cassette SYP2C98/79 Syphilis Rapid Test Dipstick (Serum/Plasma)98/79 Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma)98/79 Syphilis Rapid Test ISY-ACO10298/79 Syphilis Test Cassette (Whole Blood/ Serum/ Plasma) ACO-SYP-40298/79 Syphilis Test Kit (CLIA)98/79 Tetanus Control SCTET-D-L98/79 Tetanus Rapid Test Cassette ITE-40298/79 TPHA Reagents3 réf.98/79 Trichomonas Vaginalis Control SCTV-D-L98/79 Trichomonas Vaginalis Rapid Test Cassette (Vaginal Swab) ITV-50298/79 Tuberculosis Control98/79 Typhoid Rapid Test Cassette (Serum/Plasma)98/79 Typhoid Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Typhoid Rapid Test Dipstick (Whole Blood/Serum/Plasma)98/79 Typhoid Test Cassette (Whole Blood/Serum/Plasma)98/79 Urine Analyzer ACA3043 réf. Varicella Zoster Virus IgM Rapid Test Cassette IVZM-ACO40298/79 Vibrio cholerae O1/O139 Control98/79 Zika antigen Test Cassette (Whole Blood/ Serum/ Plasma) ACO-ZI-40298/79 Zika IgG/IgM and NS1 Combo Rapid Test Cassette98/79 Zika IgG/IgM and NS1 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Zika IgG/IgM Control SCZIB-L98/79 Zika IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IZIB-40298/79 Zika IgM Test Cassette (Whole Blood/ Serum/ Plasma) ACO-ZIM-40298/79 Zika NS1 Control98/79 Zika NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79	A IVDR, 98/79	Présent sur le marché en France info@acrobiotech.com Fiche EUDAMED Signaler une erreur
Euroimmun FDA	Allemagne	Anti-Adenovirus ELISA (IgA) EI 2680 A98/79 Anti-Adenovirus ELISA (IgG) EI 2680 G98/79 Anti-Adenovirus ELISA (IgM) EI 2680 M98/79 Anti-Bordetella FHA ELISA (IgA) EI 2050-3 A98/79 Anti-Bordetella FHA ELISA (IgG) EI 2050-3 G98/79 320 autres Anti-Bordetella pertussis ELISA (IgM) EI 2050 M98/79 Anti-Bordetella pertussis toxin ELISA (IgA) EI 2050 A98/79 Anti-Bordetella pertussis toxin ELISA (IgG) EI 2050 G98/79 Anti-Borrelia afzelii-WESTERNBLOT (IgG) DY 2131 G2 réf.98/79 Anti-Borrelia afzelii-WESTERNBLOT (IgM) DY 2131 M2 réf.98/79 Anti-Borrelia burgdorferi-WESTERNBLOT (IgM) DY 2132 M2 réf.98/79 Anti-Borrelia ChLIA (IgG) LI 2132 G98/79 Anti-Borrelia ChLIA (IgM) LI 2132 M98/79 Anti-Borrelia CSF ELISA 2.0 (IgM) EI 2132-2L M Anti-Borrelia ELISA (IgM) EI 2132 M98/79 Anti-Borrelia EUROLINE-RN-AT (IgG) DN 2131 G3 réf.98/79 Anti-Borrelia EUROLINE-RN-AT (IgM) DN 2131 M3 réf.98/79 Anti-Borrelia EUROLINE-RN-AT-11 (IgG) DN 2131-11 G2 réf.98/79 Anti-Borrelia EUROLINE-RN-AT-11 (IgM) DN 2131-11 M2 réf.98/79 Anti-Borrelia EUROLINE-RN-AT-adv (IgM) DN 2131-2 M3 réf.98/79 Anti-Borrelia EUROLINE-WB (IgG) DY 2131-1 G4 réf.98/79 Anti-Borrelia EUROLINE-WB (IgM) DY 2131-1 M4 réf.98/79 Anti-Borrelia garinii-WESTERNBLOT (IgG) DY 2134 G2 réf.98/79 Anti-Borrelia garinii-WESTERNBLOT (IgM) DY 2134 M2 réf.98/79 Anti-Borrelia plus VlsE ELISA (IgG) EI 2132-2 G98/79 Anti-Borrelia Select ELISA (IgG) EI 2132-5 G98/79 Anti-Borrelia Select ELISA (IgM) EI 2132-5 M98/79 Anti-Brucella abortus ELISA (IgG) EI 2189 G98/79 Anti-Brucella abortus ELISA (IgM) EI 2189 M98/79 Anti-Chikungunya Virus ELISA (IgG) EI 293a G98/79 Anti-Chikungunya Virus ELISA (IgM) EI 293a M98/79 Anti-Chikungunya virus IIFT (IgG) FI 293a G3 réf.98/79 Anti-Chikungunya virus IIFT (IgM) FI 293a M3 réf.98/79 Anti-Chikungunya virus IIFT EUROPattern (IgG) FR 293a G2 réf.98/79 Anti-Chikungunya virus IIFT EUROPattern (IgM) FR 293a M2 réf.98/79 Anti-Chlamydia pneumoniae ELISA (IgA) EI 2192 A98/79 Anti-Chlamydia pneumoniae ELISA (IgG) EI 2192 G98/79 Anti-Chlamydia pneumoniae ELISA (IgM) EI 2192 M98/79 Anti-Chlamydia pneumoniae MIF (IgA) FI 2192-80 A98/79 Anti-Chlamydia pneumoniae MIF (IgG) FI 2192-80 G98/79 Anti-Chlamydia pneumoniae MIF (IgM) FI 2192-80 M98/79 Anti-Chlamydia pneumoniae MIF EUROPattern (IgA) FR 2192-80 A98/79 Anti-Chlamydia pneumoniae MIF EUROPattern (IgG) FR 2192-80 G98/79 Anti-Chlamydia pneumoniae MIF EUROPattern (IgM) FR 2192-80 M98/79 Anti-Chlamydia trachomatis Advanced ELISA (IgA) EI 2191-1 A Anti-Chlamydia trachomatis Advanced ELISA (IgG) EI 2191-1 G Anti-Chlamydia trachomatis ELISA (IgA) EI 2191 A98/79 Anti-Chlamydia trachomatis ELISA (IgG) EI 2191 G98/79 Anti-Chlamydia trachomatis ELISA (IgM) EI 2191-9601 M98/79 Anti-Chlamydia trachomatis MIF (IgA) FI 2191-80 A98/79 Anti-Chlamydia trachomatis MIF (IgG) FI 2191-80 G98/79 Anti-Chlamydia trachomatis MIF (IgM) FI 2191-80 M98/79 Anti-CMV ELISA (IgG) EI 2570 G98/79 Anti-CMV ELISA (IgM) EI 2570 M98/79 Anti-CMV gB ELISA (IgG) EI 2570-3 G98/79 Anti-CMV p52 ELISA (IgM) EI 2570-2 M98/79 Anti-Coxiella burnetii Phase 1 ELISA (IgG) EI 217a-1 G98/79 Anti-Coxiella burnetii Phase 2 ELISA (IgG) EI 217a-2 G98/79 Anti-Coxiella burnetii Phase 2 ELISA (IgM) EI 217a-2 M98/79 Anti-Crimean-Congo fever virus(CCHFV) ELISA (IgG) EI 279a G98/79 Anti-Crimean-Congo fever virus(CCHFV) ELISA (IgM) EI 279a M98/79 Anti-Dengue Virus ELISA (IgG) EI 266b G98/79 Anti-Dengue Virus ELISA (IgM) EI 266b M98/79 Anti-Dengue Virus NS1 ELISA 2.0 (IgG) EI 266a-3 G Anti-Dengue Virus Type 1-4 ELISA (IgG) EI 266a-1 G98/79 Anti-Dengue Virus Type 1-4 ELISA (IgM) EI 266a-1 M98/79 Anti-Diphtheria Toxoid ELISA (IgG) EI 2040 G98/79 Anti-EBNA IIFT FI 2793 C2 réf.98/79 Anti-EBNA-1 ChLIA (IgG) LI 2793 G98/79 Anti-EBNA-1 ELISA (IgG) EI 2793 G98/79 Anti-EBV-CA ChLIA (IgG) LI 2791 G98/79 Anti-EBV-CA ChLIA (IgM) LI 2791 M98/79 Anti-EBV-CA ELISA (IgG) EI 2791 G98/79 Anti-EBV-CA ELISA (IgM) EI 2791 M98/79 Anti-EBV-CA IIFT (IgG) FI 2791 G3 réf.98/79 Anti-EBV-CA IIFT (IgM) FI 2791 M3 réf.98/79 Anti-EBV-EA IIFT (IgG) FI 2795 G2 réf.98/79 Anti-EBV-EA-D ELISA (IgG) EI 2795 G98/79 Anti-EBV-EA-D ELISA (IgM) EI 2795 M98/79 Anti-Echinococcus ELISA (IgG) EI 2320-1 G98/79 Anti-Enterovirus ELISA (IgA) EI 2730-1 A98/79 Anti-Enterovirus ELISA (IgG) EI 2730-1 G98/79 Anti-Enterovirus ELISA (IgM) EI 2730-1 M98/79 Anti-Hanta Virus Pool 1 "Eurasia" ELISA (IgG) EI 278h-1 G98/79 Anti-Hanta Virus Pool 1 "Eurasia" ELISA (IgM) EI 278h-1 M98/79 Anti-Hanta Virus Pool 2 "America" ELISA (IgG) EI 278h-2 G98/79 Anti-Hanta Virus Pool 2 "America" ELISA (IgM) EI 278h-2 M98/79 Anti-Helicobacter pylori CagA ELISA (IgA) EI 2081 A98/79 Anti-Helicobacter pylori ELISA (IgA) EI 2080 A98/79 Anti-Helicobacter pylori ELISA (IgG) EI 2080 G98/79 Anti-Helicobacter pylori EUROLINE-Westernblot (IgA) DY 2080-1 A2 réf.98/79 Anti-Helicobacter pylori EUROLINE-Westernblot (IgG) DY 2080-1 G2 réf.98/79 Anti-Hepatitis E Virus (HEV) ELISA (IgG) EI 2525 G98/79 Anti-Hepatitis E Virus (HEV) ELISA (IgM) EI 2525 M98/79 Anti-Herpes simplex virus 1 ChLIA (IgG) LI 2531 G98/79 Anti-Herpes simplex virus 2 ChLIA (IgG) LI 2532 G98/79 Anti-HHV-6 IIFT (IgG) FI 2536 G4 réf.98/79 Anti-HHV-6 IIFT (IgM) FI 2536 M4 réf.98/79 Anti-HHV-6 IIFT EUROPattern (IgG) FR 2536 G4 réf.98/79 Anti-HHV-6 IIFT EUROPattern (IgM) FR 2536 M4 réf.98/79 Anti-HSV-1 (gC1) ELISA (IgG) EI 2531-2 G98/79 Anti-HSV-1 / HSV-2 gG-2 EUROLINE-WB (IgG) DY 2531-1 G98/79 Anti-HSV-1 / HSV-2 gG-2 EUROLINE-WB (IgM) DY 2531-1 M98/79 Anti-HSV-1/2 Pool ELISA (IgG) EI 2531-1 G98/79 Anti-HSV-1/2 Pool ELISA (IgM) EI 2531-1 M98/79 Anti-HSV-2 (gG2) ELISA (IgG) EI 2532-2 G98/79 Anti-Influenza A Virus ELISA (IgA) EI 2691 A98/79 Anti-Influenza A Virus ELISA (IgG) EI 2691 G98/79 Anti-Influenza B Virus ELISA (IgA) EI 2692 A98/79 Anti-Influenza B Virus ELISA (IgG) EI 2692 G98/79 Anti-Legionella pneumophila ELISA (IgG) EI 2150 G98/79 Anti-Legionella pneumophila ELISA (IgM) EI 2150 M98/79 Anti-Legionella pneumophila Serotype 1 IIFT (IgAGM) FI 2151 P2 réf.98/79 Anti-Leishmania donovani IIFT (IgG) FI 2231 G2 réf.98/79 Anti-Leishmania donovani IIFT (IgM) FI 2231 M2 réf.98/79 Anti-Leishmania ELISA (IgG) EI 2232 G Anti-Measles Virus ELISA (IgG) EI 2610 G98/79 Anti-Measles Virus ELISA (IgM) EI 2610 M98/79 Anti-Measles Virus ELISA 2.0 (IgG) EI 2610-2 G Anti-Measles Virus NP ELISA (IgM) EI 2610-4 M98/79 Anti-MERS-CoV ELISA (IgG) EI 2604 G98/79 Anti-Mumps Virus AT ELISA (IgG) EI 2630-3 G98/79 Anti-Mumps Virus ELISA (G5) (IgM) EI 2630-5 M98/79 Anti-Mumps Virus ELISA (IgG) EI 2630 G98/79 Anti-Mumps Virus ELISA (IgM) EI 2630 M98/79 Anti-Mycoplasma pneumoniae ELISA (IgA) EI 2202 A98/79 Anti-Mycoplasma pneumoniae ELISA (IgG) EI 2202 G98/79 Anti-Mycoplasma pneumoniae ELISA (IgM) EI 2202 M98/79 Anti-Parainfluenza Viruses Pool ELISA (IgG) EI 2721-1 G98/79 Anti-Parvovirus B19 ELISA (IgG) EI 2580 G98/79 Anti-Parvovirus B19 ELISA (IgM) EI 2580 M98/79 Anti-Plasmodium ELISA (IgG) EI 2260 G98/79 Anti-RSV ELISA (IgA) EI 2670 A98/79 Anti-RSV ELISA (IgG) EI 2670 G98/79 Anti-RSV ELISA (IgM) EI 2670 M98/79 Anti-Rubella Virus ELISA (IgG) EI 2590 G98/79 Anti-Rubella Virus ELISA 2.0 (IgG) EI 2590-3 G Anti-Rubella Virus Glycoprotein ELISA (IgM) EI 2590-2 M98/79 Anti-SARS-CoV-2 ELISA (IgA) EI 2606 A98/79 Anti-SARS-CoV-2 ELISA (IgG) EI 2606 G98/79 Anti-SARS-CoV-2 NCP ELISA (IgG) EI 2606-2 G98/79 Anti-SARS-CoV-2 QuantiVac ELISA (IgG) EI 2606-10 G98/79 Anti-SARS-CoV-2 RBD ChLIA (IgG) LI 2606-1 G98/79 Anti-Schistosoma ELISA (IgG) EI 2300 G98/79 Anti-Schistosoma ELISA (IgM) EI 2300 M98/79 Anti-Schistosoma mansoni IIFT (IgG) FI 2300 G3 réf.98/79 Anti-Schistosoma mansoni IIFT (IgM) FI 2300 M98/79 Anti-TBE virus IIFT (IgG) FI 2661 G3 réf.98/79 Anti-TBE virus IIFT (IgM) FI 2661 M2 réf.98/79 Anti-Tetanus Toxoid ELISA (IgG) EI 2060 G98/79 Anti-Toxoplasma gondii ELISA (IgG) EI 2410 G98/79 Anti-Toxoplasma gondii ELISA (IgM) EI 2410 M98/79 Anti-Toxoplasma gondii ELISA 2.0 (IgG) EI 2410-2 G Anti-Toxoplasma gondii IIFT (IgG) FI 2410 G2 réf.98/79 Anti-Toxoplasma gondii IIFT (IgM) FI 2410 M2 réf.98/79 Anti-Treponema pallidum ELISA (IgG) EI 2111 G98/79 Anti-Treponema pallidum ELISA (IgM) EI 2111 M98/79 Anti-Treponema pallidum ELISA 2.0 (IgGM) EI 2111-2 O Anti-Treponema pallidum IIFT (IgG) FI 2111 G4 réf.98/79 Anti-Treponema pallidum IIFT (IgM) FI 2111 M3 réf.98/79 Anti-Treponema pallidum Screen ELISA (IgGM) EI 2111 O98/79 Anti-Treponema pallidum WESTERNBLOT (IgG) DY 2111 G2 réf.98/79 Anti-Treponema pallidum WESTERNBLOT (IgM) DY 2111 M2 réf.98/79 Anti-Treponema pallidum WESTERNBLOT (IgM) DY 2112 M2 réf.98/79 Anti-Trypanosoma cruzi ELISA (IgG) EI 2212 G98/79 Anti-VZV ELISA (IgG) EI 2650 G98/79 Anti-VZV ELISA (IgM) EI 2650 M98/79 Anti-VZV ELISA 2.0 (IgG) EI 2650-2 G Anti-VZV Glycoprotein ELISA (IgM) EI 2650-2 M98/79 Anti-VZV IIFT (IgG) FI 2650 G2 réf.98/79 Anti-VZV IIFT (IgM) FI 2650 M3 réf.98/79 Anti-West Nile Virus ELISA (IgG) EI 2662 G98/79 Anti-West Nile Virus ELISA (IgM) EI 2662 M98/79 Anti-West Nile virus IIFT (IgG) FI 2662 G2 réf.98/79 Anti-West Nile virus IIFT (IgM) FI 2662 M3 réf.98/79 Anti-Yersinia enterocolitica ELISA (IgA) EI 2173 A98/79 Anti-Yersinia enterocolitica ELISA (IgG) EI 2173 G98/79 Anti-Yersinia enterocolitica WESTERNBLOT (IgA) DY 2173 A2 réf.98/79 Anti-Yersinia enterocolitica WESTERNBLOT (IgG) DY 2173 G2 réf.98/79 Anti-Zika Virus ELISA (IgAM) EI 2668 Q98/79 Anti-Zika Virus ELISA (IgG) EI 2668 G98/79 Anti-Zika Virus ELISA (IgM) EI 2668 M98/79 Anti-Zika virus IIFT (IgG) FI 2668 G2 réf.98/79 Anti-Zika virus IIFT (IgM) FI 2668 M2 réf.98/79 Anti-Zika virus IIFT EUROPattern (IgG) FR 2668 G2 réf.98/79 Anti-Zika virus IIFT EUROPattern (IgM) FR 2668 M2 réf.98/79 Aspergillus Antigen ELISA EQ 691198/79 Avidity: Anti-CMV ELISA (IgG) EI 2570-1 G98/79 Avidity: Anti-EBV-CA-ELISA (IgG) 2 EI 2791-21 G98/79 Avidity: Anti-EBV-CA-ELISA (IgG) EI 2791-1 G98/79 Avidity: Anti-Measles Virus ELISA (IgG) EI 2610-1 G98/79 Avidity: Anti-Rubella Virus ELISA (IgG) EI 2590-1 G98/79 Avidity: Anti-Toxoplasma gondii ELISA (IgG) EI 2410-1 G98/79 Avidity: Anti-VZV ELISA (IgG) EI 2650-1 G98/79 Avidity: Anti-West Nile Virus ELISA (IgG) EI 2662-1 G98/79 Control set Anti-Borrelia ChLIA (IgG) LR 2132 G98/79 Control set Anti-Borrelia ChLIA (IgM) LR 2132 M98/79 Control set Anti-EBNA-1 ChLIA (IgG) LR 2793 G98/79 Control set Anti-EBV-CA ChLIA (IgG) LR 2791 G98/79 Control set Anti-EBV-CA ChLIA (IgM) LR 2791 M98/79 Control set Anti-HSV 1 ChLIA (IgG) LR 2531 G98/79 Control set Anti-HSV 2 ChLIA (IgG) LR 2532 G98/79 Control set Anti-SARS-CoV-2 RBD ChLIA (IgG) LR 2606-1 G98/79 CSF: Anti-Borrelia plus VlsE ELISA (IgG) EI 2132-L G98/79 CSF: Anti-CMV ELISA (IgG) EI 2570-L G98/79 CSF: Anti-EBV-CA-ELISA (IgG) EI 2791-L G98/79 CSF: Anti-HSV-1/2 Pool ELISA (IgG) EI 2531-1 L G98/79 CSF: Anti-Measles Virus ELISA (IgG) EI 2610-L G98/79 CSF: Anti-Mumps Virus ELISA (IgG) EI 2630-L G98/79 CSF: Anti-Rubella Virus ELISA (IgG) EI 2590-L G98/79 CSF: Anti-Toxoplasma gondii ELISA (IgG ) EI 2410-L G98/79 CSF: Anti-Treponema pallidum ELISA (IgG) EI 2111-L G98/79 CSF: Anti-VZV-ELISA (IgG) EI 2650-L G98/79 CSQ pair of controls Anti-Borrelia (IgG) CK 2132-L G98/79 CSQ pair of controls Anti-CMV (IgG) CK 2570-L G98/79 CSQ pair of controls Anti-EBV-CA (IgG) CK 2791-L G98/79 CSQ pair of controls Anti-HSV-1/2 Pool (IgG) CK 2531-1 L G98/79 CSQ pair of controls Anti-Measles virus (IgG) CK 2610-L G98/79 CSQ pair of controls Anti-Mumps virus (IgG) CK 2630-L G98/79 CSQ pair of controls Anti-Rubella virus (IgG) CK 2590-L G98/79 CSQ pair of controls Anti-Toxoplasma gondii (IgG) CK 2410-L G98/79 CSQ pair of controls Anti-Treponema pallidum (IgG) CK 2111-L G98/79 CSQ pair of controls Anti-VZV (IgG) CK 2650-L G98/79 Dengue Virus NS1 ELISA EQ 266a-198/79 DY 2112 G - EWR - IVDD - Klasse Sonstige IVD2 réf.98/79 EUROArray Dermatomycosis MN 28504 réf.98/79 EUROArray HPV MN 25404 réf.98/79 EUROArray STI - 11 MN 28304 réf.98/79 EUROArrayProcessor YG 0671-1 EUROArrayScanner YG 0602 EUROBlotMaster 44 YG 0151-1 EUROBlotMaster YG 0151 EUROBlotOne YG 0153 EUROIMMUN Analyzer I YG 0014 EUROIMMUN Analyzer I-2P YG 0015 EUROLabWorkstation ELISA YG 0851 EUROLabWorkstation IFA YG 0852 EUROLINE Anti-CMV (IgG) DN 2570-2 G3 réf. EUROLINE Anti-CMV (IgM) DN 2570-2 M3 réf. EUROLINE Anti-Treponema pallidum (IgG) DN 2111 G2 réf.98/79 EUROLINE Anti-Treponema pallidum (IgM) DN 2111 M2 réf.98/79 EUROLINE Anti-Yersinia enterocolitica (IgA) DN 2173 A2 réf.98/79 EUROLINE Anti-Yersinia enterocolitica (IgG) DN 2173 G2 réf.98/79 EUROLINE Bordetella pertussis (IgA) DN 2050 A2 réf.98/79 EUROLINE Bordetella pertussis (IgG) DN 2050 G2 réf.98/79 EUROLINE-WB Anti-Echinococcus (IgG) DY 2321-2 G2 réf. EUROMicroblot Anti-Borrelia (IgG) KN 2131 G98/79 EUROMicroblot Anti-Borrelia (IgM) KN 2131 M98/79 EUROPattern Microscope Live YG 0371 EUROPattern Microscope YG 0333 EURORealTime Toxoplasma gondii MP 24102 réf. EUROStar IV Plus YG 0307 IF Sprinter YG 0032 IIFT Mosaic: Coxsackie virus A Types (IgG) FI 2730-2 G3 réf.98/79 IIFT Mosaic: Coxsackie virus A Types (IgM) FI 2730-2 M3 réf.98/79 IIFT Mosaic: L. monocytogenes 1/2a / L. monocytogenes 4b (IgG) FI 2141-1 G2 réf.98/79 IIFT Mosaic: L. monocytogenes 1/2a / L. monocytogenes 4b (IgM) FI 2141-1 M2 réf.98/79 IIFT Mosaic: Treponema pallidum / Treponema phagedenis (IgG) FI 2112 G2 réf.98/79 IIFT Mosaic: Treponema pallidum / Treponema phagedenis (IgM) FI 2112 M2 réf.98/79 IIFT: Borrelia afzelii / VlsE / Borrelia burgdorferi / OspC (IgG) FI 2136-1 G3 réf.98/79 IIFT: Borrelia afzelii / VlsE / Borrelia burgdorferi / OspC (IgM) FI 2136-1 M2 réf.98/79 IIFT: Coxsackie Virus Screen (types A) EUROPattern (IgG) FR 2730-2 G98/79 IIFT: Coxsackie Virus Screen (types A) EUROPattern (IgM) FR 2730-2 M98/79 IIFT: Coxsackie Virus Screen (types B) EUROPattern (IgG) FR 2730-3 G98/79 IIFT: Coxsackie Virus Screen (types B) EUROPattern (IgM) FR 2730-3 M98/79 IIFT: Hantavirus Mosaic 1 (IgG) FI 278h-1 G2 réf.98/79 IIFT: Hantavirus Mosaic 1 (IgM) FI 278h-1 M2 réf.98/79 IIFT: Hantavirus Mosaic 1 EUROPattern (IgG) FR 278h-1 G98/79 IIFT: Hantavirus Mosaic 1 EUROPattern (IgM) FR 278h-1 M98/79 IIFT: Hantavirus Mosaic 2: Eurasia (IgG) FI 278h-2 G2 réf.98/79 IIFT: Hantavirus Mosaic 2: Eurasia (IgM) FI 278h-2 M2 réf.98/79 IIFT: Hantavirus Mosaic 3: America (IgG) FI 278m-3 G98/79 IIFT: Hantavirus Mosaic 3: America (IgM) FI 278m-3 M98/79 IIFT: Hantavirus Mosaic 3: America EUROPattern (IgG) FR 278m-3 G98/79 IIFT: Hantavirus Mosaic 3: America EUROPattern (IgM) FR 278m-3 M98/79 IIFT: Legionella Mosaic 7 (IgAGM) FI 2150-7 P98/79 IIFT: Legionella Mosaic 8 (IgAGM) FI 2150-8 P98/79 IIFT: Legionella pneumophila Mix 5 FI 215k-1 P2 réf.98/79 IIFT: Sandfly fever virus Mosaic 1 (IgG) FI 277a-1 G3 réf.98/79 IIFT: Sandfly fever virus Mosaic 1 (IgM) FI 277a-1 M2 réf.98/79 IIFT: Sandfly fever virus Mosaic 1 EUROPattern (IgG) FR 277a-1 G98/79 IIFT: Sandfly fever virus Mosaic 1 EUROPattern (IgM) FR 277a-1 M98/79 Lyme ELISA (IgG/IgM) EI 2132-24 O98/79 Mosaic: Coxsackie virus (IgG) FI 2730-1 G98/79 Mosaic: Coxsackie virus (IgM) FI 2730-1 M98/79 Mosaic: Coxsackie virus B Types (IgG) FI 2730-3 G98/79 Mosaic: Coxsackie virus B Types (IgM) FI 2730-3 M2 réf.98/79 Mosaic: Coxsackie virus B Types FI 2730-3 G98/79 Mosaic: Coxsackie virus Type A7 / Type B1 (IgA) FI 2730-4 A2 réf.98/79 Mosaic: Coxsackie virus Type A7 / Type B1 FI 2730-4 G2 réf.98/79 Mosaic: Dengue virus types 1-4 IIFT (IgG) FI 266a-1 G3 réf.98/79 Mosaic: Dengue virus types 1-4 IIFT (IgM) FI 266a-1 M3 réf.98/79 Mosaic: Dengue virus types 1-4 IIFT EUROPattern (IgG) FR 266a-1 G2 réf.98/79 Mosaic: Dengue virus types 1-4 IIFT EUROPattern (IgM) FR 266a-1 M2 réf.98/79 Pos. control: anti-Borrelia afzelii (IgG), 50x concentrate CW 2131 G98/79 Pos. control: anti-Borrelia afzelii (IgM), 50x concentrate CW 2131 M98/79 Pos. control: anti-Borrelia burgdorferi (IgG), 50x concentrate CW 2132 G98/79 Pos. control: anti-Borrelia burgdorferi (IgM), 50x concentrate CW 2132 M98/79 Pos. control: anti-Borrelia garinii (IgG), 50x concentrate CW 2134 G98/79 Pos. control: anti-Borrelia garinii (IgM), 50x concentrate CW 2134 M98/79 Pos. control: anti-Echinococcus (IgG), 50x concentrate CW 2321 G98/79 Pos. control: anti-Helicobacter pylori (IgA), 50x concentrated CW 2080 A98/79 Pos. control: anti-Helicobacter pylori (IgG), 50x concentrated CW 2080 G98/79 Pos. control: anti-Herpes-simplex-virus (HSV) (IgG), 50x concentrate CW 2531 G98/79 Pos. control: anti-Yersinia enterocolitica (IgA), 50x concentrate CW 2173 A98/79 Pos. control: anti-Yersinia enterocolitica (IgG), 50x concentrate CW 2173 G98/79 Positive control (IgA, human), 50x concentrated CL 2050 A98/79 Positive control (IgA, human), 50x concentrated CL 2173 A98/79 Positive control (IgA, human), 50x concentrated CL 2525 A98/79 Positive control (IgG, human), 50x concentrated CL 2050 G98/79 Positive control (IgG, human), 50x concentrated CL 2111 G98/79 Positive control (IgG, human), 50x concentrated CL 2131 G98/79 Positive control (IgG, human), 50x concentrated CL 2173 G98/79 Positive control (IgG, human), 50x concentrated CL 2525 G98/79 Positive control (IgG, human), 50x concentrated CL 2570 G98/79 Positive control (IgG, human), 50x concentrated CL 2790-12 G98/79 Positive control (IgM, human), 50x concentrated CL 2111 M98/79 Positive control (IgM, human), 50x concentrated CL 2131 M98/79 Positive control (IgM, human), 50x concentrated CL 2570 M98/79 Positive control (IgM, human), 50x concentrated CL 2790-12 M98/79 Positive control: anti-Treponema pallidum (IgG), 50x concentrate CW 2111 G98/79 Positive control: anti-Treponema pallidum (IgM), 50x concentrate CW 2111 M98/79 Sprinter XL YG 0033 UNIQO 160 YG 2900 UNIQO 400 YG 0400	A, B, C IVDR, 98/79	Présent sur le marché en France Site web info@euroimmun.de Fiche EUDAMED Signaler une erreur
Sarstedt FDA	Allemagne	0,5ml Mikroröhre DNA LB3 réf. 0,5ml Mikroröhre PCR-PT2 réf.98/79 0.5ml SC Micro Tube PCT-PT98/79 1,5ml Mikroröhre Biosphere®plus98/79 1.5ml SC Micro Tube PCR-PT98/79 316 autres 100ml Schraubbecher, PP2 réf.98/79 10ml Tube 100x16PP Red Cap Boric Acid3 réf. 15ml Reagent Tubes (10/Pack)3 réf. 2,0ml Mikroröhre PCR-PT98/79 2.0ml SC Micro Tube PCT-PT98/79 2ml Control Tube98/79 3l Flasche mit Transfereinheit3 réf. 4er Set Röhre 12ml 99x16mm98/79 8er Deckelkette, flach3 réf. 96 PCR-Platte Biosphere® Plus98/79 Becher 100ml mit Verschluß3 réf. Biosphere® Deckelkette, flach98/79 Biosphere® micro tube 1.5ml98/79 Biosphere® Mikrorö.2ml, PP/POE98/79 Biosphere® Mikroröhre 0,5ml2 réf.98/79 Biosphere® Mikroröhre 1,5ml3 réf.98/79 Biosphere® Mikroröhre 2,0ml2 réf.98/79 Biosphere® SafeSeal Tube 0.5ml98/79 Biosphere® SafeSeal Tube 1.5ml3 réf.98/79 Biosphere® SafeSeal Tube 2.0ml2 réf.98/79 BloodGas Monovette®1ml2 réf.98/79 BloodGas Monovette®1ml Adapter98/79 BloodGas Monovette®1ml Ventilat98/79 BloodGas Monovette®2ml2 réf.98/79 BloodGas Monovette®2ml Adapter2 réf.98/79 BloodGas Monovette®2ml Ventilat98/79 Blutgaskapillare 100µl3 réf. Blutgaskapillare-Set 100ul3 réf. BSG-Pipette mit Skalierung2 réf. CryoPure Gefäß 1,0ml Farbmix98/79 CryoPure Gefäß 1,0ml gelb98/79 CryoPure Gefäß 1,0ml grün98/79 CryoPure Gefäß 1,0ml rot98/79 CryoPure Gefäß 1,0ml violett98/79 CryoPure Gefäß 1,0ml weiß98/79 CryoPure Gefäß 1,6ml blau98/79 CryoPure Gefäß 1,6ml Farbmix98/79 CryoPure Gefäß 1,6ml gelb98/79 CryoPure Gefäß 1,6ml grün98/79 CryoPure Gefäß 1,6ml rot98/79 CryoPure Gefäß 1,6ml violett98/79 CryoPure Gefäß 1,6ml weiß98/79 CryoPure Gefäß 1,8ml blau98/79 CryoPure Gefäß 1,8ml Farbmix98/79 CryoPure Gefäß 1,8ml gelb98/79 CryoPure Gefäß 1,8ml grün98/79 CryoPure Gefäß 1,8ml rot98/79 CryoPure Gefäß 1,8ml violett98/79 CryoPure Gefäß 1,8ml weiß98/79 CryoPure Gefäß 4,5ml dun.-grün98/79 CryoPure Gefäß 4,5ml Farbmix98/79 CryoPure Gefäß 4,5ml gelb98/79 CryoPure Gefäß 4,5ml grün98/79 CryoPure Gefäß 4,5ml rot98/79 CryoPure Gefäß 4,5ml violett98/79 CryoPure Gefäß 4,5ml weiß98/79 Eindrückstopfen, farblos3 réf. Filter tip 10 µl4 réf.98/79 Filter tip 100 µl4 réf.98/79 Filter tip 1000 µl4 réf.98/79 Filter tip 1000 µl XL4 réf.98/79 Filter tip 1250 µl XL4 réf.98/79 Filter tip 2,5 µl4 réf.98/79 Filter tip 20 µl8 réf.98/79 Filter tip 200 µl4 réf.98/79 Filter tip 300 µl4 réf.98/79 Formalin Set 25 ml2 réf. Formalin System 450 ml2 réf. Gefäss 70ml 55x44 PP+Verschl.98/79 Glasröhre für Coombs-Test Micro tube 1.3ml K3E3 réf. Micro Tube 2ml PP2 réf.98/79 Micro tube 2ml with cap98/79 Micro Tube 2ml, PP Blue Cap98/79 Micro tube 2ml, PP CD#13119198/79 Micro Tube 2ml, PP Mixed Caps98/79 Micro Tube 2ml, PP Purple Cap98/79 Micro Tube 2ml, PP Yellow Cap98/79 Micro Tube, 2ml, PP Green Cap98/79 Micro Tube, 2ml, PP Red Cap98/79 Microvette® 100 CAT3 réf. Microvette® 250 K2E3 réf. Microvette® CB 200 FE3 réf. Mikro-Röhre 0,5ml, PP blau98/79 Mikro-Röhre 0,5ml, PP braun98/79 Mikro-Röhre 1,5ml, PP/POE98/79 Mikro-Schraubröhre 0,5ml, PP19 réf.98/79 Mikro-Schraubröhre 1,5ml, PP28 réf.98/79 Mikro-Schraubröhre 2,0 ml, PP98/79 Mikro-Schraubröhre 2ml, PCR-PT98/79 Mikro-Schraubröhre 2ml, PP52 réf.98/79 Mikro-Schraubröhre 2ml, PP/POE98/79 Mikroröhre 0,5ml m. Verschluss2 réf.98/79 Mikroröhre 1,5ml m. Verschluss7 réf.98/79 Mikroröhre 1,5ml mit Verschluß4 réf.98/79 Mikroröhre 2,0ml m. Verschluss3 réf.98/79 Mikroröhre 2ml m. Verschluss98/79 Minivette® 30µl K3E3 réf. Mischstäbchen Monovette® 9ml98/79 Monovette® 9ml K3E98/79 Monovette® 9ml LH98/79 Monovette® 9ml Z2 réf.98/79 Monovette® 9ml Z-Gel98/79 Multiply®-Pro 0.2ml Biosphere®98/79 Multiply®-Pro 0.5ml Biosphere®98/79 Multiply®-Pro Farbmix3 réf. Multiply®-µStripPro Biosphere®98/79 Multivette® 600 CAT3 réf. Pipette tip 10 µl5 réf. Pipette tip 1000 µl2 réf.98/79 Pipette tip 1250 µl XL4 réf.98/79 Pipette tip 20 µl2 réf.98/79 Pipette tip 200 µl2 réf.98/79 Pipette tip 250 µl2 réf.98/79 Pipette tip 300 µl2 réf.98/79 Röhre 1,2ml, 66x8,5mm, K3E3 réf. Röhre 101x16,5mm,1ml NaCl 0,9%98/79 Röhre 101x16,5mm,3ml NaCl 0,9%98/79 Röhre 10ml 97x16PS+Verschluss98/79 Röhre 10ml, 100x16mm, PP3 réf.98/79 Röhre 10ml, 79x16mm, PP98/79 Röhre 10ml, 92x15,3mm, PP6 réf.98/79 Röhre 10ml,100x16PP+Verschluss98/79 Röhre 12ml, 110x17mm, PS98/79 Röhre 13ml, 101x16,5mm, PP98/79 Röhre 15ml, 120x17mm, PP7 réf.98/79 Röhre 15ml, 120x17mm, PS3 réf.98/79 Röhre 15ml, 76x20mm, PP98/79 Röhre 1ml, 66x11,5mm, HbA1c3 réf. Röhre 25ml 90x25PP+Verschluss6 réf.98/79 Röhre 2ml, 66x11,5mm, 4NC3 réf. Röhre 3,5ml, 66x11,5mm, PP98/79 Röhre 30ml, 107x25mm, PP3 réf.98/79 Röhre 4,5ml, 75x12mm, PP98/79 Röhre 4ml, 92x15,3 (rund), PP98/79 Röhre 50ml, 114x28mm, PP7 réf.98/79 Röhre 50ml, 114x28mm, PP braun98/79 Röhre 50ml, 115x28mm, PP5 réf.98/79 Röhre 5ml, 57x15,3mm, PP98/79 Röhre 5ml, 75x13mm, PP98/79 Röhre 70ml 55x44PP+Verschluss98/79 Röhre 8ml, 57x16,5mm, PP98/79 Röhre 90x13mm, 1ml NaCl 0,9%98/79 Röhre 90x13mm, 3ml NaCl 0,9%98/79 Röhre mit Verschluß 57x15,3mm98/79 Röhre mit Verschluß, 76x20mm98/79 S-Monovette® 1.1ml98/79 S-Monovette® 1.1ml LH-Gel3 réf.98/79 S-Monovette® 1.1ml Z-Gel98/79 S-Monovette® 1.2ml FE4 réf.98/79 S-Monovette® 1.2ml K2E2 réf.98/79 S-Monovette® 1.2ml K3E7 réf.98/79 S-Monovette® 1.2ml LH4 réf.98/79 S-Monovette® 1.2ml Serum CAT98/79 S-Monovette® 1.2ml Z2 réf.98/79 S-Monovette® 1.4ml 9NC3 réf.98/79 S-Monovette® 1.6ml Hirudin98/79 S-Monovette® 1.6ml K3E7 réf.98/79 S-Monovette® 1.6ml LH3 réf.98/79 S-Monovette® 1.6ml Serum CAT3 réf.98/79 S-Monovette® 1.8ml 9NC6 réf.98/79 S-Monovette® 1.8ml K2E98/79 S-Monovette® 1.8ml K3E5 réf.98/79 S-Monovette® 10ml 9NC2 réf.98/79 S-Monovette® 2,7ml K3E Notfall98/79 S-Monovette® 2.6ml FE4 réf.98/79 S-Monovette® 2.6ml K2E2 réf.98/79 S-Monovette® 2.6ml K3E10 réf.98/79 S-Monovette® 2.6ml LH4 réf.98/79 S-Monovette® 2.6ml LH-Gel2 réf.98/79 S-Monovette® 2.6ml NH2 réf.98/79 S-Monovette® 2.6ml Z3 réf.98/79 S-Monovette® 2.6ml Z-Gel2 réf.98/79 S-Monovette® 2.7ml3 réf.98/79 S-Monovette® 2.7ml DNA Exact98/79 S-Monovette® 2.7ml FE11 réf.98/79 S-Monovette® 2.7ml FH3 réf.98/79 S-Monovette® 2.7ml HCY/Z-Gel98/79 S-Monovette® 2.7ml Hirudin98/79 S-Monovette® 2.7ml K2E3 réf.98/79 S-Monovette® 2.7ml K3E18 réf.98/79 S-Monovette® 2.7ml LH9 réf.98/79 S-Monovette® 2.7ml LH-Gel12 réf.98/79 S-Monovette® 2.7ml Se Gel CAT98/79 S-Monovette® 2.7ml Serum CAT3 réf.98/79 S-Monovette® 2.7ml Z5 réf.98/79 S-Monovette® 2.7ml Z-Gel98/79 S-Monovette® 2.9ml 9NC7 réf.98/79 S-Monovette® 2.9ml 9NC/HCY98/79 S-Monovette® 2.9ml CTAD2 réf.98/79 S-Monovette® 25ml2 réf. S-Monovette® 2ml 4NC S-Monovette® 4NC4 réf.98/79 S-Monovette® 3.0ml 9NC3 réf.98/79 S-Monovette® 3.1ml GlucoEXACT5 réf.98/79 S-Monovette® 3.4ml K3E6 réf.98/79 S-Monovette® 3.8ml 9NC (PFA)2 réf.98/79 S-Monovette® 3ml 9NC8 réf.98/79 S-Monovette® 4.0ml K3E EDTA pre-Barcode98/79 S-Monovette® 4.0ml LH-GEL+6 réf.98/79 S-Monovette® 4.0ml Se Gel CAT98/79 S-Monovette® 4.0ml Z98/79 S-Monovette® 4.3ml 9NC5 réf.98/79 S-Monovette® 4.3ml CTAD98/79 S-Monovette® 4.7ml LH-Gel4 réf.98/79 S-Monovette® 4.7ml Z-Gel3 réf.98/79 S-Monovette® 4.9ml3 réf.98/79 S-Monovette® 4.9ml AH98/79 S-Monovette® 4.9ml FE3 réf.98/79 S-Monovette® 4.9ml K2E-Gel4 réf.98/79 S-Monovette® 4.9ml K3E18 réf.98/79 S-Monovette® 4.9ml LH8 réf.98/79 S-Monovette® 4.9ml LH-Gel13 réf.98/79 S-Monovette® 4.9ml NH98/79 S-Monovette® 4.9ml Se-Gel CAT3 réf.98/79 S-Monovette® 4.9ml Serum CAT3 réf.98/79 S-Monovette® 4.9ml Z5 réf.98/79 S-Monovette® 4.9ml Z-Gel5 réf.98/79 S-Monovette® 4ml2 réf.98/79 S-Monovette® 4ml K3E7 réf.98/79 S-Monovette® 4ml LH3 réf.98/79 S-Monovette® 4ml LH-Gel3 réf.98/79 S-Monovette® 4ml Serum CAT98/79 S-Monovette® 4ml Z2 réf.98/79 S-Monovette® 4ml Z-Gel2 réf.98/79 S-Monovette® 5.4ml 9NC3 réf.98/79 S-Monovette® 5.5ml FE2 réf.98/79 S-Monovette® 5.5ml LH5 réf.98/79 S-Monovette® 5.5ml Serum CAT98/79 S-Monovette® 5.5ml Z3 réf.98/79 S-Monovette® 5.7ml CPDA98/79 S-Monovette® 7,5ml Z Blutbank98/79 S-Monovette® 7,5ml Z Notfall98/79 S-Monovette® 7.5ml2 réf.98/79 S-Monovette® 7.5ml AH2 réf.98/79 S-Monovette® 7.5ml K2E98/79 S-Monovette® 7.5ml K2E-Gel2 réf.98/79 S-Monovette® 7.5ml K3E18 réf.98/79 S-Monovette® 7.5ml LH11 réf.98/79 S-Monovette® 7.5ml LH-Gel4 réf.98/79 S-Monovette® 7.5ml NH2 réf.98/79 S-Monovette® 7.5ml Se Gel CAT98/79 S-Monovette® 7.5ml Serum CAT3 réf.98/79 S-Monovette® 7.5ml Z7 réf.98/79 S-Monovette® 7.5ml Z-Gel5 réf.98/79 S-Monovette® 8.2ml 9NC98/79 S-Monovette® 8.8ml CPDA98/79 S-Monovette® 9ml4 réf.98/79 S-Monovette® 9ml AH2 réf.98/79 S-Monovette® 9ml K2E-Gel2 réf.98/79 S-Monovette® 9ml K3E3 réf.98/79 S-Monovette® 9ml LH3 réf.98/79 S-Monovette® 9ml Neutral Z98/79 S-Monovette® 9ml Serum CAT98/79 S-Monovette® 9ml Z4 réf.98/79 S-Monovette® 9ml Z Blutbank98/79 S-Monovette® 9ml Z-Gel3 réf.98/79 S-Monovette® cfDNA Exact98/79 S-Monovette® RNA Exact98/79 S-Monovette® SeGel LightPROTECT98/79 S-Monovette®2.7ml ThromboExact98/79 S-Sedivette® 3.5ml 4NC S-Monovette® 4NC2 réf.98/79 SafeSeal Gefäß 5ml Biosphere®2 réf.98/79 Salivette®3 réf. Schraubbecher 100ml, PP4 réf.98/79 Schraubröhre 7ml, 82x13mm, PP98/79 Schraubverschluss, rot98/79 Schutzgefäß 114x44mm98/79 Schutzgefäß 126x30mm4 réf. Schutzgefäß m.Urin-Monovette®98/79 Schutzgefäß mit Innenröhre2 réf.98/79 Screw Cap Micro Tube 0.5ml CON/S, WB98/79 Screw Cap Micro Tube 0.5ml DBG, No Cap98/79 Screw cap micro tube 0.5ml, PP8 réf.98/79 Screw cap micro tube 1.5ml, PP8 réf.98/79 Screw cap micro tube 2.0ml, PP6 réf.98/79 Screw Cap Microtube 0.5ml Brown No Cap98/79 Screw Cap Tube Conical 16x100mm98/79 Sediplus® S 2000 NX Spitze für Urin-Monovette®3 réf. Stuhlröhre 101x16,5mm4 réf.98/79 Stuhlröhre 107x25mm2 réf.98/79 Stuhlröhre 75x23,5mm98/79 Stuhlröhre 76x20mm2 réf.98/79 Transferpipette 1ml4 réf. Transferpipette 3,5ml4 réf.98/79 Transferpipette 6ml2 réf.98/79 Urin-Auffangbecher 500ml Urin-Auffangbecher für Uriset24 Urin-Becher m. Transfereinheit98/79 Urin-Becher NFT 100ml98/79 Urin-Monovette® 10ml4 réf.98/79 Urin-Monovette® 10ml Bors.-Set3 réf. Urin-Monovette® 10ml Borsäure3 réf.98/79 Urin-Monovette® 8,5ml3 réf.98/79 Urin-Monovette® Liquor 10ml98/79 Urin-Monovette® Z 8,5ml98/79 Urin-Monovette®3,2ml Borsäure98/79 Urin-Monovette®8,5ml Borsäure98/79 UriSet 24 Uriset243 réf. V-Monovette® 10.2ml, K3E2 réf.98/79 V-Monovette® 10.2ml, Neutral Z98/79 V-Monovette® 10.2ml, Z98/79 V-Monovette® 6.4ml, K3E98/79 V-Monovette® 6.4ml, Z98/79 V-Monovette® 9.5ml, K2E-Gel2 réf.98/79 V-Monovette® Urin 4ml Borsäure2 réf.98/79 V-Monovette® Urin 9ml Borsäure98/79 V-Monovette® Urin Stabilur®98/79 V-Monovette® Urin Z 10ml2 réf.98/79 V-Monovette® Urin Z 4ml98/79 V-Monovette® Urin Z 6ml98/79 V-Monovette® Urin Z 9,5ml98/79 V-Monovette®Urin 10ml Borsäure4 réf.98/79 V-Monovette®Urin 9ml Borsäure98/79 Verschlusskappe 1,60-2,10mm2 réf. ZB-Röhre CSF 2,5ml, 75x1398/79	A IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Zeta FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	2026-10-02 00:00:00 ZM904 réf.98/79 2026-10-02 00:00:00 ZR2274 réf.98/79 ACTH ZM984 réf.98/79 Actin, Muscle Specific (MSA) HHF354 réf.98/79 Actin, Smooth Muscle (SMA) 1A44 réf.98/79 314 autres Adenovirus 20.11 & 2.64 réf.98/79 AFP C34 réf.98/79 ALDH1A1 ZM714 réf.98/79 ALK ZR3054 réf.98/79 AMACR 13H44 réf.98/79 AMACR+p63 13H4+ZM704 réf.98/79 AMACR+p63+HMW CK (Triple cocktail) 13H4+ZM70+34βE124 réf.98/79 Androgen receptor (AR) ZR3344 réf.98/79 Annexin A1 ZM2114 réf.98/79 Arginase-1 ZR3684 réf.98/79 ATRX ZR2444 réf.98/79 BCA-22598/79 BCA-225 (Cu-18)3 réf.98/79 BCL-2 1244 réf.98/79 BCL-2 ZR1304 réf.98/79 BCL-6 ZM224 réf.98/79 BCL-6 ZR3804 réf.98/79 BCOR C-104 réf.98/79 Beta-catenin ZM134 réf.98/79 BOB1 ZM744 réf.98/79 BRCA-1 MS1104 réf.98/79 BRG1/SMARCA4 ZR3904 réf.98/79 Bruchyury ZR3914 réf.98/79 c-myc ZR3554 réf.98/79 C3d ZM3694 réf.98/79 C4d ZM784 réf.98/79 CA IX ZR3674 réf.98/79 CA125 / MUC16 ZM534 réf.98/79 CA19-9 121SLE4 réf.98/79 Calcitonin ZM3014 réf.98/79 Caldesmon ZM794 réf.98/79 Calponin-1 ZM214 réf.98/79 Calponin-1 ZR2974 réf.98/79 Calretinin ZM854 réf.98/79 CD10 ZR3294 réf.98/79 CD117 ZM3214 réf.98/79 CD11c ZM1034 réf.98/79 CD123 ZM804 réf.98/79 CD13 ZM2874 réf.98/79 CD138 ZR2514 réf.98/79 CD14 ZM1044 réf.98/79 CD15 MMA4 réf.98/79 CD163 ZM294 réf.98/79 CD19 ZM1794 réf.98/79 CD19 ZR2124 réf.98/79 CD1a O104 réf.98/79 CD2 ZR1004 réf.98/79 CD20 L264 réf.98/79 CD205 ZM3604 réf.98/79 CD21 ZM754 réf.98/79 CD22 ZM1834 réf.98/79 CD23 ZM2094 réf.98/79 CD23 ZR2254 réf.98/79 CD3 ZM454 réf.98/79 CD30 Ber-H24 réf.98/79 CD30 ZR2484 réf.98/79 CD31 JC70A4 réf.98/79 CD31 ZR2744 réf.98/79 CD34 QBEnd-104 réf.98/79 CD35 ZR584 réf.98/79 CD38 ZR3514 réf.98/79 CD4 ZM1804 réf.98/79 CD4 ZR1104 réf.98/79 CD43 DF-T14 réf.98/79 CD44 ZR1844 réf.98/79 CD45 (LCA) ZR3614 réf.98/79 CD45RA ZR1184 réf.98/79 CD45RB (LCA) 2B11/PD7-264 réf.98/79 CD45RO UCHL14 réf.98/79 CD5 ZM614 réf.98/79 CD5 ZR2284 réf.98/79 CD56 123C3.D54 réf.98/79 CD57 NK-14 réf.98/79 CD61 ZM334 réf.98/79 CD68 KP14 réf.98/79 CD68 ZR3024 réf.98/79 CD7 ZM2134 réf.98/79 CD71 ZM1364 réf.98/79 CD79a JCB1174 réf.98/79 CD79a ZR2374 réf.98/79 CD8 ZM544 réf.98/79 CD8 ZR2864 réf.98/79 CD99 ZM1394 réf.98/79 CDK4 DCS-314 réf.98/79 CDX2 ZR2154 réf.98/79 CEA-M CEA314 réf.98/79 CEA-P (Poly)4 réf.98/79 CEACAM5 ZR3704 réf.98/79 Chromogranin A ZM124 réf.98/79 Collagen IV ZM1774 réf.98/79 Collagen IV ZR1084 réf.98/79 Cyclin D1 ZM1784 réf.98/79 Cyclin D1 ZR1974 réf.98/79 Cyclin-E ZM1214 réf.98/79 Cytokeratin 14 LL0024 réf.98/79 Cytokeratin 14 ZM3724 réf.98/79 Cytokeratin 17 E34 réf.98/79 Cytokeratin 18 DC-104 réf.98/79 Cytokeratin 18 ZM2054 réf.98/79 Cytokeratin 19 BA174 réf.98/79 Cytokeratin 19 ZR1434 réf.98/79 Cytokeratin 20 Ks20.84 réf.98/79 Cytokeratin 20 ZM424 réf.98/79 Cytokeratin 5 ZM1864 réf.98/79 Cytokeratin 5 ZR2804 réf.98/79 Cytokeratin 5/6 D5/16B44 réf.98/79 Cytokeratin 7 OV-TL-12/304 réf.98/79 Cytokeratin 8 ZM1234 réf.98/79 Cytokeratin 8/18 B22.1 & B23.14 réf.98/79 Cytokeratin 8/18 ZM1254 réf.98/79 Cytokeratin CAM 5.2* CAM5.22 réf.98/79 Cytokeratin, HMW 34βE124 réf.98/79 Cytokeratin, Pan AE1/AE34 réf.98/79 Cytokeratin, Pan OSCAR4 réf.98/79 Desmin ZM344 réf.98/79 Desmin ZR2404 réf.98/79 Desmoglein-3 ZR1284 réf.98/79 DOG-1 DOG1.14 réf.98/79 DOG-1 ZR1464 réf.98/79 DPC4 (SMAD4) B-84 réf.98/79 DPC4 (SMAD4) ZR3924 réf.98/79 E-cadherin ZM634 réf.98/79 E-cadherin ZR3754 réf.98/79 EGFR ZR164 réf.98/79 EMA E294 réf.98/79 EMA ZR1334 réf.98/79 EP-CAM / ESA MOC-314 réf.98/79 EP-CAM / ESA ZR3074 réf.98/79 EP-CAM Ber-EP44 réf.98/79 EP-CAM ZM1314 réf.98/79 ER ZM3194 réf.98/79 ER ZR1474 réf.98/79 ERG ZR3314 réf.98/79 Erythropoietin ZM1354 réf.98/79 EZH2 ZR1504 réf.98/79 Factor VIII-R Ag ZM644 réf.98/79 Factor XIIIa ZM844 réf.98/79 Fascin ZM1924 réf.98/79 FoxP1 ZR3334 réf.98/79 FSH ZR2464 réf.98/79 Galectin-3 ZM1824 réf.98/79 Gastrin ZM3594 réf.98/79 GATA-3 L50-8234 réf.98/79 GATA-3 ZR3584 réf.98/79 GCDFP-15 ZM234 réf.98/79 GFAP GA-54 réf.98/79 GFAP ZR3564 réf.98/79 Glucagon EP744 réf.98/79 GLUT-1 ZM1374 réf.98/79 GLUT-1 ZR3084 réf.98/79 Glutamine Synthetase ZM3774 réf.98/79 Glypican 3 1G124 réf.98/79 Glypican 3 ZM1384 réf.98/79 Granzyme B ZM664 réf.98/79 Growth Hormone ZM1404 réf.98/79 H. Pylori Poly4 réf.98/79 HBME-14 réf.98/79 HCG ZR3624 réf.98/79 HepPar-1 OCH1E54 réf.98/79 HHV-8 LN534 réf.98/79 HHV-8 ZR1064 réf.98/79 HSP70 ZR1524 réf.98/79 HSV I 10A34 réf.98/79 IDH1 ZR74 réf.98/79 IgA ZR2914 réf.98/79 IgD ZR1564 réf.98/79 IgG ZR2474 réf.98/79 IgG4 ZM564 réf.98/79 IgG4 ZR2994 réf.98/79 IgM ZR2494 réf.98/79 IMP-3 EP2864 réf.98/79 Inhibin-α R14 réf.98/79 Inhibin-α ZM1134 réf.98/79 INI-1 254 réf.98/79 INI-1 ZR2824 réf.98/79 INSM1 A84 réf.98/79 Insulin ZM83a & ZM83b4 réf.98/79 Kappa ZM814 réf.98/79 Ki-67 MIB-14 réf.98/79 Ki-67 ZM674 réf.98/79 Lambda LcN-24 réf.98/79 Langerin ZR1704 réf.98/79 LEF1 ZR3364 réf.98/79 LH ZR1734 réf.98/79 LMO2 ZR874 réf.98/79 Lysozyme ZM1204 réf.98/79 Mammaglobin 304-1A54 réf.98/79 Mammaglobin 31-A54 réf.98/79 Mammaglobin Cocktail 304-1A5+31-A54 réf.98/79 Mammaglobin ZR3634 réf.98/79 MDM2 SMP144 réf.98/79 Melan-A (MART-1) A1034 réf.98/79 Melanosome (HMB-45)4 réf.98/79 Mesothelin ZM254 réf.98/79 MGMT ZM3144 réf.98/79 MiTF C5/D54 réf.98/79 MLH-1 G168-7284 réf.98/79 MLH-1 ZR3474 réf.98/79 MMP-2 CA-40014 réf.98/79 MSH-2 G219-11294 réf.98/79 MSH-2 ZR2604 réf.98/79 MSH-6 ZM994 réf.98/79 MSH-6 ZR3424 réf.98/79 MUC-1 ZM324 réf.98/79 MUC-2 Ccp584 réf.98/79 MUC-2 ZR1754 réf.98/79 MUC-4 ZR2014 réf.98/79 MUC-5AC ZM1484 réf.98/79 MUC-5AC ZR194 réf.98/79 MUC-6 ZM894 réf.98/79 Myelin basic protein (MBP) ZM2024 réf.98/79 Myelin basic protein (MBP) ZR1094 réf.98/79 Myeloperoxidase ZM3524 réf.98/79 MyoD1 ZR2624 réf.98/79 Myogenin F5D4 réf.98/79 Myogenin ZM1494 réf.98/79 Myoglobin ZR694 réf.98/79 Myosin, SMHC SMMS-14 réf.98/79 Napsin A ZR2064 réf.98/79 Napsin-A ZM114 réf.98/79 NeuN A604 réf.98/79 NeuN ZR3864 réf.98/79 Neurofilament 2F114 réf.98/79 Neurofilament ZR2164 réf.98/79 NGFR ZM554 réf.98/79 NKX2.2 ZM144 réf.98/79 NKX3.1 ZM954 réf.98/79 NKX3.1 ZR2224 réf.98/79 NSE ZM244 réf.98/79 Nucleophosmin (NPM1) ZM824 réf.98/79 OCT-4 C-104 réf.98/79 OCT-4 ZR3644 réf.98/79 Olig2 ZR3404 réf.98/79 p120 ZR3164 réf.98/79 p16INK4a G175-4054 réf.98/79 p16INK4a JC24 réf.98/79 p16INK4a MX0074 réf.98/79 p21WAF1 ZR2884 réf.98/79 p27Kip1 SX53G84 réf.98/79 P40 ZR3034 réf.98/79 p40 ZR84 réf.98/79 p53 DO-74 réf.98/79 p53 ZR1534 réf.98/79 p57Kip2 KP104 réf.98/79 p57Kip2 ZR2304 réf.98/79 p63 ZM704 réf.98/79 Parathyroid hormone (PTH) ZM2074 réf.98/79 PAX-2 ZR2244 réf.98/79 PAX-5 ZM264 réf.98/79 PAX-5 ZR2684 réf.98/79 PAX-8 ZM284 réf.98/79 PAX-8 ZR14 réf.98/79 PCNA ZR3784 réf.98/79 PD-1 (PDCD1) ZM3574 réf.98/79 PD-L1 ZR34 réf.98/79 Perforin ZM1594 réf.98/79 PGP9.5 ZM1604 réf.98/79 PHH3 ZR2854 réf.98/79 PHOX2B ZR2924 réf.98/79 PIT1 ZM3854 réf.98/79 PLAP ZM1614 réf.98/79 PMS2 ZR3174 réf.98/79 Podoplanin D2-404 réf.98/79 Podoplanin ZM314 réf.98/79 PR ZR2904 réf.98/79 PR ZR44 réf.98/79 Prolactin ZM2034 réf.98/79 Prostein (P501S) ZR94 réf.98/79 RCC 66.4.C24 réf.98/79 Retinoblastoma (Rb) 1F84 réf.98/79 RRM1 ZR1144 réf.98/79 S-100 4C4.94 réf.98/79 S-100P ZR1154 réf.98/79 SALL4 ZR2764 réf.98/79 SATB2 ZR1674 réf.98/79 SDHB ZR3394 réf.98/79 Smoothelin ZR1694 réf.98/79 Somatostatin Receptor Type 2 ZR2334 réf.98/79 SOX-10 ZM104 réf.98/79 SOX-10 ZR2754 réf.98/79 SOX-2 ZM574 réf.98/79 SOX-9 ZM1714 réf.98/79 STAT6 ZR2894 réf.98/79 Stathmin ZR3984 réf.98/79 Steroidogenic Factor-1 (SF-1) N16654 réf.98/79 Surfactant ZM1244 réf.98/79 Synaptophysin ZM2084 réf.98/79 TCL1 ZM924 réf.98/79 TdT ZM514 réf.98/79 TFE3 ZR3654 réf.98/79 Thrombomodulin / CD141 ZM1054 réf.98/79 Thymidylate Synthase (TS) TS1064 réf.98/79 Thymidylate Synthase (TS) ZR2454 réf.98/79 Thyroglobulin 2H11+6E14 réf.98/79 TIA-1 2G9A10F54 réf.98/79 TIA-1 ZR2844 réf.98/79 TLE1 ZM934 réf.98/79 Toxoplasma gondii Poly4 réf.98/79 TRAcP ZM1744 réf.98/79 TRAcP ZR2344 réf.98/79 Treponema pallidum Poly4 réf.98/79 TROP2 ZR3884 réf.98/79 TRPS1 ZR3824 réf.98/79 Tryptase ZM964 réf.98/79 TSH ZM2944 réf.98/79 TTF-1 8G7G3/14 réf.98/79 TTF-1/NKX2.1 ZR1764 réf.98/79 Tyrosinase T3114 réf.98/79 Ubiquitin ZM1914 réf.98/79 Uroplakin ZM2044 réf.98/79 VEGF ZR3894 réf.98/79 Vimentin ZR3814 réf.98/79 WT-1 6F-H24 réf.98/79 ZAP-70 ZM974 réf.98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Turquie	24 IN 1 PANEL qPCR KIT 3'Ü 1 ARADA SOLUNUM HIZLI TEST KİTİ RESPIRATORY 3 IN 1 RAPID TEST KIT 4'Ü 1 ARADA SOLUNUM HIZLI TEST KİTİ RESPIRATORY 4 IN 1 RAPID TEST KIT 5'İ 1 ARADA SOLUNUM HIZLI TEST KİTİ RESPIRATORY 5 IN 1 RAPID TEST KIT 7 IN 1 PANEL qPCR KIT 283 autres ACANTAMEOBEBA TESPİT KİTİ Adenovirüs Detection Test Kit VSNR015 ADENOVİRÜS MİKTARLANDIRMA KİTİ ADEP SCREENING KIT AGAROSE GEL DNA EXTRACTION KIT S ALT SOLUNUM YOLLARI ETKENLERİ MULTIPLLEX PCR TANI KİTİ ANTİBİYOTİK DİRENCİ/MİKOLAZMA GENİTALYUM TARAMA KİTİ Aspergillus Detection Kit VSNMP007 AUTOMATED BACTERIAL DNA EXTRACTION KIT AUTOMATED EXTRACTION KIT VIS100231 B. PERTUSSIS/PARAPERTUSSIS GENOTİPLEME KİTİ Bacterial Meningitis Screening Kit BATI NİL TESPİT KİTİ Beyaz Akciğer Sendromu Mini Panel Hızlı Test Kiti BKV Kantifikasyon Kiti BKV TESPİT KİTİ BOCAVIRUS DETECTION KIT VSNR016 BONE&JOINT INFECTIONS KIT Bordatella Multiplex Gerçek Zamanlı PCR Kiti BORDETELLA PERTUSSIS DETECTION KIT VSNR005 BRUCELLA SPP. DETECTION KIT VSNMP066 BRUCELLOSIS AG HIZLI TEST KİTİ C. DIFFICILE TOXIN A/TOXIN B/GDH RAPID TEST KIT VISD075 C. DIFFICILE/ GDH HIZLI TEST KİTİ C.TRAKHOMATİS/ UREAPLAZMA/ M. GENITALIUM/ M. HOMINIS TEST KİTİ CAMPYLOBACTER JEJUNI DETECTION KIT CANDIDA ALBICANS TESPİT KİTİ cDNA SENTEZ KİTİ CH DILUENT CH WASH CHLAMYDIA RAPID TEST KIT VISD029 CHLAMYDIA TRACHOMATIS DETECTION KIT VSNR020 Cinsel Yolla Bulaşan Enfeksiyonlar (STI) Genital Ülserler PCR Kiti Cinsel Yolla Bulaşan Hastalıklar Tarama Kiti CİNSEL YOLLA BULAŞAN ENFEKSİYONLAR KİTİ CİNSEL YOLLA BULAŞAN ENFEKSİYONLAR PANELİ MAKSİMUM KİTİ CİNSEL YOLLA BULAŞAN ENFEKSİYONLAR PANELİ MIDI KİTİ CİNSEL YOLLA BULAŞAN ENFEKSİYONLAR TARAMA KİTİ 14T SEXUALLY TRANSMITTED INFECTIONS SCREENING KIT 14T CİNSEL YOLLA BULAŞAN HASTALIKLAR TARAMA KİTİ CLOSTRIDIUM DIFFICILE TESPİT KİTİ Clostridium Difficile Toxin A+B Rapid Test VISD125 CMV AB HIZLI TESTİ CMV MİKTAR TEST KİTİ COVID 19 HIZLI ANTİJEN TEST KİTİ COVID 19 RAPID ANTIGEN TEST KIT COVID 19 RAPID POC TEST KIT COVID 19 SAMPLING AND VIRAL RNA EXTRACTION KIT S2 réf. COVID-19 A/B- RSV- ADENO ÇOKLU HIZLI TEST KİTİ COVID-19 EASY PREP PCR TANI KİTİ COVID-19 EASY-PREP PCR DIAGNOSTIC KIT COVID-19 MULTIPREP FAST COVID-INF A/B- RSV MULTI RAPID TEST KIT COVID-INF A/B- RSV- ADENO- HMPV MULTI RAPID TEST KIT COVID-INFLUENZA A/B RAPID TEST KIT2 réf. CRYPTOCOCCUS NEOFORMANS RAPID TEST KIT CRYPTOCOCCUS NEOFORMANS/CANDIDA PCR KİTİ CRYPTOCOCCUS SPP TESPİT KİTİ DENGUE Ag RAPID TEST KIT VISD035 DENGUE IgG/IgM RAPID TEST KIT VISD025 DENGUE NS1 & IgG-IgM RAPID TEST DENGUE NS1 HIZLI TEST KİTİ DENGUE NS1 RAPID TEST KIT DENGUE VİRÜSÜ GENOTİPLEME KİTİ DENGUE VİRÜSÜ TESPİT KİTİ DİFTERİ TESPİT KİTİ DRIED BLOOD RNA EXTRACTION S KIT EAR/NOSE/THROAT PANEL MAXI KIT EBV Quantification Kit ENTERİK/ADENO PZR KİTİ ENTEROVIRUS DETECTION KIT VSNMP054 ERKEK SAĞLIĞI ENFEKSİYONLARI PANELİ MAKSİMUM KİTİ EXTRA MINI EXTRACTION SYSTEM EXTRACTION KIT VIS100232 F&R TESPİT KİTİ V1 F&R DETECTION KIT V1 F&R TESPİT KİTİ V2 F&R DETECTION KIT V2 FLU A/B-RSV RAPID TEST KIT GASTROENTERITIS PANEL MAXI KIT GENERAL DNA/RNA EXTRACTION KIT VIS100300 GONORE HIZLI TEST KİTİ H.PYLORI AB RAPID TEST VISD013 H.PYLORI AG RAPID TEST VISD012 H1N1 TESPİT KİTİ H1N1 DETECTION KIT HAEMOFİL INFLUENZAE TESPİT TEST KİTİ HAEMOFİL İNFLUENZA TİPLEME (A/B/C/D/E/F) TESPİT KİTİ HELİKOBAKTER PYLORİ TESPİT KİTİ HELMINTHS REAL-TIME PCR KIT HHV-6 Quantification Kit HHV-8 DETECTION KIT HHV6-HHV7 DETECTION KIT HPV (16-18) HIGH RISK DETECTION KIT HPV (16-18-31) HIGH RISK DETECTION KIT HPV 6/11 Tespit Kiti HPV 6/11 DETECTION KIT HPV DÜŞÜK RİSKLİ GENOTİPLEME GERÇEK ZAMANLI PCR KİTİ HPV YÜKSEK RİSK VE 6-11 GERÇEK ZAMANLI PCR KİTİ HPV HIGH RISK AND 6-11 REAL-TIME PCR KIT HSV-1 Detection Test Kit HSV-2 DetectionTest Kit HUMAN METAPNEUMOVIRUS DETECTION KIT VSNR001 HUMAN PARECHOVIRUS DETECTION KIT VSNR019 INF A/H1 TESPİT KİTİ INF A/H1 DETECTION KIT INF A/H1-2009 TESPİT KİTİ INF A/H1-2009 DETECTION KIT INF A/H3 TESPİT KİTİ INF A/H3 DETECTION KIT INFLUENZA A/B RAPID TEST KIT VISD007 INFLUENZA A/B RSV RAPID TEST KIT VISD073 İDRAR YOLU ENFEKSİYONLARI KİTİ (İDRAR YOLU ENFEKSİYONLARI KİTİ) İDRAR YOLU ENFEKSİYONLARI PANELİ MİDİ KİTİ İNFLUENZA A-H5N1 TESPİT KİTİ INFLUENZA A- H5N1 DETECTION KIT İNFLUENZA -A,B TESPİT KİTİ İNFLUENZA -B TESPİT KİTİ İNFLUENZA A-B-C TARAMA KİTİ İNFLUENZA A-B/RSV/ADENO HIZLI TEST KİTİ İNFLUENZA H5N2 TESPİT KİTİ INFLUENZA H5N2 DETECTION KIT İNFLUENZA TİPLEME KİTİ İNFLUENZA-A TESPİT KİTİ JCV Quantification Kit KADIN SAĞLIĞI TARAMA KİTİ KADIN SAĞLIĞI/VAJİNİT ENFEKSİYONLARI PANELİ MİDİ KİTİ KAMPİLOBAKTER PZR KİTİ KÜLTÜR VE HASSASİYET KENELERLE BULAŞAN HASTALIKLAR PANELİ MAKSİ KİTİ LAM LEGIONELLA PNEUMOPHILA DETECTION KIT LEISHMANIA TESPİT KİTİ LEJYONELLA ÇOKLU TESPİT KİTİ LEPTOSPIRA SPP. DETECTION KIT VSNMP059 LISTERIA MONOCYTOGENES TESPİT KİTİ LYME HASTALIĞI TESPİT KİTİ MALARYA Pf/Pv/Pan HIZLI TEST KİTİ Manuel Viral/ Bacterial Extraction kit for Blood Samples Manuel Viral/ Bacterial Extraction kit for Serum Samples Manuel Viral/ Bacterial Extraction kit for Stool Samples Manuel Viral/ Bacterial Extraction kit for Urine Samples MENENGITIS/ENCEPHALIS SCREENING KIT MINI SMEAR SET MINI SMEAR SET V2 MINI SMEAR SETİ V2 Mini Solunum Yolu Patojenleri Panel Tipi Test Kiti MONKEYPOX AB RAPID TEST KIT VISD051 Monkeypox Detection Test Kit VISMPX001 MONO HIZLI TEST KİTİ MTBC Detection Kit MTBC/NTM TESPİT KİTİ MYCOPLASMA GENITALIUM AG HIZLI TEST KİTİ MYCOPLASMA GENITALIUM DETECTION KIT VSNS005 MYCOPLASMA PNEUMONIAE AB HIZLI TEST KİTİ SARS-CoV-2 NEUTRALIZING ANTIBODY RAPID TEST KIT NEISSERIA GONORRHOEAE DETECTION KIT VSNS006 NEISSERIA GONORRHOEAE/TRICHOMONAS VAGINALIS TESPİT KİTİ NEISSERIA MENINGITIDIS TESPİT TEST KİTİ NOROVIRUS-ROTAVIRUS AG RAPID TEST KIT VISD134 PARAİNFLUENZA (1, 2, 3, 4) TESPİT KİTİ PARAINFLUENZA (1, 2, 3, 4) DETECTION KIT Parvovirus B19 Quantification Kit PERIODONTAL PATHOGENS PCR KIT PLASMID DNA EXTRACTION KIT S PNEUMOCYSTIS JIROVECII DETECTION KIT VSNR007 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T1 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T2 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T3 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T4 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T5 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T6 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T7 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T8 PURIFY AUTOMATED RNA EXTRACTION KIT PURIFY BACTERIAL DNA EXTRACTION KIT M PURIFY BAKTERİYEL DNA EKSTRAKSİYON S KİTİ PURIFY BAKTERİYEL RNA EKSTRAKSİYON M KİTİ PURIFY BAKTERİYEL RNA EKSTRAKSİYON S KİTİ PURIFY BİTKİ DNA EKSTRAKSİYON M KİTİ PURIFY BİTKİ DNA EKSTRAKSİYON S KİTİ PURIFY BİTKİ RNA EKSTRAKSİYON M KİTİ PURIFY BİTKİ RNA EKSTRAKSİYON S KİTİ PURIFY DNA EXTRACTION KIT S PURIFY DOKU DNA EKSTRAKSİYON M KİTİ PURIFY DOKU DNA EKSTRAKSİYON S KİTİ PURIFY DOKU RNA EKSTRAKSİYON M KİTİ PURIFY DOKU RNA EKSTRAKSİYON S KİTİ PURIFY DRIED BLOOD DNA EXTRACTION S KIT PURIFY GAİTA DNA EKSTRAKSİYON M KİTİ PURIFY GAİTA DNA EKSTRAKSİYON S KİTİ PURIFY GAİTA RNA EKSTRAKSİYON M KİTİ PURIFY GAİTA RNA EKSTRAKSİYON S KİTİ PURIFY GENOMIC DNA EXTRACTION KIT S PURIFY KEMİK DNA EKSTRAKSİYON M KİTİ PURIFY KEMİK DNA EKSTRAKSİYON S KİTİ PURIFY KEMİK RNA EKSTRAKSİYON S KİTİ PURIFY KÜF-MAYA DNA EKSTRAKSİYON M KİTİ PURIFY KÜF-MAYA DNA EKSTRAKSİYON S KİTİ PURIFY KÜF-MAYA RNA EKSTRAKSİYON M KİTİ PURIFY KÜF-MAYA RNA EKSTRAKSİYON S KİTİ PURIFY OSTEOID RNA EXTRACTION KIT M PURIFY RNA EXTRACTION KIT S PURIFY SALIVA RNA EXTRACTION S KIT PURIFY TAM KAN DNA EKSTRAKSİYON M KİTİ PURIFY TAM KAN DNA EKSTRAKSİYON S KİTİ PURIFY TAM KAN RNA EKSTRAKSİYON M KİTİ PURIFY TAM KAN RNA EKSTRAKSİYON S KİTİ PURIFY VIRAL DNA/RNA EXTRACTION KIT S PURIFY VİRAL DNA EKSTRAKSİYON M KİTİ PURIFY VİRAL DNA EKSTRAKSİYON S KİTİ PURIFY VİRAL RNA EKSTRAKSİYON M KİTİ PURIFY VİRAL RNA EKSTRAKSİYON S KİTİ Q14-53 Q19-23 RASH-FEVER SCREENING KIT RESPIRATORY BACTERIAL BASIC SCREENING KIT RESPIRATORY PATHOGENS SCREENING KIT V1 RHINOVIRUS (A,B,C) DETECTION KIT VSNR017 ROTA-ADENO-ASTRO-NOROVİRÜS ÇOKLU HIZLI TEST KİTİ ROTA-ADENO-NOROVIRUS RAPID TEST KIT ROTAVIRUS-ADENOVIRUS AG RAPID TEST VISD009 RSV HIZLI TEST KİTİ RSV-GRİP TESPİT KİTİ RUBELLA DETECTION KIT VSNRD007 SALMONELLA ENTERITIDIS TESPİT KİTİ SALMONELLA TYPHIMURIUM TESPİT KİTİ SALMONELLA TÜRLERİ TESPİT KİTİ SAMPLE CONTAINER VSNS009 SARS-COV-2 MUTATION DETECTION KİT SARS-CoV-2/FLU DETECTION KIT SARS-COV-2/FLU/RSV DETECTION KIT SMEAR SAMPLING KIT SOLUNUM PATOJENLERİ TARAMA KİTİ V1 SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) -A,B TESPİT KİTİ SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) – B TESPİT KİTİ SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) – TEST KİTİ SOLUNUM YOLU HIZLI ÇOKLU PCR KİTİ SOLUNUM YOLU PATOJENLERİ PANELİ (RPP) MIDI SOLUNUM YOLU PATOJENLERİ PANELİ (RPP) MİNİ SOLUNUM YOLU PATOJENLERİ PANELİ (RPP)MAXI SOLUNUM YOLU PATOJENLERİ TARAMA 24 PARÇALI KİTİ RESPIRATORY PATHOGENS SCREENING 24P KIT SOLUNUM YOLU PATOJENLERİ TARAMA KİTİ SOLUNUM YOLU VİRÜSLERİ TEMEL TARAMA KİTİ SOLUNUM YOLU VİRÜSÜ PANELİ 21 PARÇA KİTİ RESPIRATORY TRACT VIRUS PANEL 21P KIT STD PANEL TEST D V2 PANEL TEST KİTİ ST KİT STD V2 PANEL TEST KIT STD PANEL TEST KİTİ STI Bakteriyel Vajinoz PCR Kiti STI Essential PCR Kiti STI PANEL TEST KİTİ STI TARAMA KİTİ STREP A RAPID TEST KIT VISD024 STREPTOCOCCUS ACG PCR TEST KİTİ STREPTOCOCCUS AGALACTIAE TESPİT KİTİ STREPTOCOCCUS AURES TESPİT KİTİ Streptococcus Pneumoniae Hızlı Test Kiti STREPTOCOCCUS PNEUMONIAE TESPİT KİTİ STREPTOCOCCUS PNEUMONIAE-LEGIONELLA PNEUMOPHILA HIZLI TEST KİTİ STREPTOCOCCUS PYOGENES DETECTION KIT Sıtma Genotipleme Kiti Sıtma PAN Hızlı Test Kiti Sıtma Pf Hızlı Test Kiti Sıtma PF-PAN Hızlı Testi Sıtma Tespit Kiti TAM KANDAN RNA EKSTRAKSİYON KİTİ TORCH IgG-IgM RAPID TEST KIT TOXIN A/B RAPID TEST KIT VISD034 TPHA HIZLI TEST KİTİ TREPONEMA PALLIDUM DETECTION KIT VSNS003 TRICHOMONAS VAGINALIS DETECTION KIT VSNS002 TROPİKAL ATEŞ TARAMA KİTİ TÜBERKÜLOZ (TB) PCR KİTİ UREAPLASMA UREALYTICUM TESPİT KİTİ UREAPLAZMA UREALYTICUM/PARVUM TESPİT KİTİ UTI/ABR PANEL TEST KİTİ VACUCARE %3,2 CITRATE TUBE VACUCARE GEL&CLOT ACTIVATOR TUBE VACUCARE K3 EDTA TUBE VACUUM URINE CONTAINER VACUUM-FREE URINE CONTAINER VSNIK1 VESICULAR SCREENING KIT VIRAL DNA/RNA EXTRACTION KIT S WITH MAGNETIC BEAD VIS100230 VIS-MAG EXTRACTION SYSTEM VIS-MAG EXTRACTION SYSTEM 32 VISION COVID-19 EASYPREP-FAST PCR DIAGNOSTIC KIT VISION MULTIPLEX GASTROINTESTINAL PATHOGEN DETECTION KIT VSNR002 VISION PARASITE INFECTIONS SCREENING KIT VSNPI001 VISIPURIFY AUTOMATED DNA EXTRACTION KIT VZV (HHV-3) MİKTARLANDIRMA KİTİ VZV (HHV-3) QUANTIFICATION KIT VZV Detection Kit VSNMP013 West Nile Virus Quantification Kit WHITE LUNG SYNDROME MIDDLE PANEL PCR TEST KIT White Lung Syndrome Middle Panel Rapid Test Kit VISD079 WHITE LUNG SYNDROME MINI PANEL PCR TEST KIT YARA VE TIRNAK TARAMA KİTİ YARA/SEPSİS PANELİ MAKSİ KİTİ YERSINIA PESTIS TESPİT KİTİ ZIKA VİRÜSÜ TESPİT KİTİ ÇİKUNGUNYA VİRÜSÜ TESPİT KİTİ ÜREAPLAZMA PARVUM TESPİT KİTİ ÜST SOLUNUM YOLLARI ETKENLERİ MULTIPLLEX PCR TANI KİTİ	A, B, C IVDR	Site web info@visionbiotechnology.com Fiche EUDAMED Signaler une erreur
TestLine Clinical Diagnostics s.r.o	Tchéquie	BLOT-LINE Bordetella IgA98/79 BLOT-LINE Bordetella IgG98/79 BLOT-LINE Bordetella IgM98/79 BLOT-LINE Borrelia afzelii IgG98/79 BLOT-LINE Borrelia afzelii IgM98/79 275 autres BLOT-LINE Borrelia b. sensu stricto IgG98/79 BLOT-LINE Borrelia b. sensu stricto IgM98/79 BLOT-LINE Borrelia garinii IgG98/79 BLOT-LINE Borrelia garinii IgM98/79 BLOT-LINE Borrelia/HGA IgG98/79 BLOT-LINE Borrelia/HGA IgM98/79 BLOT-LINE Chlamydia pneumoniae IgA98/79 BLOT-LINE Chlamydia pneumoniae IgG98/79 BLOT-LINE Chlamydia pneumoniae IgM98/79 BLOT-LINE Chlamydia trachomatis IgA98/79 BLOT-LINE Chlamydia trachomatis IgG98/79 BLOT-LINE CMV IgG98/79 BLOT-LINE CMV IgM98/79 BLOT-LINE EBV IgA98/79 BLOT-LINE EBV IgG98/79 BLOT-LINE EBV IgM98/79 BLOT-LINE Helicobacter IgA98/79 BLOT-LINE Helicobacter IgG98/79 BLOT-LINE Mycoplasma IgA98/79 BLOT-LINE Mycoplasma IgG98/79 BLOT-LINE Mycoplasma IgM98/79 BLOT-LINE Toxoplasma IgG98/79 BLOT-LINE Toxoplasma IgM98/79 BLOT-LINE Treponema IgG98/79 BLOT-LINE Treponema IgM98/79 BLOT-LINE Yersinia IgA98/79 BLOT-LINE Yersinia IgG98/79 BLOT-LINE Yersinia IgM98/79 BlueBLOT-LINE Bordetella IgA98/79 BlueBLOT-LINE Bordetella IgG98/79 BlueBLOT-LINE Borrelia IgG98/79 BlueBLOT-LINE Borrelia IgM98/79 BlueBLOT-LINE EBV IgG98/79 BlueBLOT-LINE EBV IgM98/79 BlueBLOT-LINE Helicobacter IgA98/79 BlueBLOT-LINE Helicobacter IgG98/79 BlueBLOT-LINE Mycoplasma IgA98/79 BlueBLOT-LINE Mycoplasma IgG98/79 BlueBLOT-LINE Mycoplasma IgM98/79 BlueBLOT-LINE Treponema IgG98/79 BlueBLOT-LINE Treponema IgM98/79 BlueBLOT-LINE Yersinia IgA98/79 BlueBLOT-LINE Yersinia IgG98/79 CLIA Borrelia CSF IgG CLIA Borrelia CSF IgM CLIA Borrelia recombinant IgG98/79 CLIA Borrelia recombinant IgM98/79 CLIA Chlamydia pneumoniae IgA98/79 CLIA Chlamydia pneumoniae IgG98/79 CLIA Chlamydia pneumoniae IgM98/79 CLIA Chlamydia trachomatis IgA98/79 CLIA Chlamydia trachomatis IgG98/79 CLIA Chlamydia trachomatis IgM98/79 CLIA CMV IgG98/79 CLIA CMV IgM98/79 CLIA COVID-19 NP IgA98/79 CLIA COVID-19 NP IgG98/79 CLIA COVID-19 NP IgM98/79 CLIA COVID-19 RBD IgA98/79 CLIA COVID-19 RBD IgG98/79 CLIA COVID-19 RBD IgM98/79 CLIA EBV EA-D IgG98/79 CLIA EBV EA-D IgM98/79 CLIA EBV EBNA-1 IgG98/79 CLIA EBV VCA IgG98/79 CLIA EBV VCA IgM98/79 CLIA Helicobacter MONO IgA98/79 CLIA Helicobacter MONO IgG98/79 CLIA HSV 1+2 IgG CLIA HSV 1+2 IgM CLIA IL-698/79 CLIA Mycoplasma IgA CLIA Mycoplasma IgG CLIA Mycoplasma IgM CLIA Parvovirus B19 IgG CLIA Parvovirus B19 IgM CLIA Rubella IgG98/79 CLIA Rubella IgM98/79 CLIA Tetanus Toxoid IgG CLIA Toxoplasma IgG CLIA Toxoplasma IgM CLIA VZV IgG CLIA VZV IgM EIA Adenovirus IgA98/79 EIA Adenovirus IgG98/79 EIA Adenovirus IgM98/79 EIA Bordetella parapertussis IgA98/79 EIA Bordetella parapertussis IgG98/79 EIA Bordetella parapertussis IgM98/79 EIA Bordetella pertussis Toxin IgA98/79 EIA Bordetella pertussis Toxin IgG98/79 EIA Bordetella pertussis Toxin IgM98/79 EIA Borrelia afzelii IgM (192)98/79 EIA Borrelia afzelii VlsE IgG (192)98/79 EIA Borrelia garinii IgM (192)98/79 EIA Borrelia garinii VlsE IgG (192)98/79 EIA Borrelia IgM98/79 EIA Borrelia recombinant IgG (192)98/79 EIA Borrelia recombinant IgM (192)98/79 EIA Borrelia VlsE IgG98/79 EIA Chlamydia pneumoniae IgA98/79 EIA Chlamydia pneumoniae IgG98/79 EIA Chlamydia pneumoniae IgM98/79 EIA Chlamydia pneumoniae REC IgA98/79 EIA Chlamydia pneumoniae REC IgG98/79 EIA Chlamydia trachomatis IgA98/79 EIA Chlamydia trachomatis IgG98/79 EIA Chlamydia trachomatis IgM98/79 EIA CMV IgG98/79 EIA CMV IgM98/79 EIA COVID-19 NP IgA98/79 EIA COVID-19 NP IgG98/79 EIA COVID-19 NP IgM98/79 EIA COVID-19 RBD IgA98/79 EIA COVID-19 RBD IgG98/79 EIA COVID-19 RBD IgM98/79 EIA EBV EA-D IgG98/79 EIA EBV EA-D IgM98/79 EIA EBV EBNA-1 IgG98/79 EIA EBV VCA IgG98/79 EIA EBV VCA IgM98/79 EIA Helicobacter MONO IgA98/79 EIA Helicobacter MONO IgG98/79 EIA Helicobacter MONO IgM98/79 EIA HSV 1 IgG98/79 EIA HSV 1 IgM98/79 EIA HSV 1+2 IgG98/79 EIA HSV 1+2 IgM98/79 EIA HSV 2 IgG98/79 EIA HSV 2 IgM98/79 EIA Influenza A IgA98/79 EIA Influenza A IgG98/79 EIA Influenza A IgM98/79 EIA Influenza B IgA98/79 EIA Influenza B IgG98/79 EIA Influenza B IgM98/79 EIA Measles IgG98/79 EIA Measles IgM98/79 EIA Mumps IgG98/79 EIA Mumps IgM98/79 EIA Mycoplasma IgA98/79 EIA Mycoplasma IgG98/79 EIA Mycoplasma IgM98/79 EIA Mycoplasma REC IgA98/79 EIA Mycoplasma REC IgG98/79 EIA Mycoplasma REC IgM98/79 EIA Parainfluenza mix IgA98/79 EIA Parainfluenza mix IgG98/79 EIA Parainfluenza mix IgM98/79 EIA Parvovirus B19 IgG98/79 EIA Parvovirus B19 IgM98/79 EIA RSV IgA98/79 EIA RSV IgG98/79 EIA RSV IgM98/79 EIA Rubella IgG98/79 EIA Rubella IgM98/79 EIA Tetanus Toxoid IgG98/79 EIA Toxoplasma IgG98/79 EIA Toxoplasma IgM98/79 EIA Treponema pallidum IgG98/79 EIA Treponema pallidum IgM98/79 EIA Treponema pallidum TOTAL98/79 EIA VZV IgG98/79 EIA VZV IgM98/79 EIA Yersinia IgA98/79 EIA Yersinia IgG98/79 EIA Yersinia IgM98/79 Microblot-Array Bordetella IgA98/79 Microblot-Array Bordetella IgG98/79 Microblot-Array Bordetella IgM98/79 Microblot-Array Borrelia IgG98/79 Microblot-Array Borrelia IgM98/79 Microblot-Array CMV IgG Microblot-Array CMV IgM Microblot-Array COVID-19 IgA98/79 Microblot-Array COVID-19 IgG98/79 Microblot-Array COVID-19 IgM98/79 Microblot-Array EBV IgA98/79 Microblot-Array EBV IgG98/79 Microblot-Array EBV IgM98/79 Microblot-Array Helicobacter IgA98/79 Microblot-Array Helicobacter IgG98/79 Microblot-Array HSV 1+2 IgG Microblot-Array HSV 1+2 IgM Microblot-Array Mycoplasma IgA98/79 Microblot-Array Mycoplasma IgG98/79 Microblot-Array Mycoplasma IgM98/79 Microblot-Array Yersinia IgA98/79 Microblot-Array Yersinia IgG98/79 SmartEIA Adenovirus IgA98/79 SmartEIA Adenovirus IgG98/79 SmartEIA Adenovirus IgM98/79 SmartEIA Bordetella parapertussis IgA98/79 SmartEIA Bordetella parapertussis IgG98/79 SmartEIA Bordetella parapertussis IgM98/79 SmartEIA Bordetella pertussis Toxin IgA98/79 SmartEIA Bordetella pertussis Toxin IgG98/79 SmartEIA Bordetella pertussis Toxin IgM98/79 SmartEIA Borrelia afzelii IgM98/79 SmartEIA Borrelia afzelii VlsE IgG98/79 SmartEIA Borrelia b. sensu stricto IgM98/79 SmartEIA Borrelia b. sensu stricto VlsE IgG98/79 SmartEIA Borrelia garinii IgM98/79 SmartEIA Borrelia garinii VlsE IgG98/79 SmartEIA Borrelia IgM98/79 SmartEIA Borrelia recombinant IgG98/79 SmartEIA Borrelia recombinant IgM98/79 SmartEIA Borrelia VlsE IgG98/79 SmartEIA Chlamydia pneumoniae IgA98/79 SmartEIA Chlamydia pneumoniae IgG98/79 SmartEIA Chlamydia pneumoniae IgM98/79 SmartEIA Chlamydia pneumoniae REC IgA98/79 SmartEIA Chlamydia pneumoniae REC IgG98/79 SmartEIA Chlamydia trachomatis IgA98/79 SmartEIA Chlamydia trachomatis IgG98/79 SmartEIA Chlamydia trachomatis IgM98/79 SmartEIA CMV IgG98/79 SmartEIA CMV IgM98/79 SmartEIA COVID-19 NP IgA98/79 SmartEIA COVID-19 NP IgG98/79 SmartEIA COVID-19 NP IgM98/79 SmartEIA COVID-19 RBD IgA98/79 SmartEIA COVID-19 RBD IgG98/79 SmartEIA COVID-19 RBD IgM98/79 SmartEIA EBV EA-D IgG98/79 SmartEIA EBV EA-D IgM98/79 SmartEIA EBV EBNA-1 IgG98/79 SmartEIA EBV VCA IgG98/79 SmartEIA EBV VCA IgM98/79 SmartEIA Helicobacter MONO IgA98/79 SmartEIA Helicobacter MONO IgG98/79 SmartEIA Helicobacter MONO IgM98/79 SmartEIA HSV 1 IgG98/79 SmartEIA HSV 1 IgM98/79 SmartEIA HSV 1+2 IgG98/79 SmartEIA HSV 1+2 IgM98/79 SmartEIA HSV 2 IgG98/79 SmartEIA HSV 2 IgM98/79 SmartEIA Influenza A IgA98/79 SmartEIA Influenza A IgG98/79 SmartEIA Influenza A IgM98/79 SmartEIA Influenza B IgA98/79 SmartEIA Influenza B IgG98/79 SmartEIA Influenza B IgM98/79 SmartEIA Measles IgG98/79 SmartEIA Measles IgM98/79 SmartEIA Mumps IgG98/79 SmartEIA Mumps IgM98/79 SmartEIA Mycoplasma IgA98/79 SmartEIA Mycoplasma IgG98/79 SmartEIA Mycoplasma IgM98/79 SmartEIA Mycoplasma REC IgA98/79 SmartEIA Mycoplasma REC IgG98/79 SmartEIA Mycoplasma REC IgM98/79 SmartEIA Parainfluenza mix IgA98/79 SmartEIA Parainfluenza mix IgG98/79 SmartEIA Parainfluenza mix IgM98/79 SmartEIA Parvovirus B19 IgG98/79 SmartEIA Parvovirus B19 IgM98/79 SmartEIA RSV IgA98/79 SmartEIA RSV IgG98/79 SmartEIA RSV IgM98/79 SmartEIA Rubella IgG98/79 SmartEIA Rubella IgM98/79 SmartEIA Tetanus Toxoid IgG98/79 SmartEIA Toxoplasma IgG98/79 SmartEIA Toxoplasma IgM98/79 SmartEIA Treponema pallidum IgG98/79 SmartEIA Treponema pallidum IgM98/79 SmartEIA Treponema pallidum TOTAL98/79 SmartEIA VZV IgG98/79 SmartEIA VZV IgM98/79 SmartEIA Yersinia IgA98/79 SmartEIA Yersinia IgG98/79 SmartEIA Yersinia IgM98/79	B, C IVDR, 98/79	Site web info@testlinecd.com Fiche EUDAMED Signaler une erreur
Leicabiosystems FDA Mandataire UE : AR Experts B.V. (Pays-Bas) et 1 autre	Allemagne, Australie, United Kingdom (ex Northern Ireland), États-Unis	0.5% Acid Alcohol3 réf. 23GT450DXIVD Alcoholic Eosin Y 5153 réf. Alpha-Methylacyl-CoA Racemase EPMU1 7 mL PA021098/79 Anaplastic Lymphoma Kinase 5A4 7 mL PA083198/79 271 autres Aperio CS5 DX 23CS5DXIVD Aperio GT 180 DX 23GT180DXIVD Aperio GT 450 DX (refurbished) Aperio GT 450 SAM DX Software Aperio SAM DX 23APERIOSAMSWDX1 ASP6025 S3 réf. Basket Spaced3 réf. Bcl-2 bcl-2/100-D5 7 mL PA011798/79 Bcl-6 LN22 7 mL PA020498/79 BOND Controller (7.0)3 réf. BOND FISH Kit DS9636 BOND Oracle HER2 IHC System TA914598/79 BOND Polymer Refine Detection DS9800 BOND Polymer Refine Red Detection DS9390 BOND RNAScope Brown Detection DS9815 BOND-PRIME Polymer AP Detection System DS9304 BOND-PRIME Polymer DAB Detection System DS9284 c-erbB-2 Oncoprotein CB11 7mL PA098398/79 c-erbB-2 Oncoprotein CB11 13.5mL PA057198/79 CA125 Ov185:1 7mL PA053998/79 Calretinin CAL6 7 mL PA034698/79 Carcinoembryonic Antigen (CD66e) COL-1 7 mL PA084898/79 CD10 56C6 30 mL PA013198/79 CD10 56C6 7 mL PA027098/79 CD117 EP10 7 mL PA000798/79 CD11c 5D11 7 mL PA055498/79 CD138 MI15 7 mL PA008898/79 CD15 MMA 7 mL PA047398/79 CD163 10D6 7 mL PA009098/79 CD19 BT51E 7 mL PA084398/79 CD1a MTB1 7 mL PA023598/79 CD20 L26 30 mL PA035998/79 CD20 L26 7 mL PA020098/79 CD23 1B12 7 mL PA016998/79 CD3 LN10 30 mL PA012298/79 CD3 LN10 7 mL PA055398/79 CD30 JCM182 7 mL PA079098/79 CD31 JC70A 7 mL PA041498/79 CD34 QBEnd/10 30 mL PA035498/79 CD34 QBEnd/10 7 mL PA021298/79 CD4 4B12 7 mL PA042798/79 CD45 X16/99 7 mL PA004298/79 CD45RO UCHL1 7 mL PA014698/79 CD5 4C7 7 mL PA016898/79 CD56 CD564 7 mL PA019198/79 CD68 514H12 7 mL PA027398/79 CD7 LP15 7 mL PA026698/79 CD8 4B11 7 mL PA018398/79 CDX2 EP25 7 mL PA037598/79 Chromogranin A 5H7 7 mL PA051598/79 ChromoPlex 1 Dual Detection DS94772 réf. ChromoPlex 1 Dual Detection for BOND-PRIME DS9397 Cyclin D1 EP12 7 mL PA004698/79 Cytokeratin 14 LL002 7 mL PA007498/79 Cytokeratin 19 b170 7 mL PA079998/79 Cytokeratin 20 Ks20.8 30 mL PA003798/79 Cytokeratin 20 Ks20.8 7 mL PA002298/79 Cytokeratin 5 XM26 7 mL PA046898/79 Cytokeratin 7 RN7 30 mL PA013898/79 Cytokeratin 7 RN7 7 mL PA094298/79 Cytokeratin AE1/AE3 7 mL PA009498/79 CytoVision DX 23GSL10XBFF230DX3 réf. Desmin DE-R-11 7 mL PA003298/79 DNA Negative Control 6.25 mL PB073198/79 DNA Positive Control Probe 6.25 mL PB068298/79 DOG-1 K9 7 mL PA021998/79 E-Cadherin 36B5 7 mL PA038798/79 EA-503 réf. EBER Probe 5.5 mL PB058998/79 Estrogen Receptor 6F11 30 mL PA000998/79 Estrogen Receptor 6F11 7 mL PA015198/79 FISH Digestion Kit KBI-60006 FISH Reagent Kit KBI-60005 Gastrin Polyclonal 7 mL PA068198/79 Glial Fibrillary Acidic Protein GA5 7 mL PA002698/79 Gross Cystic Disease Fluid Protein-15 23A3 7 mL PA070898/79 Harris Hematoxylin3 réf. Herpesvirus (Type 8) 13B10 7 mL PA005098/79 HistoCore AUTOCUT3 réf. HistoCore BIOCUT3 réf. HistoCore CHROMAX CV2 réf. HistoCore CHROMAX ST HistoCore MULTICUT3 réf. HistoCore PEARL HistoCore PEGASUS HistoCore PEGASUS Plus HistoCore SPECTRA CV HistoCore SPECTRA CV X1 Mounting Media3 réf. HistoCore SPECTRA ST HistoCore Water Bath M HPV Probe (subtypes 16, 18, 31, 33, 51) 6.25 mL PB082998/79 HPV Probe (subtypes 6, 11) 6.25 mL PB078098/79 Immunoglobulin D DRN1C 7 mL PA006198/79 Immunoglobulin G RWP49 7 mL PA090598/79 Immunoglobulin M 8H6 7 mL PA027898/79 Kappa Light Chain CH15 7 mL PA060698/79 Kappa Probe 5.5 mL PB064598/79 Ki67 MM1 30 mL PA041098/79 Ki67 MM1 7 mL PA011898/79 Lambda Light Chain SHL53 7 mL PA057098/79 Lambda Probe 5.5 mL PB066998/79 Leica ASP300 S2 réf. Leica Autostainer XL (ST5010)2 réf. Leica CM15203 réf. Leica CM18602 réf. Leica CM1860 UV2 réf. Leica CM19503 réf. Leica CM3050 S3 réf. Leica CV50303 réf. Leica RM2125 RTS3 réf. Leica SM2010 R3 réf. Leica ST4020 Leica TP10203 réf. Mast Cell Tryptase 10D11 7 mL PA001998/79 Melan A A103 30 mL PA004498/79 Melan A A103 7 mL PA023398/79 Melanoma Marker HMB45 30 mL PA062598/79 Melanoma Marker HMB45 7 mL PA002798/79 Multiple Myeloma Oncogene 1 PA012998/79 Muramidase (Lysozyme) Polyclonal 7 mL PA039198/79 Myeloperoxidase 59A5 7 mL PA049198/79 Napsin A IP64 7 mL PA006498/79 NCL-b-DG98/79 NCL-d-SARC98/79 NCL-DRP298/79 NCL-DYS198/79 NCL-DYS298/79 NCL-DYS398/79 NCL-EMERIN98/79 NCL-g-SARC98/79 NCL-HAMLET98/79 NCL-HAMLET-298/79 NCL-L-5D398/79 NCL-L-a-SARC98/79 NCL-L-AE1/AE3-60198/79 NCL-L-AFP98/79 NCL-L-ALK98/79 NCL-L-AMACR98/79 NCL-L-AR-31898/79 NCL-L-B-CAT98/79 NCL-L-b-SARC98/79 NCL-L-bcl-298/79 NCL-L-Bcl-6-56498/79 NCL-L-CA12598/79 NCL-L-CAIX98/79 NCL-L-CALCITONIN98/79 NCL-L-CALRET-56698/79 NCL-L-CB1198/79 NCL-L-CD10-27098/79 NCL-L-CD117-03298/79 NCL-L-CD11c-56398/79 NCL-L-CD12398/79 NCL-L-CD13-30498/79 NCL-L-CD15-60598/79 NCL-L-CD1698/79 NCL-L-CD16398/79 NCL-L-CD19-16398/79 NCL-L-CD1a-23598/79 NCL-L-CD2-27198/79 NCL-L-CD20-L2698/79 NCL-L-CD21-2G998/79 NCL-L-CD23-1B1298/79 NCL-L-CD3-56598/79 NCL-L-CD30-59198/79 NCL-L-CD31-60798/79 NCL-L-CD3398/79 NCL-L-CD38-29098/79 NCL-L-CD4-36898/79 NCL-L-CD5-4C798/79 NCL-L-CD56-50498/79 NCL-L-CD6898/79 NCL-L-CD7-58098/79 NCL-L-CD71-30998/79 NCL-L-CD8-4B1198/79 NCL-L-CD99-18798/79 NCL-L-CEA-60998/79 NCL-L-CHROM-43098/79 NCL-L-CK1798/79 NCL-L-CK2098/79 NCL-L-CK598/79 NCL-L-CK7-56098/79 NCL-L-CK7-OVTL98/79 NCL-L-CYCLIN D1-GM98/79 NCL-L-DES-DERII98/79 NCL-L-DOG-198/79 NCL-L-E-Cad98/79 NCL-L-EGFR98/79 NCL-L-EMA98/79 NCL-L-END98/79 NCL-L-ER-6F1198/79 NCL-L-ER-6F11/298/79 NCL-L-EZH298/79 NCL-L-FRalpha98/79 NCL-L-GCDFP1598/79 NCL-L-GEMININ98/79 NCL-L-GFAP-GA598/79 NCL-L-GRAN-B98/79 NCL-L-HHV8-LNA98/79 NCL-L-HMB4598/79 NCL-L-Hpylori98/79 NCL-L-IgA98/79 NCL-L-IgD98/79 NCL-L-IgG98/79 NCL-L-IgM98/79 NCL-L-InhibinA98/79 NCL-L-KAP-58198/79 NCL-L-Ki67-MM198/79 NCL-L-LAM-57898/79 NCL-L-LANGERIN98/79 NCL-L-LCA98/79 NCL-L-LL00298/79 NCL-L-MelanA98/79 NCL-L-MESO98/79 NCL-L-MLH198/79 NCL-L-MSA-59498/79 NCL-L-MSH2-61298/79 NCL-L-MSH698/79 NCL-L-MUM198/79 NCL-L-Myf-498/79 NCL-L-NAPSINA NCL-L-NAPSIN A98/79 NCL-L-NF200-N5298/79 NCL-L-OCT3/498/79 NCL-L-p53-DO798/79 NCL-L-p5798/79 NCL-L-p6398/79 NCL-L-PAX-598/79 NCL-L-PGP9.598/79 NCL-L-PGR-31298/79 NCL-L-PGR-312/298/79 NCL-L-PLAP-8A998/79 NCL-L-PMS298/79 NCL-L-PTH-48898/79 NCL-L-S100-16798/79 NCL-L-SMA98/79 NCL-L-SYNAP-29998/79 NCL-L-TDT-33998/79 NCL-L-TPO98/79 NCL-L-TTF-198/79 NCL-L-TYROS98/79 NCL-L-VIM-V998/79 NCL-L-vWF98/79 NCL-L-WT1-56298/79 NCL-MEROSIN98/79 NCL-SPEC198/79 Negative (Rabbit) 7mL PA0777 Negative (Rabbit) 7mL PA0996 Neurofilament 200kD N52.1.7 7 mL PA037198/79 Novocastra Enzyme Proteinase K (IHC) RE7160-K Novocastra Polymer Detection System (250 tests) RE7140-K3 réf. Oct-3/4 N1NK 7 mL PA019398/79 p16 6H12 7 mL PA001698/79 p53 DO-7 7 mL PA005798/79 p63 7JUL 7 mL PA010398/79 Pax-5 1EW 7 mL PA055298/79 Placental Alkaline Phosphatase 8A9 7 mL PA016198/79 Progesterone Receptor 16 30 mL PA043698/79 Progesterone Receptor 16 7 mL PA031298/79 Programmed Death Ligand 1 73-10 7 mL PA083298/79 RNA Negative Control Probe PB080998/79 RNA Positive Control probe 5.5 mL PB078598/79 S-100 EP32 7 mL PA003198/79 Scott’s Tap Water Substitute Working Solution3 réf. Smooth Muscle Actin αsm-1 7 mL PA094398/79 ST Infinity 2.0 H&E Staining System2 réf. Synaptophysin 27G12 7 mL PA0299 Thyroid Transcription Factor-1 SPT24 7 mL PA036498/79 Tissue Digestion Kit I KBI-60007 Tissue Digestion Kit II KBI-60004 Vimentin V9 7 mL PA064098/79 von Willebrand Factor 36B11 7 mL PA005598/79 Wilms' Tumor WT49 7 mL PA056298/79	A, B, C IVDR, 98/79	Site web support.de@LeicaBiosystems.com Fiche EUDAMED Signaler une erreur
Gold Standard Diagnostics FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Allemagne, États-Unis	Adenovirus IgA98/79 Adenovirus IgG98/79 Adenovirus IgM98/79 AIX1000 Analyzer AIX1000 Analyzer 00400 269 autres Aspergillus fumigatus IgG98/79 Aspergillus fumigatus IgM98/79 Avidity Cytomegalovirus (CMV) IgG ELISA98/79 Avidity Rubella Virus IgG ELISA98/79 Avidity Toxoplasma gondii IgG98/79 Avidity Toxoplasma gondii IgG ELISA98/79 Bolt (CLIA) 00500-CL Bolt 00500 Bordetella pertussis IgA98/79 Bordetella pertussis IgG98/79 Bordetella pertussis IgM98/79 Bordetella pertussis toxin (PT) IgA98/79 Bordetella pertussis toxin (PT) IgG98/79 Borrelia burgdorferi IgG98/79 Borrelia burgdorferi IgM98/79 Brucella IgG98/79 Brucella IgM98/79 Candida albicans IgA98/79 Candida albicans IgG98/79 Candida albicans IgM98/79 Chagas (Trypanosoma cruzi) IgG98/79 Chagas (Trypanosoma cruzi) IgG ELISA2 réf.98/79 Chikungunya Virus IgG capture RE5883198/79 Chikungunya Virus IgM μ-capture RE5884198/79 Chlamydia pneumoniae IgA ELISA98/79 Chlamydia pneumoniae IgA RE5703198/79 Chlamydia pneumoniae IgG ELISA98/79 Chlamydia pneumoniae IgG RE5704198/79 Chlamydia pneumoniae IgM ELISA98/79 Chlamydia pneumoniae IgM RE5705198/79 Chlamydia trachomatis IgA ELISA98/79 Chlamydia trachomatis IgA RE5700198/79 Chlamydia trachomatis IgG ELISA98/79 Chlamydia trachomatis IgG RE5701198/79 Chlamydia trachomatis IgM ELISA98/79 Chlamydia trachomatis IgM RE5702198/79 Citrat Stopplösung/Stopping Solution ELISA Clostridium tetani toxin 5S IgG98/79 Clostridium tetani toxin 5S IgG plus98/79 Clostridium tetani toxin IgG98/79 Corynebacterium diphtheriae toxin 5S IgG98/79 Corynebacterium diphtheriae toxin 5S IgG plus98/79 Corynebacterium diphtheriae toxin IgG98/79 Coxiella burnetii (Q-Fever) Phase 2 IgG98/79 Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA98/79 Coxiella burnetii (Q-Fever) Phase 1 IgG98/79 Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA98/79 Coxiella burnetii (Q-Fever) Phase 2 IgM98/79 Coxiella burnetii (Q-Fever) Phase 2 IgM ELISA98/79 Cytomegalovirus (CMV) IgG ELISA98/79 Cytomegalovirus (CMV) IgG RE5706198/79 Cytomegalovirus (CMV) IgM ELISA98/79 Cytomegalovirus (CMV) IgM RE5707198/79 Dengue Virus IgG RE5867198/79 Dengue Virus IgM RE5868198/79 Dengue Virus IgM µ-capture RE5858198/79 Echinococcus IgG98/79 Entamoeba histolytica IgG RE5863198/79 Epstein-Barr Virus (EA-D) IgG98/79 Epstein-Barr Virus (EBNA) IgG RE5874198/79 Epstein-Barr Virus (VCA) IgG RE5875198/79 Epstein-Barr Virus (VCA) IgM RE5876198/79 GSD NovaLisa SARS-CoV-2 (COVID-19) quantitative IgG98/79 GSD NovaPrime® TSP SARS-CoV-22 réf.98/79 HAILSTORM 00350 Hantavirus IgG98/79 Hantavirus IgM98/79 Helicobacter pylori IgA ELISA98/79 Helicobacter pylori IgG98/79 Helicobacter pylori IgG ELISA98/79 Helicobacter pylori IgG plus98/79 Helicobacter pylori IgM98/79 Helicobacter pylori IgM ELISA98/79 Herpes simplex Virus 1 (HSV 1) IgG98/79 Herpes simplex Virus 1 (HSV 1) IgG ELISA98/79 Herpes simplex Virus 1 (HSV 1) IgM98/79 Herpes simplex Virus 1 (HSV 1) IgM ELISA98/79 Herpes Simplex Virus 1 IgG ELISA98/79 Herpes Simplex Virus 1 IgM ELISA98/79 Herpes simplex Virus 1+2 (HSV) IgG98/79 Herpes simplex Virus 1+2 (HSV) IgG ELISA98/79 Herpes simplex Virus 1+2 (HSV) IgM98/79 Herpes simplex Virus 1+2 (HSV) IgM ELISA98/79 Herpes Simplex Virus 1+2 IgG ELISA98/79 Herpes Simplex Virus 1+2 IgM ELISA98/79 Herpes simplex Virus 2 (HSV 2) IgG98/79 Herpes simplex Virus 2 (HSV 2) IgG ELISA98/79 Herpes simplex Virus 2 (HSV 2) IgM98/79 Herpes simplex Virus 2 (HSV 2) IgM ELISA98/79 Herpes Simplex Virus 2 IgG ELISA98/79 Herpes Simplex Virus 2 IgM ELISA98/79 IgA 2 Konjugat/Conjugate (anti-human) ELISA3 réf. IgA Konjugat/Conjugate (anti-human) LINE3 réf. Influenza Virus A IgA98/79 Influenza Virus A IgG98/79 Influenza Virus A IgM98/79 Influenza Virus B IgA98/79 Influenza Virus B IgG98/79 Influenza Virus B IgM98/79 Legionella pneumophila IgG98/79 Legionella pneumophila IgM98/79 Leishmania infantum IgG98/79 Leishmania infantum IgG ELISA2 réf.98/79 Leptospira IgG RE5893198/79 Leptospira IgM RE5894198/79 Malaria ELISA98/79 Malaria RE5890198/79 Measles Virus IgG98/79 Measles Virus IgG ELISA2 réf.98/79 Measles Virus IgM98/79 Measles Virus IgM ELISA2 réf.98/79 Mumps Virus IgG98/79 Mumps Virus IgM98/79 Mycoplasma pneumoniae IgA RE5879198/79 Mycoplasma pneumoniae IgG RE5877198/79 Mycoplasma pneumoniae IgM RE5878198/79 NovaLisa® Adenovirus IgM2 réf.98/79 NovaLisa® Adenovirus IgA2 réf.98/79 NovaLisa® Adenovirus IgG2 réf.98/79 NovaLisa® Aspergillus fumigatus IgG2 réf.98/79 NovaLisa® Aspergillus fumigatus IgM2 réf.98/79 NovaLisa® Avidity Cytomegalovirus (CMV) IgG98/79 NovaLisa® Avidity Epstein-Barr Virus (VCA) IgG98/79 NovaLisa® Avidity Measles Virus IgG98/79 NovaLisa® Avidity Rubella Virus IgG98/79 NovaLisa® Avidity Toxoplasma gondii IgG98/79 NovaLisa® Bordetella pertussis IgA2 réf.98/79 NovaLisa® Bordetella pertussis IgG2 réf.98/79 NovaLisa® Bordetella pertussis IgM2 réf.98/79 NovaLisa® Bordetella pertussis toxin (PT) IgA2 réf.98/79 NovaLisa® Bordetella pertussis toxin (PT) IgG98/79 NovaLisa® Borrelia burgdorferi IgG2 réf.98/79 NovaLisa® Borrelia burgdorferi IgM98/79 NovaLisa® Brucella IgG2 réf.98/79 NovaLisa® Brucella IgM2 réf.98/79 NovaLisa® Candida albicans IgA2 réf.98/79 NovaLisa® Candida albicans IgG2 réf.98/79 NovaLisa® Candida albicans IgM2 réf.98/79 NovaLisa® Chagas (Trypanosoma cruzi) IgG2 réf.98/79 NovaLisa® Chikungunya Virus IgG capture2 réf.98/79 NovaLisa® Chikungunya Virus IgM μ-capture2 réf.98/79 NovaLisa® Chlamydia pneumoniae IgA2 réf.98/79 NovaLisa® Chlamydia pneumoniae IgG2 réf.98/79 NovaLisa® Chlamydia pneumoniae IgM2 réf.98/79 NovaLisa® Chlamydia trachomatis IgA2 réf.98/79 NovaLisa® Chlamydia trachomatis IgG2 réf.98/79 NovaLisa® Chlamydia trachomatis IgM2 réf.98/79 NovaLisa® Clostridium tetani toxin 5S IgG2 réf.98/79 NovaLisa® Clostridium tetani toxin 5S IgG plus2 réf.98/79 NovaLisa® Clostridium tetani toxin IgG2 réf.98/79 NovaLisa® Corynebacterium diphtheriae toxin 5S IgG2 réf.98/79 NovaLisa® Corynebacterium diphtheriae toxin 5S IgG plus2 réf.98/79 NovaLisa® Corynebacterium diphtheriae toxin IgG98/79 NovaLisa® Coxiella burnetii (Q-Fever) Phase 2 IgG2 réf.98/79 NovaLisa® Coxiella burnetii (Q-Fever) Phase 1 IgG2 réf.98/79 NovaLisa® Coxiella burnetii (Q-Fever) Phase 2 IgM2 réf.98/79 NovaLisa® Cytomegalovirus (CMV) IgG2 réf.98/79 NovaLisa® Cytomegalovirus (CMV) IgM2 réf.98/79 NovaLisa® Dengue Virus IgG2 réf.98/79 NovaLisa® Dengue Virus IgM2 réf.98/79 NovaLisa® Dengue Virus IgM µ-capture2 réf.98/79 NovaLisa® Dengue Virus NS1 Antigen98/79 NovaLisa® Echinococcus IgG2 réf.98/79 NovaLisa® Entamoeba histolytica IgG2 réf.98/79 NovaLisa® Epstein-Barr Virus (EA-D) IgG98/79 NovaLisa® Epstein-Barr Virus (EBNA) IgG2 réf.98/79 NovaLisa® Epstein-Barr Virus (VCA) IgG2 réf.98/79 NovaLisa® Epstein-Barr Virus (VCA) IgM2 réf.98/79 NovaLisa® Hantavirus IgG98/79 NovaLisa® Hantavirus IgM98/79 NovaLisa® Helicobacter pylori IgG2 réf.98/79 NovaLisa® Helicobacter pylori IgG plus2 réf.98/79 NovaLisa® Helicobacter pylori IgM98/79 NovaLisa® Hepatitis E Virus (HEV) IgG98/79 NovaLisa® Hepatitis E Virus (HEV) IgM98/79 NovaLisa® Herpes simplex Virus 1 (HSV 1) IgG2 réf.98/79 NovaLisa® Herpes simplex Virus 1 (HSV 1) IgM2 réf.98/79 NovaLisa® Herpes simplex Virus 1+2 (HSV) IgG2 réf.98/79 NovaLisa® Herpes simplex Virus 1+2 (HSV) IgM2 réf.98/79 NovaLisa® Herpes simplex Virus 2 (HSV 2) IgG2 réf.98/79 NovaLisa® Herpes simplex Virus 2 (HSV 2) IgM2 réf.98/79 NovaLisa® Influenza Virus A IgA2 réf.98/79 NovaLisa® Influenza Virus A IgG2 réf.98/79 NovaLisa® Influenza Virus A IgM2 réf.98/79 NovaLisa® Influenza Virus B IgA2 réf.98/79 NovaLisa® Influenza Virus B IgG2 réf.98/79 NovaLisa® Influenza Virus B IgM2 réf.98/79 NovaLisa® Legionella pneumophila IgG2 réf.98/79 NovaLisa® Legionella pneumophila IgM2 réf.98/79 NovaLisa® Leishmania infantum IgG2 réf.98/79 NovaLisa® Leptospira IgG98/79 NovaLisa® Leptospira IgM2 réf.98/79 NovaLisa® Malaria2 réf.98/79 NovaLisa® Measles Virus IgG2 réf.98/79 NovaLisa® Measles Virus IgM2 réf.98/79 NovaLisa® Mumps Virus IgG2 réf.98/79 NovaLisa® Mumps Virus IgM2 réf.98/79 NovaLisa® Mycoplasma pneumoniae IgA98/79 NovaLisa® Mycoplasma pneumoniae IgG2 réf.98/79 NovaLisa® Mycoplasma pneumoniae IgM2 réf.98/79 NovaLisa® Parainfluenza Virus 1, 2, 3 IgA2 réf.98/79 NovaLisa® Parainfluenza Virus 1, 2, 3 IgG2 réf.98/79 NovaLisa® Parvovirus B19 IgG98/79 NovaLisa® Parvovirus B19 IgM2 réf.98/79 NovaLisa® Respiratory Syncytial Virus IgA2 réf.98/79 NovaLisa® Respiratory Syncytial Virus IgG2 réf.98/79 NovaLisa® Respiratory Syncytial Virus IgM2 réf.98/79 NovaLisa® Rubella Virus IgG98/79 NovaLisa® Rubella Virus IgM μ-capture2 réf.98/79 NovaLisa® SARS-CoV-2 (COVID-19) IgA98/79 NovaLisa® SARS-CoV-2 (COVID-19) IgG98/79 NovaLisa® Schistosoma mansoni IgG2 réf.98/79 NovaLisa® Schistosoma mansoni IgM98/79 NovaLisa® TBE / FSME IgM2 réf.98/79 NovaLisa® TBE/FSME IgG2 réf.98/79 NovaLisa® TBE/FSME IgG plus2 réf.98/79 NovaLisa® Toxoplasma gondii IgG2 réf.98/79 NovaLisa® Toxoplasma gondii IgM μ-capture2 réf.98/79 NovaLisa® Varicella-Zoster Virus (VZV) IgG2 réf.98/79 NovaLisa® Varicella-Zoster Virus (VZV) IgM2 réf.98/79 NovaLisa® Yersinia enterocolitica IgA98/79 NovaLisa® Yersinia enterocolitica IgG98/79 NovaLisa® Zika Virus IgG capture2 réf.98/79 NovaLisa® Zika Virus IgM μ-capture2 réf.98/79 Parainfluenza Virus 1, 2, 3 IgA98/79 Parainfluenza Virus 1, 2, 3 IgG98/79 Parvovirus B19 IgG98/79 Parvovirus B19 IgG ELISA98/79 Parvovirus B19 IgM98/79 Parvovirus B19 IgM ELISA98/79 PBS-Verdünnungspuffer/Dilution Buffer ELISA PBS-Waschlösung/Washing Solution ELISA Respiratory Syncytial Virus IgA98/79 Respiratory Syncytial Virus IgG98/79 Respiratory Syncytial Virus IgM98/79 RF-SorboTech3 réf. RSV A, RSV B PRSV616198/79 RSV A, RSV B PRSV616498/79 Rubella Virus IgG ELISA98/79 Rubella Virus IgG RE5708198/79 Rubella Virus IgM μ-capture ELISA98/79 Rubella Virus IgM μ-capture RE5709198/79 SARS-CoV-2 (COVID-19) IgA98/79 SARS-CoV-2 (COVID-19) IgG98/79 Schistosoma mansoni IgG98/79 Schistosoma mansoni IgM98/79 Substrat/Substrate LINE TBE / FSME IgM98/79 TBE/FSME IgG98/79 TBE/FSME IgG plus98/79 Tetanus Toxid IgG ELISA98/79 ThunderBolt EIA (CLIA) 00300-CL ThunderBolt EIA 00300 TMB-Substrat/Substrate ELISA Toxoplasma gondii IgG98/79 Toxoplasma gondii IgG ELISA98/79 Toxoplasma gondii IgM μ-capture98/79 Toxoplasma gondii IgM μ-capture ELISA98/79 Varicella-Zoster Virus (VZV) IgG ELISA2 réf.98/79 Varicella-Zoster Virus (VZV) IgG RE5737198/79 Varicella-Zoster Virus (VZV) IgM98/79 Varicella-Zoster Virus (VZV) IgM ELISA2 réf.98/79 Verd.-/Waschpuffer Dilution-/Washbuffer LINE Washing Buffer (20x concentrated)2 réf. Yersinia enterocolitica IgA98/79 Yersinia enterocolitica IgG98/79 Zika Virus IgG capture ELISA98/79 Zika Virus IgM μ-capture98/79 Zika Virus IgM μ-capture ELISA98/79	A IVDR, 98/79	Site web info.frankfurt@eu.goldstandarddiagnostics.com Fiche EUDAMED Signaler une erreur
Dymind Mandataire UE : Eunitor GmbH (Allemagne)	Chine	Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT 1 test/kit98/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT 10 tests/kit98/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT 15 tests/kit98/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT 30 tests/kit98/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT R1: 1.0 mL×10, R2 1.0 mL×1098/79 249 autres Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT R1: 4.0 mL×1, R2: 4.0 mL×198/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT R1: 4.0 mL×10, R2: 4.0 mL×1098/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT:R2:2.0 mL × 10, R1:2.0 mL × 1098/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT：R1:2.0mL×1,R2:2.0mL×198/79 Activated Partial Thromboplastin Time Assay Kit(Ellagic Acid)(Coagulation Method) CA-APTT Specification 1：R1: 2.0 mL × 10, R2: 2.0 mL × 1098/79 Activated Partial Thromboplastin Time Assay Kit(Ellagic Acid)(Coagulation Method) CA-APTT Specification 2 ：R1: 4.0 mL × 10, R2: 4.0 mL × 1098/79 Activated Partial Thromboplastin Time Assay Kit(Ellagic Acid)(Coagulation Method) CA-APTT Specification 3 ：R1: 1.0 mL × 10, R2: 1.0 mL × 1098/79 Allergen-Specific IgE Antibody Calibrator Kit (Fluorescence flow cytometry) 25 tests/kit98/79 Anti-Xa Testing Kit(Chromogenic Assay) CA Anti-Xa Specification 2 ：R1: 4 × 4.0 mL, R2: 4 × 4.0 mL, R3: 4 × 2.0 mL98/79 Anti-Xa Testing Kit(Chromogenic Assay) CA Anti-Xa Specification 3 ：15 tests/kit98/79 Anti-Xa Testing Kit(Chromogenic Assay) CA Anti-Xa Specification 4 ：15×3 tests/kit98/79 Anti-Xa Testing Kit(Chromogenic Assay) CA Anti-Xa Specification 5 ：15×5 tests/kit98/79 Anti-Xa Testing Kit(Chromogenic Assay) CA Anti-Xa Specification 1 ：R1: 4 × 2.0 mL, R2: 4 × 2.0 mL, R3: 4 × 2.0 mL98/79 Antithrombin III Control CTRL-AT III,10 × 1.0 mL (high value)98/79 Antithrombin III Control CTRL-AT III,10 × 1.0 mL (low value)98/79 Antithrombin III Control CTRL-AT III,10×1.0 mL (low value), 10×1.0 mL (high value)98/79 Antithrombin III Control CTRL-AT III,1×1.0 mL (low value), 1×1.0 mL (high value)98/79 Antithrombin III Control CTRL-AT III：1×1.0mL (high value)98/79 Antithrombin III Control CTRL-AT III：1×1.0mL (low value)98/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) CA AT-III (L) Specification 1：R1: 3.5 mL × 1, R2: 1.0 mL × 1, R3: 5.0 mL × 198/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) CA AT-III (L) Specification 4：R1: 3.5 mL × 1, R2: 1.0 mL × 198/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) CA AT-III (L)，1 test/kit98/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) CA AT-III (L)，10 tests/kit98/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) CA AT-III (L)，30 tests/kit98/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) CA AT-III (L)，R1: 7.0 mL × 4, R2: 2.0 mL × 498/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) Model : CA AT-III (L) Specification 2: R1: 3.5 mL × 4, R2: 1.0 mL × 4, R3: 5.0 mL × 498/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) Model : CA AT-III (L) Specification 3: R1: 7.0 mL × 4, R2: 2.0 mL × 4, R3: 8.0 mL × 598/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) Model : CA AT-III (L) Specification 9: 15 tests/kit98/79 Antithrombin III Testing Kit (Chromogenic Substratrate Method) CA AT-III (L)，R1: 3.5 mL × 4, R2: 1.0 mL × 498/79 Antithrombin Ⅲ Calibrator Model：CAL AT-III 1× 1.0 mL/kit98/79 Antithrombin Ⅲ Calibrator Model：CAL AT-III 6× 1.0 mL/kit98/79 Auto Bio-Immuno Hematology Analzyer DP-H21 Plus98/79 Auto Hematology Analyzer D7-CRP98/79 Auto Hematology Analyzer DF1-CRP3 réf. Auto Hematology Analyzer DF5-CRP98/79 Auto Hematology Analyzer DF502 réf. Auto Hematology Analyzer DF50CRP98/79 Auto Hematology Analyzer DF5198/79 Auto Hematology Analyzer DF5398/79 Auto Hematology Analyzer DF53CRP98/79 Auto Hematology Analyzer DF5598/79 Auto Hematology Analyzer DH-61598/79 Auto Hematology Analyzer DH-8098/79 Auto Hematology Analyzer DH-800[H1]98/79 Auto Hematology Analyzer DH-800[H8]98/79 Auto Hematology Analyzer DH-800[T6]CS98/79 Auto Hematology Analyzer DH-800[T7]CS98/79 Auto Hematology Analyzer DH-800[T8]CRP98/79 Auto Hematology Analyzer DH-800[T8]CS98/79 Auto Hematology Analyzer DH-80、DH-82、DH-85、DH-88、DH-88CS2 réf. Auto Hematology Analyzer DH-8298/79 Auto Hematology Analyzer DH-8598/79 Auto Hematology Analyzer DH-870、DH-860、DH-850、DH-820、DH-800[H6]、DH-800[H7]、DH-800[T6]CRP、DH-800[T7]CRP、DH-800[T6]CS、DH-800[T7]CS、DH-870CRP、DH-870CS、DH-860CRP、DH-860CS、DH-850CRP、DH-850CS、DH-820CRP、DH-820CS3 réf. Auto Hematology Analyzer DH202 réf. Auto Hematology Analyzer DH2198/79 Auto Hematology Analyzer DH2398/79 Auto Hematology Analyzer DH2598/79 Auto Hematology Analyzer DH2698/79 Auto Hematology Analyzer DH3198/79 Auto Hematology Analyzer DH3398/79 Auto Hematology Analyzer DH36 Auto Hematology Analyzer DH36X98/79 Auto Hematology Analyzer DH712 réf. Auto Hematology Analyzer DH7398/79 Auto Hematology Analyzer DM79X98/79 Auto Hematology Analyzer DP-H1098/79 Auto Hematology Analyzer EH36098/79 Auto Hematology Analyzer EH59098/79 Auto Hematology Analyzer UN7198/79 Auto Hematology-Immunoassay Glycohemoglobin Analyzer DH-88[H]98/79 Auto Hematology-Immunoassay Glycohemoglobin Analyzer DH-88CS[H] 、 DH-88[H] Auto Immuno Hematology Analyzer DP-H2098/79 Auto Slide Maker and Stainer SPAT X13 réf. Automated Flow Fluorescence Immunoassay Analyzer MF12803 réf. Automatic Coagulation Analyzer CA12003 réf. Automatic Coagulation Analyzer CA510、CA520、CA5303 réf. Automatic Sample Processing System DH-60002 réf. Cleanser CLE-P3 réf. Cleanser CLR 500mL2 réf. CTRL Coag Coagulation control (level 1) : 1 × 1.0 mL98/79 CTRL Coag Coagulation control (level 1) : 10 × 1.0 mL98/79 CTRL Coag Coagulation control (level 2) : 1 × 1.0 mL98/79 CTRL Coag Coagulation control (level 2) : 10 × 1.0 mL98/79 D-Dimer Assay Kit (Immunoturbidimetry) CA D-Dimer：R2: 2.0 mL×4, R1: 4.0 mL×498/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification10:15 tests/kit98/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification11:30 tests/kit98/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification3:R2:2.0mL×1,R1:4.0mL×198/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification4:R2:1.0 mL×4,R1:4.0 mL×298/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification5:1.0 mL×498/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification6: 2.0 mL×498/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification7:4.0 mL×498/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification8:1 test/kit98/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification9:10 tests/kit98/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification2:R2:4.0 mL×4,R1:4.0 mL×898/79 D-Dimer Calibrator Model : CAL-DD 1×0.5 mL/kit (volume after reconstitution)98/79 D-Dimer Calibrator Model : CAL-DD 6×0.5 mL/kit (volume after reconstitution)98/79 D-Dimer Calibrator Model : CAL-DD 6×1.0 mL/kit (volume after reconstitution)98/79 D-Dimer Control CAL-DD：1 × 1.0 mL/kit98/79 D-Dimer Control CTRL-DD:10×1.0 mL (low value)98/79 D-Dimer Control CTRL-DD：10 × 1.0 mL (high value)98/79 D-Dimer Control Model : CTRL-DD Specification 1:1 × 0.5 mL (low value)98/79 D-Dimer Control Model : CTRL-DD Specification 2:1 × 0.5 mL (high value)98/79 D-Dimer Control Model : CTRL-DD Specification 3:10 × 0.5 mL (low value)98/79 D-Dimer Control Model : CTRL-DD Specification 4:10 × 0.5 mL (high value)98/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，1 test/kit98/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，10 tests/kit98/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，30 test/kit98/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，R1: 1 × 2.0 mL, R2: 1 × 2.0 mL98/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，R1: 2.0 mL × 1, R2: 2.0 mL × 1, R3: 2.0 mL × 198/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，R1: 2.0 mL × 4, R2: 2.0 mL × 498/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，R1: 4 × 2.0 mL, R2: 4 × 2.0 mL, R3: 2 × 2.0 mL98/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，R1: 4.0 mL × 4, R2: 4.0 mL × 498/79 Fibrin and Fibrinogen Degradation Products Assay Kit（Immunoturbidimetry） Model : CA-FDP Specification 3:R1: 4 × 4.0 mL, R2: 4 × 4.0 mL, R3: 4 × 2.0 mL98/79 Fibrin and Fibrinogen Degradation Products Assay Kit（Immunoturbidimetry） Model : CA-FDP Specification 9:15 tests/kit98/79 Fibrin and Fibrinogen Degradation Products Calibrator CAL-FDP,Calibrator 1: 1 × 1.0 mL，Calibrator 2: 1 ×1.0 mL，Calibrator 3: 1 × 1.0 mL，Calibrator 4: 1 × 1.0 mL，Calibrator 5: 1 × 1.0 Ml98/79 Fibrin and Fibrinogen Degradation Products Calibrator CAL-FDP,Calibrator 1: 2 × 1.0 mL，Calibrator 2: 2 × 1.0 mL，Calibrator 2: 2 × 1.0 mL，Calibrator 3: 2 × 1.0 mL，Calibrator 4: 2 × 1.0 mL，Calibrator 5: 2 ×1.0 mL98/79 Fibrin and Fibrinogen Degradation Products Calibrator CAL-FDP,Calibrator 5: 3 × 1.0 mL98/79 Fibrin and Fibrinogen Degradation Products Calibrator CAL-FDP，Calibrator 5: 1 × 1.0 mL98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,1 × 0.5 mL (high value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,1 × 0.5 mL (low value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,1 × 1.0 mL (high value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,1 × 1.0 mL (low value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,10 × 0.5 mL (high value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,10 × 0.5 mL (low value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,10 × 1.0 mL (high value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,10 × 1.5 mL (high value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,10 × 1.5 mL (low value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,10×1.0mL (low value)98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) Specification 1 :R1 2.0 mL× 10, R2 5.0 mL×122 réf.98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) Specification 2 :R1 4.0 mL× 10, R2 30.0 mL× 52 réf.98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 1 test/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 10 tests/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 15 tests/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 30 tests/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 1.0 mL× 1098/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 1.0 mL× 10, R2: 5.0 mL× 698/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 2.0 mL× 1098/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 4.0 mL× 1, R2: 30.0 mL× 198/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 4.0 mL× 1098/79 Fibrinogen Calibrator CAL-FIB：1 × 1.0 mL/kit98/79 Fibrinogen Calibrator Model : CAL-FIB Specification 2:6×1.0 mL/kit98/79 HbA1c Calibrator A1c-CAL 2×1.0 mL（A1c-CAL1, A1c-CAL2）98/79 HbA1c Control Material A1c-QC 2x1.0 mL（A1c-QC1、A1c-QC2）98/79 Hematology Analysis Reagent Kit PFD-1A 50 tests/kit Hematology Analyzer Diluent D-80DIL:10L3 réf. Hematology Analyzer Diluent D-80DR(M)3 réf. Hematology Analyzer Diluent DIL-A:20L2 réf. Hematology Analyzer Diluent DIL-C:20L2 réf. Hematology Analyzer Diluent DIL-E ,20L Hematology Analyzer Diluent DIL-K:20L3 réf. Hematology Analyzer Diluent DIL-N:10L3 réf. Hematology Analyzer Diluent DIL-R 10L2 réf. Hematology Analyzer Dye D-80FD:12mL3 réf. Hematology Analyzer Dye D-80FR(M)2 réf. Hematology Analyzer Dye FDN-R:24mL3 réf. Hematology Analyzer Lyse D-80LD:500mL，1L，2L，4L；D-80LH:200mL，500mL，1L，2L，4L； D-80LN:500mL，1L，2L，4L；D-80LW:200mL，500mL，1L，2L，4L3 réf. Hematology Analyzer Lyse L1：1L3 réf. Hematology Analyzer Lyse LP3 réf. Hematology Analyzer Lyse LYA-1：1L3 réf. Hematology Analyzer Lyse LYC-1：1L3 réf. Hematology Analyzer Lyse LYD-1：1L3 réf. Hematology Analyzer Lyse LYE-1：1L Hematology Analyzer Lyse LYG-13 réf. Hematology Analyzer Lyse LYK-13 réf. Hematology Analyzer Lyse LYN-G:1L3 réf. Hematology Analyzer Lyse LYR-1:1L3 réf. Hematology Analyzer Reagent Kit (Diluent and Lyse) PTD-1 25 test/kit2 réf. Hematology Analyzer Reagent Kit PTD-103 25 test/kit2 réf. Hematology Calibrator DM-CAL 3mL × 13 réf. Hematology Calibrator DM-CAL PLUS 3mL × 13 réf. Hematology Calibrator DM-CAL-PF3 réf. Hematology Control DM-3D High (H):3mL×14 réf. Hematology Control DM-5D High (H):3mL×14 réf. Hematology Control Model:DM-6DR , Specification:2mL（H）×298/79 Hematology Control Model:DM-6DR , Specification:2mL（H）×398/79 Hematology Control Model:DM-6DR , Specification:2mL（L）×298/79 Hematology Control Model:DM-6DR , Specification:2mL（L）×398/79 Hematology Control Model:DM-6DR , Specification:2mL（N）×198/79 Hematology Control Model:DM-6DR , Specification:3mL（H）×198/79 Hematology Control Model:DM-6DR , Specification:3mL（H）×298/79 Hematology Control Model:DM-6DR , Specification:3mL（L）×1+3mL（N）×1+ 3mL（H）×198/79 Hematology Control Model:DM-6DR, Specification:3mL（L）×298/79 Hematology Control Model:DM-6DR,Specification：3mL（L）×1+3mL（N）×1+ 3mL（H）×1、2mL（L）×1+2mL（N）×1+ 2mL（H）×13 réf. Heparin Calibrator CAL Anti-Xa Specification 1：Calibrator 1: 1 ×1.0 mL；Calibrator 2: 1 ×1.0 mL；Calibrator 3: 1 ×1.0 mL98/79 Low Molecular Weight Heparin Control CTRL-LMWH Specification 3 ：10 × 1.0 mL (low-level)98/79 Low Molecular Weight Heparin Control CTRL-LMWH Specification 4 ：10 × 1.0 mL (high-level)98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-dRVVT Specification 1：dRVVT screen: 1 x 2.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-dRVVT Specification 2 dRVVT screen: 10 x 1.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-dRVVT Specification 3: dRVVT screen: 10 × 2mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-dRVVT Specification 4 dRVVT confirm: 1 x 2.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-dRVVT Specification 5 dRWVT confirm: 10 x 1.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-dRVVT Specification 6: dRVVT confirm: 10 × 2.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-SCT Specification 1： SCT screen: 4 × 1.0 mLSCT confirm: 4 × 1.0 mL SCT CaCl2: 4 × 2.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-SCT Specification 2： SCT screen: 4 × 2.0 mL SCT confirm: 4 × 2.0 mL SCT CaCl2: 4 × 4.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-SCT Specification 3： SCT screen: 4 × 2.0 mL SCT CaCl2: 4 ×2.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-SCT Specification 4： SCT confirm: 4 × 2.0 mL; SCT CaCl2: 4 ×2.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-SCT Specification 5： 15 tests/kit98/79 Lupus Anticoagulant Control CTRL-LA Specification 1：1 × 1.0 mL (Negative)98/79 Lupus Anticoagulant Control CTRL-LA Specification 2：1 × 1.0 mL (Positive)98/79 Lupus Anticoagulant Control CTRL-LA Specification 3：10 × 1.0 mL (Negative)98/79 Lupus Anticoagulants Control CTRL-LA Specification 4: 10 × 1.0 mL (Positive)98/79 Portable Multi-Function Analyzer DP-H50 Pro Protein C Activity Testing Kit(Chromogenic Substrate Method) CA-PC specification 1：PC activator: 1×2.0 mL, PC substrate: 1×2.0 mL, PC diluent: 1×5.0 mL98/79 Protein C Activity Testing Kit(Chromogenic Substrate Method) CA-PC specification 2：PC activator: 2×2.0 mL, PC substrate: 2×2.0 mL, PC diluent: 2×5.0 mL98/79 Protein C Activity Testing Kit(Chromogenic Substrate Method) CA-PC specification 3：PC activator: 2×4.0 mL, PC substrate: 2×4.0 mL, PC diluent: 4×5.0 mL98/79 Protein C Activity Testing Kit(Chromogenic Substrate Method) CA-PC specification 4：PC activator: 1×2.0 mL, PC substrate: 1×2.0 mL98/79 Protein C Activity Testing Kit(Chromogenic Substrate Method) CA-PC specification 5：PC activator: 2×2.0 mL, PC substrate: 2×2.0 mL98/79 Protein C Activity Testing Kit(Chromogenic Substrate Method) CA-PC specification 6：PC activator: 2×4.0 mL, PC substrate: 2×4.0 mL98/79 Protein C Calibrator CAL-PC Specification 1：1×0.5 mL/kit (reconstituted volume)98/79 Protein S Testing Kit (Immunoturbidimetry) CA-PS Specification 1 ：PS buffer: 1×2.0 mL. PS latex reagent: 1×2.0 mL. FPS diluent: 1×3.0 mL98/79 Protein S Testing Kit (Immunoturbidimetry) CA-PS Specification 2 ：PS buffer: 2×2.0 mL. PS latex reagent: 2×2.0 mL. FPS diluent: 2×3.0 mL98/79 Protein S Testing Kit (Immunoturbidimetry) CA-PS Specification 3 ：PS buffer: 2×4.0 mL. PS latex reagent: 2×4.0 mL. FPS diluent: 4×3.0 mL98/79 Protein S Testing Kit (Immunoturbidimetry) CA-PS Specification 4 ：PS buffer: 1×2.0 mL. PS latex reagent: 1×2.0 mL98/79 Protein S Testing Kit (Immunoturbidimetry) CA-PS Specification 5 ：PS buffer: 2×2.0 mL. PS latex reagent: 2×2.0 mL98/79 Protein S Testing Kit (Immunoturbidimetry) CA-PS Specification 6 ：PS buffer: 2×4.0 mL. PS latex reagent: 2×4.0 mL98/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 30 tests/kit98/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 1 test/kit98/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 10 tests/kit98/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 15 tests/kit98/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 2.0 mL × 198/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT Specification 1: 4.0 mL × 1098/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT Specification 2: 2.0 mL × 1098/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT Specification 3: 4.0 mL × 198/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 2.0 mL×1098/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 4.0 mL×198/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT：4.0 mL×1098/79 Sample Diluent PTD-A 25 bottle/bag3 réf. Semi-auto Chemistry Analyzer DP-C163 réf. Semi-auto Coagulation Analyzer DC1040、DC1041、DC1020、DC10213 réf. Thrombin Time Assay Reagent (Coagulation Method) CA-TT Specification 1:5.0 mL× 1098/79 Thrombin Time Assay Reagent (Coagulation Method) CA-TT Specification 2:3.0 mL×1098/79 Thrombin Time Assay Reagent (Coagulation Method) CA-TT Specification 3:1.5 mL×1098/79 Thrombin Time Assay Reagent (Coagulation Method) CA-TT 1.5 mL×1098/79 Thrombin Time Assay Reagent (Coagulation Method) CA-TT 3.0 mL×1098/79 Thrombin Time Assay Reagent (Coagulation Method) CA-TT：5.0 mL× 1098/79 Thrombin Time Assay Reagent（Coagulation Method） CA-TT 1 test/kit98/79 Thrombin Time Assay Reagent（Coagulation Method） CA-TT 10 tests/kit98/79 Thrombin Time Assay Reagent（Coagulation Method） CA-TT 15 tests/kit98/79 Thrombin Time Assay Reagent（Coagulation Method） CA-TT 3.0 mL× 198/79 Thrombin Time Assay Reagent（Coagulation Method） CA-TT 30 tests/kit98/79 Unfractionated Heparin Control CTRL-UFH Specification 1 ：1 × 1.0 mL (low-level)98/79 Unfractionated Heparin Control CTRL-UFH Specification 3 ：10 × 1.0 mL (low-level)98/79 Unfractionated Heparin Control CTRL-UFH Specification 4 ：10 × 1.0 mL (high-level)98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 1 ：VWF buffer: 1 × 2.0 mL, VWF latex reagent: 1 × 2.0 mL, VWF diluent: 1 × 3.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 2 ：VWF buffer: 2 × 2.0 mL, VWF latex reagent: 2 × 2.0 mL, VWF diluent: 2 × 3.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 3 ：VWF buffer: 2 × 4.0 mL, VWF latex reagent: 2 × 4.0 mL, VWF diluent: 4 × 3.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 4 ：VWF buffer: 1 × 2.0 mL, VWF latex reagent: 1 × 2.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 5 ：VWF buffer: 2 × 2.0 mL, VWF latex reagent: 2 × 2.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 6 ：VWF buffer: 2 × 4.0 mL, VWF latex reagent: 2 × 4.0 mL98/79	A, B IVDR, 98/79	regulationdept@dymind.com Fiche EUDAMED Signaler une erreur
Healgen FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	États-Unis	"AHTV01-AHG48E， AHTV01-AHG96E"98/79 101A0227EY98/79 ABPTS02-AHG48E/ ABPTS02-AHG96E98/79 ACAB01-AHG48E; ACAB01-AHG96E98/79 ACAB04D-BHG48E98/79 246 autres ACOV01-AHG48E; ACOV01-AHG96E98/79 ACOV03-AHG48E; ACOV03-AHG96E; ACOV03D-AHG48E; ACOV03D-AHG96E98/79 ACOV03D-AHG48E; ACOV03D-AHG96E98/79 Adenovirus Antigen Control Kit GCADE-PN298/79 Adenovirus Antigen FIA Control Kit FCADE-PN298/79 Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab) FCADE-502a98/79 Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab) FCADE-502Ca98/79 Adenovirus Antigen Rapid Test Cassette (Swab) GCADE-502a98/79 Adenovirus Antigen Rapid Test Cassette (Swab) GCADE-502Ca98/79 Adenovirus Rapid Test Cassette (Feces) GCADE-602a98/79 Adenovirus Rapid Test Cassette (Feces) GCADE-602Ca98/79 ADV01-AHG48E; ADV01-AHG96E; ADV01D-AHG48E; ADV01D-AHG96E98/79 ADV01D-AHG48E; ADV01D-AHG96E98/79 ADZCOM01D-AHG48E98/79 AEBV01-AHG48E; AEBV01D-AHG48E98/79 AEBV01D-AHG48E98/79 AFAB01-AHG48E; AFAB01-AHG96E98/79 AFAB03-AHG48E; AFAB03-AHG96E; AFAB03D-AHG48E; AFAB03D-AHG96E98/79 AFAB03D-AHG48E; AFAB03D-AHG96E98/79 AFR01-AHG48E; AFR01-AHG96E; AFR01D-AHG48E; AFR01D-AHG96E98/79 AGAS01-AHG48E; AGAS01D-AHG48E98/79 AHPV1401-AHG48E98/79 AHPV1401D-AHG48E98/79 AHPV1801-AHG48E98/79 AHPV1801-BHG48E,AHPV1801-BHG96E98/79 AHPV1801-CHG48E98/79 AHPV2301-AHG48E98/79 AHPV2301D-AHG48E98/79 AHSV101-AHG48E; AHSV101-AHG96E; AHSV101D-AHG48E; AHSV101D-AHG96E98/79 AHSV201-AHG48E; AHSV201-AHG96E; AHSV201D-AHG48E; AHSV201D-AHG96E98/79 AHSV201D-AHG48E; AHSV201D-AHG96E98/79 AHTV01D-AHG48E98/79 AIAH501D-AHG48E; AIAH501D-AHG96E98/79 AMP01-AHG48E; AMP01-AHG96E; AMP01D-AHG48E; AMP01D-AHG96E98/79 AMP01D-AHG48E; AMP01D-AHG96E98/79 AMPV01-AHG48E; AMPV01-AHG96E98/79 AMPV01D-AHG48E; AMPV01D-AHG96E98/79 AMTBC01-AHG48E; AMTBC01-AHG96E; AMTBC01D-AHG48E; AMTBC01D-AHG96E98/79 AMTBC01D-AHG48E, AMTBC01D-AHG96E98/79 AMTBZK01-AHG2E98/79 ANG01-AHG48E; ANG01-AHG96E; ANG01D-AHG48E; ANG01D-AHG96E98/79 ANG01D-AHG48E; ANG01D-AHG96E98/79 APA01-AHG48E; APA01-AHG96E; APA01D-AHG48E; APA01D-AHG96E98/79 ATP01-AHG48E/ATP01-AHG96E/ATP01D-AHG48E/ATP01D-AHG96E98/79 ATP01D-AHG48E/ATP01D-AHG96E98/79 Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) GCBRU-402a98/79 Brucella IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCBRU(IgG/IgM)-402a98/79 CAMRZK01-AHG4E98/79 Candida albicans Antigen Rapid Test Cassette (Swab) GCCA-502a98/79 CCDIF01A-AHG4E98/79 CCDIFZK01-AHG4E98/79 CCNS801A-AHG4E98/79 CCNSZK01-AHG4E98/79 CDGV01A-AHG4E98/79 CDGVZK01-AHG4E98/79 CFFCR01A-AHG4E98/79 CGBS01A-AHG4E98/79 CGBSZK01A-AHG4E98/79 CGCT01A-AHG4E98/79 CGI601A-AHG4E98/79 CGIBAC01A-AHG4E98/79 CGIBACZK01-AHG4E98/79 CGIZK01-AHG4E98/79 CGTUC01A-AHG4E98/79 Chagas Ab Rapid Test Cassette (Serum/Plasma) GCCHA-302a98/79 Chagas Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCHA-402a98/79 Chikungunya IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) GCCHK(IgG/IgM)-402b98/79 Chikungunya IgM Rapid Test Cassette (Serum/Plasma) GCCHK(IgM)-302a98/79 Chikungunya IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCHK(IgM)-402a98/79 Chikungunya IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCHK(IgM/IgG)-402a98/79 CHPV1401A-AHG4E98/79 CHPV1402A-AHG4E98/79 CHPV14ZK01-AHG4E98/79 Clostridium difficile Antigen GDH Rapid Test Cassette (Feces) GCCD(GDH)-602a98/79 Clostridium difficile GDH & Toxin A/B Rapid Test Cassette (Feces) GCCD-602a98/79 Clostridium difficile Toxin A&B Rapid Test Cassette (Feces) GCCD(Toxin A/B)-602a98/79 CMTB01A-AHG4E98/79 CMTBMDR01A-AHG4E98/79 CMTBMDRZK01-AHG4E98/79 CMTBNTM01A-AHG4E98/79 CMTBNTMZK01A-AHG4E98/79 CMTBRIF01A-AHG4E98/79 CMTBRIFZK01-AHG4E98/79 CNCMT01A-AHG4E98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NA98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NN98/79 COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab) GCCOV(B117)-525a98/79 COVID-19 Ag Rapid Test Cassette (Oral Fluid) GCCOV-702a98/79 COVID-19 Antigen Control Kit GCCOV(Ag)-PN1098/79 COVID-19 Antigen Control Kit GCCOV(Ag)-PN2098/79 COVID-19 IgG/IgM CONTROL Kit GCCOV-PN1098/79 COVID-19 IgG/IgM CONTROL Kit GCCOV-PN2098/79 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402a98/79 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402Ba98/79 COVID-19+Flu A&B+RSV Ag Combo Rapid Test Cassette (Swab) GCFCR-T525Sa-DD98/79 COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) GCFC-T502a98/79 COVID-19/Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab) GCFCR-T525a98/79 COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) GCFCRA-T525a98/79 COVID-19/Flu A&B/RSV/Adeno Ag Control Kit GCFCRA-PN298/79 COVID-19/Flu A&B/RSV/Adeno/HPIV/HMPV/RhV/M. pneumoniae Ag Combo Rapid Test Cassette (Swab) GCRESA-T555a98/79 COVID-19/Flu A/Flu B/RSV/ADV/M.P Ag Combo Rapid Test Cassette (Swab) GCFCRAMP-T535a98/79 CRTI601A-AHG4E98/79 CRTI701A-AHG4E98/79 CRTI7A01A-AHG4E98/79 CRTI7B01A-AHG4E98/79 CRTI7BZK01-AHG4E98/79 CRTI7C01A-AHG4E98/79 CRTI7CZK01-AHG4E98/79 Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid) GCCr(Ag)-402a98/79 CSTD601A-AHG4E98/79 CSTI6ZK01A-AHG4E98/79 CSTI7A01A-AHG4E98/79 CSTI7B01A-AHG4E98/79 CSTIAZK01-AHG4E98/79 CSTIBZK01-AHG4E98/79 CSTIZK01A-AHG4E98/79 CVAG01A-AHG4E98/79 CVAGZK01-AHG4E98/79 CVCB601A-AHG4E98/79 CVCB801A-AHG4E98/79 CVCBZK01-AHG4E98/79 D-Dimer Control FDDDI-PN2098/79 D-Dimer Quantitative Test Kit (Time-Resolved FIA) FDDDI-402a98/79 D-Dimer Rapid Test Cassette (Whole Blood/Plasma) GDDDI-402b98/79 D-Dimer Test Kit (CLIA)98/79 Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(ab)-402e98/79 Dengue IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(ab)-402c98/79 Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(NS)-402c98/79 Dengue NS1 Ag Rapid Test Cassette(Whole Blood/Serum/Plasma) GCDEN(NS)-402d98/79 Dengue NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN-425a98/79 Digital COVID-19 Ag Rapid Test (Swab) GCCOV-D503a98/79 EV71 IgM Rapid Test Cassette (Serum/Plasma) GCEV71(IgM)-302a98/79 EV71 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCEV71(IgM)-402a98/79 Flu A Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) FCFLU(A)-502a98/79 Flu A Ag Rapid Test Cassette (Swab) GCFLU(A)-U502a98/79 Flu A(H5) Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) FCFLU(AH5)-502a98/79 Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab) GCFCRA-545a98/79 Giardia lamblia Antigen Rapid Test Cassette (Feces) GCGIA-602a98/79 Gonorrhea Rapid Test Cassette (Swab) GCGON-502b98/79 H. pylori Ab Rapid Test Cassette (Serum/Plasma) GCHP-302a98/79 H. pylori Ab Rapid Test Cassette (Whole blood/Serum/Plasma) GCHP-402a98/79 H. pylori Ag Control Kit GCHP-PN298/79 H. pylori Ag Rapid Test Cassette (Feces) GCHP-602a98/79 H. pylori Ag Rapid Test Cassette (Feces) GCHP-602Ca98/79 H. pylori Ag Rapid Test Strip (Feces) GCHP-601a98/79 H. pylori Ag Rapid Test Strip (Feces) GCHP-601Ca98/79 H.pylori Ag Rapid Test Device (Feces) GCHP-606a98/79 H. pylori Ab Rapid Test Strip (Serum/Plasma) GCHP-301a98/79 H. pylori Ab Rapid Test Strip (Whole blood/Serum/Plasma) GCHP-401a98/79 Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHV(IgG/IgM)-402a98/79 Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHV(IgM)-402a98/79 HAV IgG/IgM Rapid Test Cassette (Serum/Plasma) GCHAV(IgG/IgM)-302a98/79 HAV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHAV(IgG/IgM)-402a98/79 HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette) GCHCV-302a98/79 HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette) GCHCV-402a98/79 Healgen® Gonorrhoea Fluorescent Rapid Test FCGON-502a98/79 HEV IgM Rapid Test Cassette (Serum/Plasma) GCHEV-302a98/79 HIV 1/2 Human Immunodeficiency Virus Rapid Test (Serum/Plasma)(Cassette) GCHIV-302a98/79 HIV 1/2 Human Immunodeficiency Virus Rapid Test st (Whole blood/Serum/Plasma)(Cassette) GCHIV-402a98/79 HPIV Antigen Rapid Test Kit (Time-Resolved FIA) FCHPIV-502a98/79 HSV IgG Rapid Test Cassette (Serum/Plasma) GCHSV(IgG)-302a98/79 HSV IgG Rapid Test Cassette (Whole blood/Serum/Plasma) GCHSV(IgG)-402a98/79 HSV IgM Rapid Test Cassette (Serum/Plasma) GCHSV(IgM)-302a98/79 HSV IgM Rapid Test Cassette (Whole blood/Serum/Plasma) GCHSV(IgM)-402a98/79 Human Metapneumovirus (HMPV) Ag Rapid Test GCHMPV-502a98/79 Human Papillomavirus E7 Protein Rapid Test Cassette (Swab) GCHPV-502a98/79 IL-6 Quantitative Test Kit (Time-Resolved FIA)98/79 Influenza A & B Ag Rapid Test Cassette (Swab) GCFLU(A/B)-502a98/79 Influenza A & B Ag Rapid Test Cassette (Swab) GCFLU(A/B)-502Ca98/79 Influenza A & B Ag Rapid Test Strip (Swab) GCFLU(A/B)-501a98/79 Influenza A (H5) Ag Rapid Test Cassette (Swab) GCFLU(AH5)-502a98/79 Interleukin 6 Test Kit (CLIA)98/79 Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCKal-402a98/79 Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma) GCKal-401a98/79 Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCKal-T402a98/79 Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCLEP(IgG/IgM)-402a98/79 M. pneumonia IgM Rapid Test Cassette (Serum/Plasma) GCMP(IgM)-302a98/79 M. pneumoniae Ag Rapid Test Cassette (Swab) GCMP-502a98/79 Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pv)-402a98/79 Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pan)-402a98/79 Malaria Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pan)-402a98/79 Malaria Pf Ag Rapid Test Cassette (Whole Blood) GCMAL(Pf)-402a98/79 Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma) GCMAL(pf/pv Ab)-302a98/79 Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma) GCMAL(pf/pv Ab)-402a98/79 MFIA02-E98/79 MNAP0198/79 Monkeypox Ag Rapid Test Cassette (Swab) GCMKP-502b98/79 Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMKP-402a98/79 Mononucleosis IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma) GCMON-425a98/79 Mononucleosis IgG/lgM Rapid Test Cassette(Serum/Plasma) GCMON-325a98/79 Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMON-402a98/79 Norovirus Antigen Rapid Test Cassette (Feces) GCNOR-602a98/79 Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method)98/79 Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method)98/79 Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)98/79 Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)98/79 One Step Chikungunya Ag Test Cassette (Whole Blood/Serum/Plasma) GCCHK-402a98/79 Rapid COVID-19 Antigen Test Strip GCCOV-501a98/79 Rapid COVID-19+Influenza Antigen Test GCFC-525a98/79 RGAS01-AHG5E/ RGAS01-AHG25E98/79 RHPV201-AHG5E/RHPV201-AHG25E98/79 RHPV301-AHG5E/RHPV301-AHG25E98/79 RMTB01-AHG5E, RMTB01-AHG25E98/79 Rotavirus and Adenovirus Antigen Control Kit GCROA/ADE-PN298/79 Rotavirus Rapid Test Cassette (Feces) GCROA-602a98/79 Rotavirus Rapid Test Cassette (Feces) GCROA-602Ca98/79 RSV Antigen Control Kit GCRSV-PN1098/79 RSV Antigen Control Kit GCRSV-PN298/79 RSV Antigen FIA Control Kit FCRSV-PN298/79 RSV Antigen Fluorescence Rapid Test Cassette (Swab) FCRSV-502Ca98/79 RSV Antigen Fluorescent Rapid Test Cassette (Swab) FCRSV-502a98/79 RSV Antigen Rapid Test Cassette (Swab) GCRSV-502a98/79 RSV Antigen Rapid Test Cassette (Swab) GCRSV-502Ca98/79 RVZV01-AHG5E98/79 RVZV01-AHG5E/RVZV01-AHG25E98/79 S. typhi Ag Rapid Test Cassette (Serum/Plasma/Feces) GCSAL(ST)-602a98/79 SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab) FCCOV-502a98/79 SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab) GCCOV(Del)-T502a98/79 SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV(NAb)-402b98/79 SCLS01-AHG10E98/79 Smart Rapid COVID-19 & Flu A/B Ag Test Device GCFC-T503a98/79 Smart Rapid COVID-19 Ag Test Device GCCOV-503a98/79 SNCE01-AHG48/ SNCE01-AHG96/ SNCE02-AHG16/ SNCE02-AHG48/ SNCE02-AHG9698/79 SNCE05-AHG48E98/79 SNCE07-AHG50E98/79 Strep A Antigen Control Kit GCSTR-PN298/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502a98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502Ca98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502CSa98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501a98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501Ca98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501CSa98/79 Syphilis Ab Rapid Test Cassette (Serum/Plasma) GCSYP-302a98/79 Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCSYP-402a98/79 Syphilis Ab Rapid Test Strip (Serum/Plasma) GCSYP-301a98/79 Syphilis Ab Rapid Test Strip (Whole Blood/Serum/Plasma) GCSYP-401a98/79 Trichomonas Ag Rapid Test Cassette (Swab) GCTV-502a98/79 Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma) GCTB-302a98/79 Tuberculosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCTB-402a98/79 Tuberculosis Interferon-Gamma Release Assay Test Kit (CLIA)98/79 Typhoid IgG/IgM Rapid Test Cassette (Serum/Plasma) GCTYP-302a98/79 Typhoid IgG/IgM Rapid Test Cassette (Serum/Plasma) GCTYP-302b98/79 Zika IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCZIK(IgG)-402b98/79 Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) GCZIK(IgG/IgM)-T402a98/79 Zika NS1 Ag Rapid Test Cassette(Whole blood/Serum/Plasma) GCZIK(NS1)-402a98/79	– 98/79	quality@healgen.com Fiche EUDAMED Signaler une erreur
Rapid Labs Mandataire UE : Advena Limited (Malte) et 1 autre	United Kingdom (ex Northern Ireland)	Adenovirus + RSV Control D-S-CARC98/79 Adenovirus Control D-PL-CADE98/79 Adenovirus pneumoniae and RSV Combo Test Device- Nasopharyngeal Swab D-FIARNSD2098/79 Adenovirus pneumoniae Antigen Control D-S-CADE98/79 Adenovirus pneumoniae/RSV/Influenza A+B Combo Test Device-Nasopharyngeal Swab D-FIARID2098/79 231 autres Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19 Combo Test Device-Nasopharyngeal Swab98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Device-Nasopharyngeal Swab98/79 Adenovirus Rapid Test Device – Feces D-ADOD2598/79 Adenovirus/Rotavirus Control D-PL-CAR98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Control98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test Device-Swab98/79 Adenovirus/RSV/HMPV/Influenza A+B/COVID-19 Combo Rapid Test Device-Swab98/79 Adenovirus/RSV/Influenza A+B Control D-S-CARI98/79 Anti-A Monoclonal BG-A1098/79 Anti-A,B Monoclonal BG-AB1098/79 Anti-A,B,AB，D (IgG&IgM) Kit Reagent BG-ABOD1098/79 Anti-A,B,D (IgG&IgM) Kit BG-ABD1098/79 Anti-B Monoclonal BG-B1098/79 Anti-D Monoclonal (lgG+lgM)98/79 Astrovirus Control D-PL-CAS98/79 Astrovirus Rapid Test Device – Feces D-ASTD1098/79 Automatic Chemiluminescence Immunoassay Analyzer Blood Glucose Meter II D-BGM22 réf. Brucella Abortus Antigen Rapid Test Device – WB/S/P98/79 Brucella Abortus Control2 réf.98/79 C. difficile GDH+ Toxin A +Toxin B Combo Rapid Test -Faeces D-CLOSGTD1098/79 C.difficile GDH + Toxin A + Toxin B Combo Rapid Test Device – Feces D-CDGTABD1098/79 C.difficile GDH Rapid Test Device – Feces D-CLOSD2098/79 C.difficile Toxin A +Toxin B Combo Rapid Test Device – Feces D-CDTABD1098/79 Campylobacter Control D-PL-CCAM98/79 Candida Albicans Control D-PL-CCA98/79 Chagas Control D-P-CCHA98/79 Chagas Rapid Test Device – S/P D-CHAD4098/79 Chagas Rapid Test Device – WB/S/P98/79 Chikungunya control D-L-CCHIGM98/79 Chikungunya IgG/IgM Antibody Control D-PL-CCHIGM98/79 Chikungunya IgG/IgM Rapid Test Device – S/P D-CHIKGMD4098/79 Clostridium difficile GDH + Toxin A + Toxin B Control D-PL-CCD98/79 Clostridium difficile GDH Control D-PL-CCDG98/79 Clostridium difficile GDH Test Device -Feces D-FICDGD1098/79 Clostridium difficile GDH Test Device-Feces D-FICLOSD1098/79 Clostridium difficile GDH Test Device-Feces D-FICLOSD2598/79 Clostridium difficile GDH+Toxin A/B Test Device-Feces D-FICDGTABD1098/79 Clostridium difficile GDH+Toxin A/B Test Device-Feces D-FICDGTABD2598/79 Clostridium difficile Toxin A+ Toxin B Control D-PL-CCDT98/79 Clostridium difficile Toxin A/Toxin B Combo Test Device-Feces D-FICDTABD1098/79 Clostridium difficile Toxin A/Toxin B Combo Test Device-Feces D-FICDTABD2598/79 COVID-19 Ag/Influenza A+B Combo Test Device – Nasopharyngeal Swab98/79 COVID-19 Ag/Influenza A+B Control98/79 COVID-19 and Influenza A+B Antigen Combo Control98/79 COVID-19 Antigen Control98/79 COVID-19 Antigen Rapid Test Device-Nasopharyngeal Swab2 réf.98/79 COVID-19 IgG/IgM Test Device -Finger Prick WB, WB/S/P2 réf.98/79 COVID-19 S-RBD IgG Antibody Test Device -WB/S/P2 réf.98/79 Cryptococcus Antigen Rapid Test Device – WB/S/P/CSF98/79 Cryptosporidium Ag and Giardia Lamblia Ag Combo Test Device-Feces D-FICRYGLD1098/79 Cryptosporidium Ag and Giardia Lamblia Ag Combo Test Device-Feces D-FICRYGLD2598/79 Cryptosporidium Antigen Control D-PL-CCRY98/79 Cryptosporidium Control D-L-CCRY98/79 Cup Reader RL-CD-1A D-Dimer Rapid Test Device – WB/P98/79 Dengue IgG/IgM Rapid Test Device -WB/S/P98/79 Dengue Combo Rapid Test Device D-DAGMD2098/79 Dengue Combo(NS1+IgG/IgM)+Chikungunya IgG/IgM+Zika IgG/IgM Rapid Test Device98/79 Dengue IgG&IgM/Zika IgG&IgM/Chikungunya IgG/Chikungunya IgM Combo Rapid Test Device D-DGMCMD2098/79 Dengue IgG/IgM Control D-L-CDEGM98/79 Dengue IgG/IgM Control D-P-FIDEN98/79 Dengue NS1 Control4 réf.98/79 Dengue NS1 Rapid Test Device-WB/S/P98/79 Dengue/Zika/Chikungunya Combo Rapid Test Device-WB/S/P98/79 EBV VCA IgA Rapid Test Device-WB/S/P98/79 Entamoeba Histolytica Control D-PL-CEH98/79 Entamoeba/Giardia/Crypto Control2 réf.98/79 Enterovirus 71 Ag Test Device-Feces2 réf.98/79 FLU A+B Control98/79 Fluorescence Immunoassay Analyzer3 réf. Giardia Lamblia Control D-PL-CGL98/79 Gonorrhea Control98/79 Gonorrhea Rapid Test Cassette Device - Swab98/79 Gonorrhea Rapid Test Device – Swab98/79 H. pylori Antigen Control D-P-FIHPG98/79 H. pylori Antigen Rapid Test Device -Feces D-RHPAGD2598/79 H. pylori Antigen Rapid Test strip-Feces D-HPAGS2598/79 H.pylori Ag Control D-S-CHPG98/79 H.pylori Antibody Control D-L-CHPB98/79 H.pylori antibody Rapid Test Device – S/P D-HPABD4098/79 H.pylori Antibody Rapid Test Device – WB/S/P98/79 H.pylori Antigen Control D-PL-CHPG98/79 H.pylori Rapid Test Device – WB/S/P98/79 HAV IgG/IgM Combo Rapid Test Device – WB/S/P98/79 HAV IgM Rapid Test Device – WB/S/P98/79 HAV IgM Rapid Test S/P D-HAVMD2098/79 HB Hemoglobin Strip D-HBMS5098/79 HEV IgG/IgM Rapid Test Device D-HEVD2098/79 HPV 16/18 qPCR Kit-Cervical Swab2 réf.98/79 HPV Antigen Control D-S-CHPV98/79 HPV Antigen Rapid Test -Cervical Swab D-HPVCSD2598/79 HPV Antigen Rapid Test Device – Cervical Swab D-HPVD2098/79 HSV 1/2 IgG Rapid Test Device – S/P98/79 HSV 1/2 IgG Rapid Test Device – WB/S/P98/79 HSV 1/2 IgG/IgM Combo Rapid Test Device – S/P98/79 HSV 1/2 IgG/IgM Combo Rapid Test Device – WB/S/P98/79 HSV 1/2 IgG/IgM Rapid Test Device – S/P98/79 HSV 1/2 IgG/IgM Rapid Test Device – WB/S/P98/79 HSV 1/2 IgM Rapid Test Device - WB/S/P2 réf.98/79 HSV-1 IgG/IgM Rapid Test -WB/S/P98/79 HSV-2 IgG/IgM Rapid Test -WB/S/P98/79 Human Metapneumovirus Antigen Control D-PL-HMPV98/79 Influenza A Rapid Test Device -Swab/Nasal Aspirate98/79 Influenza A Rapid Test Strip – Swab/Nasal Aspirate98/79 Influenza A+B Control D-S-CFLAB98/79 Influenza A+B Rapid Test Device – Swab/Nasal Aspirate98/79 Influenza A+B Rapid Test Device-Swab D-RINFABD2598/79 Influenza A+B Rapid Test Strip – Swab/Nasal Aspirate2 réf.98/79 Influenza A+B Test Device -Swab D-FIIABD2098/79 Influenza A/B+H1N1 Control98/79 Lateral Flow Reader Plus Legionella pneumophila Control5 réf.98/79 Legionella pneumophila Rapid Test Device – Urine98/79 Legionella pneumophila Test Device -Urine2 réf.98/79 Leishmania IgG/IgM Rapid Test Device D-LEIGMD2098/79 Malaria P.f. Control D-P-CMPF98/79 Malaria P.f./P.v. Control D-P-CMPV98/79 Malaria P.f./P.v. Rapid Test Device - WB98/79 Malaria P.f./P.v. Rapid Test Device -WB/S/P98/79 Malaria P.f./P.v./Pan Control D-P-CMPVF98/79 Malaria P.f./P.v./Pan Rapid Test Device – WB98/79 Malaria P.f./P.v./Pan Test Device--WB2 réf.98/79 Malaria P.f./Pan Control D-P-CMPN98/79 Malaria P.f./Pan Rapid Test Device – WB98/79 Malaria Pf Rapid Test Strip – WB98/79 Monkeypox Virus Antibody Control D-L-CMPOX98/79 Monkeypox Virus Antibody Rapid Test--Whole Blood/Serum/Plasma D-MPOXD2598/79 Monkeypox Virus Antigen Control D-PL-CMPOXAG98/79 Monkeypox Virus Antigen Rapid Test-Whole Blood/Serum/Plasma D-MPOXAGD2598/79 Monkeypox Virus Antigen Test Device-Fingerstick WB, WB/S/P/Rash Exudate Swab/Throat Swab98/79 MONO Control D-L-CMONO98/79 MONO Rapid Test Device -WB/S/P2 réf.98/79 Multiplex 5 Respiratory Antigen Rapid Test Device-Swab2 réf.98/79 Multiplex 6 Respiratory Antigen Rapid Test Device-Swab2 réf.98/79 Multiplex 7 Respiratory Antigen Rapid Test Device-Swab2 réf.98/79 Multiplex 8 Respiratory Antigen Rapid Test Device-Swab2 réf.98/79 Multiplex 9 Respiratory Antigen Rapid Test Device-Swab2 réf.98/79 Multiplex Respiratory Antigen Control D-S-CRT998/79 Mycoplasma Pneumoniae Antigen Control D-S-CMP98/79 Mycoplasma Pneumoniae IgG/Ig M Rapid Test Device – WB/S/P98/79 Mycoplasma pneumoniae IgG/IgM Control D-L-CMPGM98/79 Mycoplasma pneumoniae IgM Control D-L-CMPM98/79 Mycoplasma Pneumoniae IgM Rapid Test Device – WB/S/P98/79 Mycoplasma pneumoniae/Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Device-Nasopharyngeal Swab98/79 Norovirus Control D-PL-CNOR98/79 Norovirus+Rotavirus/Adenovirus+Astrovirus+Enterovirus Combo Rapid Test Device-Feces D-NRAAED1098/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Device - Feces D-NRAAD0198/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Device - Feces D-NRAAD1098/79 Norovirus/Rotavirus/Adenovirus Combo Test Device-Feces D-FINRAD1098/79 Norovirus/Rotavirus/Adenovirus Combo Test Device-Feces D-FINRAD2598/79 Norovirus/Rotavirus/Adenovirus Control D-PL-CNRA98/79 Portable Lateral Flow (LF) Reader Rotavirus and Adenovirus Combo Control D-P-FIRAC98/79 Rotavirus and Adenovirus Test Device-Feces D-FIROAAGD1098/79 Rotavirus and Adenovirus Test Device-Feces D-FIROAAGD2598/79 Rotavirus Control D-PL-CROT98/79 RSV Control D-S-CRSV98/79 RSV Control D-S-FIRSV98/79 RSV Rapid Test Device-Nasopharyngeal swab/Nasal Aspirate98/79 RSV Test Device -Swab D-FIRSVD2098/79 RSV/HMPV Combo Rapid Test Device-Nasopharyngeal Swab98/79 RSV/HMPV/Adenovirus/HPIV/Influenza A+B Combo Rapid Test Device98/79 RSV/Influenza A+B Control D-S-CRI98/79 RSV/Influenza A+B/COVID-19 Combo Test Device-Nasopharyngeal Swab98/79 Rubella Ig M Rapid Test Device – Serum/Plasma D-RUBMD1098/79 S. pneumoniae and L. pneumophila Control98/79 S. pneumoniae/L. pneumophila Control98/79 Salmonella paratyphi Antigen Control98/79 Salmonella paratyphi Antigen Rapid Test Device -Feces98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test Device – WB/S/P98/79 Salmonella typhi Antigen Control98/79 Salmonella typhi Antigen Rapid Test Device – Feces98/79 SARS-CoV-2 & Inﬂuenza A+B & RSV & Adenovirus & M.pneumoniae Antigen Combo Rapid Test98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test Device-Swab98/79 SARS-CoV-2 Antigen Control98/79 SARS-CoV-2 Antigen Control (Swab)98/79 SARS-CoV-2 Antigen Rapid Test Device – Swab2 réf.98/79 SARS-CoV-2 Neutralization Antibody Rapid Test Devie-WB/S/P98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Control98/79 SARS-CoV-2/Influenza A+B/RSV/ Adenovirus/M. pneumoniae Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test Device-Nasopharyngeal Swab2 réf.98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test-Nasopharyngeal Swab98/79 Scrub Typhus IgG/IgM Control2 réf.98/79 Shigella Rapid Test Device D-SHID2098/79 Sickle Cell Rapid Test Device-WB98/79 Strep A Control D-L-CSTA98/79 Strep A Control D-P-FISTA98/79 Strep A Rapid Test Device -Throat Swab3 réf.98/79 Strep A RTC Rapid Test Device – Throat Swab98/79 Strep A Test Device -Swab D-FISTRAS2098/79 Strep B Control D-L-CSTB98/79 Strep B Rapid Test Device – Swab D-STRBD2098/79 Strep B Rapid Test Strip – Swab D-STRBS2098/79 Streptococcus pneumoniae antigen Rapid Test Device – Urine98/79 Streptococcus pneumoniae Control3 réf.98/79 Streptococcus pneumoniae Test Device -Urine2 réf.98/79 Syphilis Control D-L-CSYP98/79 Syphilis Control D-P-CSYP98/79 Syphilis Control D-P-FISYP98/79 Syphilis Rapid Test Device -S/P D-RTPD4098/79 Syphilis Rapid Test Device – S/P D-TPSPD4098/79 Syphilis Rapid Test Device – WB/S/P2 réf.98/79 Syphilis Rapid Test Strip – S/P D-TPSPS5098/79 Syphilis Rapid Test Strip – WB/S/P2 réf.98/79 Syphilis Test Device -WB/S/P3 réf.98/79 Syphilis Test Kit-human serum or plasma D-CITPK4098/79 Tetanus Control D-PL-CTET98/79 Tetanus Rapid Test Device – WB/S/P2 réf.98/79 Toxoplasmosis IgG/ Ig M Rapid Test Strip – WB/S/ P98/79 Trichomonas Vaginalis Control D-PL-CTV98/79 Trichomonas Vaginalis Rapid Test Device D-TVD1098/79 Trichomonas Vaginalis Rapid Test Device – Swab D-TRVAD1098/79 Tuberculosis Control98/79 Typhoid Rapid Test Device – WB/S/P98/79 Typhoid IgG/IgM Rapid Tes Device– WB/S/P98/79 Typhoid Rapid Test Device – S/P2 réf.98/79 Typhoid Rapid Test Strip - WB/S/P98/79 Typhoid Rapid Test Strip – S/P98/79 Uric Acid Meter RL-AUAR-1002 réf. Urine Analyzer RL-UA-5A2 réf. Vibrio cholerae O1/O139 Control98/79 Widal Kit Salmonella Ha,Hb,Hc,Hd,OA,OB,OC,OD. +tve/-tve Control98/79 Zika antigen Test Device -WB/S/P98/79 Zika IgG/IgM & NS1 Combo Rapid Test Device – WB/S/P98/79 Zika IgG/IgM Control D-L-CZIB98/79 Zika IgG/IgM Rapid Test Device – WB/S/P98/79 Zika IgM Test Device -WB/S/P98/79 Zika NS1 Control98/79 Zika NS1 Rapid Test Device -WB/S/P98/79	A IVDR, 98/79	Site web info@rapidlabs.co.uk Fiche EUDAMED Signaler une erreur
Dartmon FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 2 autres	Chine	AACT Antibody Reagent (Immunohistochemistry) DMRD017098/79 ACTH Antibody Reagent (Immunohistochemistry) MMB1A12098/79 Actin Antibody Reagent (Immunohistochemistry) DMRD017298/79 ALK Antibody Reagent (Immunohistochemistry) RMB1A00198/79 Alkaline Phosphatase Red Detection Kit DMRD055898/79 228 autres Alpha-1-Fetoprotein Antibody Reagent (Immunohistochemistry) RMF1B13798/79 AMACR/p504s Antibody Reagent (Immunohistochemistry) RMB1A03998/79 Androgen Receptor Antibody Reagent (Immunohistochemistry) DMRDB15398/79 Arginase-1 Antibody Reagent (Immunohistochemistry) DMRD017398/79 ATRX Antibody Reagent (Immunohistochemistry) DMRD034198/79 bcl-2 Antibody Reagent (Immunohistochemistry) RMB1A04098/79 bcl-6 Antibody Reagent (Immunohistochemistry) RMB1A05198/79 Beta-catenin Antibody Reagent (Immunohistochemistry) RMB1A08598/79 Bob.1 Antibody Reagent (Immunohistochemistry) DMRD016698/79 BRAF Antibody Reagent (Immunohistochemistry) RMB1A10698/79 c-KIT/CD117 Antibody Reagent (Immunohistochemistry) DMRD017798/79 c-MYC Antibody Reagent (Immunohistochemistry) MMB1A11198/79 C4D Antibody Reagent (Immunohistochemistry) DMRD034298/79 CA 125 Antibody Reagent (Immunohistochemistry) RMA1B13898/79 CA 19-9 Antibody Reagent (Immunohistochemistry) DMRDB13998/79 Calcitonin Antibody Reagent (Immunohistochemistry) RPB1A10498/79 Caldesmon Antibody Reagent (Immunohistochemistry) DMRD059398/79 Caldesmon Antibody Reagent (Immunohistochemistry) MMB1A11298/79 Calponin Antibody Reagent (Immunohistochemistry) RMF1A05298/79 Calretinin Antibody Reagent (Immunohistochemistry) RMB1A05398/79 Carbonic Anhydrase IX Antibody Reagent (Immunohistochemistry) DMRD017698/79 CD10 Antibody Reagent (Immunohistochemistry) RMA1A00298/79 CD123 Antibody Reagent (Immunohistochemistry) DMRD017898/79 CD138 Antibody Reagent (Immunohistochemistry) RMB1A05498/79 CD138 Antibody Reagent DMRD037498/79 CD15 Antibody Reagent (Immunohistochemistry) MMB1A10298/79 CD163 Antibody Reagent (Immunohistochemistry) MMB1A13098/79 CD19 Antibody Reagent (Immunohistochemistry) DMRDB14598/79 CD1a Antibody Reagent (Immunohistochemistry) RMB1A05598/79 CD2 Antibody Reagent (Immunohistochemistry) DMRD059298/79 CD2 Antibody Reagent (Immunohistochemistry) MMB1A12698/79 CD20 Antibody Reagent (Immunohistochemistry) DMRD017998/79 CD21 Antibody Reagent (Immunohistochemistry) RMA1A00398/79 CD23 Antibody Reagent (Immunohistochemistry) RMA1A00498/79 CD3 Antibody Reagent (Immunohistochemistry) RMA1A00598/79 CD30 Antibody Reagent (Immunohistochemistry) RMF1A05698/79 CD31 Antibody Reagent (Immunohistochemistry) RMA1A05798/79 CD34 Antibody Reagent (Immunohistochemistry) RMA1A00698/79 CD35 Antibody Reagent (Immunohistochemistry) DMRD018198/79 CD38 Antibody Reagent (Immunohistochemistry) RMB1A05898/79 CD4 Antibody Reagent (Immunohistochemistry) RMA1A00798/79 CD41 Antibody Reagent (Immunohistochemistry) DMRD034498/79 CD43 Antibody Reagent (Immunohistochemistry) MMB1A11698/79 CD44 Antibody Reagent (Immunohistochemistry) DMRDB14098/79 CD45 Antibody Reagent (Immunohistochemistry) MMB1A09698/79 CD45RO Antibody Reagent (Immunohistochemistry) DMRD018398/79 CD5 Antibody Reagent (Immunohistochemistry) RMF1A05998/79 CD56 Antibody Reagent (Immunohistochemistry) MMB1A06098/79 CD57 Antibody Reagent (Immunohistochemistry) DMRD018498/79 CD61 Antibody Reagent (Immunohistochemistry) DMRD018598/79 CD68 Antibody Reagent (Immunohistochemistry) RMA1A00898/79 CD7 Antibody Reagent (Immunohistochemistry) MMB1A09798/79 CD71 Antibody Reagent (Immunohistochemistry) DMRD030398/79 CD79a Antibody Reagent (Immunohistochemistry) RMA1A06198/79 CD8 Antibody Reagent (Immunohistochemistry) RMA1A00998/79 CD99 Antibody Reagent (Immunohistochemistry) RMF1A09498/79 CDK4 Antibody Reagent (Immunohistochemistry) DMRDB15898/79 CDX-2 Antibody Reagent (Immunohistochemistry) RMA1A06298/79 CEA Antibody Reagent (Immunohistochemistry) RPB1A01098/79 Chromogranin A Antibody Reagent (Immunohistochemistry) RMF1A06398/79 Claudin18.2 Antibody Reagent (Immunohistochemistry) DMRD029798/79 Collagen Type IV Antibody Reagent (Immunohistochemistry) MMB1A12298/79 CXCL-13 Antibody Reagent (Immunohistochemistry) DMRD018998/79 Cyclin D1 Antibody Reagent (Immunohistochemistry) DMRDB14298/79 Cytokeratin (HMW) Antibody Reagent (Immunohistochemistry) MMB1A06598/79 Cytokeratin (LMW) Antibody Reagent (Immunohistochemistry) MMB1A08798/79 Cytokeratin (Pan) Antibody Reagent (Immunohistochemistry) MMB1A08898/79 Cytokeratin 14 Antibody Reagent (Immunohistochemistry) RMA1A01198/79 Cytokeratin 17 Antibody Reagent (Immunohistochemistry) DMRD018698/79 Cytokeratin 18 Antibody Reagent (Immunohistochemistry) MMB1A12498/79 Cytokeratin 19 Antibody Reagent (Immunohistochemistry) RMA1A01298/79 Cytokeratin 20 Antibody Reagent (Immunohistochemistry) RMA1A01398/79 Cytokeratin 5&6 Antibody Reagent (Immunohistochemistry) RMB1A01498/79 Cytokeratin 7 Antibody Reagent (Immunohistochemistry) RMB1A01598/79 Cytokeratin 8 Antibody Reagent (Immunohistochemistry) DMRDB14198/79 Cytokeratin 8&18 Antibody Reagent (Immunohistochemistry) RMB1A06498/79 Cytokeratin CAM 5.2 Antibody Reagent (Immunohistochemistry) DMRDB14498/79 Desmin Antibody Reagent (Immunohistochemistry) DMRD059198/79 Desmin Antibody Reagent (Immunohistochemistry) RMA1A01698/79 DOG1 Antibody Reagent (Immunohistochemistry) RMA1A01798/79 E-Cadherin Antibody Reagent (Immunohistochemistry) DMRD055598/79 E-Cadherin Antibody Reagent (Immunohistochemistry) RMB1A01898/79 EGFR Antibody Reagent (Immunohistochemistry) RMF1A06698/79 EMA Antibody Reagent (Immunohistochemistry) DMRD055398/79 EMA Antibody Reagent (Immunohistochemistry) MMB1A06798/79 Ep-CAM Antibody Reagent (Immunohistochemistry) RMA1A06898/79 Epstein-Barr Virus Antibody Reagent (Immunohistochemistry) DMRD019098/79 ERCC1 Antibody Reagent (Immunohistochemistry) DMRD019298/79 ERG Antibody Reagent (Immunohistochemistry) DMRD019398/79 Estrogen Receptor Antibody Reagent (Immunohistochemistry) DMRD019198/79 FLI-1 Antibody Reagent (Immunohistochemistry) MMB1A11798/79 FSH Antibody Reagent (Immunohistochemistry) MMB1A12198/79 Fully Automatic IHC Stainer AS1003 réf. Fully Automatic IHC Stainer AS3003 réf. Fully Automatic IHC Stainer AS6003 réf. Galectin-3 Antibody Reagent (Immunohistochemistry) RMF1A06998/79 Gastrin Antibody Reagent (Immunohistochemistry) DMRD019998/79 GATA3 Antibody Reagent (Immunohistochemistry) DMRD039498/79 GATA3 Antibody Reagent (Immunohistochemistry) RMB1A07098/79 GCDFP-15 Antibody Reagent (Immunohistochemistry) MMB1A12798/79 Glial Fibrillary Acidic Protein Antibody Reagent (Immunohistochemistry) RMA1A01998/79 Glutamine Synthetase Antibody Reagent (Immunohistochemistry) MMB1A11998/79 Glycophorin A Antibody Reagent (Immunohistochemistry) DMRD018098/79 Glypican 3 Antibody Reagent (Immunohistochemistry) MMB1A12598/79 Granzyme B Antibody Reagent (Immunohistochemistry) RMB1A12898/79 GST-π Antibody Reagent (Immunohistochemistry) RMF1A11898/79 H3.3G34W Antibody Reagent (Immunohistochemistry) DMRD020298/79 Helicobacter pylori Antibody Reagent (Immunohistochemistry) RMG1A13398/79 Hepatocyte Specific Antigen Antibody Reagent (Immunohistochemistry) MMB1A09598/79 HER2 Antibody Reagent (Immunohistochemistry) DMRD020398/79 HER2 Antibody Reagent (Immunohistochemistry) DMRD039698/79 HPV Antibody Reagent (Immunohistochemistry) DMRD024298/79 Human Placental Lactogen Antibody Reagent (Immunohistochemistry) DMRD020798/79 IDH-1 Antibody Reagent (Immunohistochemistry) DMRD020898/79 IgA Antibody Reagent (Immunohistochemistry) MMB1A13298/79 IgG Antibody Reagent (Immunohistochemistry) RMB1A07198/79 IgG4 Antibody Reagent (Immunohistochemistry) MMB1A11498/79 IgM Antibody Reagent (Immunohistochemistry) DMRD020998/79 Immunochromogenic Reagent DMRD4044 Immunochromogenic Reagent DMRD514998/79 Immunochromogenic Reagent DMRD515098/79 Immunochromogenic Reagent Kit DS I DMRD034998/79 Immunochromogenic Reagent Kit DS Ⅱ DMRD035098/79 Immunochromogenic Reagent Ⅱ DMRD036998/79 In-situ Denaturation and Hybridization Processor DH1003 réf. Inhibin, alpha Antibody Reagent (Immunohistochemistry) RMB1A07298/79 INI-1 Antibody Reagent (Immunohistochemistry) DMRD021198/79 INI-1 Antibody Reagent (Immunohistochemistry) DMRD055698/79 INSM1 Antibody Reagent (Immunohistochemistry) DMRD016898/79 ISH Detection Kit DMRD058298/79 ISH Detection Kit DMRD058698/79 ISH EBER Probe DMRD057798/79 ISH Kappa Probe DMRD057998/79 ISH Lambda Probe DMRD058098/79 Kappa Light Chain Antibody Reagent (Immunohistochemistry) RMF1A08698/79 Ki-67 Antibody Reagent (Immunohistochemistry) RMA1A02098/79 Ki-67 Antibody Reagent DMRD035998/79 Lambda Light Chain Antibody Reagent (Immunohistochemistry) DMRD021498/79 LEF-1 Antibody Reagent (Immunohistochemistry) DMRD021798/79 LH Antibody Reagent (Immunohistochemistry) DMRD022098/79 Mammaglobin Antibody Reagent (Immunohistochemistry) DMRD022198/79 MART-1/melan A Antibody Reagent (Immunohistochemistry) RMF1A07398/79 MC Antibody Reagent (Immunohistochemistry) MMB1A09898/79 MDM2 Antibody Reagent (Immunohistochemistry) DMRD058898/79 MDM2 Antibody Reagent (Immunohistochemistry) MMB1A07498/79 Melanoma Antibody Reagent (Immunohistochemistry) DMRD022398/79 Melanoma Pan Antibody Reagent (Immunohistochemistry) DMRD022298/79 MLH1 Antibody Reagent (Immunohistochemistry) MMB1A07598/79 MSH2 Antibody Reagent (Immunohistochemistry) RMB1A07698/79 MSH6 Antibody Reagent (Immunohistochemistry) RMB1A07798/79 MUC-1 Antibody Reagent (Immunohistochemistry) MMB1A09998/79 MUC-4 Antibody Reagent (Immunohistochemistry) DMRD022798/79 MUC-4 Antibody Reagent (Immunohistochemistry) DMRD058998/79 MUC2 Antibody Reagent (Immunohistochemistry) DMRDB14698/79 MUC5AC Antibody Reagent (Immunohistochemistry) DMRD022898/79 MUC6 Antibody Reagent (Immunohistochemistry) DMRD022998/79 MUM1 Antibody Reagent (Immunohistochemistry) RMF1A10998/79 MUM1 Antibody Reagent DMRD037598/79 Myeloperoxidase Antibody Reagent (Immunohistochemistry) RMB1A07898/79 Myo D1 Antibody Reagent (Immunohistochemistry) RMB1A10098/79 Myogenin Antibody Reagent (Immunohistochemistry) DMRDB15298/79 Napsin A Antibody Reagent (Immunohistochemistry) RMB1A02298/79 Nkx2.2 Antibody Reagent (Immunohistochemistry) DMRD023598/79 NKX3.1 Antibody Reagent (Immunohistochemistry) DMRD023698/79 NSE Antibody Reagent (Immunohistochemistry) MMB1A10898/79 NUT Antibody Reagent (Immunohistochemistry) DMRDB15698/79 Oct2 Antibody Reagent (Immunohistochemistry) DMRD023898/79 Oct3/4 Antibody Reagent (Immunohistochemistry) DMRD023998/79 Olig2 Antibody Reagent (Immunohistochemistry) DMRD024098/79 p120 Antibody Reagent (Immunohistochemistry) RMA1A07998/79 p16 Antibody Reagent (Immunohistochemistry) RMB1A09198/79 p16 Antibody Reagent DMRD035898/79 p40 Antibody Reagent (Immunohistochemistry) RMA1A02398/79 p53 Antibody Reagent (Immunohistochemistry) MMB1A02498/79 p57 Antibody Reagent (Immunohistochemistry) MMB1A10198/79 p63 Antibody Reagent (Immunohistochemistry) RMA1A02698/79 Parathyroid Hormone Antibody Reagent (Immunohistochemistry) DMRD025298/79 Pax-2 Antibody Reagent (Immunohistochemistry) DMRDB14798/79 Pax-5 Antibody Reagent (Immunohistochemistry) RMB1A09398/79 Pax-8 Antibody Reagent (Immunohistochemistry) DMRD039598/79 Pax-8 Antibody Reagent (Immunohistochemistry) RMB1A11098/79 PD-1 Antibody Reagent (Immunohistochemistry) RMB1A03898/79 PD-L1 Antibody Reagent (Immunohistochemistry) DMRD024498/79 Phosphohistone H3 Antibody Reagent (Immunohistochemistry) DMRD024698/79 PLAP Antibody Reagent (Immunohistochemistry) DMRD024798/79 PMS2 Antibody Reagent (Immunohistochemistry) RMB1A08098/79 Podoplanin Antibody Reagent (Immunohistochemistry) MMB1A09298/79 PRAME Antibody Reagent (Immunohistochemistry) DMRD033098/79 PRL Antibody Reagent (Immunohistochemistry) RMB1A08198/79 Progesterone Receptor Antibody Reagent (Immunohistochemistry) DMRD024998/79 PSMA Antibody Reagent (Immunohistochemistry) RMB1A02898/79 PTEN Antibody Reagent (Immunohistochemistry) DMRD029098/79 PTEN Antibody Reagent (Immunohistochemistry) DMRD059098/79 Rb Gene Protein Antibody Reagent (Immunohistochemistry) DMRD025398/79 Renal Cell Carcinoma Marker Antibody Reagent (Immunohistochemistry) DMRD025498/79 ROS1 Antibody Reagent (Immunohistochemistry) DMRD025598/79 ROS1 Antibody Reagent (Immunohistochemistry) DMRD055798/79 S100 Antibody Reagent (Immunohistochemistry) RMA1A02998/79 SALL4 Antibody Reagent (Immunohistochemistry) MMB1A10398/79 SATB2 Antibody Reagent (Immunohistochemistry) DMRD025898/79 SDHB Antibody Reagent (Immunohistochemistry) DMRD025998/79 SMA Antibody Reagent (Immunohistochemistry) MMB1A08298/79 SMARCA4/Brg1 Antibody Reagent (Immunohistochemistry) DMRDB15798/79 Smooth Muscle Myosin Antibody Reagent (Immunohistochemistry) DMRD026298/79 Somatostatin Antibody Reagent (Immunohistochemistry) DMRD026398/79 SOX-10 Antibody Reagent (Immunohistochemistry) DMRD026498/79 SOX-10 Antibody Reagent (Immunohistochemistry) DMRD039798/79 SOX-11 Antibody Reagent (Immunohistochemistry) DMRD016598/79 STAT6 Antibody Reagent (Immunohistochemistry) DMRD026598/79 Synaptophysin Antibody Reagent (Immunohistochemistry) RMA1A03098/79 TdT Antibody Reagent (Immunohistochemistry) RMB1A08398/79 TFE3 Antibody Reagent (Immunohistochemistry) RMF1A11398/79 Thyroglobulin Antibody Reagent (Immunohistochemistry) RMA1A03198/79 TIA-1 Antibody Reagent (Immunohistochemistry) MMB1A13198/79 TintoStainer Plus Automated System BSB-7400 TintoStainer Plus LX Automated System BSB-7400-60 TintoStainer Plus Mini Automated System BSB-7400-10 TOP2A Antibody Reagent (Immunohistochemistry) RMA1A03298/79 TPO Antibody Reagent (Immunohistochemistry) RMB1A11598/79 TROP2 Antibody Reagent (Immunohistochemistry) DMRD029898/79 TSH Antibody Reagent (Immunohistochemistry) DMRD027198/79 TTF-1 Antibody Reagent (Immunohistochemistry) MMB1A03398/79 Uroplakin Ⅲ Antibody Reagent (Immunohistochemistry) DMRD027298/79 VEGF Antibody Reagent (Immunohistochemistry) DMRD027398/79 Villin Antibody Reagent (Immunohistochemistry) RMA1A03498/79 Vimentin Antibody Reagent (Immunohistochemistry) RMA1A03598/79 WT1 Antibody Reagent (Immunohistochemistry) DMRD055298/79 WT1 Antibody Reagent (Immunohistochemistry) MMB1A08498/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Vircell	Espagne	ADENOVIRUS ELISA IgG/IgM G/M100498/79 ADENOVIRUS VIRCLIA® IgG MONOTEST VCM00298/79 AMPLIRUN® ADENOVIRUS DNA CONTROL MBC001 AMPLIRUN® CHLAMYDIA TRACHOMATIS DNA CONTROL MBC012 AMPLIRUN® CHLAMYDOPHILA PNEUMONIAE DNA CONTROL MBC011 220 autres AMPLIRUN® CYTOMEGALOVIRUS DNA CONTROL MBC016 AMPLIRUN® ENTEROVIRUS 68 RNA CONTROL MBC125 AMPLIRUN® ENTEROVIRUS 71 RNA CONTROL MBC019 AMPLIRUN® EPSTEIN-BARR VIRUS DNA CONTROL MBC065 AMPLIRUN® HERPES SIMPLEX 1 DNA CONTROL MBC023 AMPLIRUN® HERPES SIMPLEX 2 DNA CONTROL MBC024 AMPLIRUN® INFLUENZA A H1 RNA CONTROL MBC028 AMPLIRUN® INFLUENZA A H3 RNA CONTROL MBC029 AMPLIRUN® INFLUENZA A H5 RNA CONTROL MBC052 AMPLIRUN® INFLUENZA B RNA CONTROL MBC030 AMPLIRUN® MYCOBACTERIUM TUBERCULOSIS DNA CONTROL MBC034 AMPLIRUN® MYCOPLASMA GENITALIUM DNA CONTROL MBC085 AMPLIRUN® MYCOPLASMA HOMINIS DNA CONTROL MBC084 AMPLIRUN® MYCOPLASMA PNEUMONIAE DNA CONTROL MBC035 AMPLIRUN® NEISSERIA GONORRHOEAE DNA CONTROL MBC075 AMPLIRUN® NOVEL INFLUENZA A H1N1 RNA CONTROL MBC082 AMPLIRUN® PARAINFLUENZA 1 RNA CONTROL MBC037 AMPLIRUN® PARAINFLUENZA 2 RNA CONTROL MBC038 AMPLIRUN® PARAINFLUENZA 3 RNA CONTROL MBC039 AMPLIRUN® PARAINFLUENZA 4 A RNA CONTROL MBC050 AMPLIRUN® RESPIRATORY SYNCYTIAL VIRUS (A) RNA CONTROL MBC041 AMPLIRUN® RESPIRATORY SYNCYTIAL VIRUS (B) RNA CONTROL MBC083 AMPLIRUN® RHINOVIRUS RNA CONTROL MBC091 AMPLIRUN® SARS-CoV-2 RNA CONTROL MBC13798/79 AMPLIRUN® TOTAL CT/NG CONTROL (EXUDATE) MBTC00698/79 AMPLIRUN® TOTAL CT/NG CONTROL (URINE) MBTC00398/79 AMPLIRUN® TOTAL FLU A/FLU B/RSV CONTROL (SWAB) MBTC02898/79 AMPLIRUN® TOTAL GASTROINTESTINAL BACTERIAL PANEL CONTROL (STOOL) MBTC02198/79 AMPLIRUN® TOTAL HSV-1/HSV-2/VZV CONTROL (EXUDATE) MBTC01698/79 AMPLIRUN® TOTAL MACROLIDE RESISTANT MGE CONTROL PANEL (SWAB) MBTC02998/79 AMPLIRUN® TOTAL MDR-TB VERIFICATION & CONTROL PANEL MBTC02798/79 AMPLIRUN® TOTAL MTB CONTROL (SPUTUM) MBTC01398/79 AMPLIRUN® TOTAL MTB INH RESISTANT CONTROL (SPUTUM) MBTC01598/79 AMPLIRUN® TOTAL MTB RIF RESISTANT CONTROL (SPUTUM) MBTC01498/79 AMPLIRUN® TOTAL RESPIRATORY VIRAL PANEL CONTROL (SWAB) MBTC02098/79 AMPLIRUN® TOTAL SARS-CoV-2 CONTROL (SWAB) MBTC03098/79 AMPLIRUN® TOTAL SARS-CoV-2/FluA/FluB/RSV CONTROL (SWAB) MBTC03198/79 AMPLIRUN® TOTAL ZIKV/DENV/CHIKV CONTROL (PLASMA) MBTC02398/79 AMPLIRUN® TOXOPLASMA GONDII DNA CONTROL MBC047 AMPLIRUN® TREPONEMA PALLIDUM DNA CONTROL MBC109 AMPLIRUN® TRICHOMONAS VAGINALIS DNA CONTROL MBC079 AMPLIRUN® UREAPLASMA UREALYTICUM DNA CONTROL MBC112 AMPLIRUN® VARICELLA-ZOSTER VIRUS DNA CONTROL MBC048 ASPERGILLUS GALACTOMANNAN AG VIRCLIA® MONOTEST VCM073 BORDETELLA PERTUSSIS TOXIN VIRCLIA® IgG MONOTEST VCM09298/79 BORDETELLA REALTIME PCR KIT RTPCR030 BORRELIA VIRCLIA® IgG MONOTEST VCM009 BORRELIA VIRCLIA® IgM MONOTEST VCM010 Brucella ELISA IgG G100398/79 BRUCELLA ELISA IgM M100698/79 BRUCELLA VIRCLIA® IgG MONOTEST VCM00598/79 BRUCELLA VIRCLIA® IgM MONOTEST VCM00798/79 BRUCELLACAPT® BRUCAPT98/79 CHAGAS ELISA IgG+IgM T102098/79 CHAGAS IFA IgG+IgM PCHAG98/79 CHAGAS TESA ELISA IgG+IgM T102398/79 CHAGAS TESA VIRCLIA® IgG+IgM MONOTEST VCM09998/79 CHAGAS VIRCLIA® IgG+IgM MONOTEST VCM00898/79 CHIKUNGUNYA ELISA IgG G101098/79 CHIKUNGUNYA ELISA IgM M101098/79 CHIKUNGUNYA VIRCLIA® IgG MONOTEST VCM05998/79 CHIKUNGUNYA VIRCLIA® IgM MONOTEST VCM06398/79 CHLAMYDOPHILA PNEUMONIAE ELISA IgG G1007 CHLAMYDOPHILA PNEUMONIAE ELISA IgM M1007 CHLAMYDOPHILA PNEUMONIAE IFA IgG PCHPNG98/79 CHLAMYDOPHILA PNEUMONIAE IFA IgM PCHPNM98/79 CHLAMYDOPHILA PNEUMONIAE VIRCLIA® IgA MONOTEST VCM016 CHLAMYDOPHILA PNEUMONIAE VIRCLIA® IgG MONOTEST VCM017 CHLAMYDOPHILA PNEUMONIAE VIRCLIA® IgM MONOTEST VCM018 CLOSTRIDIUM DIFFICILE GDH Ag VIRCLIA® MONOTEST VCM108 CLOSTRIDIUM DIFFICILE TOXINS REAL TIME PCR KIT RTPCR020 COVID-19 SPIKE QUANTITATIVE VIRCLIA® IgG MONOTEST VCM10098/79 COVID-19 VIRCLIA® IgG MONOTEST VCM09798/79 COVID-19 VIRCLIA® IgM+IgA MONOTEST VCM09898/79 COXIELLA BURNETII ELISA IgG G100198/79 COXIELLA BURNETII ELISA IgM M100198/79 COXIELLA BURNETII I+II IFA IgG/IgM/IgA PCOBUI+II98/79 COXIELLA BURNETII IFA IgG PCOBUG98/79 COXIELLA BURNETII IFA IgM PCOBUM98/79 COXIELLA BURNETII IFA SLIDE SCOBU98/79 COXIELLA BURNETII VIRCLIA® IgG MONOTEST VCM01998/79 COXIELLA BURNETII VIRCLIA® IgM MONOTEST VCM02098/79 CT/NG/TV/MG REALTIME PCR KIT RTPCR0062 réf.98/79 DENGUE ELISA IgG G101898/79 DENGUE ELISA IgM CAPTURE M101898/79 DENGUE VIRCLIA® IgG MONOTEST VCM02398/79 DENGUE VIRCLIA® IgM MONOTEST VCM02498/79 DIPHTHERIA VIRCLIA® IgG MONOTEST VCM00698/79 DIRECT SARS-COV-2 REALTIME PCR KIT RTPCR0023 réf.98/79 EPSTEIN-BARR EA ELISA IgG G120598/79 EPSTEIN-BARR EA VIRCLIA® IgG MONOTEST VCM04498/79 EPSTEIN-BARR EBNA ELISA IgG G110598/79 EPSTEIN-BARR EBNA VIRCLIA® IgG MONOTEST VCM02698/79 EPSTEIN-BARR VCA ELISA IgG G100598/79 EPSTEIN-BARR VCA ELISA IgM M100598/79 EPSTEIN-BARR VCA VIRCLIA® IgG MONOTEST VCM027 EPSTEIN-BARR VCA VIRCLIA® IgM MONOTEST VCM02898/79 GASTROBACTERIA REALTIME PCR KIT RTPCR029 GASTROPARASITES 1 REALTIME PCR KIT RTPCR024 GASTROVIRUS REALTIME PCR KIT RTPCR028 GENITAL ULCER REALTIME PCR KIT RTPCR007 HELICOBACTER PYLORI Ag VIRCLIA® MONOTEST VCM1032 réf. HELICOBACTER PYLORI ELISA IgA A102298/79 HELICOBACTER PYLORI ELISA IgG G102298/79 HELICOBACTER PYLORI VIRCLIA® IgA MONOTEST VCM02998/79 HELICOBACTER PYLORI VIRCLIA® IgG MONOTEST VCM03098/79 HEPATITIS DELTA REALTIME PCR KIT RTPCR017 HEPATITIS E VIRCLIA® IgG AVIDITY MONOTEST VCM093 HEPATITIS E VIRCLIA® IgG MONOTEST VCM066 HEPATITIS E VIRCLIA® IgM MONOTEST VCM067 HERPES SIMPLEX 1 ELISA IgG/IgM (gG1 recombinant) G/M101298/79 HERPES SIMPLEX 1 VIRCLIA® IgG MONOTEST VCM03198/79 HERPES SIMPLEX 1 VIRCLIA® IgM MONOTEST VCM03998/79 HERPES SIMPLEX 1+2 ELISA IgG/IgM G/M101698/79 HERPES SIMPLEX 1+2 VIRCLIA® IgG MONOTEST VCM03498/79 HERPES SIMPLEX 1+2 VIRCLIA® IgM MONOTEST VCM036 HERPES SIMPLEX 2 ELISA IgG/IgM (gG2 purified) G/M101398/79 HERPES SIMPLEX 2 VIRCLIA® IgG MONOTEST VCM03798/79 HERPES SIMPLEX 2 VIRCLIA® IgM MONOTEST VCM04198/79 HHV-6 VIRCLIA® lgG MONOTEST VCM00398/79 HYDATIDOSIS ELISA IgG G100698/79 HYDATIDOSIS VIRCLIA® IgG MONOTEST VCM04098/79 INFLUENZA A ELISA IgG/IgM G/M100798/79 INFLUENZA A VIRCLIA® IgG MONOTEST VCM04298/79 INFLUENZA B ELISA IgG/IgM G/M100898/79 INFLUENZA B VIRCLIA® IgG MONOTEST VCM04598/79 INVASIVE CANDIDIASIS (CAGTA) IFA IgG PCAALG98/79 INVASIVE CANDIDIASIS (CAGTA) VIRCLIA® IgG MONOTEST VCM09498/79 LEGIONELLA PL IFA IgG PLPLG98/79 LEGIONELLA PNEUMOPHILA IFA IgG PLEPNG98/79 LEGIONELLA PNEUMOPHILA IFA IgM PLEPNM98/79 LEGIONELLA PNEUMOPHILA SEROGROUP 1 ELISA IgG G100098/79 LEGIONELLA PNEUMOPHILA SEROGROUP 1 ELISA IgM M100098/79 LEGIONELLA PNEUMOPHILA SEROGROUPS 1-6 ELISA IgG+IgM T100198/79 LEGIONELLA PNEUMOPHILA SEROGROUPS 1-6 IFA IgG PLESXG98/79 LEGIONELLA PNEUMOPHILA SG 1 VIRCLIA® IgG MONOTEST VCM04998/79 LEGIONELLA PNEUMOPHILA SG 1 VIRCLIA® IgM MONOTEST VCM05098/79 LEGIONELLA PNEUMOPHILA SG 1-6 VIRCLIA® IgG+IgM MONOTEST VCM05298/79 LEGIONELLA SP IFA IgG PLESPG98/79 LEISHMANIA ELISA IgG+IgM T100098/79 LEISHMANIA IFA IgG PLEDOG98/79 LEISHMANIA IFA SLIDE SLEDO98/79 LEISHMANIA VIRCLIA® IgG+IgM MONOTEST VCM05398/79 LEPTOSPIRA ELISA IgM M100398/79 LEPTOSPIRA VIRCLIA® IgM MONOTEST VCM01498/79 MEASLES ELISA IgG/IgM G/M100198/79 MEASLES REALTIME PCR KIT RTPCR036 MEASLES VIRCLIA® IgM MONOTEST VCM057 MH/UU/UP REALTIME PCR KIT RTPCR026 MUMPS ELISA IgG/IgM G/M101498/79 MUMPS VIRCLIA® IgG MONOTEST VCM06098/79 MUMPS VIRCLIA® IgM MONOTEST VCM06198/79 MYCOBACTERIUM REALTIME PCR KIT RTPCR0162 réf. MYCOPLASMA PNEUMONIAE ELISA IgG G100298/79 MYCOPLASMA PNEUMONIAE ELISA IgG/IgM G/M101598/79 MYCOPLASMA PNEUMONIAE ELISA IgM M100298/79 MYCOPLASMA PNEUMONIAE IFA IgG PMYPNG98/79 MYCOPLASMA PNEUMONIAE IFA IgM PMYPNM98/79 MYCOPLASMA PNEUMONIAE VIRCLIA® IgG MONOTEST VCM062 MYCOPLASMA PNEUMONIAE VIRCLIA® IgM MONOTEST VCM064 PARAINFLUENZA 1 ELISA IgG/IgM G/M100998/79 PARAINFLUENZA 1 VIRCLIA® IgG MONOTEST VCM06598/79 PARAINFLUENZA 2 ELISA IgG/IgM G/M101098/79 PARAINFLUENZA 2 VIRCLIA® IgG MONOTEST VCM06898/79 PARAINFLUENZA 3 ELISA IgG/IgM G/M101198/79 PARAINFLUENZA 3 VIRCLIA® IgG MONOTEST VCM07198/79 PARVOVIRUS ELISA IgG G103198/79 PARVOVIRUS ELISA IgM CAPTURE M103198/79 PARVOVIRUS VIRCLIA® IgG MONOTEST VCM07598/79 PARVOVIRUS VIRCLIA® IgM MONOTEST VCM07698/79 RESPIRATORY SYNCYTIAL VIRUS ELISA IgG/IgM G/M100698/79 RESPIRATORY SYNCYTIAL VIRUS VIRCLIA® IgG MONOTEST VCM07798/79 RICKETTSIA CONORII ELISA IgG/IgM G/M100598/79 RICKETTSIA CONORII IFA IgG PRICOG98/79 RICKETTSIA CONORII IFA IgM PRICOM98/79 RICKETTSIA CONORII IFA SLIDE SRICO98/79 RICKETTSIA CONORII VIRCLIA® IgG MONOTEST VCM08098/79 RICKETTSIA CONORII VIRCLIA® IgM MONOTEST VCM08298/79 RICKETTSIA TYPHI IFA IgG PRITYG98/79 RICKETTSIA TYPHI IFA IgM PRITYM98/79 ROSE BENGAL RB00198/79 RUBELLA ELISA IgG G102698/79 RUBELLA ELISA IgM CAPTURE M102698/79 SARS-COV-2 OMICRON REALTIME PCR KIT RTPCR01298/79 SARS-COV-2 PLUS UK REALTIME PCR KIT RTPCR0092 réf.98/79 SARS-CoV-2/FluA/FluB/RSV REAL TIME PCR KIT RTPCR0212 réf. STD VIRPLEX® MINILAB PANEL ML001 SYPHILIS ELISA IgG G106098/79 SYPHILIS ELISA IgG+IgM T106098/79 SYPHILIS VIRCLIA® IgG MONOTEST VCM08598/79 SYPHILIS VIRCLIA® IgG+IgM MONOTEST VCM08698/79 SYPHILIS VIRCLIA® IgM MONOTEST VCM03298/79 TETANUS ELISA IgG G100898/79 TETANUS VIRCLIA® IgG MONOTEST VCM00498/79 TICK-BORNE ENCEPHALITIS VIRCLIA® IgG MONOTEST VCM047 TICK-BORNE ENCEPHALITIS VIRCLIA® IgM MONOTEST VCM04898/79 TOXOPLASMA ELISA IgG G102798/79 VAGINAL PANEL REALTIME PCR KIT RTPCR00598/79 VARICELLA-ZOSTER ELISA IgG/IgM G/M100298/79 VARICELLA-ZOSTER VIRCLIA® IgM MONOTEST VCM09198/79 VIRAL MENINGITIS REALTIME PCR KIT RTPCR0112 réf.98/79 VIRAPID® CLOSTRIDIUM DIFFICILE (GDH) Ag VRC004 VIRAPID® CLOSTRIDIUM DIFFICILE (GDH/TOX A/TOX B) Ag VRC005 VIRAPID® INFLUENZA A/INFLUENZA B Ag FIA VRF004 VIRAPID® LEGIONELLA CULTURE VR00298/79 VIRAPID® LEGIONELLA PNEUMOPHILA Ag FIA VRF002 VIRAPID® MONO M&G VR00198/79 VIRAPID® RESPIRATORY SYNCYTIAL VIRUS Ag FIA VRF003 VIRAPID® STREPTOCOCCUS GROUP A Ag VRC003 Vircell S.L SE002 VIRCELL® ASPERGILLUS GALACTOMANNAN AG CONTROL VEC001 VIRCLIA® EXTRACTION SOLUTION VCES001 VIRCLIA® LOTUS VCLTS-CL WEST NILE VIRUS VIRCLIA® IgG MONOTEST VCM07898/79 WEST NILE VIRUS VIRCLIA® IgM MONOTEST VCM07998/79 ZIKA ELISA IgG G102398/79 ZIKA ELISA IgM M102398/79 ZIKA VIRCLIA® IgG MONOTEST VCM033 ZIKA VIRCLIA® IgM MONOTEST VCM03598/79 ZIKV/DENV/CHIKV REALTIME PCR KIT RTPCR0042 réf.	A, B, C, D IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Orientgene FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	101A0227EY98/79 ABPTS02-AOG48E/ ABPTS02-AOG96E98/79 ACAB04D-BOG48E98/79 ACOV03-AOG48E; ACOV03-AOG96E; ACOV03D-AOG48E; ACOV03D-AOG96E98/79 Adenovirus Antigen Control Kit GCADE-PN298/79 212 autres Adenovirus Antigen FIA Control Kit FCADE-PN298/79 Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab) FCADE-502a98/79 Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab) FCADE-502Ca98/79 Adenovirus Antigen Rapid Test Cassette (Swab) GCADE-502a98/79 Adenovirus Antigen Rapid Test Cassette (Swab) GCADE-502Ca98/79 Adenovirus Rapid Test Cassette (Feces) GCADE-602a98/79 ADV01-AOG48E;,ADV01-AOG96E,ADV01D-AOG48E,ADV01D-AOG96E98/79 AEBV01-AOG48E, AEBV01D-AOG48E98/79 AFAB01-AOG48E; AFAB01-AOG96E98/79 AFAB03-AOG48E; AFAB03-AOG96E; AFAB03D-AOG48E; AFAB03D-AOG96E98/79 AFR01-AOG48E; AFR01-AOG96E; AFR01D-AOG48E; AFR01D-AOG96E98/79 AGAS01-AOG48E; AGAS01D-AOG48E98/79 AHPV1401-AOG48E98/79 AHPV1401D-AOG48E98/79 AHPV1801-AOG48E98/79 AHPV1801-BOG48E，AHPV1801-BOG96E98/79 AHPV2301-AOG48E,AHPV2301-AOG96E98/79 AHSV101-AOG48E; AHSV101-AOG96E; AHSV101D-AOG48E; AHSV101D-AOG96E98/79 AHSV201-AOG48E; AHSV201-AOG96E; AHSV201D-AOG48E; AHSV201D-AOG96E98/79 AMP01-AOG48E; AMP01-AOG96E; AMP01D-AOG48E; AMP01D-AOG96E98/79 AMPV01-AOG48E; AMPV01-AOG96E98/79 AMTBC01-AOG48E； AMTBC01-AOG96E；AMTBC01D-AOG48E； AMTBC01D-AOG96E；98/79 AMTBZK01-AHG2E98/79 ANG01-AOG48E;,ANG01-AOG96E,ANG01D-AOG48E, ANG01D-AOG96E98/79 APA01-AOG48E; APA01-AOG96E; APA01D-AOG48E; APA01D-AOG96E98/79 Automatic Biochemistry Analyzer Diag-H200 Bordetella Pertussis Antigen Rapid Test Kit (Colloidal Gold) GCBP-502a98/79 Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) GCBRU-402a98/79 Brucella IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCBRU(IgG/IgM)-402a98/79 CAMRZK01-AOG4E98/79 Candida albicans Antigen Rapid Test Cassette (Swab) GCCA-502a98/79 CCDIF01A-AOG4E98/79 CCDIFZK01-AOG4E98/79 CCNS801A-AOG4E98/79 CCNSZK01-AOG4E98/79 CDGV01A-AOG4E98/79 CDGVZK01-AOG4E98/79 CFFCR01A-AOG4E98/79 CGBS01A-AOG4E98/79 CGBSZK01A-AOG4E98/79 CGCT01A-AOG4E98/79 CGI601A-AOG4E98/79 CGIBAC-AOG4E98/79 CGIBACZK01-AOG4E98/79 CGIZK01-AOG4E98/79 CGTUC01A-AOG4E98/79 Chagas Ab Rapid Test Cassette (Serum/Plasma) GCCHA-302a98/79 Chagas Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCHA-402a98/79 Chikungunya IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) GCCHK(IgG/IgM)-402b98/79 Chikungunya IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCHK(IgM)-402a98/79 Chikungunya IgM Rapid Test Cassette (Serum/Plasma) GCCHK(IgM)-302a98/79 Chikungunya IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCHK(IgM/IgG)-402a98/79 Chlamydia Trachomatis Antigen Rapid Test (Cassette) (Swab/Urine) GCCHL-502a98/79 CHPV1401A-AOG4E98/79 CHPV1402A-AOG4E98/79 CHPV14ZK01-AOG4E98/79 Clostridium difficile Antigen GDH Rapid Test Cassette (Feces) GCCD(GDH)-602a98/79 Clostridium difficile GDH & Toxin A/B Rapid Test Cassette (Feces) GCCD-602a98/79 Clostridium difficile Toxin A&B Rapid Test Casette (Feces) GCCD(Toxin A/B)-602a98/79 CMTB01A-AOG4E98/79 CMTBMDRZK01-AOG4E98/79 CMTBNTM01A-AOG4E98/79 CMTBNTMZK01-AHG4E98/79 CMTBRIFZK01-AOG4E98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NA98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NN98/79 COVID-19 & Influenza A/B Rapid Test Cassette (Swab) GCFC-525Sa98/79 COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab) GCCOV(B117)-525a98/79 COVID-19 Ag Rapid Test Cassette (Oral Fluid) GCCOV-702a98/79 COVID-19 Antigen Control Kit GCCOV(Ag)-PN10，GCCOV(Ag)-PN2098/79 COVID-19 IgG/IgM CONTROL Kit GCCOV-PN10，GCCOV-PN2098/79 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402a98/79 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402Ba98/79 COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) GCFC-T502a98/79 COVID-19/Flu A&B/RSV/Adeno Ag Control Kit GCFCRA-PN298/79 CRTI601A-AOG4E98/79 CRTI701A-AOG4E98/79 CRTI7B01A-AOG4E98/79 CRTI7BZK01-AOG4E98/79 CRTI7C01A-AOG4E98/79 CRTI7CZK01-AOG4E98/79 CRTIZK01-AOG4E98/79 Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid) GCCr(Ag)-402a98/79 CSTI401A-AOG4E98/79 CSTI601A-AOG4E98/79 CSTI6ZK01A-AOG4E98/79 CSTI7A01A-AOG4E98/79 CSTI7B01A-AOG4E98/79 CSTIAZK01-AOG4E98/79 CSTIBZK01-AOG4E98/79 CSTIZK01A-AOG4E98/79 CVAG01A-AOG4E98/79 CVAGZK01-AOG4E98/79 CVCB601A-AOG4E98/79 CVCB801A-AOG4E98/79 CVCBZK01-AOG4E98/79 D-Dimer Control FDDDI-PN2098/79 D-Dimer Quantitative Test Kit (Time-Resolved FIA) FDDDI-402a98/79 D-Dimer Rapid Test Cassette (Whole Blood/Plasma) GDDDI-402b98/79 Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(ab)-402e98/79 Dengue IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(ab)-402c98/79 Dengue NS1 Ag Rapid Test Cassette(Whole Blood/Serum/Plasma) GCDEN(NS)-402d98/79 Dengue NS1 Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(NS)-402c98/79 Dengue NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN-425a98/79 Digital COVID-19 Ag Rapid Test (Swab) GCCOV-D503a98/79 EV71 IgM Rapid Test Cassette (Serum/Plasma) GCEV71(IgM)-302a98/79 EV71 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCEV71(IgM)-402a98/79 FDDDI-402a-DR10/FDDDI-402a-DR/FDDDI-402a-DR10LH/FDDDI-402a-DRLH/FDDDI-402a-DR10HG/FDDDI-402a-DRHG3 réf. Flu A Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) FCFLU(A)-502a98/79 Flu A Ag Rapid Test Cassette (Swab) GCFLU(A)-U502a98/79 Flu A(H5) Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) FCFLU(AH5)-502a98/79 Giardia lamblia Antigen Rapid Test Cassette (Feces) GCGIA-602a98/79 Gonorrhea Rapid Test Cassette (Swab) GCGON-502b98/79 H. pylori Ag Control Kit GCHP-PN298/79 H. pylori Ag Rapid Test Cassette (Feces) GCHP-602a，GCHP-602Ca98/79 H. pylori Ag Rapid Test Strip (Feces) GCHP-601a，GCHP-601Ca98/79 H.pylori Ag Rapid Test Device (Feces) GCHP-606a98/79 H. pylori Ab Rapid Test Cassette (Serum/Plasma) GCHP-302a98/79 H. pylori Ab Rapid Test Cassette (Whole blood/Serum/Plasma) GCHP-402a98/79 H. pylori Ab Rapid Test Strip (Serum/Plasma) GCHP-301a98/79 H. pylori Ab Rapid Test Strip (Whole blood/Serum/Plasma) GCHP-401a98/79 Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHV(IgG/IgM)-402a98/79 Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHV(IgM)-402a98/79 HAV Ag Rapid Test Cassette (Feces) GCHAV-602a98/79 HAV IgG/IgM Rapid Test Cassette (Serum/Plasma) GCHAV(IgG/IgM)-302a98/79 HAV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHAV(IgG/IgM)-402a98/79 HAV IgM Rapid Test Cassette (Serum/Plasma) GCHAV(IgM)-302Ba98/79 Healgen-800 Urine Analyzer Healgen® Gonorrhoea Fluorescent Rapid Test FCGON-502a98/79 HEV IgM Rapid Test Cassette (Serum/Plasma) GCHEV-302a98/79 HPIV Antigen Rapid Test Kit (Time-Resolved FIA) FCHPIV-502a98/79 HSV IgG Rapid Test Cassette (Serum/Plasma) GCHSV(IgG)-302a98/79 HSV IgG Rapid Test Cassette (Whole blood/Serum/Plasma) GCHSV(IgG)-402a98/79 HSV IgM Rapid Test Cassette (Serum/Plasma) GCHSV(IgM)-302a98/79 HSV IgM Rapid Test Cassette (Whole blood/Serum/Plasma) GCHSV(IgM)-402a98/79 Human Metapneumovirus (HMPV) Ag Rapid Test GCHMPV-502a98/79 IL-6 Quantitative Test Kit (Time-Resolved FIA)98/79 Influenza A & B Ag Rapid Test Cassette (Swab) GCFLU(A/B)-502a98/79 Influenza A & B Ag Rapid Test Cassette (Swab) GCFLU(A/B)-502a, GCFLU(A/B)-502Ca98/79 Influenza A & B Ag Rapid Test Cassette (Swab) GCFLU(A/B)-502Ca98/79 Influenza A & B Ag Rapid Test Strip (Swab) GCFLU(A/B)-501a98/79 Influenza A (H5) Ag Rapid Test Cassette (Swab) GCFLU(AH5)-502a98/79 Influenza A Ag Rapid Test Strip (Swab) GCFLU(A)-501a98/79 Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCKal-402a98/79 Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma) GCKal-401a98/79 Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCKal-T402a98/79 Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCLEP(IgG/IgM)-402a98/79 M. pneumonia IgM Rapid Test Cassette (Serum/Plasma) GCMP(IgM)-302a98/79 M. pneumoniae Ag Rapid Test Cassette (Swab) GCMP-502a98/79 Malaria P.f. Ag Rapid Test Casssette (Whole Blood) GCMAL(pf)-402a98/79 Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pv)-402a98/79 Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pan)-402a98/79 Malaria Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pan)-402a98/79 Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma) GCMAL(pf/pv Ab)-302a98/79 Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma) GCMAL(pf/pv Ab)-402a98/79 Monkeypox Ag Rapid Test Cassette (Swab) GCMKP-502b98/79 Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMKP-402a98/79 Mononucleosis IgG/IgM Rapid Test Cassette (Serum/Plasma) GCMON-325a98/79 Mononucleosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMON-425a98/79 Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMON-402a98/79 Norovirus Antigen Rapid Test Cassette (Feces) GCNOR-602a98/79 Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method)98/79 Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method)98/79 Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)98/79 Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)98/79 One Step Chikungunya Ag Test Cassette (Whole Blood/Serum/Plasma) GCCHK-402a98/79 Rapid COVID-19 Antigen Test Strip GCCOV-501a98/79 Rapid Influenza A & B Antigen Test GCFLU(A/B)-502a-DRH1,GCFLU(A/B)-502a-DRH2,GCFLU(A/B)-502a-DRH5,GCFLU(A/B)-502a-DRH7,GCFLU(A/B)-502a-DRH203 réf. RMTB01-AHG5E, RMTB01-AHG25E98/79 Rotavirus and Adenovirus Antigen Control Kit GCROA/ADE-PN298/79 Rotavirus Rapid Test Cassette (Feces) GCROA-602a98/79 RSV Antigen Control Kit GCRSV-PN2，GCRSV-PN1098/79 RSV Antigen FIA Control Kit FCRSV-PN298/79 RSV Antigen Fluorescence Rapid Test Cassette (Swab) FCRSV-502Ca98/79 RSV Antigen Fluorescent Rapid Test Cassette (Swab)98/79 RSV Antigen Rapid Test Cassette (Swab) GCRSV-502a98/79 S. typhi Ag Rapid Test Cassette (Serum/Plasma/Feces) GCSAL(ST)-602a98/79 SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)98/79 SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab) GCCOV(Del)-T502a98/79 SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Whole Blood/Serum/Plasma) GCCOV(NAb)-402b98/79 Smart Rapid COVID-19 & Flu A/B Ag Test Device GCFC-T503a98/79 Smart Rapid COVID-19 Ag Test Device GCCOV-503a98/79 SNCE01-AOG48/ SNCE01-AOG96/ SNCE02-AOG16/ SNCE02-AOG48/ SNCE02-AOG9698/79 SNCE05-BOG48E98/79 SNCE07-AOG50E98/79 Strep A Antigen Control Kit GCSTR-PN298/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-501a-DR,GCSTR-501Ca-DR,GCSTR-502a-DR,GCSTR-502Ca-DR3 réf. Strep A Rapid Test Cassette (Throat Swab) GCSTR-502a98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502Ca98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502CSa98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501a98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501Ca98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501CSa98/79 Syphilis Ab Rapid Test Cassette (Serum/Plasma) GCSYP-302a98/79 Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCSYP-402a98/79 Syphilis Ab Rapid Test Strip (Serum/Plasma) GCSYP-301a98/79 Syphilis Ab Rapid Test Strip (Whole Blood/Serum/Plasma) GCSYP-401a98/79 Toxoplasma gondii (Toxo) IgG Rapid Test GCTOX(IgG)-302a98/79 Toxoplasma gondii (Toxo) IgG/IgM Rapid Test GCTOX(IgG/IgM)-302a98/79 Toxoplasma gondii (Toxo) IgM Rapid Test GCTOX(IgM)-302a98/79 Trichomonas Ag Rapid Test Cassette (Swab) GCTV-502a98/79 Typhoid IgG/IgM Rapid Test Cassette (Serum/Plasma) GCTYP-302b98/79 Typhoid IgG/IgM Rapid Test Cassette(Serum/Plasma) GCTYP-302a98/79 URcheck™ NeoChem Analyzer AC-H800 Urine Analyzer Healgen 500 Urine Analyzer Healgen 501 Vaginal pH Rapid Test Cassette (Vaginal Secretions) VPH-502a98/79 Vaginal pH Rapid Test Strip (Swab) VPH-501a98/79 Zika IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCZIK(IgG)-402b98/79 Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) GCZIK(IgG/IgM)-T402a98/79 Zika NS1 Ag Rapid Test Cassette(Whole blood/Serum/Plasma) GCZIK(NS1)-402a98/79	A, B, C IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Abbott FDA Mandataire UE : Abbott B.V. (Pays-Bas) et 5 autres	Allemagne, Corée du Sud, Irlande, Japon, United Kingdom (ex Northern Ireland), États-Unis	7D2227 ABBOTT REALTIME HIV-15 réf. Abbott VP2000 Processor3 réf. Alere™ Malaria Ag P.f 05FK14098/79 Alere™ Malaria Ag P.f 05FK14198/79 213 autres Alere™ Malaria Ag P.f 05FK14398/79 Alinity39 réf. Alinity 06S610198/79 Alinity 06S611098/79 Alinity 06S612098/79 ALINITY h-series CONTROL 29P4 réf. Alinity HSV-1 IgG3 réf. Alinity HSV-2 IgG3 réf. Alinity m37 réf. ALINITY M RESP-4-PLEX4 réf. ALINITY M SAMPLE PREP 1 ALINITY M SAMPLE PREP 2 ALINITY M SARS-COV-22 réf. Alinity mp Alinity SARS-CoV-2 IgG3 réf.98/79 Alinity SARS-CoV-2 IgG II Quant3 réf. Alinity SARS-CoV-2 IgM2 réf.98/79 Alinity-Architect ARCHITECT34 réf. ARCHITECT 06S600198/79 ARCHITECT 06S601098/79 ARCHITECT 06S602098/79 ARCHITECT HSV-1 IgG3 réf. ARCHITECT HSV-2 IgG3 réf. ARCHITECT SARS-CoV-2 IgG98/79 ARCHITECT SARS-CoV-2 IgG (Cal & Ctrl)2 réf.98/79 ARCHITECT SARS-CoV-2 IgG II Quant3 réf. ARCHITECT SARS-CoV-2 IgM3 réf.98/79 BinaxNOW™ 780-00098/79 BinaxNOW™ 852-01298/79 BinaxNOW™ Influenza A & B Card 416-00098/79 BinaxNOW™ Influenza A & B Card Control Swab Kit 416-08098/79 BinaxNOW™ Legionella Urinary Antigen Card (22T) 852-10098/79 BinaxNOW™ Malaria (25T) 660-00098/79 BinaxNOW™ Malaria 6600598/79 BinaxNOW™ RSV Card (22T) 430-02298/79 BinaxNOW™ RSV Card (42T) 430-00098/79 BinaxNOW™ RSV Control Swab Kit (10 POS+10 NEG) 430-08098/79 BinaxNOW™ Strep A Card (25T) 735-02598/79 BinaxNOW™ Strep A Control Swab Kit (5 POS+5 NEG) 730-01098/79 BinaxNOW™ Streptococcus pneumoniae Antigen Card (12T) 710-01298/79 BinaxNOW™ Streptococcus pneumoniae Antigen Card (22T) 710-10098/79 Binax™ 851-00098/79 Binax™ Legionella EIA Wash Buffer Accessory Kit (4 WASHCONC) 851-10098/79 Bioline™ Chagas Ab 49FK102 réf.98/79 Bioline™ Dengue Duo 11FK452 réf.98/79 Bioline™ Dengue Duo 11FK462 réf.98/79 Bioline™ Dengue IgG Capture ELISA 11EK1098/79 Bioline™ Dengue IgG/IgM 11FK1098/79 Bioline™ Dengue IgG/IgM WB 11FK202 réf.98/79 Bioline™ Dengue IgM Capture ELISA 11EK2098/79 Bioline™ Dengue NS1 Ag 11FK5098/79 Bioline™ Dengue NS1 Ag ELISA 11EK5098/79 Bioline™ H.pylori 04FK1098/79 Bioline™ H.pylori 04FK1198/79 Bioline™ H.pylori Ag 04FK2098/79 Bioline™ Hantaanvirus 17FK1098/79 Bioline™ Hantaanvirus 17FK1198/79 Bioline™ HAV IgG/IgM 13FK103 réf.98/79 Bioline™ HCV 02FK10CE98/79 Bioline™ HCV 02FK16CE98/79 Bioline™ HCV 02FK17CE98/79 Bioline™ HIV 1/2 3.0 03FK10CE2 réf.98/79 Bioline™ HIV 1/2 3.0 03FK16CE2 réf.98/79 Bioline™ Influenza Ag A/B/A (H1N1) 19FK3198/79 Bioline™ Influenza Ag A/B/A (H1N1) 19FK3298/79 Bioline™ Influenza Ag A/B/A(H1N1) Pandemic 19FK3198/79 Bioline™ Influenza Ag A/B/A(H1N1) Pandemic 19FK3298/79 Bioline™ Influenza Antigen 19FK1198/79 Bioline™ Influenza Antigen 19FK122 réf.98/79 Bioline™ Influenza Ultra 19FK133 réf.98/79 Bioline™ Leptospira 16FK1098/79 Bioline™ Leptospira 16FK1198/79 Bioline™ Leptospira IgM 16FK3098/79 Bioline™ Malaria Ag P.f (HRP2/pLDH) 05FK9098/79 Bioline™ Malaria Ag P.f 05FK502 réf.98/79 Bioline™ Malaria Ag P.f/P.f/P.v98/79 Bioline™ Malaria Ag P.f/P.f/P.v 05FK12098/79 Bioline™ Malaria Ag P.f/P.f/P.v 05FK12398/79 Bioline™ Malaria Ag P.f/P.v 05FK8098/79 Bioline™ Malaria Ag P.f/Pan 05FK602 réf.98/79 Bioline™ Malaria Ag P.f/Pan 05FK6198/79 Bioline™ Malaria Ag P.f/Pan 05FK6398/79 Bioline™ Malaria Control Kit 05FK10C98/79 Bioline™ Norovirus 52FK102 réf.98/79 Bioline™ Rota/Adeno98/79 Bioline™ Rota/Adeno 14FK203 réf.98/79 Bioline™ Rotavirus98/79 Bioline™ Rotavirus 14FK1098/79 Bioline™ RSV 40FK122 réf.98/79 Bioline™ Salmonella typhi IgG/IgM Fast98/79 Bioline™ Salmonella typhi IgG/IgM Fast 15FK1298/79 Bioline™ Strep A98/79 Bioline™ Strep A 45FK1298/79 Bioline™ Syphilis 3.0 06FK102 réf.98/79 Bioline™ Syphilis Fast 3.0 06FK1198/79 Bioline™ Syphilis Fast 3.0 06FK1298/79 Bioline™ TB Ag MPT64 08FK5098/79 Bioline™ Zika IgM 12FK2198/79 Bioline™ Zika IgM 12FK2698/79 CELL-DYN7 réf. CELL-DYN EMERALD 22 CELL-DYN Emerald 22 Autoloader Analyzer CELL-DYN Emerald 22 Diluent CELL-DYN Emerald 22 Lyse2 réf. CheckNow™ 455340902398/79 CheckNow™ 456342902398/79 CheckNow™ 456381902398/79 Determine2 réf.98/79 Determine HIV Early Detect98/79 Determine Syphilis TP 30T 7D244298/79 Determine™ TB LAM Ag (25T) 7D274198/79 DIGIVAL Tray 1 Pack LFR-003 / LFR-0042 réf. DIGIVAL™ LFR-000 FreeStyle Optium Neo H Blood Glucose and Ketone Monitoring System3 réf. FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System2 réf. i-STAT ACT Control Level 1 06P17-1598/79 i-STAT ACT Control Level 2 06P17-1698/79 i-STAT Celite ACT Cartridge 03P86-2598/79 i-STAT Kaolin ACT Cartridge98/79 i-STAT PTplus cartridge 03P89-50 i-STAT PTplus Control Level 1 06P17-172 réf. ID NOW™ COVID-19 2.0 Control Swab Kit (12 POS+12 NEG) 192-08098/79 ID NOW™ Influenza A & B 2 (24T) 427-00098/79 ID NOW™ Influenza A & B 2 Control Swab Kit (12 POS+12 NEG) 425-08098/79 ID NOW™ Instrument (OUS) LFR-003 / LFR-004 ID NOW™ RSV (24T) 435-00098/79 ID NOW™ RSV Control Swab Kit (12 POS+12 NEG) 435-08098/79 ID NOW™ Strep A 2 (24T) 734-00098/79 ID NOW™ Strep A 2 Control Swab Kit (12 POS+12 NEG) 734-08098/79 M2000 MICROPLATE ACCESSORIES2 réf. M2000 PIPETTE TIPS3 réf. M2000RT INSTRUMENT SYSTEM M2000SP INSTRUMENT E- SERIES NxTek™ Eliminate Malaria Pf 05FK14098/79 Panbio Dengue Duo IgM Capture and IgG Capture ELISA 07PE1098/79 Panbio Dengue Early ELISA 01PE4098/79 Panbio Dengue Early Rapid 01PF2098/79 Panbio Dengue IgG Capture ELISA 01PE1098/79 Panbio Dengue IgG Indirect ELISA 01PE3098/79 Panbio Dengue IgM Capture ELISA 01PE2098/79 Panbio Leptospira lgM ELISA 02PE1098/79 Panbio™ 01PE1098/79 Panbio™ 455556902298/79 Panbio™ 455996902298/79 Panbio™ 455997902298/79 Panbio™ 456339902298/79 Panbio™ 456340902298/79 Panbio™ 456751902298/79 Panbio™ AF41FK11CON98/79 Panbio™ AF41FK11CONA98/79 Panbio™ AF62FK11CONA98/79 Panbio™ AF62FK11CONB98/79 Panbio™ AF62FK11CONC98/79 Panbio™ AF62FK11COND98/79 Panbio™ Dengue Duo IgM Capture and IgG Capture ELISA 07PE1098/79 Panbio™ Dengue Early ELISA 01PE4098/79 Panbio™ Dengue Early Rapid98/79 Panbio™ Dengue Early Rapid 01PF2098/79 Panbio™ Dengue IgG Indirect ELISA 01PE3098/79 Panbio™ Dengue IgM Capture ELISA 01PE2098/79 Panbio™ Dengue IgM Capture ELISA 01PE2198/79 Panbio™ Leptospira IgM ELISA 02PE1098/79 RealTime21 réf. SD BIOLINE Chagas Ab Rapid 49FK1098/79 SD BIOLINE Dengue Duo 11FK4598/79 SD BIOLINE Dengue Duo 11FK4698/79 SD BIOLINE Dengue IgG/IgM 11FK1098/79 SD BIOLINE Dengue IgG/IgM WB 11FK2098/79 SD BIOLINE Dengue NS1 Ag 11FK5098/79 SD BIOLINE H.pylori 04FK1098/79 SD BIOLINE H.pylori 04FK1198/79 SD BIOLINE H.pylori Ag 04FK2098/79 SD BIOLINE Hantaan virus 17FK1098/79 SD BIOLINE Hantaan virus 17FK1198/79 SD BIOLINE HAV IgG/IgM 13FK1098/79 SD BIOLINE Influenza Ag A/B/A(H1N1) Pandemic 19FK3198/79 SD BIOLINE Influenza Antigen 19FK1198/79 SD BIOLINE Influenza Antigen 19FK1298/79 SD BIOLINE Influenza Ultra 19FK1398/79 SD Bioline Leptospira lgM 16FK3098/79 SD BIOLINE Malaria Ag P.f (HRP2/pLDH) 05FK9098/79 SD BIOLINE Malaria Ag P.f (HRP2/pLDH) 05FK9398/79 SD BIOLINE Malaria Ag P.f 05FK502 réf.98/79 SD BIOLINE Malaria Ag P.f 05FK5398/79 SD BIOLINE Malaria Ag P.f./Pan 05FK602 réf.98/79 SD BIOLINE Malaria Ag P.f./Pan 05FK612 réf.98/79 SD BIOLINE Malaria Ag P.f./Pan 05FK6398/79 SD BIOLINE Malaria Ag P.f./Pan 05FK6798/79 SD BIOLINE Malaria Ag P.f/P.f/P.v 05FK12098/79 SD BIOLINE Malaria Ag P.f/P.f/P.v 05FK12398/79 SD BIOLINE Malaria Ag P.f/P.v 05FK8098/79 SD BIOLINE Malaria Ag P.f/P.v 05FK8298/79 SD BIOLINE Malaria Ag P.f/P.v 05FK8698/79 SD BIOLINE Malaria Control Kit 05FK10C98/79 SD BIOLINE Norovirus 52FK1098/79 SD BIOLINE Rota/Adeno Rapid 14FK2098/79 SD BIOLINE Rotavirus 14FK1098/79 SD BIOLINE RSV 40FK1298/79 SD BIOLINE Salmonella typhi IgG/IgM Fast 15FK1298/79 SD Bioline Strep A 45FK1298/79 SD BIOLINE Syphilis 3.0 06FK1098/79 SD BIOLINE Syphilis 3.0 06FK1198/79 SD BIOLINE Syphilis Fast 3.0 06FK1298/79 SD BIOLINE TB Ag MPT64 Rapid 08FK5098/79 SD BIOLINE Zika IgM 12FK2698/79 SD Dengue IgG Capture ELISA (Working TMB) 11EK1098/79 SD Dengue IgM Capture ELISA (Working TMB) 11EK2098/79 SD Dengue NS1 Ag ELISA (96 tests/kit) 11EK5098/79 TestPack Plus Strep A with OBC98/79 Vysis2 réf. Panbio Dengue IgM Capture ELISA98/79 (plus commercialisé) SD BIOLINE Zika IgM98/79 (plus commercialisé)	A, B, C, D IVDR, 98/79	Présent sur le marché en France Site web ratransfusionmedicine@abbott.com Fiche EUDAMED Signaler une erreur
ZytoVision FDA	Allemagne	Aura Probe BCL2 Break Apart FISH Aura Probe BCL6 Break Apart FISH Aura Probe ERBB2/CEN 17 FISH Aura Probe MET/CEN 7 FISH Aura Probe MYC Break Apart FISH 210 autres FlexISH ALK/ROS1 DistinguISH Probe2 réf. FlexISH BCL2/BCL6 DistinguISH Probe2 réf. FlexISH ERBB2/CEN 17 Dual Color Probe2 réf. FlexISH MYC/IGH TriCheck Probe FlexISH NTRK1/NTRK3 DistinguISH Probe2 réf.98/79 FlexISH RET/KIF5B TriCheck Probe Rabbit anti-Helicobacter pylori [polyclonal]3 réf. VisionArray HPV Chip 1.02 réf.98/79 VisionArray HPV PreCise Master Mix98/79 VisionArray MYCO Chip 2.02 réf.98/79 VisionArray MYCO PreCise Master Mix 2.098/79 ZytoDot 2C Glioma 1p/19q Probe Set2 réf. ZytoDot 2C SPEC 19q13/19p13 Probe2 réf. ZytoDot 2C SPEC 1p36/1q25 Probe2 réf. ZytoDot 2C SPEC ALK Break Apart Probe2 réf. ZytoDot 2C SPEC BCL2 Break Apart Probe ZytoDot 2C SPEC BCL6 Break Apart Probe ZytoDot 2C SPEC CDK4/CEN 12 Probe ZytoDot 2C SPEC CDKN2A/CEN 9 Probe98/79 ZytoDot 2C SPEC DDIT3 Break Apart Probe ZytoDot 2C SPEC EGFR/CEN 7 Probe2 réf. ZytoDot 2C SPEC ERBB2/CEN 17 Probe2 réf. ZytoDot 2C SPEC ERBB2/CEN 17 Probe Kit2 réf. ZytoDot 2C SPEC EWSR1 Break Apart Probe ZytoDot 2C SPEC FGFR2/CEN 10 Probe ZytoDot 2C SPEC IGH Break Apart Probe ZytoDot 2C SPEC MDM2/CEN 12 Probe2 réf. ZytoDot 2C SPEC MET/CEN 7 Probe ZytoDot 2C SPEC MYC Break Apart Probe ZytoDot 2C SPEC RET Break Apart Probe ZytoDot 2C SPEC ROS1 Break Apart Probe2 réf. ZytoDot 2C SPEC SS18 Break Apart Probe ZytoDot 2C SPEC USP6 Break Apart Probe ZytoDot SPEC ERBB2 Probe ZytoDot SPEC ERBB2 Probe Kit ZytoDot SPEC MDM2 Probe ZytoDot SPEC MYCN Probe ZytoFast EBV Probe ZytoFast HPV High-Risk (HR) Types Probe ZytoFast HPV Screening Probe98/79 ZytoFast HPV type 16/18 Probe ZytoFast HPV type 31/33 Probe ZytoFast HPV type 6/11 Probe ZytoFast human lg-kappa Probe ZytoFast human lg-kappa/lg-lambda CISH Kit ZytoFast human lg-kappa/lg-lambda Permanent CISH Kit ZytoFast human lg-kappa/lg-lambda Probe ZytoFast human lg-lambda Probe ZytoLight Aneuploidy Panel 18/X/Y and 13/2198/79 ZytoLight Aneuploidy Panel X/Y and 13/18/212 réf.98/79 ZytoLight Bladder Cancer Quadruple Color Probe2 réf.98/79 ZytoLight CEN 11 Probe98/79 ZytoLight CEN 12 Probe98/79 ZytoLight CEN 17/SPEC ERBB2 Dual Color Probe2 réf. ZytoLight CEN 8 Probe2 réf. ZytoLight CEN X/Y Dual Color Probe98/79 ZytoLight CEN X/Yq12 Dual Color Probe2 réf.98/79 ZytoLight Glioma 1p/19q Probe Set ZytoLight SPEC 11q gain/loss Triple Color Probe ZytoLight SPEC 13/21 Dual Color Probe98/79 ZytoLight SPEC 13/CEN 18/SPEC 21 Triple Color Probe2 réf.98/79 ZytoLight SPEC 18/CEN X/Y Triple Color Probe98/79 ZytoLight SPEC 19q13/19p13 Dual Color Probe2 réf. ZytoLight SPEC 1p36/1q25 Dual Color Probe2 réf. ZytoLight SPEC 21/CEN X/Yq12 Triple Color Probe98/79 ZytoLight SPEC 4p11/CEN 10/17 Triple Color Probe ZytoLight SPEC ABL1 Dual Color Break Apart Probe ZytoLight SPEC ABL2 Dual Color Break Apart Probe ZytoLight SPEC ALK Dual Color Break Apart Probe2 réf. ZytoLight SPEC ALK/2q11 Dual Color Probe ZytoLight SPEC ALK/EML4 TriCheck Probe2 réf. ZytoLight SPEC Angelman Dual Color Probe98/79 ZytoLight SPEC ATM/CEN 11 Dual Color Probe ZytoLight SPEC ATM/CEN 12 Dual Color Probe ZytoLight SPEC BCL2 Dual Color Break Apart Probe2 réf. ZytoLight SPEC BCL2/IGH Dual Color Dual Fusion Probe2 réf. ZytoLight SPEC BCL6 Dual Color Break Apart Probe2 réf. ZytoLight SPEC BCOR Dual Color Break Apart Probe98/79 ZytoLight SPEC BCR/ABL1 Dual Color Dual Fusion Probe2 réf. ZytoLight SPEC BIRC3/MALT1 Dual Color Dual Fusion Probe2 réf.98/79 ZytoLight SPEC BRAF Dual Color Break Apart Probe ZytoLight SPEC BRAF/CEN 7 Dual Color Probe ZytoLight SPEC C19MC/19p13 Dual Color Probe ZytoLight SPEC CBFB Dual Color Break Apart Probe ZytoLight SPEC CCND1 Break Apart/2q11/CEN 6 Quadruple Color Probe ZytoLight SPEC CCND1 Dual Color Break Apart Probe2 réf. ZytoLight SPEC CCND1/CEN 11 Dual Color Probe2 réf. ZytoLight SPEC CCND1/IGH Dual Color Dual Fusion Probe2 réf. ZytoLight SPEC CD274,PDCD1LG2/CEN 9 Dual Color Probe2 réf. ZytoLight SPEC CDK4/CEN 12 Dual Color Probe2 réf. ZytoLight SPEC CDKN2A/CEN 3/7/17 Quadruple Color Probe2 réf. ZytoLight SPEC CDKN2A/CEN 9 Dual Color Probe2 réf. ZytoLight SPEC CIC Dual Color Break Apart Probe ZytoLight SPEC CKS1B/CDKN2C Dual Color Probe2 réf. ZytoLight SPEC COL1A1 Dual Color Break Apart Probe ZytoLight SPEC COL1A1/PDGFB Dual Color Dual Fusion Probe2 réf. ZytoLight SPEC CREBBP Dual Color Break Apart Probe98/79 ZytoLight SPEC CRLF2 Dual Color Break Apart Probe98/79 ZytoLight SPEC CSF1R Dual Color Break Apart Probe98/79 ZytoLight SPEC CSF1R/D5S23,D5S721 Dual Color Probe98/79 ZytoLight SPEC CUX1/EZH2/CEN 7 Triple Color Probe ZytoLight SPEC D13S319/13q34 Dual Color Probe2 réf. ZytoLight SPEC D13S319/13q34/CEN 12 Triple Color Probe2 réf. ZytoLight SPEC DDIT3 Dual Color Break Apart Probe2 réf. ZytoLight SPEC DiGeorge Triple Color Probe98/79 ZytoLight SPEC DiGeorge/Phelan McDermid Dual Color Probe98/79 ZytoLight SPEC EGFR/CEN 7 Dual Color Probe2 réf. ZytoLight SPEC EGR1/D5S23,D5S721 Dual Color Probe ZytoLight SPEC ERBB2/CEN 17 Dual Color Probe2 réf. ZytoLight SPEC ERBB2/CEN 17 Dual Color Probe Kit2 réf. ZytoLight SPEC ERBB2/D17S122 Dual Color Probe2 réf. ZytoLight SPEC ERBB2/TOP2A/CEN 17 Triple Color Probe2 réf. ZytoLight SPEC ERG Dual Color Break Apart Probe ZytoLight SPEC ERG/TMPRSS2 TriCheck Probe ZytoLight SPEC ESR1/CEN 6 Dual Color Probe ZytoLight SPEC ETV6 Dual Color Break Apart Probe2 réf. ZytoLight SPEC ETV6/RUNX1 Dual Color Dual Fusion Probe2 réf.98/79 ZytoLight SPEC EWSR1 Dual Color Break Apart Probe2 réf. ZytoLight SPEC EWSR1/FLI1 TriCheck Probe ZytoLight SPEC FGFR1 Dual Color Break Apart Probe2 réf. ZytoLight SPEC FGFR1/CEN 8 Dual Color Probe2 réf. ZytoLight SPEC FGFR2 Dual Color Break Apart Probe2 réf. ZytoLight SPEC FGFR2/CEN 10 Dual Color Probe ZytoLight SPEC FGFR3 Dual Color Break Apart Probe2 réf. ZytoLight SPEC FGFR3/4p11 Dual Color Probe ZytoLight SPEC FGFR3/IGH Dual Color Dual Fusion Probe98/79 ZytoLight SPEC FOXO1 Dual Color Break Apart Probe2 réf. ZytoLight SPEC FOXO1/PAX3 Dual Color Single Fusion Probe2 réf. ZytoLight SPEC FOXO1/PAX3 TriCheck Probe ZytoLight SPEC FOXO1/PAX7 Dual Color Single Fusion Probe2 réf. ZytoLight SPEC FUS Dual Color Break Apart Probe ZytoLight SPEC GATA2/MECOM Dual Color Dual Fusion Probe ZytoLight SPEC IGH Dual Color Break Apart Probe2 réf. ZytoLight SPEC IGK Dual Color Break Apart Probe ZytoLight SPEC IGL Dual Color Break Apart Probe ZytoLight SPEC IKZF1/CEN 7 Dual Color Probe98/79 ZytoLight SPEC IRF4,DUSP22 Dual Color Break Apart Probe2 réf. ZytoLight SPEC JAK2 Dual Color Break Apart Probe ZytoLight SPEC JAZF1 Dual Color Break Apart Probe ZytoLight SPEC KMT2A Dual Color Break Apart Probe2 réf. ZytoLight SPEC KRAS/CEN 12 Dual Color Probe ZytoLight SPEC MAF/IGH Dual Color Dual Fusion Probe98/79 ZytoLight SPEC MAFB/IGH Dual Color Dual Fusion Probe98/79 ZytoLight SPEC MALT1 Dual Color Break Apart Probe2 réf. ZytoLight SPEC MALT1/IGH Dual Color Dual Fusion Probe ZytoLight SPEC MAML2 Dual Color Break Apart Probe2 réf. ZytoLight SPEC MCL1/1p12 Dual Color Probe ZytoLight SPEC MDM2/CEN 12 Dual Color Probe2 réf. ZytoLight SPEC MDM4/1p12 Dual Color Probe ZytoLight SPEC MET/CEN 7 Dual Color Probe2 réf. ZytoLight SPEC MYB Dual Color Break Apart Probe2 réf. ZytoLight SPEC MYB/CEN 6 Dual Color Probe ZytoLight SPEC MYC Dual Color Break Apart Probe2 réf. ZytoLight SPEC MYC/CEN 8 Dual Color Probe2 réf. ZytoLight SPEC MYC/IGH Dual Color Dual Fusion Probe2 réf. ZytoLight SPEC MYCN/2q11 Dual Color Probe2 réf. ZytoLight SPEC NECTIN4/1p12 Dual Color Probe2 réf. ZytoLight SPEC NR4A3 Dual Color Break Apart Probe ZytoLight SPEC NRG1 Dual Color Break Apart Probe ZytoLight SPEC NRG1/CD74 TriCheck Probe ZytoLight SPEC NTRK1 Dual Color Break Apart Probe2 réf. ZytoLight SPEC NTRK2 Dual Color Break Apart Probe2 réf. ZytoLight SPEC NTRK3 Dual Color Break Apart Probe2 réf. ZytoLight SPEC NUP214 Dual Color Break Apart Probe98/79 ZytoLight SPEC NUP98 Dual Color Break Apart Probe ZytoLight SPEC NUTM1 Dual Color Break Apart Probe ZytoLight SPEC PAX5 Dual Color Break Apart Probe98/79 ZytoLight SPEC PDGFB Dual Color Break Apart Probe2 réf. ZytoLight SPEC PDGFRA/FIP1L1 TriCheck Probe ZytoLight SPEC PDGFRB Dual Color Break Apart Probe ZytoLight SPEC PHF1 Dual Color Break Apart Probe ZytoLight SPEC PIK3CA/CEN 3 Dual Color Probe ZytoLight SPEC PML/RARA Dual Color Dual Fusion Probe2 réf.98/79 ZytoLight SPEC Prader-Willi Dual Color Probe98/79 ZytoLight SPEC PTEN/CEN 10 Dual Color Probe2 réf. ZytoLight SPEC PTPRT/20q11 Dual Color Probe ZytoLight SPEC RB1/13q34 Dual Color Probe2 réf.98/79 ZytoLight SPEC RET Dual Color Break Apart Probe2 réf. ZytoLight SPEC ROS1 Dual Color Break Apart Probe2 réf. ZytoLight SPEC ROS1/CEN 6 Dual Color Probe2 réf. ZytoLight SPEC RREB1/MYB/CEN 6 Triple Color Probe2 réf. ZytoLight SPEC RUNX1/RUNX1T1 Dual Color Dual Fusion Probe2 réf.98/79 ZytoLight SPEC SMARCB1/22q12 Dual Color Probe ZytoLight SPEC SS18 Dual Color Break Apart Probe2 réf. ZytoLight SPEC SS18/SSX1 TriCheck Probe98/79 ZytoLight SPEC TCF3/PBX1 Dual Color Dual Fusion Probe98/79 ZytoLight SPEC TERT Dual Color Break Apart Probe ZytoLight SPEC TERT/5q31 Dual Color Probe2 réf. ZytoLight SPEC TFE3 Dual Color Break Apart Probe2 réf. ZytoLight SPEC TP53/17q22 Dual Color Probe ZytoLight SPEC TP53/ATM Dual Color Probe2 réf. ZytoLight SPEC TP53/CEN 17 Dual Color Probe2 réf. ZytoLight SPEC TP63/TBL1XR1 TriCheck Probe98/79 ZytoLight SPEC USP6 Dual Color Break Apart Probe2 réf. ZytoLight SPEC VHL/1p12/CEN 7/17 Quadruple Color Probe2 réf. ZytoLight SPEC VHL/CEN 3 Dual Color Probe ZytoLight SPEC Williams-Beuren Dual Color Probe98/79 ZytoLight SPEC WT1 Dual Color Break Apart Probe98/79 ZytoLight SPEC WWTR1 Dual Color Break Apart Probe98/79 ZytoLight SPEC YWHAE Dual Color Break Apart Probe ZytoLight SPEC ZNF384 Dual Color Break Apart Probe98/79 ZytoMation ALK Dual Color Break Apart FISH Probe98/79 ZytoMation BCL2 Dual Color Break Apart FISH Probe ZytoMation BCL6 Dual Color Break Apart FISH Probe98/79 ZytoMation ERBB2/CEN 17 Dual Color FISH Probe ZytoMation IGH Dual Color Break Apart FISH Probe98/79 ZytoMation MET/CEN 7 Dual Color FISH Probe98/79 ZytoMation MYC Dual Color Break Apart FISH Probe98/79 ZytoMation RET Dual Color Break Apart FISH Probe98/79 ZytoMation ROS1 Dual Color Break Apart FISH Probe	C IVDR, 98/79	Site web info@zytovision.com Fiche EUDAMED Signaler une erreur
Shanghai Zj Bio-Tech FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	14 RP Panel I98/79 20 RP Panel I98/79 4 Respiratory Pathogens Real Time RT-PCR Kit98/79 4 STIs Pathogens Lyo Multiplex Test98/79 6 RP Panel I98/79 207 autres 6 RP Panel II98/79 8 Common Leukemia Fusion Genes Screening Real Time RT-PCR Kit98/79 Adenovirus Real Time PCR Kit98/79 Avian Influenza Virus H5 Real Time RT-PCR Kit98/79 Avian Influenza Virus H5N1 Real Time RT-PCR Kit98/79 Avian Influenza Virus H7 Real Time RT-PCR Kit98/79 Avian Influenza Virus H9 Real Time RT-PCR Kit98/79 Avian Influenza Virus Real Time RT-PCR Kit98/79 Bacillus Diphtheriae Real Time PCR Kit98/79 Blood Genomic DNA Isolation Kit (Preloaded for Auto-Extraction) MVD022 réf. Bordetella Pertussis & Bordetella Parapertussis Real Time PCR Kit98/79 Bordetella Pertussis Real Time PCR Kit98/79 Brucella (Melitensis) Real Time PCR Kit98/79 Brucella (Ovis) Real Time PCR Kit98/79 Brucella Abortus Real Time PCR Kit98/79 Brucella Real Time PCR Kit98/79 Campylobacter Jejuni Real Time PCR Kit98/79 Candida Albicans Real Time PCR Kit98/79 Chikungunya Virus Real Time RT-PCR Kit98/79 Clostridium Difficile Real Time PCR Kit98/79 Coxiella burnetii Real Time PCR Kit98/79 Coxsackievirus A10 Real Time RT-PCR Kit98/79 Coxsackievirus A6 Real Time RT-PCR Kit98/79 Crimean-Congo Hemorrhagic Fever Virus(CCHFV) Real Time RT-PCR Kit98/79 Cryptosporidium Real Time PCR Kit98/79 Dengue Fever Virus & Chikungunya Virus Real Time RT-PCR Kit98/79 Dengue Fever Virus Genotyping Ⅰ/Ⅱ/Ⅲ/Ⅳ Real Time RT-PCR Kit98/79 Dengue Virus (DENV)Lyo RT-PCR Kit98/79 Dengue Virus General-type Real Time RT-PCR Kit98/79 Dengue Virus I Real Time RT-PCR Kit98/79 Dengue Virus II Real Time RT-PCR Kit98/79 Dengue Virus III Real Time RT-PCR Kit98/79 Dengue Virus IV Real Time RT-PCR Kit98/79 Diarrheagenic E.coli Genotype Real Time PCR Kit98/79 E. Coli O157：H7 Real Time PCR Kit98/79 Ebola Virus (EBOV) Real Time RT-PCR Kit98/79 EBV Real Time PCR Kit2 réf.98/79 Enteroadhesive E.Coli (EAEC) Real Time PCR Kit98/79 Enterohemorrhagic E.Coli (EHEC) Real Time PCR Kit98/79 Enteroinvasive E.Coli (EIEC) Real Time PCR Kit98/79 Enteropathogenic E.Coli (EPEC) Real Time PCR Kit98/79 Enterovirus 70（EV70）Real Time RT-PCR Kit98/79 Enterovirus 71(EV71) Real Time RT-PCR Kit98/79 Enterovirus Real Time RT-PCR Kit98/79 Foot-and-Mouth Disease Virus (FMDV) A Strain Real Time RT-PCR Kit98/79 Foot-and-Mouth Disease Virus (FMDV) Asia 1 Strain Real Time RT-PCR Kit98/79 Foot-and-Mouth Disease Virus (FMDV) O Strain Real Time RT-PCR Kit98/79 Foot-and-Mouth Disease Virus (FMDV) Serotype A22 Real Time RT-PCR Kit98/79 Group A Streptococcus (GAS) Real Time PCR Kit98/79 Group B Streptococcus (GBS) Real Time PCR Kit98/79 Hantavirus Pulmonary Syndrome Real Time RT-PCR Kit98/79 HantaVirus Renal Syndrome General-type I&II Real Time RT-PCR Kit98/79 Hantavirus Renal Syndrome Type II Real Time RT-PCR Kit98/79 Hantavirus Renal Syndrome Typing I&II Real Time RT-PCR Kit98/79 HarmoniaHPV Test3 réf.98/79 HAV Real Time RT-PCR Kit98/79 Helicobacter Pylori and Toxin (VacA/CagA) Real Time PCR Kit98/79 Helicobacter Pylori Real Time PCR Kit98/79 Hemophilus Influenza B Real Time PCR Kit98/79 HEV General Type Real Time RT-PCR Kit98/79 HEV I &III Real Time RT-PCR Kit98/79 HEV Real Time RT-PCR Kit98/79 HEV Ⅰ,Ⅱ,Ⅲ&Ⅳ Real Time RT-PCR Kit98/79 HGV Real Time RT-PCR Kit98/79 High-Risk Human Papillomavirus ( HPV) and Genotyping 16&18 Diagnostic Kit(PCR-Fluorescence)3 réf.98/79 High-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit2 réf.98/79 High-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit（PCR-Fluorescence）2 réf.98/79 HPV16&18 Real Time PCR Kit98/79 HPV16/HPV18/HPV6+11 Multiplex Real Time PCR Kit98/79 HPV6&11 Real Time PCR Kit98/79 HRV/RSV/HMPV Multiplex Real Time RT-PCR Kit98/79 HSVI&II Typing Real Time PCR Kit98/79 HSVⅠ&Ⅱ Real Time PCR Kit98/79 Human Astrovirus (HAstV) Real Time RT-PCR Kit98/79 Human Bocavirus（HBoV）Real Time PCR Kit98/79 Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit2 réf.98/79 Human Herpers Virus (HHV-6) Real Time PCR Kit98/79 Human Herpers Virus (HHV-8) Real Time PCR Kit98/79 Human Infections with Avian Influenza A Virus (H7N9) RNA Real Time RT-PCR Kit98/79 Human Metapneumovirus (hMPV) Real Time RT-PCR kit98/79 Human Parainfluenza Virus Type 1 Real Time RT-PCR Kit98/79 Human Parainfluenza Virus Type 2 Real Time RT-PCR Kit98/79 Human Parainfluenza Virus Type 3 Real Time RT-PCR Kit98/79 Human Parainfluenza Virus Type 4 Real Time RT-PCR Kit98/79 Human Parvovirus (B19) Real Time PCR Kit98/79 IFVA/H1N1/IFVB Test98/79 Influenza Virus A Real Time RT-PCR Kit98/79 Influenza Virus A&B Real Time RT-PCR Kit98/79 Influenza Virus A,B&C Real Time RT-PCR Kit98/79 Influenza Virus B Real Time RT-PCR Kit98/79 Influenza Virus B Typing Real Time RT-PCR Kit98/79 Influenza Virus C Real Time RT-PCR Kit98/79 Influenza Virus H1 Real Time RT-PCR Kit98/79 Influenza Virus H3 Real Time RT-PCR Kit98/79 Influenza Virus H3N2 Real time RT-PCR Kit98/79 Influenza Virus H5N1 Real Time RT-PCR Kit98/79 Influenza virus H5N2 Real Time RT-PCR Kit98/79 Influenza Virus A H1&H3 Real Time RT-PCR Kit98/79 Japanese Encephalitis Virus (JEV) Real Time RT-PCR Kit98/79 JCV Real Time PCR Kit98/79 Leptospira Real Time PCR Kit98/79 Leukemia AML1-ETO Fusion Gene Real Time RT-PCR Kit98/79 Leukemia AML1-EVI1 Fusion Gene Real Time RT-PCR Kit98/79 Leukemia BCR-ABL Fusion Gene Typing Real Time RT-PCR Kit98/79 Leukemia CBFB-MYH11 A Fusion Gene Real Time RT-PCR Kit98/79 Leukemia CBFB-MYH11 D Fusion Gene Real Time RT-PCR Kit98/79 Leukemia CBFB-MYH11 E Fusion Gene Real Time RT-PCR Kit98/79 Leukemia CBFB-MYH11 Fusion Gene Typing Real Time RT-PCR Kit98/79 Leukemia DEK-CAN Fusion Gene Real Time RT-PCR Kit98/79 Leukemia E2A-PBX1 Fusion Gene Real Time RT-PCR Kit98/79 Leukemia FIP1L1-PDGFRA Fusion Gene Real Time RT-PCR Kit98/79 Leukemia Gene JAK2 V617F Mutation Real Time RT-PCR Kit98/79 Leukemia M-BCR Fusion Gene Real Time RT-PCR Kit2 réf.98/79 Leukemia MLL-AF4 Fusion Gene Real Time RT-PCR Kit98/79 Leukemia MLL-AF9 Fusion Gene Real Time RT-PCR Kit98/79 Leukemia MLL-ENL Fusion Gene Real Time RT-PCR Kit98/79 Leukemia mu-BCR Fusion Gene Real Time RT-PCR Kit98/79 Leukemia PML-RAR a V Fusion Gene Real Time RT-PCR Kit98/79 Leukemia PML-RARa Fusion Gene Typing Real Time RT-PCR Kit98/79 Leukemia PML-RARa L Fusion Gene Real Time RT-PCR Kit98/79 Leukemia PML-RARa S Fusion Gene Real Time RT-PCR Kit98/79 Leukemia SIL-TAL1 Fusion Gene Real Time RT-PCR Kit98/79 Leukemia TEL-AML1 Fusion Gene Real Time RT-PCR Kit98/79 Leukemia WT-1Gene Real Time RT-PCR Kit98/79 Liferiver AU Nucleic Acid Extraction kit MVR063 réf. Liferiver ® Auto AT96S A Extraction Kit2 réf. Liferiver ® AutoAT96S C Extraction Kit2 réf. Liferiver ® AutoEX16P A Extraction Kit2 réf. Liferiver ® AutoEX36 C Extraction Kit2 réf. Liferiver ® AutoEX36 D Extraction Kit2 réf. Liferiver ® AutoEX36 E Extraction Kit2 réf. Liferiver ® AutoEX36 F Extraction Kit2 réf. Liferiver® AutoAT96P A Extraction Kit MVR102 réf. Liferiver® AutoEX36 A Extraction Kit MVR012 réf. Liferiver® AutoEX36 B Extraction Kit MVR092 réf. Liferiver® Beads Column A Extraction Kit2 réf. Liferiver® Preservation Medium MCS013 réf. Liferiver® Preservation Solution ACS013 réf. Listeria Monocytogenes Real Time PCR Kit98/79 LyoHarmonyHPV Test2 réf.98/79 Malaria Parasite Real Time PCR Kit98/79 Measles Virus and Rubella Virus Real Time RT-PCR Kit98/79 Measles Virus Real Time RT-PCR Kit98/79 Meningococcus Real Time PCR Kit98/79 Methicillin-resistant Staphylococcus Aureus (MRSA) Real Time PCR Kit98/79 Mumps Virus Real Time RT-PCR Kit98/79 Mycobacterium Tuberculosis (TB) Real Time PCR Kit2 réf.98/79 N.meningitides Group A Real Time PCR Kit98/79 N.meningitides Group W135 Real Time PCR Kit98/79 N1 Gene of Influenza Virus A Real Time RT-PCR Kit98/79 N2 Gene of Influenza Virus A Real Time RT-PCR Kit98/79 N3 Gene of Influenza Virus A Real Time RT-PCR Kit98/79 N7 Gene of Influenza Virus A Real Time RT-PCR Kit98/79 New influenza A virus Real Time RT-PCR Panel98/79 New influenza A virus（H1N1） Real Time RT-PCR Kit98/79 NoroVirus Genogroup I Real Time RT-PCR Kit98/79 Norovirus Genogroup II Real Time RT-PCR Kit98/79 NoroVirus Real Time RT-PCR Kit2 réf.98/79 Plasmodium Falciparum Real Time PCR Kit98/79 Plasmodium Malariae Real Time PCR Kit98/79 Plasmodium Ovale Real Time PCR Kit98/79 Plasmodium Vivax Real Time PCR Kit98/79 Polyomavirus BK (PBK) Real Time PCR Kit2 réf.98/79 QG28800 Respiratory AdenoVirus Real Time PCR Kit98/79 Respiratory Syncytial Virus (RSV) Typing A &B Real Time RT-PCR Kit2 réf.98/79 Respiratory Syncytial Virus(RSV) Real Time RT-PCR Kit98/79 Rickettsia Real Time PCR Kit98/79 RNA Isolation Kit (Paramagnetic Beads Column)2 réf. Rotavirus (Group B) Real Time RT-PCR Kit98/79 Rotavirus (Group C) Real Time RT-PCR Kit98/79 Rotavirus Real Time RT-PCR Kit98/79 Rubella Virus Real Time RT-PCR Kit98/79 Salmonella & Shigella Real Time PCR Kit98/79 Salmonella paratyphi Real Time PCR Kit98/79 Salmonella Real Time PCR Kit98/79 Salmonella Typhi Real Time PCR Kit98/79 Schistosoma Haematobium Real Time PCR Kit98/79 Schistosoma Mansoni Real Time PCR Kit98/79 Schistosomiasis Real Time PCR Kit98/79 Shigella Real Time PCR Kit98/79 Staphylococcus Aureus Real Time PCR Kit98/79 Streptococcus Pneumoniae Real Time PCR Kit98/79 Streptococcus Pyogenes Real Time PCR Kit98/79 Streptococcus Suis Real Time PCR Kit98/79 Streptococcus Suis Type 2 Real Time PCR Kit98/79 Tick-borne Encephalitis Virus (TBEV) Real Time RT-PCR Kit98/79 Treponema Pallidum (TP) Real Time PCR Kit98/79 Trypanosoma Brucei Real Time PCR Kit98/79 Trypanosoma Cruzi Real Time PCR Kit98/79 Uterine Cervix Cancer of High-risk HPV Genotype Related Real Time PCR Kit2 réf.98/79 Vancomycin-Resistant Staphylococcus Aureus (VRSA) Real Time PCR Kit98/79 Varicella Zoster Virus (VZV) Real Time PCR Kit98/79 VenusHPV Test2 réf.98/79 Vibrio Cholerae O1/O139/CTX Lyo-PCR Kit98/79 Viral DNA/RNA Isolation Kit (Centrifuge Column) LVN01 Viral DNA/RNA Isolation Kit (for Auto-Extraction) MVR183 réf. Viral RNA Extraction Kit (for Auto-Extraction) MVR102 réf. Viral RNA Extraction Kit (Preloaded for Auto-Extraction) MVR152 réf. Viral RNA Extraction Kit MVR092 réf. Viral RNA Isolation Kit (Preloaded for Auto-Extraction) MVR012 réf. Viral Transport Medium RVR093 réf. VZV/HSV2/HSV1 Multiplex Real Time PCR Kit98/79 West Nile Virus Real Time RT-PCR Kit98/79 Yersinia Enterocolitica Real Time PCR Kit98/79 Yersinia pestis Real Time PCR Kit98/79 Zika Virus (ZIKV) Real Time RT-PCR Kit2 réf.98/79	A IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Ttt Sağlik Hi̇zmetleri̇ Eği̇ti̇m İnşaat Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇	Turquie	0.25 mL Fluoride/Oxalate Micro Blood Collection Tube, Grey Cap 10x45mm 250898/79 0.5 mL K2EDTA Blood Collection Tube, Purple Cap 13x75mm 224298/79 0.5 mL K2EDTA Micro Blood Collection Tube, Purple Cap 10x45mm 292598/79 0.5 mL K3EDTA Blood Collection Tube, Purple Cap 13x75mm 224398/79 0.5 mL K3EDTA Micro Blood Collection Tube, Purple Cap 10x45mm 292798/79 202 autres 0.5 mL Lithium Heparin Micro Blood Collection Tube, Green Cap 10x45mm 292998/79 0.5 mL Serum Separator Micro Blood Collection Tube with Gel and Clot Activator, Yellow Cap 10x45mm 292398/79 0.5 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 208998/79 0.6 mL Sodium Fluoride/Sodium EDTA Micro Blood Collection Tube, Grey Cap 10x45mm 251098/79 1 mL K2EDTA Micro Blood Collection Tube, Purple Cap 10x45mm 292698/79 1 mL K3EDTA Micro Blood Collection Tube, Purple Cap 10x45mm 292898/79 1 mL Lithium Heparin Micro Blood Collection Tube, Green Cap 10x45mm 293098/79 1 mL Serum Separator Micro Blood Collection Tube with Gel and Clot Activator, Yellow Cap 10x45mm 292498/79 1 mL Vacuum Clot Activator Blood Collection Tube, Red Cap 13x75mm 260198/79 1 mL Vacuum K2EDTA Blood Collection Tube, Purple Cap 13x75mm 220398/79 1 mL Vacuum K3EDTA Blood Collection Tube, Purple Cap 13x75mm 221298/79 1 mL Vacuum Lithium Heparin Blood Collection Tube, Green Cap 13x75mm 231998/79 1 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 240598/79 1.28 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate, Black Cap 8x120mm 270498/79 1.28 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate, Black Cap 8x120mm 271098/79 1.6 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate, Black Cap 9x120mm 270398/79 1.6 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate, Black Cap 8x120mm 270998/79 1.6 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate, Black Cap 9x120mm 270698/79 1.8 mL Vacuum CTAD Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 209298/79 1.8 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 240298/79 1.8 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Pre-Barcoded, Blue Cap 13x75mm 294098/79 1.8 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate, Black Cap 8x100mm 270798/79 1.8 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate (0.129M), Blue Cap 13x75mm 241398/79 10 mL Vacuum Cell-Free DNA Blood Collection Tube with Stabilizer, Clear Cap 16x100mm 212298/79 10 mL Vacuum Clot Activator Blood Collection Tube, Red Cap 16x100mm 262398/79 10 mL Vacuum K2EDTA Blood Collection Tube, Purple Cap 16x100mm 222198/79 10 mL Vacuum K3EDTA Blood Collection Tube, Purple Cap 16x100mm 222998/79 10 mL Vacuum Lithium Heparin Blood Collection Tube, Green Cap 16x100mm 231598/79 10 mL Vacuum Sodium Fluoride/Sodium EDTA Blood Collection Tube, Grey Cap 16x100mm 250798/79 10 mL Vacuum Sodium Heparin Blood Collection Tube, Green Cap 16x100mm 233098/79 2 mL Vacuum Clot Activator Blood Collection Tube, Red Cap 13x75mm 260298/79 2 mL Vacuum Fluoride/Oxalate Blood Collection Tube, Grey Cap 13x75mm 250198/79 2 mL Vacuum Fluoride/Oxalate Blood Collection Tube, Pre-Barcoded, Grey Cap 13x75mm 294198/79 2 mL Vacuum GLP-1/GIP/Glucagon/Ghrelin Preservation Blood Collection Tube with EDTA/Inhibitor, Clear Cap 13x75mm 212498/79 2 mL Vacuum K2EDTA Blood Collection Tube, Pre-Barcoded, Purple Cap 13x75mm 293898/79 2 mL Vacuum K2EDTA Blood Collection Tube, Purple Cap 13x75mm 220298/79 2 mL Vacuum K3EDTA Blood Collection Tube, Grey Cap 13x75mm 251198/79 2 mL Vacuum K3EDTA Blood Collection Tube, Purple Cap 13x75mm 221398/79 2 mL Vacuum K3EDTA Blood Collection Tube, Purple Cap 13x75mm 224498/79 2 mL Vacuum Lithium Heparin Blood Collection Tube, Green Cap 13x75mm 230198/79 2 mL Vacuum Serum Separator Blood Collection Tube with Gel, Yellow Cap 210498/79 2 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 240398/79 2 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate, Black Cap 13x75mm 270198/79 2 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate (0.129M), Blue Cap 13x75mm 241498/79 2 mL Vacuum Sodium Fluoride/Citric Acid Blood Collection Tube, Grey Cap 13x75mm 251398/79 2 mL Vacuum Sodium Fluoride/Heparin Blood Collection Tube, Grey Cap 13x75mm 251598/79 2 mL Vacuum Sodium Fluoride/Sodium EDTA Blood Collection Tube, Grey Cap 13x75mm 250498/79 2 mL Vacuum Sodium Heparin Blood Collection Tube, Green Cap 13x75mm 230898/79 2 mL Vacuum Trace Element Blood Collection Tube with Clot Activator, Navy Blue Cap 13x75mm 295298/79 2.4 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate, Black Cap 13x75mm 270298/79 2.4 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate, Black Cap 13x75mm 270598/79 2.5 mL Vacuum K2EDTA Blood Collection Tube, Clear Cap 13x75mm 212098/79 2.5 mL Vacuum RNA Blood Collection Tube with Stabilizer, Clear Cap 16x100mm 212198/79 2.5 mL Vacuum Serum Separator Blood Collection Tube with Gel and Clot Activator, Yellow Cap 13x75mm 211198/79 2.5 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 240498/79 2.5 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate (0.129M), Blue Cap 13x75mm 241598/79 2.7 mL Vacuum CTAD Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 209398/79 2.7 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 240198/79 2.7 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate (0.129M), Blue Cap 13x75mm 241698/79 3 mL Vacuum Blood Collection Tube with No Additive, Clear Cap 13x75mm 211798/79 3 mL Vacuum Clot Activator Blood Collection Tube, Pre-Barcoded, Red Cap 13x75mm 294598/79 3 mL Vacuum Clot Activator Blood Collection Tube, Red Cap 13x75mm 260398/79 3 mL Vacuum Fluoride/Oxalate Blood Collection Tube, Grey Cap 13x75mm 250998/79 3 mL Vacuum K2EDTA Blood Collection Tube with Gel, Purple Cap 13x75mm 220998/79 3 mL Vacuum K2EDTA Blood Collection Tube, Pre-Barcoded, Purple Cap 13x75mm 293998/79 3 mL Vacuum K2EDTA Blood Collection Tube, Purple Cap 13x75mm 220198/79 3 mL Vacuum K2EDTA Blood Collection Tube, Tan Cap 13x75mm 290498/79 3 mL Vacuum K3EDTA Blood Collection Tube, Purple Cap 13x75mm 221498/79 3 mL Vacuum Lithium Heparin Blood Collection Tube with Gel, Green Cap 13x75mm 230498/79 3 mL Vacuum Lithium Heparin Blood Collection Tube with Mechanical Separator, Green Cap 13x75mm 232598/79 3 mL Vacuum Lithium Heparin Blood Collection Tube, Green Cap 13x75mm 231198/79 3 mL Vacuum Serum Separator Blood Collection Tube with Gel and Clot Activator, Yellow Cap 13x100mm 211498/79 3 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 240698/79 3 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate (0.129M), Blue Cap 13x75mm 241798/79 3 mL Vacuum Sodium Fluoride/Citric Acid Blood Collection Tube, Grey Cap 13x75mm 251498/79 3 mL Vacuum Sodium Fluoride/Heparin Blood Collection Tube, Grey Cap 13x75mm 251698/79 3 mL Vacuum Sodium Heparin Blood Collection Tube, Navy Blue Cap 13x75mm 297698/79 3 mL Vacuum Trace Element Blood Collection Tube with Clot Activator, Navy Blue Cap 13x75mm 295498/79 3 mL Vacuum Trace Element Blood Collection Tube with Clot Activator, Pre-Barcoded, Navy Blue Cap 13x75mm 294498/79 3 mL Vacuum Trace Element Blood Collection Tube with K2EDTA, Navy Blue Cap 13x75mm 297798/79 3,5 mL Vacuum Serum Separator Blood Collection Tube with Gel, Yellow Cap 210298/79 3.15 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 242298/79 3.5 mL Vacuum K2EDTA Blood Collection Tube, Purple Cap 13x75mm 220498/79 3.5 mL Vacuum K3EDTA Blood Collection Tube, Purple Cap 13x75mm 221598/79 3.5 mL Vacuum Lithium Heparin Blood Collection Tube with Gel, Green Cap 13x100mm 230598/79 3.5 mL Vacuum Lithium Heparin Blood Collection Tube with Gel, Green Cap 13x75mm 232498/79 3.5 mL Vacuum Lithium Heparin Blood Collection Tube with Mechanical Separator, Green Cap 13x100mm 232698/79 3.5 mL Vacuum Lithium Heparin Blood Collection Tube, Green Cap 13x75mm 232098/79 3.5 mL Vacuum Rapid Serum Blood Collection Tube with Gel and Clot Activator, Orange Cap 13x75mm 261898/79 3.5 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate (0.129M), Blue Cap 13x75mm 241898/79 3.6 mL Vacuum CTAD Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 209498/79 3.6 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 240798/79 4 mL Vacuum Clot Activator Blood Collection Tube, Red Cap 13x100mm 260598/79 4 mL Vacuum Clot Activator Blood Collection Tube, Red Cap 13x75mm 260498/79 4 mL Vacuum Crossmatch Blood Collection Tube with Clot Activator, Pink Cap 13x75mm 223398/79 4 mL Vacuum EDTA Aprotinin Blood Collection Tube, Purple Cap 13x75mm 223198/79 4 mL Vacuum Fluoride/Oxalate Blood Collection Tube, Grey Cap 13x75mm 250298/79 4 mL Vacuum K2EDTA Blood Collection Tube with Gel, Purple Cap 13x75mm 221098/79 4 mL Vacuum K2EDTA Blood Collection Tube, Pink Cap 13x75mm 223698/79 4 mL Vacuum K2EDTA Blood Collection Tube, Pre-Barcoded, Purple Cap 13x75mm 222698/79 4 mL Vacuum K2EDTA Blood Collection Tube, Purple Cap 13x75mm 220598/79 4 mL Vacuum K3EDTA Blood Collection Tube, Grey Cap 13x75mm 251298/79 4 mL Vacuum K3EDTA Blood Collection Tube, Pink Cap 13x75mm 223998/79 4 mL Vacuum K3EDTA Blood Collection Tube, Purple Cap 13x75mm 221698/79 4 mL Vacuum Lithium Heparin Blood Collection Tube, Green Cap 13x75mm 230298/79 4 mL Vacuum Serum Separator Blood Collection Tube with Gel and Clot Activator, Yellow Cap 13x100mm 210998/79 4 mL Vacuum Serum Separator Blood Collection Tube with Gel, Yellow Cap 210398/79 4 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 240898/79 4 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate (0.129M), Blue Cap 13x75mm 241998/79 4 mL Vacuum Sodium Fluoride/Sodium EDTA Blood Collection Tube, Grey Cap 13x75mm 250598/79 4 mL Vacuum Sodium Heparin Blood Collection Tube, Green Cap 13x75mm 230998/79 4 mL Vacuum Trace Element Blood Collection Tube with Clot Activator, Navy Blue Cap 13x75mm 295398/79 4.5 mL Vacuum CTAD Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x100mm 209598/79 4.5 mL Vacuum K2EDTA Blood Collection Tube with Gel, Purple Cap 13x100mm 222598/79 4.5 mL Vacuum K2EDTA Blood Collection Tube, Purple Cap 13x100mm 220798/79 4.5 mL Vacuum K2EDTA Blood Collection Tube, Purple Cap 13x75mm 220698/79 4.5 mL Vacuum K3EDTA Blood Collection Tube, Purple Cap 13x100mm 221898/79 4.5 mL Vacuum K3EDTA Blood Collection Tube, Purple Cap 13x75mm 221798/79 4.5 mL Vacuum Lithium Heparin Blood Collection Tube with Gel, Green Cap 13x100mm 230698/79 4.5 mL Vacuum Lithium Heparin Blood Collection Tube with Gel, Pre-Barcoded, Green Cap 13x100mm 294298/79 4.5 mL Vacuum Lithium Heparin Blood Collection Tube with Mechanical Separator, Green Cap 13x100mm 232798/79 4.5 mL Vacuum Lithium Heparin Blood Collection Tube, Green Cap 13x100mm 232198/79 4.5 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x100mm 241098/79 4.5 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x75mm 240998/79 4.5 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate (0.129M), Blue Cap 13x100mm 242198/79 4.5 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate (0.129M), Blue Cap 13x75mm 242098/79 4.8 mL Vacuum Rapid Serum Blood Collection Tube with Clot Activator, Orange Cap 13x75mm 261998/79 5 mL Vacuum Blood Collection Tube with No Additive, Clear Cap 13x100mm 211898/79 5 mL Vacuum Clot Activator Blood Collection Tube, Red Cap 13x100mm 260698/79 5 mL Vacuum EDTA Aprotinin Blood Collection Tube, Purple Cap 13x75mm 223298/79 5 mL Vacuum Fluoride/Oxalate Blood Collection Tube, Grey Cap 13x100mm 251798/79 5 mL Vacuum K2EDTA Blood Collection Tube with Gel, Purple Cap 13x100mm 221198/79 5 mL Vacuum K2EDTA Blood Collection Tube, Purple Cap 13x100mm 223098/79 5 mL Vacuum K3EDTA Blood Collection Tube, Purple Cap 13x100mm 221998/79 5 mL Vacuum Lithium Heparin Blood Collection Tube with Gel, Green Cap 13x100mm 230798/79 5 mL Vacuum Lithium Heparin Blood Collection Tube with Gel, Pre-Barcoded, Green Cap 13x100mm 294398/79 5 mL Vacuum Lithium Heparin Blood Collection Tube with Mechanical Separator, Green Cap 13x100mm 232898/79 5 mL Vacuum Lithium Heparin Blood Collection Tube, Green Cap 13x100mm 232298/79 5 mL Vacuum Rapid Serum Blood Collection Tube with Gel and Clot Activator, Orange Cap 13x100mm 262298/79 5 mL Vacuum Serum Separator Blood Collection Tube with Gel and Clot Activator, Pre-Barcoded, Yellow Cap 13x100mm 293798/79 5 mL Vacuum Serum Separator Blood Collection Tube with Gel, Yellow Cap 210198/79 5 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x100mm 241198/79 5 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate, Black Cap 10.5x120mm 270898/79 5 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate (0.129M), Blue Cap 13x100mm 209198/79 5 mL Vacuum Sodium Heparin Blood Collection Tube, Navy Blue Cap 13x100mm 297898/79 5 mL Vacuum Trace Element Blood Collection Tube with Clot Activator, Navy Blue Cap 13x100mm 297198/79 5 mL Vacuum Trace Element Blood Collection Tube with K2EDTA, Navy Blue Cap 13x100mm 297998/79 5,5 mL Vacuum Serum Separator Blood Collection Tube with Gel, Yellow Cap 210598/79 5.5 mL Vacuum Fluoride/Oxalate Blood Collection Tube, Grey Cap 13x100mm 250398/79 5.5 mL Vacuum Lithium Heparin Blood Collection Tube with Mechanical Separator, Green Cap 13x100mm 232998/79 6 mL Vacuum ACD-A Blood Collection Tube, Yellow Cap 13x100mm 209698/79 6 mL Vacuum ACD-B Blood Collection Tube, Yellow Cap 13x100mm 210098/79 6 mL Vacuum Clot Activator Blood Collection Tube, Red Cap 13x100mm 260798/79 6 mL Vacuum Crossmatch Blood Collection Tube with Clot Activator, Pink Cap 13x100mm 223498/79 6 mL Vacuum K2EDTA Blood Collection Tube, Pink Cap 13x100mm 223798/79 6 mL Vacuum K2EDTA Blood Collection Tube, Purple Cap 13x100mm 220898/79 6 mL Vacuum K3EDTA Blood Collection Tube, Pink Cap 13x100mm 224098/79 6 mL Vacuum K3EDTA Blood Collection Tube, Purple Cap 13x100mm 222098/79 6 mL Vacuum Lithium Heparin Blood Collection Tube, Green Cap 13x100mm 230398/79 6 mL Vacuum Lithium Heparin Blood Collection Tube, Green Cap 16x100mm 232398/79 6 mL Vacuum Rapid Serum Blood Collection Tube with Clot Activator, Orange Cap 13x100mm 262198/79 6 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 13x100mm 241298/79 6 mL Vacuum Sodium Heparin Blood Collection Tube, Green Cap 13x100mm 231098/79 6 mL Vacuum Trace Element Blood Collection Tube with Clot Activator, Navy Blue Cap 13x100mm 290698/79 6 mL Vacuum Trace Element Blood Collection Tube with K2EDTA, Navy Blue Cap 13x100mm 290598/79 6 mL Vacuum Trace Element Blood Collection Tube with K2EDTA, Navy Blue Cap 13x100mm 297498/79 6 mL Vacuum Trace Element Blood Collection Tube with No Additive, Navy Blue Cap 13x100mm 298098/79 7 mL Vacuum Clot Activator Blood Collection Tube, Red Cap 16x100mm 261498/79 7 mL Vacuum Lithium Heparin Blood Collection Tube, Green Cap 16x100mm 231298/79 7 mL Vacuum Serum Separator Blood Collection Tube with Gel and Clot Activator, Yellow Cap 16x100mm 210798/79 7 mL Vacuum Trace Element Blood Collection Tube with K2EDTA, Navy Blue Cap 13x100mm 297598/79 7 mL Vacuum Trace Element Blood Collection Tube with K2EDTA, Navy Blue Cap 13x100mm 298198/79 7.5 mL Vacuum Serum Separator Blood Collection Tube with Gel and Clot Activator, Yellow Cap 16x100mm 211298/79 8 mL Vacuum Blood Collection Tube with No Additive, Clear Cap 16x100mm 211998/79 8 mL Vacuum Clot Activator Blood Collection Tube, Red Cap 16x100mm 261598/79 8 mL Vacuum K2EDTA Blood Collection Tube with Gel, Purple Cap 16x100mm 222398/79 8 mL Vacuum K2EDTA Blood Collection Tube, Purple Cap 16x100mm 222498/79 8 mL Vacuum K3EDTA Blood Collection Tube, Purple Cap 16x100mm 222898/79 8 mL Vacuum Lithium Heparin Blood Collection Tube with Gel, Green Cap 16x100mm 231698/79 8 mL Vacuum Lithium Heparin Blood Collection Tube, Green Cap 16x100mm 231398/79 8 mL Vacuum Serum Separator Blood Collection Tube with Gel and Clot Activator, Yellow Cap 16x100mm 210698/79 8 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 16x100mm 242898/79 8 mL Vacuum Sodium Heparin Blood Collection Tube, Green Cap 16x100mm 231798/79 8.5 mL Vacuum GLP-1/GIP/Glucagon/Ghrelin Preservation Blood Collection Tube with EDTA/Inhibitor, Clear Cap 16x100mm 212598/79 8.5 mL Vacuum Plasma Protein Preservation Blood Collection Tube with EDTA/Inhibitor, Clear Cap 16x100mm 212398/79 8.5 mL Vacuum Serum Separator Blood Collection Tube with Gel and Clot Activator, Yellow Cap 16x100mm 211398/79 9 mL Vacuum ACD-A Blood Collection Tube, Yellow Cap 16x100mm 209898/79 9 mL Vacuum ACD-B Blood Collection Tube, Yellow Cap 16x100mm 211598/79 9 mL Vacuum Clot Activator Blood Collection Tube with Gel, Red Cap 16x100mm 262098/79 9 mL Vacuum Clot Activator Blood Collection Tube, Red Cap 16x100mm 261698/79 9 mL Vacuum Crossmatch Blood Collection Tube with Clot Activator, Pink Cap 16x100mm 223598/79 9 mL Vacuum K2EDTA Blood Collection Tube, Pink Cap 16x100mm 223898/79 9 mL Vacuum K2EDTA Blood Collection Tube, Purple Cap 16x100mm 222798/79 9 mL Vacuum K3EDTA Blood Collection Tube, Pink Cap 16x100mm 224198/79 9 mL Vacuum K3EDTA Blood Collection Tube, Purple Cap 16x100mm 222298/79 9 mL Vacuum Lithium Heparin Blood Collection Tube, Green Cap 16x100mm 231498/79 9 mL Vacuum Serum Separator Blood Collection Tube with Gel and Clot Activator, Yellow Cap 16x100mm 210898/79 9 mL Vacuum Sodium Citrate Blood Collection Tube with 3.13% Sodium Citrate (0.109M), Blue/Grey Cap 16x100mm 242498/79 9 mL Vacuum Sodium Citrate Blood Collection Tube with 3.2% Sodium Citrate (0.109M), Blue Cap 16x100mm 242598/79 9 mL Vacuum Sodium Citrate Blood Collection Tube with 3.8% Sodium Citrate (0.129M), Blue Cap 16x100mm 242398/79 9 mL Vacuum Sodium Fluoride/Sodium EDTA Blood Collection Tube, Grey Cap 16x100mm 250698/79 9 mL Vacuum Sodium Heparin Blood Collection Tube, Green Cap 16x100mm 231898/79	– 98/79	Fiche EUDAMED Signaler une erreur
Idilbiotech	Turquie	DirEXT Nucleic Acid Extraction Reagent3 réf.98/79 DirEXT OneStep HPV DNA Extraction Reagent2 réf.98/79 DirEXT OneStep Pathogen DNA/RNA Extraction Reagent2 réf.98/79 RevoDx Viral DNA Purification Kit3 réf.98/79 RevoDx Viral RNA Purification Kit3 réf.98/79 195 autres RevoDx Acinetobacter baumannii qPCR Kit2 réf.98/79 RevoDx Adenovirus (F40/41) qPCR Kit2 réf.98/79 RevoDx Adenovirus / CMV / EBV qPCR Kit2 réf.98/79 RevoDx Adenovirus qPCR Kit2 réf.98/79 RevoDx African Swine Fever Virus qPCR Kit2 réf.98/79 RevoDx Aspergillus qPCR Kit2 réf.98/79 RevoDx Astrovirus qPCR Kit2 réf.98/79 RevoDx Atypical pneumonia Pathogen Detection Kit2 réf.98/79 RevoDx Avian Influenza (H5N1) qPCR Kit2 réf.98/79 RevoDx Bacterial Respiratory Pathogen Detection Kit2 réf.98/79 RevoDx Bacterial/Fungal Meningitis-Encephalitis Pathogen Detection Kit3 réf.98/79 RevoDx BK Virus qPCR Kit2 réf.98/79 RevoDx BK Virus Quantitative qPCR Kit2 réf.98/79 RevoDx Bocavirus 1/2/3/4 qPCR Kit2 réf.98/79 RevoDx Bordetella pertussis qPCR Kit2 réf.98/79 RevoDx Bordetella pertussis/parapertussis qPCR Kit2 réf.98/79 RevoDx Campylobacter spp (C. jejuni, C. upsaliensis, C. coli) qPCR Kit2 réf.98/79 RevoDx Campylobacter spp / Salmonella spp / Yersinia Enterocolitica qPCR Kit2 réf.98/79 RevoDx Candida albicans qPCR Kit2 réf.98/79 RevoDx Candida auris qPCR Kit2 réf.98/79 RevoDx Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit3 réf.98/79 RevoDx Cervical Specimens Transport Reagent3 réf.98/79 RevoDx Chikungunya Virus qPCR Kit2 réf.98/79 RevoDx Chlamydia Trachomatis qPCR Kit2 réf.98/79 RevoDx Chlamydophila pneumoniae qPCR Kit2 réf.98/79 RevoDx Clostridium difficile qPCR Kit3 réf.98/79 RevoDx Colistin (mcr) resistance qPCR Kit2 réf.98/79 RevoDx Coronavirus 229E/NL63/OC43/HKU1 qPCR Kit2 réf.98/79 RevoDx Crimean-Congo Hemorrhagic Fever Virus qPCR Kit2 réf.98/79 RevoDx Cryptococcus neoformans/gattii qPCR Kit2 réf.98/79 RevoDx Cryptosporidium spp qPCR Kit2 réf.98/79 RevoDx CT/NG plus Mycoplasma Hominis qPCR Kit3 réf.98/79 RevoDx CT/NG qPCR Kit98/79 RevoDx Cyclospora cayetanensis qPCR Kit2 réf.98/79 RevoDx Dengue / Zika / Chikungunya Virus qPCR Kit2 réf.98/79 RevoDx Dengue Virus Screening qPCR Kit2 réf.98/79 RevoDx Dengue Virus Typing qPCR Kit2 réf.98/79 RevoDx Diarrheagenic Escherichia coli (DEC) Detection Kit2 réf.98/79 RevoDx Diarrheagenic Escherichia coli (DEC) version 2.0 Detection Kit2 réf.98/79 RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)3 réf.98/79 RevoDx DNA Purification Kit from Bacteria3 réf.98/79 RevoDx DNA Purification Kit from Blood2 réf.98/79 RevoDx DNA Purification Kit from Blood Culture3 réf.98/79 RevoDx DNA Purification Kit from Respiratory Samples3 réf.98/79 RevoDx DNA Purification Kit from Tissue and Paraffin-Embedded Tissue3 réf.98/79 RevoDx E. coli O157:H7 qPCR Kit2 réf.98/79 RevoDx Eastern Equine Encephalitis Virus qPCR Kit2 réf.98/79 RevoDx Entamoeba Histolytica qPCR Kit2 réf.98/79 RevoDx Enterobacter cloacae qPCR Kit2 réf.98/79 RevoDx Enterococcus faecalis qPCR Kit2 réf.98/79 RevoDx Enterococcus faecium qPCR Kit2 réf.98/79 RevoDx Enterovirus/Rhinovirus qPCR Kit2 réf.98/79 RevoDx Epstein-Barr Virus / Adenovirus qPCR Kit2 réf.98/79 RevoDx Epstein-Barr Virus qPCR Kit3 réf.98/79 RevoDx Epstein-Barr Virus qPCR Kit (Quantitative) IP202216-25098/79 RevoDx Escherichia coli K1 qPCR Kit2 réf.98/79 RevoDx Escherichia coli qPCR Kit2 réf.98/79 RevoDx Extended Spectrum Beta-Lactamases (ESBL) Genes (CTX-M, TEM, SHV) qPCR Kit2 réf.98/79 RevoDx Flu A / Flu B / RSV / SARS-CoV-2 qPCR Kit2 réf.98/79 RevoDx Flu A&B / RSV / SARS-CoV-2 qPCR Kit2 réf.98/79 RevoDx Flu A&B / SARS-CoV-2 qPCR Kit2 réf.98/79 RevoDx Gardnerella Vaginalis qPCR Kit2 réf.98/79 RevoDx Gastro Bacterial Pathogen Detection Kit3 réf.98/79 RevoDx Gastro Parasitic Pathogen Detection Kit3 réf.98/79 RevoDx Gastro Pathogen Detection Kit9 réf.98/79 RevoDx Gastro Viral Pathogen Detection Kit3 réf.98/79 RevoDx GEL/PCR Product Purification Kit3 réf.98/79 RevoDx Genomic DNA Purification Kit from Blood98/79 RevoDx Genomic DNA Purification Kit from Yeast2 réf.98/79 RevoDx Giardia Lamblia / Entamoeba Histolytica / Cryptosporidium spp qPCR Kit2 réf.98/79 RevoDx Giardia Lamblia qPCR Kit2 réf.98/79 RevoDx Haemophilus Ducreyi qPCR Kit2 réf.98/79 RevoDx Haemophilus influenzae / Human Metapneumovirus / Mycoplasma pneumoniae qPCR Kit2 réf.98/79 RevoDx Haemophilus influenzae / Neisseria Meningitidis / Streptococcus pneumoniae qPCR Kit2 réf.98/79 RevoDx Haemophilus influenzae qPCR Kit2 réf.98/79 RevoDx HBV qPCR Kit7 réf.98/79 RevoDx HBV qPCR Kit (Qualitative)98/79 RevoDx HBV/HCV/HIV1&2 qPCR Kit2 réf.98/79 RevoDx HCV Genotyping qPCR Kit v012 réf.98/79 RevoDx HCV qPCR Kit8 réf.98/79 RevoDx HDV qPCR Kit4 réf.98/79 RevoDx Helicobacter pylori qPCR Kit2 réf.98/79 RevoDx Hepatitis A Virus Qualitative qPCR Kit4 réf.98/79 RevoDx Hepatitis A Virus Quantitative qPCR Kit4 réf.98/79 RevoDx HIV-1 qPCR Kit6 réf.98/79 RevoDx HIV-1/2 qPCR Kit2 réf.98/79 RevoDx HIV-2 qPCR Kit4 réf.98/79 RevoDx HPV 14 Genotyping Kit2 réf.98/79 RevoDx HPV 26 Screening Kit2 réf.98/79 RevoDx HPV 6/11 Genotyping Kit2 réf.98/79 RevoDx HPV Screening plus 16/18 Kit2 réf.98/79 RevoDx HSV-1 qPCR Kit2 réf.98/79 RevoDx HSV-1/2 Screening qPCR Kit2 réf.98/79 RevoDx HSV-2 qPCR Kit2 réf.98/79 RevoDx Human herpes virus 6 (HHV-6) qPCR Kit2 réf.98/79 RevoDx Human herpes virus 7 (HHV-7) qPCR Kit2 réf.98/79 RevoDx Human Metapneumovirus qPCR Kit2 réf.98/79 RevoDx Human parechovirus qPCR Kit2 réf.98/79 RevoDx Influenza A H1N1 (pdm09) qPCR Kit2 réf.98/79 RevoDx Influenza A&B qPCR Kit2 réf.98/79 RevoDx Influenza A-H3 qPCR Kit2 réf.98/79 RevoDx JC Virus qPCR Kit2 réf.98/79 RevoDx JC Virus Quantitative qPCR Kit2 réf.98/79 RevoDx Klebsiella pneumonia qPCR Kit3 réf.98/79 RevoDx Legionella pneumophila qPCR Kit2 réf.98/79 RevoDx Leptospira spp qPCR Kit2 réf.98/79 RevoDx Listeria monocytogenes qPCR Kit2 réf.98/79 RevoDx Magnetic Pathogen DNA/RNA Purification Kit3 réf.98/79 RevoDx Magnetic Viral Nucleic Acid Purification Kit3 réf.98/79 RevoDx Malaria qPCR Kit2 réf.98/79 RevoDx Measles morbillivirus qPCR Kit2 réf.98/79 RevoDx Meningitis/Encephalitis Pathogen PLUS Detection Kit9 réf.98/79 RevoDx Methicillin resistance (mecA/mecC) qPCR Kit2 réf.98/79 RevoDx Monkeypox qPCR Kit2 réf.98/79 RevoDx Moraxella catarrhalis/ Haemophilus influenzae/ Streptococcus pyogenes qPCR Kit4 réf.98/79 RevoDx MRSA qPCR Kit2 réf.98/79 RevoDx MTBC qPCR Kit2 réf.98/79 RevoDx Mumps virus qPCR Kit2 réf.98/79 RevoDx Mycoplasma genitalium / Ureaplasma Parvum/Urealytıcum qPCR Kit3 réf.98/79 RevoDx Mycoplasma Genitalium qPCR Kit2 réf.98/79 RevoDx Mycoplasma Hominis qPCR Kit2 réf.98/79 RevoDx Mycoplasma Hominis/Genitalium qPCR Kit3 réf.98/79 RevoDx Mycoplasma pneumoniae qPCR Kit2 réf.98/79 RevoDx Neisseria Gonorrhoeae qPCR Kit2 réf.98/79 RevoDx Neisseria Meningitidis qPCR Kit2 réf.98/79 RevoDx Norovirus genogroup I&II qPCR Kit2 réf.98/79 RevoDx Parainfluenza virus 1 qPCR Kit2 réf.98/79 RevoDx Parainfluenza virus 2 qPCR Kit2 réf.98/79 RevoDx Parainfluenza virus 3 qPCR Kit2 réf.98/79 RevoDx Parainfluenza virus 4 qPCR Kit2 réf.98/79 RevoDx Parvovirus B19 Qualitative qPCR Kit2 réf.98/79 RevoDx Parvovirus B19 Quantitative qPCR Kit2 réf.98/79 RevoDx Pathogen DNA/RNA Purification Kit3 réf.98/79 RevoDx Plasmid DNA Purification Kit3 réf.98/79 RevoDx Plesiomonas shigelloides qPCR Kit2 réf.98/79 RevoDx Pseudomonas aeruginosa qPCR Kit2 réf.98/79 RevoDx Respiratory-11 Pathogen Detection Kit2 réf.98/79 RevoDx Respiratory-24 Pathogen Detection Kit9 réf.98/79 RevoDx Respiratory-24 Pathogen Detection Kit W010507050398/79 RevoDx Respiratory-24 v2.0 Pathogen Detection Kit9 réf.98/79 RevoDx Respiratory-24 v3.0 Pathogen Detection Kit2 réf.98/79 RevoDx Respiratory-27 Pathogen Detection Kit3 réf.98/79 RevoDx Respiratory-34 Pathogen Detection Kit3 réf.98/79 RevoDx Respiratory-5 Pathogen Detection Kit3 réf.98/79 RevoDx Respiratory-5 version 2.0 Pathogen Detection Kit2 réf.98/79 RevoDx Respiratory-5 version 3.0 Pathogen Detection Kit2 réf.98/79 RevoDx Respiratory-5 version 4.0 Pathogen Detection Kit2 réf.98/79 RevoDx Respiratory-6 Pathogen Detection Kit3 réf.98/79 RevoDx Respiratory-6 version 3.0 Pathogen Detection Kit2 réf.98/79 RevoDx Respiratory-7 Pathogen Detection Kit3 réf.98/79 RevoDx Respiratory-9 Pathogen Detection Kit3 réf.98/79 RevoDx Rotavirus A qPCR Kit2 réf.98/79 RevoDx RSV qPCR Kit2 réf.98/79 RevoDx Rubella Virus qPCR Kit2 réf.98/79 RevoDx Salmonella qPCR Kit3 réf.98/79 RevoDx Sapovirus (I, II, IV, V) qPCR Kit2 réf.98/79 RevoDx SARS-CoV-2 qPCR Kit v2.22 réf.98/79 RevoDx SARS-CoV-2 qPCR Kit v2.32 réf.98/79 RevoDx Sepsis Pathogen Detection Kit9 réf.98/79 RevoDx Sepsis Pathogen PLUS Detection Kit3 réf.98/79 RevoDx Sexually Transmitted Infections (STIs) Pathogen Detection Kit9 réf.98/79 RevoDx Sexually Transmitted Infections (STIs) Pathogen PLUS Detection Kit9 réf.98/79 RevoDx Staphyloccocus aureus qPCR Kit2 réf.98/79 RevoDx Staphyloccocus spp. qPCR Kit2 réf.98/79 RevoDx Stenotrophomonas maltophilia qPCR Kit2 réf.98/79 RevoDx STI-11 Pathogen Detection Kit9 réf.98/79 RevoDx STI-18 Pathogen Detection Kit9 réf.98/79 RevoDx STI-6 Pathogen Detection Kit3 réf.98/79 RevoDx STI-8 Pathogen Detection Kit3 réf.98/79 RevoDx Stool Pathogen DNA/RNA Purification Kit3 réf.98/79 RevoDx Streptococcus agalactiae qPCR Kit2 réf.98/79 RevoDx Streptococcus pneumoniae / pyogenes / agalactiae qPCR Kit2 réf.98/79 RevoDx Streptococcus pneumoniae qPCR Kit2 réf.98/79 RevoDx Streptococcus pyogenes qPCR Kit2 réf.98/79 RevoDx TORCH qPCR Kit3 réf.98/79 RevoDx Toxoplasma gondii qPCR Kit2 réf.98/79 RevoDx Transplant Pathogen Detection Kit3 réf.98/79 RevoDx Treponema pallidum qPCR Kit2 réf.98/79 RevoDx Trichomonas Vaginalis qPCR Kit2 réf.98/79 RevoDx Trypanosoma cruzi qPCR Kit98/79 RevoDx Ureaplasma Parvum qPCR Kit2 réf.98/79 RevoDx Ureaplasma Parvum/Urealytıcum qPCR Kit3 réf.98/79 RevoDx Ureaplasma Urealytıcum qPCR Kit2 réf.98/79 RevoDx Urinary Tract Infections (UTIs) Pathogen Detection Kit3 réf.98/79 RevoDx Vancomycin resistance (vanA/vanB) qPCR Kit2 réf.98/79 RevoDx Vibrio cholerae qPCR Kit2 réf.98/79 RevoDx Vibrio parahaemolyticus qPCR Kit2 réf.98/79 RevoDx Vibrio vulnificus qPCR Kit2 réf.98/79 RevoDx Viral Meningitis-Encephalitis Pathogen Detection Kit3 réf.98/79 RevoDx Viral Nucleic Acid Purification Kit5 réf.98/79 RevoDx Viral Transport Medium3 réf.98/79 RevoDx VZV qPCR Kit2 réf.98/79 RevoDx West Nile virus qPCR Kit2 réf.98/79 RevoDx Yersinia Enterocolitica qPCR Kit2 réf.98/79 RevoDx Zika Virus qPCR Kit2 réf.98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Sansure FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 3 autres	Chine	15 High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit (PCR-Fluorescence Probing)98/79 15 High-risk Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3360E-12-P98/79 15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3360E-4898/79 213 autres 4 HFMD related Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 5 Diarrhea Escherichia coli Nucleic Acid Detection Kit (PCR-Fluorescence Probing)2 réf.98/79 5 Encephalitis related Viruses Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 6 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 9 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Acinetobacter baumannii and Canidia albican Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Adenovirus 40 and 41 Nucleic Acid Detection Kit (PCR-Fluorescence Probing)2 réf.98/79 Adenovirus 41 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Adenovirus and Adenovirus 3/7 Subtypes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Adenovirus and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)3 réf.98/79 Adenovirus Rapid Antigen Test (Colloidal Gold Method)3 réf.98/79 Astrovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Avian Influenza Virus (H7N9) Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)98/79 Avian influenza virus H3 RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Avian influenza virus H3N2 RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Avian influenza virus H5 RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Avian influenza virus H7 RNA Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Avian influenza virus H9 RNA Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 BK Virus DNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Bordetella Parapertussis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Bordetella Pertussis DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Brucella Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Campylobacter coli Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Campylobacter fetus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Campylobacter jejuni / Campylobacter coli / Campylobacter lari Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Campylobacter jejuni Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Candida Albicans, Acinetobacter Baumannii and Pneumocystis Jiroveci Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Candida Albicans, Cryptococcus Neoformans and Pneumocystis Jiroveci Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Chikungunya virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Chlamydia Trachomatis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Clostridium difficile DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Coxsachievirus A10 Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)98/79 Coxsachievirus A6 and A10 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Coxsachievirus A6 Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)98/79 Coxsackievirus A16/Enterovirus 71 RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Coxsackievirus A6/A10/A16/Enterovirus 71 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Cryptosporidium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 D-Dimer Assay Kit (Chemiluminescent Immunoassay)2 réf.98/79 D-Dimer Chemiluminescence Immunoassay Kit6 réf.98/79 Dengue Fever Virus General-type Diagnostic Kit (PCR-Fluorescence Probing)98/79 Dengue virus, Zika virus, and Chikungunya virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)3 réf.98/79 Diagnostic Kit for Coxsackievirus A16 RNA (PCR-Fluorescence Probing)98/79 Diagnostic Kit for Enterovirus 71 RNA (PCR-Fluorescence Probing)98/79 Diagnostic Kit for Enterovirus RNA (PCR-Fluorescence Probing)98/79 Diagnostic Kit for Influenza A (H1N1) Virus（PCR-Fluorescence Probing）2 réf.98/79 Drug Resistant Bordetella pertussis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Ebola Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Echovirus E11 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Echovirus E30 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Entamoeba Histolytica Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Enterococcus Faecalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Enterococcus Faecium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Enterococcus Faeciuma and Enterococcus Faecalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Enteropathogenic Escherichia Coli Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Enterovirus/Coxsackievirus A16/Enterovirus 71 RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Epstein-Barr virus DNA Quantitative Fluorescence Diagnostic Kit(PCR-Fluorescence Probing)98/79 Epstein-Barr Virus(EBV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Escherichia coli O157 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Fibrin/fibrinogen Degradation Products Chemiluminescence Immunoassay Kit6 réf.98/79 Forest encephalitis Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Fully Automated Nucleic Acid Extraction System S-S13A Giardia Lamblia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Group A Streptococcus (GAS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)3 réf. Haemophilus influenzae (HI) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Helicobacter pylori typingl Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Helicobacter pylori universal Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Hepatitis A Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Hepatitis B Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing)98/79 Hepatitis C Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing)98/79 Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Hepatitis E Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Herpes Simplex Virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Herpes Simplex Virus Type 2 DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Human Cytomegalovirus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Human papillomavirus (Type 16 and 18) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Human papillomavirus (Type 6 and 11) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Human Papillomavirus DNA (23 genotypes) Diagnostic Kit (PCR-Fluorescence Probing)98/79 Human Papillomavirus DNA (26 Genotypes) Diagnostic Kit (PCR-Fluorescence Probing)98/79 Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)2 réf. Human Parvovirus B19 DNA Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Human Rhinovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Human Rotavirus A and B Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Human Rotavirus A/B/C Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Influenza A (H5N1) Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing）2 réf.98/79 Influenza A and BV/BY RNA Diagnositc Kit（PCR-Fluorescence Probing）2 réf.98/79 Influenza A Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Influenza A/B Virus and Respiratory Syncytial Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Influenza A/B Virus Nucleic Acid Diagnostic Kit ( PCR-Fluorescence Probing)2 réf.98/79 Influenza A/B Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Influenza BV/BY RNA Diagnostic Kit（PCR-Fluorescence Probing）2 réf.98/79 Interleukin-10 Chemiluminescence Immunoassay Kit6 réf.98/79 Interleukin-1β Chemiluminescence Immunoassay Kit6 réf.98/79 Interleukin-2 Receptor Chemiluminescence Immunoassay Kit6 réf.98/79 Interleukin-6 Assay Kit (Chemiluminescent Immunoassay)2 réf.98/79 Interleukin-6 Chemiluminescence Immunoassay Kit6 réf.98/79 Interleukin-8 Chemiluminescence Immunoassay Kit6 réf.98/79 Japanese Encephalitis virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Japanese Encephalitis Virus/Tick-Borne Encephalitis Virus/West Nile Virus/Dengue Virus (JEV/TBEV/WNV/DFV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 JC Virus DNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Legionella pneumophila Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)3 réf.98/79 Listeria Monocytogenes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Masern virus, Rubella virus, and Mumps virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Measles and Rubella virus (MeV/RV) RNA Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Methicillin-resistant Staphylococcus aureus mecA Gene Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Multi-type Sample DNA/RNA Extraction-Purification Kit (Magnetic beads method) S1006E3 réf. Multiple Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Mycobacterium Multiplex Nucleic Acid Diagnostic Kit(Multiplex PCR-Fluorescence Probing)98/79 Mycobacterium tuberculosis (MTB) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)2 réf. Mycoplasma pneumoniae Nucleic Acid And Drug Resistence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Neisseria Gonorrhoeae DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Neisseria meningitidis (Nm) nucleic acid Diagnostic Kit（PCR-Fluorescence Probing)2 réf.98/79 Neisseria Meningitidis Serogroup A, B, and C nucleic acid Diagnostic Kit（PCR-Fluorescence Probing)2 réf.98/79 Neisseria Meningitidis Serogroup W, X, and Y nucleic acid Diagnostic Kit（PCR-Fluorescence Probing)2 réf.98/79 Norovirus GI/GII/Rotavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Norovirus GI/GII/Sapovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Novel Coronavirus （COVID-19）Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Nucleic Acid (DNA/RNA) Extraction or Purification Kit (Magnetic beads method) S1002E-24 Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method) S1001E3 réf. Nucleic Acid Analysis Device S-Q35C Nucleic acid extraction (DNA/RNA) or purification kit(Magnetic beads method) S10013E3 réf. Nucleic acid extraction (DNA) or purification kit(Magnetic beads method) S10012E3 réf. Nucleic Acid Extraction-Purification Kit IV-IX3 réf. Nucleic Acid Extraction-Purification Kit S10016E3 réf. Nucleic Acid Extraction-Purification Kit S10018E3 réf. Nucleic Acid Extraction-Purification Kit S50015E3 réf. Nucleic Acid Extraction-Purification Kit S50016E3 réf. Nucleic Acid Extraction-Purification Kit S5005E3 réf. Nucleic Acid Extraction-Purification Kit V-VI3 réf. Nucleic Acid Extraction-Purification Kit V-VII S5007E-483 réf. Parainfluenza Virus type 1, 2 and 3 Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)3 réf.98/79 Plasmodium DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Pneumocystis Jiroveci, Cryptococcus Neoformans and Aspergillus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Portable Molecular Diagnostic System S-Q37A2 réf. Portable Molecular Workstation S-Q36A, S-Q36B2 réf. Portable Molecule Workstation S-Q31A Portable Molecule Workstation S-Q31B Red Blood Cell Lysis Buffer Respiratory Adenovirus DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)98/79 Respiratory Syncytial Virus Rapid Antigen Test (Colloidal Gold Method)3 réf.98/79 Respiratory Syncytial Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 S-S13E-P; S-S13E-P12 réf. S3102E-242 réf. S3213E-48 S3401E98/79 Salmonella Paratyphi Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Salmonella Typhi and Salmonella Paratyphoid Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Salmonella Typhi Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Sample Diluent2 réf. Sample Release and Storage Reagent X1009E-24D-2 Sample Release Reagent S1011E2 réf. Sample Release Reagent S1012E3 réf. Sample Release Reagent S1013E3 réf. Sample Release Reagent S1014E3 réf. Sample Release Reagent S1015E-243 réf. Sample Storage Reagent X X1010E-48-13 réf. Sample Storage Reagent X1001E2 réf. Sample Storage Reagent X1002E3 réf. Sample Storage Reagent X1003E3 réf. Sample Storage Reagent X1004E3 réf. Sample Storage Reagent X1006E3 réf. Sample Storage Reagent XI X1011E-24A-33 réf. SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)2 réf.98/79 SARS-CoV-2 Neutralizing Antibodies Test (Colloidal Gold)98/79 SARS-CoV-2 S-RBD Antibodies Test (Colloidal Gold)98/79 SARS-CoV-2, Influenza A and Influenza B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus Multiple Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)4 réf.98/79 SARS-CoV-2, Influenza Viruses and Respiratory Syncytial Virus Multiple Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Severe Fever With Thrombocytopenia Syndrome Bunyavirus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Six Bacterial Meningitis Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)2 réf. Six Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf. Staphylococcus Aureus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Streptococcus Pneumoniae Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Surelite 82 réf. Thrombin-Antithrombin III Complex Chemiluminescence Immunoassay Kit6 réf.98/79 Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1 Complex Chemiluminescence Immunoassay Kit6 réf.98/79 Toxigenic Clostridium difficile DNA Diagnostic Kit (PCR-Fluorescence Probing)3 réf.98/79 Treponema Pallidum DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Tumor Necrosis Factor α Chemiluminescence Immunoassay Kit6 réf.98/79 Varicella-zoster virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Vibrio Cholerae Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Vibrio Cholerae O1 and O139 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 West Nile Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Yersinia Enterocolitica Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 Zika Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Adenovirus Group F Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 (plus commercialisé) Bocavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 (plus commercialisé) Dengue Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 (plus commercialisé) High-risk Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 (plus commercialisé) Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 (plus commercialisé) Human Rotavirus A Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 (plus commercialisé) Human Rotavirus B Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 (plus commercialisé) Influenza B Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 (plus commercialisé) MBGV/RVFV/CHIKV Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 (plus commercialisé) Mycoplasma Pneumoniae Rapid Antigen Test (Colloidal Gold Method)3 réf.98/79 (plus commercialisé) Norovirus GI and GII Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 (plus commercialisé) Norovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 (plus commercialisé) Nucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method) S10011E2 réf. (plus commercialisé) Plasmodium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 (plus commercialisé) Plesiomonas Shigelloides Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 (plus commercialisé) Q Fever Rickettsia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 réf.98/79 (plus commercialisé) SARS Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 (plus commercialisé) SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)4 réf.98/79 (plus commercialisé) Severe Fever with Thrombocytopenia Syndrome Bunyavirus（SFTSV） Nucleic Acid Detection Kit(PCR-Fluorescence Probing)2 réf.98/79 (plus commercialisé)	A, B, C IVDR, 98/79	Présent sur le marché en France Site web info@sansure.com.cn Fiche EUDAMED Signaler une erreur
Newlink Biotech Mandataire UE : VidaQuick Biotech S.L. (Espagne)	Chine	Adenovirus + RSV Control L51-AR02S98/79 Adenovirus Control L51-AD01PR98/79 Adenovirus pneumoniae and RSV Combo Assay F11-AR01C598/79 Adenovirus pneumoniae Antigen Control L51-AD01S98/79 Adenovirus&RSV Combo Rapid Test L11-AR02C598/79 184 autres Adenovirus&RSV&HMPV&HPIV&Flu A+B Combo Antigen Control98/79 Adenovirus&RSV&HMPV&Influenza A+B Combo Antigen Control98/79 Adenovirus&RSV&HMPV&SARS-CoV-2&Influenza A+B Combo Control98/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test L11-ARI03C598/79 Adenovirus/Rotavirus Control L51-AR02PR98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/Influenza A+B Control L51-ARI03S98/79 Astrovirus Control L51-AS01PR98/79 Automatic Chemiluminescence Immunoassay Analyzer Brucella Abortus Control2 réf.98/79 Campylobacter Control L51-CAM01PR98/79 Candida Albicans Control L51-CA01PR98/79 Chagas Control L51-CHA01P98/79 Chikungunya IgG/IgM Control L51-CHI01P98/79 Chikungunya IgG/IgM Control L51-CHI01PR98/79 Chikungunya IgG/IgM Control L51-CHI01R98/79 Clostridium difficile GDH Assay F11-CDG01C698/79 Clostridium difficile GDH Control L51-CDG01PR98/79 Clostridium difficile GDH Rapid Test L11-CDG01C698/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test L11-CD03C698/79 Clostridium difficile GDH+Toxin A+Toxin B Control L51-CD03PR98/79 Clostridium difficile GDH+Toxin A/B Assay F11-CD01C698/79 Clostridium difficile Toxin A + Toxin B Control L51-CDT02PR98/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test L11-CDT02C698/79 Clostridium difficile Toxin A/ toxin B Combo Assay F11-CDT01C698/79 Clostridium difficile Toxin A/Toxin B Combo Assay F11-CDT02C698/79 COVID-19 Antigen Assay98/79 COVID-19 S-RBD IgG Quantitative Assay98/79 Cryptococcus Antigen Control L51-CRG01PR98/79 Cryptosporidium and Giardia lamblia Control L51-CG02PR98/79 Cryptosporidium Control L51-CR01PR98/79 Dengue IgG/IgM Control L51-DEN01R98/79 Dengue NS1 Control3 réf.98/79 EBNA IgG Rapid Test L11-EBG01C498/79 EBV VCA and EBNA IgG Combo Rapid Test L11-EBV02C498/79 EBV VCA IgG Rapid Test L11-EBA01C498/79 Entamoeba Histolytica Control L51-EH01PR98/79 Entamoeba/Giardia/Crypto Control2 réf.98/79 EV71 IgM Rapid Test98/79 Fluorescence Immunoassay Analyzer3 réf. Fluorescence lmmunoassay Control (Clostridium difficile GDH)98/79 Fluorescence lmmunoassay Control (Clostridium difficile GDH+Toxin A/B)98/79 Fluorescence lmmunoassay Control (Dengue IgG/IgM)98/79 Fluorescence lmmunoassay Control (Dengue NS1)98/79 Fluorescence lmmunoassay Control (H. pylori Antigen)98/79 Fluorescence lmmunoassay Control (HBsAb)98/79 Fluorescence lmmunoassay Control (HBsAg)98/79 Fluorescence lmmunoassay Control (HCV)98/79 Fluorescence lmmunoassay Control (Influenza A+B)98/79 Fluorescence lmmunoassay Control (Legionella pneumophila)98/79 Fluorescence lmmunoassay Control (Rotavirus and Adenovirus Combo)98/79 Fluorescence lmmunoassay Control (RSV)98/79 Fluorescence lmmunoassay Control (SARS-CoV-2 Ag/Influenza A+B)98/79 Fluorescence lmmunoassay Control (SARS-CoV-2 Antigen)98/79 Fluorescence lmmunoassay Control (Strep A)98/79 Fluorescence lmmunoassay Control (Streptococcus pneumoniae)98/79 Fluorescence lmmunoassay Control (Syphilis)98/79 Giardia Lamblia Control L51-GL01PR98/79 Gonorrhea Control98/79 H. pylori Antibody Control L51-HP01R98/79 H. pylori Antigen Control L51-HPG01PR98/79 H.pylori Antigen Control L51-HP01S98/79 H1N1 Antigen Rapid Test2 réf.98/79 Hemoglobin Test strip C41-HBB498/79 HPIV Control98/79 HPV L51-HPV01S98/79 HSV 1/2 IgG Rapid Test2 réf.98/79 HSV 1/2 IgG/IgM Rapid Test4 réf.98/79 HSV 1/2 IgM Rapid Test2 réf.98/79 Human Metapneumovirus Control L51-HMPV01PR98/79 Influenza A Control L51-FLA01S98/79 Influenza A Rapid Test L11-FLA01C598/79 Influenza A+B Assay F11-FLU01C598/79 Influenza A+B Control L51-FLU01S98/79 Influenza A/B+H1N1 Combo Control98/79 Influenza A/B+H1N1 Combo Rapid Test98/79 Legionella pneumophila Assay98/79 Legionella pneumophila Control2 réf.98/79 Legionella pneumophila Rapid Test98/79 Leptospira IgG/IgM Control L51-LEP01PR98/79 Leptospira IgG/IgM Control L51-LEP01R98/79 Malaria P.f. Control L51-MPF01P98/79 Malaria P.f. Rapid Test L11-MAF01A498/79 Malaria P.f./ Pan Control L51-MPN02P98/79 Malaria P.f./P.v. /Pan Rapid Test L11-MPVF01C498/79 Malaria P.f./P.v. Control L51-MPV02P98/79 Malaria P.f./P.v./Pan Assay F11-MAL01C498/79 Malaria P.f./P.v./Pan Control L51-MPVF03P98/79 Measles IgG/IgM Antibody Control L51-MEA01PR98/79 Monkeypox Virus Antibody Assay F11-MXB01C498/79 Monkeypox Virus Antibody Control L51-MXB01R98/79 Monkeypox Virus Antigen Assay F11-MXG01C298/79 Monkeypox Virus Antigen Assay F11-MXG01C498/79 Monkeypox Virus Antigen Control L51-MXG01PR98/79 MONO Control L51-MON01R98/79 MONO Rapid Test L11-MON01C498/79 Multiplex Respiratory Antigen Control (Adeno/HPIV/RSV/COVID-19/MP/RhV/Flu B/Flu A/HMPV)98/79 Multiplex Respiratory Antigen Rapid Test L11-RT905C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC02C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC03C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC04C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC05C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC06C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC07C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTCXXC598/79 Mycoplasma Pneumoniae Antigen Control L51-MP01S98/79 Mycoplasma pneumoniae IgG/IgM Control L51-MPB01R98/79 Mycoplasma pneumoniae IgM Control L51-MPM01R98/79 Norovirus Control L51-NO01PR98/79 Norovirus, Rotavirus and Adenovirus Combo Rapid Test L11-NRA02C698/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test L11-NRAA03C698/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test L11-NRAA03F698/79 Norovirus,Rotavirus,Adenovirus,Astrovirus Control L51-NRAA04PR98/79 Norovirus/Rotavirus/Adenovirus Control L51-NRA03PR98/79 One Step Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Test98/79 One Step Adenovirus/RSV/HMPV/Influenza A+B Combo Test98/79 One Step Dengue/Chikungunya/Zika Combo Test98/79 One Step Dengue/Zika/Chikungunya Combo Test98/79 One Step Influenza A+B Test98/79 One Step Malaria Antibody Test98/79 One Step Monkeypox Virus Antibody Test98/79 One Step Monkeypox Virus Antigen Test98/79 One Step Norovirus, Rotavirus and Adenovirus Combo Test98/79 One Step SARS-CoV-2 and M.pneumoniae IgG Combo Test98/79 One Step SARS-CoV-2 Antigen Test2 réf.98/79 One Step SARS-CoV-2 Antigen Test (Oral Fluid)98/79 One Step SARS-CoV-2 IgG Test2 réf.98/79 One Step SARS-CoV-2 IgG/IgM Test2 réf.98/79 One Step SARS-CoV-2 Neutralization Antibody Test98/79 One Step Syphilis Test98/79 One Step Clostridium difficile GDH+ Toxin A +Toxin B Combo Test98/79 Rapid Test Reader - for Urine Test Cup L21-LR200 Rapid Test Reader L21-LR1002 réf. Respiratory Syncytial Virus (RSV) Assay F11-RSV01C598/79 Rotavirus and Adenovirus Assay F11-RAC01C698/79 Rotavirus and Adenovirus Combo Rapid Test L11-RAC01C698/79 Rotavirus and Adenovirus Combo Rapid Test L11-RAC01F698/79 Rotavirus Control L51-RO01PR98/79 RSV Control L51-RSV01S98/79 RSV&Influenza A+B Combo Rapid Test L11-RI02C598/79 RSV/Influenza A+B Control L51-RI02S98/79 S. pneumoniae/L. pneumophila Control2 réf.98/79 Salmonella paratyphi Control98/79 Salmonella Typhi Antigen Control98/79 SARS-CoV-2 Ag/Influenza A+B Combo Assay98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test98/79 SARS-CoV-2 and Influenza A+B Combo Control98/79 SARS-CoV-2 and M.pneumoniae IgG/IgM Combo Rapid Test98/79 SARS-CoV-2 Antigen (Swab) Control98/79 SARS-CoV-2 Antigen Assay98/79 SARS-CoV-2 Antigen Control98/79 SARS-CoV-2 IgG/IgM Assay98/79 SARS-CoV-2 Rapid Antigen Test98/79 SARS-CoV-2 Rapid Antigen Test (Oral Fluid)98/79 SARS-CoV-2 S-RBD IgG Antibody Assay98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Control98/79 SARS-CoV-2/InfluenzaA+B/RSV/Adenovirus Control98/79 Scrub Typhus IgG/IgM Control2 réf.98/79 Strep A Assay F11-STA01C598/79 Strep A Control L51-STA01R98/79 Strep A Rapid Test L11-ST01A598/79 Strep A Rapid Test L11-ST01C598/79 Strep A Rapid Test L11-STB01A598/79 Strep A Rapid Test L11-STB01C598/79 Strep B Control L51-SB01R98/79 Strep B Rapid Test L11-SB01A598/79 Streptococcus pneumoniae Antigen Rapid Test98/79 Streptococcus pneumoniae Assay98/79 Streptococcus pneumoniae Control2 réf.98/79 Syphilis Assay F11-SYP01C498/79 Syphilis Control L51-SYP01P98/79 Syphilis Control L51-SYP01R98/79 Tetanus Control L51-TET01PR98/79 Trichomonas Vaginalis Control L51-TV01PR98/79 Tuberculosis Control98/79 Urinalysis Analyzer C21-UA1003 réf. Vibrio cholerae O1/O139 Control98/79 Zika IgG/IgM Control L51-ZIB01R98/79 Zika NS1 Control98/79	A IVDR, 98/79	Site web info@kylinew.com Fiche EUDAMED Signaler une erreur
Agilent FDA Mandataire UE : Agilent Technologies Denmark ApS (Danemark)	Singapour, États-Unis	4150 TapeStationDx Instrument K2992A2 réf. Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A K589911-21 AriaDx Real-Time PCR Instrument K8930A Artisan 50x Wash Solution AR102 Artisan Acid-Fast Bacillus (AFB) Stain Kit AR162 199 autres Artisan Alcian Blue pH 2.5 Stain Kit AR160 Artisan Alcian Blue/PAS Stain Kit AR169 Artisan Alcian Blue/PAS/Hematoxylin Stain Kit AR178 Artisan Alpha Amylase AR171 Artisan Artisan Clearing Solution AR309 Artisan Colloidal Iron Stain Kit AR307 Artisan Congo Red Stain Kit AR161 Artisan Elastic Stain Kit AR163 Artisan Giemsa Stain Kit AR164 Artisan Gomori's Green Trichrome Stain Kit AR166 Artisan Gram Yellow Stain Kit AR306 Artisan Grocott's Methenamine Silver Stain Kit AR176 Artisan Iron Stain Kit AR158 Artisan Jones Basement Membrane H&E (PAS-M) Stain Kit AR480 Artisan Jones' Basement Membrane Stain Kit AR180 Artisan Link Pro AR310 Artisan Masson's Trichrome Stain Kit AR173 Artisan Mucicarmine Stain Kit AR168 Artisan Orcein Stain Kit AR313 Artisan PAS-Green Stain Kit AR172 Artisan Periodic Schiff Stain Kit AR165 Artisan Reticulin - No Counterstain Kit AR182 Artisan Reticulin-Nuclear Fast Red Stain Kit AR179 Artisan Warthin-Starry Stain Kit AR181 Autostainer Link 48 AS4802 réf. Dako Antibody Diluent with Background Reducing Components S3022 Dako EnVision+ System- HRP Labelled Polymer Anti-Rabbit K4003 Dako Antibody Diluent S0809 Dako Automation Hematoxylin Histological Staining Reagent S3301 Dako Bluing Buffer CS70230-2 Dako Cover Glass, 24 x 50 mm CS70430-2 Dako CoverStainer CS1002 réf. Dako DAB Away DAB Chromogen Removal System S1967 Dako DAB Enhancer S19612 réf. Dako Differentiation Solution CS70730-2 Dako EnVision+ System- HRP Labelled Polymer Anti-mouse K4001 Dako Eosin CS70130-2 Dako Eosin Y Phloxine B CS71030-2 Dako Faramount Aqueous Mounting Medium Ready-to-use S3025 Dako Fluorescence Mounting Medium S3023 Dako Gill's 3 Hematoxylin CS70830-2 Dako Glycergel Mounting Medium C0563 Dako Harris Hematoxylin CS70930-2 Dako Hematoxylin CS70030-2 Dako Liquid DAB+ Substrate Chromogen System K3467 Dako Liquid DAB+ Substrate Chromogen System K3468 Dako Liquid Permanent Red K0640 Dako Mayer's Hematoxylin (Lillie's Modification) Histological Staining Reagent S3309 Dako Modified Eosin Y CS71130-2 Dako Mounting Medium CS70330-2 Dako Omnis GI100/GI300/GI4003 réf. Dako Proteinase K Ready-to-use S3020 Dako REAL Antibody Diluent S202230-2 Dako REAL Detection System Alkaline Phosphatase/RED Rabbit/Mouse K500511-2 Dako REAL EnVision Detection System Peroxidase/DAB+, Rabbit/Mouse K500711-2 Dako REAL Peroxidase-Blocking Solution S202386-2 Dako Target Retrieval Solution (10x) S1699 Dako Target Retrieval Solution Citrate pH 6 (x 10) S236984-2 Dako Target Retrieval Solution, pH 9 (10x) S236784-2 Dako Toluene-Free Mounting Medium CS70530-2 Dako Wash Buffer 10x S3006 EBER RNA CISH (Dako Omnis) G111798/79 EnVision FLEX DAB+ Substrate Chromogen System (Dako Omnis) GV82511-2 EnVision FLEX HRP Magenta Substrate Chromogen System (Dako Omnis) GV92511-2 EnVision FLEX HRP Magenta, High pH (Dako Omnis) GV90011-2 EnVision FLEX Mini Kit, High pH (Dako Omnis) GV82311-2 EnVision FLEX Target Retrieval Solution High pH (50x) (Dako Omnis) GV80411-2 EnVision FLEX Target Retrieval Solution Low pH (50x) (Dako Omnis) GV80511-2 EnVision FLEX+ Mouse LINKER (Dako Omnis) GV82111-2 EnVision FLEX+ Rabbit LINKER (Dako Omnis) GV80911-2 EnVision FLEX, High pH (Dako Omnis) GV80011-2 FLEX IHC Microscope Slides K802021-2 FLEX Monoclonal Mouse Anti-Cytomegalovirus, Clone CCH2 + DDG9, Ready-to-Use (Dako Omnis) GA75298/79 FLEX Monoclonal Mouse Anti-Cytomegalovirus, Clone CCH2 + DDG9, Ready-to-Use (Dako Omnis) GA752/IR752 FLEX Monoclonal Mouse Anti-Cytomegalovirus, Clones CCH2 + DDG9, Ready-to-Use (Link) IR75298/79 FLEX Polyclonal Rabbit Anti-Herpes Simplex Virus Type 1, Ready-to-Use (Dako Omnis) GA52198/79 Fluorescence Mounting Medium (Dako Omnis) GM30411-2 Hematoxylin (Dako Omnis) GC80811-2 Hematoxylin (Link) SK308 Histology FISH Accessory Kit K579911-2 ISH Ethanol Solution 96% (Dako Omnis) GM30011-2 ISH Pepsin (Dako Omnis) GM30211-2 ISH Pre-Treatment Solution (20x) (Dako Omnis) GM30111-2 ISH Stringent Washing Buffer (20x) (Dako Omnis) GM30311-2 MagnisDx NGS Prep System K1007A Monoclonal Mouse Anti-Cytomegalovirus, Clones CCH2 + DDG9 M085498/79 Monoclonal Mouse Anti-Human B Cell/FITC, Clone FMC7 F711098/79 Monoclonal Mouse Anti-Human CD10/FITC, Clone SS2/36 F082698/79 Monoclonal Mouse Anti-Human CD10/RPE, Clone SS2/36 R084898/79 Monoclonal Mouse Anti-Human CD103, Mucosa Lymphocyte Antigen/RPE, Clone Ber-ACT8 R718898/79 Monoclonal Mouse Anti-Human CD103, Mucosa Lymphocytt Antigen/FITC, Clone Ber-ACT8 F713898/79 Monoclonal Mouse Anti-Human CD117, c-kit/APC, Clone 104D2 C724498/79 Monoclonal Mouse Anti-Human CD11c, Protein 150, 95/FITC, Clone KB90 F071398/79 Monoclonal Mouse Anti-Human CD13/FITC, Clone WM-47 F083198/79 Monoclonal Mouse Anti-Human CD138/APC, Clone MI15 C725698/79 Monoclonal Mouse Anti-Human CD138/RPE, Clone MI15 R722998/79 Monoclonal Mouse Anti-Human CD14/FITC, Clone TÜK4 F084498/79 Monoclonal Mouse Anti-Human CD15/FITC, Clone C3D-1 F083098/79 Monoclonal Mouse Anti-Human CD16, Fc Gamma Receptor III/FITC F701198/79 Monoclonal Mouse Anti-Human CD19/APC, Clone HD37 C722498/79 Monoclonal Mouse Anti-Human CD19/FITC, Clone HD37 F076898/79 Monoclonal Mouse Anti-Human CD19/RPE, Clone HD37 R080898/79 Monoclonal Mouse Anti-Human CD19/RPE-Cy5, Clone HD37 C706698/79 Monoclonal Mouse Anti-Human CD2/FITC, Clone MT910 F076798/79 Monoclonal Mouse Anti-Human CD20/FITC, Clone B-Ly1 F079998/79 Monoclonal Mouse Anti-Human CD22/APC, Clone 4KB128 C728198/79 Monoclonal Mouse Anti-Human CD22/FITC, Clone 4KB128 F706098/79 Monoclonal Mouse Anti-Human CD22/RPE, Clone 4KB128 R706198/79 Monoclonal Mouse Anti-Human CD235a, Glycophorin A/FITC, Clone JC159 F087098/79 Monoclonal Mouse Anti-Human CD24/FITC, Clone SN3 F713498/79 Monoclonal Mouse Anti-Human CD25, Interleukin-2 Receptor/FITC, Clone ACT-1 F080198/79 Monoclonal Mouse Anti-Human CD3/APC, Clone UCHT1 C722598/79 Monoclonal Mouse Anti-Human CD3/FITC, Clone UCHT 1 F081898/79 Monoclonal Mouse Anti-Human CD3/PerCP, Clone UCHT1 PR70298/79 Monoclonal Mouse Anti-Human CD3/RPE, Clone UCHT1 R081098/79 Monoclonal Mouse Anti-Human CD30/FITC, Clone Ber-H2 F084998/79 Monoclonal Mouse Anti-Human CD33/FITC, Clone WM-54 F083298/79 Monoclonal Mouse Anti-Human CD34 Class III/APC, Clone BIRMA-K3 C723898/79 Monoclonal Mouse Anti-Human CD38/FITC, Clone AT13/5 F710198/79 Monoclonal Mouse Anti-Human CD4/FITC, Clone MT310 F076698/79 Monoclonal Mouse Anti-Human CD4/RPE, Clone MT310 R080598/79 Monoclonal Mouse Anti-Human CD45 Leucocyte Common Antigen/APC, Clone T29/33 C723098/79 Monoclonal Mouse Anti-Human CD45 Leucocyte Common Antigen/FITC, Clone T29/33 F086198/79 Monoclonal Mouse Anti-Human CD45R0/FITC, Clone UCHL1 F080098/79 Monoclonal Mouse Anti-Human CD5/APC, Clone DK23 C724298/79 Monoclonal Mouse Anti-Human CD5/FITC, Clone DK23 F079598/79 Monoclonal Mouse Anti-Human CD5/RPE, Clone DK23 R084298/79 Monoclonal Mouse Anti-Human CD57/FITC, Clone TB01 F727098/79 Monoclonal Mouse Anti-Human CD61, Platelet Glycoprotein IIIa/APC, Clone Y2/51 C728098/79 Monoclonal Mouse Anti-Human CD61, Platelet Glycoprotein IIIa/FITC, Clone Y2/51 F080398/79 Monoclonal Mouse Anti-Human CD64, Fc Gamma Receptor I/APC, Clone 10.1 C727898/79 Monoclonal Mouse Anti-Human CD7/FITC, Clone CBC.37 F727698/79 Monoclonal Mouse Anti-Human CD7/PerCP-Cy5.5, Clone CBC.37 PR71198/79 Monoclonal Mouse Anti-Human CD7/RPE, Clone CBC.37 R727798/79 Monoclonal Mouse Anti-Human CD71, Transferrin Receptor/FITC, Clone Ber-T9 F082998/79 Monoclonal Mouse Anti-Human CD79ß/RPE, Clone SN8 R727298/79 Monoclonal Mouse Anti-Human CD79αcy/APC, Clone HM57 C725298/79 Monoclonal Mouse Anti-Human CD79β/FITC, Clone SN8 F713798/79 Monoclonal Mouse Anti-Human CD8/APC, Clone DK25 C722798/79 Monoclonal Mouse Anti-Human CD8/FITC, Clone DK25 F076598/79 Monoclonal Mouse Anti-Human CD8/RPE, Clone DK25 R080698/79 Monoclonal Mouse Anti-Human HLA-DP, DQ, DR Antigen/FITC, Clone CR3/43 F081798/79 Monoclonal Mouse Anti-Human HLA-DR Antigen/RPE, Clone AB3 R726798/79 Monoclonal Mouse Anti-Human Myeloperoxidase/APC, Clone MPO-7 C724698/79 Monoclonal Mouse Anti-Human Myeloperoxidase/FITC, Clone MPO-7 F071498/79 Monoclonal Mouse Anti-Human Terminal Deoxynucleotidyl Transferase/ iFluor 488, Clone DAK-TDT C1001/IF001/IF0023 réf. MultiMix Triple-Colour Reagent Anti-Human B Cell (FMC7)/FITC, Anti-Human CD23/RPE, Anti-Human CD19/APC TC68398/79 MultiMix Triple-Colour Reagent Anti-Human CD19/FITC, Anti-Human Lambda Light Chains/RPE, Anti-Human Kappa Light Chains/APC TC66998/79 MultiMix Triple-Colour Reagent Anti-Human CD2/FITC, Anti-Human CD7/RPE, Anti-Human CD3/APC TC67798/79 MultiMix Triple-Colour Reagent Anti-Human CD20/FITC, Anti-Human CD5/RPE, Anti-Human CD19/APC TC66398/79 MultiMix Triple-Colour Reagent Anti-Human CD5/FITC, Anti-Human CD10/RPE, Anti-Human CD19/APC TC66498/79 MultiMix Triple-Colour Reagent Anti-Human CD8/FITC, Anti-Human CD4/RPE, Anti-Human CD3/APC TC66098/79 MultiMix Triple-Colour Reagent Anti-Human Kappa Light Chains/FITC, Anti- Human Lambda Light Chains/RPE, Anti-Human CD19/RPE-Cy5 TC05198/79 MultiMix Triple-Colour Reagent Anti-Human Plasma Cell/FITC, Anti-Human Lambda Light Chains/RPE, Anti-Human Kappa Light Chains/APC TC67098/79 MultiMix™ Dual-Colour Reagent, Anti-Human Kappa Light Chains/FITC + Anti-Human Lambda Light Chains/RPE FR4812 réf.98/79 PNA ISH Detection Kit K520111-2 Polyclonal Rabbit Anti-Human IgA/FITC, Rabbit F(ab')2 F018898/79 Polyclonal Rabbit Anti-Human IgD/FITC, Rabbit F(ab')2 F018998/79 Polyclonal Rabbit Anti-Human IgD/RPE, Rabbit F(ab')2 R511298/79 Polyclonal Rabbit Anti-Human IgG/FITC, Rabbit F(ab')2 F018598/79 Polyclonal Rabbit Anti-Human IgM/FITC, Rabbit F(ab')2 F005898/79 Polyclonal Rabbit Anti-Human IgM/RPE, Rabbit F(ab')2 R511198/79 Polyclonal Rabbit Anti-Human Kappa Light Chains/APC, Rabbit F(ab')2 C022298/79 Polyclonal Rabbit Anti-Human Kappa Light Chains/FITC, Rabbit F(ab')2 F04343 réf.98/79 Polyclonal Rabbit Anti-Human Kappa Light Chains/RPE, Rb F(ab')2 R043698/79 Polyclonal Rabbit Anti-Human Lambda Light Chains/FITC, Rabbit F(ab')2 F04352 réf.98/79 Polyclonal Rabbit Anti-Human Lambda Light chains/PerCP-Cy5.5 Rabbit, F(ab')2 PR71298/79 Polyclonal Rabbit Anti-Human Lambda Light Chains/RPE Rabbit F(ab')2 R04372 réf.98/79 Polyclonal Rabbit Anti-Human Lysozyme EC 3.2.1.17/FITC F037298/79 Protein Block Serum-Free Ready-to-Use X0909 PT Link PT200 TapeStationDx Software K2964-64030 Target Retrieval Solution pH 9 (50x) (Dako Omnis) GC309 Wash Buffer (20x) (Dako Omnis) GC80711-2 Dako Silanized Slides S300330-2 (plus commercialisé) Monoclonal Mouse Anti-Human CD19/PerCP-Cy5.5, Clone HD37 PR7032 réf.98/79 (plus commercialisé) Monoclonal Mouse Anti-Human CD2/RPE, Clone MT910 R080798/79 (plus commercialisé) Monoclonal Mouse Anti-Human CD20/RPE, Clone B-Ly1 R701398/79 (plus commercialisé) Monoclonal Mouse Anti-Human CD22/PerCP-Cy5.5, Clone 4KB128 PR70798/79 (plus commercialisé) Monoclonal Mouse Anti-Human CD3/RPE-Cy5, Clone UCHT1 C706798/79 (plus commercialisé) Monoclonal Mouse Anti-Human CD38/RPE, Clone AT13/5 R714498/79 (plus commercialisé) Monoclonal Mouse Anti-Human CD4/APC, Clone MT310 C722698/79 (plus commercialisé) Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen/RPE-Cy5, Clone T29/33 C709998/79 (plus commercialisé) Monoclonal Mouse Anti-Human CD45R0/RPE, Clone UCHL1 R084398/79 (plus commercialisé) Monoclonal Mouse Anti-Human CD45RA/RPE, Clone 4KB5 R708698/79 (plus commercialisé) Monoclonal Mouse Anti-Human CD7/FITC, Clone DK24 F078998/79 (plus commercialisé) Monoclonal Mouse Anti-Human HLA-DR Antigen/FITC, Clone AB3 F726698/79 (plus commercialisé) MultiMix Triple-Colour Reagent Anti-Human CD8/FITC, Anti-Human CD4/RPE, Anti-Human CD3/RPE-Cy5 TC64198/79 (plus commercialisé) MultiMix™ Dual-Colour Reagent, Anti-Human CD10/FITC + Anti-Human CD19/RPE FR88398/79 (plus commercialisé) MultiMix™ Dual-Colour Reagent, Anti-Human CD2/FITC + Anti-Human CD19/RPE FR89498/79 (plus commercialisé) MultiMix™ Dual-Colour Reagent, Anti-Human CD3/FITC + Anti-Human CD19/RPE FR86698/79 (plus commercialisé) MultiMix™ Dual-Colour Reagent, Anti-Human CD3/FITC + Anti-Human CD4/RPE FR87598/79 (plus commercialisé) MultiMix™ Dual-Colour Reagent, Anti-Human CD3/FITC + Anti-Human CD8/RPE FR88198/79 (plus commercialisé) MultiMix™ Dual-Colour Reagent, Anti-Human CD4/FITC + Anti-Human CD8/RPE FR86898/79 (plus commercialisé) MultiMix™ Dual-Colour Reagent, Anti-Human CD45/FITC + Anti-Human CD20/RPE FR72998/79 (plus commercialisé) MultiMix™ Dual-Colour Reagent, Anti-Human CD5/FITC + Anti-Human CD19/RPE FR88298/79 (plus commercialisé) MultiMix™ Dual-Colour Reagent, Anti-Human HLA-DP, DQ, DR Antigen/FITC + Anti-Human CD3/RPE FR86798/79 (plus commercialisé) MultiMix™ Dual-Colour Reagent, Anti-Human Kappa Light Chains/FITC + Anti-Human CD19/RPE FR04898/79 (plus commercialisé) MultiMix™ Dual-Colour Reagent, Anti-Human Lambda Light Chains/FITC + Anti-Human CD19/RPE FR04498/79 (plus commercialisé)	A, C IVDR, 98/79	Présent sur le marché en France Site web info.dk@agilent.com Fiche EUDAMED Signaler une erreur
Biocyc	Allemagne	Albumin FITC4 réf.98/79 ALK (QR017)3 réf. AMACR (QR108)3 réf. Androgen receptor (QR135)3 réf. Arginase-1 (QR083)7 réf.98/79 170 autres BAP1 (QR119)3 réf. Bcl2 (QR062)7 réf.98/79 Bcl6 (QR047)7 réf.98/79 Beta-Catenin (QR095)7 réf.98/79 BOB.1 (QR072)7 réf.98/79 c-Myc (QR061)3 réf. C1q FITC4 réf.98/79 C3c FITC4 réf.98/79 C4c FITC4 réf.98/79 C4d (QR053)7 réf.98/79 Cadherin 17 (QR098)7 réf.98/79 Caldesmon (QR063)7 réf.98/79 Calponin 1 (QR139)3 réf. Calretinin (QR059)7 réf.98/79 Carbonic anhydrase 9 (QR114)3 réf. CD10 (QR021)3 réf. CD103 (QR081)7 réf.98/79 CD117 (QR012)3 réf. CD138 (QR102)7 réf.98/79 CD15 (MMA)7 réf.98/79 CD171/L1CAM (QR039)7 réf.98/79 CD1a (QR123)3 réf. CD20 (QR094)7 réf.98/79 CD21 (QR076)7 réf.98/79 CD23 (QR036)7 réf.98/79 CD30 (QR109)7 réf.98/79 CD31 (QR034)7 réf.98/79 CD34 (QR093)7 réf.98/79 CD3e (QR004)3 réf. CD4 (QR032)7 réf.98/79 CD45/LCA (QR106)7 réf.98/79 CD5 (QR111)7 réf.98/79 CD56 (QR044)7 réf.98/79 CD68 (QR105)3 réf. CD71 (QR073)7 réf.98/79 CD79a (QR033)7 réf.98/79 CD8 (QR068)7 réf.98/79 CD99 (QR067)7 réf.98/79 CDK4 (QR115)3 réf. CDX2 (QR045)7 réf.98/79 CEA (QR117)3 réf. Chromogranin A (QR096)7 réf.98/79 Claudin 4 (QR137)3 réf. Cyclin D1 (QR022)7 réf.98/79 Cytokeratin 14 (QR057)7 réf.98/79 Cytokeratin 18 (QR147)3 réf. Cytokeratin 19 (QR125)3 réf. Cytokeratin 20 (Ks20.8)7 réf.98/79 Cytokeratin 5 (QR027)7 réf.98/79 Cytokeratin 5/14 (QR027 & QR057)7 réf.98/79 Cytokeratin 5/6 (QR027 & QR028)7 réf.98/79 Cytokeratin 6 (QR028)7 réf.98/79 Cytokeratin 7 (QR049)7 réf.98/79 Cytokeratin 8 (QR112)7 réf.98/79 Cytokeratin HMW (34betaE12)7 réf.98/79 Cytokeratin pan (MNF116)7 réf.98/79 Cytokeratin pan (QR124)3 réf. Desmin (QR026)7 réf.98/79 DOG1 (QR070)7 réf.98/79 E-Cadherin (QR035)7 réf.98/79 EGFR (QR078)7 réf.98/79 EMA (QR118)3 réf. ERG (QR040)7 réf.98/79 Estrogen Receptor (QR013)3 réf. Factor XIIIa (QR086)7 réf.98/79 Fibrinogen FITC4 réf.98/79 GATA3 (QR018)3 réf. GFAP (QR066)7 réf.98/79 GLUT1 (QR082)7 réf.98/79 Glutamine synthetase (QR090)7 réf.98/79 Glypican 3 (QR103)7 réf.98/79 Granzyme B (QR130)3 réf. Helicobacter pylori (QR091)7 réf.98/79 Hep Par-1 (QR122)3 réf. Her2/Neu (QR003)7 réf.98/79 Histone H3.3 G34W (QR133)3 réf. HSP70 (QR087)7 réf.98/79 IDH1 R132H (QM002)7 réf.98/79 IgA (QR050)7 réf.98/79 IgA FITC4 réf.98/79 IgG FITC4 réf.98/79 IgG4 (QR092)7 réf.98/79 IgM FITC4 réf.98/79 Inhibin alpha (QR088)7 réf.98/79 INSM1 (QR128)3 réf. IRTA1 (QM005)3 réf.98/79 Kappa FITC4 réf.98/79 Kappa light chain (QR051)7 réf.98/79 Ki-67 (QR015) Ki67 (QR015)3 réf. Lambda FITC4 réf.98/79 Lambda light chain (QR052)7 réf.98/79 Langerin (QR065)7 réf.98/79 Mammaglobin (QR080)7 réf.98/79 MDM2 (SMP14)6 réf.98/79 Melan A (A103)7 réf.98/79 Melan A (QR138)3 réf. Melanoma (HMB-45)7 réf.98/79 MLH1 (QM003)3 réf. MPO (QR101)7 réf.98/79 MSH2 (QR010)3 réf. MSH6 (QR011)3 réf. MTAP (QR131)3 réf. MUM1 (QR075)7 réf.98/79 MyoD1 (QR069)7 réf.98/79 Myogenin (QR089)7 réf.98/79 Myosin heavy chain 11 (QR064)7 réf.98/79 Napsin A (QR058)6 réf.98/79 Napsin A (QR058) C-N002-02598/79 NKX2.2 (QR077)7 réf.98/79 NKX3.1 (QR055)3 réf. NSE (QR104)6 réf.98/79 NSE (QR105) NSE (QR104)98/79 NUT (QR043)7 réf.98/79 Olig2 (QR071)7 réf.98/79 p16 (QR019)3 réf. p21 (QR085)7 réf.98/79 p40 (QR020)7 réf.98/79 p40 (QR152)3 réf. p53 (QR025)7 réf.98/79 p63 (QR007)3 réf. pan-TRK (QR008)7 réf.98/79 PAX2 (QR060)7 réf.98/79 PAX5 (QR056)7 réf.98/79 PAX8 (QR016)3 réf. PD-1 (QR002)7 réf.98/79 PD-L1 (QR001)7 réf.98/79 PIN-Cocktail AMACR/p63 (QR108 & QM006)3 réf. PLAP (QR084)7 réf.98/79 PMS2 (QR009)3 réf. Podoplanin (QR048)7 réf.98/79 PolyQ Stain 1 step detection system goat anti-mouse AP3 réf. PolyQ Stain 1 step detection system goat anti-mouse HRP3 réf. PolyQ Stain 1 step detection system goat anti-mouse HRP, Peroxidase quench, DAB kit3 réf. PolyQ Stain 1 step detection system goat anti-mouse/rabbit AP3 réf. PolyQ Stain 1 step detection system goat anti-mouse/rabbit AP, Permanent Red kit3 réf. PolyQ Stain 1 step detection system goat anti-mouse/rabbit HRP3 réf. PolyQ Stain 1 step detection system goat anti-mouse/rabbit HRP, Peroxidase quench, DAB kit3 réf. PolyQ Stain 1 step detection system goat anti-rabbit AP3 réf. PolyQ Stain 1 step detection system goat anti-rabbit HRP3 réf. PolyQ Stain 1 step detection system goat anti-rabbit HRP, Peroxidase quench, DAB kit3 réf. PolyQ Stain 1 step double stain goat anti-mouse HRP, goat anti-rabbit AP3 réf. PolyQ Stain 1 step double stain goat anti-rabbit HRP, goat anti-mouse AP3 réf. PolyQ Stain 2 step detection system goat anti-mouse/rabbit AP3 réf. PolyQ Stain 2 step detection system goat anti-mouse/rabbit AP, Permanent Red kit3 réf. PolyQ Stain 2 step detection system goat anti-mouse/rabbit HRP3 réf. PolyQ Stain 2 step detection system goat anti-mouse/rabbit HRP, Peroxidase quench, DAB kit3 réf. PolyQ Stain DAB Substrate Buffer3 réf. PolyQ Stain DAB, 2 components3 réf. PolyQ Stain Permanent Red, 2 components3 réf. PRAME (QR005)3 réf. Progesterone Receptor (QR014) Progesteron Receptor (QR014)3 réf. PSA (QR038)3 réf. PSMA (QR079)7 réf.98/79 PTEN (QR042)7 réf.98/79 S100B (QR031)7 réf.98/79 SALL4 (QR024)7 réf.98/79 SATB2 (QR023)3 réf. SMA (QR110)3 réf. SMAD4 (QR029)7 réf.98/79 SMARCA4 (QR132)3 réf. SOX10 (QR006)3 réf. SOX11 (QR074)7 réf.98/79 STAT6 (QR041)3 réf. Synaptophysin (QR054)7 réf.98/79 TdT (QR037)7 réf.98/79 TRPS1 (QR099)3 réf. TTF1 (QR046)7 réf.98/79 Tyrosinase (T311)7 réf.98/79 Vimentin (QR097)7 réf.98/79 WT1 (QR030)7 réf.98/79	A, C IVDR, 98/79	Site web info@biocyc.de Fiche EUDAMED Signaler une erreur
Vitro FDA	Espagne, Roumanie	Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA) VT-HPBSP-25 master diagnóstica MAD-000101Q3 réf. master diagnóstica MAD-000125Q3 réf. master diagnóstica MAD-000135Q15 réf.98/79 168 autres master diagnóstica MAD-000189Q15 réf.98/79 master diagnóstica MAD-000198Q3 réf. master diagnóstica MAD-000237QP-100/V2 réf. master diagnóstica MAD-000305Q9 réf. master diagnóstica MAD-000306Q3 réf. master diagnóstica MAD-000308Q3 réf. master diagnóstica MAD-000309Q3 réf. master diagnóstica MAD-000310Q3 réf. master diagnóstica MAD-000317Q3 réf. master diagnóstica MAD-000319Q8 réf. master diagnóstica MAD-000320Q3 réf. master diagnóstica MAD-000333Q9 réf. master diagnóstica MAD-000340Q3 réf. master diagnóstica MAD-000375Q3 réf. master diagnóstica MAD-000380Q9 réf. master diagnóstica MAD-000402Q3 réf. master diagnóstica MAD-000421Q15 réf.98/79 master diagnóstica MAD-000425Q15 réf.98/79 master diagnóstica MAD-000434Q3 réf. master diagnóstica MAD-000435Q3 réf. master diagnóstica MAD-000436Q3 réf. master diagnóstica MAD-000440Q15 réf.98/79 master diagnóstica MAD-000475Q3 réf. master diagnóstica MAD-000487Q3 réf. master diagnóstica MAD-000526Q15 réf.98/79 master diagnóstica MAD-000533Q3 réf. master diagnóstica MAD-000539Q3 réf. master diagnóstica MAD-000578Q8 réf. master diagnóstica MAD-000599Q8 réf. master diagnóstica MAD-000600Q3 réf. master diagnóstica MAD-000602Q3 réf. master diagnóstica MAD-000603Q3 réf. master diagnóstica MAD-000606Q3 réf. master diagnóstica MAD-000607Q3 réf. master diagnóstica MAD-000616Q3 réf. master diagnóstica MAD-000619Q3 réf. master diagnóstica MAD-000621Q16 réf.98/79 master diagnóstica MAD-000630Q3 réf. master diagnóstica MAD-000635Q3 réf. master diagnóstica MAD-000636Q3 réf. master diagnóstica MAD-000638Q9 réf. master diagnóstica MAD-000644Q9 réf. master diagnóstica MAD-000645Q3 réf. master diagnóstica MAD-000646Q16 réf.98/79 master diagnóstica MAD-000647Q16 réf.98/79 master diagnóstica MAD-000648Q16 réf.98/79 master diagnóstica MAD-000650Q3 réf. master diagnóstica MAD-000651Q3 réf. master diagnóstica MAD-000652Q9 réf. master diagnóstica MAD-000654Q3 réf. master diagnóstica MAD-000656Q3 réf. master diagnóstica MAD-000658Q16 réf.98/79 master diagnóstica MAD-000659Q3 réf. master diagnóstica MAD-000667Q16 réf.98/79 master diagnóstica MAD-000669Q9 réf. master diagnóstica MAD-000670Q3 réf. master diagnóstica MAD-000671Q3 réf. master diagnóstica MAD-000672Q16 réf.98/79 master diagnóstica MAD-000673Q9 réf. master diagnóstica MAD-000674Q3 réf. master diagnóstica MAD-000675Q9 réf. master diagnóstica MAD-000676Q3 réf. master diagnóstica MAD-000677Q3 réf. master diagnóstica MAD-000681Q3 réf. master diagnóstica MAD-000682Q3 réf. master diagnóstica MAD-000686Q3 réf. master diagnóstica MAD-000691Q3 réf. master diagnóstica MAD-000692Q3 réf. master diagnóstica MAD-000695Q3 réf. master diagnóstica MAD-000696Q3 réf. master diagnóstica MAD-000697Q8 réf. master diagnóstica MAD-000698Q15 réf.98/79 master diagnóstica MAD-000699Q15 réf.98/79 master diagnóstica MAD-000701Q15 réf.98/79 master diagnóstica MAD-000706Q3 réf. master diagnóstica MAD-000710Q16 réf.98/79 master diagnóstica MAD-000711Q9 réf. master diagnóstica MAD-000712Q3 réf. master diagnóstica MAD-000716Q3 réf. master diagnóstica MAD-000718Q3 réf. master diagnóstica MAD-000722Q3 réf. master diagnóstica MAD-000726Q3 réf. master diagnóstica MAD-000728Q3 réf. master diagnóstica MAD-000733Q3 réf. master diagnóstica MAD-000734Q3 réf. master diagnóstica MAD-000735Q3 réf. master diagnóstica MAD-000739Q3 réf. master diagnóstica MAD-000742Q16 réf.98/79 master diagnóstica MAD-000747Q3 réf. master diagnóstica MAD-000749Q3 réf. master diagnóstica MAD-000757Q16 réf.98/79 master diagnóstica MAD-000761Q15 réf.98/79 master diagnóstica MAD-000763Q3 réf. master diagnóstica MAD-000765Q3 réf. master diagnóstica MAD-000779Q11 réf.98/79 master diagnóstica MAD-000793Q3 réf. master diagnóstica MAD-000819Q3 réf. master diagnóstica MAD-000916Q3 réf. master diagnóstica MAD-001000Q3 réf. master diagnóstica MAD-001004Q3 réf. master diagnóstica MAD-001011Q3 réf. master diagnóstica MAD-001100Q3 réf. master diagnóstica MAD-001115Q16 réf.98/79 master diagnóstica MAD-001122Q16 réf.98/79 master diagnóstica MAD-001195Q3 réf. master diagnóstica MAD-001200Q3 réf. master diagnóstica MAD-001215Q16 réf.98/79 master diagnóstica MAD-001221Q3 réf. master diagnóstica MAD-001361Q3 réf. master diagnóstica MAD-001380Q3 réf. master diagnóstica MAD-001613Q8 réf. master diagnóstica MAD-001619Q3 réf. master diagnóstica MAD-001645Q3 réf. master diagnóstica MAD-001701Q3 réf. master diagnóstica MAD-001707Q3 réf. master diagnóstica MAD-001709Q98/79 master diagnóstica MAD-001720Q16 réf.98/79 master diagnóstica MAD-001904Q3 réf. master diagnóstica MAD-001VS2 réf. master diagnóstica MAD-002022Q9 réf. master diagnóstica MAD-002037Q9 réf. master diagnóstica MAD-002045Q9 réf. master diagnóstica MAD-002048Q9 réf. master diagnóstica MAD-002066Q3 réf. master diagnóstica MAD-002084Q3 réf. master diagnóstica MAD-002095Q3 réf. master diagnóstica MAD-002097Q3 réf. master diagnóstica MAD-002163Q3 réf. master diagnóstica MAD-002VS master diagnóstica MAD-003930MU-HS12-243 réf. master diagnóstica MAD-003938M-HS123 réf. master diagnóstica MAD-003949M-W master diagnóstica MAD-003955M master diagnóstica MAD-003963M-W2 réf. master diagnóstica MAD-003966M-L2 réf. master diagnóstica MAD-003VS2 réf. master diagnóstica MAD-004VS2 réf. master diagnóstica MAD-005084Q9 réf. master diagnóstica MAD-005103Q3 réf. master diagnóstica MAD-005105Q3 réf. master diagnóstica MAD-005138Q16 réf.98/79 master diagnóstica MAD-005151Q16 réf.98/79 master diagnóstica MAD-005671Q3 réf. master diagnóstica MAD-005860Q9 réf. master diagnóstica MAD-005VS2 réf. master diagnóstica MAD-006VS2 réf. master diagnóstica MAD-007VS2 réf. master diagnóstica MAD-008VS2 réf. master diagnóstica MAD-009059Q3 réf. master diagnóstica MAD-009VS2 réf. master diagnóstica MAD-010VS2 réf. master diagnóstica MAD-011VS2 réf. master diagnóstica MAD-013VS2 réf. master diagnóstica MAD-014VS2 réf. master diagnóstica MAD-015VS2 réf. master diagnóstica MAD-016VS2 réf. master diagnóstica MAD-017VS2 réf. master diagnóstica MAD-018VS2 réf. master diagnóstica MAD-019VS2 réf. master diagnóstica MAD-024VS2 réf. master diagnóstica MAD-025VS2 réf. master diagnóstica MAD-103.020 master diagnóstica MAD-104.250M master diagnóstica MAD-HDH3-100VS2 réf. master diagnóstica VIT-VTC Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse Syphilis (Whole blood /Serum /Plasma) Rapid Test Cassette Test rapid Sifilis (sange total/ser/plasma) caseta TEST RAPID H. PYLORI ANTIGEN CASETA(SCAUN)	A, B, C IVDR, 98/79	Site web regulatory@vitro.bio Fiche EUDAMED Signaler une erreur
Wuhan Life Origin Biotech Joint Stock Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne) et 1 autre	Chine	C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 1 test/kit98/79 C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 10 tests/kit98/79 C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 100 tests/kit98/79 C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 25 tests/kit98/79 C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 5 tests/kit98/79 154 autres C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 50 tests/kit98/79 C.difficile GDH Assay Kit(Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 C.difficile GDH Assay Kit(Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 C.difficile GDH Assay Kit(Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 C.difficile GDH Assay Kit(Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 C.difficile Toxin A/B Assay Kit(Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 C.difficile Toxin A/B Assay Kit(Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 C.difficile Toxin A/B Assay Kit(Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 C.difficile Toxin A/B Assay Kit(Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 1 test/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 10 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 100 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 25 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 5 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 50 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 7 tests/kit98/79 D-Dimer Assay Kit (Chemiluminescent Immunoassay) 100 Tests/Kit98/79 D-Dimer Assay Kit (Chemiluminescent Immunoassay) 25 Tests/Kit98/79 D-Dimer Assay Kit (Chemiluminescent Immunoassay) 50 Tests/Kit98/79 Dengue NS1 Antigen/IgM Antibody/IgG Antibody Combined Detection Kit (Colloidal Gold) 1 test/kit98/79 Dengue NS1 Antigen/IgM Antibody/IgG Antibody Combined Detection Kit (Colloidal Gold) 10 tests/kit98/79 Dengue NS1 Antigen/IgM Antibody/IgG Antibody Combined Detection Kit (Colloidal Gold) 100 tests/kit98/79 Dengue NS1 Antigen/IgM Antibody/IgG Antibody Combined Detection Kit (Colloidal Gold) 25 tests/kit98/79 Dengue NS1 Antigen/IgM Antibody/IgG Antibody Combined Detection Kit (Colloidal Gold) 5 tests/kit98/79 Dengue NS1 Antigen/IgM Antibody/IgG Antibody Combined Detection Kit (Colloidal Gold) 50 tests/kit98/79 Dengue Virus IgM/IgG Antibody Combined Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Dengue Virus IgM/IgG Antibody Combined Assay Kit (Fluorescence Immunochromatographic Assay) 20 tests/kit98/79 Dengue Virus IgM/IgG Antibody Combined Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Dengue Virus IgM/IgG Antibody Combined Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Dengue Virus IgM/IgG Antibody Combined Assay Kit (Fluorescence Immunochromatographic Assay)Dengue Virus IgM/IgG Antibody Combined Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Dengue Virus Non-Structural Protein 1 Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Dengue Virus Non-Structural Protein 1 Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Dengue Virus Non-Structural Protein 1 Assay Kit (Fluorescence Immunochromatographic Assay) 20 tests/kit98/79 Dengue Virus Non-Structural Protein 1 Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Dengue Virus Non-Structural Protein 1 Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 1 test/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 5 tests/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 1 test/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 10 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 100 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 25 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 5 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 50 tests/kit98/79 Group B Streptococcus Antigen Detection Kit (Colloidal Gold) 1 test/kit98/79 Group B Streptococcus Antigen Detection Kit (Colloidal Gold) 10 tests/kit98/79 Group B Streptococcus Antigen Detection Kit (Colloidal Gold) 100 tests/kit98/79 Group B Streptococcus Antigen Detection Kit (Colloidal Gold) 25 tests/kit98/79 Group B Streptococcus Antigen Detection Kit (Colloidal Gold) 5 tests/kit98/79 Group B Streptococcus Antigen Detection Kit (Colloidal Gold) 50 tests/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 1 test/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 10 tests/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 100 tests/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 25 tests/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 5 tests/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 50 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 20 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Helicobacter pylori Antigen Assay Kit (Enzyme-Linked Immunosorbent Assay) 96 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 20 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Hepatitis C Virus Antibody Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Hepatitis C Virus Antibody Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Hepatitis C Virus Antibody Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit2 réf.98/79 Hepatitis C Virus Antibody Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 1 test/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 10 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 100 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 25 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 5 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 50 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 1 test/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 10 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 100 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 25 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 5 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 50 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 1 test/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 10 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 100 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 25 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 5 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 50 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 1 test/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 5 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 1 test/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 10 tests/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 100 tests/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 25 tests/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 5 tests/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 50 tests/kit98/79 Respiratory Syncytial Virus Antigen Assay Kit(Colloidal Gold) 1 test/kit98/79 Respiratory Syncytial Virus Antigen Assay Kit(Colloidal Gold) 10 tests/kit98/79 Respiratory Syncytial Virus Antigen Assay Kit(Colloidal Gold) 100 tests/kit98/79 Respiratory Syncytial Virus Antigen Assay Kit(Colloidal Gold) 25 tests/kit98/79 Respiratory Syncytial Virus Antigen Assay Kit(Colloidal Gold) 5 tests/kit98/79 Respiratory Syncytial Virus Antigen Assay Kit(Colloidal Gold) 50 tests/kit98/79 Rota/Adeno Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Rota/Adeno Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Rota/Adeno Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Rota/Adeno Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 SARS-CoV -2 Neutralizing Antibody Assay Kit (Colloidal Gold) 1 test/kit98/79 SARS-CoV -2 Neutralizing Antibody Assay Kit (Colloidal Gold) 100 tests/kit98/79 SARS-CoV -2 Neutralizing Antibody Assay Kit (Colloidal Gold) 25 tests/kit98/79 SARS-CoV -2 Neutralizing Antibody Assay Kit (Colloidal Gold) 50 tests/kit98/79 SARS-CoV-2 / Influenza Virus Antigen Combined Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 SARS-CoV-2 / Influenza Virus Antigen Combined Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 SARS-CoV-2 / Influenza Virus Antigen Combined Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 SARS-CoV-2 / Influenza Virus Antigen Combined Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 1 test/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 10 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 100 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 25 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 5 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 50 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) SF24007298/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (ELISA) 48 tests/kit98/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (ELISA) 96 tests/kit98/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) 1 test/kit98/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) 100 tests/kit98/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) 25 tests/kit98/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) 50 tests/kit98/79 SARS-CoV-2 Nucleic Acid Dual-Detection Kit (Real-Time PCR Method) 25 tests/kit98/79 SARS-CoV-2 Nucleic Acid Dual-Detection Kit (Real-Time PCR Method) 50 tests/kit98/79 SARS-CoV-2 S-RBD IgG Antibody Assay Kit (ELISA) 48 tests/kit98/79 SARS-CoV-2 S-RBD IgG Antibody Assay Kit (ELISA) 96 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 1 test/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 10 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 100 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 25 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 5 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 50 tests/kit98/79 Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay) 100 Tests/Kit98/79 Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay) 25 Tests/Kit98/79 Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay) 50 Tests/Kit98/79 Treponema Pallidum Antibody Rapid Detection Kit (Colloidal Gold) 1 test/kit98/79 Treponema Pallidum Antibody Rapid Detection Kit (Colloidal Gold) 10 tests/kit98/79 Treponema Pallidum Antibody Rapid Detection Kit (Colloidal Gold) 100 tests/kit98/79 Treponema Pallidum Antibody Rapid Detection Kit (Colloidal Gold) 25 tests/kit98/79 Treponema Pallidum Antibody Rapid Detection Kit (Colloidal Gold) 5 tests/kit98/79 Treponema Pallidum Antibody Rapid Detection Kit (Colloidal Gold) 50 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
SSI Diagnostica FDA	Danemark	ImmuView Reader version 1.098/79 ImmuView® Reader 2.0 Pneumococcus Factor 10b98/79 Pneumococcus Factor 10d98/79 Pneumococcus Factor 10f98/79 153 autres Pneumococcus Factor 11b98/79 Pneumococcus Factor 11c98/79 Pneumococcus Factor 11f98/79 Pneumococcus Factor 11g98/79 Pneumococcus Factor 12b98/79 Pneumococcus Factor 12c98/79 Pneumococcus Factor 12e98/79 Pneumococcus Factor 15b98/79 Pneumococcus Factor 15c98/79 Pneumococcus Factor 15e98/79 Pneumococcus Factor 15h98/79 Pneumococcus Factor 16b98/79 Pneumococcus Factor 16c98/79 Pneumococcus Factor 17b98/79 Pneumococcus Factor 17c98/79 Pneumococcus Factor 18c98/79 Pneumococcus Factor 18d98/79 Pneumococcus Factor 18e98/79 Pneumococcus Factor 18f98/79 Pneumococcus Factor 19b98/79 Pneumococcus Factor 19c98/79 Pneumococcus Factor 19f98/79 Pneumococcus Factor 20b98/79 Pneumococcus Factor 22b98/79 Pneumococcus Factor 22c98/79 Pneumococcus Factor 23b98/79 Pneumococcus Factor 23c98/79 Pneumococcus Factor 23d98/79 Pneumococcus Factor 24c98/79 Pneumococcus Factor 24d98/79 Pneumococcus Factor 24e98/79 Pneumococcus Factor 25b98/79 Pneumococcus Factor 25c98/79 Pneumococcus Factor 28b98/79 Pneumococcus Factor 28c98/79 Pneumococcus Factor 29b98/79 Pneumococcus Factor 32a98/79 Pneumococcus Factor 32b98/79 Pneumococcus Factor 33b98/79 Pneumococcus Factor 33e98/79 Pneumococcus Factor 33f98/79 Pneumococcus Factor 35a98/79 Pneumococcus Factor 35b98/79 Pneumococcus Factor 35c98/79 Pneumococcus Factor 41a98/79 Pneumococcus Factor 41b98/79 Pneumococcus Factor 42a98/79 Pneumococcus Factor 43b98/79 Pneumococcus Factor 47a98/79 Pneumococcus Factor 6a98/79 Pneumococcus Factor 6b98/79 Pneumococcus Factor 6b high titer2 réf.98/79 Pneumococcus Factor 6c98/79 Pneumococcus Factor 6c high titer2 réf.98/79 Pneumococcus Factor 6d98/79 Pneumococcus Factor 6d high titer98/79 Pneumococcus Factor 7b98/79 Pneumococcus Factor 7b high titer98/79 Pneumococcus Factor 7c98/79 Pneumococcus Factor 7e98/79 Pneumococcus Factor 7f98/79 Pneumococcus Factor 7h98/79 Pneumococcus Factor 9b98/79 Pneumococcus Factor 9d98/79 Pneumococcus Factor 9e98/79 Pneumococcus Factor 9g98/79 Pneumococcus Group 1098/79 Pneumococcus Group 10 high titer98/79 Pneumococcus Group 1198/79 Pneumococcus Group 11 high titer98/79 Pneumococcus Group 1298/79 Pneumococcus Group 12 high titer98/79 Pneumococcus Group 1598/79 Pneumococcus Group 15 high titer98/79 Pneumococcus Group 1698/79 Pneumococcus Group 16 high titer98/79 Pneumococcus Group 1798/79 Pneumococcus Group 17 high titer98/79 Pneumococcus Group 1898/79 Pneumococcus Group 18 high titer98/79 Pneumococcus Group 1998/79 Pneumococcus Group 2298/79 Pneumococcus Group 22 high titer98/79 Pneumococcus Group 2398/79 Pneumococcus Group 23 high titer98/79 Pneumococcus Group 2498/79 Pneumococcus Group 24 high titer98/79 Pneumococcus Group 2598/79 Pneumococcus Group 2898/79 Pneumococcus Group 3298/79 Pneumococcus Group 3398/79 Pneumococcus Group 33 high titer98/79 Pneumococcus Group 3598/79 Pneumococcus Group 35 high titer98/79 Pneumococcus Group 4198/79 Pneumococcus Group 4798/79 Pneumococcus Group 698/79 Pneumococcus Group 6 high titer98/79 Pneumococcus Group 798/79 Pneumococcus Group 7 high titer98/79 Pneumococcus Group 998/79 Pneumococcus Pool A98/79 Pneumococcus Pool B98/79 Pneumococcus Pool C98/79 Pneumococcus Pool D98/79 Pneumococcus Pool E98/79 Pneumococcus Pool F98/79 Pneumococcus Pool G98/79 Pneumococcus Pool H98/79 Pneumococcus Pool I98/79 Pneumococcus Pool P98/79 Pneumococcus Pool Q98/79 Pneumococcus Pool R98/79 Pneumococcus Pool S98/79 Pneumococcus Pool T98/79 Pneumococcus Type 198/79 Pneumococcus Type 1 high titer98/79 Pneumococcus Type 1398/79 Pneumococcus Type 1498/79 Pneumococcus Type 14 high titer98/79 Pneumococcus Type 298/79 Pneumococcus Type 2 high titer98/79 Pneumococcus Type 2098/79 Pneumococcus Type 20 high titer98/79 Pneumococcus Type 2198/79 Pneumococcus Type 21 high titer98/79 Pneumococcus Type 2798/79 Pneumococcus Type 2998/79 Pneumococcus Type 398/79 Pneumococcus Type 3 high titer98/79 Pneumococcus Type 3198/79 Pneumococcus Type 31 high titer98/79 Pneumococcus Type 3498/79 Pneumococcus Type 34 high titer98/79 Pneumococcus Type 3698/79 Pneumococcus Type 3798/79 Pneumococcus Type 3898/79 Pneumococcus Type 38 high titer98/79 Pneumococcus Type 3998/79 Pneumococcus Type 498/79 Pneumococcus Type 4 high titer98/79 Pneumococcus Type 4098/79 Pneumococcus Type 4298/79 Pneumococcus Type 4398/79 Pneumococcus Type 4498/79 Pneumococcus Type 4598/79 Pneumococcus Type 4698/79 Pneumococcus Type 4898/79 Pneumococcus Type 598/79 Pneumococcus Type 5 high titer98/79 Pneumococcus Type 898/79 Pneumococcus Type 8 high titer98/79 Salmonella antisera98/79	A IVDR, 98/79	Site web info@ssidiagnostica.com Fiche EUDAMED Signaler une erreur
Oacp	Irlande	Bladder Cancer cells chromosome and gene anomaly detection probe98/79 CL-004 fp-001 FP-00298/79 FP-00398/79 149 autres FP-004 (FP-044)98/79 FP-00598/79 FP-00698/79 FP-00798/79 FP-0115 réf.98/79 FP-011-698/79 FP-01298/79 FP-01398/79 FP-0143 réf.98/79 FP-01598/79 FP-01698/79 FP-01898/79 FP-01998/79 FP-02098/79 FP-02198/79 FP-02298/79 FP-02398/79 FP-02498/79 FP-02598/79 FP-02698/79 FP-02798/79 FP-02898/79 FP-02998/79 FP-03098/79 FP-03198/79 FP-03298/79 FP-03398/79 FP-03498/79 FP-03598/79 FP-03698/79 FP-03798/79 FP-03898/79 FP-03998/79 FP-04098/79 FP-04198/79 FP-04298/79 FP-04398/79 FP-04598/79 FP-04698/79 FP-04998/79 FP-05198/79 FP-05298/79 FP-05398/79 FP-05498/79 FP-05598/79 FP-05998/79 FP-06298/79 FP-07498/79 FP-07598/79 FP-07698/79 FP-07798/79 FP-07998/79 FP-08098/79 FP-08198/79 FP-08298/79 FP-08398/79 FP-08598/79 FP-09198/79 FP-09298/79 FP-09398/79 FP-09498/79 FP-10098/79 FP-10198/79 FP-10898/79 FP-11298/79 FP-11398/79 FP-11798/79 FP-11898/79 FP-12398/79 FP-12598/79 FP-12898/79 FP-13798/79 FP-14198/79 FP-14298/79 FP-14398/79 FP-14898/79 FP-14998/79 FP-15098/79 FP-15198/79 FP-15498/79 FP-15898/79 FP-15998/79 FP-16098/79 FP-16898/79 FP-17498/79 FP-18198/79 FP-18398/79 FP-18598/79 FP-18698/79 FP-19198/79 FP-19398/79 FP-19798/79 FP-19898/79 FP-20698/79 FP-20898/79 FP-21698/79 FP-22698/79 FP-22798/79 FP-230-598/79 FP-23298/79 FP-232-198/79 FP-232-298/79 FP-232-398/79 FP-233-198/79 FP-233-298/79 FP-233-398/79 FP-233-498/79 FP-234-198/79 FP-234-298/79 FP-234-398/79 FP-24098/79 FP-242-398/79 FP-242-498/79 FP-243-198/79 FP-243-298/79 FP-243-398/79 FP-245-398/79 FP-245-498/79 FP-25198/79 FP-26098/79 FP-26298/79 FP-26598/79 FP-26698/79 FP-26798/79 FP-29798/79 FP-30498/79 FP-31498/79 FP-315-198/79 FP-315-298/79 FP-34098/79 FP-34198/79 FP-342-298/79 FP-342-398/79 FP-34498/79 FP-34998/79 FP-37098/79 FP-38698/79 FP-39898/79 FP-40898/79 FP-41098/79 FP-41298/79 In situ Hybridization staining solution CL-004 Rapid ISH Integra Plus Rapid-ISH Hemato Rapid-ISH Integra Rapid-ISH Integra Recovery Smart-ISH Solve SSAL-601-0 TOP2A gene amplification probe detection kit98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Stago FDA	France	ADP98/79 Arachidonic acid98/79 Asserachrom® HPIA98/79 Asserachrom® HPIA - IgG98/79 Asserachrom® D-Di98/79 141 autres Asserachrom® Free Protein S98/79 Asserachrom® IX:Ag98/79 Asserachrom® PAI-198/79 Asserachrom® PF498/79 Asserachrom® Protein C98/79 Asserachrom® Total Protein S98/79 Asserachrom® tPA98/79 Asserachrom® VWF:CB98/79 Asserachrom® VWF:FVIIIB98/79 Asserachrom® Washing Solution Asserachrom® ß-TG98/79 C.K. Prest® 298/79 C.K. Prest® 598/79 Coag Control N + P98/79 Collagen98/79 Cuvettes D-Di Test®98/79 Epinephrine98/79 Etaloquick®98/79 F.S. Test98/79 F.S. Test Unit98/79 FDP Plasma98/79 PTT Automate 598/79 PTT-LA98/79 SPA 2098/79 SPA Buffer STA Satellite Cuvettes Stachrom® Heparin98/79 Stachrom® PAI98/79 Staclot® LA98/79 STart Max2 réf. STA® - Apixaban Calibrator STA® - Apixaban Control STA® - C.K. Prest® STA® - CaCl2 0.01 M STA® - CaCl2 0.025 M STA® - Coag Control (N + ABN) PLUS STA® - Coag Control N + P STA® - Control LA 1 + 298/79 STA® - Cuvettes STA® - Dabigatran Calibrator STA® - Dabigatran Control STA® - Deficient II98/79 STA® - Deficient IX STA® - Deficient V STA® - Deficient VII98/79 STA® - Deficient VIII STA® - Deficient X STA® - Deficient XI98/79 STA® - ECA II STA® - Edoxaban Calibrator STA® - Edoxaban Control STA® - FDP Calibrator98/79 STA® - FDP Control STA® - Fibrinogen 5 STA® - FM Calibrator STA® - FM Control98/79 STA® - Hepanorm® HBPM/LMWH98/79 STA® - Hepato-Prest 102 réf. STA® - ImmunoDef II98/79 STA® - ImmunoDef IX98/79 STA® - ImmunoDef VIII STA® - ImmunoDef XI98/79 STA® - ImmunoDef XII98/79 STA® - Liatest® D-Di PLUS STA® - Liatest® FDP STA® - Liatest® FM STA® - Liatest® Free Protein S 22 réf. STA® - Liatest® VWF:Ag98/79 STA® - Liquid Anti-Xa 42 réf. STA® - Liquid Fib STA® - Multi Hep Calibrator STA® - NeoPTimal 103 réf. STA® - Néoplastine® CI Plus 102 réf. STA® - Owren-Koller STA® - PTT A 598/79 STA® - Quali-Clot I STA® - Quali-Clot II STA® - Quality HBPM/LMWH STA® - Quality HNF/UFH STA® - Reptilase®98/79 STA® - Routine QC 2 ml STA® - SPA + STA® - Stachrom® AT III 398/79 STA® - Stachrom® AT III 698/79 STA® - Stachrom® Plasminogen98/79 STA® - Stachrom® Protein C STA® - Staclot® APC-R98/79 STA® - Staclot® dRVV Confirm STA® - Staclot® dRVV Screen 22 réf. STA® - Staclot® Protein C 1 STA® - Staclot® Protein S98/79 STA® - System Control N+P98/79 STA® - Thrombin 102 réf. STA® - Unicalibrator STA® - VWF:Ag Calibrator98/79 STA® - VWF:RCo98/79 STG® - Cal&Fluo98/79 STG® - Cuvettes sthemA CAL-CBC sthemO AT L sthemO CaCl2 M sthemO CK Prest sthemO Complete QC 1&2 sthemO Cuvettes sthemO Daily QC 1&2 sthemO DDi M sthemO dRVV confirm sthemO dRVV screen L2 réf. sthemO FDP sthemO FDP cal sthemO FDP QC 1&2 sthemO Fib M sthemO FVII QC sthemO Heparin cal sthemO II sthemO IX sthemO LA QC 1&2 sthemO LMWH QC 1&2 sthemO Owren Koller M sthemO PC chrom sthemO PC clot M sthemO PS clot sthemO PS Free L sthemO PS VWF QC 1&2 sthemO PT M sthemO PTT A sthemO Thrombin M sthemO UFH QC 1&2 sthemO Unical sthemO V sthemO VII sthemO VIII sthemO VWF Ag sthemO VWF cal sthemO X sthemO XI System Control N+P98/79 TRAP-698/79 Unicalibrator98/79 Citrate Buffer (plus commercialisé)	A, B, C IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
DiaSorin FDA Mandataire UE : DiaSorin Italia S.p.A. (Italie)	Italie, États-Unis	ETI-Max 3000 HerpeSelect® 1 and 2 Immunoblot IgG98/79 HerpeSelect® 2 ELISA IgG98/79 LIAISON ® EBV IgM LIAISON® Adenovirus98/79 139 autres LIAISON® Adenovirus Control Set98/79 LIAISON® Anti-HAV LIAISON® Biotrin Control Parvovirus B19 IgG98/79 LIAISON® Biotrin Control Parvovirus B19 IgG Plus LIAISON® Biotrin Control Parvovirus B19 IgM98/79 LIAISON® Biotrin Control Parvovirus B19 IgM Plus LIAISON® Biotrin Parvovirus B19 IgG98/79 LIAISON® Biotrin Parvovirus B19 IgG Plus LIAISON® Biotrin Parvovirus B19 IgM98/79 LIAISON® Biotrin Parvovirus B19 IgM Plus LIAISON® Bordetella pertussis Toxin IgA LIAISON® Bordetella pertussis Toxin IgG LIAISON® Borrelia IgG LIAISON® Borrelia IgM II LIAISON® Borrelia IgM Quant LIAISON® C. difficile GDH98/79 LIAISON® C. difficile GDH Control Set98/79 LIAISON® C. difficile Toxins A&B98/79 LIAISON® C. difficile Toxins A&B Control Set98/79 LIAISON® Campylobacter Ag98/79 LIAISON® Chlamydia trachomatis IgA LIAISON® Chlamydia trachomatis IgG LIAISON® CMV IgG Avidity II LIAISON® CMV IgG II98/79 LIAISON® Control Anti-HAV LIAISON® Control Bordetella pertussis Toxin IgA LIAISON® Control Bordetella pertussis Toxin IgG LIAISON® Control Borrelia IgG LIAISON® Control Borrelia IgG Liquor LIAISON® Control Borrelia IgM Liquor LIAISON® Control Borrelia IgM Quant / Borrelia IgM II LIAISON® Control Chlamydia trachomatis IgA LIAISON® Control Chlamydia trachomatis IgG LIAISON® Control CMV IgG Avidity II LIAISON® Control CMV IgG II98/79 LIAISON® Control EA IgG LIAISON® Control EBNA IgG LIAISON® Control EBV IgM LIAISON® Control HSV-1 IgG98/79 LIAISON® Control HSV-1/2 IgG LIAISON® Control HSV-1/2 IgM98/79 LIAISON® Control HSV-2 IgG LIAISON® Control Legionella Urinary Ag LIAISON® Control LymeDetect® LIAISON® Control Measles IgM LIAISON® Control Mumps IgG98/79 LIAISON® Control Mumps IgM LIAISON® Control Mycoplasma pneumoniae IgG98/79 LIAISON® Control Mycoplasma pneumoniae IgM LIAISON® Control QuantiFERON®-TB Gold Plus2 réf. LIAISON® Control QuantiFERON®-TB Gold Plus II LIAISON® Control Rubella IgG98/79 LIAISON® Control Rubella IgG II LIAISON® Control Rubella IgM LIAISON® Control S. pneumoniae Ag LIAISON® Control SARS-CoV-2 Ag LIAISON® Control Toxo IgG II LIAISON® Control Toxo IgM LIAISON® Control VCA IgG LIAISON® Control VZV IgG98/79 LIAISON® Control VZV IgG HT LIAISON® Control VZV IgM LIAISON® Cuvettes on tray LIAISON® diluteX LIAISON® EA IgG LIAISON® EBNA IgG LIAISON® H. pylori IgG98/79 LIAISON® H. pylori IgG Control Set98/79 LIAISON® HAV IgM98/79 LIAISON® HSV-1 Type Specific IgG98/79 LIAISON® HSV-1/2 IgG LIAISON® HSV-1/2 IgM98/79 LIAISON® HSV-2 IgG LIAISON® Legionella Urinary Ag LIAISON® MDX LIAISON® Measles IgM LIAISON® Meridian H. pylori SA98/79 LIAISON® Meridian H. pylori SA Control Set98/79 LIAISON® Module LIAISON® Mumps IgG98/79 LIAISON® Mumps IgM LIAISON® MUREX Anti-HEV IgG LIAISON® MUREX Anti-HEV IgM LIAISON® MUREX Control Anti-HEV IgG LIAISON® MUREX Control Anti-HEV IgM LIAISON® Mycoplasma pneumoniae IgG98/79 LIAISON® Mycoplasma pneumoniae IgM LIAISON® Q.S.E.T. Device Plus LIAISON® Q.S.E.T. Quick Pick LIAISON® QuantiFERON® LymeDetect® Blood Collection Tubes LIAISON® Rotavirus98/79 LIAISON® Rotavirus Control Set98/79 LIAISON® Rubella IgG98/79 LIAISON® Rubella IgG II LIAISON® Rubella IgM LIAISON® S. pneumoniae Ag LIAISON® SARS-CoV-2 Ag LIAISON® SARS-CoV-2 Sample Inactivation Buffer LIAISON® SARS-CoV-2 TrimericS IgG98/79 LIAISON® SARS-CoV-2 TrimericS IgG Control Set98/79 LIAISON® Toxo IgG II LIAISON® Toxo IgM LIAISON® VCA IgG LIAISON® VZV IgG98/79 LIAISON® VZV IgG HT LIAISON® VZV IgM LIAISON® XL LIAISON® XL Control Toxo IgG Avidity LIAISON® XL Cuvettes LIAISON® XL LAS LIAISON® XL Toxo IgG Avidity LIAISON® XS LIAISON®Control HAV lgM98/79 Q Fever IFA IgG98/79 Q Fever IFA IgM98/79 Rickettsia IFA IgG98/79 Rickettsia IFA IgM98/79 Simplexa™ C. Difficile Sample Prep Kit Simplexa™ Bordetella Direct98/79 Simplexa™ Bordetella Positive Control Pack98/79 Simplexa™ Bordetella Universal Direct2 réf.98/79 Simplexa™ C. auris Direct Simplexa™ C. auris Positive Control Pack Simplexa™ C. difficile Direct98/79 Simplexa™ C. difficile Universal Direct98/79 Simplexa™ Congenital CMV Direct Simplexa™ Congenital CMV Positive Control Pack Simplexa™ COVID-19 & Flu A/B Positive Control Pack98/79 Simplexa™ COVID-19 / Flu A/B & RSV Direct Simplexa™ COVID-19 / Flu A/B & RSV Positive Control Pack Simplexa™ COVID-19 Direct98/79 Simplexa™ COVID-19 Positive Control Pack98/79 Simplexa™ Flu A/B & RSV Positive Control Pack98/79 Simplexa™ GBS Direct98/79 Simplexa™ Group A Strep Positive Control Pack98/79 Simplexa™ HSV 1 & 2 Positive Control Pack98/79 Simplexa™ VZV Direct98/79 Simplexa™ VZV Swab Direct98/79 STRATIFY JCV® DxSelect™98/79	A, B, C IVDR, 98/79	Présent sur le marché en France Site web ivdr_dsu@diasorin.com Fiche EUDAMED Signaler une erreur
Technoclone	Autriche	Abnormal Human Control Plasma3 réf. AK-Calibrant98/79 AK-Verification2 réf. APC Control Kit98/79 APC Resistance Kit2 réf.98/79 137 autres APIX CalSet APIX ControlSet98/79 CaCl2 25 mM3 réf. CaCl2 50 mM2 réf. Ceveron c100 Ceveron 100 series3 réf. Ceveron m13 réf. Ceveron TGA CAL98/79 Citrate Buffer2 réf. Coagulation CON N3 réf. Coagulation Control A98/79 Coagulation Control AK98/79 Coagulation Control N98/79 Coagulation Reference2 réf. DABI CalSet DABI ControlSet Dapttin3 réf. DTI Chrom EDOX CalSet EDOX ControlSet98/79 Factor II immunads. Deficient Plasma98/79 Factor IX DP2 réf. Factor IX immunads. Deficient Plasma98/79 Factor IX native Deficient Plasma98/79 Factor V immunads. Deficient Plasma98/79 Factor VII immunads. Deficient Plasma98/79 Factor VIII DP native2 réf. Factor VIII immunads. Deficient Plasma2 réf.98/79 Factor VIII INH CON Factor VIII INH Kit2 réf. Factor VIII Inhibitor Plasma98/79 Factor X immunads. Deficient Plasma98/79 Factor X native Deficient Plasma98/79 Factor XI immunoads. Deficient Plasma98/79 Factor XI native Deficient Plasma98/79 Factor XII immunoads. Deficient Plasma98/79 Factor XII native Deficient Plasma98/79 Fibrinogen C Fibrinogen Reagent98/79 Fibrinogen Reagent Kit98/79 Fitzgerald Trait Plasma98/79 Fletcher Trait Plasma98/79 Imidazole Buffer3 réf. Lupus Anticoagulant Test98/79 Lupus Inhibitor Plasma2 réf.98/79 Lupus Inhibitor Plasma Low98/79 NaCl 0.9 % Platelet Poor Plasma98/79 Protein C immunads. Deficient Plasma98/79 Protein S Deficient Plasma98/79 RIVA CalSet RIVA ControlSet Siron LIS3 réf. Siron LS3 réf. TECHNOCHROM anti-Xa98/79 Technochrom AT manual TECHNOCHROM ATIII98/79 Technochrom Dilution Buffer Technochrom DTI Technochrom FVIII:C 2G Technochrom FVIII:C 2G CAL TECHNOCHROM FXIII98/79 Technochrom Plasmin INH98/79 Technochrom Plasminogen98/79 TECHNOCHROM Protein C98/79 Technochrom Protein C 2G98/79 TECHNOCLOT Control A98/79 Technoclot Control A298/79 TECHNOCLOT Control N98/79 Technoclot dRVVT Confirm98/79 Technoclot dRVVT Screen98/79 Technoclot DTI TECHNOCLOT LA Confirm98/79 TECHNOCLOT LA Screen98/79 TECHNOCLOT Protein C98/79 Technoclot PT Owren capillary CAL set Technoclot PT plus2 réf. TECHNOCLOT® PT Owren Capillary Control Set98/79 Technofluor ADAMTS13:Act 0 CAL Technofluor FXIII:Act TECHNOLEIA D-Dimer Calibrator 0 ng/mL98/79 TECHNOLEIA D-Dimer Calibrator ~3000 ng/mL98/79 TECHNOLEIA D-Dimer Control high98/79 TECHNOLEIA D-Dimer Control low98/79 TECHNOLEIA D-Dimer Latex Kit2 réf.98/79 Technoplastin HIS4 réf. Technoplastin HIS Ceveron3 réf. Technoview allXa CON98/79 Technoview Apixaban CAL98/79 Technoview Apixaban CON H98/79 Technoview Apixaban CON L98/79 Technoview Argatroban CAL98/79 Technoview Argatroban CON H2 réf. Technoview Arixtra CAL Technoview Arixtra CON H98/79 Technoview Arixtra CON L98/79 Technoview Dabigatran CAL98/79 Technoview Dabigatran CON H2 réf. Technoview Edoxaban CAL98/79 Technoview Edoxaban CON H3 réf. Technoview LMWH CAL Technoview LMWH CON H2 réf. Technoview LMWH CON M98/79 Technoview Orgaran CAL Technoview Orgaran CON H2 réf. Technoview Rivaroxaban CAL98/79 Technoview Rivaroxaban CAL H98/79 Technoview Rivaroxaban CON H2 réf. Technoview Rivaroxaban CON M98/79 Technoview UFH CAL Technoview UFH CON H98/79 Technoview UFH CON L TECHNOZYM ADAMTS13 Activity CAL Set98/79 TECHNOZYM ADAMTS13 Activity CONT Set98/79 TECHNOZYM ADAMTS13 Antigen CAL Set98/79 TECHNOZYM ADAMTS13 Antigen CONT Set98/79 TECHNOZYM ADAMTS13 CAL Set98/79 TECHNOZYM ADAMTS13 CONT Set98/79 TECHNOZYM ADAMTS13 INH CAL Set98/79 TECHNOZYM ADAMTS13 INH CONT Set98/79 TECHNOZYM PAI-1 Actibind CAL Set98/79 TECHNOZYM PAI-1 Actibind CONT Set98/79 TECHNOZYM PAI-1 Actibind ELISA98/79 TECHNOZYM PAI-1 Antigen CAL Set98/79 TECHNOZYM PAI-1 Antigen CONT Set98/79 TECHNOZYM PAI-1 Antigen ELISA98/79 TECHNOZYM Protein C ELISA98/79 TECHNOZYM t-PA Ag EDTA CONT Set98/79 TECHNOZYM t-PA Ag EDTA ELISA98/79 TECHNOZYM t-PA EDTA CAL Set98/79 TECHNOZYM vWF:Ag CAL Set98/79 TECHNOZYM vWF:Ag CONT Set98/79 TECHNOZYM vWF:Ag ELISA98/79 Technozym VWF:CBA (I)98/79 TECHNOZYM vWF:CBA CAL Set98/79 TECHNOZYM vWF:CBA CONT Set98/79 TECHNOZYM vWF:CBA ELISA98/79 Thrombin Time	A, C IVDR, 98/79	Site web regulatory@technoclone.com Fiche EUDAMED Signaler une erreur
Shenzhen Zijian Biotechnology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	15 High-risk HPV DNA Diagnostic Kit(type16,18,31,33,35,39,45,51,52,53,56,58,59,66,68) (PCR-Fluorescence Probing) 48 Tests/kit98/79 50 Tests/box6 réf. Activated type:25pcs/kit V 20-10-2598/79 Adenovirus FIA Kit 25 Tests/kit98/79 Adenovirus IgM Detection Kit(CLIA) 50 Tests/kit98/79 134 autres Automatic Nucleic Acid Extractor NEX-3298/79 Automatic Nucleic Acid Extractor NEX-9698/79 BAS-102 réf. Coxsackie virus group A type 16 (CA16) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 D-Dimer Detection Kit(CLIA) 50 Tests/kit98/79 D-dimer Detection Kit(Fluorescence Immunoassay) 25 Tests/kit98/79 Dengue IgG/IgM FIA Kit 25 Tests/kit98/79 Dengue NS1 Ag FIA Kit 25 Tests/kit98/79 Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method) 100 Tests/kit98/79 Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method) 25 Tests/kit98/79 Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method) 50 Tests/kit98/79 Disposable Virus Sampling Tube Activated type:100pcs/kit V 10-3.5-10098/79 Disposable Virus Sampling Tube Activated type:100pcs/kit V 15-6-10098/79 Disposable Virus Sampling Tube Activated type:100pcs/kit V 2-1-10098/79 Disposable Virus Sampling Tube Activated type:100pcs/kit V 5-3.5-10098/79 Disposable Virus Sampling Tube Activated type:200pcs/kit V 2-1-20098/79 Disposable Virus Sampling Tube Activated type:25pcs/kit V 10-3.5-2598/79 Disposable Virus Sampling Tube Activated type:25pcs/kit V 15-6-2598/79 Disposable Virus Sampling Tube Activated type:25pcs/kit V 30-12-2598/79 Disposable Virus Sampling Tube Activated type:25pcs/kit V 5-3.5-2598/79 Disposable Virus Sampling Tube Activated type:25pcs/kit V 50-10-2598/79 Disposable Virus Sampling Tube Activated type:25pcs/kit V 50-15-2598/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 5-2-5098/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 10-3.5-5098/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 15-6-5098/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 20-10-5098/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 30-12-5098/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 5-2.5-5098/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 5-3.5-5098/79 Disposable Virus Sampling Tube Inactivated type I:100pcs/kit VI 10-3.5-10098/79 Disposable Virus Sampling Tube Inactivated type I:100pcs/kit VI 15-6-10098/79 Disposable Virus Sampling Tube Inactivated type I:100pcs/kit VI 2-1-10098/79 Disposable Virus Sampling Tube Inactivated type I:100pcs/kit VI 5-3.5-10098/79 Disposable Virus Sampling Tube Inactivated type I:200pcs/kit VI 2-1-20098/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 10-3.5-2598/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 15-6-2598/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 20-10-2598/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 30-12-2598/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 5-3.5-2598/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 50-10-2598/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 50-15-2598/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 10-3.5-5098/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 15-6-5098/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 20-10-5098/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 30-12-5098/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 5-2-5098/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 5-2.5-5098/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 5-3.5-5098/79 Disposable Virus Sampling Tube Inactivated type II:100pcs/kit VII 10-3.5-10098/79 Disposable Virus Sampling Tube Inactivated type II:100pcs/kit VII 15-6-10098/79 Disposable Virus Sampling Tube Inactivated type II:100pcs/kit VII 2-1-10098/79 Disposable Virus Sampling Tube Inactivated type II:100pcs/kit VII 5-3.5-10098/79 Disposable Virus Sampling Tube Inactivated type II:200pcs/kit VII 2-1-20098/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 10-3.5-2598/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 15-6-2598/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 20-10-2598/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 30-12-2598/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 5-3.5-2598/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 50-10-2598/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 50-15-2598/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 10-3.5-5098/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 15-6-5098/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 20-10-5098/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 30-12-5098/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 5-2-5098/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 5-2.5-5098/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 5-3.5-5098/79 Disposable Virus Sampling Tube Inactivated type III: 100pcs/kit VIII 2-1-10098/79 Disposable Virus Sampling Tube Inactivated type III:100pcs/kit VIII 15-6-10098/79 Disposable Virus Sampling Tube Inactivated type III:100pcs/kit VIII 10-3.5-10098/79 Disposable Virus Sampling Tube Inactivated type III:100pcs/kit VIII 5-3.5-10098/79 Disposable Virus Sampling Tube Inactivated type III:200pcs/kit VIII 2-1-20098/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 10-3.5-2598/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 15-6-2598/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 20-10-2598/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 30-12-2598/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 5-3.5-2598/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 50-10-2598/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 50-15-2598/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 10-3.5-5098/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 15-6-5098/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 20-10-5098/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 30-12-5098/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 5-2-5098/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 5-2.5-5098/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 5-3.5-5098/79 Enterovirus type 71 (EV71) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Enterovirus Universal Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Fibrin/Fibrinogen Degradation Products(FDP) Detection Kit(CLIA) 50 Tests/kit98/79 Flu A & Flu B Antigen Rapid Detection Kit (Lateral Flow Method) 100 Tests/kit98/79 Flu A & Flu B Antigen Rapid Detection Kit (Lateral Flow Method) 25 Tests/kit98/79 Flu A & Flu B Antigen Rapid Detection Kit (Lateral Flow Method) 50 Tests/kit98/79 Flu A Flu B+RSV+ ADV Rapid Detection Kit(Colloidal Gold) 25 Tests/kit98/79 Fluorescence Immunoassay Analyzer FIS-10002 réf. H. Pylori Ab FIA Kit 25 Tests/kit98/79 H. Pylori Ag FIA Kit 25 Tests/kit98/79 Helicobacter Pylori IgG (HP IgG) Detection Kit(CLIA) 50 Tests/kit98/79 HPV (Type 16 and 18) DNA Fluorescence Diagnostic Kit(PCR-Fluorescence Probing) 48 Tests/kit98/79 Influenza A (H1N1) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Influenza A+B virus Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Influenza A/B Virus Antigen Detection Kit(Fluorescence Immunoassay) 25 Tests/kit98/79 Interleukin 6 (IL-6) Detection Kit(CLIA) 50 Tests/kit98/79 Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 100 Tests/kit98/79 Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 25 Tests/kit98/79 Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 50 Tests/kit98/79 Multifunctional blood analyzer HEA-5000S3 réf. Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Mycoplasma Pheumonia IgM (MP IgM) Detection Kit(CLIA) 50 Tests/kit98/79 Norovirus type GI/GII Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Nucleic Acid Extraction or Purification Kit Bulk Type A: 48 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Bulk Type B: 48 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 20 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 32 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 36 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 40 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 48 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 64 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 96 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 20 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 32 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 36 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 40 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 48 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 64 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 96 reactions/ kit98/79 Respiratory Syncytial Virus IgM (RSV-IgM) Detection Kit(CLIA) 50 Tests/kit98/79 Rotavirus (group A/B/C) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 RSV FIA Kit 25 Tests/kit98/79 Salmonella IgM FIA Kit 25 Tests/kit98/79 Thrombin-Antithrombin Complex(TAT) Detection Kit(CLIA) 50 Tests/kit98/79 Tissue plasminogen activator-Plasminogen activator inhibitor Complex(t-PAIC) Detection Kit(CLIA) 50 Tests/kit98/79 Ureaplasma urealyticum (UU) and Neisseria Gonorrhoeae (NG) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 ZJ-B-2003 réf. α2-plasmininhibitor-Plasmin Complex(PIC) Detection Kit(CLIA) 50 Tests/kit98/79	A IVDR, 98/79	Site web sales@szzijian.com Fiche EUDAMED Signaler une erreur
Dirui FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas) et 1 autre	Chine	Activated Partial Thromboplastin Time Detection Kit (Coagulation Assay) APTTEllagic Acid Reagent: 10×2mL, Calcium Chloride Solution: 1×51mL98/79 Activated Partial Thromboplastin Time Detection Kit (Coagulation Assay) APTTEllagic Acid Reagent: 10×5mL, Calcium Chloride Solution: 1×51mL98/79 Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay)3 réf. Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay) R1: 2×5mL, R2: 1×2mL, R1 Reconstitution Fluid: 1×15mL, OVB Buffer: 1×51mL98/79 Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay) R1: 6×5mL, R2: 3×2mL, R1 Reconstitution Fluid: 1×35mL, OVB Buffer: 1×51mL98/79 133 autres Auto-Chemistry Analyzer CS-120098/79 Auto-Chemistry Analyzer CS-1300A98/79 Auto-Chemistry Analyzer CS-1300B98/79 Auto-Chemistry Analyzer CS-1400i3 réf. Auto-Chemistry Analyzer CS-160098/79 Auto-Chemistry Analyzer CS-200098/79 Auto-Chemistry Analyzer CS-2000i98/79 Auto-Chemistry Analyzer CS-300B98/79 Auto-Chemistry Analyzer CS-40098/79 Auto-Chemistry Analyzer CS-45098/79 Auto-Chemistry Analyzer CS-48098/79 Auto-Chemistry Analyzer CS-65098/79 Auto-Chemistry Analyzer CS-68098/79 Auto-Chemistry Analyzer CS-T18098/79 Auto-Chemistry Analyzer CS-T240Plus98/79 Automatic Hematology Analyzer BCC-360098/79 Automatic Hematology Analyzer BCC-390098/79 Automatic Hematology Analyzer BCC-396098/79 Automatic Hematology Analyzer BF-680098/79 Automatic Hematology Analyzer BF-690098/79 Automatic Hematology Analyzer BF-6900CRP98/79 Automatic Hematology Analyzer BF-6960CRP98/79 Automatic Hematology Systerm BF-720098/79 Automatic Hematology Systerm BF-7200PLus98/79 Automatic Hematology Systerm BF-760098/79 Automatic Hematology Systerm BF-7600PLus98/79 B-Z Cleanser3 réf. BCA-1000 Automatic Blood Coagulation Analyzer BCA-1000 BCA-30003 réf. BCC-3D Lyse 500mL BF-CRP Lyse 200mL BF-DS Diluent 20L BF-FBH Lyse 500mL BF-FDO Lyse 5L BF-FDOI Lyse 500mL, 5L BF-FDT Lyse 500mL BF-FDTI Lyse 200mL, 500mL BF-LD Lyse 500mL， 1L2 réf. BF-LH Lyse 100mL， 200mL2 réf. BF-SLS-I Lyse 500mL BF-SLS-II Lyse 2L BF-WFL Lyse 4L BF-WNL Lyse 4L BSP-800 Automated Hematology Smear Slide Processor2 réf. Calibrator for Automatic Hematology Analyzer (5-part) 2.5 mL98/79 CM-180 Chemiluminescence Immunoassay Analyzer CM-320 Chemiluminescence Immunoassay Analyzer CM-320i Chemiluminescence Immunoassay Analyzer Coagulation Analysis Multi-Calibrator3 réf. Coagulation Analysis Multi-Calibrator 10×1mL98/79 Coagulation Analysis Multi-Calibrator 1×1mL98/79 Coagulation Analysis Multi-Control3 réf. Coagulation Analysis Multi-Control level 1: 10×1mL98/79 Coagulation Analysis Multi-Control level 1: 1×1mL98/79 Coagulation Analysis Multi-Control level 2: 10×1mL98/79 Coagulation Analysis Multi-Control level 2: 1×1mL98/79 Control for Reticulocyte Level 1: 1×3.0mL98/79 Control for Reticulocyte Level 2: 1×3.0mL98/79 Control for Reticulocyte Level 3: 1×3.0mL98/79 CS-600B CS-650 CS-680 CS-12003 réf. D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)3 réf. D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL, Calibrator: 6×0.5mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL,Control: Low value 5×1mL, High value 5×1mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL,Diluent: 1×55mL,Control: Low value 5×1mL, High value 5×1mL, Calibrator: 6×0.5mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL, Calibrator: 6×0.5mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL, Control: Low value 5×1mL, High value 5×1mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL, Control: Low value 5×1mL, High value 5×1mL, Calibrator: 6×0.5mL98/79 DIRUI 1 biochemistry module + 1 immunoassay module + 1 sample unit +1ISE module+ 1 detergent proportioning module + 1 computer & cart98/79 DIRUI 1×100 test/kit R1:1×2mL; R2:1×2.5mL; R3:1×2.5mL Calibrator High value:1×1mL; Calibrator Low value:1×1mL Control Level 1:1×1mL Control Level 2: 1×1mL98/79 DIRUI 1×100 test/kit R1:1×4mL R2:1×5mL R3:1×9mL Calibrator High value:1×1mL; L Calibrator Low value:1×1mL Control Level 1: 1×1mL; Control Level 2: 1×1mL98/79 DIRUI Analytical module + Pre-storage tray + Connecting bridge + Reclaiming tray + Sample feeder + Computer98/79 DIRUI Analytical module + sample feeder + computer2 réf.98/79 DIRUI CAL1：1×0.5mL CAL2：1×0.5mL CAL3：1×0.5mL CAL4：1×0.5mL CAL5：1×0.5mL CAL6：1×0.5mL98/79 DIRUI High value:1×0.5mL; Low value:1×0.5mL2 réf.98/79 DR-7000D CS-T180 CS-T240 CS-T240Plus CS-300B CS-400 CS-4803 réf. FE Dye 1. Dye A: 1×50mL/bottle; Dye B: 1× 50mL/bottle 2. Dye A: 1×100mL/bottle, Dye B: 1×100mL/bottle 3. Dye A: 1×200mL/bottle, Dye B: 1×200mL/bottle 4. Dye A: 1×400mL/bottle, Dye B: 1×400mL/bottle 5. Dye A: 1×500mL/bottle, Dye B: 1×500mL/bottle2 réf. Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay)3 réf. Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL98/79 Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL, Control: Low value 5×1mL, High value 5×1mL, Calibrator: 6×0.5mL98/79 Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL98/79 Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL, Control: Low value 5×1mL, High value 5×1mL, Calibrator: 6×0.5mL98/79 Fibrinogen Detection Kit (Coagulation Assay)3 réf. Fibrinogen Detection Kit (Coagulation Assay) FIB Fluid Reagent: 10×10mL, OVB Buffer: 4×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Fluid Reagent: 10×2mL, OVB Buffer: 2×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Fluid Reagent: 10×5mL, OVB Buffer: 2×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Reagent: 10×2.2mL, FIB Reconstitution fluid: 1×30mL, FIB Buffer: 1×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Reagent: 10×5mL, FIB Reconstitution fluid: 1×51mL, FIB Buffer: 2×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Reagent: 10×5mL, FIB Reconstitution fluid: 1×51mL, FIB Buffer: 2×51mL, Calibrator: 1×1mL98/79 Fluorescent Calibrator 1×3.5mL98/79 H-100,H-500,HC-3003 réf. Human Interleukin-6 Detection Kit (Chemiluminescence Immunoassay) 1×100 Tests/kit98/79 Human Interleukin-6 Detection Kit (Chemiluminescence Immunoassay) 1×50 Tests/kit98/79 Human Interleukin-6 Detection Kit (Chemiluminescence Immunoassay) 2×50 Tests/kit98/79 Integrated System CSM-80002 réf.98/79 Integrated System CSM-900098/79 LA-60 Sample Processing System Lyse 500mL2 réf. Prothrombin Time Detection Kit (Coagulation Assay)6 réf. Prothrombin Time Detection Kit (Coagulation Assay) PT Fluid Reagent: 10×2 mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Fluid Reagent: 10×2 mL, Control Level 1: 1×1 mL, Control Level 2: 1×1 mL, Calibrator: 1×1 mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Fluid Reagent: 10×5 mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Fluid Reagent: 10×5 mL, Control Level 1: 1×1 mL, Control Level 2: 1×1 mL, Calibrator: 1×1 mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Reagent: 10×2.2mL, PT Reconstitution fluid: 1×30mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Reagent: 10×5mL, PT Reconstitution fluid: 1×51mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Reagent: 10×5mL, PT Reconstitution fluid: 1×51mL, Calibrator: 1×1mL98/79 R1: 2×5mL; R2: 1×2mL; OVB Buffer: 1×51 mL; Calibrator: 1×1mL; Control:1×1mL98/79 R1: 5×5mL; R2: 5×5mL; D-Dimer Diluent:1×50mL; Calibrator: 1×1mL; Control Low value:1×1mL; Control High value: 1×1mL98/79 R: 10×2.2mL; FIB Buffer: 1×51mL; FIB Reconstitution Fluid: 1×30mL; Calibrator: 1×1mL98/79 R: 10×2.2mL; PT Reconstitution Fluid: 1×30mL; Calibrator: 1×1mL98/79 R: 10×2.2mL; TT Reconstitution Fluid: 1×3098/79 Sample Diluent Blood Coagulation2 réf. Thrombin Time Detection Kit (Coagulation Assay)3 réf. Thrombin Time Detection Kit (Coagulation Assay) TT Fluid Reagent: 10×10mL98/79 Thrombin Time Detection Kit (Coagulation Assay) TT Fluid Reagent: 10×2mL98/79 Thrombin Time Detection Kit (Coagulation Assay) TT Fluid Reagent: 10×5mL98/79 Thrombin Time Detection Kit (Coagulation Assay) TT Reagent: 10×5mL, TT Reconstitution fluid: 1×51mL98/79 Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay) 1×100 Tests/kit98/79 Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay) 1×50 Tests/kit98/79 Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay) 2×50 Tests/kit98/79 UA Dye 100mL/bottle, 150mL/bottle2 réf. Urinalysis Hybrid FUS-100098/79 Urinalysis Hybrid FUS-200098/79 Urinalysis Hybrid FUS-3000Plus98/79 Urinalysis System MUS-360098/79 Urinalysis System MUS-960098/79 Urine Analyzer H-160098/79 Urine Analyzer H-180098/79 Urine Analyzer H-80098/79 Urine Sediment Analyzer FUS-10098/79 Urine Sediment Analyzer FUS-36098/79 Urine Sediment Analyzer FUS-56098/79 Vaginal Infections Analyzer GMD-S60098/79	A, B, C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
LGC Clinical Diagnostics FDA Mandataire UE : MediMark Europe Sarl. (France)	États-Unis	A1 Series 2400 2000-000198/79 A1 Series 2500 2000-000298/79 A1 Series 2700 2000-000598/79 A1 Series 4000 2000-000898/79 A1 Series 4400 2000-001098/79 127 autres A106 HIV-1 Ag 2015-006598/79 A106 HIV-1 Ag 2015-006698/79 A113 Anti-HBc IgM 2015-006898/79 A115 Anti-HBc IgG 2015-007098/79 A127 Anti-Delta 2015-007998/79 A21 Series 2000 CE 2000-003198/79 A325 Series 200 HBV DNA 2020-009698/79 A325 Series 700 HBV DNA 2020-009898/79 A51 Hepatitis Multi-Marker 2000-004098/79 A51 Hepatitis Multi-Marker 2000-004198/79 A52 Hepatitis Multi-Marker 2000-004398/79 Accurun 1 S8100 Positive Control 2000-002298/79 Accurun 1 Series 5100 positive control 2000-001698/79 Accurun 1 Series 5100 Positive Control 2000-001798/79 ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control 2015-007298/79 ACCURUN 120 Anti-HAV IgG 2015-007398/79 ACCURUN 121 HAV IgM Positive Control 2015-007498/79 ACCURUN 121 HAV IgM Positive Control 2015-007698/79 ACCURUN 125 Anti-HBs Positive Control 2015-007798/79 ACCURUN 125 Anti-HBs Positive Control 2015-007898/79 ACCURUN 130 Borrelia burgdorferi IgG Positive Control 2015-008098/79 ACCURUN 132 Borrelia burgdorferi IgM Positive Control 2015-008198/79 ACCURUN 135 Toxoplasma IgG Positive Control 2015-008298/79 ACCURUN 136 Toxoplasma IgM Positive Control 2015-008398/79 ACCURUN 140 Rubella IgG Positive Control 2015-008498/79 ACCURUN 141 Rubella IgM Positive Control 2015-008698/79 ACCURUN 145 CMV IgG Positive Control 2015-008798/79 ACCURUN 146 CMV IgM Positive Control 2015-008898/79 ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 2000 2015-009098/79 ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000 2015-009298/79 ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000 2015-009398/79 ACCURUN 156 Reagin (Syphilis) Positive Control 2015-009498/79 ACCURUN 190 Chagas Positive Control 2015-009798/79 Accurun 2 Series 2700 2000-002398/79 Accurun 2 Series 2700 2000-002498/79 ACCURUN 21 Multi-Marker control Series 1000 2000-0028 ACCURUN 25 ToRCH IgG Positive Control S2000 2000-007498/79 ACCURUN 25 ToRCH IgG Positive Control S5000 2000-003498/79 ACCURUN 26 ToRC IgM Positive Control Series 5000 2000-003598/79 ACCURUN 30 EBV IgG Positive Control 2000-003798/79 ACCURUN 305 Series 100 HCV RNA 2020-008098/79 ACCURUN 305 Series 150 HCV RNA Positive Control 2020-007898/79 ACCURUN 305 Series 300 HCV RNA 2020-008398/79 ACCURUN 305 Series 400 HCV RNA 2020-008598/79 ACCURUN 31 EBV IgM Positive Control 2000-003898/79 ACCURUN 315 HIV-1 RNA Positive Quality Control Series 500 2020-009398/79 ACCURUN 315 Series 150 HIV-1 RNA 2020-008798/79 ACCURUN 315 Series 200 HIV-1 RNA 2020-009098/79 ACCURUN 315 Series 400 HIV-1 RNA 2020-009298/79 ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100 2025-006798/79 ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 700 2025-006898/79 ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 2020-010498/79 ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 2020-010598/79 ACCURUN 372 HPV DNA Positive Control Series 400 2025-003798/79 ACCURUN 372 HPV DNA Positive Control Series 600 2025-004198/79 ACCURUN 378 HPV DNA Positive Control Series 5000 2025-004398/79 ACCURUN 381 HPV Type 16 and 18 mRNA Positive Control 2025-006098/79 ACCURUN 501 C. difficile Control 2050-000898/79 ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000 2000-006298/79 ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000 2000-006798/79 ACCURUN 841 CT/NG Negative Control 2025-006198/79 ACCURUN 872 HPV DNA Negative Control 2035-000998/79 ACCURUN 873 HPV DNA Negative Control 2035-000598/79 ACCURUN Anti-SARS-CoV-2 IgM Controls Kit 2015-023298/79 ACCURUN Anti-SARS-CoV-2 Series 1000 2015-022298/79 ACCURUN Anti-SARS-CoV-2 Series 2000 2015-022598/79 ACCURUN BKV Positive Control 2020-0209 ACCURUN EBV Positive Control 2020-0210 ACCURUN117 Hepatitis B e Antigen Positive Control 2015-007198/79 ACCURUN® 2 Multi-Marker Positive Control Series 2900 2000-0080 ACCURUN® 350 CMV DNA Positive Control 2020-0162 ACCURUN® Babesia Positive Molecular Control Kit 2020-0155 ACCURUN® TV/MG Positive Molecular Control Kit 2020-0164 Multichem ID HAV IgM Positive Control Multichem ID Rubella IgM Positive Control 2015-024098/79 Multichem ID ToRC IgM Positive Control 2000-010298/79 Multichem ID ToRCH IgG Positive Control 2000-010198/79 Optitrol Blue SR11011 Optitrol Blue SR11013 Optitrol Blue SR11019 Optitrol Chagas-1, 1x pos, 1mL SR160252 réf. Optitrol Chagas-2, 1x pos, 1mL SR160352 réf. Optitrol HEPA-1, 1x pos, 1mL SR120252 réf. Optitrol HEPA-2, 1x pos, 1mL SR120352 réf. Optitrol HEPR-1 SR120472 réf. Optitrol HEPR-2, 1x pos, 1mL SR120572 réf. Optitrol HIV 2, 1x pos, 1mL SR111133 réf. Optitrol HIV p24, 1x pos,1mL SR111013 réf. Optitrol HSV 2 SR130372 réf. Optitrol Lyme/TBE G SR170183 réf. Optitrol Lyme/TBE M SR170283 réf. Optitrol Malaria SR160172 réf. Optitrol Measles M SR150453 réf. Optitrol Mumps M, 1x pos, 1mL SR150653 réf. Optitrol NAT CMV, 10x 1.2 mL NT020212 réf. Optitrol NAT CT/NG, 10x 1.2 mL NT020112 réf. Optitrol NAT HAV, 10x 1.2 mL NT050112 réf. Optitrol NAT HBV Screening, 10x 1,2 mL NT010112 réf. Optitrol NAT HBV Viral Load, 10x 1.2 mL NT010132 réf. Optitrol NAT HCV Screening, 10x 1,2 mL NT010212 réf. Optitrol NAT HCV Viral Load, 10x 1.2 mL NT010232 réf. Optitrol NAT HEV, 10x 1.2 mL NT011212 réf. Optitrol NAT HIV Screening, 10x 1,2 mL NT010312 réf. Optitrol NAT HIV Viral Load, 5x 1.2 mL NT01033 Optitrol NAT HIV-2, 10x 1,2 mL NT010352 réf. Optitrol NAT HPV neg, 10x 1.2 mL NT060132 réf. Optitrol NAT HPV, 10x 1.2 mL NT060112 réf. Optitrol NAT NEG, 10x 1,2 mL NT010512 réf. Optitrol NAT Parvo B19, 10x 1,2 mL NT050212 réf. Optitrol NAT Triplex, 10x 1,2 mL NT010412 réf. Optitrol Orange, 1x pos, 1mL SR110613 réf. Optitrol Paediatric G negative, 2x neg, 2,5mL SR150253 réf. Optitrol Paediatric G Pos SR150152 réf. Optitrol Paediatric M Neg SR150032 réf. Optitrol Parvo M SR150573 réf. Optitrol Red, 1x pos, 1mL SR110513 réf. Optitrol SeroNeg, 2x neg, 1mL SR110003 réf. Optitrol Syphilis G SR111372 réf. Optitrol ToRCH G Neg SR130193 réf. Optitrol ToRCH M Neg SR130293 réf. Optitrol VZV M SR150783 réf. Optitrol Yellow 4x5 mL SR110213 réf. VALIDATE® Anti-SARS-CoV2 IgG Test Set 510mm98/79 VALIDATE® HbA1c Test Set 60598/79 VALIDATE® HbA1c Test Set 605sa98/79 VALIDATE® HbA1c Test Set 605to98/79 VALIDATE® IL-6 Test Set 509ro98/79	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Mindray FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Activated Partial Thromboplastin Time (APTT) Assay Kit (Clotting Method) 105-023616-00、105-023617-00、105-023618-003 réf. Anti-HAV Control 105-038862-00, 105-038863-00, 105-045982-00, 105-045981-00, 105-045980-00, 105-045979-003 réf. Anti-Thyrotropin Receptor Antibody (CLIA) 105-010975-00/105-010976-00/105-010214-00/105-020852-00 Antithrombin III (AT Ⅲ) Assay Kit (Chromogenic Substrate Method) 105-023634-00、105-023635-00、105-023636-00、105-023637-00、105-023640-00、105-023641-003 réf. Auto Coagulation Analyzer BC-5000、BC-5120、BC-5130、BC-5140、BC-5150、Unicorn 5、Counter 29、Mispa CountZ3 réf. 122 autres Auto Coagulation Analyzer CX-2000 Auto Coagulation Analyzer CX-3000 Auto Coagulation Analyzer CX-6000、CX-6010、CX-6200、CX-62103 réf. Auto Coagulation Analyzer CX-9000、CX-9010、CX-9200、CX-92103 réf. Auto Hematology Analyzer BC-5310 CRP、BC-5100 CRP2 réf. Auto Hematology Analyzer BC-5380、BC-51802 réf. Auto Hematology Analyzer BC-5390 CRP、BC-5180 CRP2 réf. Auto Hematology Analyzer BC-5390, Counter 31 AL2 réf. Auto Hematology Analyzer BC-6000、BC-6000Plus、BC-6200、BC-6100、BC-6100Plus、Counter 60 AL3 réf. Auto Hematology Analyzer BC-6600Plus、BC-6700Plus、BC-6800Plus3 réf. Auto Hematology Analyzer BC-700[B]、BC-700[R]、BC-720[R]、BC-760[B], BC-760[R], BC-780[R]3 réf. Auto Hematology Analyzer BC-7500[B] CRP、BC-7500[N] CRP、BC-7500[R] CRP、BC-7500[NR] CRP、BC-7300[B] CRP、BC-7300[N] CRP、BC-7300[R] CRP、BC-7300[NR] CRP、BC-7500[B] CS、BC-7500[N] CS、BC-7500[R] CS、BC-7500[NR] CS3 réf. Auto Hematology Analyzer BC-7600, BC-7800, BC-79003 réf. Auto Hematology Analyzer BC-760[B]98/79 Auto Hematology Analyzer BC-760[R]98/79 Auto Hematology Analyzer Please see UDI-DI for details6 réf. Auto Slide Maker & Stainer SC-120 Auto Specific Protein and ESR Analyzer BP 200n、BP 260n2 réf. Automated Blood Culture System FA-M400 Automated Blood Culture System FA-N60、FA-N120、FA-N2403 réf. Automated Digital Cell Morphology Analyzer MC-30, MC-322 réf. Automated Dosing System AP-100 Automated Glycohemoglobin Analyzer H-120, H-120P2 réf. Automated Glycohemoglobin Analyzer H50、H50P2 réf. Automatic Dry Chemistry Urine Analyzer UA-5600 Automatic Urinalysis System EU-5600pro2 réf. B30 Hematology Control BR60 Hematology Control，SC-CAL RET Hematology Calibrator3 réf. B30 HEMATOLOGY CONTROLS 0031-30-6072498/79 B30 HEMATOLOGY CONTROLS 0031-30-6072598/79 B30 HEMATOLOGY CONTROLS 0031-30-6072698/79 B30 HEMATOLOGY CONTROLS 0031-30-6072798/79 B30 HEMATOLOGY CONTROLS 0031-30-6072998/79 B30 HEMATOLOGY CONTROLS 0031-30-6073098/79 B30 HEMATOLOGY CONTROLS 0031-30-6073198/79 B55 HEMATOLOGY CONTROLS 105-000124-0098/79 B55 HEMATOLOGY CONTROLS 105-000125-0098/79 B55 HEMATOLOGY CONTROLS 105-000126-0098/79 B55 HEMATOLOGY CONTROLS 105-011161-0098/79 B55 HEMATOLOGY CONTROLS 105-011193-0098/79 B55 HEMATOLOGY CONTROLS 105-011195-0098/79 BC-3D Hematology Control Please see UDI-DI for details3 réf. BC-5D Hematology Control Please see UDI-DI for details3 réf. BC-RET Hematology Control Please see UDI-DI for details3 réf. BR60 Hematology Contro 105-018565-00、105-018566-002 réf. BR60 Hematology Control 105-009064-0098/79 BR60 Hematology Control 105-009068-0098/79 BR60 Hematology Control 105-009072-0098/79 BR60 Hematology Control 105-009073-0098/79 BR60 Hematology Control 105-009074-0098/79 CD3-FITC/CD16+56-PE/CD45-PerCP/CD19-APC Reagent 105-005725-0098/79 CD3-FITC/CD16+56-PE/CD45-PerCP/CD19-APC Reagent 105-035114-00 CD3-FITC/CD8-PE/CD45-PerCP/CD4-APC Reagent 105-035033-00 Chemiluminescence Immunoassay Analyzer CL-2600i、CL-2800i3 réf. Chemiluminescence Immunoassay Analyzer CL-9000i/CL-9200i2 réf. Chemiluminescence Immunoassay Analyzer Please see UDI-DI for detail11 réf. Chemistry Analyzer BS-1000M、BS-1100M3 réf. Chemistry Analyzer BS-5000,BS-5200,BS-5400,BS-5600,BS-4200,BS-40003 réf. Chemistry Analyzer Please see UDI-DI for detail42 réf. CL-8000i、CL-8200i2 réf. Clean Solution 105-023651-00 Cleaning Solution B 105-056286-00 Coagulation Control 105-023642-00、105-023643-002 réf. Concentrated Reagent Delivery System CR-30[H] CRP Cleanser 105-004887-00、105-011300-002 réf. Cytomegalovirus IgG (CLIA) 105-012536-00, 105-012537-00, 105-012539-00, 105-012540-003 réf. Cytomegalovirus IgM (CLIA) 105-012542-00, 105-012543-00, 105-012545-00, 105-012546-003 réf. D-Dimer (CLIA) 105-046778-00, 105-046779-003 réf. D-Dimer Assay Kit (Immunoturbidimetry Method) 105-023628-00、105-023629-00、105-023630-00、105-023647-00、105-024608-00、105-024609-00、105-024610-003 réf. DCT DILUENT 105-020869-00/105-020868-00/105-020867-003 réf. DS DILUENT Please see UDI-DIs for details.3 réf. ESR Solution Reagent Please see UDI-DIs for details2 réf. EU-20 Diluent 105-039328-00 EU-70 Diluent 105-035270-00 Fibrin(ogen) Degradation Products (FDP) Assay Kit (lmmunoturbidimetry Method) 105-023631-00、105-023632-00、105-023633-00、105-023648-00、105-023644-00、105-023645-00、105-023646-003 réf. Fibrinogen (FIB) Assay Kit (Clotting Method) 105-023622-00、105-023623-00、105-023624-00、105-023625-00、105-023626-00、105-023627-003 réf. HAV IgM and HEV IgM Multi Control 105-043944-00, 105-043943-00, 105-043942-00, 105-043941-003 réf. HBsAg121, HBsAg1223 réf. HCY Control 105-009174-00、105-009175-00、105-009176-00、105-009194-003 réf. Hepatitis A Virus IgM Antibody (CLIA) 105-038860-00, 105-038861-002 réf. Hepatitis E Virus IgM Antibody (CLIA) 105-038866-00, 105-038867-002 réf. Herpes Simplex Virus 1+2 IgG（CLIA） 105-012494-00、105-012495-00、105-012497-00、105-012498-003 réf. Herpes Simplex Virus 1+2 IgM（CLIA） 105-012488-00、105-012489-00、105-012491-00、105-012492-003 réf. Herpes Simplex Virus-1 IgG（CLIA） 105-012500-00、105-012501-00、105-012503-00、105-012504-003 réf. Herpes Simplex Virus-2 IgG（CLIA） 105-012506-00 、105-012507-00、105-012509-00、105-012510-003 réf. HEV IgG Control 105-038864-00, 105-038865-00, 105-045978-00, 105-045977-00, 105-045975-00, 105-045976-003 réf. HLA-B27 Reagent 105-005727-0098/79 HLA-B27 Reagent 105-034921-00 Laboratory Automation System AQC-100 Laboratory Automation System MT 8000 Laboratory Automation System MT 8000S LS LYSE 105-023579-00、105-023578-002 réf. M-10CFL LYSE Please see UDI-DIs for details.3 réf. M-18E E-Z CLEANSER Please see UDI-DIs for details.3 réf. M-52D DILUENT Please see UDI-DIs for details3 réf. M-6FM DYE Please see UDI-DI for details3 réf. Microplate Reader Please see UDI-DI for detail2 réf. Prothrombin Time (PT) Assay Kit (Clotting Method) 105-023613-00、105-023614-00、105-023615-003 réf. Rubella Virus IgG (CLIA) 105-012518-00, 105-012519-00, 105-012521-00, 105-012522-003 réf. Rubella Virus IgM (CLIA) 105-012512-00, 105-012513-00, 105-012515-00, 105-012516-003 réf. S30 CALIBRATOR 0031-30-6073298/79 S30 CALIBRATOR 0031-30-6073398/79 S50 Calibrator 0031-30-8452598/79 S50 Calibrator 0031-30-8452698/79 Sample Diluent 105-024613-00 Sample Diluent 105-024614-00 Sample Processing System CAL 8000、CAL 60002 réf. Sample Processing System CAL 9000, CAL 7000, CAL 7000E3 réf. Sample Processing System EU 86002 réf. Sample Processing System Please see UDI-DI for detail3 réf. Sample Processing System TM-1000 Specific Protein Analyzer Please see UDI-DI for detail TDR-X060\TDR-X120\TDR-X120II\TDR-X240\TDR-X3603 réf. Thrombin Time (TT) Assay Kit (Clotting Method) 105-023619-00、105-023620-00、105-023621-003 réf. ToRCH IgG Positive Control 105-024832-00、105-024833-00、105-024834-00、105-024835-003 réf. ToRCH IgG/IgM Negative Control 105-024824-00、105-024825-00、105-024826-00、105-024827-003 réf. ToRCH IgM Positive Control 105-024840-00、105-024841-00、105-024842-00、105-024843-003 réf. Toxo IgG Avidity Control 105-029863-00、105-029867-00、105-029872-00、105-029873-00、105-029874-00、105-029875-00、105-029876-00、105-029877-00、105-029878-00、105-029879-003 réf. Toxoplasma gondii IgG (CLIA) 105-012524-00, 105-012525-00, 105-012527-00, 105-012528-003 réf. Toxoplasma gondii IgM (CLIA) 105-012530-00, 105-012531-00, 105-012533-00, 105-012534-003 réf. Urine Analyzer Please see UDI-DI for detail3 réf. Urine Analyzer UA-610T Urine Formed Element Analyzer EH-2090B、EH-2090C、EH-2090B PRO、EH-2090C PRO	A, B, C, D IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Biobase FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	5-Part Auto Hematology Analyzer Activated Partial Thromboplastin Time (APTT) Test kit (Coagulation) Reagent:2mL×10,CaCl2:25mL×1（501004）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Quality control plasma(abnormal):0.5mL×1（521014）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Quality control plasma(abnormal):1.0mL×1（521016）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Quality control plasma(normal):0.5mL×1（521013）98/79 118 autres Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Quality control plasma(normal):1.0mL×1（521015）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Reagent:2.5mL×10,CaCl2:30mL×1（502004）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Reagent:4mL×10,CaCl2:45mL×1（503004）98/79 Auto ESR Analyzer BK-ESR203 réf. Auto Hematology Analyzer BS010 Automated Blood Culture System BK-BC series3 réf. Automated Liquid Handler BK-ASP48，BK-ASP48P，BK-ASP96, etc.3 réf. Automated Sample Processing System BS0032 réf. Automatic Chemistry Analyzer BK-20003 réf. Automatic Chemistry Analyzer Spin XS， Spin XL ， Spin XT2 réf. Automatic Nucleic Acid Extraction System BK-HS32mini3 réf. Biobase COVID-19 Antigen Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Biobase COVID-19 Antigen Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79 Biological Safety Cabinet 11231BBC86-Pro3 réf. Biological Safety Cabinet 11234 BBC 863 réf. Blood Coagulation Analyzer BS011 Centrifuge BKC-AU5BT3 réf. Combined Detection Kit For Influenza A/B (Colloidal Gold) 20 tests / kit98/79 Combined Detection Kit For Influenza A/B (Colloidal Gold) 25 tests / kit98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) Calibrator：1mL×1(91134)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) Quality Control：1mL×2(92146)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×1 R2:6mL×1(702)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4(709)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（707）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（710）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（796）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:40mL×3 R2:20mL×2（704）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:32mL×1（792）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:32mL×1（793）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2(705)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2(713)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2（715）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2（716）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2（791）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2（798）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×1 R2:20mL×1（703）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2(701)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（706）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（794）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×6 R2:60mL×2（795）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:90mL×1 R2:30mL×1(708)98/79 Dengue Rapid Test Kit（Colloidal Gold） 20 tests / kit98/79 Dengue Rapid Test Kit（Colloidal Gold） 25 tests / kit98/79 Electrolyte Analyzer BS006 Elisa Microplate Reader3 réf. Elisa Plate Reader DIA2000 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) Calibrator：1mL×1(91036)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) Quality Control：1mL×1(92031)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×1 R2:6mL×1(702)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4(707)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4(709)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（710）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（796）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:40ml×3 R2:20ml×2（704）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（705）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（713）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（715）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（716）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（791）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（793）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（798）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:32ml×1（792）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60ml ×1 R2:20ml×1（703）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2(701)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（706）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（794）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60ml×6 R2:60ml×2（795）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:90ml×1 R2:30ml×1（708）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Calibration plasma: 0.5mL×1（511001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Calibration plasma: 1.0mL×1（511002）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried： Reagent:2.5mL×5, Diluent:50mL×2（502001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried：Reagent:1mL×10,Diluent:50mL×2（503001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried：Reagent:2mL×5, Diluent:50mL×2（501001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (abnormal): 0.5mL×1（521002）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (abnormal): 1.0mL×1（521004）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (normal): 0.5mL×1（521001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (normal): 1.0mL×1（521003）98/79 Fluorescence Immunoassay Analyzer BKP1000，BKP2000, BKP30003 réf. Freezer BDF-86V608T Fume Hood XBX005 Helicobacter Pylori Antibody Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Helicobacter Pylori Antibody Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79 Helicobacter pylori antigen Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Helicobacter pylori antigen Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79 Hematology Analyzer Diluent3 réf. Hematology Analyzer Diluent 10×SFL-1 2L（10106）98/79 Hematology Analyzer Diluent 10×WFL-2 2L（15004）98/79 Hematology Analyzer Diluent SFL-1 10L（10201）98/79 Hematology Analyzer Lyse3 réf. Hematology Analyzer Lyse WFL-DIFF 250mL（15006）98/79 Hematology Analyzer Lyse WFL-LH 200mL（15202）98/79 Hematology Analyzer Lyse WFL-LH 250mL（15002）98/79 Laboratory Refrigerator BPR-5V1008F3 réf. Laminar Flow Cabinet XBX004 Malaria P.Falciparum/P.Vivax Rapid Test Kit（Colloidal Gold） 20 tests / kit98/79 Malaria P.Falciparum/P.Vivax Rapid Test Kit（Colloidal Gold） 25 tests / kit98/79 Medical Centrifuge BKC-DL6C3 réf. Nucleic Acid Extraction Kit II (Magnetic Beads Method) KY002 Nucleic Acid Extraction Kit (Magnetic Beads Method) 16 tests / box（121001）3 réf. Portable Fluorescence Immunoassay Analyzer BKP500, BKP600, etc. Prothrombin Time (PT) Test Kit (Coagulation) Freeze-dried：Reagent:2.5mL×10,Reconstitution solution:30mL×1（502003）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Freeze-dried：Reagent:2mL×10,Reconstitution solution:25mL×1（502003）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Freeze-dried：Reagent:4mL×10,Reconstitution solution:45mL×1（503003）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Quality control plasma (abnormal): 0.5mL×1（521010）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Quality control plasma (abnormal): 1.0mL×1（521012）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Quality control plasma (normal): 0.5mL×1（521009）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Quality control plasma (normal): 1.0mL×1（521011）98/79 Respiratory syncytial virus Antigen Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Respiratory syncytial virus Antigen Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79 Semi-auto Chemistry Analyzer Biobase-Silver2 réf. Thrombin Time (TT) Test Kit (Coagulation) Freeze-dried：Reagent 2.5mL×10, Reconstitution solution 30mL×1（502002）98/79 Thrombin Time (TT) Test Kit (Coagulation) Freeze-dried：Reagent 2mL×10, Reconstitution solution 25mL×1（501002）98/79 Thrombin Time (TT) Test Kit (Coagulation) Freeze-dried：Reagent 4mL×10, Reconstitution solution 45mL×1（503002）98/79 Thrombin Time (TT) Test Kit (Coagulation) Quality control plasma (abnormal): 0.5mL×1（521006）98/79 Thrombin Time (TT) Test Kit (Coagulation) Quality control plasma (abnormal): 1.0mL×1（521008）98/79 Thrombin Time (TT) Test Kit (Coagulation) Quality control plasma (normal): 0.5mL×1（521005）98/79 Thrombin Time (TT) Test Kit (Coagulation) Quality control plasma (normal): 1.0mL×1（521007）98/79 Urine Analyzer BS017	I, A IVDR, MDR, 98/79	Fiche EUDAMED Signaler une erreur
Hangzhou Laihe Biotech FDA Mandataire UE : Medunion S.L. (Espagne) et 1 autre	Chine	303034-0198/79 303034-0598/79 303034-4098/79 303057; 3030582 réf.98/79 303059; 303060; 30306198/79 117 autres BIOSYNEX 86079398/79 Cassette IGC-525 Cassette IGO-502 Chlamydia Antigen Rapid Test Kit Cassette ICH-502 ICD-502N-0198/79 ICD-502N-0298/79 ICD-502N-0598/79 ICD-502N-0798/79 ICD-502N-2098/79 ICD-502N-2598/79 ICD-502N-4098/79 IEB-402-0198/79 IEB-402-0298/79 IEB-402-0598/79 IEB-402-0798/79 IEB-402-2098/79 IEB-402-2598/79 IEB-402-4098/79 IHAV-402-0198/79 IHAV-402-0298/79 IHAV-402-0598/79 IHAV-402-0798/79 IHAV-402-2098/79 IHAV-402-2598/79 IHAV-402-4098/79 IHEV-402-0198/79 IHEV-402-0298/79 IHEV-402-0598/79 IHEV-402-0798/79 IHEV-402-2098/79 IHEV-402-2598/79 IHEV-402-4098/79 IHPV-502-0198/79 IHPV-502-0298/79 IHPV-502-0598/79 IHPV-502-0798/79 IHPV-502-2098/79 IHPV-502-2598/79 IHPV-502-4098/79 IHSV-402-0198/79 IHSV-402-0298/79 IHSV-402-0598/79 IHSV-402-0798/79 IHSV-402-2098/79 IHSV-402-2598/79 IHSV-402-4098/79 ILEP-402-0198/79 ILEP-402-0298/79 ILEP-402-0598/79 ILEP-402-0798/79 ILEP-402-2098/79 ILEP-402-2598/79 ILEP-402-4098/79 ILYM-402-4098/79 LYHER 303021901 LYHER 3030340023 réf. LYHER 303034701-01;303034701-05;303034701-20;303034701-25;303034701-403 réf. LYHER 3030348013 réf. LYHER 3030419013 réf. LYHER 303045201-01;303045201-05;303045201-20;303045201-25;303045201-403 réf. LYHER ICO-502-01; ICO-502-05; ICO-502-20; ICO-502-25; ICO-502-403 réf. LYHER IDE-425-01; IDE-425-05; IDE-425-20; IDE-425-25; IDE-425-403 réf. LYHER IDE-A402-01; IDE-A402-05; IDE-A402-20; IDE-A402-25; IDE-A402-403 réf. LYHER IDE-B402-01; IDE-B402-05; IDE-B402-20; IDE-B402-25; IDE-B402-403 réf. LYHER IFL-5022 réf. LYHER IFL-A5022 réf. LYHER IHP-4022 réf. LYHER IHP-402X-0198/79 LYHER IHP-402X-0298/79 LYHER IHP-402X-0598/79 LYHER IHP-402X-0798/79 LYHER IHP-402X-2098/79 LYHER IHP-402X-2598/79 LYHER IHP-402X-4098/79 LYHER IHP-6022 réf. LYHER ILYM-402-0198/79 LYHER ILYM-402-0298/79 LYHER ILYM-402-0598/79 LYHER ILYM-402-0798/79 LYHER ILYM-402-2098/79 LYHER ILYM-402-2598/79 LYHER IMA-402-0198/79 LYHER IMA-402-0298/79 LYHER IMA-402-0598/79 LYHER IMA-402-0798/79 LYHER IMA-402-2098/79 LYHER IMA-402-2598/79 LYHER IMA-402-4098/79 LYHER IMPXVAB-502-0198/79 LYHER IMPXVAB-502-0598/79 LYHER IMPXVAB-502-2098/79 LYHER IMPXVAB-502-2598/79 LYHER IMPXVAB-502-4098/79 LYHER IMPXVAG-502-0198/79 LYHER IMPXVAG-502-0598/79 LYHER IMPXVAG-502-2098/79 LYHER IMPXVAG-502-2598/79 LYHER IMPXVAG-502-4098/79 LYHER IRS-5022 réf. LYHER IRS-582-0198/79 LYHER IRS-582-0298/79 LYHER IRS-582-0598/79 LYHER IRS-582-0798/79 LYHER IRS-582-2098/79 LYHER IRS-582-2598/79 LYHER IRS-582-4098/79 LYHER ISA-502-0198/79 LYHER ISA-502-0298/79 LYHER ISA-502-0598/79 LYHER ISA-502-0798/79 LYHER ISA-502-2098/79 LYHER ISA-502-2598/79 LYHER ISA-502-4098/79 LYHER ISY-401-01;ISY-401-05; ISY-401-20; ISY-401-25; ISY-401-403 réf. LYHER ISY-402-01; ISY-402-05; ISY-402-20; ISY-402-25; ISY-402-403 réf. Malaria Antigen Test Kit98/79 Respiratory Multiple Rapid Test98/79	B, C IVDR, 98/79	Présent sur le marché en France office@lyher.com Fiche EUDAMED Signaler une erreur
AusDiagnostics Mandataire UE : Advena Limited (Malte) et 1 autre	Australie	Demi DNA Reagent Cassette3 réf. Extraction Control HighPlex Ascend System3 réf. MT-Prep 24 System3 réf. MT-Prep Blood DNA Extraction kit 1200 (48 samples)3 réf. 115 autres Respiratory Pathogens 12-well98/79 Respiratory Pathogens 12-well 80618P98/79 RIDA®Plex Atypical Pneumonia 8 well Step 198/79 RIDA®Plex Atypical Pneumonia 8 well Step 298/79 RIDA®Plex CSF 16 well Step 198/79 RIDA®Plex CSF 16 well Step 298/79 RIDA®Plex Enteric Viruses 8 well Step 198/79 RIDA®Plex Enteric Viruses 8 well Step 298/79 RIDA®Plex Faecal Bacteria and Parasites 12 well Step 198/79 RIDA®Plex Faecal Bacteria and Parasites 12 well Step 298/79 RIDA®Plex Faecal Pathogens A 16 well Step 198/79 RIDA®Plex Faecal Pathogens A 16 well Step 298/79 RIDA®Plex Faecal Pathogens B 16 well Step 198/79 RIDA®Plex Faecal Pathogens B 16 well Step 298/79 RIDA®Plex Faecal Pathogens M 16 well Step 198/79 RIDA®Plex Faecal Pathogens M 16 well Step 298/79 RIDA®Plex Parasites 8 well Step 198/79 RIDA®Plex Parasites 8 well Step 298/79 RIDA®Plex Pneumonia 16 well Step 198/79 RIDA®Plex Pneumonia 16 well Step 298/79 RIDA®Plex Positive Control Bacteria and Resistances98/79 RIDA®Plex Positive Control CSF98/79 RIDA®Plex Positive Control Faecal Pathogens98/79 RIDA®Plex Positive Control Fungal Panels98/79 RIDA®Plex Positive Control Pneumonia98/79 RIDA®Plex Positive Control Respiratory Pathogens98/79 RIDA®Plex Positive Control STIs and Herpes98/79 RIDA®Plex Respiratory Pathogens 12 well Step 198/79 RIDA®Plex Respiratory Pathogens 12 well Step 298/79 RIDA®Plex Respiratory Pathogens 16 well Step 198/79 RIDA®Plex Respiratory Pathogens 16 well Step 298/79 RIDA®Plex Respiratory Pathogens 24 well Step 198/79 RIDA®Plex Respiratory Pathogens 24 well Step 298/79 RIDA®Plex Respiratory Pathogens B 16 well Step 198/79 RIDA®Plex Respiratory Pathogens B 16 well Step 298/79 RIDA®Plex Respiratory Pathogens C 16 well Step 198/79 RIDA®Plex Respiratory Pathogens C 16 well Step 298/79 RIDA®Plex Respiratory Viruses 16 well Step 198/79 RIDA®Plex Respiratory Viruses 16 well Step 298/79 RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well Step 198/79 RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well Step 298/79 RIDA®Plex Staphylococcus and VRE 8 well Step 198/79 RIDA®Plex Staphylococcus and VRE 8 well Step 298/79 RIDA®Plex Staphylococcus Typing 8 well Step 198/79 RIDA®Plex Staphylococcus Typing 8 well Step 298/79 RIDA®Plex STI 16 well Step 198/79 RIDA®Plex STI 16 well Step 298/79 RIDA®Plex Upper Respiratory Pathogens 16 well Step 198/79 RIDA®Plex Upper Respiratory Pathogens 16 well Step 298/79 RIDA®Plex Urinogenital 8 well Step 198/79 RIDA®Plex Urinogenital 8 well Step 298/79 RIDA®Plex Urinogenital and Resistance 12 well Step 12 réf.98/79 RIDA®Plex Urinogenital and Resistance 12 well Step 22 réf.98/79 RIDA®Plex Vaginitis and Vaginosis 12 well Step 198/79 RIDA®Plex Vaginitis and Vaginosis 12 well Step 298/79 RIDA®Plex Vaginitis and Vaginosis 8 well Step 198/79 RIDA®Plex Vaginitis and Vaginosis 8 well Step 298/79 RIDA®Prep Tissue Digestion Kit Step 1 tubes for Atypical Pneumonia (8-well)98/79 Step 1 tubes for CSF 16-well98/79 Step 1 tubes for Enteric Viruses 8-well98/79 Step 1 tubes for Faecal Bacteria and Parasites 12-well98/79 Step 1 tubes for Faecal Pathogens A 16-well98/79 Step 1 tubes for Faecal Pathogens B 16-well98/79 Step 1 tubes for Faecal Pathogens M 16-well98/79 Step 1 tubes for High Risk HPV Genotyping 8-well98/79 Step 1 tubes for Parasites 8-well98/79 Step 1 tubes for Pneumonia (16-well)98/79 Step 1 tubes for Respiratory Pathogens 16-well98/79 Step 1 tubes for Respiratory Pathogens 24-well98/79 Step 1 tubes for Respiratory Pathogens B 16-well98/79 Step 1 tubes for Respiratory Pathogens C 16-well98/79 Step 1 tubes for Respiratory Viruses (16-well)98/79 Step 1 tubes for SARS-CoV-2, Influenza and RSV 8-well98/79 Step 1 tubes for Staphylococcus + VRE 8-well98/79 Step 1 tubes for Staphylococcus typing 8-well98/79 Step 1 tubes for STI (16-well)98/79 Step 1 tubes for Upper Respiratory Pathogens 16-well98/79 Step 1 tubes for Urinogenital (8-well)98/79 Step 1 tubes for Urinogenital and Resistance 12 well2 réf.98/79 Step 1 tubes for Vaginitis and vaginosis 12-well98/79 Step 1 tubes for Vaginitis and vaginosis 8-well98/79 Step 2 Plates for Atypical Pneumonia 8-well98/79 Step 2 Plates for CSF 16-well98/79 Step 2 Plates for Enteric Viruses 8-well98/79 Step 2 Plates for Faecal Bacteria and Parasites 12-well98/79 Step 2 Plates for Faecal Pathogens A 16-well98/79 Step 2 Plates for Faecal Pathogens B 16-well98/79 Step 2 Plates for Faecal Pathogens M 16-well98/79 Step 2 Plates for High Risk HPV Genotyping 8-well98/79 Step 2 Plates for Parasites 8-well98/79 Step 2 Plates for Pneumonia (16-well)98/79 Step 2 Plates for Respiratory Pathogens 16-well98/79 Step 2 Plates for Respiratory Pathogens 24-well98/79 Step 2 Plates for Respiratory Pathogens B 16-well98/79 Step 2 Plates for Respiratory Pathogens C 16-well98/79 Step 2 Plates for Respiratory Viruses (16-well)98/79 Step 2 Plates for SARS-CoV-2, Influenza and RSV 8-well98/79 Step 2 Plates for Staphylococcus + VRE 8-well98/79 Step 2 Plates for Staphylococcus typing 8-well98/79 Step 2 Plates for STI (16-well)98/79 Step 2 Plates for Upper Respiratory Pathogens 16-well98/79 Step 2 Plates for Urinogenital (8-well)98/79 Step 2 Plates for Urinogenital and Resistance 12 well Multiple sexually transmitted pathogen (Annex II) nucleic acid IVD, reagent98/79 Step 2 Plates for Urinogenital and Resistance 12-well98/79 Step 2 Plates for Vaginitis and vaginosis 12-well98/79 Step 2 Plates for Vaginitis and vaginosis 8-well98/79 Synthetic Positive Controls for Atypical Pneumonia98/79 Synthetic Positive Controls for Bacteria and Bacterial Resistance98/79 Synthetic Positive Controls for CSF98/79 Synthetic Positive Controls for Faecal Panels98/79 Synthetic Positive Controls for Fungal Panels98/79 Synthetic Positive Controls for HPV98/79 Synthetic Positive Controls for Respiratory Pathogens98/79 Synthetic Positive Controls for STIs and Herpes98/79	A IVDR, 98/79	Site web regulatory@r-biopharm.com.au Fiche EUDAMED Signaler une erreur
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Turquie	Adenovirus Quantification Kit (24)3 réf.98/79 Adenovirus Quantification Kit (48)3 réf.98/79 Adenovirus Quantification Kit (96)3 réf. Aspergillus Identification and Monitoring Kit (24)3 réf.98/79 Aspergillus Identification and Monitoring Kit (48)3 réf.98/79 113 autres Aspergillus Identification and Monitoring Kit (96)3 réf.98/79 Aspergillus/Fusarium/Trichosporon Detection and Monitoring Kit (24)3 réf.98/79 Bacterial Meningitis Detection and Monitoring Kit (24)3 réf.98/79 Bacterial Meningitis Detection and Monitoring Kit (48)3 réf.98/79 Bacterial Meningitis Detection and Monitoring Kit (96)3 réf.98/79 Bacterial Sepsis Detection and Monitoring Kit (24)3 réf.98/79 BKV Quantification Kit (24)3 réf.98/79 BKV Quantification Kit (48)3 réf.98/79 BKV Quantification Kit (96)3 réf.98/79 Bordetella Detection and Monitoring Kit (24)3 réf.98/79 Candida Auris Detection and Monitoring Kit (24)3 réf.98/79 Candida Auris Detection and Monitoring Kit (48)3 réf.98/79 Candida Auris Detection and Monitoring Kit (96)3 réf.98/79 Candida Detection and Monitoring Kit (24)98/79 Clostridioides difficile Detection and Monitoring Kit (24)3 réf.98/79 Clostridioides difficile Detection and Monitoring Kit (48)3 réf.98/79 Covid Flu RSV Detection and Monitoring Kit (24)3 réf.98/79 Covid Flu RSV Detection and Monitoring Kit (48)3 réf.98/79 Covid Flu RSV Detection and Monitoring Kit (96)3 réf.98/79 EBV Quantification Kit (24)3 réf.98/79 EBV Quantification Kit (48)3 réf.98/79 EBV Quantification Kit (96)3 réf.98/79 Enteric Bacterial Detection and Monitoring Kit (24)3 réf.98/79 Enteric Bacterial Detection and Monitoring Kit (48)3 réf.98/79 Enteric Parasite Detection and Monitoring Kit (24)3 réf.98/79 Enteric Parasite Detection and Monitoring Kit (48)3 réf.98/79 Eye Infection Detection and Monitoring Kit (24)3 réf.98/79 Gastrointestinal Detection and Monitoring Kit (24)3 réf.98/79 Gastrointestinal Detection and Monitoring Kit (48)3 réf.98/79 Gastrointestinal Detection and Monitoring Kit (96)3 réf.98/79 HCV Genotyping Kit (24)3 réf.98/79 HCV Genotyping Kit (48)3 réf.98/79 HCV Genotyping Kit (96)3 réf.98/79 Helicobacter pylori Detection and Monitoring Kit (24)2 réf.98/79 Helicobacter pylori Detection and Monitoring Kit (24) Helicobacter pylori Detection and Monitoring Kit (48)98/79 Helicobacter pylori Detection and Monitoring Kit (48)3 réf.98/79 HHV6 Quantification Kit (24)3 réf.98/79 HHV6 Quantification Kit (48)3 réf.98/79 HHV6 Quantification Kit (96)3 réf.98/79 HPV Genotyping and Monitoring Kit (24)3 réf.98/79 HPV Genotyping and Monitoring Kit (48)3 réf.98/79 HPV Genotyping and Monitoring Kit (96)3 réf.98/79 HPV Genotyping and Monitoring Plus Kit (24)3 réf.98/79 HPV Genotyping and Monitoring Plus Kit (48)3 réf.98/79 HPV Genotyping and Monitoring Plus Kit (96)3 réf.98/79 HPV LR Genotyping and Monitoring Kit (24)3 réf.98/79 HPV LR Genotyping and Monitoring Kit (48)3 réf.98/79 HPV LR Genotyping and Monitoring Kit (96)3 réf.98/79 HPV Screening and Monitoring Kit (24)3 réf.98/79 HPV Screening and Monitoring Kit (48)3 réf.98/79 HPV Screening and Monitoring Kit (96)3 réf.98/79 HSV 1/2 Quantification Kit (24)3 réf.98/79 HSV 1/2 Quantification Kit (48)3 réf.98/79 HSV 1/2 Quantification Kit (96)3 réf.98/79 Influenza-A Virus Detection and Monitoring Kit (24)3 réf.98/79 Influenza-A Virus Detection and Monitoring Kit (48)3 réf.98/79 Influenza-A Virus Detection and Monitoring Kit (96)3 réf.98/79 JCV Quantification Kit (24)3 réf.98/79 JCV Quantification Kit (48)3 réf.98/79 JCV Quantification Kit (96)3 réf.98/79 Joint Infection Detection and Monitoring Kit (24)3 réf.98/79 Joint Infection Detection and Monitoring Kit (48)3 réf.98/79 Joint Infection Detection and Monitoring Kit (96)3 réf.98/79 Legionella pneumophila Detection and Monitoring Kit (24)3 réf.98/79 Measles VirusDetection and Monitoring Kit (24)2 réf.98/79 Measles VirusDetection and Monitoring Kit (24) Measles Virus Detection and Monitoring Kit (24)98/79 Meningitis Detection and Monitoring Kit (24)3 réf.98/79 Meningitis Detection and Monitoring Kit (48)3 réf.98/79 Meningitis Detection and Monitoring Kit (96)3 réf.98/79 Monkeypox Virus Detection and Monitoring Kit (24)3 réf.98/79 MTB Detection and Monitoring Kit (24)3 réf.98/79 MTB Detection and Monitoring Kit (48)3 réf.98/79 MTB Detection and Monitoring Kit (96)3 réf.98/79 MTB/MDR Detection and Monitoring Kit (24)3 réf.98/79 MTB/MDR Detection and Monitoring Kit (48)3 réf.98/79 MTB/MDR Detection and Monitoring Kit (96)3 réf.98/79 MTB/NTM Detection and Monitoring Kit (24)3 réf.98/79 MTB/NTM Detection and Monitoring Kit (48)3 réf.98/79 MTB/NTM Detection and Monitoring Kit (96)3 réf.98/79 Mumps Virus Detection and Monitoring Kit (24)3 réf.98/79 Parvovirus B19 Quantification Kit (24)3 réf.98/79 Parvovirus B19 Quantification Kit (48)3 réf.98/79 Parvovirus B19 Quantification Kit (96)3 réf.98/79 Plasmodium Detection and Monitoring Kit (24)3 réf.98/79 Respiratory Fast Screening and Monitoring Kit (24)3 réf.98/79 Respiratory Fast Screening and Monitoring Kit (48)3 réf.98/79 Respiratory Fast Screening and Monitoring Kit (96)3 réf.98/79 Respiratory Pathogens Detection and Monitoring Kit (24)3 réf.98/79 Respiratory Pathogens Detection and Monitoring Kit (48)3 réf.98/79 Respiratory Pathogens Detection and Monitoring Kit (96)3 réf.98/79 Salmonella spp Detection and Monitoring Kit (24)3 réf.98/79 Sapovirus Detection and Monitoring Kit (24)3 réf.98/79 Sapovirus Detection and Monitoring Kit (48)3 réf.98/79 SARS-CoV-2 Detection and Monitoring Kit (24)3 réf.98/79 SARS-CoV-2 Detection and Monitoring Kit (48)3 réf.98/79 SARS-CoV-2 Detection and Monitoring Kit (96)3 réf.98/79 Sepsis Detection and Monitoring Kit (24)3 réf.98/79 STDs Detection and MonitoringKit (24)3 réf.98/79 STDs Detection and MonitoringKit (48)3 réf.98/79 STDs Detection and MonitoringKit (96)3 réf.98/79 Streptococcus Pyogenes Detection and Monitoring Kit (24)3 réf.98/79 TB-XDR Detection and Monitoring Kit (24)3 réf.98/79 Tropical Fever Detection and Monitoring Kit (24)3 réf.98/79 Urinary Tract Infection Detection and Monitoring Kit (24)3 réf.98/79 Viral Meningitis Detection and Monitoring Kit (24)3 réf.98/79 Viral Meningitis Detection and Monitoring Kit (48)3 réf.98/79 Viral Meningitis Detection and Monitoring Kit (96)3 réf.98/79 VZV Quantification Kit (24)3 réf.98/79 VZV Quantification Kit (48)3 réf.98/79 VZV Quantification Kit (96)3 réf.98/79 West Nile Virus Detection and Monitoring Kit (24)3 réf.98/79 West Nile Virus Detection and Monitoring Kit (48)3 réf.98/79 West Nile Virus Detection and Monitoring Kit (96)3 réf.98/79	C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Maccura Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 2 autres	Chine	APTT4 réf.98/79 Automatic Chemiluminescence Analyzer i 1000； i 1000L； i 1000S Automatic Chemiluminescence Analyzer i 6000 Automatic Chemiluminescence Analyzer i 800； i 820； i 6000； i 8000； i 9000 Automatic Chemistry Analyzer C 400, C410, C 600, C 610, C 1000, C 1100 113 autres Automatic Coagulation Analyzer H 3600/H 3800 Automatic Coagulation Analyzer H 5000/H 52002 réf. Automatic Hematology Analyzer CC-5 Cell Clean A 2 mL×6 Automatic Hematology Analyzer F 56098/79 Automatic Hematology Analyzer F 560, F 580 Automatic Hematology Analyzer F 58098/79 Automatic Hematology Analyzer F 600 Automatic Hematology Analyzer F 680 Automatic Hematology Analyzer F 80098/79 Automatic Hematology Analyzer F 81098/79 Automatic Hematology Analyzer F 88098/79 Automatic Hematology Analyzer F 880; F 810; F 8003 réf. Automatic Hematology Analyzer F-DC Diluent BL2200243: 1 L×1 BL2201243: 20 L×12 réf. Automatic Hematology Analyzer GD-5 Diluent A 20 L×1 Automatic Hematology Analyzer LD-5 Lysing Reagent A 1 L×4; 1 L×1 Automatic Hematology Analyzer LD-6 Lysing Reagent 500 mL×1 , 500 mL×2 ,1000 mL×1 ,1000 mL×23 réf. Automatic Hematology Analyzer LH-5 Lysing Reagent A 500 mL×1; 500 mL×4 Automatic Hematology Analyzer LS-6 Lysing Reagent 500 mL×1, 500 mL×2, 1000 mL×1, 1000 mL×23 réf. Automatic Nucleic Acid Extraction System N 32，N 962 réf. Automatic Slide Maker and Stainer AS 120 Automatic Specific Proteins Analyzer P 100; P 100S Automatic Urinalysis System U 2000, U 2000S Chemiluminescence Analyzer Reaction Cuvettes 3500 Tests, 24 kits/Box Coagulation Analyzer Wash Buffer A (Coa-Wash A) 200.0 mL×2 Coagulation Analyzer Wash Buffer B (Coa-Wash B) 20.0 mL×12 Coagulation Quality Control Plasma (CQC)8 réf.98/79 Cuvettes 1000/Tray, 6Trays/Box Cuvettes 17Strip/Box ,1 Strip/Box D-Dimer Calibrator EBL218100598/79 D-Dimer Calibrator EBL218200598/79 D-Dimer Calibrator EBL218300598/79 D-Dimer EBL210100898/79 D-Dimer EBL210200898/79 D-Dimer EBL210300898/79 D-Dimer EBL210400898/79 D-Dimer EBL210500898/79 D-Dimer EBL210600898/79 D-Dimer EBL210700898/79 Demagnetization Beads 1700 Tests; 220 Tests EIM4410015 EIM4411015 EIM4414015 EIM44150153 réf. EIM4410016 EIM4411016 EIM4414016 EIM44150163 réf. Fibrinogen (Fib)4 réf.98/79 Fibrinogen Degradation Product (FDP)7 réf.98/79 Fibrinogen Degradation Product (FDP) Calibrator98/79 Glycated Hemoglobin Analyzer Column S EC940300198/79 Glycated Hemoglobin Analyzer Column S EC940400198/79 Hematology Analysis Automation Workflow System LABAS F 2000 Hematology Analysis Automation Workstation LABAS F 9000 X Hematology Analyzer Calibrator EBL220100198/79 Hematology Analyzer Calibrator EBL220200198/79 Hematology Analyzer Calibrator EBL220300198/79 Hematology Analyzer Calibrator EBL220400198/79 Hematology Analyzer Calibrator EBL220500198/79 Hematology Analyzer Calibrator EBL220600198/79 Hematology Analyzer Fluorescent Platelets Calibrator6 réf.98/79 Hematology Analyzer Fluorescent Platelets Control13 réf.98/79 Hematology Analyzer Reticulocyte Calibrator EBL228110098/79 Hematology Analyzer Reticulocyte Calibrator EBL228210098/79 Hematology Analyzer Reticulocyte Calibrator EBL228310098/79 Hematology Analyzer Reticulocyte Calibrator EBL228410098/79 Hematology Analyzer Reticulocyte Calibrator EBL228510098/79 Hematology Analyzer Reticulocyte Calibrator EBL228610098/79 Hematology Analyzer Reticulocyte Calibrator EBL228710098/79 Hematology Analyzer Reticulocyte Calibrator EBL228810098/79 Hematology Analyzer Reticulocyte Calibrator EBL228910098/79 Hematology Analyzer Reticulocyte Control EBL220110098/79 Hematology Analyzer Reticulocyte Control EBL220210098/79 Hematology Analyzer Reticulocyte Control EBL220310098/79 Hematology Analyzer Reticulocyte Control EBL220410098/79 Hematology Analyzer Reticulocyte Control EBL220510098/79 Hematology Analyzer Reticulocyte Control EBL220610098/79 Hematology Analyzer Reticulocyte Control EBL220710098/79 Hematology Analyzer Reticulocyte Control EBL220810098/79 Hematology Analyzer Reticulocyte Control EBL220910098/79 Hematology Analyzer Reticulocyte Control EBL221010098/79 Hematology Analyzer Reticulocyte Control EBL221110098/79 Hematology Analyzer Reticulocyte Control EBL221210098/79 Hematology Analyzer Reticulocyte Control EBL221310098/79 Hematology Analyzer Reticulocyte Control EBL221410098/79 Hematology Analyzer Reticulocyte Control EBL221510098/79 Hematology Analyzer Reticulocyte Control EBL221610098/79 Hematology Analyzer Reticulocyte Control EBL221710098/79 Hematology Analyzer Reticulocyte Control EBL221810098/79 Hematology Analyzer Reticulocyte Control EBL221910098/79 Hematology Analyzer Reticulocyte Control EBL222010098/79 Hematology Analyzer Reticulocyte Control EBL222110098/79 Hematology Analyzer Reticulocyte Control EBL222210098/79 Hematology Analyzer Reticulocyte Control EBL222310098/79 Hematology Analyzer Reticulocyte Control EBL222410098/79 Hematology Analyzer Reticulocyte Control EBL222610098/79 Hematology Analyzer Reticulocyte Control EBL222710098/79 HEV IgG Antibody Chemiluminescent Immunoassay Kit6 réf.98/79 HEV IgM Antibody Chemiluminescent Immunoassay Kit6 réf.98/79 HSV-1/2 IgG2 réf.98/79 HSV-1/2 IgM4 réf.98/79 HSV-1/2 IgM Antibody Chemiluminescent Immunoassay Kit4 réf.98/79 HSV-2 IgG3 réf.98/79 IL-6 Chemiluminescent Immunoassay Kit4 réf.98/79 IM4402017 IM4403017 IM4406017 IM4407017 EIM44920173 réf. IM4405010 IM4401010 IM4406010 IM44070103 réf. IM4410040 IM4411040 IM4414040 IM44150403 réf. IM4410041 IM4411041 IM4414041 IM44150413 réf. Mag-Bind RNA Extraction Kit 16 Tests, 32 Tests, 48 Tests, 96 Tests (A), 480 Tests (A) ,96 Tests（C）, 480 Tests（C）, 32 Tests（C） Prothrombin Time (PT)5 réf.98/79 Real-Time PCR System N 904 S-Coagulation Reaction Cuvettes 4 Tests×200； 4 Tests×50 SARS-CoV-2 Antigen (CLIA)98/79 Semi-Automatic Coagulation Analyzer H-04 Semi-Automatic Urine Analyzer U 350; U 370; U 3902 réf. Thrombin Time (TT)4 réf.98/79 TOXO IgG Antibody Chemiluminescent Immunoassay Kit2 réf.98/79 TOXO IgM Antibody Chemiluminescent Immunoassay Kit2 réf.98/79 Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)3 réf.98/79	A, B IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Mikrogen	Allemagne	B. pertussis IgA Positivkontrollserum98/79 B. pertussis IgG Positivkontrollserum98/79 B. pertussis IgG/IgA Negativkontrollserum98/79 Borrelia IgG Positivkontrollserum98/79 Borrelia IgG/IgM Negativkontrollserum98/79 113 autres Borrelia IgM Positivkontrollserum98/79 Campylobacter IgA Positivkontrollserum98/79 Campylobacter IgG Positivkontrollserum98/79 Campylobacter IgG/IgA Negativkontrollserum98/79 Chlamydia IgA Positivkontrollserum (C. pneumoniae, C. trachomatis)98/79 Chlamydia IgG Positivkontrollserum (C. pneumoniae, C. trachomatis)98/79 Chlamydia IgG/IgA Negativkontrollserum98/79 CMV IgG Positivkontrollserum98/79 CMV IgG/IgM Negativkontrollserum98/79 CMV IgM Positivkontrollserum98/79 EBV IgA Positivkontrollserum98/79 EBV IgG Positivkontrollserum98/79 EBV IgG/IgM/IgA Negativkontrollserum98/79 EBV IgM Positivkontrollserum98/79 Hantavirus IgG Positivkontrollserum98/79 Hantavirus IgG/IgM Negativkontrollserum98/79 Hantavirus IgM Positivkontrollserum98/79 Helicobacter IgA Positivkontrollserum98/79 Helicobacter IgG Positivkontrollserum98/79 Helicobacter IgG/IgA Negativkontrollserum98/79 HEV IgG Positivkontrollserum98/79 HEV IgG/IgM Negativkontrollserum98/79 HEV IgM Positivkontrollserum98/79 HSV IgG Negativkontrollserum98/79 HSV IgG Positivkontrollserum98/79 Parvovirus IgG Positivkontrollserum98/79 Parvovirus IgG/IgM Negativkontrollserum98/79 Parvovirus IgM Positivkontrollserum98/79 recomBead Anti-human IgA conjugate3 réf. recomBead Borrelia IgG 2.098/79 recomBead Borrelia IgM 2.098/79 recomBead Treponema IgG 2.098/79 recomBead Treponema IgM 2.098/79 recomBead Wash- and Dilution buffer 6x3 réf. recomBead Yersinia IgA [IgM] 2.098/79 recomBead Yersinia IgG 2.098/79 recomBlot Rubella IgG recomBlot, recomLine Substrate TMB prec.3 réf. recomCLIA Borrelia IgG recomCLIA Borrelia IgM recomCLIA Control Set Borrelia IgG recomCLIA Control Set Borrelia IgM recomCLIA Control Set HEV IgG recomCLIA Control Set HEV IgM recomCLIA HEV IgG recomCLIA HEV IgM recomCLIA Sample Diluent A recomLine Bordetella pertussis IgA98/79 recomLine Bordetella pertussis IgG98/79 recomLine Borrelia IgG2 réf.98/79 recomLine Borrelia IgM2 réf.98/79 recomLine CMV IgG [Avidität]98/79 recomLine CMV IgM recomLine EBV IgM2 réf.98/79 recomLine HantaPlus IgG98/79 recomLine HantaPlus IgM98/79 recomLine HCV IgG98/79 recomLine Helicobacter IgA 2.098/79 recomLine Helicobacter IgG 2.098/79 recomLine HEV IgG/IgM2 réf.98/79 recomLine HSV-1 & HSV-2 IgG98/79 recomLine HTLV-1 & HTLV-2 IgG98/79 recomLine Parvovirus B19 IgG [Avidität]98/79 recomLine Parvovirus B19 IgM98/79 recomLine SARS-CoV-2 IgG [Avidität]98/79 recomLine Toxoplasma IgG [Avidität] recomLine Toxoplasma IgM [IgA]98/79 recomLine Treponema IgG2 réf.98/79 recomLine Treponema IgM2 réf.98/79 recomLine Yersinia IgA [IgM] 2.02 réf.98/79 recomLine Yersinia IgG 2.02 réf.98/79 recomWell Borrelia IgG98/79 recomWell Borrelia IgM98/79 recomWell Chlamydia pneumoniae IgA98/79 recomWell Chlamydia pneumoniae IgG98/79 recomWell Chlamydia pneumoniae IgM98/79 recomWell Chlamydia trachomatis IgA98/79 recomWell Chlamydia trachomatis IgG98/79 recomWell EBV EA IgG98/79 recomWell EBV EBNA IgG98/79 recomWell EBV IgM98/79 recomWell EBV VCA IgG98/79 recomWell Helicobacter IgA98/79 recomWell Helicobacter IgG98/79 recomWell HEV IgG98/79 recomWell HEV IgM98/79 recomWell Parvovirus B19 IgG98/79 recomWell Parvovirus B19 IgM98/79 recomWell SARS-CoV-2 IgA98/79 recomWell SARS-CoV-2 IgG98/79 recomWell Treponema IgG recomWell Treponema IgM98/79 recomWell Yersinia IgA98/79 recomWell Yersinia IgG98/79 recomWell Yersinia IgM98/79 Rubella IgG Negativkontrollserum98/79 Rubella IgG Positivkontrollserum98/79 SARS-CoV-2 IgG Negativkontrollserum98/79 SARS-CoV-2 IgG Positivkontrollserum98/79 T-Track® SARS-CoV-2 Quant PCR98/79 T-Track® SARS-CoV-2 Stimulation98/79 T-Track® TB Quant PCR98/79 T-Track® TB Stimulation98/79 Toxoplasma IgG Positivkontrollserum98/79 Toxoplasma IgG/IgM Negativkontrollserum98/79 Toxoplasma IgM Positivkontrollserum98/79 Treponema IgG Positivkontrollserum98/79 Treponema IgG/IgM Negativkontrollserum98/79 Treponema IgM Positivkontrollserum98/79 Yersinia IgA Positivkontrollserum98/79 Yersinia IgG Positivkontrollserum98/79 Yersinia IgG/IgM/IgA Negativkontrollserum98/79 Yersinia IgM Positivkontrollserum98/79	A, B, C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş	Turquie	Adenovirus Test IADV0198/79 Adenovirus Test RTADV0198/79 Adenovirus Test TADV0198/79 Adenovirus Test TIADV0198/79 Adenovirus Test TIADV0100198/79 112 autres Adenovirus Test TIADV0101098/79 Anti-HCV Test Eco TIHC0298/79 Anti-HCV Test IHC0198/79 Anti-HCV Test IHC0298/79 Anti-HCV Test Plus TIHC0214098/79 Anti-HCV Test Pro TIHC0234098/79 Anti-HCV Test RTHC0198/79 Anti-HCV Test RTHC0298/79 Anti-HCV Test Single TIHC0220598/79 Anti-HCV Test Single TIHC0222098/79 Anti-HCV Test THC0198/79 Anti-HCV Test THC0298/79 Anti-HCV Test TIHC0198/79 Anti-HIV 1/2 Test7 réf.98/79 Anti-HIV 1/2 Test Eco98/79 Anti-HIV 1/2 Test Plus98/79 Anti-HIV 1/2 Test Pro98/79 Anti-HIV 1/2 Test Single2 réf.98/79 Anti-Syphilis Test Eco TITP0298/79 Anti-Syphilis Test ITP0198/79 Anti-Syphilis Test ITP0298/79 Anti-Syphilis Test Plus TITP0214098/79 Anti-Syphilis Test Pro TITP0234098/79 Anti-Syphilis Test RTTP0198/79 Anti-Syphilis Test RTTP0298/79 Anti-Syphilis Test Single TITP0220598/79 Anti-Syphilis Test Single TITP0222098/79 Anti-Syphilis Test TITP0200198/79 Anti-Syphilis Test TITP0201098/79 Anti-Syphilis Test TTP0198/79 Anti-Syphilis Test TTP0298/79 Covid-19 Ag Test8 réf.98/79 Dengue IgG/IgM Test IDG0198/79 Dengue IgG/IgM Test RTDG0198/79 Dengue IgG/IgM Test TDG0198/79 Dengue IgG/IgM Test TIDG0198/79 Dengue IgG/IgM Test TIDG0100198/79 Dengue IgG/IgM Test TIDG0101098/79 Dengue NS1 Test6 réf.98/79 Dengue NS1, IgG/IgM Test6 réf.98/79 H.Pylori Ab Test IHP0198/79 H.Pylori Ab Test IHP0298/79 H.Pylori Ab Test RTHP0198/79 H.Pylori Ab Test RTHP0298/79 H.Pylori Ab Test THP0198/79 H.Pylori Ab Test THP0298/79 H.Pylori Ab Test TIHP0298/79 H.Pylori Ab Test TIHP0200198/79 H.Pylori Ab Test TIHP0201098/79 H.Pylori Ag Test IHP0398/79 H.Pylori Ag Test RTHP0398/79 H.Pylori Ag Test THP0398/79 H.Pylori Ag Test TIHP0398/79 H.Pylori Ag Test TIHP0300198/79 H.Pylori Ag Test TIHP0301098/79 HBsAg Test Eco TIHB0498/79 HBsAg Test IHB0398/79 HBsAg Test IHB0498/79 HBsAg Test Plus TIHB0414098/79 HBsAg Test Pro TIHB0434098/79 HBsAg Test RTHB0398/79 HBsAg Test RTHB0498/79 HBsAg Test Single TIHB0420598/79 HBsAg Test Single TIHB0422098/79 HBsAg Test THB0398/79 HBsAg Test THB0498/79 HBsAg Test TIHB0398/79 Influenza A/B Test IIAB0198/79 Influenza A/B Test RTIAB0198/79 Influenza A/B Test TIAB0198/79 Influenza A/B Test TIIAB0100198/79 Influenza A/B Test TIIAB0101098/79 Influenza A/B Test, Eco TIIAB0198/79 Influenza A/B Test, Plus TIIAB0114098/79 Influenza A/B Test, Single TIIAB0120598/79 Influenza A/B Test, Single TIIAB0122098/79 Malaria Test IML0198/79 Malaria Test RTML0198/79 Malaria Test TIML0198/79 Malaria Test TIML0100198/79 Malaria Test TIML0101098/79 Malaria Test TML0198/79 Rotavirus Adenovirus Test IRA0198/79 Rotavirus Adenovirus Test RTRA0198/79 Rotavirus Adenovirus Test TIRA0198/79 Rotavirus Adenovirus Test TIRA0100198/79 Rotavirus Adenovirus Test TIRA0101098/79 Rotavirus Adenovirus Test TRA0198/79 Rotavirus Test IROV0198/79 Rotavirus Test RTROV0198/79 Rotavirus Test TIROV0198/79 Rotavirus Test TIROV0100198/79 Rotavirus Test TIROV0101098/79 Rotavirus Test TROV0198/79 RSV Test TIRSV0102598/79 Sars-CoV-2 + Flu A/B + RSV + ADV Test98/79 Sars-CoV-2 + Flu A/B + RSV Test98/79 Sars-CoV-2 + Flu A/B Test98/79 SARS-CoV-2 IgM/IgG Ab Test4 réf.98/79 Strep A Test ISA0198/79 Strep A Test ISA10198/79 Strep A Test RTSA0198/79 Strep A Test RTSA10198/79 Strep A Test TISA0101098/79 Strep A Test TISA10198/79 Strep A Test TSA0198/79 Strep A Test TSA10198/79 Strep A Test, Eco TISA0198/79 Strep A Test, Plus TISA0114098/79 Strep A Test, Single TISA0120598/79 Strep A Test, Single TISA0122098/79 TEST IT Gel AB (x4)98/79	– 98/79	Site web info@turklab.com.tr Fiche EUDAMED Signaler une erreur
Beckman Coulter FDA Mandataire UE : Beckman Coulter Ireland Inc. (Irlande)	Allemagne, Irlande, Japon, États-Unis	Access 2 Immunoassay System 81600N Access 2 Module, DxC 500i C132523 réf. Access 2 Module, DxC 500i DxC 500i Clinical Analyzer3 réf. Access anti-HAV C39444 Access anti-HAV Calibrator C39445 111 autres Access anti-HAV IgM C39447 Access anti-HAV IgM Calibrator C39448 Access anti-HAV IgM QC C39449 Access anti-HAV QC C39446 Access CMV IgG A4070298/79 Access CMV IgG Calibrators A4070398/79 Access CMV IgM A4070598/79 Access CMV IgM, Calibrators A4070698/79 Access HAV IgM (Reagent Pack)98/79 Access HBc Ab98/79 Access HBc IgM (Reagent Pack)98/79 Access HBs Ab A2429698/79 Access HBs Ag A2429198/79 Access HBs Ag Confirmatory A2429598/79 Access IL-6 (Reagent Pack) A16369 Access IL-6 A16369 Access Rubella IgG98/79 Access Rubella IgM A3293798/79 Access RUBELLA IgM CALIBRATORS98/79 Access Toxo IgG98/79 Access Toxo IgG Calibrators98/79 Access Toxo IgM II98/79 AcT 5 diff OV98/79 Aliquot Tips, Case of 30003 réf. Allegra V-15R3 réf. Allegra X-30 series Centrifuge3 réf. APC (675/633) Setup Kit98/79 AQUIOS CL Flow Cytometer2 réf. AQUIOS Immuno-Trol Cells3 réf. AQUIOS PLG Panel 400 Test3 réf. AQUIOS Tetra-1 Panel2 réf. AutoMate 2500 Family AutoMate 1200, AutoMate 1250, AutoMate 2500, AutoMate 2550 AVANTI J-15R, 120 VAC IVD Avanti J-15 series centrifuge3 réf. Avanti JXN-26, 200V/208V/240V, 50/60 HZ, 24A-IVD centrifuge Avanti JXN series centrifuge3 réf. Beckman Coulter CHEMISTRY ANALYZER AU4802 réf. Beckman Coulter CHEMISTRY ANALYZER AU58002 réf. Beckman Coulter CHEMISTRY ANALYZER AU6803 réf. Beckman Coulter DxH Slides B012762 réf. CD8-ECD3 réf. CellMek SPS2 réf. CHEMISTRY ANALYZER DxC 700 AU Beckman Coulter DxC 700 AU3 réf. ClearLLab Bcell tube3 réf. ClearLLab Compensation Beads ClearLLab Control Cells Abnormal ClerLLab Control Cells2 réf. Coulter 5C Cell Control8 réf.98/79 COULTER 628026 COULTER 6280274 réf. COULTER 6C Plus Cell Control98/79 COULTER AcT 5diff Autoloader Hematology Analyzer98/79 COULTER AcT 5dIff Calibrator98/79 COULTER Ac•T 5diff Control Plus98/79 COULTER CYTO-TROL Control Cells Kit98/79 COULTER CYTO-TROL Control Cells Kit Flow Cytometry Control Cells3 réf. COULTER Retic-X Cell Control98/79 COULTER S-CAL Calibrator Kit2 réf.98/79 CYTO-STAT CD3(IgG1)-FITC/CD56-RD198/79 CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC598/79 CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent2 réf. CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC598/79 Cyto-Stat Tirchrome CD45-FITC/CD8-RD1/CD3-PC598/79 CYTO-STAT triCHROME CD45-FITC/CD19-RD1 ICD3-PC598/79 CYTO-STAT triCHROME CD45-FITC/CD4-RD1/CD3-PC598/79 CYTO-STAT triCHROME CD45-FITC/CD56-RD1/CD3-PC598/79 CYTO-STAT triCHROME CD8-FITC/CD4-RD1/CD3-PC598/79 CYTO-STAT/COULTER CLONE CD3 (IgG1)-FITC/T8-RD198/79 CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC/84-RD198/79 CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC/T4-RD198/79 CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC98/79 CYTO-STAT/COULTER CLONE T11-RD1/B4-FITC98/79 CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC98/79 CYTO-STAT/COULTER CLONE T8-RD1/T4-FITC98/79 DxA 5000, DxA 5000 Fit3 réf. DxC 500 AU Clinical Chemistry Analyzer2 réf. DxC 6000 AU-10, Chemistry Analyzer DxC 6000 AU DxC 6000 AU Chemistry Analyzer2 réf. DxH 500 B4060198/79 DxH 500 Series Calibrator B3688098/79 DxH 520 B4060298/79 DxH 560 B4060398/79 DxI 9000 Access Immunoassay Analyzer C11137 DxU 810c Iris C4951298/79 DxU 840m Iris C7694798/79 DxU 850m Iris C4951398/79 Flow Check Fluorospheres Flow Set Pro Fluorospheres Flow-Check Pro Fluorospheres Flow-Set Fluorospheres98/79 HAV Ab (Reagent pack)98/79 HbDIL DxC98/79 iChemVELOCITY Urine Chemistry System B7550298/79 iChemVELOCITY Urine Chemistry System B7550398/79 IMMAGE 800 4800 IMMUNO-BRITE Standards Kit98/79 IMMUNO-TROL Cells98/79 IMMUNO-TROL Low Cells98/79 iQ200 ELITE98/79 iQ200 SELECT98/79 iQ200 SPRINT98/79 Leuko-Trol Platelet Control Cells98/79 Microfuge 20 IVD 100V 50/60 Hz Microfuge 20 series centrifuges3 réf. Optima XE – 100K (IVD)3 réf. PC7 (770/488) SETUP KIT98/79 Power Link Test Tube, PS, 16 x 100 800-32153 réf. TQ Prep UniCel DxH 600 Coulter Cellular Analysis System98/79 UniCel DxH 690T Coulter Cellular Analysis System98/79 UniCel DxH 800 Coulter Cellular Analysis System3 réf.98/79 UniCel DxI 600 Access Immunoassay System 9731003 réf. UniCel DxI 600 Access Immunoassay System UniCel DxI 800 Access Immunoassay System3 réf. UniCel® DxH 900 Coulter® Cellular Analysis System98/79 S-CAL Calibrator98/79 (plus commercialisé)	A, B, C IVDR, 98/79	Présent sur le marché en France Site web ra.clare@beckman.com Fiche EUDAMED Signaler une erreur
Disera	Turquie	ANACLIN3 réf. VACUSERA21 réf. VACUSERA VACSUERA® 4 ml Crossmatch K2E/K2EDTA Blood Collection Tube98/79 VACUSERA ® 3ml NH / Sodium Heparin&Gel Blood Collection Tube98/79 VACUSERA ®1,8 ml Coagulation 9NC %3,2 Sodium Citrate Blood Collection Tube2 réf.98/79 110 autres VACUSERA ®1,8 ml Coagulation 9NC %3,2 Sodium Citrate Blood Collection Tube-Double Tube2 réf.98/79 VACUSERA ®2,7 ml Coagulation 9NC %3,2 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA ®2,7 ml Coagulation 9NC %3,2 Sodium Citrate Blood Collection Tube-Double Tube2 réf.98/79 VACUSERA® 1 ml CAT Serum Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 1 ml Coagulation 9NC %3,2 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA® 1 ml Coagulation 9NC %3,2 Sodium Citrate Blood Collection Tube-Double Tube2 réf.98/79 VACUSERA® 1 ml Coagulation 9NC %3,8 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA® 1 ml Coagulation 9NC %3,8 Sodium Citrate Blood Collection Tube-Double Tube2 réf.98/79 VACUSERA® 1 ml K2E/K2EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 1 ml K3E/K3EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 1,28 ml ESR 4NC %3,2 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA® 1,6 ml ESR 4NC %3,2 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA® 1,8 ml Coagulation 9NC %3,8 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA® 1,8 ml Coagulation 9NC %3,8 Sodium Citrate Blood Collection Tube-Double Tube2 réf.98/79 VACUSERA® 1,8 ml Coagulation CTAD Blood Collection Tube2 réf.98/79 VACUSERA® 1,8 ml Coagulation CTAD Blood Collection Tube-Double Tube2 réf.98/79 VACUSERA® 10 ml Boric Acid Urine Tube3 réf.98/79 VACUSERA® 10 ml CAT Serum Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 10 ml Chlorhexidine Urine Tube3 réf.98/79 VACUSERA® 10 ml Z No Additive Blood Collection Tube2 réf.98/79 VACUSERA® 10 ml Z No Additive Urine Tube3 réf.98/79 VACUSERA® 2 ml CAT Serum Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 2 ml CAT Serum Gel&Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 2 ml ESR 4NC % 3,2 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA® 2 ml FE / Sodium Fluoride & Na2EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 2 ml FE/Sodium Fluoride&K3EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 2 ml FX/Sodium Fluoride&Potassium Oxalate Blood Collection Tube2 réf.98/79 VACUSERA® 2 ml K2E/K2EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 2 ml K3E/K3EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 2 ml LH / Lithium Heparin Blood Collection Tube, IVD General98/79 VACUSERA® 2 ml LH/Lithium Heparin Blood Collection Tube98/79 VACUSERA® 2 ml Z No Additive Blood Collection Tube2 réf.98/79 VACUSERA® 2,5 ml CAT Serum Gel&Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 2,7 ml Coagulation CTAD Blood Collection Tube2 réf.98/79 VACUSERA® 2,7 ml Coagulation 9NC %3,8 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA® 2,7 ml Coagulation 9NC %3,8 Sodium Citrate Blood Collection Tube-Double Tube2 réf.98/79 VACUSERA® 2,7 ml Coagulation CTAD Blood Collection Tube-Double Tube2 réf.98/79 VACUSERA® 3 ml CAT Serum Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 3 ml K2E/K2EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 3 ml K2E/K2EDTA&Gel Blood Collection Tube2 réf.98/79 VACUSERA® 3 ml K3E/K3EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 3 ml LH / Lithium Heparin&Gel Blood Collection Tube2 réf.98/79 VACUSERA® 3 ml NH/Sodium Heparin&Gel Blood Collection Tube98/79 VACUSERA® 3,5 ml CAT Serum Gel&Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 3,6 ml Coagulation 9NC %3,2 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA® 3,6 ml Coagulation 9NC %3,8 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA® 3,6 ml Coagulation CTAD Blood Collection Tube-Double Tube98/79 VACUSERA® 3.6 ml Coagulation CTAD Blood Collection Tube98/79 VACUSERA® 4 ml Boric Acid Urine Tube2 réf.98/79 VACUSERA® 4 ml CAT Serum Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 4 ml CAT Serum Gel&Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 4 ml Crossmatch K2E / K2EDTA Blood Collection Tube98/79 VACUSERA® 4 ml Crossmatch K3E / K3EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 4 ml FE / Sodium Fluoride & Na2EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 4 ml FE/Sodium Fluoride&K3EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 4 ml FX/Sodium Fluoride&Potassium Oxalate Blood Collection Tube2 réf.98/79 VACUSERA® 4 ml K2E/K2EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 4 ml K3E/K3EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 4 ml LH / Lithium Heparin Blood Collection Tube, IVD General98/79 VACUSERA® 4 ml LH/Lithium Heparin Blood Collection Tube98/79 VACUSERA® 4 ml NH / Sodium Heparin Blood Collection Tube2 réf.98/79 VACUSERA® 4 ml Z No Additive Blood Collection Tube2 réf.98/79 VACUSERA® 4,5 ml Coagulation 9NC %3,2 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA® 4,5 ml Coagulation 9NC %3,8 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA® 4,5 ml Coagulation CTAD Blood Collection Tube-Double Tube98/79 VACUSERA® 4,5 ml K2E/K2EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 4,5 ml K3E/K3EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 4.5 ml Coagulation CTAD Blood Collection Tube98/79 VACUSERA® 4ml K3E/K3EDTA Aprotinin Blood Collection Tube2 réf.98/79 VACUSERA® 5 ml CAT Serum Gel&Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 5 ml CAT Serum Gel&Thrombin Blood Collection Tube2 réf.98/79 VACUSERA® 5 ml Coagulation 9NC %3,2 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA® 5 ml FE/Sodium Fluoride&Na2EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 5 ml K2E/K2EDTA&Gel Blood Collection Tube2 réf.98/79 VACUSERA® 5 ml LH / Lithium Heparin&Gel Blood Collection Tube2 réf.98/79 VACUSERA® 5 ml NH / Sodium Heparin&Gel Blood Collection Tube2 réf.98/79 VACUSERA® 5ml Coagulation 9NC %3,8 Sodium Citrate Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml ACD-A Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml ACD-B Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml Boric Acid Urine Tube2 réf.98/79 VACUSERA® 6 ml CAT Serum Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml Crossmatch CAT Serum Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml Crossmatch K2E / K2EDTA Blood Collection Tube98/79 VACUSERA® 6 ml Crossmatch K3E / K3EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml K2E/K2EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml K3E/K3EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml LH / Lithium Heparin Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml NH/ Sodium Heparin Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml Trace Element CAT Serum Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml Trace Element K2E/K2EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml Trace Element NH / Sodium Heparin Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml Z No Additive Blood Collection Tube2 réf.98/79 VACUSERA® 6 ml Z No Additive Urine Tube2 réf.98/79 VACUSERA® 6ml Crossmatch K2E/K2EDTA Blood Collection Tube98/79 VACUSERA® 8 ml CAT Serum Gel&Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 8 ml Chlorhexidine Urine Tube2 réf.98/79 VACUSERA® 8 ml K2E/K2EDTA&Gel Blood Collection Tube2 réf.98/79 VACUSERA® 8 ml LH/Lithium Heparin&Gel Blood Collection Tube2 réf.98/79 VACUSERA® 8 ml NH/Sodium Heparin&Gel Blood Collection Tube2 réf.98/79 VACUSERA® 9 ml ACD-A Blood Collection Tube2 réf.98/79 VACUSERA® 9 ml ACD-B Blood Collection Tube2 réf.98/79 VACUSERA® 9 ml CAT Serum Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 9 ml CAT Serum Gel&Clot Activator Blood Collection Tube98/79 VACUSERA® 9 ml Crossmatch CAT Serum Clot Activator Blood Collection Tube2 réf.98/79 VACUSERA® 9 ml K2E/K2EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 9 ml K3E/K3EDTA Blood Collection Tube2 réf.98/79 VACUSERA® 9 ml LH/Lithium Heparin Blood Collection Tube2 réf.98/79 VACUSERA® 9 ml NH/Sodium Heparin Blood Collection Tube2 réf.98/79 VACUSERA® 9 ml Z No Additive Blood Collection Tube2 réf.98/79 VACUSERA® Petri Dish (90x16)mm-Sterile98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Siemens Healthcare Diagnostics Products FDA Mandataire UE : Siemens Healthcare Diagnostics Manufacturing Limited (Irlande)	Allemagne, United Kingdom (ex Northern Ireland)	ADVIA Centaur HBc Total 2 (HBcT2) IVDR_67_LLB_DUB-C_D_KIT_HBc Total 22 réf. ADVIA Centaur HBc Total 2 (HBcT2) Quality Control IVDR_67_LLB_DUB-C_D_REAG_HBc Total 2 QC2 réf. ADVIA Centaur Quantitative HBsAg (QHBs) IVDR_67_LLB_DUB-C_C_KIT_QHBs2 réf. ADVIA Centaur Quantitative HBsAg (QHBs) Quality Control IVDR_67_LLB_DUB-C_C_REAG_QHBs QC2 réf. Antiserum to Human Antithrombin III IVDR_27_MAR EB_C_REAG _AS_ATIII 110 autres Antiserum to Human Fibrinogen IVDR_27_MAR EB_C_REAG_AS_FIB Antiserum to Human Plasminogen IVDR_27_MAR EB_B_REAG_AS_Plasm Atellica NEPH 630 System IVDR_27_MAR EB_A_INST_ANEPH630 Batroxobin Reagent IVDR_27_MAR EB_C_REAG_Batrox2 réf. BC Thrombin Reagent IVDR_27_MAR EB_C_KIT_BC_Thromb BC von Willebrand Reagent IVDR_27_MAR EB_C_REAG_BC_vW2 réf. BCS XP System IVDR_27_MAR EB_A_INST_BCS_XP Berichrom a2-Antiplasmin IVDR_27_MAR EB_B_KIT_Ber_a2-Antipl3 réf. Berichrom Antithrombin III (A) IVDR_27_MAR EB_C_PROF_KIT_Ber_ATIII3 réf. Berichrom F XIII IVDR_27_MAR EB_C_KIT_Ber_FXIII2 réf. Berichrom Plasminogen IVDR_27_MAR EB_B_KIT_Ber_Plasm3 réf. Berichrom Protein C IVDR_27_MAR EB_C_KIT_Ber_Prot_C3 réf. BFT II Analyzer IVDR_27_MAR EB_A_INST_BFT_II BN II Evaporation Stoppers IVDR_27_MAR EB_A_INST_BNII3 réf. Calcium Chloride Solution IVDR_27_MAR EB_A_PROF_REAG_CaCl23 réf. Coagulation Factor II Deficient Plasma IVDR_27_MAR EB_B_REAG_FII_Def_Pl3 réf. Coagulation Factor IX Deficient Plasma IVDR_27_MAR EB_C_PROF_REAG_FIX_Def_Pl3 réf. Coagulation Factor V Deficient Plasma IVDR_27_MAR EB_B_REAG_FV_Def_Pl3 réf. Coagulation Factor VII Deficient Plasma IVDR_27_MAR EB_C_REAG_FVII_Def_Pl3 réf. Coagulation Factor VIII Deficient Plasma IVDR_27_MAR EB_C_PROF_REAG_FVIII_Def_Pl2 réf. Coagulation Factor X Deficient Plasma IVDR_27_MAR EB_C_REAG_FX_Def_Pl3 réf. Coagulation Factor XI Deficient Plasma IVDR_27_MAR EB_B_PROF_REAG_FXI_Def_Pl3 réf. Coagulation Factor XII Deficient Plasma IVDR_27_MAR EB_B_PROF_REAG_FXII_Def_Pl3 réf. Control Plasma N IVDR_27_MAR EB_C_PROF_REAG_CPN3 réf. Control Plasma P IVDR_27_MAR EB_C_PROF_REAG_CPP3 réf. Dabigatran Standards IVDR_27_MAR EB_C_REAG_Dabi_Stand2 réf. Dade Actin Activated Cephaloplastin Reagent IVDR_27_MAR EB_C_PROF_REAG_Actin3 réf. Dade Actin FS Activated PTT Reagent IVDR_27_MAR EB_C_PROF_REAG_Actin_FS3 réf. Dade Actin FSL Activated PTT Reagent IVDR_27_MAR EB_C_PROF_REAG_Actin_FSL3 réf. Dade CA System Buffer IVDR_27_MAR EB_A_PROF_REAG_CA_Sys_Buff3 réf. Dade Ci-Trol 1 IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 13 réf. Dade Ci-Trol 2 IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 23 réf. Dade Ci-Trol 3 IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 33 réf. Dade Ci-Trol Heparin Control, High IVDR_27_MAR EB_C_REAG_Ci-Trol_Hep_Con3 réf. Dade Data-Fi Abnormal Fibrinogen Control IVDR_27_MAR EB_C_REAG_Data-Fi_Abn_Fib_Con2 réf. Dade Fibrinogen Determination Reagents IVDR_27_MAR EB_C_KIT_Fib_Determ_Reag3 réf. Dade Innovin IVDR_27_MAR EB_C_PROF_REAG_Innovin3 réf. Dade Owren's Veronal Buffer IVDR_27_MAR EB_A_REAG_OVB3 réf. Dade PFA Collagen/ADP Test Cartridge IVDR_27_MAR EB_B_REAG_PFA_Coll_ADP_EPI2 réf. Dade Thrombin Reagent IVDR_27_MAR EB_C_REAG_Thromb_Reag3 réf. Enzygnost F1+2 monoclonal IVDR_27_MAR EB_C_KIT_Enz_F1+2_mono Enzygnost TAT micro IVDR_27_MAR EB_C_KIT_Enz_TAT_mic Factor VIII Chromogenic Assay IVDR_27_MAR EB_C_KIT_FVIII_Chrom2 réf. Fibrinogen Calibrator Kit IVDR_27_MAR EB_C_KIT_Fib_Cal2 réf. Hematek 3000 System IVDR_27_MAR EB_A_INST_Hematek_3000 Imidazole Buffer Solution IVDR_27_MAR EB_A_REAG_Imidazol IMMULITE 2000 IL-6 IVDR_67_LLB_DUB-C_B_KIT_IL-6 IMMULITE 2000 Anti-HBc IgM DX LS_LEGACY_0063041496172998/79 IMMULITE 2000 Anti-HBc IVDR_67_LLB_DUB-C_D_KIT_Anti-HBc IMMULITE 2000 Anti-HBs DX LS_LEGACY_0063041496100298/79 IMMULITE 2000 CMV IgG IVDR_67_LLB_DUB-C_C_REAG_KIT_CMV IgG IMMULITE 2000 CMV IgM IVDR_67_LLB_DUB-C_C_KIT_CMV IgM IMMULITE 2000 D-Dimer IVDR_67_LLB_DUB-C_C_KIT_D-Dimer IMMULITE 2000 EBV-EBNA IgG IVDR_67_LLB_DUB-C_B_KIT_EBV-EBNA IgG IMMULITE 2000 EBV-VCA IgG IVDR_67_LLB_DUB-C_B_KIT_EBV-VCA IgG IMMULITE 2000 EBV-VCA IgM IVDR_67_LLB_DUB-C_B_KIT_EBV-VCA IgM IMMULITE 2000 H. pylori IgG IVDR_67_LLB_DUB-C_B_KIT_H. pylori IgG2 réf. IMMULITE 2000 HBsAg Confirmatory Kit DX LS_LEGACY_0063041498217598/79 IMMULITE 2000 HBsAg DX LS_LEGACY_0063041496158398/79 IMMULITE 2000 Herpes I & II IgG IVDR_67_LLB_DUB-C_C_KIT_Herpes I & II IgG IMMULITE 2000 IL-10 IVDR_67_LLB_DUB-C_B_KIT_IL-10 IMMULITE 2000 IL-1β IVDR_67_LLB_DUB-C_B_KIT_IL-1β IMMULITE 2000 IL-8 IVDR_67_LLB_DUB-C_B_KIT_IL-8 IMMULITE 2000 IL2R IVDR_67_LLB_DUB-C_B_KIT_IL2R IMMULITE 2000 Rubella IgM IVDR_67_LLB_DUB-C_C_KIT_Rubella IgM IMMULITE 2000 Rubella Quantitative IgG IVDR_67_LLB_DUB-C_C_REAG_KIT_Rubella Quantitative IgG2 réf. IMMULITE 2000 Syphilis Screen IVDR_67_LLB_DUB-C_C_KIT_Syphilis Screen2 réf. IMMULITE 2000 TNFα IVDR_67_LLB_DUB-C_B_KIT_TNFα IMMULITE 2000 Toxoplasma IgM (µ-Capture) IVDR_67_LLB_DUB-C_C_KIT_Toxoplasma IgM IMMULITE 2000 Toxoplasma Quantitative IgG IVDR_67_LLB_DUB-C_C_KIT_Toxoplasma Quantitative IgG IMMULITE CMV IgG Control IVDR_67_LLB_DUB-C_C_REAG_CMV IgG Controls IMMULITE Cytokine Control Module IVDR_67_LLB_DUB-C_B_REAG_Cytokine Control Module IMMULITE H. pylori IgG Control Module IVDR_67_LLB_DUB-C_B_REAG_H. pylori IgG Control Module IMMULITE IL-10 Control Module IVDR_67_LLB_DUB-C_B_REAG_IL-10 Controls IMMULITE Rubella IgG Controls IVDR_67_LLB_DUB-C_C_REAG_Rubella IgG Controls IMMULITE Rubella IgM Control Module IVDR_67_LLB_DUB-C_C_REAG_Rubella IgM Controls IMMULITE Syphilis Control Module IVDR_67_LLB_DUB-C_C_REAG_Syphilis Control Module IMMULITE Toxoplasma IgG Control Module IVDR_67_LLB_DUB-C_C_REAG_Toxoplasma IgG Control Module IMMULITE® 2000 XPi Immunoassay System IVDR_67_LLB_DUB-C_A_INST_XPi INNOVANCE Anti-Xa IVDR_27_MAR EB_C_KIT_INN_A-Xa2 réf. INNOVANCE Antithrombin IVDR_27_MAR EB_C_PROF_KIT_INN_AT3 réf. INNOVANCE Apixaban Standards IVDR_27_MAR EB_C_INN_Riva_Stand3 réf. INNOVANCE D-Dimer 2.0 DILUENT IVDR_27_MAR EB_a_PROF_INN_D_Di_Sam_Dil_22 réf. INNOVANCE D-Dimer 2.0 IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di_22 réf. INNOVANCE D-Dimer IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di3 réf. INNOVANCE D-Dimer Sample Diluent IVDR_27_MAR EB_A_PROF_REAG_NN_D-Di_Sam_Dil3 réf. INNOVANCE Free PS Ag IVDR_27_MAR EB_B_REAG_INN_Free_PS_Ag2 réf. INNOVANCE Heparin Calibrator IVDR_27_MAR EB_C_REAG_INN_Hep_Cal2 réf. INNOVANCE Heparin IVDR_27_MAR EB_C_KIT_INN_Hep2 réf. INNOVANCE PFA P2Y IVDR_27_MAR EB_B_REAG _INN_PFA_P2Y INNOVANCE PFA-200 System IVDR_27_MAR EB_A_INST_INN_PFA-200 INNOVANCE VWF Ac IVDR_27_MAR EB_C_KIT_INN_VWF_Ac3 réf. IVDR_27_MAR EB_B_KIT _vWF_Ag2 réf. IVDR_27_MAR EB_C_KIT_ProC_Ac_R2 réf. IVDR_27_MAR EB_C_REAG_Thromboclotin2 réf. LA 1 Screening Reagent IVDR_27_MAR EB_B_REAG_LA1/23 réf. LA Control High IVDR_27_MAR EB_B_REAG_LA_Con3 réf. Multifibren U IVDR_27_MAR EB_C_REAG_Multifib_U3 réf. N Antiserum to Human Antithrombin III IVDR_27_MAR EB_C_REAG _N_AS_ATIII N Antiserum to Human Fibrinogen IVDR_27_MAR EB_C_REAG_N_AS_FIB N Antiserum to Human Plasminogen IVDR_27_MAR EB_B_REAG_N_AS_Plasm Pathromtin SL IVDR_27_MAR EB_C_PROF_REAG_Pathr_SL3 réf. ProC Control Plasma IVDR_27_MAR EB_C_REAG_ProC_Con2 réf. ProC Global IVDR_27_MAR EB_C_KIT_ProC_Glob2 réf. Protein C Reagent IVDR_27_MAR EB_C_KIT _ProC_Reag2 réf. Protein S Ac IVDR_27_MAR EB_C_KIT_Prot_S_Ac3 réf. PT Multi-Calibrator IVDR_27_MAR EB_C_PROF_KIT_PT-Multi_Cal2 réf. Standard Human Plasma IVDR_27_MAR EB_C_PROF_REAG_SHP3 réf. Test Thrombin Reagent IVDR_27_MAR EB_C_KIT _Test_Thromb3 réf. Thromborel S IVDR_27_MAR EB_C_PROF_REAG_Thr_S3 réf.	A, B, C, D IVDR, 98/79	Site web contact@siemens-healthineers.com Fiche EUDAMED Signaler une erreur
Siemens Healthcare Diagnostics FDA Mandataire UE : Siemens Healthcare Diagnostics Manufacturing Limited (Irlande)	États-Unis	ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (ABN1 Control) IVDR_67_TTN_DUB-C_B_REAG_TESTpt 3-in -1 Control Abnor 1 ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (ABN2 Control) IVDR_67_TTN_DUB-C_B_REAG_TESTpoint 3-in-1 Con Abnor 2 ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (Norm Control) IVDR_67_TTN_DUB-C_B_REAG_TESTpoint 3-in -1 Con Normal ADVIA 120/2120/2120i OPTIpoint IVDR_67_TTN_DUB-C_B_REAG_OPTIpoint ADVIA 120/2120/2120i SETpoint Calibrator IVDR_67_TTN_DUB-C_B_REAG_SETpoint Calibrator 109 autres ADVIA 120/2120/2120i TESTpoint Hematology Controls (Norm) IVDR_67_TTN_DUB-C_B_REAG_Control Normal ADVIA 120/2120/2120i TESTpoint Reticulocyte Controls (High) IVDR_67_TTN_DUB-C_B_REAG_Reticulocyte Control High2 réf. ADVIA 120/2120/2120i® AUTOretic IVDR_67_TTN_DUB-C_A_REAG_autoRETIC2 réf. ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC IVDR_67_TTN_DUB-C_A_INST_CN-Free CBC TIMEPAC ADVIA 120/2120/2120i® Defoamer IVDR_67_TTN_DUB-C_A_REAG_Defoamer ADVIA 120/2120/2120i® DIFF TIMEpac IVDR_67_TTN_DUB-C_A_REAG_DIFF TIMEPAC ADVIA 120/2120/2120i® Perox Sheath IVDR_67_TTN_DUB-C_A_REAG_PEROX SHEATH ADVIA 120/2120/2120i® Sheath/Rinse IVDR_67_TTN_DUB-C_A_REAG_Sheath/Rinse2 réf. ADVIA 2120 and ADVIA 2120i Aspiration Pathway Wash IVDR_67_TTN_DUB-C_A_KIT_Aspiration Pathway Wash Kit ADVIA 2120 and ADVIA 2120i Perox Flow Cell Wash IVDR_67_TTN_DUB-C_A_REAG_Perox Flow Cell Wash Kit ADVIA 2120 and ADVIA 2120i RBC Flow Cell Wash IVDR_67_TTN_DUB-C_A_REAG_RBC Flow Cell Wash Kit ADVIA 2120 and ADVIA 2120i Vent Line Wash IVDR_67_TTN_DUB-C_A_INST_Vent Line Wash Reagent ADVIA 2120i with DAA Autosampler IVDR_67_TTN_DUB-C_B_Inst_Sample Rack3 réf. ADVIA 2120i with SAA Autosampler DX_LS_LEGACY_0063041401978998/79 ADVIA 2120i without Autosampler IVDR_67_TTN_DUB-C_B_Inst _No Sample Rack ADVIA 360 Cleaner IVDR_67_TTN_DUB-C_A_REAG_360 Cleaner ADVIA 360 Hematology System IVDR_67_TTN_DUB-C_B_INST_Hematology System2 réf. ADVIA 360/560 Calibrator IVDR_67_TTN_DUB-C_B_REAG_Calibrator ADVIA 360/560 Dil IVDR_67_TTN_DUB-C_A_REAG_Dil ADVIA 360/560 Hypoclean CC IVDR_67_TTN_DUB-C_A_REAG_Hypoclean CC ADVIA 360/560 Hypoclean IVDR_67_TTN_DUB-C_A_REAG_Hypoclean ADVIA 560 5P Diff IVDR_67_TTN_DUB-C_A_REAG_5P Diff ADVIA Autoloader IVDR_67_TTN_DUB-C_A_INST_Autoloader ADVIA Autoslide Giemsa Stain IVDR_67_TTN_DUB-C_A_INST_Autoslide Giemsa Stain ADVIA Autoslide May-Grünwald Giemsa Buffer IVDR_67_TTN_DUB-C_A_REAG_A.slide May-Grünwald Gie Buff ADVIA Autoslide May-Grünwald Stain IVDR_67_TTN_DUB-C_A_INST_AutoSlide May-Grunwald Stain ADVIA Autoslide Modified Wright Buffer IVDR_67_TTN_DUB-C_A_REAG_A.slide Modified Wright's Buff ADVIA Autoslide Modified Wright Stain IVDR_67_TTN_DUB-C_A_REAG_A.slide Modified Wright's Stn ADVIA Autoslide Wright Giemsa Buffer IVDR_67_TTN_DUB-C_A_REAG_Autoslide Wright Giemsa Buffer ADVIA Autoslide® Slide Maker Stainer IVDR_67_TTN_DUB-C_A_INST_Autoslide Slide Maker Stainer ADVIA Centaur aHAVT assay IVDR_67_TTN_DUB-C_B_KIT_aHAVT2 réf. ADVIA Centaur Anti-HBe2 (aHBe2) IVDR_67_TTN_DUB-C_D_REAG_KIT_aHBe22 réf. ADVIA Centaur Anti-HBe2 Quality Control (aHBe2 QC) IVDR_67_TTN_DUB-C_D_REAG_KIT_aHBe2 QC2 réf. ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control IVDR_67_TTN_DUB-C_D_REAG_Anti-HBs2 QC2 réf. ADVIA Centaur anti-HBs2 IVDR_67_TTN_DUB-C_D_KIT_Anti-HBs22 réf. ADVIA Centaur CHIV IVDR_67_TTN_DUB-C_D_KIT_HIV Ag/Ab Combo2 réf. ADVIA Centaur CMV IgM (CMV IgM) IVDR_67_TTN_DUB-C_C_REAG_KIT_CMV IgM2 réf. ADVIA Centaur CMV IgM Quality Control (CMV IgM QC) IVDR_67_TTN_DUB-C_C_REAG_CMV IgM QC2 réf. ADVIA Centaur HAV IgM (aHAVM) Quality Control IVDR_67_TTN_DUB-C_B_REAG_aHAVM_QC2 réf. ADVIA Centaur HAV Total (aHAVT) Quality Control IVDR_67_TTN_DUB-C_B_REAG_aHAVT_QC2 réf. ADVIA Centaur HBc IgM (aHBcM) Quality Control IVDR_67_TTN_DUB-C_D_REAG_aHBcM QC2 réf. ADVIA Centaur HBeAg (HBe) Quality Control IVDR_67_TTN_DUB-C_D_REAG_Hepatitis B e Antigen QC2 réf. ADVIA Centaur HBsAg Confirmatory (Conf) IVDR_67_TTN_DUB-C_D_REAG_HBsAg Confirmatory2 réf. ADVIA Centaur HBsAg Quality Control Material IVDR_67_TTN_DUB-C_D_REAG_HBsAg Quality Control2 réf. ADVIA Centaur HBsAgII IVDR_67_TTN_DUB-C_D_KIT_HBsAgII3 réf. ADVIA Centaur HCV Quality Control IVDR_67_TTN_DUB-C_D_REAG_aHCV QC2 réf. ADVIA Centaur Hepatitis B e Antigen IVDR_67_TTN_DUB-C_D_KIT_HBeAg2 réf. ADVIA Centaur Herpes-1 IgG (HSV1) IVDR_67_TTN_DUB-C_C_KIT_HSV12 réf. ADVIA Centaur Herpes-1 IgG (HSV1) Quality Control IVDR_67_TTN_DUB-C_C_REAG_HSV1 QC2 réf. ADVIA Centaur Herpes-2 IgG (HSV2) IVDR_67_TTN_DUB-C_C_KIT_HSV22 réf. ADVIA Centaur Herpes-2 IgG (HSV2) Quality Control IVDR_67_TTN_DUB-C_C_REAG_HSV2 QC2 réf. ADVIA Centaur HIV Ag/Ab Combo Quality Control (CHIV QC) IVDR_67_TTN_DUB-C_D_REAG_ HIV Ag/Ab Combo QC2 réf. ADVIA Centaur Interleukin-6 (IL6) assay DX_LS_LEGACY_0063041401043498/79 ADVIA Centaur Rub G quality control material IVDR_67_TTN_DUB-C_C_REAG_Rub G QC2 réf. ADVIA Centaur Rub M quality control material IVDR_67_TTN_DUB-C_C_REAG_Rubella M Quality Control Material2 réf. ADVIA Centaur Rubella G assay IVDR_67_TTN_DUB-C_C_REAG_Rub G assay2 réf. ADVIA Centaur Rubella M IVDR_67_TTN_DUB-C_C_REAG_KIT_Rubella M2 réf. ADVIA Centaur Syphilis DX LS_LEGACY_0063041458017398/79 ADVIA Centaur Syphilis Quality Control Material DX LS_LEGACY_0063041458061698/79 ADVIA Centaur Toxo G Quality Control Material IVDR_67_TTN_DUB-C_C_REAG_ToxoG_QC2 réf. ADVIA Centaur Toxo M Quality Control Material IVDR_67_TTN_DUB-C_C_REAG_Toxo M QC2 réf. ADVIA Centaur Toxoplasma G IVDR_67_TTN_DUB-C_C_KIT_Toxo G2 réf. ADVIA Centaur Toxoplasma M IVDR_67_TTN_DUB-C_C_KIT_Toxo M2 réf. ADVIA Centaur XPT Immunoassay System IVDR_67_TTN_DUB-C_A_INST_ADVIA Centaur XPT ADVIA Centaur Zika Ab DX_LS_LEGACY_0063041424702198/79 ADVIA Centaur Zika IgM DX_LS_LEGACY_0063041424700798/79 ADVIA Centaur® CP Immunoassay System IVDR_67_TTN_DUB-C_A_INST_CP Immunoassay System ADVIA Centaur® HAV IgM IVDR_67_TTN_DUB-C_B_KIT_aHAVM2 réf. ADVIA Centaur® HBc IgM IVDR_67_TTN_DUB-C_D_KIT_aHBcM2 réf. ADVIA Centaur® HCV IVDR_67_TTN_DUB-C_D_KIT_aHCV2 réf. ADVIA ® 120/2120/2120i EZ WASH IVDR_67_TTN_DUB-C_A_REAG_EZ Wash ADVIA® 120/2120/2120i CBC TIMEpac IVDR_67_TTN_DUB-C_A_REAG_CBC TIMEPAC ADVIA® 360 Lyse 3P Diff IVDR_67_TTN_DUB-C_A_REAG_Lyse 3P Diff ADVIA® 560 Lyse IVDR_67_TTN_DUB-C_A_REAG_Lyse ADVIA® Autoslide Rinse IVDR_67_TTN_DUB-C_A_REAG_Autoslide Rinse ADVIA® Autoslide Wright Giemsa Stain IVDR_67_TTN_DUB-C_A_REAG_Autoslide Wright Giemsa Stain Atellica VTLi Docking Station IVDR_69_TTN_DUB-C_A_NPT_VTLi-DS Atellica CH 930 Analyzer IVDR_67_TTN_DUB-C_A_INST_930 Analyzer2 réf. Atellica CI Analyzer IVDR_67_TTN_DUB-C_A_INST_Atellica CI 1900 Analyzer Atellica Direct Connect for CI IVDR_67_TTN_DUB-C_A_INST_ATELLICA CI DIRECT CONNECT Atellica HEMA Calibrator DX LS_LEGACY_0063041428720198/79 Atellica HEMA Control (H) DX LS_LEGACY_0063041429007298/79 Atellica HEMA Control (L) DX LS_LEGACY_0063041429005898/79 Atellica HEMA Control (N) DX LS_LEGACY_0063041429006598/79 Atellica HEMA Control RETIC (H) DX LS_LEGACY_0063041429010298/79 Atellica HEMA Control RETIC (L) DX LS_LEGACY_0063041429008998/79 Atellica HEMA Control RETIC (N) DX LS_LEGACY_0063041429009698/79 Atellica HEMA WBC DIFF IVDR_27_TTN_DUB-C_A_REAG_HEMA WBC Diff Atellica IM 1300 Analyzer IVDR_67_TTN_DUB-C_A_INST_1300 Analyzer2 réf. Atellica IM 1600 Analyzer IVDR_67_TTN_DUB-C_A_INST_1600 Analyzer2 réf. Atellica IM Ancillary Seal Kit IVDR_67_TTN_DUB-C_A_KIT_Ancillary Seal Kit Atellica IM Interleukin-6 (IL6) IVDR_67_TTN_DUB-C_A_KIT_Interleukin-6 Atellica IM Syphilis (Syph) DX LS_LEGACY_0063041459988598/79 Atellica IM Syphilis Quality Control (Syph QC) DX LS_LEGACY_0063041459989298/79 Atellica IM Zika Ab DX_LS_LEGACY_0063041428685398/79 Atellica IM Zika IgM DX_LS_LEGACY_0063041428683998/79 Atellica UAS 800 Analyzer IVDR_69_TTN_DUB-C_B_INST_Centralized Urin- Atellica Atellica UAS 800 Cuvettes IVDR_69_TTN_DUB-C_A_Centralized Urin- Atellica CLINITEK Advantus Analyzer IVDR_69_TTN_DUB-C_A_NPT_INST_De-Centralized Urin Adv CLINITEK Novus® Automated Urine Chemistry Analyzer IVDR_69_TTN_DUB-C_A_INST_Centralized Urin Novus2 réf. CLINITEK Status+ Analyzer IVDR_69_TTN_DUB-C_A_NPT_INST_De-Centralized Urin Stat3 réf. DCA Vantage Analyzer (Professional Use) IVDR_69_TTN_DUB-C_A_NPT_INST_DCA-ACR2 réf. Dimension® EXL™ 200 Integrated Chemistry System IVDR_67_GLA_DUB-C_A_INST_EXL 200 integrated chemistry system Dimension® EXL™ with LM Integrated Chemistry System IVDR_67_GLA_DUB-C_A_INST_EXL 200 w/LM integrated chem system Hematek Stain Pak – Modified Wright’s Stain IVDR_67_TTN_DUB-C_A_REAG_Hematek Modified Wright Stain Pak Hematek Stain Pak – Wright-Giemsa Stain IVDR_67_TTN_DUB-C_A_REAG_Hematek Modified W.Giemsa Stain Pak IVDR_67_TTN_DUB-C_A_INST_Atellica Rack Handler RAPIDLab 348EX System IVDR_69_TTN_DUB-C_A_NPT_INST_BG-348EX2 réf. RAPIDLab® 1240 Blood Gas Analyzer IVDR_69_TTN_DUB-C_A_NPT_INST_BG-RapidLab12003 réf.	A, B, C, D IVDR, 98/79	Site web contact@siemens-healthineers.com Fiche EUDAMED Signaler une erreur
Medcaptain FDA Mandataire UE : R Sight B.V. (Pays-Bas)	Chine	Activated Partial Thromboplastin Time Assay MCC00301E98/79 Activated Partial Thromboplastin Time Assay MCC00302E98/79 Activated Partial Thromboplastin Time Assay MCC00313E98/79 Activated Partial Thromboplastin Time Assay MCC00314E98/79 Activated Partial Thromboplastin Time Assay MCC00316E98/79 108 autres Activated Partial Thromboplastin Time Assay W010302010298/79 Anti-Xa Assay MCH00101E98/79 Anti-Xa Assay MCH00102E98/79 Anti-Xa Assay MCH00103E98/79 Anti-Xa Assay MCH00104E98/79 Anti-Xa Assay MCH00133E98/79 Anti-Xa Assay MCH00134E98/79 Anti-Xa Assay MCH00135E98/79 Anti-Xa Assay MCH00136E98/79 Anti-Xa Assay MCH00137E98/79 Anti-Xa Assay MCH00138E98/79 Anti-Xa Assay MCH00139E98/79 Anti-Xa Assay MCH00140E98/79 Anti-Xa Assay MCH00141E98/79 Anti-Xa Assay MCH00142E98/79 Anti-Xa Assay MCH00143E98/79 Anti-Xa Assay MCH00144E98/79 Antithrombin Ⅲ Assay MCC00801E98/79 Antithrombin Ⅲ Assay MCC00802E98/79 Antithrombin Ⅲ Assay MCC00813E98/79 Antithrombin Ⅲ Assay MCC00814E98/79 Antithrombin Ⅲ Assay MCC00815E98/79 Antithrombin Ⅲ Assay MCC00816E98/79 Automated Chemiluminescence Immunoassay Analyzer Immu F6, Immu F6S2 réf. AutoMated Nucleic Acid Extraction System GeneX E6, GeneX E6s2 réf. BT-70, BT-712 réf. Coagulation Calibrators MCH01701E98/79 Coagulation Calibrators MCH01706E98/79 Coagulation Calibrators MCH01707E98/79 Coagulation Calibrators MCH01708E98/79 Coagulation Calibrators MCH01709E98/79 Coagulation Control MCC00101E98/79 Coagulation Control MCC00102E98/79 Coagulation Control MCC00105E98/79 Coagulation Control MCC00106E98/79 D-Dimer (CLIA)2 réf.98/79 D-Dimer Assay MCC00601E98/79 D-Dimer Assay MCC00602E98/79 D-Dimer Assay MCC00621E98/79 D-Dimer Assay MCC00622E98/79 D-Dimer Assay MCC00623E98/79 D-Dimer Assay MCC00624E98/79 D-Dimer Assay MCC00625E98/79 D-Dimer Assay MCC00626E98/79 D-Dimer Assay MCC00627E98/79 D-Dimer Assay MCC00628E98/79 Diluent for Coagulation Analysis3 réf. FDP（CLIA）2 réf.98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00701E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00702E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00721E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00722E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00723E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00726E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00727E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00728E98/79 Fibrin and Fibrinogen Degradation Products MCC00724E98/79 Fibrinogen Assay MCC00501E98/79 Fibrinogen Assay MCC00502E98/79 Fibrinogen Assay MCC00513E98/79 Fibrinogen Assay MCC00514E98/79 Fibrinogen Assay MCC00515E98/79 Fibrinogen Assay MCC00516E98/79 Fully Automated Blood Grouping System BT-30, BT-31, BT-30s, BT-31s3 réf. Fully-automated Haemostasis Analyzer Haema TX, Haema TA2 réf. Functional Fibrinogen Assay MCT00601E98/79 Functional Fibrinogen Assay MCT00602E98/79 Functional Fibrinogen Assay MCT00603E98/79 Functional Fibrinogen Assay MCT01501E3 réf. Haema N7/Haema N7p/Haema N9/Haema N9p/Haema NX/Haema NXp3 réf. Haemostasis Analyzer Haema T4, Haema T4S2 réf. IL-6（CLIA）2 réf.98/79 Immu F200C, Immu F220C, Immu F200L, Immu F220L, Immu F400L, Immu F600L3 réf. Lupus Anticoagulant Assay MCH00801E98/79 Lupus Anticoagulant Assay MCH00802E98/79 Lupus Anticoagulant Assay MCH00813E98/79 Lupus Anticoagulant Assay MCH00815E98/79 Lupus Anticoagulant Assay MCH00816E98/79 Lupus Anticoagulant Controls MCH01801E98/79 Lupus Anticoagulant Controls MCH01802E98/79 Lupus Anticoagulant Controls MCH01805E98/79 Lupus Anticoagulant Controls MCH01806E98/79 Plasmin-α2 Plasmin Inhibitor Complex（CLIA）2 réf.98/79 Protein C Assay MCH00601E98/79 Protein C Assay MCH00602E98/79 Protein C Assay MCH00609E98/79 Protein C Assay MCH00610E98/79 Protein S Assay MCH00701E98/79 Protein S Assay MCH00702E98/79 Protein S Assay MCH00707E98/79 Prothrombin Time MCC00201E2 réf. Prothrombin Time MCC00203E3 réf. Special Coagulation Controls MCH01601E98/79 Special Coagulation Controls MCH01602E98/79 Special Coagulation Controls MCH01607E98/79 Special Coagulation Controls MCH01608E98/79 Special Coagulation Controls MCH01609E98/79 Special Coagulation Controls MCH01610E98/79 Thrombin Time MCC00401E98/79 Thrombin Time MCC00402E98/79 Thrombin Time MCC00413E98/79 Thrombin Time MCC00414E98/79 Thrombin Time MCC00415E98/79 Thrombin Time MCC00416E98/79 Thrombin-Anti-thrombin III Complex (CLIA)2 réf.98/79 Thromboelastographic Platelet Assay(AA/ADP)8 réf. W010302050298/79 Washing Solution MCC01001E3 réf.	A, C IVDR, 98/79	Site web info@medcaptain.com Fiche EUDAMED Signaler une erreur
Rayto Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	100 Tests/Kit14 réf.98/79 10mL×1098/79 200 Tests/Kit14 réf.98/79 2mL×1098/79 30 Tests/Kit19 réf.98/79 106 autres 50 Tests/Kit28 réf.98/79 5mL×1098/79 Auto Chemistry Analyzer Chemray 120 Auto Chemistry Analyzer Chemray 2000 Auto Chemistry Analyzer Chemray 2020 Auto Chemistry Analyzer Chemray 240 Auto Chemistry Analyzer Chemray 310 Auto Chemistry Analyzer Chemray 330 Auto Chemistry Analyzer Chemray 380 Auto Chemistry Analyzer Chemray 420 Auto Chemistry Analyzer Chemray 800 Auto Hematology Analyzer Hemaray 51 Auto Hematology Analyzer Hemaray 86 Auto Hematology Analyzer RT-7600 Automated Coagulation Analyzer RAC-050 Automated Coagulation Analyzer RAC-120 Automated Coagulation Analyzer RAC-130 Automated Coagulation Analyzer RAC-1800 Automated Coagulation Analyzer RAC-2800 Automated Coagulation Analyzer RAC-5800 Automated Specific Protein Analyzer Protray 750 Chemiluminescence Analyzer Lumiray 1200 Chemiluminescence Analyzer Lumiray 1600 Chemiluminescence Analyzer Lumiray 4030 Chemiluminescence Analyzer Lumiray 4080 Chemiluminescence Analyzer Lumiray 600 Chemiluminescence Analyzer Lumiray 630 Chemiluminescence Analyzer Lumiray 650 Chemiluminescence Analyzer Lumiray 670 Chemiluminescence Analyzer Lumiray 680 Chemiluminescence Analyzer Lumiray4000 Cleanser RC-1, RC-23 réf. Cleanser RC-863 réf. Concentrated Cleanser RC-86C2 réf. Concentrated Cleanser REC3 réf. Diluent for Hematology Analyzer RD-502 réf. Diluent for Hematology Analyzer RD-73 réf. Diluent for Hematology Analyzer RD-862 réf. Folate Lysis Reagent 200Tests/Kit3 réf. Hemaray 50CRP98/79 Hemaray 5298/79 Hemaray 5398/79 Hemaray 5498/79 Hemaray 55CRP98/79 Hemaray 56CRP98/79 Hemaray 57CRP98/79 Hemaray 58CRP98/79 Hemaray 59CRP98/79 Hemaray 8198/79 Hemaray 8298/79 Hemaray 8398/79 Hemaray 8598/79 Hemaray 8698/79 Hemaray 8898/79 Hemaray 8998/79 Lyse for Hematology Analyzer RL-50D，RL-50H3 réf. Lyse for Hematology Analyzer RL-73 réf. Lyse for Hematology Analyzer RL-86D，RL-86H3 réf. Microplate Reader RT-2100C Microplate Reader RT-6000 Microplate Reader RT-6100 Microplate Reader RT-6500 Microplate Reader RT-6900 Microplate Washer RT-2600C Microplate Washer RT-3000 Microplate Washer RT-3100 Microplate Washer RT-3500 R1: 10 mL×10, R2: 120 mL×198/79 R1: 10mL×10, R2: 120mL×198/79 R1: 1mL×10, R2: 15mL×12 réf.98/79 R1: 1mL×5, R2: 100mL×1, R3: 1mL×198/79 R1: 1mL×5, R2: 15mL×12 réf.98/79 R1: 1mL×5, R2: 50mL×1, R3: 1mL×198/79 R1: 20ml x1, R2: 20ml x 198/79 R1: 3ml x 6, R2: 3ml x 698/79 R1: 3ml x 9, R2: 3ml x32 réf.98/79 R1: 4ml x 9, R2: 4ml x 32 réf.98/79 R1: 5ml x 9, R2: 5ml x 32 réf.98/79 R1:10mL×10，R2:60mL×22 réf.98/79 R1:2ml×10,R2:30ml×12 réf.98/79 R1:2ml×5,R2:100ml×1,R3:1ml×12 réf.98/79 R1:30mL×1 R2:10mL×12 réf.98/79 R1:30mL×2 R2:10mL×22 réf.98/79 R1:3mL×6 R2:3mL×22 réf.98/79 R1:4mlx5,R2:100ml×1,R3:1ml×198/79 R1:4ml×10,R2:50ml×12 réf.98/79 R1:4mL×5,R2:100mL×1,R3:1mL×198/79 R1:5mL×10，R2:60mL×12 réf.98/79 R1:8mL×5,R2:100mL×2,R3:1mL×12 réf.98/79 R1:9mL×3 R2:3mL×32 réf.98/79 R1:9mL×6 R2:3mL×62 réf.98/79 Rayto RT-1904C Rayto RT-9700 RT-720098/79 RT-730098/79 RT-760098/79 RT-7600S98/79 RT-790098/79 Sample Diluent RD-L1, RD-L23 réf. Semi-auto Chemistry Analyzer RT-9000 Semi-auto Chemistry Analyzer RT-9200 Semi-auto Chemistry Analyzer RT-9500 Semi-auto Coagulation Analyzer RT-2201C Semi-auto Coagulation Analyzer RT-2202 Semi-auto Coagulation Analyzer RT-2204C Vitamin B12 Lysis Reagent 200Tests/Kit3 réf.	A, B IVDR, 98/79	Site web support@rayto.com Fiche EUDAMED Signaler une erreur
Beijing Applied Biological Technologies Mandataire UE : Luxus Lebenswelt GmbH (Allemagne) et 1 autre	Chine	2019-nCoV Antigen Rapid Test Cassette28 réf.98/79 2019-nCoV Antigen Rapid Test Cassette Anterior Nasal Swab98/79 2019-nCoV Antigen Rapid Test Cassette Nasopharyngeal and Oropharyngeal Swab98/79 2019-nCoV Antigen Rapid Test Cassette Saliva98/79 2019-nCoV Neutralization Antibody Rapid Test Cassette (Colloidal Gold Method)7 réf.98/79 104 autres 6 Respiratory Pathogen Antigens Rapid Test Cassette (Colloidal Gold Method)116 réf.98/79 ABT-24 ARMS-PCR Detection Kit for 2019-nCoV HV69-70del and N501Y mutation98/79 ARMS-PCR Detection Kit for SARS-CoV-2 L452R and E484Q Mutation98/79 ARMS-PCR Diagnostic Detection Kit for 2019-nCoV HV69-70del and N501Y mutation98/79 Automatic Nucleic Acid Extraction and Real-Time PCR System ABT-24 Bacterial DNA Extraction Kit Chikungunya Virus IgM Rapid Test Cassette (Colloidal Gold Method)98/79 D-Dimer rapid test cassette (Rare earth nano fluorescence immunochromatography)98/79 Dengue Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method)98/79 Duplex Real-time PCR Detection Kit for Bordetella Pertussis2 réf.98/79 Duplex Real-time PCR Detection Kit for Campylobacter Jejuni and Campylobacter coli2 réf.98/79 Duplex Real-Time PCR Detection Kit for Influenza Virus A and Influenza Virus B3 réf.98/79 Duplex Real-Time PCR Detection Kit for Mycoplasma Pneumoniae and Bordetella Pertussis2 réf.98/79 Duplex Real-Time PCR Detection Kit for Mycoplasma pneumoniae and Legionella pneumophila98/79 Duplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N5 réf.98/79 Duplex Real-Time PCR Diagnostic Kit for Identifying Tox Virulence Gene in Corynebacterium Diphtheriae(TaqMan probe method)98/79 Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Ebola-Zaire2 réf.98/79 Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Influenza Viruse A and Influenza Viruse B98/79 Duplex Real-Time PCR Kit for Detection of Mycoplasma Pneumoniae and Bordetella Pertussis98/79 Duplex Real-Time PCR Kit for Rapid Detection of 2019-nCoV ORF1ab/N gene98/79 Fibrinogen/Fibrin Degradation Products (PDF) rapid test cassette (Rare earth nano fluorescence immunochromatography)98/79 Helicobacter Pylori Antigen Rapid Test Cassette (Lateral Flow Method)98/79 Hepatitis A Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)98/79 Hepatitis E Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)98/79 IgE (Immunoglobulin E) rapid test cassette (Rare earth nano fluorescence immunochromatography)98/79 IL-6 Rapid Test Cassette (Rare earth nano fluorescence immunochromatography)98/79 MagiCube 48 Monkeypox virus (MPXV) Antigen Rapid Test Cassette9 réf.98/79 Multiple Real-Time PCR Detection Kit for Norovirus GI/GII2 réf.98/79 Multiple Real-Time PCR Kit for Detection of 2019-nCoV6 réf.98/79 Multiplex PCR Detection Kit for 5 Diarrheagenic Escherichia coli2 réf.98/79 Multiplex PCR Diagnostic Kit for Rapid Detection of Five Genera of Diarrheogenic E. coli (GB.V.)(Freeze-dried Type)2 réf.98/79 Multiplex Real-Time PCR Detection Kit for 17 Species of Respiratory Pathogens3 réf.98/79 Multiplex Real-Time PCR Detection Kit for 6 Respiratory Viruses98/79 Multiplex Real-time PCR Diagnostic Kit for Rapid Detection of Six Diarrheal Viruses2 réf.98/79 Mycobacterium Tuberculosis IgG Antibody Rapid Test Cassette (Colloidal Gold Method)98/79 Mycoplasma Pneumoniae IgM/IgG Antibody Test Cassette (Colloidal Gold Method)98/79 Nucleic Acid Extraction Kit CN8033 Nucleic Acid Extraction Kit CN8043 PCR-based Group B Streptococcus Test Kit (Fluorometric PCR)98/79 PCR-based HPV Test and 1618 Genotyping Test Kit (Fluorometric PCR)98/79 PCR-based Mycobacterium Tuberculosis Complex Test Kit (Fluorometric PCR)98/79 PCR-based Neisseria Gonorrhoeae Test Kit (Fluorometric PCR)98/79 PCR-based Ureaplasma Urealyticum Test Kit (Fluorometric PCR)98/79 Plasmodium Falciparum/Plasmodium Vivax Antigen Rapid Test Cassette (Colloidal Gold Method)98/79 Quadruplex Real-time PCR Detection Kit for Dengue / Marburg / Rift Valley Fever / Lassa98/79 Quadruplex Real-time PCR Detection Kit for Dengue Fever Type I / II / III / IV98/79 Quadruplex Real-Time PCR Detection Kit for SARS-CoV-2 and Influenza Viruses A/B98/79 Quadruplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N and Influenza Viruses A/B3 réf.98/79 Quadruplex Real-Time PCR Detection Kit for SARS-CoV-2, Influenza Viruses A/B and Respiratory Syncytial Virus98/79 Quadruplex Real-Time PCR Diagnostic Kit for Rapid Detection of 2019-nCoV and Influenza Viruses A/B98/79 Real-time PCR Detection Kit for Bocavirus98/79 Real-time PCR Detection Kit for Chikungunya98/79 Real-time PCR Detection Kit for Dengue Type I98/79 Real-time PCR Detection Kit for Enteral Adenovirus98/79 Real-Time PCR Detection Kit for Enterovirus98/79 Real-Time PCR Detection Kit for Hepatitis A Virus98/79 Real-time PCR Detection Kit for Hepatitis E Virus98/79 Real-time PCR Detection Kit for Monkeypox Virus2 réf.98/79 Real-time PCR Detection Kit for Mycoplasma Pneumoniae98/79 Real-time PCR Detection Kit for Norovirus GI98/79 Real-time PCR Detection Kit for Norovirus GII98/79 Real-time PCR Detection Kit for Novel Bunyavirus98/79 Real-time PCR Detection Kit for Plasmodium Malariae98/79 Real-time PCR Detection Kit for Plasmodium Ovale98/79 Real-time PCR Detection Kit for Plasmodium Vivax98/79 Real-time PCR Detection Kit for Respiratory Syncytial Virus98/79 Real-time PCR Detection Kit for Salmonella98/79 Real-time PCR Detection Kit for Shigella Strains98/79 Real-Time PCR Detection Kit for Universal Dengue98/79 Real-Time PCR Detection Kit for Universal Plasmodium Falciparum98/79 Real-time PCR Detection Kit for Varicella-Zoster98/79 Real-time PCR Detection Kit for Zika98/79 Real-Time PCR Diagnostic Kit for Human Enterovirus 71 (EV71) (TaqMan probe method)98/79 Real-time PCR Diagnostic Kit for Rapid Detection of Clostridium difficile98/79 Real-time PCR Diagnostic Kit for Rapid Detection of Enterohemorrhagic E. coli (EHEC)98/79 Real-Time PCR Diagnostic Kit for Rapid Detection of Respiratory Adenovirus98/79 Salmonella typhi IgM/IgG Antibody Rapid Test Cassette (Colloidal Gold Method)98/79 Sample Release Reagent B2150 Sample Release Reagent CN8063 Sample Release Reagent CN8073 SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette98/79 SARS-CoV-2 Antigen Rapid Test Cassette5 réf.98/79 SARS-CoV-2 Antigen Rapid Test Cassette Anterior Nasal Swab98/79 SARS-CoV-2 Antigen Rapid Test Cassette Nasopharyngeal and Oropharyngeal Swab98/79 SARS-CoV-2 Antigen Rapid Test Cassette Saliva98/79 SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)98/79 SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method)98/79 Treponema Pallidum Antibody Rapid Test Cassette(Colloidal Gold Method)98/79 Triple Real-time PCR Detection Kit for Salmonella / Shigella / Vibrio Cholerae98/79 Triplex Real-time PCR Detection Kit for Group A Rotavirus / Norovirus GI / Norovirus GII98/79 Triplex Real-Time PCR Detection Kit for Human metapneumovirus/Human rhinovirus /Human bocavirus98/79 Triplex Real-Time PCR Detection Kit for Klebsiella pneumoniae/Pseudomonas aeruginosa/Acinetobacter baumannii98/79 Triplex Real-time PCR Detection Kit for Middle East Respiratory Syndrome (MERS)98/79 Triplex Real-Time PCR Detection Kit for Staphylococcus aureus/Enterococcus faecalis/Enterococcus faecium98/79 Triplex Real-Time PCR Detection Kit for Streptococcus pneumonia, Haemophilus influenza and Moraxella catarrhala98/79 Triplex Real-time PCR Detection Kit for Yellow Fever/Zika/Chikungunya98/79 Triplex Real-time PCR Diagnostic Kit for Rapid Detection of C. jejuni, C. coli and C. lari98/79 Triplex Real-Time PCR Kit for Detection of Aspergillus, Cryptococcus neoformans and Pneumocystis98/79 Triplex Real-Time PCR Kit for Detection of Escherichia coli/Enterobacter cloacae complex/ Burkholderia cepacia complex98/79 Triplex Real-Time PCR Kit for Detection of Norovirus, Rotavirus and Adenovirus98/79 X-Poche 162 réf. Zika Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method)98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Lifotronic FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne) et 1 autre	Chine	1000 mL2 réf. 3 × 2L 32T/Kit 48T/Kit 500 mL2 réf. 103 autres 600 mL3 réf. 64T/Kit 8T/Kit 96T/Kit Automated ECL Immunoassay Analyzer eCL8000,eCL8000i,eCL8000p,eCL8000x, Robot_R1 Automated ECLImmunoassay Analyzer eCL8600, eCL8600i, eCL8600p, eCL8800, eCL8800i, eCL8800p3 réf. Automated ECLImmunoassay Analyzer eCL9000、eCL9600、eCL9900、eCL9900i3 réf. Chagas (eCLIA) 100T98/79 Chagas (eCLIA) 200T98/79 Chagas (eCLIA) 2×50T98/79 Chagas (eCLIA) 50T98/79 Chagas Controls Level 1: 3×1.0 mL, Level 2: 3×1.0 mL98/79 D-dimer Assay Kit (Lateral Flow Immunoassay) 50 Tests/Kit98/79 D-Dimer STAT (eCLIA) 100T98/79 D-Dimer STAT (eCLIA) 2×100T98/79 D-Dimer STAT (eCLIA) 2×50T98/79 D-Dimer STAT (eCLIA) 50T，2×50T，100T，2×100T2 réf. D-dimer Assay Kits (Lateral Flow Immunoassay)3 réf. Dengue IgG/IgM Antibody Test (GICA) 25T98/79 Dengue NS1 Antigen Test (GICA) 25T98/79 Dengue NS1/IgG/IgM Test (GICA) 25T98/79 EBV EBNA IgG (eCLIA) 100T98/79 EBV EBNA IgG (eCLIA) 2×100T98/79 EBV EBNA IgG (eCLIA) 2×50T98/79 EBV EBNA IgG (eCLIA) 50T98/79 EBV IgM (eCLIA) 100T98/79 EBV IgM (eCLIA) 2×100T98/79 EBV IgM (eCLIA) 2×50T98/79 EBV IgM (eCLIA) 50T98/79 EBV VCA IgG (eCLIA) 100T98/79 EBV VCA IgG (eCLIA) 2×100T98/79 EBV VCA IgG (eCLIA) 2×50T98/79 EBV VCA IgG (eCLIA) 50T98/79 FDP (eCLIA) 100T98/79 FDP (eCLIA) 2×50T98/79 FDP (eCLIA) 50T98/79 FDP (eCLIA) 50T, 2×50T, 100T, 2×100T H.Pylori Ag Test (GICA) 25 Tests/Kit98/79 H898/79 Hb NEXT Hemoglobin analyzer(HPLC) Hb NEXT（50 samples,110 samples ）2 réf. HbA1c calibrator 2×0.1mL98/79 HbA1c Calibrator The kit includes calibrator level 1and level 2 2 × 0.1 mL / vials98/79 HbA1c Control Material 2×0.1mL98/79 HbA1c Control Material Level 1: 1×0.5mL; Level 2: 1×0.5mL98/79 HbA1c Control Material The kit includes Control Material Level 1 and Level 2 2 × 0.1mL / vials98/79 Hemoglobin Analyzer(HPLC) H6, H8, H9, H100, H100Plus, 96TH, A10TH, A10,3 réf. HSV-I IgG (eCLIA) 100T98/79 HSV-I IgG (eCLIA) 2×100T98/79 HSV-I IgG (eCLIA) 2×50T98/79 HSV-I IgG (eCLIA) 50T98/79 HSV-I IgM (eCLIA) 100T98/79 HSV-I IgM (eCLIA) 2×100T98/79 HSV-I IgM (eCLIA) 2×50T98/79 HSV-I IgM (eCLIA) 50T98/79 HSV-II IgG (eCLIA) 100T98/79 HSV-II IgG (eCLIA) 2×100T98/79 HSV-II IgG (eCLIA) 2×50T98/79 HSV-II IgG (eCLIA) 50T98/79 HSV-II IgM (eCLIA) 100T98/79 HSV-II IgM (eCLIA) 2×100T98/79 HSV-II IgM (eCLIA) 2×50T98/79 HSV-II IgM (eCLIA) 50T98/79 IL-6 STAT (eCLIA) 100T98/79 IL-6 STAT (eCLIA) 50T98/79 IL-6 STAT (eCLIA) 50T，2×50T，100T，2×100T2 réf. Influenza A&B Test (GICA) 25T98/79 Interleukin-6 (Electrochemiluminescence Immunoassay)3 réf. Interleukin-6 (Electrochemiluminescence Immunoassay) 2×100 T98/79 Interleukin-6 (Electrochemiluminescence Immunoassay) 50 T98/79 Malaria P.f/Pan Test (GICA) 25T98/79 PIC (eCLIA) 100T98/79 PIC (eCLIA) 2×100T98/79 PIC (eCLIA) 2×50T98/79 PIC (eCLIA) 50T98/79 Syphilis (eCLIA) 100T98/79 Syphilis (eCLIA) 2×100T98/79 Syphilis (eCLIA) 2×50T98/79 Syphilis (eCLIA) 50T98/79 t-PAIC (eCLIA) 100T98/79 t-PAIC (eCLIA) 2×100T98/79 t-PAIC (eCLIA) 2×50T98/79 t-PAIC (eCLIA) 50T98/79 TAT (eCLIA) 100T98/79 TAT (eCLIA) 2×100T98/79 TAT (eCLIA) 2×50T98/79 TAT (eCLIA) 50T98/79 TNF-alpha (eCLIA) 100T98/79 TNF-alpha (eCLIA) 2×100T98/79 TNF-alpha (eCLIA) 2×50T98/79 TNF-alpha (eCLIA) 50T98/79 V60 analytical column 1 piece/box98/79 V80 analytical column 1 piece/box98/79 VITROS™ ECL 260 Immunodiagnostic System VITROS™ ECL 300 Immunodiagnostic System VITROS™ ECL 86 Immunodiagnostic System VITROS™ ECL Assay Cup 3000 T VITROS™ ECL Assay Cup/Assay Tip 6×6×105 ß-THALASSAEMIA & HbA1c Assay Column (HPLC) H998/79 ß-THALASSAEMIA & HbA1c Calibrator ß-THALASSAEMIA & HbA1c Calibrator The kit includes calibrator level 1, level 2, 2×0.1mL98/79 ß-THALASSAEMIA & HbA1c Control Material ß-THALASSAEMIA & HbA1c Control Material The kit includes Control Material Level 1, Level 2, 2×0.1mL98/79 ß-THALASSAEMIA & HbA1c Control Material The kit includes Control Material Level 1, Level 2. ：2×0.5mL.98/79	A, B, C IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Instrumentation Laboratory FDA Mandataire UE : Instrumentation Laboratory SpA (Italie)	États-Unis	ACL AcuStar 0009801000 ACL ELITE 00000880311 ACL ELITE PRO 00001000311 ACL ELITE Pro Refurbished 00001000311R ACL Elite Refurbished 00000880311R 99 autres ACL TOP 350 CTS 00000280065 ACL TOP 370 00000280067 ACL TOP 550 CTS 00000280045 ACL TOP 570 00000280047 ACL TOP 750 00000280015 ACL TOP 750 CTS 00000280055 ACL TOP 750 LAS 00000280035 ACL TOP 770 00000280057 ACL TOP 770 LAS 00000280037 ACL TOP 770s 00000280017 ACL TOP 970 CL 00000280097 GEM Premier 3500 (Refurbished) 00026000000R GEM Premier 3500 00026000000 GEM Premier 5000 00024019255 GEM Premier 7000 with iQM3 00000015279 GEM Premier ChemSTAT 00044000000 HemosIL AcuStar ADAMTS13 Activity 0009802048 HemosIL AcuStar D-Dimer 0009802000 HemosIL AcuStar D-Dimer Controls 0009802100 HemosIL AcuStar HIT Controls 0009802122 HemosIL AcuStar HIT-IgG(PF4-H) 0009802028 HemosIL AcuStar VWF Controls 0009802119 HemosIL AcuStar VWF:Ag 0009802020 HemosIL AcuStar VWF:RCo 0009802024 HemosIL Apixaban Calibrators 0020014200 HemosIL Apixaban Controls 0020014300 HemosIL APTT-SP 0020006300 HemosIL Calibration Plasma 0020003700 HemosIL Chromogenic Factor IX 0020001900 HemosIL CL HIT-IgG(PF4-H) 0029706200 HemosIL CL Multi-Ab Controls 0029704000 HemosIL D-Dimer 0020008500 HemosIL D-Dimer 500 0020301000 HemosIL D-Dimer Controls 0020013000 HemosIL D-Dimer HS 0020007700 HemosIL D-Dimer HS 500 0020500100 HemosIL D-Dimer HS 500 Controls 0020013100 HemosIL Dabigatran Calibrators 0020013400 HemosIL Dabigatran Controls 0020013500 HemosIL Direct Thrombin Inhibitor Assay 0020302800 HemosIL dRVVT Confirm 0020301600 HemosIL dRVVT Screen 0020301500 HemosIL Factor II deficient plasma 0020012200 HemosIL Factor IX deficient plasma 0020011900 HemosIL Factor V deficient plasma 0020011500 HemosIL Factor V Leiden (APC Resistance V) 0020008700 HemosIL Factor VII deficient plasma 0020011700 HemosIL Factor VIII deficient plasma 0020011800 HemosIL Factor VIII deficient plasma 0020012800 HemosIL Factor X deficient plasma 0020010000 HemosIL Factor XI deficient plasma 0020011300 HemosIL Factor XII deficient plasma 0020011200 HemosIL Factor XIII Antigen 0020201300 HemosIL Fibrinogen-C 0020301100 HemosIL Fibrinogen-C XL 0020003900 HemosIL Free Protein S 0020002700 HemosIL Heparin 0020009400 HemosIL Heparin Calibrators 0020300600 HemosIL High Abnormal Control Assayed 0020003310 HemosIL Homocysteine 0020007800 HemosIL Homocysteine Controls 0020007900 HemosIL INR Validate 0020010500 HemosIL ISI Calibrate 0020010600 HemosIL LA Negative Control 0020012600 HemosIL LA Positive Control 0020012500 HemosIL Liquid Anti-Xa 00020302601 HemosIL Liquid Antithrombin 0020002500 HemosIL Liquid Antithrombin 0020030100 HemosIL Liquid Antithrombin 0020300400 HemosIL Liquid Antithrombin 0020300440 HemosIL LMW Heparin Controls 0020300200 HemosIL Low Abnormal Control Assayed 0020003210 HemosIL Low Fibrinogen Control 0020004200 HemosIL Normal Control Assayed 0020003110 HemosIL Plasma Coagulation Control Level I 0020010700 HemosIL Plasma Coagulation Control Level II 0020010800 HemosIL Plasmin Inhibitor 0020009200 HemosIL Plasminogen 0020009000 HemosIL ProClot 0008468310 HemosIL ProClot diluent 0008468600 HemosIL Protein C 0020300500 HemosIL Protein S Activity 0020302000 HemosIL PT-Fibrinogen HS PLUS 0008469810 HemosIL Q.F.A. Thrombin (Bovine) 0020301700 HemosIL Q.F.A. Thrombin (Bovine) 0020301800 HemosIL ReadiPlasTin 0020301400 HemosIL RecombiPlasTin 2G (20 mL) 0020003050 HemosIL RecombiPlasTin 2G (8 mL) 0020002950 HemosIL Rivaroxaban Calibrators 0020013600 HemosIL Rivaroxaban Controls 0020013700 HemosIL Silica Clotting Time 0020004800 HemosIL Special Test Control Level 1 0020011000 HemosIL Special Test Control Level 2 0020012000 HemosIL SynthAFax 0020007400 HemosIL SynthASil 0020006800 HemosIL Thrombin Time 0009758515 HemosIL UF Heparin Controls 0020300300 HemosIL von Willebrand Factor Activity 0020004700 HemosIL von Willebrand Factor Antigen 0020002300	A, B, C IVDR	Site web Regulatory@werfen.com Fiche EUDAMED Signaler une erreur
Talentbiomedical Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	0.2ml98/79 100 Tests2 réf.98/79 100ml98/79 10ml2 réf.98/79 1100 Tests2 réf.98/79 96 autres 11ml98/79 125ml98/79 1ml98/79 300 Tests98/79 30ml98/79 3ml98/79 50ml98/79 600 Tests98/79 6ml98/79 CD123 Antibody (Immunohistochemistry) 0.2ml98/79 CD123 Antibody (Immunohistochemistry) 11ml98/79 CD123 Antibody (Immunohistochemistry) 1ml2 réf.98/79 CD123 Antibody (Immunohistochemistry) 3ml98/79 CD123 Antibody (Immunohistochemistry) 6ml98/79 CD163 Antibody (Immunohistochemistry) 0.2ml98/79 CD163 Antibody (Immunohistochemistry) 11ml98/79 CD163 Antibody (Immunohistochemistry) 1ml2 réf.98/79 CD163 Antibody (Immunohistochemistry) 3ml98/79 CD163 Antibody (Immunohistochemistry) 6ml98/79 CD57 Antibody (Immunohistochemistr 0.2ml98/79 CD57 Antibody (Immunohistochemistr 11ml98/79 CD57 Antibody (Immunohistochemistr 1ml2 réf.98/79 CD57 Antibody (Immunohistochemistr 3ml98/79 CD57 Antibody (Immunohistochemistr 6ml98/79 CD61 Antibody (Immunohistochemistry) 0.2ml98/79 CD61 Antibody (Immunohistochemistry) 11ml98/79 CD61 Antibody (Immunohistochemistry) 1ml2 réf.98/79 CD61 Antibody (Immunohistochemistry) 3ml98/79 CD61 Antibody (Immunohistochemistry) 6ml98/79 CDK4 Antibody (Immunohistochemistry) 0.2ml98/79 CDK4 Antibody (Immunohistochemistry) 11ml98/79 CDK4 Antibody (Immunohistochemistry) 1ml2 réf.98/79 CDK4 Antibody (Immunohistochemistry) 3ml98/79 CDK4 Antibody (Immunohistochemistry) 6ml98/79 Claudin 18.2 Antibody (Immunohistochemistry) 0.2ml98/79 Claudin 18.2 Antibody (Immunohistochemistry) 11ml98/79 Claudin 18.2 Antibody (Immunohistochemistry) 1ml2 réf.98/79 Claudin 18.2 Antibody (Immunohistochemistry) 3ml98/79 Claudin 18.2 Antibody (Immunohistochemistry) 6ml98/79 DD23-3-30098/79 DD23-3-60098/79 DD23-4-30098/79 DD23-4-60098/79 EBER ISH Kit II\ 200 Tests98/79 Human Growth Hormone (hGH) Antibody (Immunohistochemistry) 0.2ml98/79 Human Growth Hormone (hGH) Antibody (Immunohistochemistry) 11ml98/79 Human Growth Hormone (hGH) Antibody (Immunohistochemistry) 1ml98/79 Human Growth Hormone (hGH) Antibody (Immunohistochemistry) 3ml98/79 Human Growth Hormone (hGH) Antibody (Immunohistochemistry) 6ml98/79 Human Growth Hormone (hGH) Antibody (Immunohistochemistry) AP0125G198/79 I\ 20 Tests2 réf.98/79 I\100 Tests98/79 I\50 Tests98/79 I\50 TestsEBER ISH Kit98/79 II\ 20 Tests98/79 II\100 Tests2 réf.98/79 II\50 Tests2 réf.98/79 Lmo2 Antibody (Immunohistochemistry) 0.2ml98/79 Lmo2 Antibody (Immunohistochemistry) 11ml98/79 Lmo2 Antibody (Immunohistochemistry) 1ml2 réf.98/79 Lmo2 Antibody (Immunohistochemistry) 3ml98/79 Lmo2 Antibody (Immunohistochemistry) 6ml98/79 NKX3.1 Antibody (Immunohistochemistry) 0.2ml98/79 NKX3.1 Antibody (Immunohistochemistry) 11ml98/79 NKX3.1 Antibody (Immunohistochemistry) 1ml2 réf.98/79 NKX3.1 Antibody (Immunohistochemistry) 3ml98/79 NKX3.1 Antibody (Immunohistochemistry) 6ml98/79 OCT 3/4 Antibody (Immunohistochemistry) 0.2ml98/79 OCT 3/4 Antibody (Immunohistochemistry) 0693745544793498/79 OCT 3/4 Antibody (Immunohistochemistry) 11ml98/79 OCT 3/4 Antibody (Immunohistochemistry) 1ml98/79 OCT 3/4 Antibody (Immunohistochemistry) 3ml98/79 OCT 3/4 Antibody (Immunohistochemistry) 6ml98/79 Renal Cell Carcinoma Marker Antibody (Immunohistochemistry) 0.2ml98/79 Renal Cell Carcinoma Marker Antibody (Immunohistochemistry) 11ml98/79 Renal Cell Carcinoma Marker Antibody (Immunohistochemistry) 1ml2 réf.98/79 Renal Cell Carcinoma Marker Antibody (Immunohistochemistry) 3ml98/79 Renal Cell Carcinoma Marker Antibody (Immunohistochemistry) 6ml2 réf.98/79 SALL4 Antibody (Immunohistochemistry) 0.2ml98/79 SALL4 Antibody (Immunohistochemistry) 11ml98/79 SALL4 Antibody (Immunohistochemistry) 1ml2 réf.98/79 SALL4 Antibody (Immunohistochemistry) 3ml98/79 SALL4 Antibody (Immunohistochemistry) 6ml98/79 Smooth Muscle Myosin Antibody (Immunohistochemistry) 0.2ml98/79 Smooth Muscle Myosin Antibody (Immunohistochemistry) 11ml98/79 Smooth Muscle Myosin Antibody (Immunohistochemistry) 1ml2 réf.98/79 Smooth Muscle Myosin Antibody (Immunohistochemistry) 3ml98/79 TGF-β1 Antibody (Immunohistochemistry) 0.2ml98/79 TGF-β1 Antibody (Immunohistochemistry) 11ml98/79 TGF-β1 Antibody (Immunohistochemistry) 1ml98/79 TGF-β1 Antibody (Immunohistochemistry) 3ml98/79 TLE1 Antibody (Immunohistochemistry) 0.2ml98/79 TLE1 Antibody (Immunohistochemistry) 11ml98/79 TLE1 Antibody (Immunohistochemistry) 1ml2 réf.98/79 TLE1 Antibody (Immunohistochemistry) 3ml98/79 TLE1 Antibody (Immunohistochemistry) 6ml98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Vivachek FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	206 Rapid Test 26098/79 2in1 Max Blood Glucose Monitoring System VGM0398/79 Blood Glucose Meter VGM02 Blood Glucose Monitoring System VGM0298/79 C. difficile Toxin A/B Rapid Test VICT98/79 95 autres C. difficile Toxin A/B+GDH Rapid Test VITG98/79 D-Dimer Rapid Test VCDI98/79 D-Dimer Test Kit (FIA) VID1198/79 Dengue IgG/IgM and NS1 Combo Rapid Test VIDE98/79 Dengue IgG/IgM and NS1 Combo Rapid Test VIDE-42698/79 Dengue IgG/IgM Rapid Test VIDEb98/79 Dengue IgG/IgM Rapid Test VIDEb-40298/79 Dengue NS1 Ag Rapid Test VIDEg98/79 Dengue NS1 Ag Rapid Test VIDEg-40298/79 Des-Gamma-Carboxy Prothrombin Test Kit (FIA) VID13698/79 Gonorrhea Rapid Test VIGO98/79 H. pylori Ab Rapid Test VIHP2 réf.98/79 H. pylori Ag Rapid Test VIHP98/79 H. pylori Ag Rapid Test VIHP-40198/79 H. pylori Antibody Test Kit (FIA) VID8298/79 H. pylori Antigen Test Kit ( FIA) VID8398/79 H.Pylori Antibody Test Kit VID82-98/79 H.Pylori Antigen Test Kit VID83-98/79 Hemoglobin Meter VOM012 réf. Hemoglobin Testing System Control Solution VOC0298/79 Herpes Simplex Virus Type 1 IgG Test Kit (FIA) VID13398/79 Herpes Simplex Virus Type 1/2 IgG Test Kit (FIA) VID13598/79 Influenza A Rapid Test VIFLa98/79 Influenza A+B Ag Test Kit (FIA) VID3698/79 Influenza A+B Rapid Test VIFLab98/79 Influenza A+B/RSV Test Kit (FIA) VID11198/79 Interleukin 6 Test Kit (FIA) VID0598/79 Klinion Blood Glucose meter VGM074 réf.98/79 Lecteur de glycémie VivaChek Ino VGM0198/79 Legionella Pneumophila Rapid Test VILEG-10198/79 Malaria P.f. Rapid Test VIMPf98/79 Malaria P.f./P.v. Rapid Test VIMPfv98/79 Malaria P.f./P.v. Rapid Test VIMPfv-22698/79 Malaria P.f./P.v./Pan Rapid Test VIMP98/79 Malaria P.f./Pan Rapid Test VIMP98/79 Malaria P.v. Rapid Test VIMPv98/79 Max BT Blood Glucose Monitoring System VGM0598/79 Mononucleosis Rapid Test VIMO98/79 Mononucleosis Rapid Test VIMO-40198/79 Multiplex Respiratory Antigen Rapid Test VIRI3 réf.98/79 Mycoplasma pneumoniae Ag Rapid Test VIMPg98/79 Mycoplasma pneumoniae IgM Rapid Test VIMPb98/79 Pic Safe Gluco Monitor 0205600010000098/79 POCT Analyzer VIM1000 POCT Analyzer VIM1000M6 POCT Analyzer VIM2000 POCT Analyzer VIM30002 réf. POCT Multifunction Meter VIM220H Portable FIA Analyzer VIM300H3 réf. Pro SARS-CoV-2 Ag Rapid Test VCD1698/79 Quick MASTER Adenovirus Test Kit (FIA) VID16698/79 Quick MASTER SARS-CoV-2 Ag FIA Test VID442 réf.98/79 Quick MASTER Strep A Test Kit (FIA) VID1072 réf.98/79 Rotavirus Test Kit (FIA) VID12398/79 RSV Rapid Test VIRS2 réf.98/79 S.pneumoniae Rapid Test VISP98/79 SARS-CoV-2 Ag Rapid Test VCD0598/79 SARS-CoV-2 IgG Rapid Test VCD24-01-01398/79 SARS-CoV-2 S-RBD IgG Ab Rapid Test VCD25-01-01398/79 SARS-CoV-2/Flu A/Flu BAg Rapid Test VLD0198/79 SARS-CoV-2/Influenza A+B Ag Combo Rapid Test VIRI98/79 SARS-CoV-2/Influenza A+B Ag Combo Rapid Test VLD01-03-1398/79 Strep A Rapid Test VIST98/79 Strep A Rapid Test VIST-70198/79 Strep A Test VIST98/79 Strep B Rapid Test VISB98/79 Streptococcus pneumoniae Ag Rapid Test VISP98/79 Syphilis Control Solution (FIA) VIC18898/79 Syphilis Rapid Test VISY98/79 Syphilis Rapid Test VISY-40298/79 Syphilis Test Kit (FIA) VID18898/79 VivaChek Bravo Blood Glucose Meter VGM1198/79 VivaChek Bravo Blood Glucose Monitoring System VGM1198/79 VivaChek Eco Blood Glucose Meter VGM023 réf.98/79 VivaChek Eco Blood Glucose Monitoring System VGM022 réf.98/79 VivaChek Eco Plus Blood Glucose Meter VGM184 réf.98/79 VivaChek Eco Plus Blood Glucose Monitoring System VGM182 réf.98/79 VivaChek FAD Blood Glucose Meter VGM034 réf.98/79 VivaChek Fad Blood Glucose Monitoring System VGM032 réf.98/79 VivaChek Fad Plus Blood Glucose Meter VGM234 réf.98/79 VivaChek Fad Plus Blood Glucose Monitoring System VGM232 réf.98/79 VivaChek Fad Smart Blood Glucose Monitoring System VGM0798/79 VivaChek Fad Sound Blood Glucose Meter VGM284 réf.98/79 VivaChek Fad Sound Blood Glucose Monitoring System VGM282 réf.98/79 VivaChek Ino Blood Glucose Meter VGM012 réf.98/79 VivaChek Ino Blood Glucose Meter VGM01-01498/79 VivaChek Ino Blood Glucose Monitoring System VGM012 réf.98/79 VivaChek Ino Plus Blood Glucose Meter VGM224 réf.98/79 VivaChek Ino Plus Blood Glucose Monitoring System VGM222 réf.98/79 VivaChek Ino Sound Blood Glucose Meter VGM273 réf.98/79 VivaChek Ino X Blood Glucose Meter VGM4998/79 VivaDiag Herpes Simplex Virus Type 1 IgG Test Kit (FIA) VID13398/79 VivaDiag Herpes Simplex Virus Type 1 IgM Test Kit (FIA) VID13498/79 VivaDiag Influenza A+B/RSV Test Kit (FIA) VID11198/79 Vivadiag LP-101/LP-1022 réf. (plus commercialisé)	A IVDR, 98/79	Présent sur le marché en France info@vivachek.com Fiche EUDAMED Signaler une erreur
Acesolab FDA Mandataire UE : VidaQuick Biotech S.L. (Espagne)	États-Unis	Adenovirus &RSV Combo Test SW25-ARC98/79 Adenovirus pneumoniae and RSV Combo FIA Test98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19 Combo FIA Test98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo FIA Test98/79 Adenovirus, RSV & Flu A+B Combo Test98/79 91 autres Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Test98/79 Adenovirus/RSV/Influenza A+B Combo FIA Test98/79 Automatic chemiluminescence Immunoassay Analyzer Chikungunya/Zika Combo Test BSP25-CZ98/79 Clostridium difficile GDH & Toxin A &Toxin B Combo Test F35-CD98/79 Clostridium difficile GDH & Toxin A &Toxin B Combo Test F37-CD98/79 Clostridium difficile GDH FIA Test98/79 Clostridium difficile GDH Test F02-CDG98/79 Clostridium difficile GDH+Toxin A/B FIA Test98/79 Clostridium difficile GDH/Toxin A/Toxin B FIA Test98/79 Clostridium difficile Toxin A &Toxin B Combo Test F25-CDT98/79 Clostridium difficile Toxin A/Toxin B Combo FIA Test98/79 COVID-19 Ag/Influenza A+B Combo FIA Test98/79 COVID-19 Antigen FIA Test98/79 COVID-19 IgG/IgM FIA Test98/79 COVID-19 S-RBD IgG Antibody FIA Test98/79 Dengue/Chikungunya/Zika Combo Test BSP35-DCZ98/79 Dengue/Zika/Chikungunya Combo Test BSP45-DZC98/79 EBNA IgG Test BSP02-ENG98/79 EBV VCA & EBNA IgG Combo Test BSP25-ECN98/79 EBV VCA IgG Test BSP02-ECG98/79 Flu A Test2 réf.98/79 FLU A+B FIA Test98/79 Flu A+B Test2 réf.98/79 Flu A+B Test (Swab/Nasal Aspirate)98/79 Flu A/B & H1N1 Combo Test98/79 Fluorescence Immunoasasy Analyzer3 réf. H1N1 Ag Test98/79 HPV 16/18 qPCR Assay98/79 HSV 1/2 IgG Test2 réf.98/79 HSV 1/2 IgG/IgM Test4 réf.98/79 HSV 1/2 IgM Test2 réf.98/79 Legionella pneumophila FIA Test98/79 Legionella pneumophila Test98/79 Malaria P.f. Test B01-MAL98/79 Malaria P.f. Test B02-MAL98/79 Malaria P.f./ P.v. /Pan Test B02-MPVF98/79 Malaria P.f./ P.v. Test B02-MPV98/79 Malaria P.f./ Pan Test B02-MPN98/79 Malaria P.f./P.v./Pan FIA Test98/79 Monkeypox Virus Ab Test BSP02-MXB98/79 Monkeypox Virus Ag FIA Test98/79 Monkeypox Virus Ag Test Q02-MXG98/79 MONO Test BSP02-MONO98/79 Multi-Respiratory Antigen Test SW55-RT998/79 Multi-Respiratory Antigen Test SW67-RTC98/79 Multi-Respiratory Antigen Test SW85-RTC98/79 Mycoplasma pneumoniae/Adenovirus pneumoniae/ RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo FIA Test98/79 Norovirus+Rotavirus, Adenovirus +Astrovirus+Enterovirus Combo Test F55-NRAAE98/79 Norovirus, Rotavirus & Adenovirus Combo Test F35-NRA98/79 Norovirus, Rotavirus & Adenovirus Combo Test F37-NRA98/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test F45-NRAA98/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test F47-NRAA98/79 Norovirus/Rotavirus/Adeno virus Combo FIA Test98/79 Portable Rapid Test Reader EQC01-RD Rapid Cup Test Reader EQB01-RD Rapid Test Reader EQA01-RD Rotavirus & Adenovirus Combo Test F02-RA98/79 Rotavirus & Adenovirus Combo Test F07-RA98/79 Rotavirus and Adenovirus FIA Test98/79 RSV FIA Test98/79 RSV Test SW02-RSV98/79 RSV&Flu A+B Combo Test98/79 RSV/Influenza A+B/COVID-19 Combo FIA Test98/79 SARS-CoV-2 & Flu A+B Ag Combo Test2 réf.98/79 SARS-CoV-2 & M.pneumoniae IgG Combo Test98/79 SARS-CoV-2 & M.pneumoniae IgG/IgM Combo Test98/79 SARS-CoV-2 Ag Test5 réf.98/79 SARS-CoV-2 IgG/IgM Test3 réf.98/79 SARS-CoV-2 Neutralization Antibody Test98/79 SARS-CoV-2 S-RBD IgG Antibody Test98/79 SARS-CoV-2/Flu A+B/RSV Ag Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus Ag Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus/M.pneumoniae Ag Combo Test98/79 Strep A FIA Test98/79 Strep A Test SW01-STA98/79 Strep A Test SW01B-STA98/79 Strep A Test SW02-STA98/79 Strep A Test SW02B-STA98/79 Strep B Test SW01-STB98/79 Strep B Test SW02-STB98/79 Streptococcus pneumoniae Ag Test98/79 Streptococcus pneumoniae FIA Test98/79 Syphilis FIA Test98/79 Syphilis Test BSP01-SYP98/79 Syphilis Test BSP02-SYP98/79 Syphilis Test SP01-SYP98/79 Syphilis Test SP02-SYP98/79 Urine Analyzer EQA01-UA2 réf.	A IVDR, 98/79	info@acesolab.com Fiche EUDAMED Signaler une erreur
Bioperfectus FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne) et 2 autres	Chine	Avian Influenza Virus (H5/H7/H9) Real Time PCR Kit YJC10301NW-25T98/79 Avian Influenza Virus (H5/H7/H9) Real Time PCR Kit YJC10301NW-50T98/79 Avian Influenza Virus Subtype H5N2 Real Time PCR Kit JC10215NW-25T98/79 Avian Influenza Virus Subtype H5N2 Real Time PCR Kit JC10215NW-50T98/79 Bacteria DNA Extraction Kit (Magnetic Bead Method) SDK60108-48T3 réf. 89 autres Borrelia Burgdorferi Real Time PCR Kit YJC60113NW-25T98/79 Borrelia Burgdorferi Real Time PCR Kit YJC60113NW-50T98/79 Brucella Real Time PCR Kit2 réf.98/79 Cell Nucleic Acid Extraction Kit (Magnetic Bead Method) SDK80125-48T3 réf. Clostridium botulinum Real Time PCR Kit YJB20130NW-25T98/79 Clostridium botulinum Real Time PCR Kit YJB20130NW-50T98/79 Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit SC20301W-1T98/79 Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit SC20301W-20T98/79 Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit SC20301W-25T98/79 Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit SC20301W-50T98/79 Dengue NS1 Ag Rapid Test Kit SC20101W-1T98/79 Dengue NS1 Ag Rapid Test Kit SC20101W-20T98/79 Dengue NS1 Ag Rapid Test Kit SC20101W-25T98/79 Dengue NS1 Ag Rapid Test Kit SC20101W-50T98/79 E. coli Pathotyping (5) Real Time PCR Kit YJB11201NW-25T98/79 E. coli Pathotyping (5) Real Time PCR Kit YJB11201NW-50T98/79 Enteric Adenovirus Real Time PCR Kit YJC50106NW-25T98/79 Enteric Adenovirus Real Time PCR Kit YJC50106NW-50T98/79 Enterovirus Real Time PCR Kit JC20101NW-25T98/79 Enterovirus Real Time PCR Kit JC20101NW-50T98/79 FFPE DNA Isolation Kit (Magnetic Bead Method)2 réf. Genetic-Specific Whole Blood DNA Extraction Kit (Magnetic Bead Method) SDK60128-48T(163)3 réf. Group B Streptococcus Real Time PCR Kit JB20112NW-25T98/79 Group B Streptococcus Real Time PCR Kit JB20112NW-50T98/79 Herpes Simplex Virus Type I/II Real Time PCR Kit JC60202NW-24T98/79 Herpes Simplex Virus Type I/II Real Time PCR Kit JC60202NW-48T98/79 Human Cytomegalovirus Real Time PCR Kit2 réf. Human Papillomavirus Genotyping Real Time PCR Kit2 réf.98/79 Human Papillomavirus Real Time PCR Kit98/79 Influenza A and B Viruses Real Time PCR Kit2 réf.98/79 Influenza A&B Rapid Test Kit SC10101W-1T98/79 Influenza A&B Rapid Test Kit SC10101W-20T98/79 Influenza A&B Rapid Test Kit SC10101W-25T98/79 Influenza A&B Rapid Test Kit SC10101W-50T98/79 Influenza Virus Subtype N6 Real Time PCR Kit JC10134NW-25T98/79 Influenza Virus Subtype N6 Real Time PCR Kit JC10134NW-50T98/79 Leishmania Real Time PCR Kit YJB30123NW-25T98/79 Leishmania Real Time PCR Kit YJB30123NW-50T98/79 Leptospira Real Time PCR Kit JB30101NW-25T98/79 Leptospira Real Time PCR Kit JB30101NW-50T98/79 Malaria Pf (HRP2) Ag Rapid Test Kit3 réf. Malaria Pf (HRP2) Ag Rapid Test Kit SC20102W-1T98/79 Malaria Pf (HRP2) Ag Rapid Test Kit SC20102W-20T98/79 Malaria Pf (HRP2) Ag Rapid Test Kit SC20102W-25T98/79 Malaria Pf (HRP2) Ag Rapid Test Kit SC20102W-50T98/79 Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit SC20204W-1T98/79 Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit SC20204W-20T98/79 Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit SC20204W-25T98/79 Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit SC20204W-50T98/79 Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit3 réf. Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit SC20202W-1T98/79 Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit SC20202W-20T98/79 Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit SC20202W-25T98/79 Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit SC20202W-50T98/79 Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit3 réf. Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit SC20203W-1T98/79 Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit SC20203W-20T98/79 Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit SC20203W-25T98/79 Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit SC20203W-50T98/79 Measles and Rubella Viruses Real-Time PCR Kit Monkeypox Virus Real Time PCR Kit YJC70115NW-25T98/79 Monkeypox Virus Real Time PCR Kit YJC70115NW-50T98/79 Mycobacterium Tuberculosis Real Time PCR Kit JB20123NW-25T98/79 Mycobacterium Tuberculosis Real Time PCR Kit JB20123NW-50T98/79 Neisseria Gonorrhoeae/ChlamydiaTrachomatis/U.urealyticum Real-Time PCR Kit Nucleic Acid Extraction and Purification Rapid Kit 96T (Magnetic Bead Method) Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method) SDKF60101-32T(162)3 réf. Nucleic Acid Extraction Rapid Kit 96T (Magnetic Bead Method) Pathogen DNA/RNA Extraction Kit (Magnetic Bead Method) SDK60120-48T(163)3 réf. Plasmodium DNA Real Time PCR Kit JW20102NW-25T98/79 Plasmodium DNA Real Time PCR Kit JW20102NW-50T98/79 Plasmodium Genotyping Real Time PCR K YJW20601NW-25T98/79 Plasmodium Genotyping Real Time PCR Ki YJW20601NW-50T98/79 Respiratory Virus Panel (7) Real Time PCR Kit JC150701NW-24T98/79 Respiratory Virus Panel (7) Real Time PCR Kit JC150701NW-48T98/79 Rift Valley Fever Virus Real Time PCR Kit YJC70111NW-25T2 réf.98/79 Rotavirus A B C Real Time PCR Kit YJC50301NW-25T98/79 Rotavirus A B C Real Time PCR Kit YJC50301NW-50T98/79 Sputum DNA Isolation Kit (Boiling Method)2 réf. Tissue DNA Isolation Kit (Magnetic Bead Method)3 réf. Viral DNA/RNA Extraction Kit (Magnetic Bead Method) SDK60116-48T(163)3 réf. Viral Nucleic Acid Extraction Kit (Magnetic Bead Method) SDK60104-32T(162)3 réf. Viral Nucleic Acid Isolation Kit (Silica-Based Spin Column) West Nile Virus Real Time PCR Kit YJC70109NW-25T98/79 Whole Blood DNA Extraction Kit (Magnetic Bead Method) SDK60110-48T(163)3 réf. Yersinia Pestis Real Time PCR Kit YJB80101NW-25T98/79 Yersinia Pestis Real Time PCR Kit YJB80101NW-50T98/79 Zika Virus/Dengue Virus/Chikungunya Virus Real Time PCR Kit JC30302NW-25T98/79 Zika Virus/Dengue Virus/Chikungunya Virus Real Time PCR Kit JC30302NW-50T98/79	A, C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
R&D Systems FDA Mandataire UE : BIO-TECHNE SAS (France)	États-Unis	3K Retic RETIC357 réf.98/79 4K Retic RETIC37 réf.98/79 ADVIA Retic Plus RETIC77 réf.98/79 Body Fluid Control 0BF110VA298/79 Body Fluid Control 0BF220VA298/79 88 autres Body Fluid Control 0BF330VA298/79 Body Fluid Control BF00198/79 Body Fluid Control BF00298/79 Body Fluid-I 0BI004TA398/79 Body Fluid-I 0BI022TA398/79 Body Fluid-I 0BI040TA398/79 Body Fluid-I 0BI111TA398/79 Body Fluid-I 0BI202TA398/79 Body Fluid-I 0BI220TA398/79 Body Fluid-I 0BI222TA398/79 Body Fluid-I 0BI330TA398/79 Body Fluid-I 0BI400TA398/79 Body Fluid-I BFI00198/79 Body Fluid-I BFI00298/79 Body Fluid-U ABF515 réf.98/79 CBC-3D Plus CRP CBC-3D1C6 réf.98/79 CBC-3D132 réf.98/79 CBC-3K CBC-4K619 réf.98/79 CBC-5D512 réf.98/79 CBC-5DMR BC-5D314 réf.98/79 CBC-7B21 réf.98/79 CBC-CAL PLUS NCAL12 réf. CBC-DH DH-5D16 réf.98/79 CBC-LINE CL00998/79 CBC-LINE CL01098/79 CBC-LINE CL01198/79 CBC-LINE CL01298/79 CBC-LINE CL01398/79 CBC-LINE CL01598/79 CBC-LINE CL01698/79 CBC-LINE CL01898/79 CBC-LINE CL01998/79 CBC-LINE CL02098/79 CBC-LINE CL02198/79 CBC-LINE CL02298/79 CBC-LINE CL02598/79 CBC-LINE CL02798/79 CBC-LINE CL02998/79 CBC-LINE CL03198/79 CBC-LINE CL03298/79 CBC-LINE CL03498/79 CBC-LINE CL03598/79 CBC-LINE CL03698/79 CBC-LINE CL03798/79 CBC-LINE for HemoCue98/79 CBC-LINE LINL398/79 CBC-LINE Ultra Low98/79 CBC-LINE Ultra Low Plus RBC98/79 CBC-PIX4 réf. CBC-ST Plus ST222 réf.98/79 CBC-SYS SF323 réf.98/79 CBC-Tech T815 réf.98/79 CBC-X X00298/79 CBC-X X00398/79 CBC-X X003X98/79 CBC-XE19 réf.98/79 CBC-XN14 réf.98/79 CBC-XR20 réf.98/79 HC WBC Control3 réf.98/79 HC WBC Diff Control4 réf.98/79 HCT Extended 0EH110TA398/79 HCT Extended 0EH220TA398/79 HCT Extended 0EH400TA398/79 HCT Extended HCT00498/79 HGB Extended CBC-7B11 réf.98/79 LeukoReduced Combo Kit LRPLT, LRRBC22 réf.98/79 LeukoReduced PLT2 réf.98/79 LeukoReduced RBC LRRBC22 réf.98/79 Platelet-Trol Extended9 réf.98/79 PLT-LINE98/79 R&D Retic2 réf. R&D Retic-I5 réf. RET-LINE B RETLINE398/79 Retic-I DxH-800 RETIC72 réf.98/79 SEDRite III ESR22 réf.98/79 SEDRite Plus ESR222 réf.98/79 Sickle QC Control 0SC110VA298/79 Sickle QC Control 0SC220VA298/79 Sickle QC Control SQC00198/79 Sickle QC Control SQC00298/79 StatusFlow WBFC210 réf.98/79 StatusFlowLo WBFCD4Lo5 réf.98/79 StatusFlowPro WBFC23410 réf.98/79 SYSXR98/79 T898/79 Tech-Cal4 réf. XE-nRBC12 réf.98/79 XERet13 réf.98/79	B IVDR, 98/79	Présent sur le marché en France regulatorydiagnosticsdivision@bio-techne.com Fiche EUDAMED Signaler une erreur
Assure Tech. (Hangzhou) Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 2 autres	Chine	AcuteckTM Blood Glucose Monitoring System3 réf. Adenovirus Antigen Feces Rapid Test A49830125, A49830225 Adenovirus Antigen Nasal Rapid Test A46410120, A46410220 Adenovirus FIA ADV-F23F398/79 ADV FIA ADV-S23F398/79 82 autres Astrovirus FIA ASV-F23F398/79 Astrovirus Test ASV-F2398/79 Blood Glucose Monitoring Systems (Blood Glucose Meter, Test Strip) EG-101，EG-102，EGS-10198/79 Blood Glucose Test Strips C90100598/79 Brucella Antiboby Test BRU-W2398/79 C. difficile GDH FIA GDH-F23F398/79 C. difficile GDH Rapid Test GDH-F2398/79 C. difficile Toxin A FIA CDF A-F23F398/79 C. difficile Toxin A/B Rapid Test Format (cassette): A4A93011 A4A930125 A4A930140 A4A93021 A4A930225 A4A930240 C. difficile Toxin B FIA CDF B-F23F398/79 Campylobacter Rapid Test CAM-F2398/79 COVID 19 Rapid Test98/79 COVID-19 & Influenza A/B & RSV & ADV & HMPV Antigen Combo Test COVID-19 & Influenza A/B & RSV Antigen Combo Rapid Test98/79 COVID-19& Influenza A/B& RSV Antigen Combo Test Format (cassette): A4981011 A49810120 A49810140 A4981021 A49810220 A49810240 Format (pen): A4776011 A47760120 A4776021 A47760220 COVID-19&Influenza A/B Antigen combo Test Format (cassette): A4943011 A49430120 A49430140 A4943021 A49430220 A49430240 Format (pen): A4766011 A47660120 A4766021 A47660220 COVID-19&Influenza A/B&RSV&ADV Antigen combo Test Format (cassette): A4933011 A49330120 A49330140 A4933021 A49330220 A49330240 Format (pen): A4956011 A49560120 A4956021 A49560220 COVID-19&Influenza A/B&RSV&ADV&MP Antigen combo Test Format (cassette): A4923011 A49230120 A49230140 A4923021 A49230220 A49230240 Format (pen): A4D56011 A4D560120 A4D56021 A4D560220 COVID-19&Influenza A/B&RSV&ADV&MP&HMPV Antigen combo Test Format (cassette): A4D73011 A4D730120 A4D730140 A4D73021 A4D730220 A4D730240 COVID-19&Influenza A/B&RSV&ADV&MP&HMPV&HPIV Antigen combo Test Format (cassette): A4D83011 A4D830120 A4D830140 A4D83021 A4D830220 A4D830240 D-Dimer Chemiluminescence Immunoassay Test Kit98/79 D-Dimer FIA DDM-W23F398/79 Dengue Rapid Test Den-W23M NS1-W2398/79 Dengue Rapid Test Format (cassette): A4287011 A42870125 A42870140 A4287021 A42870225 A42870240 Device A1061011 Device A40110120 Device A41511125 Device A4291011 Device A4303011 Device A4343011 Device A4347011 Device A4353011 Device A4357011 Device A45910120 Device COV-S23004H198/79 Faecal Occult Blood Fecal Test Kit FOB-F11, FOB-F23, FOB-F4398/79 Fastep MI-S33001H598/79 Fecal Occult Blood Buffer FOB-B001 FLU A/B FIA FLU-S23F398/79 FLU A/FLU B/RSV/ADV/MP/COVID-19 Combo Test98/79 Gonorrhea Rapid Test GON-S2398/79 H. pylori Antibodies Rapid Test HP-P11, HP-P23, HP-W11, HP-W2398/79 H. pylori Antibodies Rapid Test HP-W2398/79 H. pylori Antibody FIA HP-W23F398/79 H. pylori Antibody Rapid Test Format (cassette): A4A411125, A4A411140, A4A411225, A4A411240 Format (strip): A4A410150, A4A410250 H. pylori Antigen FIA HP-F23F398/79 H. pylori Antigen Rapid Test A4A412125,A4A412225 H. pylori Antigens Rapid Test HP-F2398/79 HAV IgM Rapid Test A40310125, A40310140, A40310225, A40310240 Hemoglobin Test Strips and Hemoglobin Meter AS-XH-02,HBM-W1198/79 HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)98/79 Influenza A/B & RSV & ADV Antigen Combo Test Influenza A/B & RSV Antigen Combo Test A4C83011 Influenza A/B Rapid Test Device A46071120,A46071220 Influenza A/B Rapid Test FLU-S23M98/79 Influenza A/B&ADV Antigen combo Test Format (cassette): A4D33011 A4D330120 A4D330140 A4D33021 A4D330220 A4D330240 Format (pen): A4D36011 A4D360120 A4D36021 A4D360220 Interleukin-6 FIA IL6-W23F398/79 Legionella Antigen Rapid Test Device (Urine) LEG-U2398/79 Malaria P.f Rapid Test Mal pf-W11M, Mal pf-W23M98/79 Malaria P.f/Pan Rapid Test Mal pf/pan-W11M,Mal pf/pan-W23M98/79 Malaria pf/pv Rapid Test Mal pf/pv-W11M, Mal pf/pv-W23M98/79 Mycoplasma Pneumoniae Antigen Rapid Test Device A46710120,A46710220 Mycoplasma pneumoniae Antigen Rapid Test MP-S2398/79 Norovirus FIA NOV-F23F398/79 Respiratory Syncytial Virus Antigen Rapid Test A46210120, A46210220 Rotavirus Antigen Rapid Test A49930125, A49930225 Rotavirus FIA ROTA-F23F398/79 Rotavirus-Adenovirus-Astrovirus-Norovirus Combo Test A4B630 Rotavirus-Adenovirus-Astrovirus-Norovirus Combo test AT-MI-F4400198/79 Rotavirus-Adenovirus-Norovirus Combo Test Format (cassette): A4A13011 A4A130125 A4A130140 A4A13021 A4A130225 A4A130240 RSV Antigen Nasal test Kit RSV-W3598/79 RSV FIA RSV-S23F398/79 Saliva Collection System CS-S01 Shigella Rapid Test SGL-f2398/79 STA FIA STA-S23F398/79 Strep A Rapid Test Device Strip, Device A46310113 réf. Strep A Rapid Test STA-S2398/79 Strep B Rapid Test STB-S2398/79 Syphilis FIA SYP-W23F398/79 Syphilis Rapid Test SYP-P11, SYP-P23, SYP-W11, SYP-W2398/79 Typhoid Rapid Test TYP-F23, TYP-W2398/79 Zika IgG/IgM Rapid Test ZIKA-W23M98/79	A, B, C IVDR, 98/79	Site web contact@diareagent.com Fiche EUDAMED Signaler une erreur
Tongzhoubio FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	2019-nCoV IgG/IgM Rapid Test98/79 Adenovirus control HSCADE-D-L98/79 Adenovirus&RSV Combo Rapid Test I055-502598/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test I056-503598/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 82 autres Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Chagas Rapid Test (Serum/Plasma) I025-300298/79 Chagas Rapid Test (Whole Blood/Serum/Plasma) I025-400298/79 Chikungunya and Dengue Combo Rapid Test I202-403598/79 Clostridium Difficile GDH Test Kit YI062-600298/79 Clostridium difficile Toxin A/ toxin B Combo Test Kit YI010-602598/79 Coronavirus (SARS-CoV-2) Ag Self Test98/79 COVID-19 Antigen Test Kit98/79 COVID-19 S-RBD IgG Antibody Test Kit98/79 D-Dimer Test Kit YI029-400298/79 EBNA IgG Rapid Test I076-400298/79 EBV VCA and EBNA IgG Combo Rapid Test I077-402598/79 EBV VCA IgG Rapid Test I075-400298/79 FLU A+B Test Kit98/79 H. pylori Antibody control HSCHPB-L98/79 H. pylori Antigen control HSCHPG-D-L98/79 H.Pylori Antibody Rapid Test I021-N4002-253 réf. H1N1 Antigen Rapid Test2 réf.98/79 Hb Hemoglobin Test Strip O022-401198/79 HSV 1/2 IgG Rapid Test (S/P)98/79 HSV 1/2 IgG Rapid Test (WB/S/P)98/79 HSV 1/2 IgG/IgM Combo Rapid Test2 réf.98/79 HSV 1/2 IgG/IgM Rapid Test (Serum/Plasma)98/79 HSV 1/2 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgM Rapid Test (Serum/Plasma)98/79 HSV 1/2 IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 IL-6 Test Kit98/79 Influenza A+B control HSCFLAB-S98/79 Influenza A/B+H1N1 Combo Rapid Test98/79 Legionella pneumophila Rapid Test98/79 Legionella pneumophila Test Kit98/79 Malaria P.f. Rapid Test I039-400198/79 Malaria P.f. Rapid Test I039-400298/79 Malaria P.f./ Pan Rapid Test I040-400298/79 Malaria P.f./P.v. Rapid Test I041-400298/79 Malaria P.f./P.v./Pan Rapid Test I042-400298/79 Malaria P.f./P.v./Pan Test Kit YI063-403598/79 Malaria P.f./Pan control HSCMPN-D98/79 Monkeypox Antibody Rapid Test I089-400298/79 Monkeypox Antigen Rapid Test I090-400298/79 Monkeypox Virus Antibody Test Kit YI067-400298/79 Monkeypox Virus Antigen Test Kit YI066-400298/79 Monkeypox Virus Real Time PCR-Kit98/79 MONO Rapid Test I049-400298/79 Multiplex Respiratory Virus Antigen Rapid Test I161-507598/79 Multiplex Respiratory Virus Antigen Rapid Test I161-5XX598/79 Mycoplasma pneumoniae Antigen control HSCMP-S98/79 Mycoplasma Pneumoniae IgG/IgM control HSCMPGM-L98/79 Mycoplasma Pneumoniae IgM control HSCMPM-L98/79 Norovirus, Rotavirus and Adenovirus Combo Rapid Test I009-603598/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Cup I011-604798/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test I011-604598/79 Rotavirus and Adenovirus control HSCRAC-D-L98/79 Rotavirus control HSCROT-D-L98/79 RSV Test Kit YI053-500298/79 RSV&Influenza A+B Combo Rapid Test I054-502598/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test98/79 SARS-CoV-2 and Influenza A+B Antigen Rapid Test98/79 SARS-CoV-2 and M.pneumoniae IgG Combo Rapid Test98/79 SARS-CoV-2 and M.pneumoniae IgG/IgM Combo Rapid Test98/79 SARS-CoV-2 and RSV Antigen Combo Rapid Test98/79 SARS-CoV-2 Antigen Test-Saliva98/79 SARS-CoV-2 Antigen Test2 réf.98/79 SARS-CoV-2 IgG Rapid Test98/79 SARS-CoV-2 Neutralization Antibody Rapid Test98/79 SARS-CoV-2 NPAb and NAb Combo Rapid Test98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test98/79 Sickle Cell Rapid Test O027-400298/79 Strep A Rapid Test (Control Line in Blue)2 réf.98/79 Strep A Rapid Test (Control Line in Red) I045-500198/79 Strep A Rapid Test (Control Line in Red) I045-500298/79 Strep A Test Kit YI051-500298/79 Strep B Rapid Test I004-500198/79 Strep B Rapid Test I004-500298/79 Streptococcus pneumoniae Antigen Rapid Test98/79 Streptococcus pneumoniae Test Kit98/79 Syphilis control HSCSYP-L98/79 Trichomonas Vaginalis Rapid Test I085-500298/79	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
bioMérieux FDA Mandataire UE : bioMérieux SA (France)	France, États-Unis	ADENOVIRUS R-GENE® 69-010B AdV/hBoV R-GENE®98/79 BACT/ALERT BACT/ALERT® 3D CONTROL MODULE BACT/ALERT® 3D LEFT COMBINATION MODULE 81 autres BACT/ALERT® 3D LEFT INCUBATION MODULE BACT/ALERT® 3D RIGHT COMBINATION MODULE BACT/ALERT® 3D RIGHT INCUBATION MODULE BACT/ALERT® VIRTUO®2 réf. BACT/ALERT® VIRTUO® FIRMWARE R3.03 réf. BacT/ALERT®3D3 réf. BacT/ALERT®3D 60 Instrument98/79 BACT/LINK® software kit98/79 BK Virus R-GENE® 69-013B Bordetella parapertussis R-GENE®98/79 BORDETELLA R-GENE® 69-011B98/79 CELL Control R-GENE®98/79 CMV R-GENE® 69-003B COVID-19 R-GENE® EBV R-GENE® 69-002B ENTEROVIRUS R-GENE® 69-005B HCoV/HPIV R-GENE®98/79 HHV6 R-GENE® HSV1 HSV2 R-GENE® HSV1&2 VZV R-GENE® INFLUENZA A(M) Group & H1N1 2009 R-GENE®98/79 Influenza A/B R-GENE®98/79 Legio pneumo/Cc R-GENE®98/79 MINI VIDAS®2 réf. NUCLISENS® easyMAG® Extraction Buffer 1 NUCLISENS® easyMAG® Extraction Buffer 2 NUCLISENS® easyMAG® Extraction Buffer 3 NUCLISENS® easyMAG® Lysis Buffer NUCLISENS® easyMAG® Magnetic Silica NUCLISENS® Lysis Buffer Parechovirus R-GENE® Parvovirus B19 R-GENE® PREVI® COLOR CYTOCENTRIFUGE PREVI® COLOR GRAM V2 Rhino&EV/Cc R-GENE® RSV/hMPV R-GENE®98/79 SARS-COV-2/FLUA/FLUB/RSV R-GENE® VIDAS®98/79 VIDAS® 3 VIDAS® ANALYSER VIDAS® Anti-CHIKUNGUNYA IgG2 réf. VIDAS® Anti-CHIKUNGUNYA IgM2 réf. VIDAS® Anti-DENGUE IgG VIDAS® Anti-DENGUE IgM VIDAS® Anti-HAV Total VIDAS® Anti-HEV IgG VIDAS® Anti-HEV IgM VIDAS® C. difficile GDH VIDAS® C. difficile Toxin A & B VIDAS® CMV IgG VIDAS® CMV IgG Avidity II VIDAS® CMV IgM VIDAS® D-Dimer Exclusion II™3 réf. VIDAS® DENGUE NS1 Ag VIDAS® EBV EBNA IgG VIDAS® EBV VCA IgM VIDAS® EBV VCA/EA IgG VIDAS® H. pylori IgG VIDAS® HAV IgM VIDAS® KUBE™ CLINICAL VIDAS® Lyme IgG VIDAS® Lyme IgM VIDAS® Measles IgG98/79 VIDAS® Mumps IgG98/79 VIDAS® RUB IgG II VIDAS® RUB IgM VIDAS® TB-IGRA VIDAS® TOXO Compétition VIDAS® TOXO IgG AVIDITY VIDAS® TOXO IgG II VIDAS® TOXO IgM2 réf. VIDAS® vWF98/79 VITEK® MS2 réf. VITEK® MS knowledge base v3.3 VITEK® MS PRIME VITEK® MS PRIME Instrument Software v2.0 (Virtual) VITEK® MS SOFTWARE v1.1 VITEK® MS SOFTWARE v1.2 VITEK®MS98/79 VITEK® MI-TUBE COLLAR VZV R-GENE®	A, B, C IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Zybio FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 2 autres	Chine	01.09.31.02.Z3.052 réf. Activated Partial Thromboplastin Time Reagent Kit (Clotting Method)3 réf. Anti-Xa Controls3 réf. Anti-Xa Reagent Kit (Chromogenic Substrate Method)3 réf. Antithrombin Ⅲ Reagent Kit (Chromogenic Substrate Method)3 réf. 81 autres CAL2 réf. Cell-free DNA Extraction Kit (Magnetic Bead Method)3 réf. CHECK-BFI3 réf. CHECK-XN3 réf. CHECK-XR3 réf. Coagulation Controls2 réf. D-Dimer (D-D) Kit(Latex Enhanced Immunoturbidimetric Method)2 réf.98/79 D-Dimer Assay (CLIA)98/79 D-Dimer Controls2 réf. D-Dimer Reagent Kit (Immunoturbidimetric Method)3 réf. Diluent3 réf. EX-Accuspec EXB 120, EXB 120S, EXB 120P, EXB60-Lite, EXB60-Vita, EXB60-Nova3 réf. EXC200,EXC2202 réf. EXC400, EXC4202 réf. EXC460, EXC4702 réf. EXI 1800, EXI 1810, EXI 1820, EXI 18303 réf. EXI 2400, EXI 24202 réf. EXM30002 réf. EXM6000, EXM62002 réf. EXP 160, EXP 161, EXP 1623 réf. EXP 160R, EXP 161R2 réf. EXS 2000, EXS 2600, EXS 3000, EXS 36002 réf. EXS200098/79 EXS260098/79 EXT 3800, EXT 3810, EXT 38203 réf. EXT 4800, EXT 4810, EXT 48203 réf. EXT 9800, EXT 9810, EXT 98203 réf. EXZ 6000, EXZ 6010, EXZ 60203 réf. EXZ 6000Pro, EXZ 6010Pro, EXZ 6020Pro3 réf. Fibrin/fibrinogen Degradation Products (FDP) Controls2 réf. Fibrin/fibrinogen Degradation Products (FDP) Reagent Kit (Immunoturbidimetric Method)3 réf. Fibrinogen (FIB) Kit (Immunoturbidimetric Method)98/79 Fibrinogen Reagent Kit (Clotting Method)3 réf. Fluorescence Immunochromatography Analyzer EXR 100, EXR 110, EXR 1203 réf. H3 Check3 réf. H5 Check3 réf. H58 DN H58 DR2 réf. H58 LD2 réf. H58 LN2 réf. H58 LS2 réf. Hematology Analyzer EXZ 8000 EXZ 8000, EXZ 8010, EXZ 80203 réf. Hematology Analyzer EXZ 8000Pro EXZ 8000Pro, EXZ 8010Pro, EXZ 8020Pro3 réf. Hematology Analyzer Z3 CRP Z3 CRP, Z30 CRP, Z31 CRP3 réf. Hematology Analyzer Z3, Z30, Z313 réf. Hematology Analyzer Z50, Z522 réf. IL-6 Assay (CLIA)98/79 Interleukin-6 Assay (Immunofluorescence)98/79 Interleukin-6 Control2 réf. LA3 réf. Lyse2 réf. Molaccu Mycoplasma pneumoniae and Chlamydia pneumoniae Nucleic Acid Detection Kit (Real-time PCR)3 réf. Nucleic Acid Extraction Kit (Magnetic Bead Method) 01.09.20.00.B2.083 réf. Nucleic Acid Extraction Kit (Magnetic Bead Method) 01.09.20.08.B2.083 réf. Probe Cleanser Protein Cleaning Solution Prothrombin Time Reagent Kit (Clotting Method)3 réf. Q8 Pro Quantitative Real-time PCR System EXP 960, EXP 961, EXP 962, EXP 9633 réf. TH-PClean3 réf. TH-PDesorb2 réf. TH-SP-Diluent2 réf. Thrombin Time Reagent Kit (Clotting Method)3 réf. U160098/79 U160198/79 U160298/79 U260098/79 U260198/79 U260298/79 U261098/79 U261198/79 U261298/79 U360098/79 U360198/79 U360298/79 Urine Analyzer EXU 300, EXU 5002 réf. Z5 DN Z5 LB3 réf. Z5 LD ZIP-96V	A, B, C IVDR, 98/79	PMS@zy-ivd.com Fiche EUDAMED Signaler une erreur
Bioxol	Hongrie	BioClean AX Cleaning reagent 1L BioClean CD Cleaning reagent 10L BioClean cleaning reagent 1L BioClean CT Cleaning reagent 1L BioClean M22 cleaning reagent 1L 80 autres BioClean MN cleaning reagent 1L BioClean NK cleaning reagent 1L2 réf. BioClean SYS Cleaning reagent 1L BioClenz enzimatic cleaner concentrate 1L BioClenz Strong enzimatic cleaner concentrate 100mL BioDil AX Diluent 10L BioDil CD 3.5 Diluent 20L BioDil CD Diluent 20L BioDil CT Diluent 10L BioDil M22 diluent 10L BioDil MN diluent 10L BiodDil MN BioDil MN5 diluent 10L BiodDil MN5 BioDil MN53 diluent 10L BiodDil MN53 BioDil NK diluent 10L BiodDil NK BioDil RET reticulocyte buffer 1L BioDil SWE diluent 10L BioDil SYS Diluent 10L BioDil-5 AX Diluent 10L BioDil-5 CT Diluent 10L BioDil-5 NK diluent 10L BiodDil-5 NK BioDil-Diff diluent 10L BioDil-Sheath CD 3.2 Diluent 10L BioDye-4DS SYS WBC-5-diff fluorescent dye 3x42mL BioDye-4DS-eco SYS WBC-5-diff fluorescent dye 3x42mL BioDye-4DS SYS-eco BioDye-NR SYS NRBC fluorescent dye 12mL BioDye-NR-eco SYS NRBC fluorescent dye 12mL BioFix-EO AX Eosinophil/LMNE reagent 0.5L BioFix-EO CT Eosinophil/LMNE reagent 0.5L BioGlobin CD 3.2 Lysing and hemoglobin reagent 1L BioGlobin SYS hemoglobin reagent 1L BioHypoclean hypochlorite cleaning reagent 1L BioHypoclean Strong hypochlorite cleaning reagent 100mL BioLyse AX Lysing/HGB reagent 0.4L BioLyse CD 3 Lysing and hemoglobin reagent 1L BioLyse CD 3.2 Reagent 10L BioLyse CD Lysing reagent 1L BioLyse CT WBC-diff lyse/HGB reagent 0.4L BioLyse M22 WBC-5-diff lysing reagent 0.5L BioLyse MN lysing/HGB reagent 0.5L BioLyse MN5 lysing/HGB reagent 0.5L BioLyse MN53 lysing and hemoglobin reagent 0.5L BioLyse NK lysing reagent 0.5L BioLyse NRBC NRBC specific lysing reagent 1L BioLyse SW WBC-3-diff lysing reagent 1L BioLyse W5P WBC-5-diff lysing reagent 5L BioLyse WIC CD 3.5 Lysing and hemoglobin reagent 1L BioLyse-3WP SYS WBC-3-diff lysing reagent 1L BioLyse-4DL SYS WBC-diff lysing reagent 1L BioLyse-5 NK WBC-5-diff reagent 0.5L BioLyse-BASO AX Basophil reagent 1L BioLyse-Baso MN5 basophil reagent 0.5L BioLyse-BASO-2 AX Basophil reagent 0.5L BioLyse-BASO-2 Basophil reagent 0.5L BioLyse-Diff diluent 1L BioLyse-EO-1 MN5 WBC-4-diff reagent 0.5L BioLyse-EO-1 MN53 WBC-4-diff reagent 0.5L BioLyse-EO-2 MN5 WBC-4-diff reagent 0.5L BioLyse-EO-2 MN53 WBC-4-diff reagent 0.5L BioLyse-FBA SYS basophil reagent 1L BioLyse-FD1 SYS WBC-4-diff reagent 1L BioLyse-FD2 SYS WBC-4-diff reagent 0.5L BioLyse-IM SYS IM specific lyser 1L BioLyse-NR SYS NRBC specific lyser 1L BioLyse-WH SYS WBC-3-diff lysing reagent 0.5L BioPack 5 WBC-5-diff reagent 1pack BioPack AcT-Diff WBC-3-diff reagent BioPack WBC-3-diff reagent Bioresh-SYS Cleaning reagent 1L BioReti Reticulocyte reagent 3.7mL BioReti-Buffer SYS Retikulocyte buffer 1L BioReti-Dye CT reticulocyte reagenst 1set BioReti-Dye SYS Reticulocyte fluorescent dye 12mL BioReti-Dye-eco SYS Reticulocyte fluorescent dye 12mL BioSheath CD 3.5 Reagent 10L BioSheath SYS Sheath reagent 10L BioStabilofix CT stabilizing reagent 0.4L BioStain NRBC fluorescent NRBC 12mL BioStain RET fluorescent reticulocyte 12mL BioStain W5P fluorescent WBC-5-diff dye 42mL Erythro-BioLyse CT lysing reagent 1.5L	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Vidia	Tchéquie	ELISA-VIDITEST anti-Aspergillus fumigatus IgA2 réf.98/79 ELISA-VIDITEST anti-Aspergillus fumigatus IgG2 réf.98/79 ELISA-VIDITEST anti-Aspergillus fumigatus IgM2 réf.98/79 ELISA-VIDITEST anti-BKV IgG2 réf.98/79 ELISA-VIDITEST anti-Borelia recombinant IgG + VIsE (CSF)4 réf.98/79 79 autres ELISA-VIDITEST anti-Borelia recombinant IgM (CSF)4 réf.98/79 ELISA-VIDITEST anti-Chlamydia pneumoniae IgA2 réf.98/79 ELISA-VIDITEST anti-Chlamydia pneumoniae IgG2 réf.98/79 ELISA-VIDITEST anti-Chlamydia pneumoniae IgM2 réf.98/79 ELISA-VIDITEST anti-Chlamydia trachomatis IgA2 réf.98/79 ELISA-VIDITEST anti-Chlamydia trachomatis IgG2 réf.98/79 ELISA-VIDITEST anti-CMV IgG2 réf.98/79 ELISA-VIDITEST anti-CMV IgG (CSF)5 réf.98/79 ELISA-VIDITEST anti-CMV IgG a avidita IgG2 réf.98/79 ELISA-VIDITEST anti-CMV IgG and IgG avidity98/79 ELISA-VIDITEST anti-CMV IgM2 réf.98/79 ELISA-VIDITEST anti-EA (D) EBV IgG3 réf.98/79 ELISA-VIDITEST anti-EA (D) EBV IgM2 réf.98/79 ELISA-VIDITEST anti-EBNA-1 EBV IgG5 réf.98/79 ELISA-VIDITEST anti-HHV-6 IgG3 réf.98/79 ELISA-VIDITEST anti-HHV-6 IgG (CSF)3 réf.98/79 ELISA-VIDITEST anti-HHV-6 IgM3 réf.98/79 ELISA-VIDITEST anti-HSV 1+2 IgG2 réf.98/79 ELISA-VIDITEST anti-HSV 1+2 IgG (CSF)2 réf.98/79 ELISA-VIDITEST anti-HSV 1+2 IgM2 réf.98/79 ELISA-VIDITEST anti-JCV IgG2 réf.98/79 ELISA-VIDITEST anti-Mycoplasma pneumoniae IgA2 réf.98/79 ELISA-VIDITEST anti-Mycoplasma pneumoniae IgG2 réf.98/79 ELISA-VIDITEST anti-Mycoplasma pneumoniae IgM2 réf.98/79 ELISA-VIDITEST anti-Pseudomonas aeruginosa IgG2 réf.98/79 ELISA-VIDITEST anti-TBEV IgG (CSF)2 réf.98/79 ELISA-VIDITEST anti-TBEV IgG and IgG avidity2 réf.98/79 ELISA-VIDITEST anti-TBEV IgM2 réf.98/79 ELISA-VIDITEST anti-Toxoplasma gondii IgG2 réf.98/79 ELISA-VIDITEST anti-Toxoplasma gondii IgG a avidita IgG98/79 ELISA-VIDITEST anti-Toxoplasma gondii IgG and IgG avidity98/79 ELISA-VIDITEST anti-Toxoplasma gondii IgM2 réf.98/79 ELISA-VIDITEST anti-VCA EBV IgG3 réf.98/79 ELISA-VIDITEST anti-VCA EBV IgG (CSF)5 réf.98/79 ELISA-VIDITEST anti-VCA EBV IgG a avidita IgG2 réf.98/79 ELISA-VIDITEST anti-VCA EBV IgG a IgG avidity98/79 ELISA-VIDITEST anti-VCA EBV IgM3 réf.98/79 ELISA-VIDITEST anti-VZV IgG (CSF)4 réf.98/79 ELISA-VIDITEST anti-VZV IgG (CSF) a avidita IgG2 réf.98/79 ELISA-VIDITEST anti-VZV IgM2 réf.98/79 ELISA-VIDITEST Interferon γ2 réf.98/79 MONO -VIDITEST anti-Aspergillus fumigatus IgA2 réf.98/79 MONO-VIDITEST anti-Aspergillus fumigatus IgG2 réf.98/79 MONO-VIDITEST anti-Aspergillus fumigatus IgM2 réf.98/79 MONO-VIDITEST anti-Borrelia sp. IgG + VIsE2 réf.98/79 MONO-VIDITEST anti-Borrelia sp. IgM2 réf.98/79 MONO-VIDITEST anti-Chlamydia pneumonieae IgA2 réf.98/79 MONO-VIDITEST anti-Chlamydia pneumonieae IgG2 réf.98/79 MONO-VIDITEST anti-Chlamydia pneumonieae IgM2 réf.98/79 MONO-VIDITEST anti-Chlamydia trachomatis IgA2 réf.98/79 MONO-VIDITEST anti-Chlamydia trachomatis IgG2 réf.98/79 MONO-VIDITEST anti-CMV IgG2 réf.98/79 MONO-VIDITEST anti-CMV IgG avidita98/79 MONO-VIDITEST anti-CMV IgG avidity98/79 MONO-VIDITEST anti-CMV IgM2 réf.98/79 MONO-VIDITEST anti-EA (D) EBV IgG2 réf.98/79 MONO-VIDITEST anti-EA (D) EBV IgM2 réf.98/79 MONO-VIDITEST anti-EBNA-1 EBV IgG2 réf.98/79 MONO-VIDITEST anti-HHV-6 IgG2 réf.98/79 MONO-VIDITEST anti-HHV-6 IgM2 réf.98/79 MONO-VIDITEST anti-HSV 1+2 IgG2 réf.98/79 MONO-VIDITEST anti-HSV 1+2 IgM2 réf.98/79 MONO-VIDITEST anti-Mycoplasma pneumoniae IgA2 réf.98/79 MONO-VIDITEST anti-Mycoplasma pneumoniae IgG2 réf.98/79 MONO-VIDITEST anti-Mycoplasma pneumoniae IgM2 réf.98/79 MONO-VIDITEST anti-Pseudomonas aeruginosa IgG2 réf.98/79 MONO-VIDITEST anti-TBEV IgG2 réf.98/79 MONO-VIDITEST anti-TBEV IgG avidity2 réf.98/79 MONO-VIDITEST anti-TBEV IgM2 réf.98/79 MONO-VIDITEST anti-Toxoplasma gondii IgG2 réf.98/79 MONO-VIDITEST anti-Toxoplasma gondii IgG avidita98/79 MONO-VIDITEST anti-Toxoplasma gondii IgG avidity98/79 MONO-VIDITEST anti-Toxoplasma gondii IgM2 réf.98/79 MONO-VIDITEST anti-VCA EBV IgG2 réf.98/79 MONO-VIDITEST anti-VCA EBV IgG avidita2 réf.98/79 MONO-VIDITEST anti-VCA EBV IgM2 réf.98/79 MONO-VIDITEST anti-VZV IgG2 réf.98/79 MONO-VIDITEST anti-VZV IgG avidita2 réf.98/79 MONO-VIDITEST anti-VZV IgM2 réf.98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
AB Medical Mandataire UE : KTR Europe GmbH (Allemagne)	Corée du Sud	Sol-M Evacuated Blood Collection Tubes Clot Activator 4.0ml98/79 Sol-M Evacuated Blood Collection Tubes Clot Activator 6.0ml98/79 Sol-M Evacuated Blood Collection Tubes Clot Activator 9.0ml98/79 Sol-M Evacuated Blood Collection Tubes Clot Activator with Gel 3.5ml98/79 Sol-M Evacuated Blood Collection Tubes Clot Activator with Gel 5.0ml98/79 78 autres Sol-M Evacuated Blood Collection Tubes Clot Activator with Gel 8.0ml98/79 Sol-M Evacuated Blood Collection Tubes Clot Activator with Thrombin & Gel 3.5ml98/79 Sol-M Evacuated Blood Collection Tubes EDTA K2 2.0ml98/79 Sol-M Evacuated Blood Collection Tubes EDTA K2 3.0ml98/79 Sol-M Evacuated Blood Collection Tubes EDTA K2 4.0ml98/79 Sol-M Evacuated Blood Collection Tubes EDTA K2 6.0ml98/79 Sol-M Evacuated Blood Collection Tubes EDTA K2 9.0ml98/79 Sol-M Evacuated Blood Collection Tubes EDTA K3 2.0ml98/79 Sol-M Evacuated Blood Collection Tubes EDTA K3 3.0ml98/79 Sol-M Evacuated Blood Collection Tubes EDTA K3 4.0ml98/79 Sol-M Evacuated Blood Collection Tubes EDTA K3 6.0ml98/79 Sol-M Evacuated Blood Collection Tubes EDTA K3 9.0ml98/79 Sol-M Evacuated Blood Collection Tubes EDTA K3 with Gel 3.5ml98/79 Sol-M Evacuated Blood Collection Tubes EDTA K3 with Gel 5.0ml98/79 Sol-M Evacuated Blood Collection Tubes Fluoride EDTA K3 2.0ml98/79 Sol-M Evacuated Blood Collection Tubes Fluoride EDTA K3 4.0ml98/79 Sol-M Evacuated Blood Collection Tubes Lithium Heparin 4.0ml98/79 Sol-M Evacuated Blood Collection Tubes Lithium Heparin 6.0ml98/79 Sol-M Evacuated Blood Collection Tubes Lithium Heparin 9.0ml98/79 Sol-M Evacuated Blood Collection Tubes Lithium Heparin and Gel 3.5ml98/79 Sol-M Evacuated Blood Collection Tubes Lithium Heparin and Gel 5.0ml98/79 Sol-M Evacuated Blood Collection Tubes Lithium Heparin and Gel 8.0ml98/79 Sol-M Evacuated Blood Collection Tubes No Additive 4.0ml98/79 Sol-M Evacuated Blood Collection Tubes No Additive 6.0ml98/79 Sol-M Evacuated Blood Collection Tubes No Additive 9.0ml98/79 Sol-M Evacuated Blood Collection Tubes Trisodium Citrate 0.109M 1.8ml98/79 Sol-M Evacuated Blood Collection Tubes Trisodium Citrate 0.109M 2.7ml98/79 V-PBMC P7280DP98/79 V-TUBE 10090098/79 V-TUBE 11040098/79 V-TUBE 12060098/79 V-TUBE 30090198/79 V-TUBE 30180298/79 V-TUBE 31020198/79 V-TUBE 31030198/79 V-TUBE 31040198/79 V-TUBE 31135298/79 V-TUBE 32060198/79 V-TUBE 32150298/79 V-TUBE 40090398/79 V-TUBE 41020398/79 V-TUBE 41030398/79 V-TUBE 41040398/79 V-TUBE 41135498/79 V-TUBE 42060398/79 V-TUBE 42150498/79 V-TUBE 50090398/79 V-TUBE 51020398/79 V-TUBE 51030398/79 V-TUBE 51040398/79 V-TUBE 52060398/79 V-TUBE 61036798/79 V-TUBE 63018798/79 V-TUBE 63027798/79 V-TUBE 70090598/79 V-TUBE 70180698/79 V-TUBE 71020598/79 V-TUBE 71030598/79 V-TUBE 71040598/79 V-TUBE 71135698/79 V-TUBE 7206052 réf.98/79 V-TUBE 72150698/79 V-TUBE 80090A98/79 V-TUBE 81020A98/79 V-TUBE 81030A98/79 V-TUBE 81040A98/79 V-TUBE 82060A98/79 V-TUBE 91020898/79 V-TUBE 91030898/79 V-TUBE 91040898/79 V-TUBE A1016998/79 V-TUBE B0180B98/79 V-TUBE B1135B98/79 V-TUBE B2150B98/79 V-TUBE C3018298/79 V-TUBE C3027298/79 V-TUBE D0090098/79 V-URINE Preservative Tube 9.0ml3 réf.	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Human	Allemagne	Automatic Sample Loader98/79 CMV IgG98/79 Dengue IgG ELISA98/79 Dengue IgM ELISA98/79 Elisys Duo 77 autres Elisys Quattro Elisys Uno H. pylori IgA ELISA98/79 H. pylori IgG ELISA98/79 HC-Acute HC-Calibrator98/79 HC-Cleaner HC-Control98/79 HC-Diluent HC-Lyse CF HC-Regular HC5D-CBC-Lyse HC5D-Clean HC5D-Control98/79 HC5D-Diff-Lyse HC5D-Diluent HC5L-Control98/79 HC5L-Diff HC5L-Diluent HC5L-Lyse HEMOGLOBIN liquicolor98/79 HemoStat Antithrombin liquid98/79 HemoStat aPTT-EL4 réf.98/79 HemoStat Calibrator98/79 HemoStat Control Plasma abnormal98/79 HemoStat Control Plasma normal98/79 HemoStat D-Dimer2 réf.98/79 HemoStat D-Dimer Control high/low98/79 HemoStat Fibrinogen98/79 HemoStat free Protein S98/79 HemoStat Protein C HemoStat Thrombin Time98/79 HemoStat Thromboplastin liquid98/79 HemoStat Thromboplastin-SI2 réf.98/79 Herpes-Simplex (HSV) 1 IgG ELISA98/79 Herpes-Simplex (HSV) 2 IgG ELISA98/79 HSRate-Control98/79 HumaBlot 44FA HumaCLIA 150 HumaClot Duo Plus HumaClot Junior HumaClot Pro HumaClot Quattro HumaCount 30TS98/79 HumaCount 5D98/79 HumaCount 5D CRP98/79 HumaCount 5L98/79 HumaCount 80TS98/79 HumaLoop M HumaLoop T HumaLyte Plus 3 HumaLyte Plus 5 HumaLyzer 4000 HumaLyzer Primus HumaLyzer Primus NG HumaMeter A1c HumaNex A1c Variant HumaReader HS HumaReader Single plus HumaSRate24PT98/79 HumaStar 100 HumaStar 200 HumaStar 300SR HumaStar 600 HumaTex Febrile Antigens Control PC/NC98/79 HumaVision HuMax HCT2 réf. IMTEC-Salmononella-Antibodies IgA (cut-off)98/79 IMTEC-Salmononella-Antibodies Screen (cut-off)98/79 Measles IgG ELISA98/79 Syphilis RPR Test3 réf.98/79 Syphilis TPHA liquid98/79 Toxo IgM µ-capture ELISA98/79 Toxoplasma g. IgG ELISA98/79 Varicella-Zoster (VZV) IgG ELISA98/79 HSV IgM ELISA98/79 (plus commercialisé) IM Quick Test98/79 (plus commercialisé)	A, B IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Sanymed	Italie	AH - Salmonella Paratyphi AH Serology R1: 1x5ml98/79 AO - Salmonella Paratyphi AO Serology R1: 1x5ml98/79 aPTT - Tromboplastina parz. attivata / Activated Part. Thromboplastin (Ellagic Acid) Bulk R1:1000mL + R2:1000mL98/79 aPTT - Tromboplastina parz. attivata / Activated Part. Thromboplastin (Ellagic Acid) Coagulation R1:2x4mL + R2:2x4mL98/79 AT - Salmonella Paratyphi A Total Serology R1: 1x5ml98/79 75 autres ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) BT Line R1:1x40mL - 160 Test98/79 ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) Bulk R1:1000mL98/79 ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) MULTI-PURPOSE KIT R1:2x20mL98/79 ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) SA1500/2500 R1:1x40mL - 160 Test98/79 ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) SA2000 R1:2x20mL - 160 Test98/79 ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) SA3500/4500/330 R1:1x40mL - 160 Test98/79 ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) Sphera R1:1x40mL - 160 Test98/79 ATIII - Antitrombina III / Antithrombin III (RID) RID R1: 1x15 Test98/79 BA - Brucella Abortus Serology R1: 1x5ml98/79 BBR - Brucella Bengal Rose Serology R1: 1x5ml + CTL+ : 1x0,5ml + CTL- : 1x0,5ml98/79 BH - Salmonella Paratyphi BH Serology R1: 1x5ml98/79 BM - Brucella Melitensis Serology R1: 1x5ml98/79 BO - Salmonella Paratyphi BO Serology R1: 1x5ml98/79 BRT - Brucella Total Serology R1: 1x5ml98/79 BT - Salmonella Paratyphi B TOTAL Serology R1: 1x5ml98/79 CH - Salmonella Paratyphi CH Serology R1: 1x5ml98/79 CO - Salmonella Paratyphi CO Serology R1: 1x5ml98/79 Coag Cal - Coagulazione CAL / Coagulation CAL Coagulation R1: 6x1ml (Lyophilized)98/79 Coag Ctrl H - Coagulazione CTRL H / Coagulation CTRL H Coagulation R1: 6x1ml (Lyophilized)98/79 Coag Ctrl N - Coagulazione CTRL N / Coagulation CTRL N Coagulation R1: 6x1ml (Lyophilized)98/79 COAG-1003 réf. D-D - D-Dimero / D-Dimer (Turbilatex) BT Line R1:1x24mL + R2:1x8mL - 120 Test98/79 D-D - D-Dimero / D-Dimer (Turbilatex) Bulk R1:750mL + R2:250mL98/79 D-D - D-Dimero / D-Dimer (Turbilatex) MULTI-PURPOSE KIT R1:2x12mL + R2:1x8mL98/79 D-D - D-Dimero / D-Dimer (Turbilatex) SA1500/2500 R1:1x24mL + R2:1x8mL - 120 Test98/79 D-D - D-Dimero / D-Dimer (Turbilatex) SA2000 R1:1x24mL + R2:1x8mL - 100 Test98/79 D-D - D-Dimero / D-Dimer (Turbilatex) SA3500/4500/330 R1:1x48mL + R2:1x16mL - 240 Test98/79 D-D - D-Dimero / D-Dimer (Turbilatex) Sphera R1:1x24mL + R2:1x8mL - 120 Test98/79 D-D Cal H - D-Dimero CAL H / D-Dimer CAL H MULTI-PURPOSE KIT CAL: 1x1mL (Lyophilized)98/79 D-D Ctrl - D-Dimero CTRL 2 Liv. / D-Dimer CTRL 2 Lev. MULTI-PURPOSE KIT CTL1: 1x1mL + CTL2: 1x1mL (Lyophilized)98/79 E - Salmonella Enteritidis Serology R1: 1x5ml98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) BT Line R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) Bulk R1:1000mL98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) MULTI-PURPOSE KIT R1:2x20mL98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) SA1500/2500 R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) SA2000 R1:2x20mL - 140 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) SA3500/4500/330 R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) Sphera R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (RID) RID R1: 1x15 Test98/79 FIB Cal - Fibrinogeno CAL / Fibrinogen CAL MULTI-PURPOSE KIT CAL: 3x0,5mL (Lyophilized)98/79 FIB Ctrl - Fibrinogeno CTRL 2Liv. / Fibrinogen CTRL 2 Lev. MULTI-PURPOSE KIT CTL1: 2x1,5mL + CTL2: 2x0,7mL (Lyophilized)98/79 Fib-C - Fibrinogeno Clauss / Fibrinogen Clauss (Clauss) Coagulation R1:3x3mL + CAL: 1x1ml + CTRL:1x1mL + DIL: 1x9mL (Lyophilized)98/79 Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) BT Line R1: 1x50mL + LYSE: 4x45mL98/79 Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) Bulk R1: 1x1000mL98/79 Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) MULTI-PURPOSE KIT R1: 1x50mL + LYSE: 4x45mL98/79 Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) SA1500/2500 R1: 1x40mL + LYSE: 1x45mL98/79 Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) SA2000 R1: 1x35mL + LYSE: 4x45mL98/79 Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) SA3500/4500/330 L Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) SA3500/4500/330 R1: 1x50mL + LYSE: 1x45mL98/79 Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) Sphera R1: 1x50mL + LYSE: 4x45mL98/79 Hb Ctrl - Emoglobina Totale CTRL 2Liv./ Total Hemoglobin CTRL 2Lev. Bulk CTL:1000mL98/79 Hb Ctrl - Emoglobina Totale CTRL 2Liv./ Total Hemoglobin CTRL 2Lev. MULTI-PURPOSE KIT CTL1:1x3mL + CTL2:1x3mL98/79 Hb STD - Emoglobina Totale STD / Total Hemoglobin STD Bulk STD:1000mL98/79 Hb STD - Emoglobina Totale STD/ Total Hemoglobin STD MULTI-PURPOSE KIT STD:1x5mL98/79 HPY-Ab - H.Pilori (Feci) / / H Pylori (Feces) (Qualitative) Rapid Test R1: 1x25pcs - 25 Test98/79 HPY-Ab - H.Pilori (s/p/w) / H Pylori (s/p/w) (Qualitative) Rapid Test R1: 1x25pcs - 25 Test98/79 Im - Imidazolo / Imidazole (for Fibrinogen) Coagulation R1: 2x50ml98/79 KAO - Caolino / Kaolin (for Fibrinogen) Coagulation R1: 8x1ml98/79 MNI - Mononucleosi (s/p/w) / Mononucleosis (s/p/w) (Qualitative) Rapid Test R1: 1x25pcs - 25 Test98/79 OX19 - Proteus OX19 Serology R1: 1x5ml98/79 POX2 - Proteus OX2 Serology R1: 1x5ml98/79 PT - Tempo di Protrombina / Prothrombin Time (Rabbit Brain) Bulk R1:1000mL98/79 PT - Tempo di Protrombina / Prothrombin Time (Rabbit Brain) Coagulation R1:10x5mL98/79 PT - Tempo di Protrombina / Prothrombin Time (Rabbit Brain) Coagulation R1:4x5mL98/79 RPR - RPR Carbone / RPR Carbon (Haemagglutination) Serology R1: 1x2ml + CTL+: 1x0,5ml + CTL-: 1x0,5ml - 100 Test98/79 SA-15003 réf. SA-65002 réf. SA-C5E Table Top Low speed 5000rpm Strep A - Streptococco A (tamp.) / Streptococcus A (swab) (Qualitative) Rapid Test R1: 1x20pcs - 20 Test98/79 SYP - Sifilide (s/p) / Syphilis (s/p) (Qualitative) Rapid Test R1: 1x20pcs + R2: 1x2ml - 20 Test98/79 TH - Salmonella Typhi H Serology R1: 1x5ml98/79 TO - Salmonella Typhi O Serology R1: 1x5ml98/79 TPHA - Sifilide TPHA / Syphilis TPHA (Haemagglutination) Serology R1: 1x8ml + R2: 1x5,5ml + R3: 1x25ml + CTL+: 1x0,5ml + CTL-: 1x0,5ml - 100 Test98/79 TT - Salmonella Typhi Total Serology R1: 1x5ml98/79 UriSany-500 VDRL - VDRL Agglutinazione / VDRL Agglutination (Reagin Ab) Serology R1: 1x5ml + CTL+: 1x1ml + CTL-: 1x1ml - 250 Test98/79	A IVDR, 98/79	Site web info@sanymed.it Fiche EUDAMED Signaler une erreur
Sysmex FDA Mandataire UE : Sysmex Europe SE (Allemagne)	Japon	Automated Blood Coagulation Analyzer CA-600 series, CA-620 CA-620, CA-650, CA-6603 réf. Automated Blood Coagulation Analyzer CN-3000 Automated Blood Coagulation Analyzer CN-3500 Automated Blood Coagulation Analyzer CN-6000 Automated Blood Coagulation Analyzer CN-6500 77 autres Automated Blood Coagulation Analyzer CN-700 AUTOMATED BLOOD COAGULATION ANALYZER CS-1600 AUTOMATED BLOOD COAGULATION ANALYZER CS-2400 AUTOMATED BLOOD COAGULATION ANALYZER CS-2500 AUTOMATED BLOOD COAGULATION ANALYZER CS-5100 Automated Hematology Analyzer XN series, XN-1098/79 Automated Hematology Analyzer XN series, XN-2098/79 Automated Hematology Analyzer XN-L series, XN-33098/79 Automated Hematology Analyzer XN-L series, XN-35098/79 Automated Hematology Analyzer XN-L series, XN-43098/79 Automated Hematology Analyzer XN-L series, XN-45098/79 Automated Hematology Analyzer XN-L series, XN-53098/79 Automated Hematology Analyzer XN-L series, XN-55098/79 Automated Hematology Analyzer XP series, XP-30098/79 AUTOMATED HEMATOLOGY ANALYZER, pocH-100i98/79 Automated Hematology Slide Preparation Unit SP-50 Automated Immunoassay System HISCL-5000 Automated Immunoassay System HISCL-800 CELLCLEAN CELLCLEAN AUTO CELLPACK2 réf. CELLPACK DCL3 réf. CELLPACK DFL2 réf. CELLPACK DST3 réf. CUVETTE, SUC-400A CyLyse LV EIGHTCHECK-3WP-H2 réf.98/79 EIGHTCHECK-3WP-L2 réf.98/79 EIGHTCHECK-3WP-N2 réf.98/79 Flow Cytometer XF-1600 Fluorocell M Fluorocell PLT Fluorocell RET2 réf. Fluorocell WDF3 réf. Fluorocell WNR Fluorocell WPC Fully Automated Urine Chemistry Analyzer UC-350098/79 Fully Automated Urine Particle Analyzer UF-400098/79 Fully Automated Urine Particle Analyzer UF-500098/79 Fully Automated Urine Particle Digital Imaging Device UD-10 Gene Amplification Detector RD-210 HISCL Cuvette (CN Series) HISCL HIT IgG Assay Kit HISCL HIT IgG Calibrator HISCL HIT IgG Control Lysercell M Lysercell WDF3 réf. Lysercell WDF II2 réf. Lysercell WNR3 réf. Lysercell WPC Platelet CHECK2 réf.98/79 pocH-pack 65 pocH-pack 65XL Pretreatment System RP-10 REACTION TUBE, SU-40 SAMPLE PLATE, SAP-400A SB Cuvette SB Cuvette II SCS-100098/79 Semi-Automated Urine Chemistry Analyzer UC-1000 STROMATOLYSER-WH SULFOLYSER3 réf. UC-1100 Semi-Automated Urine Chemistry Analyzer UF-1500 Fully Automated Urine Particle Analyzer98/79 XN CAL98/79 XN CAL PF98/79 XN CHECK6 réf.98/79 XN CHECK BF2 réf.98/79 XN-L CHECK3 réf.98/79 XQ-320 XQ-Series Automated Hematology Analyzer98/79 XQ-520 XQ-Series Automated Hematology Analyzer98/79 XR-10 XR-Series Automated Hematology Analyzer98/79 XR-20 XR-Series Automated Hematology Analyzer98/79 RET-SEARCH(II) (plus commercialisé) STROMATOLYSER-4DL2 réf. (plus commercialisé) STROMATOLYSER-4DS2 réf. (plus commercialisé) STROMATOLYSER-FB (plus commercialisé)	A, C IVDR, 98/79	Présent sur le marché en France ra_archive@sysmex.co.jp Fiche EUDAMED Signaler une erreur
Boditech FDA Mandataire UE : Obelis s.a. (Belgique)	Corée du Sud	10 μL Capillary tube 30 μL Capillary tube 35 μL Capillary tube 5 μL Capillary tube2 réf. 50uL Capilary tube 73 autres AFIAS COVID-19 Ag98/79 AFIAS D-Dimer98/79 AFIAS D-Dimer Neo98/79 AFIAS Dengue IgG/IgM AFIAS Dengue NS1 Ag98/79 AFIAS Flu A+B98/79 AFIAS H.pylori SA98/79 AFIAS IL-6 AFIAS NORO AFIAS ROTA98/79 AFIAS RSV98/79 AFIAS Strep A98/79 AFIAS-1 AFIAS-10 AFIAS-1H AFIAS-3 AFIAS-6 Alchemis Boditech CHIKV IgG/IgM Control98/79 Boditech COVID-19 Ag Control98/79 Boditech COVID-19 Ag Control Swab98/79 Boditech Dengue IgG/IgM Control98/79 Boditech Dengue NS1 Ag Control98/79 Boditech H. pylori Ag Calibrator98/79 Boditech H. pylori Ag Control98/79 Boditech IGRA-TB Control Boditech NORO Control98/79 Boditech ROTA Control98/79 Boditech Rota/Adeno Control98/79 C-tip (10 μL) C-tip (30 μL) CBChroma™ Chemichroma™ ExAmplex MTB/NTM kit98/79 EZ POC Analyzer EZ POC COVID-19 Ag98/79 EZ POC D-Dimer98/79 EZ POC Dengue IgG/IgM98/79 EZ POC Dengue NS1 Ag98/79 EZ POC IL-698/79 EZ POC Influenza A+B98/79 EZ POC RSV98/79 ez-Track¹ hemochroma PLUS Calibrator hemochroma PLUS Control hemochroma PLUS Control Set i-Chamber FPRR009 i50P Red tip ichroma™ Adeno98/79 ichroma™ CHIKV IgG/IgM98/79 ichroma™ COVID-19 Ag98/79 ichroma™ D-Dimer98/79 ichroma™ D-Dimer Neo98/79 ichroma™ Dengue IgG/IgM ichroma™ Dengue NS1 Ag ichroma™ H. pylori SA98/79 ichroma™ IGRA-TB Tube2 réf. ichroma™ II ichroma™ III ichroma™ IL-698/79 ichroma™ Influenza A+B98/79 ichroma™ M2 ichroma™ M3 ichroma™ Mycoplasma98/79 ichroma™ RSV98/79 ichroma™ Strep A98/79 ichroma™ Trio ichroma™-50 ichroma™-50 PLUS Microcuvettes QDx Instacheck™-II Rapid-OR³ Urochroma™	A, B, C IVDR, 98/79	Présent sur le marché en France Site web marketing@boditech.co.kr Fiche EUDAMED Signaler une erreur
Copan Italia FDA	Italie	1mL eNAT MEDIUM+ REGULAR FLOQSwab+ PASTEUR PIPET98/79 1mL eNAT PRESERVATION MEDIUM FOR NUCLEIC ACIDS98/79 2mL eNAT MEDIUM + REGULAR FLOQSwab + PASTEUR PIPET98/79 2mL eNAT MOLECULAR COLLECTION & PRESERVATION MEDIUM98/79 2mL eNAT PRESERVATION MEDIUM FOR NUCLEIC ACIDS98/79 73 autres BC+ BD FCT2 réf. BD Universal Viral Transport6 réf. binx healt Product Number: 5.001.050 Male Urine Specimen Collection Kit98/79 Empty Tube eMRSA Broth eNAT2 réf. GN Broth Inoculation Loops HARD LOOP 1 µL STERILE, IN BAGS OF 20 PCS98/79 Inoculation Loops Hard loop 1 ul sterile in resealable bags of 40 pcs98/79 Inoculation Loops HARD LOOP 1 UL STERILE, IN BAGS OF 10 PCS2 réf.98/79 Inoculation Loops Hard loop 1 ul sterile, in bags of 20 pcs98/79 Inoculation Loops HARD LOOP 1 UL STERILE, SINGLE WRAPPED98/79 Inoculation Loops HARD LOOP 10 µl STERILE, IN BAGS OF 20 PCS98/79 Inoculation Loops HARD LOOP 10 UL STERILE, IN BAG OF 50 PCS98/79 Inoculation Loops HARD LOOP 10 UL STERILE, IN BAGS OF 10 PCS98/79 Inoculation Loops HARD LOOP 10 UL STERILE, IN BAGS OF 20 PCS98/79 Inoculation Loops HARD LOOP 10 UL STERILE, IN RESEALABLE BAGS OF 40 PCS98/79 Inoculation Loops HARD LOOP 10 µL STERILE, IN RESEALABLE BAGS OF 40 PCS98/79 Inoculation Loops HARD LOOPS 10 UL STERILE, SINGLE WRAPPED98/79 Inoculation Loops LOOPS OF 10 µL98/79 Inoculation Loops SOFT LOOP 1 UL STERILE, IN BAG OF 10 PCS98/79 Inoculation Loops SOFT LOOP 1 ul STERILE, IN BAGS OF 10 PCS98/79 Inoculation Loops SOFT LOOP 1 ul STERILE, IN RESEALABLE BAGS OF 40 PCS98/79 Inoculation Loops SOFT LOOP 10 UL STERILE, IN BAG OF 10 PCS98/79 Inoculation Loops SOFT LOOP 10 UL STERILE, IN BAGS OF 10 PCS98/79 Inoculation Loops SOFT LOOP 10 ul STERILE, IN BAGS OF 20 PCS98/79 Inoculation Loops SOFT LOOP 10 ul STERILE, IN RESEALABLE BAGS OF 40 PCS98/79 Inoculation Loops SOFT LOOP 10 µL STERILE, IN BAG OF 20 PCS98/79 Inoculation Loops SOFT LOOP 10 µL STERILE, IN RESEALABLE BAGS OF 40 PCS98/79 Inoculation Loops SOFT LOOP 1ul STERILE, IN BAGS OF 20 PCS98/79 Inoculation Loops SOFT LOOPS 1 UL STERILE, IN BAG OF 20 PCS98/79 Inoculation Loops SOFT LOOPS 1 UL STERILE, IN BAG OF 40 PCS98/79 Inoculation Loops SOFT LOOPS 1 UL STERILE, IN BAG OF 50 PCS98/79 Inoculation Loops SOFT LOOPS 1 UL STERILE, SINGLE WRAPPED98/79 Inoculation Loops SOFT LOOPS 1 µl STERILE IN RESEABLE BAG 40 PCS PACKED98/79 Inoculation Loops SOFT LOOPS 10 ul STERILE, IN BAG OF 50 PCS98/79 Inoculation Loops SOFT LOOPS 10 UL STERILE, SINGLE WRAPPED98/79 Inoculation Loops STERILE HARD 1 µL LOOPS IN RESEALABLE BAG OF 40 PCS98/79 Inoculation Loops STERILE HARD 1 UL LOOPS IN RESEALABLE BAG OF 40 PCS98/79 Inoculation Needles98/79 Inoculation Needles HARD LOOPS 10 UL STERILE, IN BAGS OF 10 PCS98/79 Inoculation Needles INOCULATION MINI NEEDLES 10/POUCH IRRAD.98/79 Inoculation Needles INOCULATION NEEDLE STERILE, IN RESEALABLE BAGS OF 40 PCS98/79 Inoculation Needles MINI NEEDLES STERILE 10 PCS PACKED98/79 Inoculation Needles MINI NEEDLES STERILE 20 PCS PACKED98/79 Inoculation Needles STERILE NEEDLE 20 PIECES PACKED98/79 Inoculation Needles STERILE NEEDLES 20 PIECES PACKED98/79 Inoculation Needles STERILE NEEDLES IN RESEALABLE BAG OF 40 PIECES98/79 INOCULATION NEEDLES STERILE, IN BAGS OF 20 PCS98/79 LBM Myco TB2 réf. LBM BH Broth LBM CABroth LBM LIM Broth4 réf. LBM Selenite3 réf. LBM SL Solution3 réf. LBM Thiol Broth LBM TSB LBM TSB Salt5 réf. MSwab6 réf. SELF FLOQSwabs Self UriSponge SMART eNAT STERILE HARD 10 UL INOCULATION LOOPS 10 PCS PACKED98/79 STERILE HARD 1UL INOCULATION LOOPS 10 PCS PACKED98/79 STERILE SOFT 1 UL INOCULATION LOOPS 10 PCS PACKED98/79 STERILE SOFT 10 UL INOCULATION LOOPS 10 PCS PACKED98/79 TSB Broth TUBE 12X80 WITH RED CAP, STERILE, INDIVIDUALLY WRAPPED98/79 UBM6 réf. UriFree UriSponge5 réf. UTM4 réf.	A IVDR, 98/79	Site web regulatory.affairs@copangroup.com Fiche EUDAMED Signaler une erreur
R-Biopharm FDA	Allemagne	RIDA qLine® Scan RIDASCREEN® Adenovirus3 réf. RIDASCREEN® Astrovirus3 réf. RIDASCREEN® Campylobacter3 réf. RIDASCREEN® Clostridium difficile GDH3 réf. 73 autres RIDASCREEN® Clostridium difficile Toxin A/B3 réf. RIDASCREEN® Control - RIDASCREEN® Cryptosporidium3 réf. RIDASCREEN® Diluent 1 RIDASCREEN® Entamoeba3 réf. RIDASCREEN® Giardia3 réf. RIDASCREEN® Helicobacter3 réf. RIDASCREEN® Legionella3 réf. RIDASCREEN® Norovirus 3rd Generation3 réf. RIDASCREEN® Rotavirus3 réf. RIDASCREEN® Stop RIDASCREEN® Substrate RIDASCREEN® TDM Wash buffer 20x RIDASCREEN® Verotoxin3 réf. RIDASCREEN® Wash buffer 10x RIDA® TB Tubes RIDA® Vision RIDA®GENE Adenovirus98/79 RIDA®GENE Bacterial Stool Panel98/79 RIDA®GENE Bacterial Stool Panel I98/79 RIDA®GENE Bordetella98/79 RIDA®GENE CAP Bac3 réf. RIDA®GENE Clostridium difficile98/79 RIDA®GENE E. coli Stool Panel I98/79 RIDA®GENE EAEC98/79 RIDA®GENE EHEC/EPEC98/79 RIDA®GENE Enterovirus98/79 RIDA®GENE ETEC/EIEC98/79 RIDA®GENE Flu98/79 RIDA®GENE Flu & SARS-CoV-298/79 RIDA®GENE Helicobacter pylori98/79 RIDA®GENE Hospital Stool Panel98/79 RIDA®GENE Legionella98/79 RIDA®GENE MRSA RIDA®GENE Norovirus98/79 RIDA®GENE Norovirus I & II98/79 RIDA®GENE Parainfluenza98/79 RIDA®GENE Parasitic Stool Panel I98/79 RIDA®GENE Parasitic Stool Panel II98/79 RIDA®GENE SARS-CoV-298/79 RIDA®GENE STI Mycoplasma Panel98/79 RIDA®Prime H. pylori BDM RIDA®Q3 RIDA®Quick C. difficile GDH Toxin A/B Combi2 réf. RIDA®QUICK Campylobacter2 réf. RIDA®QUICK Clostridium difficile GDH2 réf. RIDA®QUICK Clostridium difficile Toxin A/B2 réf. RIDA®QUICK Cryptosporidium98/79 RIDA®QUICK Entamoeba98/79 RIDA®QUICK Giardia98/79 RIDA®QUICK Helicobacter2 réf. RIDA®QUICK Norovirus2 réf. RIDA®QUICK Parasite Combi Control98/79 RIDA®QUICK Rotavirus98/79 RIDA®QUICK Rotavirus/Adenovirus Combi Control98/79 RIDA®QUICK SCAN II RIDA®TUBE RIDA®TUBE Calprotectin RIDA®UNITY RIDA®UNITY Bacterial Stool Panel RIDA®UNITY Bordetella RIDA®UNITY C. difficile RIDA®UNITY CAP Bac RIDA®UNITY E. coli Stool Panel I RIDA®UNITY E. coli Stool Panel III RIDA®UNITY EHEC/EPEC RIDA®UNITY Flu RIDA®UNITY Norovirus I & II RIDA®UNITY Parainfluenza RIDA®UNITY Parasitic Stool Panel II RIDA®UNITY SARS-CoV-2 DT RIDA®UNITY Universal Extraction Kit RIDA®GENE Norovirus GI_GII98/79 (plus commercialisé)	A, B, C IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Fortress Diagnostics	Irlande du Nord	APTT Reagent with Calcium Chloride (Liquid Stable) COAG110A98/79 CELLCLEAN AUTO HAEM042G98/79 Celldiff Diluent HAEM09198/79 Celldiff Fluorescent Dye HAEM510A98/79 Celldiff LD-5 lyse HAEM510B98/79 72 autres Celldiff LH-5 Lyse HAEM510C98/79 CELLDIFF+ CLEAN HAEM042A98/79 CELLDIFF+ CLEAN HAEM042B98/79 CELLDIFF+ CLEAN HAEM042C98/79 CELLDIFF+ DILUENT HAEM034A98/79 CELLDIFF+ ENHANCED CLEANER HAEM033A98/79 Celldiff-560 CELLD56098/79 CLEANER NK HAEM09398/79 D-Dimer Control (Level I) COAG134A98/79 D-Dimer Control (Level II) COAG135A98/79 D-Dimer Latex Kit COAG115D98/79 D-Dimer Latex Kit COAG115E98/79 Diluent Concentrate - Powder HAEM034Q98/79 DILUENT MR HAEM66MR98/79 DILUENT NK HAEM66NK98/79 DILUENT ST HAEM66ST98/79 Diluent/Sheath HAEM67DA98/79 DYE-WDF HAEM035C98/79 DYE-WNR HAEM035B98/79 FACTOR V Assay Kit COAG128B98/79 FACTOR XI Assay Kit COAG133B98/79 Fibrinogen (L.S) Immunoturbidimetric, Multipoint BXC0442A98/79 Fortress Cell Screen 1-2-3 BGGCS12398/79 H.Pylori Device (WB/S/P) HPYC002098/79 H.Pylori Device (WB/S/P) HPYC004098/79 HAEM09298/79 Haematology Calibrator HAEMC00598/79 Haematology Control (3 Levels - 3x3x3ml) HAEMC00498/79 Haematology Control (Level 1) HAEMC00198/79 Haematology Control (Level 2) HAEMC00298/79 Haematology Control (Level 3) HAEMC00398/79 Haematology Control L2, 9 Parameter CHEMA3L298/79 HAEMATOLOGY CONTROL LOW HAEM003L98/79 Haematology Control Normal HAEMC00Z98/79 HbA2 Calibrator Set (Normal & Abnormal) BXC0664A98/79 Helicobacter Pylori Test Strip (Serum/Plasma) HPS0005098/79 Helicobacter Pylori, IgM ELISA BXE0674A98/79 HGB/NOC Lyse HAEM67HA98/79 LYSE-4DL HAEM043D98/79 LYSE-4DS HAEM043C98/79 LYSE-FBA HAEM043B98/79 LYSE-SWH HAEM043W98/79 LYSER-SLS HAEM043O98/79 LYSER-WDF HAEM043Q98/79 LYSER-WNR HAEM043P98/79 Plasma Control Level I & II (COAG112A)98/79 Plasma Control Level I COAG108A98/79 Plasma Control Level II COAG109A98/79 Proteus OXK FEPOXK0598/79 PT High Sensitivity (Liquid Stable) ISI ~1.15 COAG101C98/79 Rose Bengal FEBRB01L98/79 Salmonella AH FEBSAF1L98/79 Salmonella BH FEBSBH1L98/79 Salmonella O, Salmonella H + Positive Control FEBSOH0598/79 Salmonella paratyphi A-H FEBAH35798/79 Salmonella paratyphi A-H FEBSAH0598/79 Salmonella paratyphi A-H FEBSAH35798/79 Salmonella paratyphi A-O FEBSAO35798/79 Salmonella paratyphi B-H FEBBH35798/79 Salmonella paratyphi B-H FEBSBH0598/79 Salmonella paratyphi B-H FEBSBH35798/79 Salmonella paratyphi B-O FEBSBO0598/79 Salmonella paratyphi C-H FEBSCH0598/79 Salmonella paratyphi C-O FEBSCO0598/79 Salmonella Typhi H (Trays) FEBTH35798/79 Salmonella typhi H FEBSTH0598/79 Salmonella typhi H FEBSTH1L98/79 Salmonella Typhi O (Trays) FEBTO35798/79 Salmonella typhi O FEBSTO0598/79 Salmonella typhi O FEBSTO1L98/79 Urine Cleanser URSAUC0198/79 WBC Lyse HAEM67WA98/79	– 98/79	Site web info@fortressdiagnostics.com Fiche EUDAMED Signaler une erreur
Pro-Lab Diagnostics Mandataire UE : Advena Limited (Malte)	Canada	Bulk E.coli O157 Latex Reagent98/79 Bulk E.coli O157 Negative Control Latex Reagent98/79 Bulk Streptococcal Enzyme Group A Latex Reagent98/79 Bulk Streptococcal Enzyme Group B Latex Reagent98/79 Bulk Streptococcal Enzyme Group C Latex Reagent98/79 72 autres Bulk Streptococcal Enzyme Group D Latex Reagent98/79 Bulk Streptococcal Enzyme Group F Latex Reagent98/79 Bulk Streptococcal Enzyme Group G Latex Reagent98/79 C. difficile GDH EIA Kit98/79 C.difficile GDH Rapid Test Kit PL.3001C98/79 E. coli Non-O157 Identification Kit98/79 E.coli O157 Antiserum98/79 E.coli O157 Latex Test Reagent Kit2 réf.98/79 Extraction Reagent Set PL.04698/79 L. pneumophila DFA Mounting Medium98/79 L. pneumophila DFA Negative Control Reagent98/79 L. pneumophila DFA serogroup 1 to 14 Positive Control98/79 L. pneumophila Negative Control Latex Reagent98/79 L. pneumophila serogroup 1 DFA Kit98/79 L. pneumophila serogroup 1 Latex Reagent98/79 L. pneumophila serogroup 1 Negative Control Latex Reagent98/79 L. pneumophila serogroup 1 Positive Control Reagent98/79 L. pneumophila serogroup 1 to 14 DFA Kit98/79 L. pneumophila serogroup 1-14 Positive Control98/79 L. pneumophila serogroup 10 DFA Reagent98/79 L. pneumophila serogroup 10 Latex Reagent98/79 L. pneumophila serogroup 11 DFA Reagent98/79 L. pneumophila serogroup 11 Latex Reagent98/79 L. pneumophila serogroup 12 DFA Reagent98/79 L. pneumophila serogroup 12 Latex Reagent98/79 L. pneumophila serogroup 13 DFA Reagent98/79 L. pneumophila serogroup 13 Latex Reagent98/79 L. pneumophila serogroup 14 DFA Reagent98/79 L. pneumophila serogroup 14 Latex Reagent98/79 L. pneumophila serogroup 2 DFA Reagent98/79 L. pneumophila serogroup 2 Latex Reagent98/79 L. pneumophila serogroup 3 DFA Reagent98/79 L. pneumophila serogroup 3 Latex Reagent98/79 L. pneumophila serogroup 4 DFA Reagent98/79 L. pneumophila serogroup 4 Latex Reagent98/79 L. pneumophila serogroup 5 DFA Reagent98/79 L. pneumophila serogroup 5 Latex Reagent98/79 L. pneumophila serogroup 6 DFA Reagent98/79 L. pneumophila serogroup 6 Latex Reagent98/79 L. pneumophila serogroup 7 DFA Reagent98/79 L. pneumophila serogroup 7 Latex Reagent98/79 L. pneumophila serogroup 8 DFA Reagent98/79 L. pneumophila serogroup 8 Latex Reagent98/79 L. pneumophila serogroup 9 DFA Reagent98/79 L. pneumophila serogroup 9 Latex Reagent98/79 Phosphate Buffer Saline PL.21298/79 Staph Latex Kit2 réf.98/79 Staph Xtra Latex Kit2 réf.98/79 Streptococcal Acid Extraction Reagent 198/79 Streptococcal Acid Extraction Reagent 298/79 Streptococcal Acid Extraction Reagent 398/79 Streptococcal Acid Group A Latex Reagent PL.03198/79 Streptococcal Acid Group B Latex Reagent PL.03298/79 Streptococcal Acid Group C Latex Reagent PL.03398/79 Streptococcal Acid Group D Latex Reagent PL.03498/79 Streptococcal Acid Group F Latex Reagent PL.03598/79 Streptococcal Acid Group G Latex Reagent PL.03698/79 Streptococcal Acid Positive Control PL.04098/79 Streptococcal Enzyme Extraction Reagent PL.105798/79 Streptococcal Enzyme Group A Latex Reagent PL.105198/79 Streptococcal Enzyme Group B Latex Reagent PL.105298/79 Streptococcal Enzyme Group C Latex Reagent PL.105398/79 Streptococcal Enzyme Group D Latex Reagent PL.105498/79 Streptococcal Enzyme Group F Latex Reagent PL.105598/79 Streptococcal Enzyme Group G Latex Reagent PL.105698/79 Streptococcal Enzyme Kit PL.105098/79 Streptococcal Enzyme Polyvalent Positive Control PL.105898/79 Streptococcal Grouping Latex Kit PL.03098/79 Streptococcal Xtra Group A Latex Reagent98/79 Streptococcal Xtra Group B Latex Reagent98/79 Streptococcal Xtra Select Kit98/79 Streptococcal-Select Grouping Latex Kit98/79	– 98/79	Site web support@pro-lab.com Fiche EUDAMED Signaler une erreur
Clonit	Italie	Adenovirus Card CLZC19402098/79 Bact Extra Pure Kit EDR004050 Campylobacter spp. Card CLZC100798/79 Chlamydia trachomatis RT-2298/79 CloNext Bacterial DNA Extraction Kit OP02006-48 70 autres CloNext Blood DNA Extraction Kit 1200 OP02002-48 CLONEXT BLOOD DNA EXTRACTION KIT 200 OP02001-48 Clonext CF DNA Extraction Kit LV OP02025-48 CloNext CFC DNA Extraction Kit OP02017-48 CLONEXT CULTURED CELL DNA EXTRACTION KIT OP02005-48 CLONEXT FFPE DNA EXTRACTION KIT OP02009-48 CloNext HPV DNA Extraction Kit for Swab Sample OP02007-48 CloNext Plant DNA Extraction Kit OP02014-48 CloNext TB DNA Extraction Kit OP02008-48 CloNext Tissue DNA Extraction Kit OP02004-48 CLONEXT TOTAL RNA EXTRACTION KIT OP02015-48 CloNext Viral Nucleic Acid Extraction Kit LV OP02016-48 CloNext Viral Nucleic Acid Extraction Kit OP02003-48 CloNext Viral RNA Extraction Kit OP02013-48 CLONEXT VIRAL/PATHOGEN NUCLEIC ACID EX KIT A OP02011-48 CLONEXT VIRAL/PATHOGEN NUCLEIC ACID EX KIT B OP02012-48 Clonit’nGo Tick Borne Diseases CLNG-96-7798/79 Clostridium difficile tox A+B CLZC19405598/79 DENGUE Serotyping RT-0398/79 Duplica BLOOD DNA Kit EDI002250 Duplica NA Body Fluid Kit EDI004200 Duplica Real Time Advanced C. Difficile A/B Kit EBR02603298/79 Duplica Real Time Neisseria gonorrhoeae 2nd Generation Detection Kit EBR01803298/79 Duplica Real Time Next Trichomonas vaginalis Kit EBR03803298/79 Fassst DNA Releaser EMR057050 Giardia Card CLZC101698/79 Legionella Card CLZC8410098/79 LEISHMANIA SPP RT-6398/79 MALARIA PANEL RT-6198/79 MALARIA SCREENING RT-6698/79 O157 – E. COLI CARD CLZC101098/79 PAPILLOMA VIRUS NESTED KIT PL.0298/79 quanty Adenovirus RT-3498/79 quanty Adenovirusqs QS-3498/79 quanty BKV RT-3298/79 quanty BKVqs QS-3298/79 quanty CHIKUNGUNYA RT-0598/79 quanty CMV RT-1298/79 quanty CMVqs QS-1298/79 quanty EBV RT-132 réf. quanty Enterovirus RT-3398/79 quanty Enterovirusqs QS-3398/79 quanty HAV RT-0298/79 quanty HEV RT-4198/79 quanty HHV-7 RT-2998/79 quanty HHV-7qs QS-2998/79 quanty HHV6 RT-3098/79 quanty HHV6qs QS-3098/79 quanty HHV8 RT-3198/79 quanty HHV8qs QS-3198/79 quanty HSV1 RT-18/198/79 quanty HSV1-2 RT-18S98/79 quanty HSV1qs QS-18/198/79 quanty HSV2 RT18/298/79 quanty HSV2qs QS-18/298/79 quanty HSVqs1/2 QS-18S98/79 quanty JCV RT-2498/79 quanty JCVqs QS-2498/79 quanty LEISHMANIA RT-63q98/79 quanty Measles RT-0698/79 quanty Parvo B19 RT-1798/79 quanty Parvo B19qs QS-1798/79 quanty TOXO (RH Region) RT-9498/79 quanty VZV RT-23q98/79 quanty VZVqs QS-23q98/79 quanty WNV RT-0498/79 Rotavirus Card CLZC19402298/79 Spin DNA Purification Kit EMR061050 STREP A CARD CLZC81210/5098/79 Varicella Zoster Virus (region C – ORF66) RT-2398/79	A, C IVDR, 98/79	Site web info@clonit.it Fiche EUDAMED Signaler une erreur
Diagnostic BioSystems FDA Mandataire UE : MedEnvoy Global BV (Pays-Bas)	États-Unis	Acid Fast Bacteria (AFB) Stain Kit IHC Stains Alcian Blue (pH 1.0) Stain Kit IHC Stains Alcian Blue (pH 2.5) Stain Kit IHC Stains Amyloid Stain Kit IHC Stains BiotinStrep HRP Immunostaining Kit (For Mouse and Rabbit Primary Antibodies) Detection Systems3 réf. 69 autres Blue Hematoxylin Kit Histological Stains Calcium Stain Kit (Modified Von Kossa) IHC Stains CC/Mount Tissue Sealants2 réf. Colloidal Iron Stain Kit IHC Stains Combined Eosinophil-Mast Cell Stain Kit IHC Stains Conjugated Enzyme Labels (ALP Labels) Detection Systems2 réf. Conjugated Enzyme Labels (HRP Labels) Detection Systems2 réf. Copper Stain Kit IHC Stains DAB Auto Chromogens3 réf. DAPI Histological Stains2 réf. DBS HighLighterTM 360 Autostainer Elastic Stain Kit IHC Stains Fite’s Stain Kit IHC Stains Fluoromount Tissue Sealants2 réf. Fluoromount/Plus Tissue Sealants2 réf. Fontana-Masson Stain Kit IHC Stains Giemsa Stain Kit IHC Stains GMS Stain Kit IHC Stains Gram Stain Kit IHC Stains H. Pylori Rapid Stain Kit IHC Stains High Contrast DAB Chromogens HighLighter Core Kit Detection Systems Iron Stain Kit IHC Stains Large Volume Universal Alkaline Phosphatase Immunostaining Kit (For Mouse and Rabbit Primary Antibodies) Detection Systems3 réf. Luxol Fast Blue Stain Kit IHC Stains Moh'S HRP-Green Kit Detection Systems2 réf. Mono AEC/Plus Chromogens2 réf. Montage DAB Gone kit General Purpose Reagents Montage Opus365TM Antigen Retrieval System Antigen Retrieval Buffers Montage™ Hematoxylin Histological Stains Montage™ PolyVue Plus Auto Detection System Mouse & Rabbit Link98/79 Mouse UnoVueTM HRP/DAB Detection System Mouse/Rabbit PolyVue PlusTM HRP/DAB Detection System3 réf. Mouse/Rabbit UnoVue PlusTM AP/PermaRed Detection System3 réf. Mouse/Rabbit UnoVueTM HRP/DAB Detection System3 réf. Mucicarmine Stain Kit IHC Stains Nuclear Fast Red Histological Stains Oil Red O Stain Kit IHC Stains Papanicolaou Red Stain Kit98/79 Periodic Acid Schiff (PAS) Stain Kit IHC Stains Perma Red/HRP Chromogens2 réf. PermaBlack/HRP Chromogens2 réf. PermaBlue Plus/AP Chromogens2 réf. PermaBlue/HRP Chromogens4 réf. PermaGreen Plus/AP Chromogens2 réf. PermaRed/AP Chromogens2 réf. PermaRed/AP-Auto Chromogens2 réf. PermaRed/AP-AutoPlus Chromogens2 réf. PermaYellow/HRP Chromogens2 réf. Phosphotungstic Acid Hematoxylin (PTAH) Stain Kit IHC Stains Picro-Sirius Red Stain Kit IHC Stains Pneumocystis Stain Kit IHC Stains PolyVue'M Plus Mouse/Rabbit HRP/DAB Kit98/79 Purple Hematoxylin Histological Stains Reticulum Stain Kit IHC Stains SITVue/DAB Detection System3 réf. Stable DAB/Plus Chromogens Steiner Stain Kit IHC Stains Trichrome Stain Kit IHC Stains Universal HRP Immunostaining Kit (For Mouse and Rabbit Primary Antibodies) Detection Systems3 réf. UnoVue Mouse HRP Detection Reagent2 réf. UnoVue Mouse/Rabbit AP Detection Reagent2 réf. UnoVue Mouse/Rabbit HRP Detection Reagent2 réf. UnoVue Rabbit AP Detection Reagent2 réf. UnoVue Rabbit HRP Detection Reagent2 réf. UnoVue'M Mouse AP Detection Reagent98/79 UnoVue™ Mouse AP Detection Reagent98/79 Warthin-Starry Stain Kit IHC Stains	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Diapath FDA	Italie	10% NEUTRAL BUFFERED FORMALIN - BAG IN BOX 1x10 LT GENERAL FIXATIVE, FORMALDEHYDE (4%) - 10% NEUTRAL BUFFERED FORMALIN 10% NEUTRAL BUFFERED FORMALIN 1 LT GENERAL FIXATIVE - 10% NEUTRAL BUFFERED FORMALIN3 réf. 10% STABILIZED FORMALIN - 10 LT GENERAL FIXATIVE (FORMALDEHYDE 4%) RTU - 10% STABILIZED FORMALIN 2400 ML BUCKET FOR T-FILLER - 110 PCS 5% NEUTRAL BUFFERED FORMALIN - 10 LT GENERAL FIXATIVE - 5% NEUTRAL BUFFERED FORMALIN 69 autres A.F.O.G. (ACID FUCHSIN ORANGE G) KIT SPECIAL STAIN ACCESSIONING WORKBENCH ZEFIRO 1800 MOD. 11 ACID FAST BACTERIA ACC. ZIEHL - NEELSEN 100TEST KIT SPECIAL STAIN ALCIAN BLU PH2.5 ACC.DORLING 100TEST KIT SPECIAL STAIN ALCIAN BLUE PH 2.5 ACC. MOWRY - 1 LT STAINING SOLUTION - ALCIAN BLUE pH 2.5 ACC. MOWRY ANTIGENFIX - 5 LT FIXATIVE FOR IMMUNOHISTOCHEMISTRY - ANTIGENFIX - PARAFORMALEHYDE BASED BLUE METHYLENE ACC. MALLORY - 500 ML STAINING SOLUTION - BLUE METHYLENE ACC. MALLORY BOUIN HOLLANDE - 5 LT FIXATIVE - BOUIN HOLLANDE CARAZZI HEMATOXYLIN - 1 LT STAINING SOLUTION - CARAZZI HEMATOXYLIN CYTOPATH - FIXATIVE SOLUTION 60 ML (20ML) 25 PCS x 1 PACK CYTOPATH – HARRIS HEMATOXYLIN 1 LT CYTOPATH STAINING SOLUTION - HARRIS HEMATOXYLIN CYTOPATH-FIXATIVE SOLUTION 60 ML (20 ML) 25 PCS x 1 PACK CYTOPATH–COLLECTION AND WASHING SOLUTION - URINARY CYTOLOGY KIT2 réf. DANTE COLD PLATE DANTE EMBEDDING MODULE DIAMOUNT - 500 ML DIAPRINT SLIDE WHITE - 2000 PCS MICROSCOPE SLIDES FOR SLIDE PRINTERS DIAPRINT TISSUE CASSETTES - WHITE 1000 PCS DISPOSABLE CONTAINERS - WHITE SCREWCAP (250 ML) - 200 PCS DONATELLO SERIES AUTOMATIC TISSUE PROCESSOR DUBOSCQ-BRASIL PICROFORMALIN - 2 LT GENERAL FIXATIVE, SUITABLE FOR BIOPSIES, RTU - DUBOSCQ-BRASIL PICROFORMALIN EA50 - 1 LT STAINING SOLUTION - EA503 réf. EOSIN G OR Y ALCOHOLIC 0,5 % - 1 LT STAINING SOLUTION - EOSIN G OR Y ALCOHOLIC 0,5 %3 réf. EOSIN G OR Y POLYCHROMATIC 1% AQUEOUS - 1 LT STAINING SOLUTION - EOSIN G OR Y POLYCHROMATIC 1% AQUEOUS EOSIN-PHLOXINE - 1 LT STAINING SOLUTION - EOSIN-PHLOXINE FUCHSIN PHENOLIZED ACC. ZIEHL - 500 ML STAINING SOLUTION - FUCHSIN PHENOLIZED ACC. ZIEHL FUCHSIN PONCEAU ACC. MASSON - 500 ML STAINING SOLUTION - FUCHSIN PONCEAU ACC. MASSON GALILEO2 réf. GENIO MOLD - 23 X 33 MM GENIO MOLD - ALUMINIUM GENIO UNIVERSAL CASSETTE - WHITE - TAPED - 750 PCS - SUITABLE FOR IR LASER PRINTING UNIVERSAL AND BIOPSY GENIO CASSETTE GIEMSA ACC. PAPPENHEIM - 1 LT STAINING SOLUTION - GIEMSA ACC. PAPPENHEIM GIOTTO AUTOMATIC STAINER GREENFIX - 5 LT GENERAL FIXATIVE - GREENFIX GREENFIX PLUS - 20 LT ALTERNATIVE TO FORMALIN - GREENFIX PLUS GROCOTT ACC. CALLARD 100 TESTS KIT SPECIAL STAIN HARRIS HEMATOXYLIN - 1 LT STAINING SOLUTION - HARRIS HEMATOXYLIN HEMATOXYLIN ACC. GILL I - 1 LT STAINING SOLUTION - HEMATOXYLIN ACC. GILL I HEMATOXYLIN ACC. GILL II - 1 LT STAINING SOLUTION - HEMATOXYLIN ACC. GILL II HEMATOXYLIN ACC. GILL III - 5 LT STAINING SOLUTION - HEMATOXYLIN ACC. GILL III IRON HEMATOXYLIN ACC. WEIGERT REAGENT A - 1 LT STAINING SOLUTION - IRON HEMATOXYLIN ACC. WEIGERT REAGENT A IRON HEMATOXYLIN ACC. WEIGERT REAGENT B - 1 LT STAINING SOLUTION - IRON HEMATOXYLIN ACC. WEIGERT REAGENT B KERNECHTROT (NUCLEAR FAST RED) - 500 ML STAINING SOLUTION - KERNECHTROT (NUCLEAR FAST RED) MAY GRUNWALD ACC. PAPPENHEIM - 1 LT STAINING SOLUTION - MAY GRUNWALD ACC. PAPPENHEIM MAYER HEMATOXYLIN - 1 LT STAINING SOLUTION - MAYER HEMATOXILIN3 réf. MICROMOUNT - 500 ML2 réf. MICROSCOPE COVERSLIPS 24x40 MM - 1000 PCS3 réf. MICROSCOPE SLIDES 2 FROSTED SIDES CUT EDGE (1000 PCS)3 réf. MICROSCOPE SLIDES WHITE - 1000 PCS MICROSCOPE SLIDES FOR OPTICAL MICROSCOPY MICROZINC - ZINC FORMALIN 5 LT GENERAL FIXATIVE - MICROZINC - ZINC FORMALIN - READY TO USE (FORMALDEHYDE 4%) NEUTRAL BUFFERED CONCENTRATED FORMALIN (24%) - 5 LT GENERAL FIXATIVE - NEUTRAL BUFFERED CONCENTRATED FORMALIN (24%) - DILUITE 1:6 OG6 - 1 LT STAINING SOLUTION - OG6 PERLS - 100 TESTS KIT SPECIAL STAIN PICROFUCHSIN ACC. VAN GIESON - 500 ML STAINING SOLUTION - PICROFUCHSIN ACC. VAN GIESON SACCOMANNO FIXATIVE - 2 LT FOR CYTOLOGICAL SAMPLES TRANSPORT - SACCOMANNO FIXATIVE SAFECAPSULE PROSTATE BIOPSY KIT SAFECAPSULE – BUFFER SOLUTION (100 ML) 36 PCS SINGLE-USE BOTTLE PRE-FILLED WITH BUFFERED FORMALDEHYDE FOR THE FIXATION AND TRANSPORT OF HISTOLOGICAL SPECIMENS3 réf. SCHIFF REAGENT ACC. FEULGEN - 500 ML STAINING SOLUTION - SCHIFF REAGENT ACC. FEULGEN SCHIFF REAGENT ACC. HOTCHKISS - MCMANUS - 1 LT STAINING SOLUTION - SCHIFF REAGENT ACC. HOTCHKISS-MCMANUS SERIGRAPHED DISPOSABLE TUB XL (3000 ML) - 120 PCS SICURA PRE-FILLED CONTAINER 10% NEUTRAL BUFFERED FORMALIN RTU PRESS ON CAP 1 LT (700 ML) 40 PCS x 01 PACK SICURA FIXATIVE - 10% NEUTRAL BUFFERED FORMALIN3 réf. SILVER IMPREGNATION 100 TESTS KIT SPECIAL STAIN STAINTABS - EOSIN 10 TABS STAINTABS - HEMATOXYLIN 10 TABS TISSUE BIOPSY CASSETTE WHITE 1000 PCS TISSUE CASSETTE - WHITE 500 PCS TISSUE MEGA CASSETTES - WHITE 100 PCS TIZIANO - ULTRA-COMPACT AUTOMATIC SPECIAL STAINER AUTOMATIC STAINER VENTILATED HOOD ZEFIRO 1200 STAINLESS STEEL MOD. 07 ZEFIRO VENTILATED STORAGE CABINET 900 STAINLESS STEEL GLASS DOOR 01 PC	A IVDR	Présent sur le marché en France Site web info@diapath.com Fiche EUDAMED Signaler une erreur
Kangsheng Information Technology (Hangzhou) Mandataire UE : Crealkraft GmbH (Allemagne)	Chine	Adenovirus (Respiratory Type) Nucleic Acid Detection Kit (Fluorescence)98/79 APTT Activated Partial Thromboplastin Time Test Kit98/79 Aspergillus Nucleic Acid Detection Kit (Fluorescence, Sputum/BALF)98/79 Aspergillus Nucleic Acid Detection Kit (Sputum/BALF)98/79 Bocavirus Nucleic Acid Detection Kit (Fluorescence)98/79 69 autres Bordetella pertussis Nucleic Acid Detection Kit (Fluorescence)98/79 Bordetella pertussis Nucleic Acid Detection Kit (Fluorescence, Unvaccinated)98/79 Bordetella pertussis Nucleic Acid Detection Kit (Unvaccinated)98/79 Bordetella pertussis Nucleic Acid Detection Kit Nc01498/79 Chikungunya Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Cholera Ag Rapid Test Kit98/79 Clostridium Difficile Related Test Kit Ir04298/79 Corynebacterium diphtheriae Nucleic Acid Detection Kit98/79 COVID-19 (2019n-Cov) Antigen Detection Kit98/79 Cryptococcus Nucleic Acid Detection Kit (CSF) Nc04498/79 Cryptococcus Nucleic Acid Detection Kit (Fluorescence, CSF)98/79 D-Dimer Test Kit Ir08798/79 Dengue Ab IgM/IgG Test Kit Ir02698/79 Dengue Ag NS1 Test Kit98/79 Dengue NS1/IgM/IgG Test Panel98/79 Dengue Virus Genotyping Nucleic Acid Detection Kit (Fluorescence)98/79 Dengue Virus Genotyping Nucleic Acid Detection Kit Nc04798/79 Dengue Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Enterohemorrhagic Escherichia coli Nucleic Acid Detection Kit98/79 Enterovirus (Non-Poliovirus) Nucleic Acid Detection Kit98/79 Enterovirus (Non-Poliovirus) Nucleic Acid Detection Kit (Fluorescence)98/79 FIB Fibrinogen Test Kit98/79 Group A Streptococcus Nucleic Acid Detection Kit98/79 H.Pylori Ab Test Kit Ir03098/79 H.Pylori Ag Test Kit Ir03198/79 Haemophilus influenzae Nucleic Acid Detection Kit (Fluorescence)98/79 Haemophilus influenzae Nucleic Acid Detection Kit Nc04098/79 HSV Herpes Simplex Virus Ab Test Kit Ir05998/79 Human Coronavirus (OC43/229E/HKU1/NL63) Nucleic Acid Detection Kit98/79 Human Coronavirus (OC43/229E/HKU1/NL63) Nucleic Acid Detection Kit (Fluorescence)98/79 Influ A+B/ADV/RSV Ag 4-in-1 Test Panel98/79 Influenza A+B Ag Test Kit Ir04398/79 Influenza A/B Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Klebsiella pneumoniae Nucleic Acid Detection Kit98/79 Legionella Nucleic Acid Detection Kit (Sputum/BALF)98/79 Measles Virus Nucleic Acid Detection Kit Nc00698/79 Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Mycobacterium tuberculosis Nucleic Acid Detection Kit98/79 Mycobacterium tuberculosis Nucleic Acid Detection Kit (Fluorescence)98/79 Mycoplasma Pneumoniae Ab Test Kit Ir04798/79 Mycoplasma pneumoniae Nucleic Acid Detection Kit Nc03698/79 Neisseria meningitidis Nucleic Acid Detection Kit (Fluorescence)98/79 Neisseria meningitidis Nucleic Acid Detection Kit Nc01398/79 Norovirus GI/GII Antigen Detection Kit98/79 Parainfluenza Virus (I-IV) Nucleic Acid Detection Kit (Fluorescence)98/79 Plasmodium Nucleic Acid Detection Kit (Fluorescence)98/79 Pneumocystis jirovecii Nucleic Acid Detection Kit (Fluorescence, BALF)98/79 Pneumocystis jirovecii Nucleic Acid Detection Kit Nc04598/79 PT Prothrombin Time Test Kit98/79 PT/APTT Test Panel98/79 Respiratory Syncytial Virus (A/B) Nucleic Acid Detection Kit (Fluorescence)98/79 Rhinovirus Nucleic Acid Detection Kit (Fluorescence)98/79 Rotavirus Ag Test Kit Ir03498/79 RSV Respiratory Syncytial Virus Ag Test Kit Ir04598/79 Salmonella typhi/paratyphi Nucleic Acid Detection Kit98/79 Salmonella typhi/paratyphi Nucleic Acid Detection Kit (Fluorescence)98/79 SARS-CoV-2 Nucleic Acid Detection Kit2 réf.98/79 SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence Screening)98/79 SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence)98/79 Shigella/Entamoeba histolytica Nucleic Acid Detection Kit (Fluorescence)98/79 Shigella/Entamoeba histolytica Nucleic Acid Detection Kit Nc01098/79 Strep A Ag Test Kit Ir04498/79 Streptococcus pneumoniae Nucleic Acid Detection Kit98/79 Streptococcus pneumoniae Nucleic Acid Detection Kit (Fluorescence)98/79 TT Thrombin Time Test Kit98/79 Vibrio cholerae Nucleic Acid Detection Kit (Fluorescence)98/79 Vibrio parahaemolyticus Nucleic Acid Detection Kit98/79 West Nile Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Zika Virus Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Encode Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	(Fluorescence PCR Melting Curve Analysis) MTB and RFP Drug Resistance Gene Mutation Detection Kit 24 tests/kit98/79 Adenovirus IgM Rapid Test 25Tests/Kit98/79 Brucellosis IgM/IgG Rapid Test 25Tests/Kit98/79 Chagas Ab Combo Rapid Test 25Tests/Kit98/79 Chikungunya Antibody Rapid Test 25Tests/Kit98/79 68 autres Chlamydia Trachomatis Antigen Test Cassette 1 Test/Kit98/79 Chlamydia Trachomatis Antigen Test Cassette 10 Tests/Kit98/79 Chlamydia Trachomatis Antigen Test Cassette 2 Tests/Kit98/79 Chlamydia Trachomatis Antigen Test Cassette 20 Tests/Kit98/79 Chlamydia Trachomatis Antigen Test Cassette 25 Tests/Kit98/79 Chlamydia Trachomatis Antigen Test Cassette 3 Tests/Kit98/79 Chlamydia Trachomatis Antigen Test Cassette 40 Tests/Kit98/79 Chlamydia Trachomatis Antigen Test Cassette 5 Tests/Kit98/79 Chlamydia Trachomatis Antigen Test Cassette 50 Tests/Kit98/79 Coxsackievirus A16 IgM Rapid Test 25Tests/Kit98/79 D-Dimer Rapid Test 1Test/Kit98/79 D-Dimer Rapid Test 25Tests/Kit98/79 Dengue IgG/IgM Rapid Test 25Tests/Kit98/79 Dengue IgG/IgM/NS1 Rapid Test 25Tests/Kit98/79 Dengue NS1 Rapid Test 25Tests/Kit98/79 Enterovirus V71 IgM Rapid Test 25Tests/Kit98/79 Filariasis IgG/IgM Rapid Test 25Tests/Kit98/79 Flu A&B/ Covid-19/ RSV/ Adenovirus /MP Antigen Rapid Test Panel 20Tests/Kit98/79 Gonorrhea Antigen Rapid Test 1Test/Kit98/79 Gonorrhea Antigen Rapid Test 20Tests/Kit98/79 H.Pylori Antibody Rapid Test 25Tests/Kit98/79 H.Pylori Antibody Rapid Test 50Tests/Kit98/79 Helicobacter Pylori (HP) Antigen Test Kit 1Test/Kit98/79 Helicobacter Pylori (HP) Antigen Test Kit 20Tests/Kit98/79 Helicobacter Pylori (HP) Antigen Test Kit 25Test/Kit98/79 HPIVS Rapid Test 25Tests/Kit98/79 HSV-2 IgG/IgM Combo Rapid Test 1Test/Kit98/79 Inﬂuenza A Antigen Rapid Test 1Test/Kit98/79 Inﬂuenza A Antigen Rapid Test 20 Tests/Kit98/79 Inﬂuenza A Antigen Rapid Test 25Tests/Kit98/79 Inﬂuenza A+B Antigen Rapid Test Device 1Test/Kit98/79 Inﬂuenza A+B Antigen Rapid Test Device 20Tests/Kit98/79 Inﬂuenza A+B Antigen Rapid Test Device 25Tests/Kit98/79 Inﬂuenza B Antigen Rapid Test 1Test/Kit98/79 Inﬂuenza B Antigen Rapid Test 20Tests/Kit98/79 Inﬂuenza B Antigen Rapid Test 25Tests/Kit98/79 Leishmania Ab Rapid Test 25Tests/Kit98/79 Leptospira IgG/IgM Rapid Test 25Tests/Kit98/79 Malaria pf Rapid Test 25Tests/Kit98/79 Malaria Pf/Pan Rapid Test 25Tests/Kit98/79 Malaria pf/pv Rapid Test 25Tests/Kit98/79 MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis) MTB and Drug Resistance Gene Mutation Detection Kit 48tests/kit98/79 MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis) MTB and RFP Drug Resistance Gene Mutation Detection Kit 48tests/kit98/79 MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis) MTB and RFP/INH Drug Resistance Gene Mutation Detection Kit 48tests/kit98/79 MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis) MTB and RFP/INH Drug Resistance Gene Mutation Detection Kit 24tests/kit98/79 Mycoplasma Pneumonia IgM Rapid Test Cassette98/79 NTM Drug Resistance Gene Mutation Detection Kit(Fluorescence PCR Melting Curve Analysis) 24Tests/Kit98/79 NTM Drug Resistance Gene Mutation Detection Kit(Fluorescence PCR Melting Curve Analysis) 48Tests/Kit98/79 NTM Drugs Susceptibility Test Kit 10Tests/Kit98/79 NTM Identification and Differentiation Detection Kit(Fluorescence PCR Melting Curve Analysis) 24Tests/Kit98/79 NTM Identification and Differentiation Detection Kit(Fluorescence PCR Melting Curve Analysis) 48Tests/Kit98/79 Rotavirus Group A Antigen Rapid Test W010504060698/79 RSV Rapid Test RSV-40298/79 S.Typhoid antigen Rapid Test98/79 SARS-CoV-2 & Inﬂuenza A/B Antigen Combo Rapid Test98/79 SARS-COV-2 Antigen Rapid Test Device 1Test/Kit98/79 SARS-COV-2 Antigen Rapid Test Device 20Tests/Kit98/79 SARS-COV-2 Antigen Rapid Test Device 5Tests/Kit98/79 Strep A Rapid Test ISA-50298/79 Strep B Rapid Test ISB-50298/79 Syphilis Ab Combo Rapid Test 1Test/Kit98/79 Syphilis Ab Combo Rapid Test 25Tests/Kit98/79 Syphilis Ab Combo Rapid Test 50Tests/Kit98/79 Troponin I Rapid Test 25Tests/Kit98/79 Tuberculosis Antibody Rapid Test 25Tests/Kit98/79 Typhoid IgG/IgM Rapid Test 25Tests/Kit98/79 Zika IgG/IgM Rapid Test 1Test/Kit98/79 Zika IgG/IgM Rapid Test 25Tests/Kit98/79	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Microbiologics FDA Mandataire UE : MediMark Europe Sarl. (France)	États-Unis	8180 8181 8184 8187 8189 67 autres 8190 8191 8203 8205 8206 8208 8209 8210 8211 8219 8227 8228 8229 8230 8231 8232 8234 8235 8236 8238 8242 8246 8247 8248 8249 8250 8254 8257 8258 8267 ABT-001 HE0013S HE0026N HE0027N HE0028N HE0029N HE0030N HE0031N HE0032N HE0033N HE0034N HE0035N HE0036N HE0037N HE0040N HE0041N HE0042N HE0043N HE0044N HE0045N HE0052N HE0053NS HE0054NS HE0055NS HE0056N HE0060S HE0061S HE0065N HE0066NS HE0082HF Helix Elite Molecular Standards HE0012S Helix Elite™ Molecular Standards: Inactivated Standard HE0038N Helix Elite™ Molecular Standards: Inactivated Standard HE0039N Helix Elite™ Molecular Standards: Inactivated Standard HE0057N KWIK-STIK™ and LYFO DISK™ 0151 KWIK-STIK™ and LYFO DISK™ 0156 KWIK-STIK™ and LYFO DISK™ 0262	A, B IVDR	Présent sur le marché en France Site web info@microbiologics.com Fiche EUDAMED Signaler une erreur
Zenith Lab (Jiangsu) Mandataire UE : Umedwings Netherlands B.V. (Pays-Bas)	Chine	80-2C HC-12A HC-12C HC-12C mini HC-12C plus 67 autres HC-16A HC-16B HC-16C HC-16C plus HC-16F HC-16F mini HC-16L HC-18F HC-20C HC-20F HC-20F-V HC-20L HC-21F HC-Series LC-04A LC-04B LC-04B plus LC-04C LC-04C plus LC-04F LC-04G LC-04K LC-04L LC-04M LC-04M plus LC-04P LC-04P plus LC-04P-L LC-04R LC-04R-N LC-04S LC-04S-A LC-04S-C LC-04S-C-S LC-04W LC-05A LC-05B LC-05C LC-05F LC-05MC LC-05S LC-05S plus LC-06C LC-06F LC-06F-V LC-SERIES LCAR-12 MC-04 MC-07 MC-12 MC-Series MCKD-05 MCKD-07 MCKD-Series MCKS-1000 MCKS-1200 TDL-4A TDL-4A plus TDL-4C TDL-5A TDL-5G TDL-5G plus TDL-6A TDL-6Aplus TDL-6C TDL-Series Z-FUGA	A IVDR	Site web service@labzj.com Fiche EUDAMED Signaler une erreur
Atlas Medical FDA	Allemagne	ABO Set (Anti-A (1/256), Anti-B (1/256), Anti-AB (1/256), Anti-D (1/64)), 4x10ml/carton Box 8.02.49.0.004098/79 ABO Set (Anti-A (1/256), Anti-B (1/256), Anti-D (1/64)), 3x10ml/ Plastic Pack 8.02.47.3.003098/79 ABO Set (Anti-A (1/256), Anti-B (1/256), Anti-D (1/64)), 3x10ml/carton Box. 8.02.47.1.003098/79 ABO Set (Anti-A (1/512), Anti-B (1/512), Anti-AB (1/512) Anti-D (1/128)), 4x10ml, 4vials/Plastic Pack 8.02.53.1.004098/79 ABO Set (Anti-A (1/512), Anti-B (1/512), Anti-AB (1/512) Anti-D (1/128)), 4x10ml/Plastic Pack 8.02.53.0.004098/79 66 autres Anti-D IgG/IgM Blend Reagent (Titer: 1/128), 10ml/vial, 1 vial/carton Box 8.02.03.0.001098/79 Anti-D IgG/IgM Blend Reagent (Titer: 1/128), 10ml/vial, 10 vials/Plastic Pack 8.02.03.1.010098/79 Anti-D IgG/IgM Blend Reagent (Titer: 1/64), 10ml/vial, 10 vials/Plastic Pack 8.02.07.1.010098/79 Anti-D IgG/IgM Blend Reagent (Titer: 1/64), 10ml/vial, 1Vial/carton Box 8.02.07.0.001098/79 Atlas 8.04.37.0.002098/79 Atlas Activated Partial Thromboplastin Time (APTT) Reagent, 2 ml /Vial, 1 Vial/Box. 8.02.41.1.004098/79 Atlas Activated Partial Thromboplastin Time (APTT) Reagent, 2x2 ml APTT reagent, 1x1 ml Normal Control, 3 Vials /Box. 8.02.45.0.008098/79 Atlas Adeno - RSV Respiratory Test Device, Nasopharyngeal Sample Individually Pouched, 20 Tests/Box 8.16.39.0.002098/79 Atlas Adenovirus Antigen Test Device, Stool Sample, Individually Pouched, 20 Tests/Box. 8.04.71.0.002098/79 Atlas Adenovirus Respiratory Test Device, Nasopharyngeal Sample, Individually Pouched, 20 Tests/Box 8.16.37.0.002098/79 Atlas Bovine Albumin 22%, 10 ml/Vial, 10 vials/Pack. 8.02.08.1.010098/79 Atlas Bovine Albumin 22%, 10ml/vial,1 Vial/Box 8.02.08.0.001098/79 Atlas Bovine Albumin 30%, 10 ml/Vial, 1 vial/Box 8.02.09.0.001098/79 Atlas Bovine Albumin 30%, 10 ml/Vial, 10 vials/Pack. 8.02.09.1.010098/79 Atlas Brucella Abortus Reagent, 5 ml/vial, 1 vial/Box. 8.01.10.0.000598/79 Atlas Brucella Abortus Reagent, 5 ml/vial, 8 vials/Box. 8.01.10.1.004098/79 Atlas Brucella Antigen Kit with Controls, (5ml Brucella melitensis, 5ml Brucella abortus, 2x1.0 ml Controls) 8.01.15.1.001098/79 Atlas Brucella Antigen Kit, (5ml Brucella Melitensis, 5ml Brucella Abortus) 8.01.15.0.001098/79 Atlas Brucella Melitensis Reagent, 5 ml/vial, 1 vial/Box. 8.01.11.0.000598/79 Atlas Brucella Melitensis Reagent, 5 ml/vial, 8 vials/Box. 8.01.11.1.004098/79 Atlas Brucella Rose Bengal kit , 100 Tests 8.01.00.0.010098/79 Atlas Brucella Rose Bengal Kit , 50 Tests 8.01.00.0.005098/79 Atlas Brucella Rose Bengal Reagent, 5ml/vial 8.01.00.0.000598/79 Atlas D-Dimer Latex Kit, 25 Tests 8.00.17.0.002598/79 Atlas D-Dimer Latex, 100 Tests 8.00.17.0.010098/79 Atlas D-Dimer Latex, 50 Tests 8.00.17.0.005098/79 Atlas H.pylori Antibody Test Device, Serum/Plasma, Individually Pouched, 20 Tests/Box98/79 Atlas H.pylori Antibody Test Device, Whole Blood/Serum/Plasma, Individually Pouched H.pylori Antibody Test Device, Whole Blood/Serum/Plasma, Individually Pouched, 20 Tests/Box98/79 Atlas H.pylori Antigen Test Cassette, Stool Sample, Individually Pouched, 20 Tests/Box (Buffer to be supplied in Extraction Tubes) 8.04.23.1.002098/79 Atlas H.pylori Antigen Test Strip, 3.5mm, Stool Sample, Individually Pouched, 25 Test/Box (Buffer to be supplied in Extraction Tubes) 8.04.24.1.002598/79 Atlas Influenza A&B Test Device, Nasopharyngeal Sample, Individually Pouched, 20 Tests/Box 8.04.86.0.002098/79 Atlas Influenza A&B Test Device, Nasopharyngeal Sample, Individually Pouched, 25Tests/box 8.04.86.0.002598/79 Atlas Influenza A&B Test Strip, Nasopharyngeal Sample, Individually Pouched, 25 Tests/Box. 8.04.96.0.002598/79 Atlas Malaria PF/PV , test cassette, Whole blood, Individually packed, 20 Test/Box 8.16.14.0.002098/79 Atlas Proteus OX19 Reagent, 5 ml/vial, 1 vial/Box. 8.01.13.0.000598/79 Atlas Proteus OX19 Reagent, 5 ml/vial, 8 vials/Box. 8.01.13.1.004098/79 Atlas Proteus OX2 Reagent, 5 ml/vial, 1 vial/Box. 8.01.12.0.000598/79 Atlas Proteus OX2 Reagent, 5 ml/vial, 8 vials/Box. 8.01.12.1.004098/79 Atlas Proteus OXK Reagent, 5 ml/vial, 1 vial/Box. 8.01.14.0.000598/79 Atlas Proteus OXK Reagent, 5 ml/vial, 8 vials/Box. 8.01.14.1.004098/79 Atlas Rotavirus -Adenovirus Antigens Test Device, Stool Sample, Individually Pouched, 20 Tests/Box. 8.04.73.0.002098/79 Atlas Rotavirus -Adenovirus Antigens Test Strip, Stool Sample, Individually Pouched, 25 Tests/Box. 8.04.74.0.002598/79 Atlas Rotavirus Antigen Test Cassette, Stool Sample, Individually Pouched, 20 Tests/Box (Buffer to be supplied in Extraction Tubes) 8.04.69.0.002098/79 Atlas Salmonella Antigen , Widal (6 Antigens: OA, OB, OD, HA, HB, HD) 8.01.18.0.003098/79 Atlas Salmonella Antigen Set: 8 Antigens ( OA,OB,OC,OD, HA,HB,HC,HD), With controls. 8.01.16.1.004098/79 Atlas Salmonella Antigen Set: 8 Antigens ( OA,OB,OC,OD, HA,HB,HC,HD). 8.01.16.0.004098/79 Atlas Salmonella HA Reagent , 5 ml/vial, 8 vials/Box. 8.01.05.1.004098/79 Atlas Salmonella HA Reagent, 5 ml/vial, 1 vial/Box. 8.01.05.0.000598/79 Atlas Salmonella HB Reagent, 5 ml/vial, 1 vial/Box. 8.01.06.0.000598/79 Atlas Salmonella HB Reagent, 5 ml/vial, 8 vials/Box. 8.01.06.1.004098/79 Atlas Salmonella HC Reagent, 5 ml/vial, 1 vial/Box. 8.01.07.0.000598/79 Atlas Salmonella HC Reagent, 5 ml/vial, 8 vials/Box. 8.01.07.1.004098/79 Atlas Salmonella HD Reagent, 5 ml/vial, 1 vial/Box. 8.01.08.0.000598/79 Atlas Salmonella HD Reagent, 5 ml/vial, 8 vials/Box. 8.01.08.1.004098/79 Atlas Salmonella OA Reagent , 5 ml/vial, 1 vial/Box. 8.01.01.0.000598/79 Atlas Salmonella OA Reagent , 5 ml/vial, 8 vials/Box. 8.01.01.1.004098/79 Atlas Salmonella OB Reagent , 5 ml/vial, 8 vials/Box. 8.01.02.1.004098/79 Atlas Salmonella OB Reagent, 5 ml/vial, 1 vial/Box. 8.01.02.0.000598/79 Atlas Salmonella OC Reagent , 5 ml/vial, 8 vials/Box. 8.01.03.1.004098/79 Atlas Salmonella OC Reagent, 5 ml/vial, 1 vial/Box. 8.01.03.0.000598/79 Atlas Salmonella OD Reagent , 5 ml/vial, 8 vials/Box. 8.01.04.1.004098/79 Atlas Salmonella OD Reagent, 5 ml/vial, 1 vial/Box. 8.01.04.0.000598/79 Atlas SLE Latex , 50 Tests 8.00.11.0.005098/79 Atlas Syphilis Antibody Test Device, Whole Blood /Serum /Plasma, Individually Pouched, 20 Tests/Box98/79 Atlas Syphilis Antibody Test Strip, Serum/Plasma, Individually Pouched, 50 Tests/Box 8.04.43.0.005098/79 AtlasvDrabkins Reagent, 40x, 50ml/vial (500 Tests) 8.02.46.1.050098/79	– 98/79	Site web info@atlas-medical.com Fiche EUDAMED Signaler une erreur
Bioer FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	Adenovirus and Adenovirus type 3, 4 and 7 Nucleic Acid Detection Kit (Fluorescent PCR) BSJ06M198/79 Adenovirus and Adenovirus type 3, 4 and 7 Nucleic Acid Detection Kit (Fluorescent PCR) BSJ06S198/79 AutoGene 9600 Automatic PCR Analysis System FQD-A9600(EA4), FQD-A9600(EA5), FQD-A9600(EA6)3 réf. Automated Nucleic Acid Purification and Real Time PCR System FQD-A1600(EA4), FQD-A1600(EA5), FQD-A1600(EA6)3 réf. Automated Nucleic Acid Purification System NPAs-9600,NPAs-96202 réf. 66 autres Bioquant-96m Fluorescent Quantitative Detection System Biospin Omni Genomic DNA Extraction Kit BSC39S1, BSC39M12 réf. Biospin Virus DNA/RNA Extraction Kit BSC77S1, BSC77M1, BSC77L13 réf. Bocavirus, Human Metapneumovirus and Rhinovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ12L198/79 Bocavirus, Human Metapneumovirus and Rhinovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ12M198/79 careSTART™ Q1 Amplifier TQA-E00182 CentriDx Automated Nucleic Acid Analyzer CentriDx 200(EA4) , CentriDx 200(EA5) , CentriDx 200(EA6)3 réf. CentriDxTM Gastrointestinal Pathogen Panel Ⅰ BSJ87S198/79 CentriDxTM Lower Respiratory Pathogen Panel Ⅰ BSJ62S198/79 CentriDxTM Meningitis/Encephalitis Pathogen Panel Ⅰ BSJ97S198/79 CentriDxTM Respiratory Pathogen Panel V BSJ84S198/79 CentriDxTM Sexually Transmitted Disease Panel I BSJ69S198/79 CentriDxTM Tropical Fever Pathogen Panel Ⅰ BSJ96S198/79 Dengue Virus Nucleic Acid Detection Kit (Fluorescent PCR) BSJ43L198/79 Dengue Virus Nucleic Acid Detection Kit (Fluorescent PCR) BSJ43M198/79 Enterovirus Universal, Enterovirus 71, Coxsackievirus A6, Coxsackievirus A10 and Coxsackievirus A16 nucleic acid Detection Kit (Fluorescent PCR) BSJ26L198/79 Enterovirus Universal, Enterovirus 71, Coxsackievirus A6, Coxsackievirus A10 and Coxsackievirus A16 nucleic acid Detection Kit (Fluorescent PCR) BSJ26M198/79 GeneExplorer Thermal Cycler GE-96G, GE-96S, GE-48DG, GE-384G, GE-4I, GE-48D, GE-48DS,GE-DX3 réf. GenePure 96 Nucleic Acid Purification System NPA-96, NPA-96T, NPA-96E3 réf. GenePure Pro 16H Nucleic Acid Purification System NPA-16H GenePure Pro 9600 Nucleic Acid Purification System NPAm-9600 GenePure Pro Nucleic Acid Purification System NPA-32P, NPA-32E2 réf. Group A Streptococcus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ38L198/79 Group A Streptococcus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ38M198/79 Hepatitis A Virus Nucleic Acid Detection Kit (Fluorescent PCR) BSJ51M198/79 Hepatitis A Virus Nucleic Acid Detection Kit (Fluorescent PCR) BSJ51S198/79 HPV Genotyping Real-Time PCR Kit (Fluorescent PCR) BSJ01M1， BSJ01L12 réf. HPV Nucleic Acid Detection and 16/18 Genotyping Kit (Fluorescent PCR) BSJ50L198/79 HPV Nucleic Acid Detection and 16/18 Genotyping Kit (Fluorescent PCR) BSJ50M198/79 Human Parainfluenza Virus Type 1, Type 2, Type 3 Nucleic Acid Detection Kit (Fluorescence PCR) BSJ11L198/79 Human Parainfluenza Virus Type 1, Type 2, Type 3 Nucleic Acid Detection Kit (Fluorescence PCR) BSJ11M198/79 Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR) BSJ04S1, BSJ04M1, BSJ04L13 réf. LineGene 9600 Plus Fluorescent Quantitative Detection System FQD-96A(EA2), FQD-96A(EA4), FQD-96A(EA5), FQD-96A(EA6)3 réf. LineGene 9600 Pro Fluorescenct Quantitative Detection System FQD-96A(ED2), FQD-96A(ED4), FQD-96A(ED5), FQD-96A(ED6)3 réf. LineGene K Plus Fluorescent Quantitative Detection System FQD-48A(EA2), FQD-48A(EA4)2 réf. LineGene Mini Fluorescent Quantitative Detection System FQD-16A(EA2R), FQD-16A(EA2H), FQD-16A(EA4)3 réf. LineGene MiniS Fluorescent Quantitative Detection System FQD-16B(EA2) , FQD-16B(EA4)2 réf. MagaBio FFPE Tissue Genomic DNA Purification Kit BSC31S1, BSC31M1, BSC31M1S, BSC31N1E, BSC31T1S, BSC31S1S, BSC31M1E, BSC31L1E, BSC31T1E, BSC31S1E, BSC31T1C, BSC31S1C, BSC31M1E-T, BSC31L1E-T, BSC31T1C-C, BSC31S1C-C, BSC31S1P-A3 réf. MagaBio FFPE Tissue Genomic DNA/RNA Purification Kit BSC118T1S, BSC118S1S, BSC118M1S, BSC118N1E, BSC118T1E, BSC118S1E, BSC118M1E, BSC118L1E, BSC118T1C-C, BSC118S1C-C, BSC118M1E-T, BSC118L1E-T, BSC118S1B, BSC118M1B, BSC118S1P-A3 réf. MagaBio FFPE Tissue RNA Purification Kit BSC36S1, BSC36M1, BSC36M1S, BSC36N1E, BSC36T1S, BSC36S1S, BSC36M1E, BSC36L1E, BSC36T1E, BSC36S1E, BSC36M1E-T, BSC36L1E-T, BSC36T1C-C,BSC36S1C-C, BSC36S1P-A3 réf. MagaBio plus General Genomic DNA Purification Kit Ⅱ BSC74S1B, BSC74M1B, BSC74M1S, BSC74N1E, BSC74T1S, BSC74S1S, BSC74M1E, BSC74L1E, BSC74T1E, BSC74S1E, BSC74T1C, BSC74S1C, BSC74M1E-T, BSC74L1E-T, BSC74T1C-C, BSC74S1C-C, BSC74S1P-A3 réf. MagaBio plus Virus DNA / RNA Purification Kit Ⅱ BSC71T1S, BSC71S1S, BSC71M1S,BSC71L1S, BSC71T1E,BSC71S1E, BSC71M1E, BSC71L1E, BSC71T1C, BSC71S1C, BSC71S1B, BSC71M1B, BSC71M1E-T, BSC71L1E-T3 réf. MagaBio plus Virus DNA /RNA Purification Kit VI BSC110S1B, BSC110M1B, BSC110T1S, BSC110S1S, BSC110M1S, BSC110N1E, BSC110T1E, BSC110S1E, BSC110M1E, BSC110L1E, BSC110T1P, BSC110S1P, BSC110M1E-T, BSC110L1E-T, BSC110T1C, BSC110S1C, BSC110T1C-C, BSC110S1C-C, BSC110S1P-A3 réf. MagaBio plus Virus RNA Purification Kit Ⅱ BSC87T1S, BSC87S1S, BSC87M1S, BSC87N1E, BSC87T1E, BSC87S1E, BSC87M1E, BSC87L1E, BSC87S1B, BSC87M1B, BSC87M1E-T, BSC87L1E-T, BSC87T1P, BSC87S1P3 réf. MagaBio plus Whole Blood Genomic DNA Purification Kit BSC08S1B, BSC08M1B, BSC08T1P, BSC08S1P, BSC08T1S, BSC08S1S, BSC08M1S, BSC08T1E, BSC08S1E, BSC08M1E, BSC08L1E, BSC08T1C, BSC08S1C, BSC08M1E-T, BSC08L1E-T, BSC08T1C-C, BSC08S1C-C, BSC08N1E, BSC08S1P-A3 réf. MagaBio plus Whole Blood Genomic DNA Purification Kit II BSC73S1B, BSC73M1B, BSC73T1P, BSC73S1P, BSC73T1S, BSC73S1S, BSC73M1S, BSC73L1E, BSC73T1E, BSC73S1E BSC73M1E, BSC73N1E, BSC73S1P-A, BSC73T1C, BSC73S1C, BSC73M1E-T, BSC73L1E-T, BSC73T1C-C, BSC73S1C-C3 réf. MagaBio plus Whole Blood Total RNA Purification Kit II BSC133S1B, BSC133M1B, BSC133T1S, BSC133S1S, BSC133T1E, BSC133S1E, BSC133M1S, BSC133N1E, BSC133T1C, BSC133S1P-A, BSC133M1E, BSC133L1E, BSC133S1C, BSC133T1C-C, BSC133M1E-T, BSC133L1E-T, BSC133S1C-C3 réf. Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR) BSJ09S1, BSJ09M1, BSJ09L13 réf. Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluorescent PCR) BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A3 réf. Norovirus/Group A Rotavirus/Enteric Adenovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ35L198/79 Norovirus/Group A Rotavirus/Enteric Adenovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ35M198/79 QuantFlex Fluorometer QuantFlex 800 QuantGene 9600 Fluorescent Quantitative Detection System FQD-96C(EA4), FQD-96C(EA5), FQD-96C(EA6)3 réf. Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluorescent RT- PCR) BSJ05S1, BSJ05M1, BSJ05L13 réf. Respiratory Syncytial Virus/ Adenovirus/Parainfluenza Virus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ45L198/79 Respiratory Syncytial Virus/ Adenovirus/Parainfluenza Virus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ45M198/79 SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Lyophilized Nucleic Acid Detection Kit (Fluorescence PCR) BSJ48M198/79 SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Lyophilized Nucleic Acid Detection Kit (Fluorescence PCR) BSJ48S198/79 SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Nucleic Acid Multiple Detection Kit (Fluorescence PCR) BSJ37L198/79 SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Nucleic Acid Multiple Detection Kit (Fluorescence PCR) BSJ37M198/79 SARS-CoV-2 Lyophilized Nucleic Acid Detection Kit BSJ18S198/79 SARS-CoV-2 Lyophilized Nucleic Acid Detection Kit BSJ18S1S98/79 Simply P Virus DNA/RNA Extraction Kit BSC67S1, BSC67M1, BSC67L13 réf. Streptococcus Pneumoniae and Haemophilus Influenzae Nucleic Acid Detection Kit (Fluorescence PCR) BSJ31L198/79 Streptococcus Pneumoniae and Haemophilus Influenzae Nucleic Acid Detection Kit (Fluorescence PCR) BSJ31M198/79 VitroCycler Fluorescent Quantitative Detection System VIT-VitroCycler	A, B, C IVDR, 98/79	Site web ra_oversea@bioer.com.cn Fiche EUDAMED Signaler une erreur
Bitrumed Mandataire UE : VidaQuick Biotech S.L. (Espagne)	Chine	Adenovirus &RSV Combo Test AR-5C298/79 Adenovirus, RSV & Flu A+B Combo Test98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Ag Combo Test98/79 Clostridium difficile GDH & Toxin A &Toxin B Combo Test CD-6C398/79 Clostridium difficile GDH & Toxin A &Toxin B Combo Test CD-6F398/79 65 autres Clostridium difficile GDH Rapid Test Cassette ICDG-60298/79 Clostridium difficile GDH Test CDG-6C198/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette ICD-635B98/79 Clostridium difficile Toxin A &Toxin B Combo Test CDT-6C298/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette ICDT-625B98/79 Dengue/Chikungunya/Zika Combo Test DCZ-4C398/79 Dengue/Zika/Chikungunya Combo Test DZC-4C498/79 EBNA IgG Test ENG-4C198/79 EBV VCA & EBNA IgG Combo Test ECN-4C298/79 EBV VCA IgG Test ECG-4C198/79 Flu A Test2 réf.98/79 Flu A+B Test2 réf.98/79 Flu A/B & H1N1 Combo Test98/79 H1N1 Test98/79 HSV 1/2 IgG Test2 réf.98/79 HSV 1/2 IgG/IgM Test4 réf.98/79 HSV 1/2 IgM Test2 réf.98/79 Influenza A+B Rapid Test Cassette IIN-50298/79 Influenza A+B Rapid Test Dipstick98/79 Legionella pneumophila Rapid Test Cassette98/79 Legionella pneumophila Test98/79 Malaria P.f. Test MAL-4A198/79 Malaria P.f. Test MAL-4C198/79 Malaria P.f./ P.v. /Pan Test MPVF-4C198/79 Malaria P.f./ P.v. Test MPV-4C198/79 Malaria P.f./ Pan Test MPN-4C198/79 Monkeypox Virus Antibody Test MXB-4C198/79 MONO Test MONO-4C198/79 Norovirus, Rotavirus & Adenovirus Test NRA-6C298/79 Norovirus, Rotavirus & Adenovirus Test NRA-6F298/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test NRAA-6C398/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test NRAA-6F498/79 Rotavirus & Adenovirus Test RA-6C198/79 Rotavirus & Adenovirus Test RA-6F198/79 Rotavirus and Adenovirus Combo Rapid Test Cassette IRAC-62598/79 RSV Rapid Test Cassette IRS-50298/79 RSV Test RSV-5C198/79 RSV&Flu A+B Combo Test98/79 S. pneumoniae Antigen Rapid Test Cassette ISP-10298/79 SARS-CoV-2 & Flu A+B Ag Combo Test2 réf.98/79 SARS-CoV-2 & M.pneumoniae IgG Combo Test98/79 SARS-CoV-2 & M.pneumoniae IgG/IgM Combo Test98/79 SARS-CoV-2 Ag Test3 réf.98/79 SARS-CoV-2 Ag Test (Nasal Swab)98/79 SARS-CoV-2 Ag Test (Oral fluid)2 réf.98/79 SARS-CoV-2 IgG Test2 réf.98/79 SARS-CoV-2 IgG/IgM Test2 réf.98/79 SARS-CoV-2 Neutralization Antibody Test98/79 SARS-CoV-2 S-RBD IgG Antibody Test98/79 SARS-CoV-2/Flu A+B/RSV Ag Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus Ag Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus/M.pneumoniae Ag Combo Test98/79 Strep A Rapid Test Cassette IST-50298/79 Strep A Test STA-5A198/79 Strep A Test STA-5C198/79 Strep A Test STAB-5A198/79 Strep A Test STAB-5C198/79 Strep B Rapid Test Cassette ISB-50298/79 Strep B Test STB-5A198/79 Strep B Test STB-5C198/79 Streptococcus pneumoniae Ag Test98/79 Syphilis Test SYP-3A198/79 Syphilis Test SYP-3C198/79 Syphilis Test SYP-4A198/79 Syphilis Test SYP-4C198/79	– 98/79	info@bitrumed.com.cn Fiche EUDAMED Signaler une erreur
Wuhan Easydiagnosis Biomedicine Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 2 autres	Chine	20 tests/kit11 réf.98/79 40 tests/kit12 réf.98/79 ACT CoaguDx Test Strip 12 Strips / Kit98/79 ACT CoaguDx Test Strip 24 Strips / Kit98/79 ACT CoaguDx Test Strip 48 Strips / Kit98/79 149 autres ACT CoaguDx Test Strip 6 Strips / Kit98/79 APTT CoaguDx Test Strip 12 Strips / Kit98/79 APTT CoaguDx Test Strip 12 Strips / Kit (Note: One-step method)98/79 APTT CoaguDx Test Strip 24 Strips / Kit98/79 APTT CoaguDx Test Strip 24 Strips / Kit (Note: One-step method)98/79 APTT CoaguDx Test Strip 48 Strips / Kit98/79 APTT CoaguDx Test Strip 48 Strips / Kit (Note: One-step method)98/79 APTT CoaguDx Test Strip 6 Strips / Kit98/79 APTT CoaguDx Test Strip 6 Strips / Kit (Note: One-step method)98/79 APTT CoaguDx Test Strip 96 Strips / Kit (Note: One-step method)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Anterior nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Nasal swab + anterior nasal swab (long version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Nasal swab + anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Nasal swab + throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Positive and negative controls)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Positive control)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit （Nasal swab）98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit ()Nasal swab + anterior nasal swab (short version)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit ()Nasal swab + anterior nasal swab (short versionNasal swab + anterior nasal swab (long version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Anterior nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Positive control)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit ( Positive and negative controls)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Anterior nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Nasal swab + anterior nasal swab (long version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Nasal swab + anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Nasal swab + throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Positive control)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit(Throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Anterior nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Nasal swab + anterior nasal swab (long version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Nasal swab + throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Positive and negative controls)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Positive control)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit(Anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Anterior nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Nasal swab + anterior nasal swab (short version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Nasal swab + throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Nasal swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Positive and negative controls)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Positive control)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Throat swab)98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit(Nasal swab + anterior nasal swab (long version))98/79 COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-B0198/79 COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag05-C0198/79 COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-B0198/79 D-Dimer Test Kit (Immunofluorescence Method) 20 tests/kit98/79 PT CoaguDx Test Strip 12 Strips / Kit98/79 PT CoaguDx Test Strip 12 Strips / Kit (Note: One-step method)98/79 PT CoaguDx Test Strip 24 Strips / Kit98/79 PT CoaguDx Test Strip 24 Strips / Kit (Note: One-step method)98/79 PT CoaguDx Test Strip 48 Strips / Kit98/79 PT CoaguDx Test Strip 48 Strips / Kit (Note: One-step method)98/79 PT CoaguDx Test Strip 6 Strips / Kit98/79 PT CoaguDx Test Strip 6 Strips / Kit (Note: One-step method)98/79 PT CoaguDx Test Strip 96 Strips / Kit (Note: One-step method)98/79 100 tests/kit2 réf.98/79 (plus commercialisé) 24 tests/kit2 réf.98/79 (plus commercialisé) 25 tests/kit98/79 (plus commercialisé) 48 tests/kit4 réf.98/79 (plus commercialisé) 50 tests/kit2 réf.98/79 (plus commercialisé) 5×4 mL98/79 (plus commercialisé) 96 tests/kit3 réf.98/79 (plus commercialisé) Adeno/RSV Ag Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (plus commercialisé) Adeno/RSV Ag Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (plus commercialisé) Adenovirus(Adeno) Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (plus commercialisé) AP1: 96 tests/kit2 réf.98/79 (plus commercialisé) AP1:24 tests/kit2 réf.98/79 (plus commercialisé) AP1:48 tests/kit2 réf.98/79 (plus commercialisé) Brucellosis Rapid Test 20 tests/kit98/79 (plus commercialisé) Brucellosis Rapid Test 40 tests/kit98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Nasal swab + throat swab)98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Nasal swab + anterior nasal swab (short version))98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-10, 10Tests/kit (Positive control)98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-10, 10Tests/kit(Positive and negative controls)98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Anterior nasal swab (short version))98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Anterior nasal swab)98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Nasal swab + anterior nasal swab (long version))98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Nasal swab + throat swab)98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Nasal swab)98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Positive control)98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Throat swab)98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit(Nasal swab + anterior nasal swab (short version))98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-5, 5Tests/kit (Nasal swab + throat swab)98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-C0198/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-C0598/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-C1098/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag02-C0198/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag02-C0598/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag02-C10,98/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag03-C0198/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag03-C0598/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag03-C1098/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag04-C0198/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag04-C0598/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag04-C1098/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag05-C1098/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag06-C0198/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag06-C0598/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag06-C1098/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag07-C0198/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag07-C0598/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag07-C1098/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag08-C0198/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag08-C0598/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-C0198/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-C0598/79 (plus commercialisé) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-C2098/79 (plus commercialisé) COVID-19 Ag Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (plus commercialisé) COVID-19 Neutralizing Antibody( COVID-19 NAb) Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (plus commercialisé) COVID-19 Neutralizing Antibody( COVID-19 NAb) Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (plus commercialisé) COVID-19/Influenza Ag Combo Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (plus commercialisé) COVID-19/Influenza Ag Combo Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (plus commercialisé) Freeze-dried：100 tests/kit98/79 (plus commercialisé) Freeze-dried：25 tests/kit98/79 (plus commercialisé) Freeze-dried：50 tests/kit98/79 (plus commercialisé) HPV （16+18）Rapid Test 20 tests/kit98/79 (plus commercialisé) HPV （16+18）Rapid Test 40 tests/kit98/79 (plus commercialisé) Influenza A+B/RSV Ag Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (plus commercialisé) Influenza A+B/RSV Ag Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (plus commercialisé) Influenza A/B Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (plus commercialisé) Influenza A/B Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (plus commercialisé) Mycoplasma Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (plus commercialisé) Mycoplasma Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (plus commercialisé) Norovirus(NORO) Test Kit (Immunofluorescence Method) 20 tests/kit2 réf.98/79 (plus commercialisé) QP1：100 tests/kit2 réf.98/79 (plus commercialisé) QP1：24 tests/kit98/79 (plus commercialisé) QP1：25 tests/kit98/79 (plus commercialisé) QP1：48 tests/kit98/79 (plus commercialisé) QP1：50 tests/kit98/79 (plus commercialisé) QP1：96 tests/kit98/79 (plus commercialisé) Reagent 1: 5×5mL Reagent 2: 5×5mL98/79 (plus commercialisé) Reagent 1：5×5 mL Reagent 2：5×5 mL Dilution：2×5 mL98/79 (plus commercialisé) Reagent：5×5 mL Buffer：5×10 mL98/79 (plus commercialisé) Respiratory Syncytial Virus Antigen(RSV Ag) Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (plus commercialisé) Respiratory Syncytial Virus Antigen(RSV Ag) Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (plus commercialisé) Rota/Adeno Combo Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (plus commercialisé) Rota/Adeno Combo Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (plus commercialisé) Rotavirus (ROTA) Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (plus commercialisé) Strep A Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (plus commercialisé) Strep A Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (plus commercialisé)	– 98/79	Fiche EUDAMED Signaler une erreur
Ecolidx	Tchéquie	ePure ePure Bacterial DNA Extraction Kit ePure Blood DNA Extraction Kit 200 ePure CFC DNA Extraction Kit ePure FFPE DNA Extraction Kit 64 autres ePure Forensic DNA Extraction Kit ePure STD DNA Extraction Kit ePure TB DNA Extraction Kit ePure Tissue DNA Extraction Kit ePure Viral Nucleic Acid Extraction Kit eSens Acute intestinal infections QL PCR kit98/79 eSens ARVI screen QL PCR kit98/79 eSens Bordetella pertussis/bronchiseptica/parapertussis QL PCR kit98/79 eSens Borrelia miyamotoi QL PCR kit98/79 eSens Brucella sp. QL PCR kit98/79 eSens Candida albicans QL PCR kit98/79 eSens Candida albicans/glabrata/krusei QL PCR kit98/79 eSens Corynebacterium diphtheriae/tox genes QL PCR kit98/79 eSens Cryptococcus neoformans QL PCR kit98/79 eSens Dengue virus type QL PCR kit98/79 eSens EBV QT PCR kit98/79 eSens EBV/HHV6 QT PCR kit98/79 eSens Enterovirus QL PCR kit98/79 eSens Escherichioses QL PCR kit98/79 eSens Florocenosis/Aerobes QT PCR kit98/79 eSens Florocenosis/Bacterial Vaginosis QT PCR kit98/79 eSens Florocenosis/Candida QT PCR kit98/79 eSens Florocenosis/Mycoplasmas QT PCR kit98/79 eSens Gardnerella vaginalis/Lactobacillus sp. QT PCR kit98/79 eSens HAV QL PCR kit98/79 eSens HBV genotype QL PCR kit98/79 eSens HCV genotype QL PCR kit98/79 eSens Helicobacter pylori QL PCR kit98/79 eSens HGV QL PCR kit98/79 eSens HHV6 QT PCR kit98/79 eSens HHV7 QT PCR kit98/79 eSens HHV8 QT PCR kit98/79 eSens HPV HR 14 genotype QT PCR kit98/79 eSens HPV HR 14 screen/16,18,45 genotype QT PCR kit98/79 eSens HPV HR 16/18 genotype QT PCR kit98/79 eSens HPV LR 6/11 genotype QL PCR kit98/79 eSens HSV 1/2 genotype QL PCR kit98/79 eSens Influenza virus A H5/H7/H9 QL PCR kit98/79 eSens Legionella pneumophila QT PCR kit98/79 eSens Leptospira QL PCR kit98/79 eSens Listeria monocytogenes QT PCR kit98/79 eSens M.genitalium ML/FQ resistance QT PCR kit98/79 eSens MTC QL PCR kit98/79 eSens Mycobacterium tuberculosis/bovis/BCG QL PCR kit98/79 eSens Mycoplasma genitalium QL PCR kit98/79 eSens Mycoplasma hominis QL PCR kit98/79 eSens N.gonorrhoeae/M.genitalium/T.vaginalis QL PCR kit98/79 eSens N.meningitidis/H.influenzae/S.pneumoniae QL PCR kit98/79 eSens Neisseria gonorrhoeae QL PCR kit98/79 eSens Parvovirus B19 QT PCR kit98/79 eSens Pneumocystis jirovecii QL PCR kit98/79 eSens Rotavirus/Norovirus/Astrovirus QL PCR kit98/79 eSens Streptococcus agalactiae QT PCR kit98/79 eSens Streptococcus pyogenes QT PCR kit98/79 eSens TBEV QL PCR kit98/79 eSens TBEV/Borrelia/Anaplasma/Ehrlichia QL PCR Kit98/79 eSens Treponema pallidum QL PCR kit98/79 eSens Ureaplasma parvum/urealyticum QL PCR kit98/79 eSens Ureaplasma sp. QL PCR kit98/79 eSens Ureaplasma/M.genitalium/M.hominis QL PCR kit98/79 eSens VZV QL PCR kit98/79 eSens WNV QL PCR kit98/79 eSens Yellow fever virus QL PCR kit98/79 eSens Zika virus QL PCR kit98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
HangZhou Biotest Biotech FDA Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne) et 1 autre	Chine	Cassette IMAL-C5398/79 Cassette IRSVA-C8198/79 Ferrarihub98/79 RightSign8 réf. Rightsign CDIM-C4198/79 64 autres RightSign Home+ Rightsign IADE-C6198/79 Rightsign IADE-C8198/79 Rightsign IAST-C6198/79 Rightsign ICAG-C7198/79 Rightsign ICBAD-MC8398/79 Rightsign ICFGN-MC8398/79 Rightsign ICFR-MC8498/79 Rightsign ICFRA-MC8598/79 Rightsign ICFRAM-MC8698/79 Rightsign ICFRAN-MC8598/79 Rightsign ICGT-C6398/79 Rightsign ICKG-C4298/79 Rightsign ICOVN-C8198/79 Rightsign ICOVN-C81H98/79 Rightsign ICPT-C6198/79 Rightsign ICTG-C4198/79 Rightsign IEBA-C6198/79 Rightsign IEV71-C4198/79 Rightsign IFLU-C8298/79 Rightsign IFLU-S8298/79 Rightsign IGL-C6198/79 RightSign IHBSG-C3198/79 RightSign IHCV-C3198/79 RightSign IHIV-C4298/79 Rightsign IHMV-C8198/79 Rightsign IHPB-S4198/79 Rightsign IHPC-MC3298/79 Rightsign ILP-C1198/79 Rightsign IMAL-C5398/79 Rightsign IMON-C4198/79 Rightsign IMP-C4198/79 Rightsign IMPF-C5198/79 Rightsign IMPF-C51S98/79 Rightsign IMPN-C5298/79 Rightsign IMPN-C52S98/79 Rightsign IMPV-C5298/79 Rightsign IMPV-C52S98/79 Rightsign INCP-C8198/79 Rightsign INGM-MC4298/79 Rightsign INRV-C6198/79 Rightsign IPTG-C4198/79 Rightsign IRCF-MC8498/79 Rightsign IRCF-MC84S98/79 Rightsign IRCFN-MC8498/79 Rightsign IROT-C6198/79 Rightsign IRSV-C8198/79 Rightsign IRSVA-C8198/79 Rightsign ITET-C4198/79 Rightsign ITYP-C3298/79 Rightsign ITYP-C6198/79 Rightsign IVZV-C4198/79 Rightsign IZGM-C4298/79 Rightsign MCDIM-LC4198/79 Rightsign MIDEG-LC4198/79 Rightsign MIDEN-LC4298/79 Rightsign MIHPG-LC3198/79 Rightsign MPIL6-LC4198/79 Rightsign SCJ-C6198/79 Rightsign SEC-C6198/79 Rightsign WGON-C7198/79 Rightsign WHPV-C7298/79 Rightsign WHSM-C3198/79 Rightsign WSTB-C7198/79	B, C IVDR, 98/79	info@biotests.com.cn Fiche EUDAMED Signaler une erreur
Weihai Sunway Medical Technology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	3.2% Sodium Citrate Tube(0.109mol/L) (mini plastic) 3.2% Sodium Citrate Tube(0.109mol/L) (mini rubber) 3.2% Sodium Citrate Tubes 3.8% Sodium Citrate Tube（0.129mol/L） Clot Activator Tube (mini lock) QI-7.5.8-02 64 autres Clot Activator Tube (mini plastic) QI-7.5.8-02 Clot activator tube (PINK) Clot Activator Tube(red) Clot Activator Tube（mini rubber） Clot Activator Tube（Orange） Double-wall Sodium Citrate Tube---3.2% Sodium Citrate（0.109mol/L） Double-wall Sodium Citrate Tube---3.8% Sodium Citrate(0.129mol/L) EDTA.K2 Tube EDTA.K2 Tube (mini lock) EDTA.K2 Tube (mini plastic) EDTA.K2 Tube (mini rubber) EDTA.K2 Tube（pink） EDTA.K3 Tube EDTA.K3 Tube (mini lock) EDTA.K3 Tube (mini plastic) EDTA.K3 Tube (PINK) EDTA.K3 Tube（mini rubber） ESR RACK Faeces specimen container Faeces specimen tube Gel & Activator Tube Gel& Clot Activator Tube (mini amber plastic) Gel& Clot Activator Tube (mini lock) QI-7.5.8-02 Gel& Clot Activator Tube (mini plastic) QI-7.5.8-02 Gel& EDTA.K2 Tube Gel& EDTA.K2 Tube (White ) Gel& EDTA.K3 Tube (PURPLE) Gel& Lithium Heparin Tube (mini lock) QI-7.5.8-02 Gel& Lithium Heparin Tube (mini plastic) QI-7.5.8-02 Gel& Lithium Heparin Tube (mini rubber) QI-7.5.8-02 Gel& Lithium Heparin Tube QI-7.5.8-02 Gel& Sodium Heparin Tube QI-7.5.8-02 Gel& Thrombin tube QI-7.5.8-02 Gel&Clot Activator Tube(mini rubber) MG01C Lithium Heparin Tube Lithium Heparin Tube (mini lock) QI-7.5.8-02 Lithium Heparin Tube (mini plastic) QI-7.5.8-02 Lithium Heparin Tube (mini rubber) QI-7.5.8-02 No Activator Tube (mini lock) QI-7.5.8-02 No Additive Tube (mini plastic) QI-7.5.8-02 No Additive Tube (mini rubber) QI-7.5.8-02 No Additive Tube (Red) QI-7.5.8-02 No Additive Tube (White) QI-7.5.8-02 Saliva specimen container Saliva specimen tube Sodium Fluoride & EDTA Tube Sodium Fluoride & EDTA Tube （mini rubber） Sodium Fluoride& EDTA.K2 Tube (mini lock) Sodium Fluoride& EDTA.K2 Tube (mini plastic) Sodium Fluoride& Sodium Heparin Tube (mini lock) QI-7.5.8-02 Sodium Fluoride& Sodium Heparin Tube (mini plastic) QI-7.5.8-02 Sodium Fluoride& Sodium Heparin Tube (mini rubber) QI-7.5.8-02 Sodium Fluoride& Sodium Heparin Tube QI-7.5.8-02 Sodium Heparin Tube (mini lock) QI-7.5.8-02 Sodium Heparin Tube (mini plastic) QI-7.5.8-02 Sodium Heparin Tube (mini rubber) QI-7.5.8-02 Sodium Heparin Tube QI-7.5.8-02 Sputum specimen container Sputum specimen tube Thrombin tube QI-7.5.8-02 Urine Collection tube (yellow) boric acid Urine Collection tube （yellow） No additive Urine Collection tube(white) QI-7.5.8-02 Urine specimen container	I, A IVDR, MDR	Fiche EUDAMED Signaler une erreur
Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇	Turquie	D-Dimer 77 mL98/79 D-DIMER Kit 40mL98/79 D-Dimer Kit 52mL98/79 D-DIMER Kit 82mL98/79 D-DIMER Kit B3344798/79 63 autres D-Dimer Reagent Kit K4444798/79 D-DIMER Reagent Kit K4644798/79 Dansite Reagent R1 Dansite Reaktif R198/79 Glucose-6-Phosphate Dehydrogenase (G6PD) Reagent Kit98/79 HbA1c Kit 138mL98/79 HbA1c Kit 276mL98/79 HbA1c Kit 511mL98/79 HbA1c Kit HbA1c+Lyse Kit 520mL98/79 IgA Kit 100mL98/79 IgA Kit 50mL98/79 IgA Turbidimetry Reagent Kit98/79 IgE Kit 30mL98/79 IgE Kit 62mL98/79 IgE Reagent Kit K4619598/79 IgE Turbidimetry Reagent Kit98/79 IgG Kit 100mL2 réf.98/79 IgG Kit 50mL98/79 IgG Turbidimetry Reagent Kit98/79 IgM Kit 100mL2 réf.98/79 IgM Kit 50 mL98/79 IgM Kit 50mL98/79 IgM Turbidimetry Reagent Kit3 réf.98/79 Immunglobulin A Kit 50mL98/79 Immunglobulin E Kit 31 mL98/79 Immunglobulin G Kit 50mL98/79 Immunglobulin M 50mL Immunglobulin M Kit 50mL98/79 Immunoglobulin A (IgA) Immunoglobulin A 75 mL98/79 Immunoglobulin A 39 mL98/79 Immunoglobulin A 78 mL98/79 Immunoglobulin A Kit 100mL2 réf.98/79 Immunoglobulin A Kit 50mL4 réf.98/79 Immunoglobulin A Kit 90mL98/79 Immunoglobulin A Kit B4519098/79 Immunoglobulin A Kit IgA Kit 100mL98/79 Immunoglobulin A Kit IgA Kit 50mL98/79 Immunoglobulin E (IgE) Immunoglobulin E 60 mL98/79 Immunoglobulin E 31 mL98/79 Immunoglobulin E 62 mL98/79 Immunoglobulin E IgE Kit 30mL98/79 Immunoglobulin E Kit 160mL98/79 Immunoglobulin E Kit 30mL5 réf.98/79 Immunoglobulin E Kit 60mL2 réf.98/79 Immunoglobulin E Kit 62mL98/79 Immunoglobulin E Kit IgE Kit 60mL98/79 Immunoglobulin G (IgG) Immunoglobulin G 75 mL98/79 Immunoglobulin G 39 mL98/79 Immunoglobulin G 78 mL98/79 Immunoglobulin G Kit 100mL2 réf.98/79 Immunoglobulin G Kit 50mL6 réf.98/79 Immunoglobulin G Kit 60mL98/79 Immunoglobulin G Kit 90mL98/79 Immunoglobulin G Kit IgG Kit 50mL98/79 Immunoglobulin M (IgM) Immunoglobulin M 75 mL98/79 Immunoglobulin M 39 mL98/79 Immunoglobulin M Kit 100mL98/79 Immunoglobulin M Kit 50mL4 réf.98/79 Immunoglobulin M Kit 60mL98/79 Immunoglobulin M Kit 90mL98/79 İmmünglobulin A Reagent Kit98/79 İmmünglobulin E Reagent kit98/79 İmmünglobulin G Reagent Kit98/79 İmmünglobulin M Reagent Kit98/79 Nitrit Reagent R1 Nitrit Reaktif R198/79	– 98/79	info@kinetikkimya.com Fiche EUDAMED Signaler une erreur
Safecare FDA Mandataire UE : Medunion S.L. (Espagne) et 4 autres	Chine	"H.pylori Antibodies Rapid Test Kit (Whole Blood/serum/plasma)" HPAb-4011/HPAb-401298/79 Bacterial Vaginosis Multi-Test Kit98/79 Bacterial Vaginosis Multi-Test(Swab)98/79 Cardiac Troponin I Rapid Test Kit(Whole Blood/serum/plasma) CTNI-401298/79 COVID-19 & Influenza A+B Antigen Combo Rapid Test98/79 63 autres COVID-19 Antigen FIA Test (Swab)98/79 COVID-19 Antigen Rapid Test Kit (Swab)98/79 COVID-19 IgG/IgM FIA Test (Serum/Plasma)98/79 COVID-19 IgG/IgM FIA Test (Whole blood/Serum/Plasma)98/79 COVID-19/Flu/RSV/ADV/hMPV Antigen Combo Rapid Test98/79 COVID-19/Flu/RSV/ADV/hMPV/HPIV Antigen Combo Rapid Test98/79 COVID-19/Flu/RSV/ADV/MP Antigen Combo Rapid Test(Swab)98/79 COVID-19/FluA&B/RSV/ADV/MP Antigen Combo Rapid Test(Swab)98/79 Dengue IgG/IgM Rapid Test (Serum/Plasma) DEN-302298/79 Dengue IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) DEN-402298/79 Dengue IgG/IgM Rapid Test Kit(Whole Blood/serum/plasma) DEN-302298/79 Dengue IgG/IgM/NS1 Combo Rapid Test (WB/S/P)98/79 Dengue IgG/IgM/NS1 Combo Rapid Test (Whole Blood/Serum/Plasma)98/79 Dengue IgG/IgM/NS1 Combo Rapid Test(Serum/Plasma)98/79 Dengue NS1 Rapid Test (Serum/Plasma)98/79 Dengue NS1 Rapid Test (Whole Blood/Serum/Plasma)98/79 Dengue NS1 Rapid Test Kit(Whole Blood/serum/plasma)98/79 H.pylori Antibodies Rapid Test (Serum/Plasma) HPAb-3011/HPAb-301298/79 H.pylori Antibodies Rapid Test (Whole Blood/Serum/Plasma) HPAb-4011/HPAb-401298/79 H.pylori Antigen FIA Test (Feces)98/79 H.pylori Antigen Rapid Test (Feces) HPAg-5011/HPAg-501298/79 H.pylori Antigen Rapid Test Kit(Feces) HPAg-5011/HPAg-501298/79 Influenza A/B Antigen FIA Test (Swab)98/79 Influenza A/B Antigen Rapid Test（Swab） FLU-602298/79 Kit de Detección Rápida de Antígenos de COVID-19 (Hisopo)-Nasal98/79 Kit de prueba de antígenos de múltiples virus respiratorios ( Hisopo ) (Gripe A+B/ COVID-19)98/79 Malaria P.f. Rapid Test (Whole Blood) MAL-4011a/MAL-4012a98/79 Malaria P.v. Rapid Test (Whole Blood) MAL-4011b/MAL-4012b98/79 Malaria P.f. Rapid Test Kit(Whole Blood) MAL-4011/MAL-4012a98/79 Malaria P.f./P.v. Rapid Test Kit(Whole Blood) MAL-4022a98/79 Malaria P.f./P.v. Rapid Test (Whole Blood) MAL-4022a98/79 Malaria P.f./Pan Rapid Test Kit(Whole Blood) MAL-4022b98/79 Malaria P.f./Pan Rapid Test (Whole Blood) MAL-4022b98/79 Malaria P.v./Pan Rapid Test (Whole Blood) MAL-4022c98/79 Malaria Pan Rapid Test (Whole Blood) MAL-4011c/MAL-4012c98/79 Monkeypox Virus Antigen Rapid Test98/79 Monkeypox Virus Antigen Rapid Test(Serum/Plasma) MON Ag-301298/79 Monkeypox Virus Antigen Rapid Test(Swab) MON Ag-601298/79 Monkeypox Virus Antigen Rapid Test(Whole blood/Serum/Plasma) MON Ag-401298/79 Monkeypox Virus IgG/IgM Rapid Test(Serum/Plasma) MON Ab-302298/79 Monkeypox Virus IgG/IgM Rapid Test(Whole blood/Serum/Plasma) MON Ab-402298/79 Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19)98/79 Multi-Respiratory Virus Antigen Test(Swab) (Influenza A+B/ COVID-19)98/79 Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Kit98/79 Mycoplasma pneumoniae(MP) IgG/IgM Combo Rapid Test(Serum/Plasma)98/79 Mycoplasma pneumoniae(MP) IgG/IgM Combo Rapid Test(Whole Blood/Serum/Plasma)98/79 Prueba rápida combinada de antígenos de COVID-19/Gripe/VSR (Hisopo)98/79 Prueba Rápida Combinada de Antígenos de COVID-19 y Gripe A+B98/79 Respiratory Pathogens Antigen Combo Rapid Test MID-614298/79 Rotavirus Antigen Rapid Test(Feces) ROT-5011/ROT-501298/79 Rotavirus Rapid Test (Feces) ROT-5011/ROT-501298/79 RSV Antigen FIA Test (Swab)98/79 RSV Antigen Rapid Test RSV-6011/ RSV-601298/79 RSV Antigen Rapid Test(Swab) RSV-6011/RSV-601298/79 Strep A Rapid Test (Swab) STA-6011/STA-601298/79 Strep A Rapid Test Kit (swab) STA-6011/STA-601298/79 Strep B Rapid Test (Swab) STB-6011/STB-601298/79 Strep B Rapid Test Kit (swab) STB-6011/STB-601298/79 Syphilis Rapid Test (Serum/Plasma) SYP-3011/SYP-401198/79 Syphilis Rapid Test (Whole Blood/Serum/Plasma) SYP-4011/SYP-401298/79 Syphilis Rapid Test Kit(Whole Blood/serum/plasma)98/79 ViraxClear Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo) COVID-19/Flu A&B/RSV/ADV Antigen Combo Rapid Test98/79 Συνδυαστικό τεστ ταχείας ανίχνευσης αντιγόνου του COVID-19 και της Ινφλουέντζας A+B Για αυτοδοκιμή COVID-19 & Influenza A+B Antigen Combo Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Turquie	Anatolia Geneworks51 réf. Anatolia Geneworks Bosphore Aspergillus Detection Kit v13 réf.98/79 Anatolia Geneworks Bosphore Bacterial DNA Extraction Spin Kit v2 Anatolia Geneworks Bosphore Bacterial Meningitis Panel Kit v23 réf.98/79 Anatolia Geneworks Bosphore Bacterial Meningitis Panel Kit v33 réf.98/79 62 autres Anatolia Geneworks Bosphore Bacterial Vaginosis Screening Kit v13 réf.98/79 Anatolia Geneworks Bosphore BKV Quantification Kit v13 réf.98/79 Anatolia Geneworks Bosphore Candida auris Detection Kit v13 réf.98/79 Anatolia Geneworks Bosphore CCHFV Quantification Kit v13 réf.98/79 Anatolia Geneworks Bosphore CNS Mini Panel Kit v23 réf.98/79 Anatolia Geneworks Bosphore CNS Screening Kit v2U3 réf.98/79 Anatolia Geneworks Bosphore COVID-19 Sampling and Viral RNA Extraction Kit Anatolia Geneworks Bosphore CT/NG/MG Panel Kit v13 réf. Anatolia Geneworks Bosphore EBV Quantification Kit v13 réf.98/79 Anatolia Geneworks Bosphore Eye Infection Screening Kit v13 réf.98/79 Anatolia Geneworks Bosphore Gastroenteritis Panel Kit v42 réf.98/79 Anatolia Geneworks Bosphore Genomic DNA Extraction Spin Kit v2 Anatolia Geneworks Bosphore HCV Genotyping Kit v53 réf.98/79 Anatolia Geneworks Bosphore HDV Quantification-Detection Kit v13 réf.98/79 Anatolia Geneworks Bosphore HHV-6/7/8 Quantification Kit v13 réf.98/79 Anatolia Geneworks Bosphore HIV-1 Quantification Kit3 réf.98/79 Anatolia Geneworks Bosphore HPV Genotyping High Risk Kit v33 réf.98/79 Anatolia Geneworks Bosphore HPV HR-LR Genotyping Kit v32 réf.98/79 Anatolia Geneworks Bosphore HPV Screening Kit v13 réf.98/79 Anatolia Geneworks Bosphore HPV Screening Kit v23 réf.98/79 Anatolia Geneworks Bosphore hrHPV Screening Kit v13 réf.98/79 Anatolia Geneworks Bosphore HSV 1-2 Quantification Kit v13 réf.98/79 Anatolia Geneworks Bosphore Joint Infection Panel Kit v13 réf.98/79 Anatolia Geneworks Bosphore Malaria Genotyping Kit v23 réf.98/79 Anatolia Geneworks Bosphore Measles Detection Kit v13 réf.98/79 Anatolia Geneworks Bosphore MTBC Detection Kit v23 réf.98/79 Anatolia Geneworks Bosphore Neonatal Meningitis Panel Kit v13 réf.98/79 Anatolia Geneworks Bosphore Parvovirus B19 Quantification Kit v13 réf.98/79 Anatolia Geneworks Bosphore Respiratory Pathogens Panel Kit v122 réf.98/79 Anatolia Geneworks Bosphore Respiratory Pathogens Panel Kit v53 réf.98/79 Anatolia Geneworks Bosphore Respiratory Pathogens Panel Kit v73 réf.98/79 Anatolia Geneworks Bosphore Respiratory Viral Basic Panel Kit v23 réf.98/79 Anatolia Geneworks Bosphore Sepsis Screening Kit v33 réf.98/79 Anatolia Geneworks Bosphore STD Basic Kit v13 réf.98/79 Anatolia Geneworks Bosphore STDs Screening Kit v43 réf.98/79 Anatolia Geneworks Bosphore STDs Screening Kit v63 réf.98/79 Anatolia Geneworks Bosphore Tissue Genomic DNA Extraction Spin Kit v2 Anatolia Geneworks Bosphore Tropical Fever Panel Kit v13 réf.98/79 Anatolia Geneworks Bosphore Tropical Fever Panel Kit v43 réf.98/79 Anatolia Geneworks Bosphore UTI Panel Kit v42 réf.98/79 Anatolia Geneworks Bosphore Viral Meningitis Panel Kit v23 réf.98/79 Anatolia Geneworks Bosphore Viral Meningitis Panel Kit v33 réf.98/79 Anatolia Geneworks Bosphore VZV (HHV-3) Quantification Kit v13 réf.98/79 Anatolia Geneworks Bosphore Wound Panel Kit v13 réf.98/79 Anatolia Geneworks Magnesia 16 Nucleic Acid Extraction Instrument Anatolia Geneworks Magnesia 2448 Bacterial DNA Extraction Kit Anatolia Geneworks Magnesia 2448 Nucleic Acid Extraction & PCR Setup Robot Anatolia Geneworks Magnesia 2448 Viral DNA/RNA Extraction Kit Anatolia Geneworks Magnesia 2448 Viral DNA/RNA Extraction Kit EP2 réf. Anatolia Geneworks Magnesia 2448 Whole Blood Genomic DNA Extraction Kit Anatolia Geneworks Montania 4896 Real-Time PCR Instrument Anatolia Geneworks UNIO 448 System Anatolia Geneworks Unio 96 Extraction and PCR Setup Robot Anatolia Geneworks UNIO 96 Nucleic Acid Extraction Versatile Kit MG92 réf. Anatolia Geneworks Unio 96 Nucleic Acid Extraction Versatile Kit Anatolia Geneworks Unio A24S Extraction & PCR Setup System Anatolia Geneworks Unio B24 Extraction System Anatolia Geneworks Unio B48 Extraction System Anatolia Geneworks Unio M32 Extraction System Anatolia Geneworks Unio M32 Viral DNA/RNA Extraction Kit2 réf. Anatolia Geneworks UNIO M32 Viral Nucleic Acid Extraction TB Anatolia Geneworks Unio Viral DNA/RNA Extraction Kit 600 µl2 réf.	A, C, D IVDR, 98/79	Site web info@anatoliagenetik.com Fiche EUDAMED Signaler une erreur
Hamilton FDA Mandataire UE : Johner Medical GmbH (Allemagne)	Suisse	CO-RE II Tips, black, sterile 235646 CO-RE II Tips, black, sterile 235648 CO-RE II Tips, black, sterile 235677 CO-RE II Tips, black, sterile 235842 CO-RE II Tips, black, sterile 235935 64 autres CO-RE II Tips, black, sterile 235936 CO-RE II Tips, black, sterile 235937 CO-RE II Tips, black, sterile 235938 CO-RE II Tips, black, sterile 235939 CO-RE II Tips, black, sterile 235940 CO-RE II Tips, black, sterile 235978 CO-RE II Tips, black, sterile 235979 CO-RE II Tips, black, sterile 235983 CO-RE II Tips, black, sterile 235985 CO-RE II Tips, black, sterile 235987 CO-RE II Tips, non-sterile 10183812 CO-RE II Tips, non-sterile 10183816 CO-RE II Tips, non-sterile 235452 CO-RE II Tips, non-sterile 235900 CO-RE II Tips, non-sterile 235901 CO-RE II Tips, non-sterile 235902 CO-RE II Tips, non-sterile 235903 CO-RE II Tips, non-sterile 235904 CO-RE II Tips, non-sterile 235905 CO-RE II Tips, non-sterile 235947 CO-RE II Tips, non-sterile 235948 CO-RE II Tips, non-sterile 235949 CO-RE II Tips, non-sterile 235950 CO-RE II Tips, non-sterile 235964 CO-RE II Tips, non-sterile 235965 CO-RE II Tips, non-sterile 235966 CO-RE II Tips, non-sterile 235971 CO-RE Tips, black, non-sterile 184020 CO-RE Tips, black, non-sterile 184021 CO-RE Tips, black, non-sterile 194050 CO-RE Tips, black, non-sterile 235446 CO-RE Tips, black, non-sterile 235477 CO-RE Tips, black, non-sterile 235697 CO-RE Tips, black, non-sterile 235699 CO-RE Tips, black, non-sterile 235843 CO-RE Tips, black, non-sterile 235845 CO-RE Tips, black, non-sterile 235974 CO-RE Tips, black, non-sterile 235989 CO-RE Tips, black, non-sterile 235993 CO-RE Tips, black, sterile 184022 CO-RE Tips, black, sterile 184023 CO-RE Tips, black, sterile 235694 CO-RE Tips, black, sterile 235695 CO-RE Tips, black, sterile 235844 CO-RE Tips, black, sterile 235846 Greenline CO-RE II Tips, non-sterile 235214 Greenline CO-RE II Tips, non-sterile 235215 Greenline CO-RE II Tips, non-sterile 235216 Greenline CO-RE II Tips, non-sterile 235217 Greenline CO-RE II Tips, non-sterile 235218 Greenline CO-RE II Tips, non-sterile 235219 Greenline CO-RE II Tips, non-sterile 235222 Greenline CO-RE II Tips, non-sterile 235224 Greenline CO-RE II Tips, sterile 235221 Greenline CO-RE II Tips, sterile 235223 Greenline CO-RE II Tips, sterile 235225 Special tips, non-sterile, CO-RE II 235449 Special tips, non-sterile, CO-RE II 235541 Special tips, non-sterile, CO-RE II 235647 Special tips, non-sterile, CO-RE II 235678 Special tips, non-sterile, CO-RE II 235806 CO-RE II Tips, non-sterile 235679 (plus commercialisé) CO-RE Tips, black, non-sterile 194053 (plus commercialisé) CO-RE Tips, black, non-sterile 235447 (plus commercialisé)	A IVDR	Présent sur le marché en France Site web Contact-PRRC.rob.ch@hamilton.ch Fiche EUDAMED Signaler une erreur
gerbion	Allemagne	alphaCube Babesia98/79 alphaCube Bordetella98/79 alphaCube Borrelia98/79 alphaCube BV-198/79 alphaCube C.difficile98/79 61 autres alphaCube Entero 2.098/79 alphaCube gastroplexVirus PLUS 2.098/79 alphaCube HSV/VZV98/79 alphaCube Legionella98/79 alphaCube MRSA 3.098/79 alphaCube MTB98/79 alphaCube MTB/NTM/MAC98/79 alphaCube P.jirovecii quant98/79 alphaCube PanLegionella98/79 alphaCube PVL-MRSA98/79 alphaCube Q-Fever98/79 alphaCube TBE98/79 alphaCube TBEV/WNV98/79 alphaCube Tropical Fever 198/79 diarella Q-Fever real time PCR Kit98/79 diarellaBabesia real time PCR Kit TM98/79 diarellaBordetella real time PCR Kit98/79 diarellaBorrelia real time PCR Kit TM98/79 diarellaBV-1 real time PCR Kit98/79 diarellaC.difficile real time PCR Kit98/79 diarellaLegionella real time PCR Kit TM98/79 diarellaMRSA 3.0 TM real time PCR Kit98/79 diarellaMRSA seqc real time PCR98/79 diarellaMTB real time PCR Kit98/79 diarellaMTB/NTM/MAC real time PCR98/79 diarellaP.jirovecii quant real time PCR98/79 diarellaPanLegionella real time PCR Kit TM98/79 diarellaPVL-MRSA real time PCR98/79 diarellaRickettsia real time PCR98/79 diarellaSTI-2 real time PCR Kit98/79 gastroplexVirus PLUS 2.0 real time RT-PCR Kit98/79 gastroplexVirus real time RT-PCR Kit98/79 NukEx Mag RNA/DNA3 réf. NukEx Pure RNA/DNA2 réf. NukEx Virus respiraRNA 3.0 real time RT-PCR Kit98/79 respiraScreen 1 real time RT-PCR Kit98/79 respiraScreen 2 real time RT-PCR Kit98/79 respiraScreen 8plex seqc real time RT-PCR98/79 SMD lead Bordetella98/79 SMD lead BV 198/79 SMD lead C. diff.98/79 SMD lead EnteroRhino98/79 SMD lead gastroplexVirus98/79 SMD lead HSV/VZV98/79 SMD lead MRSA seqc98/79 SMD lead MTC/NTM/MAC98/79 SMD lead P.jirovecii quant Screen seqc98/79 SMD lead respiraRNA 3.098/79 SMD lead respiraScreen 198/79 SMD lead respiraScreen 8plex seqc98/79 SMD lead STI 298/79 SMD lead TBEV/WNV98/79 virellaEntero 2.0 TM real time RT-PCR Kit98/79 virellaHSV/VZV real time PCR98/79 virellaNoro real time RT-PCR Kit TM98/79 virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.098/79 virellaTBE real time RT-PCR Kit TM98/79 virellaTBEV/WNV real time RT-PCR98/79 virellaTropica 1 real time RT-PCR Kit98/79 virellaWNV real time RT-PCR98/79	A IVDR, 98/79	info@gerbion.com Fiche EUDAMED Signaler une erreur
Merck	Allemagne	AFB staining kit for histology for the detection of acid-fast bacteria in histological tissue Alcian blue solution, pH 2.5 for microscopy Alcian blue staining kit, pH 2.5 for the detection of acidic mucosubstances for microscopy Aquatex® (aqueous mounting agent)for microscopy Azure II (C.I.52010/52015)for microscopy2 réf. 61 autres Canada balsam for microscopy2 réf. Congo Red staining kitKit for detection of amyloid acc. to Highman CYTOCOLORTM Cytological standard stain acc. Szczepanik for microscopy DPX new non-aqueous mounting medium for microscopy Elastica van Gieson staining kit for connective tissue ELASTIN staining solution acc. to Weigert for microscopy Entellan™ new for cover slipper for microscopy Entellan™ new rapid mounting medium for microscopy2 réf. Entellan™ rapid mounting medium for microscopy Eosin Y solution 1%, alcoholic for microscopy Eosin Y-solution 0.5% aqueous for microscopy2 réf. Eosin Y-solution 0.5%, alcoholic for microscopy2 réf. Formaldehyde solution 4%,buffered, pH 6.9 (approx. 10% Formalin solution) for histology3 réf. Formaldehyde solution min. 37% free from acid stabilized with about 10% methanol and calcium carbonate for histology2 réf. Giemsa’s azur eosin methylene blue for microscopy3 réf. Giemsa’s azur eosin methylene blue solution for microscopy3 réf. Glutardialdehyde solution 25% for electron microscopy, acc. to P.J. Anderson (purified and filled under nitrogen)2 réf. Glycerol for fluorescence microscopy Hemacolor® Rapid staining of blood smear Solution 1: fixing solution Hemacolor® Rapid staining of blood smear Solution 2: colour reagent red Hemacolor® Rapid staining of blood smear Solution 3: colour reagent blue Hemacolor® Rapid staining of blood smearstaining set for microscopy2 réf. Hematoxylin cryst. (C.I.75290) for microscopy3 réf. Hematoxylin monohydrate (C.I.75290) for microscopy Certistain®3 réf. Hematoxylin solution modified acc. to Gill II for microscopy2 réf. Hematoxylin solution modified acc. to Gill III for microscopy3 réf. Histosec™ pastilles (without DMSO)solidification point 56-58°C embedding agent for histology3 réf. Histosec™ pastilles solidification point 56-58 °C embedding agent for histology Histosec™ pastilles solidification point 56-58°C embedding agent for histology3 réf. Kaiser’s glycerol gelatine,phenol-free for microscopy Leishman‘s eosin methylene blue solution modified for microscopy2 réf. Leishman’s eosin methylene blue for microscopy2 réf. M-FIX® spray fixative for cytodiagnosis2 réf. M-GLAS® liquid cover glass for microscopy Masson-Goldner staining kitfor the visualization of connective tissue withtrichromic staining May-Grünwald’s eosin methylene blue for microscopy3 réf. May-Grünwald’s eosine-methylene blue solution modified for microscopy3 réf. Mayer’s hemalum solution for microscopy3 réf. Methenamine silver plating kit acc. to Gomorifor the detection of argent-affine structuresin histological tissue Neo-Mount™ anhydrous mounting medium for microscopy2 réf. Nuclear fast red-aluminium sulfate solution 0.1% for microscopy Oil red O staining solution for the detection of neutral lipids in cryosections for microscopy Papanicolaou’s solution 1a Harris hematoxylin solution for cytology3 réf. Papanicolaou’s solution 1a Harris hematoxylin solution for cytology Papanicolaou’s solution 1b Hematoxylin solution S for cytology2 réf. Papanicolaou’s solution 2a Orange G solution (OG6) for cytology3 réf. Papanicolaou’s solution 2b Orange II solution for cytology3 réf. Papanicolaou’s solution 3a polychromatic solution EA 31 for cytology2 réf. Papanicolaou’s solution 3a polychromatic solution EA 31 for cytology Papanicolaou’s solution 3b polychromatic solution EA 50 for cytology3 réf. Papanicolaou’s solution 3c polychromatic solution EA 65 for cytology Papanicolaou’s solution 3d polychromatic solution EA 65 for cytology3 réf. Paraffin pastilles solidification point about 56-58 °C for histology Paraffin pastilles solidification point about 56-58°C for histology PAS staining kit for detection of aldehyde and mucosubstances Periodic acid solution 0.5% for the PAS reaction for the detection of aldehyde and mucosubstances in microscopy Picrofuchsin solution acc. to van Gieson for microscopy Reticulin silver plating kit acc. to Gordon & Sweets for the detection of reticular fibers in histological tissue specimens Schiff ’s reagent for microscopy2 réf. Schiff’s reagent Intense for the detection of aldehyde and mucosubstances in microscopy Shorr staining solution for hormonal cytodiagnosis Silver plating kitacc. to von Kossafor the detection of microcalcification Weigert’s iron hematoxylin kit for nuclear staining in histology Wright’s eosin methylene blue for microscopy2 réf. Wright’s eosin methylene blue solution for microscopy3 réf.	A, B IVDR	Site web service@merckgroup.com Fiche EUDAMED Signaler une erreur
Poly Diagnostics	Luxembourg	Poly Diagnostics Adenovirus, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Astrovirus, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Atopobium vaginae, Lactobacillus crispatus sensu Lato, Mobiluncus mulieris, RNase P Real-Time PCR kit3 réf. Poly Diagnostics B. parapertussis, B. pertussis, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Bacteroides fragilis, Megasphaera type I, BVAB2, RNase P Real-Time PCR kit3 réf. 61 autres Poly Diagnostics Blastocystis hominis, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Bocavirus, RNase P Real-Time PCR kit3 réf. Poly Diagnostics C. albicans, RNase P Real-Time PCR kit3 réf. Poly Diagnostics C. difficile tcdA, tcdB Toxins Real-Time PCR kit3 réf. Poly Diagnostics C. glabrata, RNase P Real-Time PCR kit3 réf. Poly Diagnostics C. krusei, RNase P Real-Time PCR kit3 réf. Poly Diagnostics C. parapsilosis, C. tropicalis, C. krusei, RNase P Real-Time PCR kit3 réf. Poly Diagnostics C. parapsilosis, RNase P Real-Time PCR kit3 réf. Poly Diagnostics C. tropicalis, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Campylobacter coli/jejuni, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Coronaviruses 229E, OC43, NL63, HKU1, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Coronaviruses 229E/HKU1, OC43, NL63, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Cryptosporidium spp., E. histolytica, G. lamblia, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Cryptosporidium spp., RNase P Real-Time PCR kit3 réf. Poly Diagnostics D. fragilis, B. hominis, C. cayetanensis, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Dientamoeba fragilis, RNase P Real-Time PCR kit3 réf. Poly Diagnostics E. coli Pathotyping Panel I Real-Time PCR kit3 réf. Poly Diagnostics E. coli Pathotyping Panel II Real-Time PCR kit3 réf. Poly Diagnostics E. coli Pathotyping Panel III Real-Time PCR kit3 réf. Poly Diagnostics E.coli, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Entamoeba histolytica, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Enterovirus, Mumps, Parechovirus, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Gastrointestinal Disease Bacterial Panel III Real-Time PCR kit3 réf. Poly Diagnostics Gastrointestinal Disease Panel I Real-Time PCR kit3 réf. Poly Diagnostics Gastrointestinal Disease Parasite Panel IV Real-Time PCR kit3 réf. Poly Diagnostics Gastrointestinal Disease Viral Panel II Real-Time PCR kit3 réf. Poly Diagnostics Giardia lamblia, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Helicobacter pylori, RNase P Real-Time PCR kit3 réf. Poly Diagnostics HMPV A/B, RNase P Real-Time PCR kit3 réf. Poly Diagnostics HRSV a/b, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Influenza A, Influenza B, Influenza C, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Influenza A, Influenza B, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Influenza A, Influenza B, SARS-CoV-2, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Influenza A, Influenza B, SARS-CoV-2, RNase P, HRSV a/b Real-Time PCR kit3 réf. Poly Diagnostics Influenza A, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Influenza B, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Influenza typing II Real-Time PCR kit3 réf. Poly Diagnostics Influenza typing Real-Time PCR kit3 réf. Poly Diagnostics K. pneumoniae, M. catarrhalis, P. aeruginosa, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Mumps virus, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Norovirus GI, Norovirus GII+GIV, Astrovirus, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Norovirus GI, Norovirus GII+GIV, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Parainfluenza viruses 1, 2, 3, 4 Real-Time PCR kit3 réf. Poly Diagnostics Parainfluenza viruses 1, 2, 3/4, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Parechovirus, HMPV A/B, Bocavirus, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Parechovirus, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Pseudomonas aeruginosa, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Respiratory Infection Viral Panel III Real-Time PCR kit3 réf. Poly Diagnostics Respiratory Infection Viral Panel V Real-Time PCR kit3 réf. Poly Diagnostics Rhinovirus/Enterovirus, Adenovirus, Bocavirus, HMPV A/B, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Rhinovirus/Enterovirus, Adenovirus, HRSV a/b, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Rhinovirus/Enterovirus, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Rotavirus A, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Salmonella spp., RNase P Real-Time PCR kit3 réf. Poly Diagnostics Sapovirus GI, II, IV, V, Adenovirus, Rotavirus A, RNase P Real-Time PCR kit3 réf. Poly Diagnostics SARS-CoV-2, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Shigella/EIEC, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Staphylococcus aureus, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Streptococcus pyogenes, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Vibrio cholerae, RNase P Real-Time PCR kit3 réf. Poly Diagnostics Yersinia enterocolitica, RNase P Real-Time PCR kit3 réf.	B IVDR	Site web info@polydiagnostics.com Fiche EUDAMED Signaler une erreur
Geneproof	Tchéquie	croBEE 101A Whole Blood DNA Extraction Kit croBEE 2.0 Universal Nucleic Acid Extraction Kit croBEE 201A Nucleic Acid Extraction Kit Easy 2 Stool Extraction Device GeneProof Adenovirus MC PCR Kit2 réf.98/79 60 autres GeneProof Adenovirus PCR Kit2 réf.98/79 GeneProof Aspergillus MC PCR Kit2 réf.98/79 GeneProof Aspergillus PCR Kit2 réf.98/79 GeneProof BK Virus (BKV) MC PCR Kit2 réf.98/79 GeneProof BK Virus (BKV) PCR Kit2 réf. GeneProof Blood Pretreatment Sample Tube2 réf. GeneProof Bordetella pertussis/parapertussis PCR Kit2 réf.98/79 GeneProof Borrelia PCR Kit2 réf.98/79 GeneProof Chlamydia pneumoniae PCR Kit3 réf. GeneProof Chlamydia trachomatis MC PCR Kit2 réf. GeneProof Chlamydia trachomatis PCR Kit3 réf. GeneProof CT/NG/MG Multiplex PCR Kit3 réf. GeneProof Cytomegalovirus (CMV) MC PCR Kit2 réf. GeneProof Cytomegalovirus (CMV) PCR Kit3 réf. GeneProof Enterovirus PCR Kit2 réf.98/79 GeneProof Epstein-Barr Virus (EBV) MC PCR Kit2 réf.98/79 GeneProof Epstein-Barr Virus (EBV) PCR Kit4 réf. GeneProof Flu Multiplex PCR Kit2 réf.98/79 GeneProof Hepatitis B Virus (HBV) PCR Kit2 réf.98/79 GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit2 réf.98/79 GeneProof Herpes Simplex Virus (HSV-1/2) MC PCR Kit2 réf.98/79 GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit4 réf. GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit2 réf.98/79 GeneProof Human Herpesvirus 6/7 (HHV-6/7) MC PCR Kit2 réf.98/79 GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit3 réf. GeneProof Human Herpesvirus 8 (HHV-8) MC PCR Kit2 réf.98/79 GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit3 réf. GeneProof Human Papillomavirus (HPV) Screening PCR Kit2 réf.98/79 GeneProof JC Virus (JCV) MC PCR Kit2 réf.98/79 GeneProof JC Virus (JCV) PCR Kit2 réf. GeneProof Legionella pneumophila PCR Kit2 réf.98/79 GeneProof MH/UU/UP Multiplex PCR Kit3 réf. GeneProof Mycobacterium tuberculosis PCR Kit2 réf.98/79 GeneProof Mycoplasma genitalium MC PCR Kit2 réf.98/79 GeneProof Mycoplasma genitalium/hominis PCR Kit4 réf. GeneProof Mycoplasma hominis MC PCR Kit2 réf.98/79 GeneProof Mycoplasma pneumoniae PCR Kit2 réf.98/79 GeneProof Neisseria gonorrhoeae MC PCR Kit2 réf.98/79 GeneProof Neisseria gonorrhoeae PCR Kit3 réf. GeneProof Parvovirus B19 PCR Kit2 réf.98/79 GeneProof PathogenFree DNA Isolation Kit GeneProof PathogenFree RNA Isolation Kit GeneProof SARS-CoV-2 Advanced PCR Kit2 réf.98/79 GeneProof SARS-CoV-2 Screening MC PCR Kit2 réf.98/79 GeneProof Treponema pallidum MC PCR Kit2 réf.98/79 GeneProof Treponema pallidum PCR Kit2 réf.98/79 GeneProof Trichomonas vaginalis MC PCR Kit2 réf.98/79 GeneProof Trichomonas vaginalis PCR Kit2 réf. GeneProof Universal Internal Control3 réf. GeneProof Urine Pretreatment Sample Tube2 réf. GeneProof Varicella-Zoster Virus (VZV) MC PCR Kit2 réf.98/79 GeneProof Varicella-Zoster Virus (VZV) PCR Kit4 réf. myCROBE Universal Control Set myCROBE Universal Internal Control98/79 myCROBE/croBEE 2.0 Universal Extraction Kit myCROBE® Fully Automated Instrument TaqPath™ Menu17 réf.98/79 TaqPath™ Menu GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit98/79 TaqPath™ Menu GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit98/79 TaqPath™ Menu GeneProof Parvovirus B19 PCR Kit98/79	A, B, C IVDR, 98/79	Site web support@geneproof.com Fiche EUDAMED Signaler une erreur
Immucor FDA Mandataire UE : IMMUCOR Medizinische Diagnostik GmbH (Allemagne)	Allemagne, États-Unis	Anti-A hel Anti-A1 Lectin2 réf. Anti-IgG,-C3d (Murine Monoclonal); Polyspecific, Gamma-clone Anti-K (Kell) quick2 réf. Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent 59 autres Anti-Kpa Blood Grouping Reagent Anti-Kpb - Blood Grouping Reagent Anti-Lea (Murine Monoclonal) Gamma-clone Blood Grouping Reagent Anti-Leb (Murine Monoclonal) Gamma-clone Blood Grouping Reagent Anti-Wr(a) Automated C3d plate Complement Control Cells Concentrated Wash 403622 DAT Positive Control Cell (1 x 10 mL) Dilution Solution 628515UDI ECHO Lumena Freeze-Dried Papain Galileo Echo Galileo NEO2 réf. GammaZyme-B GammaZyme-F immuClone (1) Anti-C Galileo IgM immuClone (1) Anti-C IgM3 réf. immuClone (1) Anti-C Galileo IgM immuClone (1) Anti-C IgM and Galileo8 réf. immuClone (1) Anti-E Galileo IgM immuClone (1) Anti-E IgM6 réf. immuClone (1) Anti-E Galileo IgM immuClone (1) Anti-E IgM and Galileo6 réf. immuClone (1) Anti-K Galileo IgM immuClone (1) Anti-K IgM and Galileo3 réf. immuClone (2) Anti-c Galileo IgM immuClone (2) Anti-c IgM3 réf. immuClone (2) Anti-c Galileo IgM immuClone (2) Anti-c IgM and Galileo8 réf. immuClone (2) Anti-E Galileo IgM immuClone (2) Anti-E IgM and Galileo10 réf. immuClone (2) Anti-K Automated IgM immuClone (2) Anti-K IgM and Automated2 réf. immuClone Anti-CDE Galileo IgM + IgG3 réf. immuClone Anti-Cw IgM2 réf. immuClone Anti-D duo IgM+IgG2 réf. immuClone Anti-H Galileo IgM2 réf. immuClone Anti-M2 réf. immuClone Anti-N Automated IgM2 réf. immuClone Anti-P(1) IgM immuClone Anti-S IgM2 réf. immuClone® Anti-A IgM2 réf. immuClone® Anti-A,B IgM2 réf. immuClone® Anti-B IgM2 réf. immuClone® Anti-D fast IgM2 réf. immuClone® Anti-D rapid Galileo IgM3 réf. LIFECODES C3d Detection 265400 LIFECODES Class I ID 628200 LIFECODES Class II IDv2 628223 LIFECODES LifeScreen Deluxe 628215 LIFECODES LifeScreen XP 628220 LIFECODES LSA Class I 265100 LIFECODES LSA Class II 265200 LIFECODES Taq Polymerase 628075 LIFECODES Wash Buffer 628211 Nuclease-Free Water 757003 Pak Lx PLX PakPlus PF4 Concentrated Wash 403624 PF4 Enhanced X-HAT132 réf. PF4 IgG HAT13G2 réf. Platelet Wash and Storage Solution Referencecells®-1 (Group A2) Referencells -2 (Group A1 and B)3 réf. Specimen Diluent Specimen Diluent 403602 Streptavidin-PE 628511 W.A.R.M.(Warm Autoantibody Removal Medium)	A, C, D IVDR	Présent sur le marché en France Site web regulatoryimmucor@werfen.com Fiche EUDAMED Signaler une erreur
Immundiagnostik FDA	Allemagne	Coenzym Q10 HPLC Kit98/79 Glutathione HPLC Kit98/79 IDK TREx® IDKhighX® stool preparaion system - prefilled Set3 réf. IDKlia® M2 réf. 59 autres IDK® anti-SARS-CoV-2 IgG ELISA2 réf.98/79 IDK® anti-SARS-CoV-2 IgG ELISA DBS98/79 IDK® anti-SARS-CoV-2 IgM ELISA98/79 IDK® Helicobacter pylori Antigen ELISA98/79 IDK® Hemoglobin (1-point-calibration) ELISA2 réf.98/79 IDK® Hemoglobin (human) ELISA2 réf.98/79 IDK® Hemoglobin/Haptoglobin Complex (1-point-calibration) ELISA2 réf.98/79 IDK® Hemoglobin/Haptoglobin Complex ELISA98/79 IDK® TNFα (Tumor Necrosis Factor alpha) ELISA98/79 IDK® TNFα ELISA ImAnOx® (TAS/TAC) (Antioxidative Kapazität)98/79 Immunglobulin G ELISA2 réf.98/79 Malondialdehyd HPLC Kit98/79 MutaCLEAN Virus3 réf. MutaPLEX C. difficile, PCR98/79 MutaPLEX® Bordetella pertussis/parapertussis, PCR2 réf.98/79 MutaPLEX® Borrelia, PCR2 réf.98/79 MutaPLEX® Coronavirus98/79 MutaPlex® Coronavirus 4G, PCR3 réf.98/79 MutaPlex® Coronavirus, PCR2 réf.98/79 MutaPlex® CoV-2 MUT 2, PCR98/79 MutaPlex® CoV-2 MUT 3, PCR2 réf.98/79 MutaPlex® CoV-2 MUT, PCR98/79 MutaPLEX® Enterovirus, PCR2 réf.98/79 MutaPLEX® GastroSys 1 (Multiplex-Panel), RT-PCR98/79 MutaPLEX® GastroSys 1 (Multiplex-Panel), RT-PCR MutaPLEX® GastroSys1 Mulitplex-Test: Adenovirus, Norovirus (GI & II), Rotavirus, PCR98/79 MutaPLEX® GastroSys 3 (Multiplex-Panel), RT-PCR2 réf.98/79 MutaPLEX® GastroSys498/79 MutaPLEX® GastroSys4 MutaPLEX® GastroSys 498/79 MutaPLEX® GBS (Group B Streptococci), PCR2 réf.98/79 MutaPLEX® Legionella pneumophila, PCR2 réf.98/79 MutaPLEX® Legionella spp., PCR2 réf.98/79 MutaPLEX® Norovirus, PCR2 réf.98/79 MutaPlex® RespiraScreen 1, PCR2 réf.98/79 MutaPlex® RespiraScreen 2 DIFF, PCR3 réf.98/79 MutaPLEX® RespiraScreen 4 DIFF seqc., PCR3 réf.98/79 MutaPLEX® RespiraSys 1, PCR2 réf.98/79 MutaPLEX® Rickettsia, PCR2 réf.98/79 MutaPlex® SC2 multi gene, PCR3 réf.98/79 MutaPLEX® Tropica 1, PCR98/79 OmicSnap Tube3 réf. OmicSnap® Meta PerOx (TOS/TOC) (Oxidative Capacity), colorimetric98/79 PreventID® C. diff Combo Tox A + B2 réf.98/79 PreventID® CC3 réf.98/79 PreventID® Entamoeba histolytica2 réf.98/79 PreventID® H. pylori2 réf.98/79 PreventID® H. pylori Antigen98/79 PreventID® Haemo/HaptOccult98/79 PreventID® Influenza A+B98/79 PreventID® SARS-CoV-2 Antigen98/79 Stool preparation system, filled with extraction buffer IDK® TurbiTUBE®3 réf. Vitamin A/E (Retinol/Tocopherol) HPLC98/79 Vitamin A/E HPLC Kit KC160098/79 Vitamin B1 HPLC Kit98/79 Vitamin B6 HPLC Kit2 réf.98/79 Vitamin C (Ascorbic Acid) HPLC98/79 Vitamin K1 HPLC Kit98/79 Zinc-Protoporphyrin HPLC KC270098/79	A, B IVDR, 98/79	Site web info@immundiagnostik.com Fiche EUDAMED Signaler une erreur
Neomedica Mandataire UE : Wellkang Ltd (Irlande du Nord)	Serbie	Adenovirus C1813ADN98/79 Adenovirus IgG N101V24IGG98/79 Adenovirus IgM N102V24IGM98/79 Astrovirus C1814AST98/79 Bordetella pertussis Toxin IgA N201T24IGA98/79 59 autres Bordetella pertussis Toxin IgG N202T24IGG98/79 Bordetella pertussis Toxin IgM N203T24IGM98/79 Borrelia afzelii IgM98/79 Borrelia afzelii VlsE IgG98/79 Borrelia garinii IgM98/79 Borrelia garinii VlsE IgG98/79 Borrelia recombinant IgG98/79 Borrelia recombinant IgM98/79 Brucella IgG N212V24IGG98/79 Brucella IgM N213V24IGM98/79 Campylobacter C1801V24CAM98/79 Campylobacter N1801V24CAM98/79 Chikungunya Virus IgG N154D24CHG98/79 Chikungunya Virus IgG U154D98/79 Chikungunya Virus IgM N153D24CHM98/79 Chikungunya Virus IgM U153D98/79 Clostridium difficile GDH N1802V24CDGDH98/79 Clostridium difficile Toxin A+B C1803V24CDT98/79 Clostridium difficile Toxin A+B N1803V24CDTAB98/79 COPROSS C100Y Cryptosporidium parvum98/79 Dengue Virus IgG N148D24DNG98/79 Dengue Virus IgG U148D98/79 Dengue Virus IgM N147D24DNM98/79 Dengue Virus IgM U147D98/79 EBV EA-D IgG N128T24IGG98/79 EBV EA-D IgM N129T24IGM98/79 EBV EA-D IgM U129T98/79 EBV EBNA-1 IgG98/79 EBV VCA IgG N126T24IGG98/79 EBV VCA IgM N127T24IGM98/79 Entamoeba histolytica C1805V24EH98/79 Enterovirus IgA N120V24IGA98/79 Enterovirus IgG N121V24IGG98/79 Enterovirus IgM N122V24IGM98/79 Giardia C1806V24GIA98/79 H. pylori 2nd Gen.98/79 Influenza A IgA N103V24IGA98/79 Influenza A IgG N104V24IGG98/79 Influenza A IgM N105V24IGM98/79 Influenza B IgA N106V24IGA98/79 Influenza B IgG N107V24IGG98/79 Influenza B IgM N108V24IGM98/79 Measles IgG N136T24IGG98/79 Measles IgM N135T24IGM98/79 Mumps IgG N138T24IGG98/79 Mumps IgM N137T24IGM98/79 Norovirus C1808V24NORV98/79 Parainfluenza IgG98/79 Parainfluenza IgM98/79 Rotavirus C1809V24ROTV98/79 RSV IgG N115V24IGG98/79 RSV IgM N116V24IGM98/79 West Nile Virus Antibodies N152D24WNA98/79 West Nile Virus Antibodies U152D98/79 Zika Virus IgG N151D24ZVG98/79 Zika Virus IgG U151D98/79 Zika Virus IgM N150D24ZVM98/79 Zika Virus IgM U150D98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Shenzhen Yhlo Biotech FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	Anti-TP Control98/79 Centrifuge Module, Model: iTLA Max Cen2 réf. Chlamydia pn. IgG Control Chlamydia pn. IgM Control CMV IgG Control CC843 59 autres CMV IgM Control CC844 EB EA IgM Control98/79 EB NA IgA Control98/79 EB NA IgG Control98/79 EB VCA IgA Control98/79 EB VCA IgG Control98/79 EB VCA IgM Control98/79 Fully Automatic Chemistry Analyzer iBC 2000-A2 réf. HSV-1 IgG Control98/79 HSV-1 IgM Control98/79 HSV-2 IgG Control98/79 HSV-2 IgM Control98/79 iBC 900-A3 réf. iFlash 1200-A iFlash 1800-A iFlash 3000-C3 réf. iFlash 9000-A iFlash-Anti-TP3 réf. iFlash-Chlamydia pn. IgG3 réf. iFlash-Chlamydia pn. IgM3 réf. iFlash-CMV IgG3 réf. iFlash-CMV IgM3 réf. iFlash-D-dimer2 réf. iFlash-EB EA IgG3 réf. iFlash-EB EA IgM3 réf. iFlash-EB NA IgG3 réf. iFlash-EB VCA IgG3 réf. iFlash-EB VCA IgM3 réf. iFlash-FDP2 réf. iFlash-HSV-1 IgG3 réf. iFlash-HSV-1 IgM3 réf. iFlash-HSV-2 IgG3 réf. iFlash-HSV-2 IgM3 réf. iFlash-IL-62 réf. iFlash-Mycoplasma pn. IgG3 réf. iFlash-Mycoplasma pn. IgM3 réf. iFlash-PIC2 réf. iFlash-Rubella IgG3 réf. iFlash-Rubella IgM3 réf. iFlash-TAT2 réf. iFlash-Toxo IgG3 réf. iFlash-Toxo IgM3 réf. iTLA mini Plus2 réf. M. Pneumoniae IgG Control CC84798/79 M. Pneumoniae IgM Control CC84898/79 Procalcitonin Control CC82098/79 Reaction vessel C6100 Rubella IgG Control CC845 Rubella IgM Control CC846 Tenfly Phoenix-A Toxo IgG Control Toxo IgM Control UNION-C VISION ESR Analyzer V610898/79 VISION ESR Analyzer V611698/79 VISION ESR Analyzer V613298/79 VISION ESR Analyzer VISION Pro-A V620898/79 VISION ESR Analyzer VISION Pro-B V621698/79 VISION ESR Analyzer VISION Pro-C V623298/79	A, C IVDR, 98/79	Présent sur le marché en France Site web info@szyhlo.com Fiche EUDAMED Signaler une erreur
Wondfo FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	2019-nCoV Antigen Test (Lateral Flow Method)3 réf. Activated Clotting Time (Non-anticoagulant) Reagent Kit (Clotting) W483P000798/79 Activated Clotting Time Reagent Kit (Clotting) W48398/79 Activated Partial Thromboplastin Time Reagent Kit (Clotting) W48198/79 Automatic Glycohemoglobin Analyzer P10, P602 réf. 59 autres BGA-102 Chikungunya Virus Antigen Test WL18P000198/79 Chikungunya Virus IgG/IgM Antibody Test WU49P000198/79 Chikungunya Virus IgG/lgM Antibody and Antigen Combo Test98/79 Coagulation Control W86398/79 Combined Diagnostic Kit for Dengue NS1 Antigen and IgG/IgM Antibody (Colloidal Gold)2 réf.98/79 Diagnostic Kit for Adenovirus Antigen (Immunochromatographic Assay)2 réf.98/79 Diagnostic Kit for Human IgM Antibody of Chlamydia Pneumoniae (Immunochromatographic Assay)98/79 Diagnostic Kit for Human IgM Antibody of Mycoplasma Pneumoniae (Immunochromatographic Assay)2 réf.98/79 Diagnostic Kit for IgM Antibody to Hepatitis A Virus (Colloidal Gold)2 réf.98/79 Diagnostic Kit for IgM Antibody to Hepatitis E Virus (Colloidal Gold)2 réf.98/79 Diagnostic Kit for IgM Antibody to Human Enterovirus71 (Immunochromatographic Assay)2 réf.98/79 Diagnostic Kit for Rotavirus Antigen (Colloidal Gold)2 réf.98/79 Fibrinogen Reagent Kit (Clotting) W48298/79 Finecare5 réf.98/79 One Step Chlamydia Swab / Urine Test98/79 One Step Dengue IgG/IgM Whole Blood/Serum/Plasma Test2 réf.98/79 One Step Dengue NS1 Antigen Whole Blood/Serum/Plasma Test2 réf.98/79 One Step Gonorrhea Swab Test2 réf.98/79 One Step H. Pylori Feces Test4 réf.98/79 One Step H.Pylori Serum/Plasma Test4 réf.98/79 One Step Influenza A Test4 réf.98/79 One Step Influenza A&B Test7 réf.98/79 One Step Influenza B Test4 réf.98/79 One Step Malaria HRP2 (P.f) Test4 réf.98/79 One Step Malaria HRP2/pLDH (P.f/P.v) Test2 réf.98/79 One Step Malaria HRP2/pLDH (P.f/Pan)Test3 réf.98/79 One Step Strep A Swab Test7 réf.98/79 One Step Syphilis Serum/Plasma Test2 réf.98/79 One Step Syphilis Whole Blood/Serum/Plasma Test4 réf.98/79 One Step Typhoid IgG/IgM Whole Blood/Serum/Plasma Test2 réf.98/79 PA-3600 PA-Bluing Reagent PA-Immunochromogenic Reagent PA-Immunochromogenic Reagent (Dual staining)2 réf. PA-Immunochromogenic Reagent (Red staining)2 réf. Prothrombin Time Reagent Kit (Clotting) W48098/79 Respiratory Syncytial Virus Antigen Test W773P000198/79 Respiratory Syncytial Virus Antigen Test W773P000298/79 Respiratory Syncytial Virus Antigen Test W773P000398/79 Respiratory Syncytial Virus Antigen Test W773P000498/79 Respiratory Syncytial Virus Antigen Test W773P000598/79 SmarLumi28 réf.98/79 SmarLumi FC-2000 (WP13, WP16, WP18), FC-2100 (WP14, WP17, WP19)3 réf. SmarLumi Herpes simplex virus-1 lgG (CLIA)4 réf.98/79 SmarLumi Herpes simplex virus-1 lgM (CLIA)4 réf.98/79 SmarLumi Herpes simplex virus-2 lgG (CLIA)4 réf.98/79 SmarLumi Herpes simplex virus-2 lgM (CLIA)4 réf.98/79 SmarLumi Interleukin-6 (CLIA)4 réf.98/79 SmarLumi Plasmin-α2-Antiplasmin Complex (CLIA)4 réf.98/79 SmarLumi Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)4 réf.98/79 Thrombin Time Reagent Kit (Clotting) W48498/79 U-CardDxTM 20012 réf.98/79 U-CardDxTM 200 WonDx-1001, WonDx-1002, WonDx-1003, WonDx-1004, WonDx-1005, WonDx-1006, WonDx-1007, WonDx-1008, U-CardDx 200-1001, U-CardDx 200-1002, U-CardDx 200-1003, U-CardDx 200-1004,U-CardDx 200-1005,U-CardDx 200-1006, U-CardDx 200-1007,U-CardDx 200-10083 réf. U-CardDx™ 200 6 Types of Diarrhea Pathogens Test3 réf.98/79 U-Card™ 20012 réf.98/79 Ucare-6000 Wondfo One Step HIV1/2 Whole Blood/Serum/Plasma Test2 réf. Wondfo Optical Coagulation Analyzer OCG-102	A, C, D IVDR, 98/79	Présent sur le marché en France Site web sales@wondfo.com.cn Fiche EUDAMED Signaler une erreur
altona Diagnostics FDA	Allemagne	AltoStar® Adenovirus PCR Kit 1.5 AltoStar® alpha Herpesvirus PCR Kit 1.5 AltoStar® BKV PCR Kit 1.5 AltoStar® CMV PCR Kit 1.5 AltoStar® EBV PCR Kit 1.5 58 autres AltoStar® HAV RT-PCR Kit 1.5 AltoStar® HCV RT-PCR Kit 1.598/79 AltoStar® HEV RT-PCR Kit 1.5 AltoStar® HHV-6 PCR Kit 1.5 AltoStar® HIV RT-PCR Kit 1.598/79 AltoStar® HSV PCR Kit 1.5 AltoStar® Influenza Screen & Type RT-PCR Kit 1.598/79 AltoStar® JCV PCR Kit 1.5 AltoStar® Malaria PCR Kit 1.5 AltoStar® MERS-CoV RT-PCR Kit 1.598/79 AltoStar® Norovirus RT-PCR Kit 1.5 AltoStar® Parvovirus B19 PCR Kit 1.5 AltoStar® Pneumocystis jirovecii PCR Kit 1.5 AltoStar® Purification Kit 1.5 AltoStar® Respiratory Sample Pretreatment Buffer 1.5 AltoStar® SARS-CoV-2 RT-PCR Kit 1.598/79 AltoStar® VZV PCR Kit 1.5 AltoStar® Whole Blood Pretreatment Buffer 1.5 ExtraStar® Purification Kit 2.0 FlexStar® (RT-)PCR Amplification Mix 1.52 réf. FlexStar® Bordetella PCR Detection Mix 1.5 FlexStar® CT & NG PCR Detection Mix 1.5 FlexStar® FLU Type & RSV RT-PCR Detection Mix 1.5 FlexStar® MG & UU & TV PCR Detection Mix 1.5 FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.598/79 FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.598/79 FlexStar® UP & MH PCR Detection Mix 1.5 RealStar® Adenovirus PCR Kit 1.098/79 RealStar® alpha Herpesvirus PCR Kit 1.098/79 RealStar® BKV PCR Kit 1.098/79 RealStar® Bordetella PCR Kit 1.098/79 RealStar® CCHFV RT-PCR Kit 1.098/79 RealStar® Chikungunya RT-PCR Kit 2.098/79 RealStar® Clostridium difficile PCR Kit 2.098/79 RealStar® CMV PCR Kit 1.098/79 RealStar® Dengue RT-PCR Kit 2.098/79 RealStar® Dengue RT-PCR Kit 3.098/79 RealStar® EBV PCR Kit 1.098/79 RealStar® EBV PCR Kit 2.098/79 RealStar® EHEC PCR Kit 2.098/79 RealStar® Enterovirus RT-PCR Kit 1.098/79 RealStar® Filovirus Screen RT-PCR Kit 1.098/79 RealStar® HEV RT-PCR Kit 2.098/79 RealStar® HHV-6 PCR Kit 1.098/79 RealStar® hMPV RT-PCR Kit 2.098/79 RealStar® HSV PCR Kit 1.098/79 RealStar® Influenza Screen & Type RT-PCR Kit 4.098/79 RealStar® JCV PCR Kit 1.098/79 RealStar® MERS-CoV RT-PCR Kit 1.098/79 RealStar® Norovirus RT-PCR Kit 3.098/79 RealStar® Parvovirus B19 PCR Kit 1.098/79 RealStar® PIV RT-PCR Kit 2.098/79 RealStar® Rotavirus RT-PCR Kit 1.098/79 RealStar® RSV RT-PCR Kit 3.098/79 RealStar® SARS-CoV-2 RT-PCR Kit 1.098/79 RealStar® VZV PCR Kit 1.098/79 RealStar® WNV RT-PCR Kit 2.098/79 RealStar® Zika Virus RT-PCR Kit 1.098/79	A, B, C IVDR, 98/79	Présent sur le marché en France info@altona-diagnostics.com Fiche EUDAMED Signaler une erreur
Certest	Espagne	CerTest C. difficile GDH+Toxin A+B3 réf. CerTest CLIA Clostridium difficile Toxin A/B Ag2 réf. CerTest CLIA Rotavirus Ag2 réf. CerTest Clostridium difficile antigen GDH3 réf. CerTest Clostridium difficile Toxin A+B3 réf. 58 autres CerTest H. pylori3 réf. CerTest Influenza A+B3 réf. CerTest Legionella CerTest RSV3 réf. CerTest S. pneumoniae CerTest SARS-CoV-23 réf. CerTest SARS-CoV-2+ Flu A + Flu B3 réf. CerTest SARS-CoV-2+ Flu A + Flu B + RSV3 réf. Universal Turbilatex® Sample Vial VIASURE Adenovirus plus Real Time PCR Detection Kit3 réf. VIASURE Adenovirus q Real Time PCR Detection Kit3 réf. VIASURE Adenovirus, Metapneumovirus & Bocavirus Real Time PCR Detection Kit3 réf. VIASURE Astrovirus Real Time PCR Detection Kit3 réf. VIASURE BK virus q Real Time PCR Detection Kit3 réf. VIASURE Blastocystis hominis + Dientamoeba fragilis Real Time PCR Detection Kit3 réf. VIASURE Bordetella Real Time PCR Detection Kit3 réf. VIASURE C. pneumoniae, M. pneumoniae & L. pneumophila Real Time PCR Detection Kit2 réf.98/79 VIASURE Candida auris Real Time PCR Detection Kit3 réf. VIASURE Chikungunya Virus Real Time PCR Detection Kit3 réf. VIASURE Clostridium difficile Real Time PCR Detection Kit3 réf. VIASURE Clostridium difficile toxB Real Time PCR Detection Kit3 réf. VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit3 réf. VIASURE Coronavirus 229E, NL63, OC43 & HKU1 Real Time PCR Detection Kit3 réf. VIASURE Cryptosporidium, Giardia & E. histolytica Real Time PCR Detection Kit3 réf. VIASURE Dientamoeba fragilis Real Time PCR Detection Kit3 réf. VIASURE EBV q Real Time PCR Detection Kit3 réf. VIASURE Entamoeba dispar Real Time PCR Detection Kit3 réf. VIASURE Flu A + B Real Time PCR Detection Kit3 réf. VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit3 réf. VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit for BD MAX™ System VIASURE Flu Typing II Real Time PCR Detection Kit3 réf. VIASURE Group A Streptococcus Real Time PCR Detection Kit3 réf. VIASURE H. influenzae, N. meningitidis & S. pneumoniae Real Time PCR Detection Kit3 réf. VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit3 réf. VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit3 réf. VIASURE Herpes virus 1, Herpes virus 2 & Varicella Zoster Virus Real Time PCR Detection Kit3 réf. VIASURE HSV-1, HSV-2 & Treponema pallidum Assay for BD MAX™ System VIASURE Human Herpes Virus 6, 7 & 8 Real Time PCR Detection Kit3 réf. VIASURE Macrolide resistance-associated mutations (23S rRNA) Real Time PCR Detection Kit3 réf. VIASURE Mycoplasma genitalium with Macrolide Resistance Assay for BD MAX™ System (2x12 tubes, 24 test) VIASURE N. gonorrhoeae, C. trachomatis & M. genitalium Real Time PCR Detection Kit3 réf. VIASURE Neisseria gonorrhoeae ciprofloxacin resistant Real Time PCR Detection Kit3 réf. VIASURE Norovirus GI + GII Real Time PCR Detection Kit3 réf. VIASURE Parainfluenza Real Time PCR Detection Kit3 réf. VIASURE Respiratory Panel VII Real Time PCR Detection Kit3 réf. VIASURE Respiratory Viral Panel I Real Time PCR Detection Kit3 réf. VIASURE Respiratory Virus Extended Mix Real Time PCR Detection Kit for BD MAX™ System VIASURE Rhinovirus + Enterovirus Real Time PCR Detection Kit3 réf. VIASURE Rotavirus Real Time PCR Detection Kit3 réf. VIASURE RSV A + B Real Time PCR Detection Kit3 réf. VIASURE Salmonella, Campylobacter & Shigella/EIEC Real Time PCR Detection Kit3 réf. VIASURE Salmonella, Campylobacter & Y. enterocolitica Real Time PCR Detection Kit3 réf. VIASURE SARS-CoV-2 Real Time PCR Detection Kit3 réf. VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit3 réf. VIASURE Toxoplasma gondii Real Time PCR Detection Kit3 réf. VIASURE Tropical Panel Plus Real Time PCR Detection Kit3 réf. VIASURE Trypanosoma cruzi Real Time PCR Detection Kit3 réf. VIASURE Viral Meningitis Panel Real Time PCR Detection Kit3 réf.	A, B, C IVDR, 98/79	Site web quality@certest.es Fiche EUDAMED Signaler une erreur
Actest Mandataire UE : VidaQuick Biotech S.L. (Espagne)	Chine	Adenovirus, RSV and Influenza A+B Combo Rapid Test Cassette ARAB-5-L98/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test Cassette ARI-5-E98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 57 autres Clostridium difficile GDH Rapid Test Cassette CLO-2-F98/79 Clostridium difficile GDH+Toxin A+Toxin B Combo Rapid Test CGAB-7-F98/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test Cassette CTAB-5-F98/79 Clostridium diffilcile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette98/79 COVID-19 and Influenza A+B Antigen Combo Control98/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test2 réf.98/79 COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test98/79 Dengue IgG&IgM/Zika IgG&IgM/Chikungunya IgG/Chikungunya IgM Combo Rapid Test Cassette DZC-5-D98/79 EBV VCA and EBNA IgG Combo Rapid Test Cassette EBCN-5-D98/79 EBV VCA IgG Rapid Test Cassette EBVG-2-D98/79 H1N1 Antigen Rapid Test Cassette98/79 HPV Test HPV-1-A98/79 HSV 1/2 IgG/IgM Rapid Test Cassette2 réf.98/79 Influenza A Rapid Test Cassette IFA-2-K98/79 Influenza A Rapid Test Dipstick98/79 Influenza A+B Control Q-FLAB-E98/79 Influenza A+B Rapid Test Cassette IFAB-2-K98/79 Influenza A+B Rapid Test Cassette IFLU-2-K98/79 Influenza A+B Rapid Test Dipstick98/79 Influenza A/B+H1N1 Combo Rapid Test Cassette98/79 Legionella pneumophila Rapid Test Cassette98/79 Malaria P.f. /Pan Rapid Test Cassetle98/79 Malaria P.f. Rapid Test Cassette MAF-2-D98/79 Malaria P.f. Rapid Test Dipstick98/79 Malaria P.f./P.v. /Pan Rapid Test Cassette MAFVN-2-D98/79 Malaria P.f./P.v. Rapid Test Cassette MAFV-2-D98/79 Monkeypox Virus Antibody Rapid Test MXB-2-D98/79 Monkeypox Virus Antigen Rapid Test Cassette MXG-2-D98/79 MONO Rapid Test Cassette MONO-2-D98/79 Multiplex Respiratory Antigen Rapid Test RT9-5-E98/79 Norovirus, Rotavirus and Adenovirus Combo Rapid Test Cassette NRA-5-F98/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Cassette NRAA-5-F98/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test NRAA-7-F98/79 Rapid Test Reader aca-A012 réf. Rotavirus and Adenovirus Combo Rapid Test Cassette ROA-2-F98/79 Rotavirus and Adenovirus Rapid Test ROA-7-F98/79 RSV Control Q-RSV-E98/79 RSV Rapid Test Cassette RSV-2-K98/79 RSV&Influenza A+B Combo Rapid Test Cassette RVIF-5-K98/79 RSV/HMPV Combo Rapid Test98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test98/79 SARS-CoV-2 Antibody rapid test98/79 SARS-CoV-2 Antigen Control98/79 SARS-CoV-2 Antigen rapid test4 réf.98/79 SARS-CoV-2 neutralizing Antibody rapid test98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Control98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test98/79 Sickle Cell Rapid Test SCD-2-D98/79 Strep A Rapid Test Cassette (Control Line in Red) STA-2-G98/79 Strep A Rapid Test Dipstick (Control Line in Red)98/79 Strep B Rapid Test Cassette STB-2-E98/79 Strep B Rapid Test Dipstick98/79 Syphilis Rapid Test Cassette SYP-2-C98/79 Syphilis Rapid Test Cassette SYP-2-D98/79 Syphilis Rapid Test Dipstick2 réf.98/79	A IVDR, 98/79	info@actest.com.cn Fiche EUDAMED Signaler une erreur
Horiba FDA	France	ABX Alphalyse 0.4L 09060043 réf. ABX Basolyse 5L 0204050 ABX Basolyse II 1L 0906003 ABX Cleaner 0.5L 09030103 réf. ABX Difftrol 20622073 réf. 57 autres ABX Diluent 10L 09010102 réf. ABX Eosinofix 1L 0206010 ABX Fluocyte 0.5L 0904011 ABX Leucodiff 1L 0206013 ABX Lysebio 0.4L 09060122 réf. ABX Micros ES 602 réf.98/79 ABX Minidil LMG 10L 08020102 réf. ABX Minipack LMG 0602050 ABX Minocal 2032002 ABX Minotrol 16 20422023 réf. ABX Minotrol Retic 2072201, 2072202, 1300136023, 1300136026, 13001360293 réf. ABX Pentra XL80 Atellica HEMA 520 CT Atellica HEMA 520 OT Atellica HEMA 530 CUVETTE SEGMENTS A11A01891 CUVETTES RACK PENTRA C200 A11A01914 ESRtrol Minilysebio 0.4L 0906020 Nucediff 1L 1300027030 Pentra C200 ISE2 réf. Pentra C400 ISE2 réf. Pentra XLR Whitediff 1L 1210906022 Yumizen 1500 (Yumizen SPS connectable) Yumizen H15003 réf. Yumizen G APTT 4 130003637798/79 Yumizen G APTT Liq 2 130003637998/79 Yumizen G APTT Liq 4 130003638198/79 Yumizen G AT 130003639098/79 Yumizen G CaCl2 4 1300036386 Yumizen G CAL 1300036416 Yumizen G CTRL DDi I & II 130003641498/79 Yumizen G CTRL I & II 1300036412 Yumizen G Cuvettes 1300036425 Yumizen G DDi 2 130003639198/79 Yumizen G FIB 2 130003638398/79 Yumizen G FIB 5 130003638498/79 Yumizen G PT 5 130003633898/79 Yumizen G PT Liq 4 130003637398/79 Yumizen G PT Reco 10 130003637698/79 Yumizen G PT Reco 5 130003637598/79 Yumizen G TT 130003638298/79 Yumizen G1500 13000363303 réf. Yumizen G200 1300036315 Yumizen G405 1300121158 Yumizen G800 13000363183 réf. Yumizen H25003 réf. Yumizen H500 CRP Yumizen H500 CT Yumizen H500 OT Yumizen H500E CT Yumizen H500E OT Yumizen H550 Yumizen H550E Yumizen SPS 1300024699 Yumizen T6000 Right Module 13 réf. Yumizen G400 DDi 1300036317 (plus commercialisé)	A, B, C IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Dezhou Guoke Medical Technology Mandataire UE : MedPath GmbH (Allemagne) et 1 autre	Chine	ADV Ag Detection Kit (Immunofluorescence Chromatography)98/79 Candida albicans / Trichomonas vaginalis / Gardnerella vaginalis Triplex Rapid Test Kit98/79 Candida albicans Ag Rapid Test Kit GKPD13598/79 Chikungunya Virus Ag Rapid Test Kit GKPD11798/79 Chikungunya Virus IgG/IgM Ab Rapid Test Kit GKPD11898/79 56 autres Chikungunya Virus IgG/IgM Antibody and Antigen Combo Rapid Test Kit GKPD11998/79 Chlamydia pneumoniae IgM/IgG Ab Rapid Test Kit GKPD10498/79 COVID-19&Flu A/B&RSV&Adenovirus Antigen Combo Rapid Test Cassette(Colloidal Gold ) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 COVID-19&Flu A/B&RSV&Adenovirus&MP&HMPV Antigen Combo Rapid Test Cassette(Colloidal Gold ) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 COVID-19&Flu A/B&RSV&Adenovirus&MPAntigen Combo Rapid TestCassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Dengue IgG/IgM Detection Kit (Immunofluorescence Chromatography)98/79 Dengue IgG/IgM/NS1 Rapid Test Kit98/79 Dengue IgG/lgM Antibody Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Dengue NS1 Antigen Rapid Test Cassette (Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79 Dengue NS1 Detection Kit (Immunofluorescence Chromatography)98/79 Dengue Virus IgG/IgM/NS1 & Chikungunya Virus IgM/IgG Combo Rapid Test Kit98/79 DOA Rapid Urine Test Device Strip/Cassette/Panel(Colloidal Gold ) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) Antigen Combo Rapid Test Kit98/79 Enterovirus 71 (EV71) IgM/IgG Antibody and Coxsackievirus A16 (CA16) IgM/IgG Antibody Combo Rapid Test Kit98/79 FOB/TRF/HP Rapid Test Cassette(Colloidal Gold 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Fully Auto 3-Part Hematology Analyzer HAS33098/79 Fully Auto 5-Part Hematology Analyzer SXHA610、SXHA660、SXHA68098/79 Group A Rotavirus & Adenovirus & Norovirus Ag Detection Kit (Immunofluorescence Chromatography)98/79 Group A Rotavirus / Adenovirus / Norovirus Antigen Triplex Rapid Test Kit98/79 Group B Streptococcus Rapid Test Kit98/79 H.pylori Ab Detection Kit (Immunofluorescence Chromatography)98/79 H.Pylori Ag Rapid Test Kit GKPD12998/79 H.Pylori Antibody Rapid Test Cassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Influenza A/B & RSV & Adenovirus & hMPV & PIV & M. pneumoniae Ag Combo Rapid Test Kit98/79 Influenza A/B Ag Detection Kit (Immunofluorescence Chromatography)98/79 Influenza A/B, SARS-CoV-2, RSV, Adenovirus, Measles Virus, Mumps Virus and HPIV Antigen Combo Rapid Test Kit98/79 Legionella pneumophila Ag Rapid Test Kit98/79 Malaria P.f/P.v Ag Rapid Test Kit GKPD11498/79 Malaria Pf Antigen Rapid Test Cassette(Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79 Malaria Pf/Pan Antigen Rapid Test Cassette(Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79 MERS-CoV Antigen Rapid Test Kit98/79 Mpox Virus Ag Rapid Test Kit GKPD12398/79 Mpox Virus IgG/IgM Ab Rapid Test Kit GKPD12498/79 Mycoplasma pneumoniae Ab Detection Kit (Immunofluorescence Chromatography)98/79 Mycoplasma pneumoniae IgG/IgM Ab Rapid Test Kit GKPD10398/79 Neisseria gonorrhoeae Ag Detection Kit (Immunofluorescence Chromatography)98/79 Plasmodium falciparum and Pan-plasmodium Antigen Detection Kit (Immunofluorescence Chromatography)98/79 Plasmodium falciparum and Plasmodium vivax Antigen Detection Kit (Immunofluorescence Chromatography)98/79 Respiratory Syncytial Virus (RSV) IgM Ab Rapid Test Kit GKPD10298/79 Rotavirus / Adenovirus / Norovirus (GI/GII) Ag Combo Rapid Test Kit98/79 RSV & ADV Ag Detection Kit (Immunofluorescence Chromatography)98/79 RSV Ag Detection Kit (Immunofluorescence Chromatography)98/79 RSV Antigen Rapid Test Cassette (ColloidalGold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Salmonella Ag Rapid Test Kit GKPD12698/79 SARS-CoV-2 Ag Detection Kit (Immunofluorescence Chromatography)98/79 SARS-CoV-2 & Influenza A/B Ag Detection Kit (Immunofluorescence Chromatography)98/79 SARS-CoV-2 / Flu A / Flu B/ ADV Ag Combo Rapid Test Kit98/79 SARS-CoV-2, Influenza A/B, RSV, Adenovirus, M. pneumoniae, hMPV, Rhinovirus, hPIV (1/2/3) and B. pertussis Antigen Combo Rapid Test Kit98/79 Streptococcus pneumoniae Ag Rapid Test Kit98/79 TB IgG/lgM Rapid Test Cassette (Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79 Toxoplasma gondii IgG/IgM Ab Rapid Test Kit98/79 Toxoplasma gondii IgG/IgM, CMV IgG/IgM and Rubella Virus IgG Antibody Combo Rapid Test Kit98/79 Treponema pallidum (TP) Antibody Detection Kit (Immunofluorescence Chromatography)98/79 Trichomonas vaginalis Ag Rapid Test Kit GKPD13798/79 Zika Virus IgG/IgM Antibody and Yellow Fever Virus IgG/IgM Antibody Combo Rapid Test Kit98/79 Zika Virus IgG/IgM Antibody Rapid Test Kit GKPD12098/79	– 98/79	office@guoke-medical.com Fiche EUDAMED Signaler une erreur
Anhui Deepblue Medical Technology FDA Mandataire UE : Luxus Lebenswelt GmbH (Allemagne) et 2 autres	Chine	Adenovirus Antigen Test Kit (Colloidal Gold) Cassette98/79 Avian influenza A (H5N1)virus Antigen Test Kit Cassette98/79 Bacterial Vaginosis Test Kit (Sialidase) Cassette98/79 Candida albicans/Trichomonas vaginalis/Gardnerella Antigen Combo Test Kit (ColloidalGold) Cassette98/79 CESONO：Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) Cassette3 réf. 55 autres Chikungunya IgG/IgM Antibody Test Kit (Colloidal Gold) Cassette98/79 Chlamydia Pneumoniae Antibody Test Kit Cassette CPAg1W-2598/79 Chlamydia Pneumoniae Antibody Test Kit Strip CPAg2W-5098/79 COVID-19/FluA/FluB/RSV Antigen Combo Test Kit(LFA) Cassette98/79 Dengue IgG/IgM Antibody Test Kit Cassette DENG/M1W-198/79 Dengue IgG/IgM Antibody Test Kit Cassette DENG/M1W-2598/79 Dengue IgG/IgM Antibody Test Kit Cassette DENG/M1W-598/79 Dengue IgG/IgM Antibody Test Kit Strip DENG/M2W-5098/79 Dengue NS1 & IgG/IgM Combo Test Ki Cassette3 réf.98/79 Dengue NS1 Antigen Test Kit Cassette4 réf.98/79 Dengue NS1 Antigen Test Kit Strip98/79 Group A Streptococcus Antigen Test Kit Cassette Strip2 réf.98/79 Group A Streptococcus Antigen Test Kit Strip98/79 H.Pylori Antibody Test Kit Cassette Strip HPAb1W-198/79 H.Pylori Antibody Test Kit Cassette Strip HPAb1W-2598/79 H.Pylori Antibody Test Kit Cassette Strip HPAb1W-598/79 H.Pylori Antibody Test Kit Cassette Strip HPAb1W-5098/79 H.Pylori Antibody Test Kit Cassette Strip HPAb2W-1098/79 H.Pylori Antibody Test Kit Cassette Strip HPAb2W-2098/79 H.Pylori Antibody Test Kit Cassette Strip HPAb2W-5098/79 H.Pylori Antigen Test Kit Cassette Tube Strip HPAg1FEST-13 réf. H.Pylori Antigen Test kit Cassette Strip Tube HPAg1FE-198/79 H.Pylori Antigen Test kit Cassette Strip Tube HPAg1FE-2598/79 H.Pylori Antigen Test kit Cassette Strip Tube HPAg1FE-5098/79 H.Pylori Antigen Test kit Cassette Strip Tube HPAg2FE-1098/79 H.Pylori Antigen Test kit Cassette Strip Tube HPAg2FE-2098/79 H.Pylori Antigen Test kit Cassette Strip Tube HPAg2FE-5098/79 H.Pylori Antigen Test kit Cassette Strip Tube HPAg4FE-198/79 H.Pylori Antigen Test kit Cassette Strip Tube HPAg4FE-1098/79 H.Pylori Antigen Test kit Cassette Strip Tube HPAg4FE-298/79 H.Pylori Antigen Test kit Cassette Strip Tube HPAg4FE-2098/79 H.Pylori Antigen Test kit Cassette Strip Tube HPAg4FE-398/79 H.Pylori Antigen Test kit Cassette Strip Tube HPAg4FE-598/79 H.Pylori Antigen Test kit Cassette Strip Tube HPAg4FE-5098/79 Human Metapneumovirus (hMPV) Antigen Test Kit Cassette2 réf.98/79 IL-6 Rapid Test Kit (Immunofluorescence Assay) Cassette98/79 Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) Cassette2 réf.98/79 Influenza A+B Antigen Test Kit (Colloidal Gold) Cassette3 réf.98/79 Malaria pf Test Kit Cassette98/79 Malaria pf/pan Test Kit Cassette98/79 Malaria pf/pv Test Kit Cassette4 réf.98/79 Malaria pf/pv Test Kit Strip98/79 Mycoplasma Pneumoniae Antigen Test Kit (Colloidal Gold) Cassette3 réf.98/79 Neisseria Gonorrhoeae Antigen Test Kit (Colloidal Gold) Cassette98/79 Noroviruses Antigen Test Kit (Colloidal Gold) Cassette98/79 Respiratory Syncytial Virus Antigen Test Kit (Colloidal Gold) Cassette98/79 Rotavirus Antigen Test Kit(Colloidal Gold) Cassette2 réf.98/79 Salmonella Typhi Antigen Rapid Test Kit Cassette98/79 Strep A Antigen Test Kit Cassette GAS1TST-13 réf. TB Tuberculosis Antibody Test Kit Cassette98/79 TB Tuberculosis Antibody Test Kit Strip98/79 TOXO IgG/IgM Antibody Test Kit Cassette2 réf.98/79 TOXO IgG/IgM Antibody Test Kit Strip98/79 TP Syphilis Antibody Test Kit Cassette Strip7 réf.98/79 Zika IgG/IgM Antibody Test Kit (Colloidal Gold） Cassette98/79	C IVDR, 98/79	sales@dbluemedical.com Fiche EUDAMED Signaler une erreur
Medotexbio Mandataire UE : HUMISS TRADING S. L. (Espagne) et 1 autre	Chine	10-in-1 Respiratory Antigen Combo Rapid Test RVC-5105a-25M 12-in-1 Respiratory Antigen Combo Rapid Test98/79 5-in-1 Respiratory Antigen Combo Rapid Test 6-in-1 Respiratory Antigen Combo Rapid Test98/79 8-in-1 Respiratory Antigen Combo Rapid Test RVC-585b98/79 55 autres 8-in-1 Respiratory Antigen Combo Rapid Test RVC-585b-25M Adenovirus Antigen Rapid Test (Feces) ADV-602a98/79 Bordetella pertussis(BP) Antigen Rapid Test98/79 Campylobacter Rapid Test CAMP-602a98/79 Candida Albicans Antigen Rapid Test CA-502a Chikungunya IgG/IgM Rapid Test CHI-422a98/79 Chlamydia pneumoniae(CP) Antigen Rapid Test98/79 Clostridium difficile GDH Rapid Test DGDH-602a98/79 Clostridium difficile Toxin A &Toxin B Combo Rapid Test DTAB-622a98/79 Dengue (DENV) IgG/IgM and NS1 Combo Rapid Test Dengue (DENV) NS1 Ag Rapid Test Dengue IgG/IgM and NS1 Combo Rapid Test DENC-435a98/79 Dengue IgG/IgM Rapid Test DEN-422a98/79 Dengue IgG/IgM Rapid Test DEN-422a-25M Dengue NS1 Ag Rapid Test DEN-402b98/79 Ebola Antigen Rapid Test EBOV-402a98/79 Flu A&B/SARS-CoV-2 Antigen Combo Test RVC-532b2 réf. Flu A&B/SARS-CoV-2/RSV Antigen Combo Test Flu A&B/SARS-CoV-2/RSV/ADV Antigen Combo Test Flu A&B/SARS-CoV-2/RSV/ADV Antigen Combo Test RVC-555b98/79 Flu A&B/SARS-CoV-2/RSV/ADV/hPIV Antigen Combo Rapid Test98/79 Flu A&B/SARS-CoV-2/RSV/ADV/MP Antigen Combo Rapid Test98/79 Flu A&B/SARS-CoV-2/RSV/hMPV Antigen Combo Test98/79 Gonorrhea Rapid Test98/79 Group A Streptococcus (Strep A) Antigen Rapid Test H. pylori Antigen Rapid Test HP-602a98/79 H. pylori Antibody Rapid Test HP-402b98/79 Influenza A/B Antigen Rapid Test FLU-522b2 réf. Leishmania IgG/IgM Rapid Test LEI-422a98/79 Malaria P.f. Rapid Test MAL-402b Malaria P.f./P.v. Rapid Test MALV-422b Malaria P.f./Pan Rapid Test MALN-422b MALV-422b98/79 Medotex H. pylori Antigen Rapid Test HP-602a Medotex H. pylori Antibody Rapid Test HP-402b Medotex SARS-CoV-2 Antigen Rapid Test 40 Tests98/79 Mycoplasma Pneumoniae Antigen Rapid Test MP-502b Mycoplasma pneumoniae IgM Rapid Test MPM-402a98/79 Norovirus Antigen Rapid Test NORO-622a98/79 Norovirus/Rotavirus/Adenovirus Antigen Combo Rapid Test GIC-635a98/79 Parainfluenza(hPIV) Antigen Rapid Test98/79 Respiratory Multiple Antigen Combo Test RVC-5X598/79 Respiratory Syncytial Virus (RSV) Antigen Rapid Test RSV-502b Rotavirus Rapid Test ROTA-602a98/79 Rotavirus/Adenovirus Combo Rapid Test RAC-622a98/79 RSV Antigen Rapid Test RSV-502b98/79 RVC-5105a98/79 RVC-535b RVC-585c98/79 SARS-CoV-2 Antigen Rapid Test Streptococcus pneumoniae (Spn) Antigen Rapid Test Syphilis Rapid Test SYP-401a Syphilis Rapid Test SYP-402b98/79 Zika IgG/IgM Rapid Test ZIKA-422a98/79 Zika NS1 Rapid Test98/79	B, C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Urit FDA Mandataire UE : Medunion S.L. (Espagne) et 1 autre	Chine	BF-730 B4 Flow Cytometer BF-730 B5R3V6、BF-730 B5R3V5、BF-730 B4R3V3、BF-730 B5R3、BF-730 B5R2、BF-730 B4R2、BF-730 B5、BF-730 B4、BF-700 B3R1、BF-700 B4、BF-700 B4R1、BF-700 B5、BF-700 B4R2、BF-700 B5R2、BF-700 B5R3、BF-710 B5R3、BF-710 B5R2、BF-710 B5 etc. BH-40P Automated Hematology Analyzer BH-40P、BH-70P BH-5100 5-Part-Diff Auto Hematology Analyzer URIT-5160、BH-5100 、BH-5390 BH-5160CRP 5-Part-Diff Auto Hematology Analyzer BH-5380CRP、BH-5160CRP、BH-5160CS BH-51S 5-Part-Diff Auto Hematology Analyzer98/79 55 autres BH-5360CRP 5-Part-Diff Auto Hematology Analyzer98/79 BH-6180 5-Part-Diff Auto Hematology Analyzer BH-6180、BH-6580、BH-6680、BH-6600、BH-6500、BH-6100 BH-7000、BH-7010、BH-7020、BH-7030、BH-7060、BH-7080 Automatic Hematology Analyzer98/79 BH-7100H/BH-7160CS/BH-7160/BH-7180CS/BH-7180 Automatic Hematology Analyzer BH-7100H、BH-7160CS、BH-7160、BH-7180CS、BH-718098/79 BH-7200H/BH-7260CS/BH-7260/BH-7280CS/BH-7280/ BH-7300H/ BH-7360CS/ BH-7360/BH-7380CS/BH-7380 Automatic Hematology Analyzer BH-7200H、BH-7260CS、BH-7260、BH-7280CS、BH-7280、BH-7300H、BH-7360CS、BH-7360、BH-7380CS、BH-738098/79 BH-7600CS、BH-7610CS、 BH-7620CS、BH-7630CS、 BH-7660CS、 BH-7680CS、BH-7680、BH-7600 5-Part-Diff Auto Hematology Analyzer98/79 BH-DR68 Diluent BH-DS68 Diluent BH-FP68 Fluorescent dye BH-FR68 Fluorescent dye BH-LD68 Lyse BH-LH68 Lyse BH-LN68 Lyse BH-LP68 Lyse CA-150 Automatic Chemistry Analyzer URIT-8031、URIT-8210、URIT-8400、URIT-8460、CA-220、CA-431A、CA-431B、CA-200、CA-641A、CA-641B、CA-641C、CA-150、CA-160、CA-180、CA-351A、CA-351B、CA-351C、CA-431C、URIT-8060、URIT-8030、URIT-8121A、URIT-8131、URIT-8136、CA-331A,etc CA-430A Automatic Chemistry Analyzer URIT-8460、CA-430A、CA-430B、CA-810A、CA-640A、CA-640B、URIT-8280、CA-810B、CA-810C CA-80 Semi-auto Chemistry Analyzer CA-80、URIT-880 D-Dimer Assay Kit (Chemiluminescent Microparticle Immunoassay)98/79 HQ-3DIFF HEMATOLOGY CONTROLS98/79 HQ-5DIFF HEMATOLOGY CONTROLS98/79 HQ-6D HEMATOLOGY CONTROLS98/79 HQ-CAL HEMATOLOGY CALIBRATOR98/79 IA-200 Interluekin-6 (IL-6) Assay Kit (Chemiluminescent Microparticle Immunoassay)98/79 LaserVision Urine Sediment Analyzer UD-2300,UD-2310 ,UD-233098/79 MP-1200、MP-1200B Reticulocyte Calibrator URIT CA 3198/79 Staining Solution for Urine Analysis UFL-61 Staining Solution for Urine Analysis UFL-70、UFL-60 UC-1800、URIT-1600、UNAMAX2 réf. UD-2300 UD-500、URIT-1280、UD-1320、UD-1300 URIT 5D 11 Diluent URIT D31、URIT 5D 11 URIT 5L 11 Lisante URIT 5L 31 Lyse URIT 5S 11 Sheath URIT CA 11 Hematology Calibrator URIT D41 Detergent URIT D41、URIT D46 URIT D43 Probe Cleaner URIT D48 DI Probe Cleaner URIT HQ 51 Hematology Control URIT HQ 60 Hematology Control URIT L21 Lytic Reagent URIT QC 11 Hematology Control URIT QC 31 Reticulocyte Control URIT R11 Soluzione colorante per analizzatore ematologico URIT-12,PH-01,PH-01A98/79 URIT-25,URIT-26,URIT-28,URIT-82,URIT-8698/79 URIT-2900Plus Automated Hematology Analyzer98/79 URIT-3000Plus Automated Hematology Analyzer URIT-3000Plus、URIT-3020 URIT-31、UC-32A、UC-32B、URIT-50、URIT-180、URIT-330、URIT-500、URIT-500C、URIT-560、UC-58、UC-280A、UC-280B、UC-600A、UC-50A、UC-50B、UC-50C、UNAMAX ONE、UNAMAX LITE3 réf. URIT-5380 5-Part-Diff Auto Hematology Analyzer98/79 URIT-5500 5-Part-Diff Auto Hematology Analyzer98/79 URIT-600/ URIT-610 Coagulation Analyzer URIT-600、URIT-61098/79 US-1680、US-500、US-1000	A, B IVDR, 98/79	Site web service@uritest.com Fiche EUDAMED Signaler une erreur
Dbbiotech	Slovaquie	Anti-Alpha Smooth Muscle Actin DB 1473 réf. Anti-Annexin A1 DB 2663 réf. Anti-b-actin DB 0013 réf. Anti-BRAF DB 1593 réf. Anti-C3d complement DB 1063 réf. 54 autres Anti-C4d complement DB 1073 réf. Anti-Cadherin1 (E-cadherin, CD324) DB 2653 réf. Anti-CD117 DB 0623 réf. Anti-CD15 DB 2113 réf. Anti-CD163 DB 0453 réf. Anti-CD1a DB 0713 réf. Anti-CD21 DB 2133 réf. Anti-CD23 DB 1353 réf. Anti-CD3 DB 0823 réf. Anti-CD34 DB 1513 réf. Anti-CD45 DB 0423 réf. Anti-CD7 DB 1143 réf. Anti-CD8 DB 0853 réf. Anti-Cerb-2 DB 0943 réf. Anti-Chromogranin A DB 1583 réf. Anti-Cytokeratin 14 DB 0993 réf. Anti-Cytokeratin 16 DB 1003 réf. Anti-Cytokeratin 17 DB 1013 réf. Anti-Cytokeratin 18 DB 1023 réf. Anti-Cytokeratin 19 DB 1033 réf. Anti-Cytokeratin 20 DB 1193 réf. Anti-Cytokeratin 5/6 DB 0973 réf. Anti-Cytokeratin 7 DB 0513 réf. Anti-Cytokeratin 8 DB 0983 réf. Anti-Desmin DB 1483 réf. Anti-EBV/LMP-1 DB 0603 réf. Anti-EBV/LMP-1 DB 0613 réf. Anti-EGFR DB 0923 réf. Anti-EMA (CD227, Mucin-1) DB 0483 réf. Anti-ER (Estrogen Receptor) DB 0533 réf. Anti-Giardin α-1 DB 3193 réf. Anti-Human IgG DB 1733 réf. Anti-Human IgG DB 1743 réf. Anti-Human Kappa Light Chain DB 0373 réf. Anti-Human Kappa Light Chain DB 0383 réf. Anti-Human Lambda Light Chain DB 0393 réf. Anti-Human SOX10 DB 2603 réf. Anti-iNOS DB 0033 réf. Anti-Ki-67 DB 3183 réf. Anti-Melan A DB 0503 réf. Anti-Melanosome DB 0493 réf. Anti-Napsin A DB 2623 réf. Anti-p16 (mouse monoclonal) DB 2533 réf. Anti-P504S (AMACR) DB 2083 réf. Anti-p53 DB 0263 réf. Anti-p60 DB 2033 réf. Anti-p63 DB 1343 réf. Anti-PLAP (Placental Alkaline Phosphatase) DB 0473 réf. Anti-PR (Progesterone Receptor) DB 1093 réf. Anti-PSA (Prostate-specific antigen) DB 2543 réf. Anti-S-100 DB 0553 réf. Anti-Synaptophysin DB 1563 réf. Anti-Thyroglobulin DB 2593 réf. Anti-TTF-1 DB 0893 réf.	C IVDR	Site web Fiche EUDAMED Signaler une erreur
Zhejiang Greylynx Biotech Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	C. difficile GDH Ag Rapid Test GICDG98/79 C. difficile Toxin A/B Rapid Test GICD98/79 C. difficile Toxin A/B+GDH Rapid Test GICD98/79 Chagas Ab Rapid Test GICA98/79 Chikungunya IgG/IgM Rapid Test GICHK98/79 54 autres Chikungunya IgM Rapid Test GICHKm98/79 D-Dimer Rapid Test GCDDM98/79 D-Dimer Test GCDDM98/79 Dengue IgG/IgM and NS1 Combo Rapid Test GIDEN98/79 Dengue IgG/IgM and NS1 Combo Test GIDEN98/79 Dengue IgG/IgM Rapid Test GIDENb98/79 Dengue NS1 Ag Rapid Test GIDENg98/79 Enterovirus Rapid Test GIHEV98/79 EV71 IgM Rapid Test GIEV7198/79 Filariasis IgG/IgM Rapid Test GIFIb98/79 Giardia Lamblia Rapid Test GIGIL98/79 Giardia Rapid Test GIGI98/79 Gonorrhea Test GIGON98/79 H. pylori Ab Rapid Test GIHPb98/79 H. pylori Ab Test GIHPb98/79 H. pylori Ag Rapid Test GIHPg98/79 H. pylori Ag Test GIHPg98/79 HAV IgG/IgM Rapid Test GIHAVb98/79 HAV IgG/IgM Test GIHAVb98/79 HAV IgM Rapid Test GIHAVm98/79 HEV IgG/IgM Rapid Test GIHEV98/79 HEV IgM Rapid Test GIHEVm98/79 Influenza A Rapid Test GIFLUA98/79 Influenza A+B Rapid Test GIFLU98/79 Legionella Pneumophila Rapid Test GILeg98/79 Legionella Rapid Test GILeg98/79 Malaria P.f. Rapid Test GIMALf98/79 Malaria P.f./P.v. Rapid Test GIMALfv98/79 Malaria P.f./P.v./Pan Rapid Test GIMP98/79 Malaria P.f./Pan Rapid Test GIMALfa98/79 Malaria Pf/Pan Ag 4 Species Rapid Test GIMAL498/79 MONO Rapid Test GIMONO98/79 Mononucleosis Rapid Test GIMONO98/79 Mononucleosis Test GIMONO98/79 Rota/Adeno Ag Rapid Test GIRA98/79 RSV Rapid Test GIRSV98/79 S.pneumoniae Rapid Test GISPNE98/79 SARS-CoV-2 Ag Rapid Test GISARSg98/79 SARS-CoV-2 Ag Saliva Rapid Test GISARSg98/79 SARS-CoV-2 IgM/IgG Rapid Test GISARSgm98/79 Strep A plus Rapid Test GIST98/79 Strep A Rapid Test GIST98/79 Strep A Rapid Test GISTA-702H3 réf. Strep A Rapid Test(Control Line in Red) GIST98/79 Strep B Rapid Test GISTB98/79 Syphilis Rapid Test GISY98/79 Tetanus Rapid Test GITET98/79 Tuberculosis IgG/IgM Rapid Test GITBb98/79 Tuberculosis IgG/IgM Test GITBb98/79 Typhoid Ag Rapid Test GITYAg98/79 Typhoid IgG/IgM Rapid Test GITYPb98/79 Zika IgG/IgM Rapid Test GIZGM98/79 Zika IgG/IgM/NS1 Combo Rapid Test GIZGMN98/79 Zika NS1 Rapid Test GIZNS198/79	C IVDR, 98/79	info@vivachek.com Fiche EUDAMED Signaler une erreur
Baso Diagnostics Zhuhai Mandataire UE : Eunitor GmbH (Allemagne)	Chine	069523833010353 réf. 1% hydrochloric acid ethanol solution2 réf. Acetone fuchsin solution3 réf. Acid Alcohol solution 1000ml2 réf. Acid alcohol solution 4×1000mL2 réf. 53 autres Acid Fast Stain (Kinyoun)3 réf. Acid Fast Stain (Phenol-free fuchsin staining method)2 réf. Acid Fast Stain (Ziehl-Neelsen)3 réf. Acid fast stain slide2 réf. Acid Fast Stain（None-phenol Auramine O staining method） Acid Phosphatase Stain(ACP)2 réf. Acid α-Naphthyl Acetate Esterase Stain(ANAE)3 réf. Alcian Blue and PAS Stain (AB-PAS)3 réf. Alcoholic Eosin method3 réf. Ammoniacal silver solution3 réf. Aqueous 100mL Auto Stainer BSJ-DB2283 réf. Basophil Stain (Toluidine blue method)2 réf. Brilliant green method2 réf. Buffer(concentrated) 1000mL2 réf. Carbolfuchsin solution2 réf. Chromosome (solution A) 1000mL3 réf. Congo Red Stain 3×100mL3 réf. Cotton Blue Stain with Lactophenol Cryptococcus Neoformans Stain Crystal violet3 réf. Diff Quick Cell Stain 4×100mL2 réf. Diff-Quik Fix2 réf. EA36 Solution3 réf. Elastin stain3 réf. Fix Solution3 réf. Flagella Stain Fungal Fluorescence Stain (One-step method)3 réf. Fungal immunofluorescence chromogenic reagent (Ⅰ)3 réf. Gill3 réf. Hemosiderin Stain2 réf. Immunofluorescence Chromogenic Reagent3 réf. Iron Stain 100 Tests3 réf. Leukocyte Peroxidase Stain (POX) (Oxidation WG-KI method)3 réf. Leukocyte Peroxidase Stain(POX)(Benzidine method)3 réf. May-Grünwald’s Stain Methyl green method3 réf. Mucicarmine Stain2 réf. Naphthol AS-D Chloroacetate Esterase Stain(AS-DCE)3 réf. Neutrophilic Leukocyte Alkaline Phosphatase Stain (NAP)3 réf. Nuclear Fast Red solution3 réf. Oil Red O Stain 2×20mL2 réf. Pathology Hepatin Stain (PAS)3 réf. Phosphate buffer (pH 6.8)3 réf. Phosphate buffer（pH 6.8）（Solution B3 réf. Reticulocyte Stain 2×100mL2 réf. S method 3×20mL Sudan Black B Stain(SBB) Tissue marking reagent (black)3 réf. Trypan blue Stain2 réf. TypeⅠ3 réf. α-Naphthyl Acetate Esterase Stain (α-NAE) (Fast blue method)3 réf. α-Naphthyl Butyrate Esterase Stain(α-NBE)3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Bioeksen	Turquie	Bio-Speedy® 5min NA Tube Bio-Speedy® Bacteria/Fungi qPCR Kit98/79 Bio-Speedy® Bacterial Atypical Pneumonia Factors qPCR Kit98/79 Bio-Speedy® Bone & Joint qPCR Panel3 réf.98/79 Bio-Speedy® Bordetella pertussis, B.parapertussis, B.bronchiseptica and B.holmesii Real-Time PCR Detection Kit2 réf.98/79 52 autres Bio-Speedy® C. difficile Toxin A-B qPCR Kit2 réf.98/79 Bio-Speedy® CCHFV RT-qPCR Detection Kit2 réf.98/79 Bio-Speedy® COVID-19/Flu RT-qPCR98/79 Bio-Speedy® GAS (Group A Streptococcus) qPCR Kit2 réf.98/79 Bio-Speedy® Gastroenteritis qPCR MX-6L Parasitic Panel2 réf.98/79 Bio-Speedy® Gastroenteritis qPCR MX-6T Parasitic Panel2 réf.98/79 Bio-Speedy® Gastroenteritis RT-qPCR MX-24L Panel2 réf.98/79 Bio-Speedy® Gastroenteritis RT-qPCR MX-24S Panel98/79 Bio-Speedy® Gastroenteritis RT-qPCR MX-24T Panel2 réf.98/79 Bio-Speedy® Gastroenteritis RT-qPCR MX-5L Viral Panel2 réf.98/79 Bio-Speedy® Gastroenteritis RT-qPCR MX-5T Viral Panel2 réf.98/79 Bio-Speedy® GBS (Group B Streptococcus) qPCR Kit2 réf.98/79 Bio-Speedy® H.pylori/Clarithromycin Resistance qPCR Kit98/79 Bio-Speedy® Human Papillomavirus 6-11-16-18-HR qPCR Kit2 réf.98/79 Bio-Speedy® Human Papillomavirus Genotyping qPCR Panel5 réf.98/79 Bio-Speedy® Human Papillomavirus High-Risk qPCR Panel5 réf.98/79 Bio-Speedy® Human Papillomavirus Low-Medium Risk qPCR Panel5 réf.98/79 Bio-Speedy® Human Papillomavirus qPCR Kit2 réf.98/79 Bio-Speedy® Influenza A (H1-3-5-7) RT-qPCR Kit2 réf.98/79 Bio-Speedy® Lower Respiratory Bacteria qPCR Panel5 réf.98/79 Bio-Speedy® Measles Virus Real-Time PCR Detection Kit2 réf.98/79 Bio-Speedy® Meningitis/Encephalitis RT-qPCR MX-17L Panel2 réf.98/79 Bio-Speedy® Meningitis/Encephalitis RT-qPCR MX-17S Panel98/79 Bio-Speedy® Meningitis/Encephalitis RT-qPCR MX-17T Panel2 réf.98/79 Bio-Speedy® MTB qPCR Kit4 réf.98/79 Bio-Speedy® MTB/NTM qPCR Kit4 réf.98/79 Bio-Speedy® Plasmodium qPCR Panel2 réf.98/79 Bio-Speedy® Respiratory ID-1 Kit2 réf.98/79 Bio-Speedy® Respiratory ID-1 Panel98/79 Bio-Speedy® Respiratory ID-2 Kit2 réf.98/79 Bio-Speedy® Respiratory ID-2 Panel98/79 Bio-Speedy® Respiratory ID-3 Panel98/79 Bio-Speedy® Respiratory Tract 4T RT-qPCR Kit5 réf.98/79 Bio-Speedy® Respiratory Tract RT-qPCR MX-19T Panel98/79 Bio-Speedy® Respiratory Tract RT-qPCR MX-24L Panel2 réf.98/79 Bio-Speedy® Respiratory Tract RT-qPCR MX-24S Panel98/79 Bio-Speedy® Respiratory Tract RT-qPCR MX-24T Panel2 réf.98/79 Bio-Speedy® Respiratory Tract Virus RT-qPCR Panel4 réf.98/79 Bio-Speedy® SARS-CoV-2 N RT-qPCR Kit2 réf.98/79 Bio-Speedy® SARS-CoV-2 Triple Gene RT-qPCR Kit4 réf.98/79 Bio-Speedy® Sepsis qPCR MX-30L Panel2 réf.98/79 Bio-Speedy® Sepsis qPCR MX-30S Panel98/79 Bio-Speedy® Sepsis qPCR MX-30T Panel2 réf.98/79 Bio-Speedy® Sexually Transmitted Infections RT-qPCR Panel5 réf.98/79 Bio-Speedy® Tropical Fever RT-qPCR Panel2 réf.98/79 Bio-Speedy® Urinary Tract Infections qPCR Panel5 réf.98/79 Bio-Speedy® West Nile Virus Real-Time PCR Detection Kit2 réf.98/79 Bioeksen 4LAB Molecular Analysis Instrument Bioeksen STL-B Sample Pre-treatment Buffer vNAT BABAA Pooling Tube vNAT BABAA Transfer Tube vNAT Transfer Tube	A IVDR, 98/79	Site web info@bioeksen.com.tr Fiche EUDAMED Signaler une erreur
Egyptian For Biotechnology-Spectrum Diagnostics Mandataire UE : MDSS GmbH (Allemagne)	Égypte	APTT Reagent (SP-UNICELIN) 626 00198/79 APTT Reagent (SP-UNICELIN) 626 00298/79 Brucella A/M 710 00198/79 Brucella A/M 710 00298/79 Brucella A/M 710 00398/79 51 autres Brucella A/M 710 00498/79 Brucella A/M 710 00598/79 D-Dimer Turbi Latex98/79 D-Dimer Turbi Latex 585 001-198/79 D-Dimer Turbi Latex 585 00298/79 D-Dimer Turbi Latex 585 002-198/79 D-Dimer Turbi Latex 585 00398/79 D-Dimer Turbi Latex 585 00498/79 FIBRINOGEN 590 00198/79 Fibrinogen-LS Clauss Clotting Time Method 631 00198/79 Fibrinogen-LS Clauss Clotting Time Method 631 00298/79 G6PD - single reagent 253 00198/79 G6PD 252 00198/79 H. pylori Ab Test 1180 00198/79 H. pylori Ag Test 1184 00198/79 Haemoglobin (Ready to Use) 611 00198/79 Haemoglobin (Ready to Use) 611 00298/79 Haemoglobin (Ready to Use) 611 00398/79 Haemoglobin (Single Reagent) 610 00198/79 Haemoglobin (Single Reagent) 610 00298/79 Haemoglobin Drabkin’s Solution 612 00198/79 Haemoglobin Drabkin’s Solution 612 00298/79 PT Reagent (SP-Normoplastin) 614 00198/79 PT Reagent (SP-Normoplastin) 614 00298/79 Recoplastin ISI 1.0 PT Reagent 624 00098/79 Recoplastin ISI 1.0 PT Reagent 624 00198/79 Recoplastin ISI 1.0 PT Reagent 624 00298/79 Recoplastin ISI 1.0 PT Reagent 624 00398/79 Rose Bengal Brucella Antigen 711 00198/79 Rose Bengal Brucella Antigen 711 00298/79 Rose Bengal Brucella Antigen 711 00398/79 Rose Bengal Brucella Antigen 711 00498/79 RPR Syphilis Test 725 00098/79 RPR Syphilis Test 725 00198/79 RPR Syphilis Test 725 00298/79 S. Typhi/Para Typhi A Antigen 1154 00198/79 S. Typhi/Para Typhi A Antigen 1154 00298/79 Typhoid Rapid Test Cassette (Serum/Plasma/Whole Blood) 1233 00198/79 Widal Test (Salmonella Ab) 718 00098/79 Widal Test (Salmonella Ab) 718 00198/79 Widal Test (Salmonella Ab) 718 00298/79 Widal Test (Salmonella Ab) 718 002-AH98/79 Widal Test (Salmonella Ab) 718 002-AO98/79 Widal Test (Salmonella Ab) 718 002-BH98/79 Widal Test (Salmonella Ab) 718 002-BO98/79 Widal Test (Salmonella Ab) 718 002-H98/79 Widal Test (Salmonella Ab) 718 002-O98/79 Widal Test (Salmonella Ab) 718 00398/79 Widal Test (Salmonella Ab) 718 00498/79 Widal Test (Salmonella Ab) 718 00598/79 Widal Test (Salmonella Ab) 718 00698/79	– 98/79	Site web info@spectrum-diagnostics.com Fiche EUDAMED Signaler une erreur
Vitassay	Espagne	Vitassay Microorganism-NA isolation kit Vitassay qPCR AMB98/79 Vitassay qPCR Aspergillosis98/79 Vitassay qPCR Astrovirus98/79 Vitassay qPCR BK98/79 51 autres Vitassay qPCR Blastocystis hominis + Dientamoeba fragilis98/79 Vitassay qPCR Bordetella pertussis + B. parapertussis+ B. holmesii98/79 Vitassay qPCR Chikungunya98/79 Vitassay qPCR Clostridium difficile98/79 Vitassay qPCR Clostridium difficile toxins A+B98/79 Vitassay qPCR Cryptosporidium+Entamoeba histolytica+Giardia , low profile, 4x8-well strips98/79 Vitassay qPCR Cryptosporidium+Entamoeba histolytica+Giardia, high profile, 4x8-well strips98/79 Vitassay qPCR Dengue98/79 Vitassay qPCR Dengue 1+2+3+498/79 Vitassay qPCR Dientamoeba fragilis98/79 Vitassay qPCR E. coli pathotypes98/79 Vitassay qPCR Flu + RSV + SARS CoV-2 N1/298/79 Vitassay qPCR Flu A + Flu B98/79 Vitassay qPCR Flu A + Flu B + RSV98/79 Vitassay qPCR H. pylori ClariRes98/79 Vitassay qPCR HCoV98/79 Vitassay qPCR High-Risk HPVs98/79 Vitassay qPCR HPV98/79 Vitassay qPCR HSM98/79 Vitassay qPCR Human Herpes Virus98/79 Vitassay qPCR Macrolide Res- 23S rRNA Mutations98/79 Vitassay qPCR Malaria 598/79 Vitassay qPCR MonkeyPox98/79 Vitassay qPCR MRSA98/79 Vitassay qPCR MTB complex98/79 Vitassay qPCR MTBC/NTM98/79 Vitassay qPCR NG CiproRes98/79 Vitassay qPCR Noro (I&II)98/79 Vitassay qPCR Parainfluenza 1-3+2-498/79 Vitassay qPCR Pneumocystis jirovecii98/79 Vitassay qPCR Primary Atypical Pneumonia Vitassay qPCR Sexually Transmitted Infections, 4 tubes x 24 test98/79 Vitassay qPCR Primary Atypical Pneumonia, high profile, 4x8-well strips98/79 Vitassay qPCR Primary Atypical Pneumonia, high profile, 8x8-well98/79 Vitassay qPCR Primary Atypical Pneumonia, high profile, 96-well plate98/79 Vitassay qPCR Primary Atypical Pneumonia, low profile, 4x8-well strips98/79 Vitassay qPCR Primary Atypical Pneumonia, low profile, 8x8-well strips98/79 Vitassay qPCR Primary Atypical Pneumonia, low profile, 96-well plate98/79 Vitassay qPCR Rotavirus98/79 Vitassay qPCR RSV A + RSV B98/79 Vitassay qPCR SARS-CoV-298/79 Vitassay qPCR SARS-CoV-2 (ORF1ab, E & N)98/79 Vitassay qPCR SARS-CoV-2 + Flu A + Flu B98/79 Vitassay qPCR Sexually Transmitted Infections, high profile, 16x8-well strips98/79 Vitassay qPCR Sexually Transmitted Infections, high profile, 8x8-well strips98/79 Vitassay qPCR Sexually Transmitted Infections, low profile, 16x8-well strips98/79 Vitassay qPCR Sexually Transmitted Infections, low profile, 8x8-well strips98/79 Vitassay qPCR Tick Borne Disease98/79 Vitassay qPCR Type I/Flu98/79 Vitassay qPCR West Nile98/79 Vitassay qPCR Zika98/79 Vitassay qPCR Zika+Dengue+Chikungunya98/79	A IVDR, 98/79	Présent sur le marché en France Site web info@vitassay.com Fiche EUDAMED Signaler une erreur
ElitechGroup FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Italie, États-Unis	Adenovirus - ELITe Positive Control3 réf. Aerospray 30 Slide Carousel3 réf. AFB/TB Stain Control Slides Aerospray Stains3 réf. ASPERGILLUS spp. - ELITe Positive Control98/79 ASPERGILLUS spp. ELITe MGB® Kit98/79 49 autres ASPERGILLUS spp. ELITe Standard98/79 BKV - ELITe Positive Control3 réf. Bordetella - ELITe Positive Control2 réf. C. difficile - ELITe Positive Control98/79 C. difficile ELITe MGB® Kit98/79 Candida auris - ELITe Positive Control2 réf. CMV - ELITe Positive Control3 réf. CMV RNA - ELITe Positive Control3 réf. CPE - Internal Control EBV - ELITe Positive Control3 réf. ELITe BeGenius®2 réf. ENTEROVIRUS - ELITe Positive Control3 réf. GI Bacterial PLUS - ELITe Positive Control2 réf. GI Norovirus PLUS - ELITe Positive Control2 réf. GI Parasitic PLUS - ELITe Positive Control2 réf. GI Viral PLUS - ELITe Positive Control2 réf. HBV ELITe MGB® Kit HCV ELITe MGB® Kit HEV - ELITe Positive Control98/79 HEV ELITe MGB® Kit98/79 HEV ELITe Standard98/79 HHV6 - ELITe Positive Control HHV6 ELITe MGB® Kit3 réf. HHV8 - ELITe Positive Control HHV8 ELITe MGB® Kit3 réf. HIV1 ELITe MGB® Kit HPV PLUS - ELITe Positive Control2 réf. HSV1 - ELITe Positive Control HSV1 ELITe MGB® Kit3 réf. HSV2 - ELITe Positive Control HSV2 ELITe MGB® Kit3 réf. JCV - ELITe Positive Control3 réf. Macrolide-R/MG - ELITe Positive Control2 réf. Meningitis Bacterial - ELITe Positive Control98/79 Meningitis Bacterial ELITe MGB® Kit98/79 Model 340098/79 MTB EXTRA ELITe MGB® Kit98/79 Parvovirus B19 - ELITe Positive Control Parvovirus B19 ELITe MGB® Kit3 réf. Pneumocystis - ELITe Positive Control3 réf. Respiratory Bacterial PLUS - ELITe Positive Control2 réf. Respiratory Viral PLUS - ELITe Positive Control98/79 Respiratory Viral PLUS ELITe MGB® Kit98/79 SARS-CoV-2 PLUS - ELITe Positive Control SARS-CoV-2 PLUS ELITe MGB® Kit2 réf. STI PLUS - ELITe Positive Control2 réf. TOXOPLASMA g. ELITe MGB® Kit2 réf. UroGen ELITe - Positive Control2 réf. Vapro Vapor Pressure Osmometer Model 560098/79 Viral Essential 1 - ELITe Positive Control Viral Essential 1 ELITe MGB® Kit2 réf. Viral Essential 2 - ELITe Positive Control Viral Essential 2 ELITe MGB® Kit2 réf. VZV - ELITe Positive Control3 réf. WNV - ELITe Positive Control98/79 WNV ELITe MGB® Kit98/79 WNV ELITe Standard98/79	A, B, C, D IVDR, 98/79	Site web info@elitechgroup.com Fiche EUDAMED Signaler une erreur
Genes2Me Mandataire UE : Obelis s.a. (Belgique)	Inde	Adeno-Q Real-Time PCR Kit G2M70782198/79 BK-Q Real Time PCR Kit for BK virus G2M70542198/79 C. Albicans-Q Real- Time PCR Kit G2M70802198/79 Chikungunya-Q Real- Time PCR Test Kit G2M70532198/79 Comprehensive Respiratory Virus Panel G2MCRVP1700198/79 49 autres CoVFlu One Step RT PCR Kit G2M27272198/79 CT/TV/NG Panel Real Time PCR kit G61002698/79 DENGUE-Q Real Time PCR Kit G2M70502198/79 EBV-Q Real Time PCR Kit G2M70562198/79 GCP-Q comprehensive Real Time PCR Kit for Gastrointestinal G2M80362198/79 H. Pylori-Q Real-Time PCR Kit G2M706321,G2M706321R98/79 HPV-Q comprehensive Real Time PCR Kit G2M80392198/79 HPV-Q Real-Time PCR Kit G2M70672198/79 HSV-Q Real-Time PCR Test Kit for Herpes simplex Virus 1 & 2 G2M70522198/79 Influenza A/B-Q Real Time PCR Kit G2M70602198/79 MagNXT FFPE DNA Extraction Kit G2M8100073 réf. MagNXT Tissue & body fluids Nucleic acid extraction kit G2M2121213 réf. Malaria-Q Real-Time PCR Kit G2M70622198/79 MCP-Q comprehensive Real Time PCR Kit for Meningitis G2M80382198/79 Measles-Q Real Time PCR Kit G2M70572198/79 Med4Me Tuberculosis Panel G2MMAP1000198/79 MTB-NTM Multiplex Real-Time PCR Kit G2M70742198/79 MTB-NTM Multiplex Real-Time PCR Kit G6100153 réf.98/79 MTC-Q Real-Time PCR Kit G2M70732198/79 MTC-Q Real-Time PCR Kit G6100143 réf.98/79 N. Gonorrhoeae-Q Real-Time PCR Kit G2M70642198/79 One PCR Ultra-Fast RT PCR System IG2M5001UF Para-Q Multiplex Real Time PCR kit G2M70612198/79 Para2-Q Real Time PCR Kit G2M80152198/79 Rapi Q HT - Micro RT PCR System IG2M50012 réf. RapiMal Rapid Antigen Test kit for Malaria G2MR17251798/79 RapiSyph Rapid Antibody Test kit for Syphilis G2MR17251598/79 RapiT.Cruzi Rapid Antibody Test kit for Trypanosoma cruzi G2MR17255098/79 RCP-Q comprehensive Real Time PCR Kit for Respiratory G2M80352198/79 Rota-Q Real Time PCR Kit for Rotavirus G2M80162198/79 RSV-Q Real Time PCR Kit G2M80122198/79 Sepsi-AMR Real Time PCR kit G61002798/79 Sepsis-Q Real Time PCR Kit G2M804026,G2M804026R98/79 Sepsis-Q Real Time PCR Kit G61002798/79 SpiNXT Cell free DNA Extraction Kit G2M8100132 réf. SpiNXT FFPE DNA Extraction Kit G2M2321212 réf. SpiNXT Tissue & body fluids Nucleic acid extraction kit G2M1314202 réf. STI-Q comprehensive Real Time PCR Kit G2M80372198/79 STI-Q Core Real Time PCR Kit G61002698/79 STI-Q Real Time PCR kit G61002698/79 STI7-Q Real-Time PCR Kit G2M70912198/79 Syphilis-Q Real Time PCR Kit G2M70552198/79 TB NGS Test Kit G71001011 réf.98/79 TB-Q Comprehensive Real Time PCR Kit for Tuberculosis G2M80312198/79 TB-Q Comprehensive Real Time PCR Kit for Tuberculosis G6100343 réf.98/79 VZV-Q Real-Time PCR Kit for Varicella-zoster virus G2M70582198/79 W. Nile-Q Real Time PCR Kit for West Nile Virus G2M80232198/79 W0105010703 G71001098/79 ZikaQ Real Time PCR Kit for Zika Virus G2M26262198/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Seegene FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	Allplex™ 2019-nCoV Assay2 réf.98/79 Allplex™ Bacterial Vaginosis plus Assay2 réf. Allplex™ Candidiasis Assay3 réf. Allplex™ CT/NG/MG/TV Assay3 réf. Allplex™ Genital ulcer Assay3 réf. 49 autres Allplex™ GI-Bacteria(I) Assay3 réf.98/79 Allplex™ GI-Bacteria(I) plus Assay2 réf. Allplex™ GI-Bacteria(II) Assay3 réf.98/79 Allplex™ GI-EB plus Screening Assay2 réf. Allplex™ GI-EB Screening Assay3 réf.98/79 Allplex™ GI-Helminth(I) Assay3 réf. Allplex™ GI-Parasite Assay3 réf. Allplex™ GI-Virus Assay3 réf. Allplex™ GI-Virus plus Assay3 réf.98/79 Allplex™ HPV HR Detection3 réf. Allplex™ HPV28 Detection2 réf. Allplex™ Meningitis-B Assay3 réf. Allplex™ Meningitis-V1 Assay3 réf.98/79 Allplex™ Meningitis-V2 Assay3 réf. Allplex™ NG & DR Assay2 réf. Allplex™ NTM Typing2 réf. Allplex™ PneumoBacter Assay3 réf. Allplex™ Respiratory Panel 1A3 réf.98/79 Allplex™ Respiratory Panel 23 réf.98/79 Allplex™ Respiratory Panel 33 réf.98/79 Allplex™ Respiratory Panel 43 réf.98/79 Allplex™ RP-Virus(I) Assay2 réf. Allplex™ RP-Virus(II) Assay2 réf. Allplex™ RP-Virus(III) Assay2 réf. Allplex™ RV Master Assay2 réf. Allplex™ SARS-CoV-2 Assay2 réf.98/79 Allplex™ SARS-CoV-2 fast PCR Assay2 réf.98/79 Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay2 réf.98/79 Allplex™ STI Essential Assay3 réf. Allplex™ STI Essential Assay Q(MH,UU)3 réf. Allplex™ TS Strep ACG&AH2 réf. Allplex™ Vaginitis screening Assay3 réf. Anyplex™ II HPV28 Detection2 réf.98/79 Anyplex™ II HPV HR Detection3 réf.98/79 Anyplex™ II STI-7e Detection3 réf. Anyplex™ MTB/NTMe Real-time Detection3 réf.98/79 SGRT STARMag 96 ProPrep2 réf. STARMag 96 ProPrep C2 réf. STARMag 96 ProPrep plus2 réf. STARMag 96 x 4 UniVersal Cartridge Kit STARMag 96 x 4 UniVersal plus Cartridge Kit STARMag 96 x 4 Viral DNA/RNA 200 C Kit STARMag™ M96 Kit2 réf. STARMag™ N/S Kit STARMag™ S96H Kit3 réf. STARMag™ S96H N Kit2 réf. STARMag™ SP32 Kit2 réf. STARprep™ EZ Buffer2 réf.	A, B, C IVDR, 98/79	Site web info@seegene.com Fiche EUDAMED Signaler une erreur
Erba	Tchéquie	APEX IA EC 90 ECL 105 ECL 412 ECL 760 48 autres ELite 580 ELite H CAL ELite H Clean ELite H5 CON3 réf. ELite H580 Dil ELite H580 Lyse13 réf. Erba Actime 3098/79 Erba Actime 5098/79 Erba Calcium Chloride98/79 Erba Control N98/79 Erba Control P98/79 Erba DDimer Control N+P98/79 Erba DDimer R 6098/79 Erba H3 CON3 réf. Erba H360 Dil Erba H360 Lyse Erba H560 Dil Erba H560 Lyse12 réf. Erba H7 CON3 réf. Erba H7 ret CON3 réf. Erba H7100 Clean 10x4 mL2 réf. Erba H7100 Dil Erba H7100 Dil Ret (1 L)2 réf. Erba H7100 Fluro Diff (22 mL)2 réf. Erba H7100 Fluro Ret (12 mL)3 réf. Erba H7100 Lyse 1 (1000 mL)3 réf. Erba Protime 2098/79 Erba Protime 4098/79 Erba Protime LS 1098/79 Erba Protime LS 10098/79 Erba Protime LS 5098/79 Erba PT - INR Multical98/79 Erba Standard Plasma98/79 Erba Thrombin Reagent 1098/79 Erba Thrombin Reagent 2098/79 Erba Thrombin Time 2098/79 H360 H560 H7100 LAURA LAURA SMART LAURA XL VERTEX CA VERTEX IA XL -180 with ISE2 réf. XL-1000 with ISE2 réf. XL-200 NEO with ISE3 réf. XL-640 with ISE2 réf.	A, B IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Gongdong FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	3.2%Sodium citrate without capillary tube Curalyn Urine Container Disposable Urine Collection Tube boric acid3 réf. Disposable Urine Collection Tube boric acid + sodium formate + sodium borate2 réf. Disposable Urine Collection Tube No addition2 réf. 48 autres Disposable Urine Collection Tube sodium fluoride/sodium borate2 réf. Disposable Urine Collection Tube Sodium Propionate +Ethyl Paraben+ Chlorhexidine2 réf. Disposable Vacuum Blood Tube19 réf. Disposable Vacuum Blood Tube 3.2%Sodium citrate3 réf. Disposable Vacuum Blood Tube cf-DNA3 réf. Disposable Vacuum Blood Tube EDTA K2+ Gel Disposable Vacuum Blood Tube EDTA K3+Sodium Fluride3 réf. Disposable Vacuum Blood Tube Heparin sodium+Sodium fluoride3 réf. Disposable Vacuum Blood Tube Thrombin3 réf. Disposable Vacuum Blood Tube Thrombin+Gel Disposable Vacuum Blood Tube(Clot activator)3 réf. Disposable Vacuum Blood Tube(clot activator+Gel)3 réf. Disposable Vacuum Blood Tube(EDTA.K2)3 réf. Disposable Vacuum Blood Tube(EDTA.K3)3 réf. Disposable Vacuum Blood Tube(EDTA.Na2)3 réf. Disposable Vacuum Blood Tube(EDTA.Na2+Sodium fluoride)3 réf. Disposable Vacuum Blood Tube(3.8% sodium citrate)3 réf. EDTA K3+ Gel EDTA Na2+ Gel EDTA.K2 capillary tube EDTA.K3 capillary tube GDC005A（No addition with capillary tube） Gongdong Yellow Heparin lithium capillary tube GD-LH Heparin sodium + Sodium Fluoride capillary tube GD-SFH Heparin sodium capillary tube GD-SH Micro Blood Collection Tube 3.2%Sodium citrate with capillary tube2 réf. Micro Blood Collection Tube 3.8%Sodium citrate with capillary tube Micro Blood Collection Tube Clot activator with capillary tube GDC005CA2 réf. Micro Blood Collection Tube Heparin Lithium+Gel with capillary tube GDC005LHG Micro Blood Collection Tube Sodium Flouride+Potassium Oxalate with capillary tube2 réf. Micro Blood Collection Tube(Clot activator without capillary tube) GD005CA Micro Blood Collection Tube(EDTAK2 with capillary tube) Micro Blood Collection Tube(EDTAK2 without capillary tube) Micro Blood Collection Tube(EDTAK3 with capillary tube) Micro Blood Collection Tube(EDTAK3 without capillary tube) Micro Blood Collection Tube(Gel+Clot activator with capillary tube) GDC005SGC Micro Blood Collection Tube(Gel+Clot activator without capillary tube) GD005SGC Micro Blood Collection Tube(Heparin lithium with capillary tube) GDC005LH Micro Blood Collection Tube(Heparin lithium without capillary tube) GD005LH Micro Blood Collection Tube(Heparin sodium + Sodium Fluoride with capillary tube) GDC005SFH Micro Blood Collection Tube(Heparin sodium + Sodium Fluoride without capillary tube) GD005SFH Micro Blood Collection Tube(Heparin sodium with capillary tube) GDC005SH Micro Blood Collection Tube(Heparin sodium without capillary tube) GD005SH Micro Blood Collection Tube(No addition without capillary tube) No addition capillary tube Sodium Flouride+Potassium Oxalate capillary tube Specimen container faeces container, secretion container, human urine container, human secretion for culture container.3 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Infitek FDA Mandataire UE : Kingsmead Service B.V. (Pays-Bas) et 1 autre	Chine	-86 ℃ Ultra Low Temperature Freezer 2-8℃ Refrigerator 3D Shaker3 réf. Auto Hematology Analyzer HEMA-D60313 réf. Biological Microscope MSC-5-500MV3 réf. 48 autres Biological Safety Cabinet BSC-IIA2-2J3 réf. Biological Safety Cabinet IN0084 Blood Gas Analyzer BGA Series Blood Gas Analyzer BGA-150-3 Centrifuge CFG Series，CFGR Series2 réf. CO2 Incubator ICB Series, EGI Series Cyto Centrifuge CFG-12D3 réf. Drying Oven/Sterilizing Oven DON Series, DOF Series, DOV Series, DOI Series Electrolyte Analyzer EA Series Electrolyte Analyzer EA-7-25-A Embedding coolling plate2 réf. Embedding Machine EBD Series ESR Analyzer ESRA Series ESR Analyzer ESRA-10 Forced-Air Drying Oven2 réf. Freezer LF Series, LF45 Series, LF25 Series, LF40 Series, LF60 Series, LF150 Series, LF86 Series Fully automatic multifunctional gel imaging system GEP-GD600MF2 réf. Fully Automatic Urine Sediment Analyzer Evo-S502 réf. Fume Hood FMH-D4F Gel Imaging System GEP Series Hematology Analyzer HEMA Series Laminar Flow Cabinet LCB-H4F3 réf. Melting Point Apparatus MTP-4 Microplate Reader3 réf. Microplate Reader MPR Series Microscope MSC Series Microtome RMT Series Osmometer FPO-2000 PH Meter BEP-M210-UK Pipette PIPE-MP2 réf. Platelet Oscillating Incubator POI Series Portable Refrigerator CLR-1.5 Real-time PCR3 réf. Real-time PCR System PCR Series Refractometer RFT-A731 Refrigerator CLR Series, MCFR Series, CR Series, BR4 Series, PR5 Series Rotary Evaporator REV-2000A Rotary Microtome RMT-M260 Shaker SHK Series Slide Stainer TSST Series，IHCS Series Thermal Cycler PCR Series, PCRTC Series Tissue Processor TSP Series, TSSP Series Titrator TITR-40C Urine Analyzer UA Series Urine Analyzer UA-SA-200 Urine Sediment Analyzer UA Series, Evo Series, USA Series Viscometer Water Bath WB-S12 réf.	I, A IVDR, MDR	info@infitek.com Fiche EUDAMED Signaler une erreur
Ustar Biotechnologies (Hangzhou) Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)98/79 EasyNAT BP Assay EasyNAT BP erythromycin Resistance Assay98/79 EasyNAT CT/NG Assay EasyNAT GBS Assay 48 autres EasyNAT LP Assay98/79 EasyNAT Malaria Assay98/79 EasyNAT MP Assay EasyNAT MTC Assay EasyNAT MTC/NTM Assay98/79 EasyNAT Rapid Flu Assay EasyNAT Rapid RSV Assay EasyNAT TP Assay98/79 EasyNAT Vibrio Cholerae Assay98/79 EasyNAT HSV 1&2 Assay Helicobacter pylori 23S rRNA Gene mutation Detection Kit98/79 MultNAT Blood Culture Identification Panel2 réf.98/79 MultNAT C.difficile Assay MultNAT EV Assay MultNAT Gastrointestinal Panel4 réf. MultNAT GBS Assay MultNAT HPV Panel2 réf.98/79 MultNAT Meningitis Encephalitis Panel98/79 MultNAT Molecular Diagnostic Testing System MultNAT Molecular Diagnostic Testing System UP0102/UP01042 réf. MultNAT Monkeypox Virus Assay98/79 MultNAT MRSA/SA Assay MultNAT MTC Assay MultNAT MTC/MDR Assay98/79 MultNAT MTC/RIF Assay MultNAT MTC/XDR Assay98/79 MultNAT Norovirus Assay98/79 MultNAT NTM Panel98/79 MultNAT Pneumonia Panel98/79 MultNAT Pneumonia Panel 22 réf.98/79 MultNAT Respiratory Panel2 réf. MultNAT Respiratory Panel 298/79 MultNAT SARS-CoV-2/Flu and RSV PCR Assay MultNAT Sexually Transmitted Infections Panel3 réf.98/79 MultNAT STI Panel MultNAT Strep A Assay98/79 MultNAT Tropical Fever Panel3 réf. PortNAT Molecular Analyzer PN0102 PortNAT TB Assay UC0102 UC0104 UC0108 UC0116 UC0204 UC0208 UC0216 UP0202 UP0204	A, B, C IVDR, 98/79	Présent sur le marché en France Site web service@bioustar.com Fiche EUDAMED Signaler une erreur
Diesse FDA	Italie	AUTO-DAT AUTODAT CHORUS BORRELIA IgG CHORUSBOG CHORUS CHIKUNGUNYA IgM CHORUS CHLAMYDOPHILA PNEUMONIAE IgA CHORUSCHA CHORUS CHLAMYDOPHILA PNEUMONIAE IgG CHORUSCHG 47 autres CHORUS CHLAMYDOPHILA PNEUMONIAE IgM CHORUSCHM CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS CCAB-C CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH CCGDH-C CHORUS CLIA HELICOBATER PYLORI Ag CHORUSCPAGDU CHORUS CLIA MEASLES IgG CMVG CHORUS CLIA MUMPS IgG CMPG CHORUS CYTOMEGALOVIRUS IgG CHORUSCMVIGG CHORUS CYTOMEGALOVIRUS IgM CAPTURE CHORUSCMVIGMCA CHORUS CYTOMEGALOVIRUS IgM CHORUSCMVIGM CHORUS EPSTEIN-BARR EARLY ANTIGEN IgG CHORUSEAG2 réf. CHORUS EPSTEIN-BARR VCA IgM II CHORUSEBMII CHORUS EVO CHORUSEVO CHORUS HELICOBACTER PYLORI IgA CHORUSPYA CHORUS HELICOBACTER PYLORI IgG CHORUSPYG CHORUS HELICOBATER PYLORI Ag CHORUSPAG CHORUS HERPES SIMPLEX 1 IgG RECOMBINANT CHORUSHSV CHORUS HERPES SIMPLEX 1+2 IgG CHORUSHSG CHORUS HERPES SIMPLEX 1+2 IgM CHORUSHSM CHORUS HSV 2 SCREEN CHORUSH2S CHORUS INFLUENZA A IgA CHORUSIAA2 réf. CHORUS INFLUENZA A IgG CHORUSIAG2 réf. CHORUS INFLUENZA B IgA CHORUSIBA2 réf. CHORUS INFLUENZA B IgG CHORUSIBG2 réf. CHORUS MYCOPLASMA PNEUMONIAE IgA CHORUSMYA CHORUS MYCOPLASMA PNEUMONIAE IgG CHORUSMYG CHORUS MYCOPLASMA PNEUMONIAE IgM CHORUSMYM CHORUS RUBELLA IgM CHORUSRVMIGM CHORUS SYPHILIS SCREEN RECOMBINANT CHORUSTPN CHORUS TOXOPLASMA IgM CAPTURE CHORUSTMC CHORUS TREPONEMA IgM CHORUSTPM2 réf. CHORUS VARICELLA IgG CHORUSVZG CHORUS WEST NILE IgG CHORUSWNG CHORUS WEST NILE IgM CHORUSWNM CUBE 30 TOUCH CUBE30T Platelia HSV (1+2) IgM PLATHSV1+2IGM Platelia Measles IgG PLATELIAMVG Platelia Measles IgM PLATELIAMVM Platelia Mumps IgG PLATELIAMPG Platelia Mumps IgM PLATELIAMPM Platelia VZV IgG PLATELIAVZG Platelia VZV IgM PLATELIAVZM RPR-DAT TREPONEMADAT TPHA-DAT ADVANCED TPHAD VACU-TEC DOUBLE LABEL ESRTUBES3 réf. VES MATIC Original VMORIGINAL VES-MATIC 5 VESMATIC5 WF-DAT ADVANCED WFDAT	A, B, C IVDR	Site web Fiche EUDAMED Signaler une erreur
Tcoag FDA	Irlande	Destiny Cuvette Trays2 réf. Ristocetin sthemA 601 (Quark) and Autoloader98/79 sthemA CL-15 sthemA CL-250 47 autres sthemA DL-2500 sthemA DL-9000 sthemA FD-50 sthemA FL-50 sthemA HB-250 sthemA WB-250 TriniCAL Fibrinogen98/79 TriniCAL PC/PS98/79 TriniCAL Reference Plasma98/79 TriniCHECK Abnormal control98/79 TriniCHECK Control 1 (Assayed)98/79 TriniCHECK Control 2 (Assayed)98/79 TriniCHECK D-Dimer 298/79 TriniCHECK D-Dimer 398/79 TriniCHECK Level 198/79 TriniCHECK Level 298/79 TriniCHECK Level 398/79 TriniCHECK LIA Control Set98/79 TriniCHROM Antithrombin IIa98/79 TriniCHROM Factor VIII:C TriniCLOT Calcium Chloride 0.025M98/79 TriniCLOT aPTT HS 10 mL98/79 TriniCLOT aPTT HS 3 mL98/79 TriniCLOT APTT S 10ML98/79 TriniCLOT aPTT S 5 mL2 réf.98/79 TriniCLOT Automated aPTT 6 mL98/79 TriniCLOT Factor II98/79 TriniCLOT Factor IX98/79 TriniCLOT Factor VII98/79 TriniCLOT Factor VIII98/79 TriniCLOT Factor X98/79 TriniCLOT Factor XI98/79 TriniCLOT Factor XII98/79 TriniCLOT Fibrinogen 6 mL98/79 TriniCLOT Fibrinogen Kit98/79 TriniCLOT Imidazole Buffer98/79 TriniCLOT Lupus Confirm98/79 TriniCLOT Owrens Buffer TriniCLOT PC II98/79 TriniCLOT PS II98/79 TriniCLOT PT Excel S 20 mL98/79 TriniCLOT PT Excel S 6ml98/79 TriniCLOT Thrombin Time 1ml98/79 TriniCLOT Thrombin Time 4ml98/79 TriniLIA D-dimer98/79 TriniLIA D-Dimer II98/79 W010302060698/79	A, B IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Vela Operations Singapore Pte FDA Mandataire UE : Vela Diagnostics Germany GmbH (Allemagne)	Singapour	Great Basin Bordetella Direct Test 30078298/79 Great Basin Group B Streptococcus Test 30078198/79 Sentosa SA BKV Controls (8x3) 30063398/79 Sentosa SA BKV PCR Test (4x24) 30008898/79 Sentosa SA BKV PCR Test (4X48) 30063698/79 47 autres Sentosa SA BKV Quantitation Controls (4x2) 30009298/79 Sentosa SA BKV Quantitation Standards (2x13) 30009198/79 Sentosa SA C. diff PCR Test v2.0 (4x24) 30024998/79 Sentosa SA CHIKV RT-PCR Test (4x8) 30004898/79 Sentosa SA CMV Controls Set (8x3) 30062498/79 Sentosa SA CMV Quantitation Controls (4x2) 30005998/79 Sentosa SA CMV Quantitative PCR Test (4x24) 30011498/79 Sentosa SA Dengue I-IV RT-PCR Test (4x8) 30005098/79 Sentosa SA Direct MRSA/SA PCR Test (4x24) 30024798/79 Sentosa SA EBV Controls Set (8x3) 30063198/79 Sentosa SA EBV PCR Test (4x24) 30010698/79 Sentosa SA EBV PCR Test (4X48) 30062798/79 Sentosa SA EBV Quantitation Controls (4x2) 30011098/79 Sentosa SA EBV Quantitation Standards (2x13) 30010998/79 Sentosa SA HHV6 Controls Set (8x3) 30068898/79 Sentosa SA HHV6 Quantitation Controls (4x2) 30017898/79 Sentosa SA HHV6 Quantitative PCR Test 300157, 300184, 300673, 30018098/79 Sentosa SA HSV1/2 Controls Set (8x3) 30068698/79 Sentosa SA HSV1/2 PCR Test (4x24) 30006498/79 Sentosa SA HSV1/2 PCR Test (4x24) 30023398/79 Sentosa SA HSV1/2 PCR Test (4x48) 30067198/79 Sentosa SA HSV1/2 Quantitation Controls (4x2) 30007298/79 Sentosa SA HSV1/2 Quantitation Standards (2x13) 30007198/79 Sentosa SA Influenza A/B & 2009 H1N1 RT-PCR Test 11126798/79 Sentosa SA Influenza A/B & RSV RT-PCR Test (4x24) 30014598/79 Sentosa SA Norovirus RT-PCR Test v2.0 (4x24) 30020298/79 Sentosa SA Rotavirus RT-PCR Test (4x24) 30019298/79 Sentosa SA RSV RT-PCR Test 11132698/79 Sentosa SA Salmonella PCR Test (4x8) 30002898/79 Sentosa SA Strep A PCR Test (4x8) 30003298/79 Sentosa SA VZV Controls (8x3) 30069098/79 Sentosa SA VZV PCR Test (4x24) 30008198/79 Sentosa SA VZV PCR Test (4x48) 30067598/79 Sentosa SA VZV Quantitation Controls (4x2) 30007798/79 Sentosa SA VZV Quantitation Standards (2x13) 30007898/79 Sentosa SA ZIKV RT-PCR Test 30061498/79 Sentosa SQ HIV Genotyping Assay (4x16) 69003798/79 Sentosa SX Lysis Beads 300291 Sentosa SX Lysis Plate (10x96) 300649, 3007042 réf. Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) 300042 Sentosa SX Virus Total Nucleic Acid Plus II Kit (4x16) 300351 Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) 300154 Sentosa SX Whole Blood Kit (4x24) 300252 Sentosa SX101 400089 ViroKey Flu A/B & RSV RT-PCR Extension Kit 30107498/79 ViroKey HT Virus Total Nucleic Acid Kit (4x96) 300678, 3010892 réf. ViroKey MP HPV 16, 18 PCR Test 301119, 301120, 30112198/79	A IVDR, 98/79	Site web infoAPAC@veladx.com Fiche EUDAMED Signaler une erreur
Cybereagen Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Adenovirus Rapid Test Device(Feces) A320401D98/79 Adenovirus Rapid Test Device（Nasal swab） A501301D98/79 Chikungunya IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) A380501D98/79 D-Dimer (DD) Assay Reagent Kit (CMIA) C2KD00198/79 D-Dimer (DD) Rapid Test Device (Whole blood/Plasma） E051001D98/79 46 autres D-Dimer (DD) Rapid Test Device (Plasma) E061101D98/79 D-Dimer Rapid Test Device (Plasma) E041101D98/79 D-Dimer Rapid Test Device (whole blood/plasma) E011001D98/79 D-Dimer Rapid Test Device(Colloidal Gold) E030501D98/79 Dengue IgGIgM Rapid Test Device (whole blood/serum/plasma) A250501D98/79 Dengue NS1 Rapid Test Device (whole blood/serum/plasma) A260501D98/79 Filariasis IgG/IgM Rapid Test Device(Whole Blood/Serum/Plasma) A390501D98/79 Gonorrhea Rapid Test Device (Swab) C061301D98/79 H. pylori (HP) Antibody Rapid Test Device(Serum/Plasma) D121401D98/79 H. pylori Antigen Rapid Test Strip(Feces) D090401S98/79 H.Pylori Ab Rapid Test Device(Whole blood/Serum/Plasma) D080501D98/79 H.Pylori Antigen Rapid Test Device (feces) D060401D98/79 H.Pylori(HP) Antibody Rapid Test Device (whole blood/serum/plasma) D070501D98/79 HAV IgM Rapid Test Device(Serum/Plasma) A531401D98/79 HCV Rapid Test Device (Serum/Plasma/Whole blood) A510501D98/79 Herpes Simplex Virus -I/II IgM (HSV-I/II IgM) Assay Reagent Kit (CMIA) C2KE00498/79 Herpes Simplex Virus -II IgM (HSVII IgM) Assay Reagent Kit (CMIA) C2KE00698/79 Herpes Simplex Virus -Ⅰ IgG (HSV-Ⅰ IgG) Assay Reagent Kit (CMIA) C2KE00198/79 Herpes Simplex Virus -Ⅰ IgM (HSV-Ⅰ IgM) Assay Reagent Kit (CMIA) C2KE00598/79 Herpes Simplex Virus -Ⅰ/Ⅱ IgG (HSV-Ⅰ/Ⅱ IgG) Assay Reagent Kit (CMIA) C2KE00398/79 Herpes Simplex Virus -Ⅱ IgG (HSV-Ⅱ IgG) Assay Reagent Kit (CMIA) C2KE00298/79 HEV IgM Rapid Test Device (Serum/Plasma) A401401D98/79 HPV IgM Rapid Test Device (serum) A111701D98/79 Infectious Mononucleosis Igm Rapid Test Device(Whole Blood/Serum/Plasma) A410501D98/79 Influenza A&B Rapid Test (Nasopharyngeal swab) A170101T98/79 Interleukin-6 (IL-6) Assay Reagent Kit (CMIA) C2KC00198/79 Leptospira IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) A490501D98/79 M.Pneumonia Antigen Rapid Test Device (swab) D020501D98/79 M.Pneumonia IgG/IgM Rapid Test Device(whole blood/serum/plasma) A120501D98/79 Malaria Ag P.f (HRP-Ⅱ) Assay Reagent Kit (CMIA) C2KC00398/79 Malaria P.f. Rapid Test Device (whole blood) A270901D98/79 Malaria P.f.Pan Antigen Rapid Test Device (whole blood) A280901D98/79 Malaria P.fP.v Rapid Test Device (whole blood) A290901D98/79 Mycoplasma pneumoniae IgG antibody Assay Reagent Kit (CMIA) C2KC00498/79 Norovirus Rapid Test Device（Feces） A420401D98/79 Rotavirus Rapid Test Device (feces) A440401D98/79 S.typhi Antigen Rapid Test Device (feces) A090401D98/79 Serum Amyloid A (SAA) Assay Reagent Kit (CMIA) C2KC00298/79 Strep A Rapid Test (Throat swab) A351301T98/79 Syphilis Rapid Test (serum/plasma) A451401D98/79 Syphilis Rapid Test Device (serum/plasma/whole blood) A300501D98/79 Syphilis Rapid Test Strip (Whole Blood/Serum/Plasma) A460501S98/79 The Anti-Treponema Pallidum(Anti-TP) Assay Reagent Kit (CMIA) C2KC00998/79 The L.pn Rapid Test Device (urine) A160301D98/79 Typhoid IgG/IgM Rapid Test (Serum/Plasma) A471401T98/79 Vaginal pH Rapid Test Panel (Vaginal Swab) C130101C98/79	– 98/79	info@cybereagen.com Fiche EUDAMED Signaler une erreur
nal von minden	Allemagne	dedicio® Strep A Test3 réf.98/79 FUTURLAB® Strep A Test98/79 Hitado D-Dimer Test2 réf.98/79 Hitado Mononucleosis Test98/79 Hitado strep a2 réf.98/79 46 autres Hitado strep a Test3 réf. Lagaay Malaria Pf/Pan Ag 4 Species Test Malaria Pf/Pan Ag 4 SpeciesTest98/79 meditrol® D-Dimer Test5 réf.98/79 meditrol® Strep A Test98/79 NADAL TPHA Microplate Haemagglutination Test98/79 NADAL® C. difficile GDH Ag Test2 réf.98/79 NADAL® C. difficile Toxin A/B Test2 réf.98/79 NADAL® C. difficile Toxin A/B+GDH Test2 réf.98/79 NADAL® Chlamydia plus Test (CE0197) Chlamydia Test (CE0197)98/79 NADAL® Chlamydia Test (CE0197)98/79 NADAL® COVID-19 Ag Test98/79 NADAL® COVID-19 Ag Test CE01979 réf.98/79 NADAL® COVID-19 IgG/IgM Test98/79 NADAL® D-Dimer Test5 réf.98/79 NADAL® Dengue NS1 Ag+IgG/IgM Test98/79 NADAL® H.pylori Ag Test2 réf.98/79 NADAL® H.pylori Ab Test2 réf.98/79 NADAL® Influenza A/B Scan Test98/79 NADAL® Influenza A/B Test2 réf.98/79 NADAL® Legionella /S. pneumoniae Test98/79 NADAL® Legionella Test2 réf.98/79 NADAL® Malaria Pf/Pan Ag 4 Species plus Test3 réf.98/79 NADAL® Malaria Pf/Pan Ag 4 Species Test2 réf.98/79 NADAL® Mononucleosis Test3 réf.98/79 NADAL® Mpox Ag Test98/79 NADAL® Norovirus GI/GII+Rota-Adenovirus Test98/79 NADAL® Rota-Adenovirus Test98/79 NADAL® RPR Carbon Test98/79 NADAL® RSV Test98/79 NADAL® S. pneumoniae Test2 réf.98/79 NADAL® Strep A Plus Test2 réf.98/79 NADAL® Strep A Scan Test98/79 NADAL® Strep A Test8 réf. NADAL® Strep B98/79 NADAL® Strep B Test98/79 NADAL® Syphilis Test2 réf.98/79 NADAL® VDRL Test98/79 NEO CITOSTREP® Strep A Test98/79 RSS III S-MedPro D-Dimer Test98/79 S-MedPro H.pylori Ab Test98/79 S-MedPro H.pylori Ag Test98/79 S-MedPro Strep A Test98/79 S-MedPro Strep B Test98/79 Secu® Strep A Test6 réf.98/79 StrepA PreMax® Test2 réf.98/79	A, B IVDR, 98/79	Présent sur le marché en France Site web info@nal-vonminden.com Fiche EUDAMED Signaler une erreur
Biosynex Mandataire UE : BIOSYNEX (France)	France, Suisse	BIOSYNEX AMPLIFLASH MALARIA2 réf. BIOSYNEX AMPLIQUICK Bordetella2 réf. BIOSYNEX AMPLIQUICK Fecal Bacteriology3 réf. BIOSYNEX AMPLIQUICK Fecal Pretreatment BIOSYNEX AMPLIQUICK Fecal Virology3 réf. 49 autres BIOSYNEX AMPLIQUICK Helminths3 réf.98/79 BIOSYNEX AMPLIQUICK Leptospira BIOSYNEX AMPLIQUICK Malaria2 réf. BIOSYNEX AMPLIQUICK Parasitology Lite3 réf. BIOSYNEX AMPLIQUICK Protozoans3 réf.98/79 BIOSYNEX AMPLIQUICK Respiratory Duplex2 réf.98/79 BIOSYNEX AMPLIQUICK Respiratory Triplex98/79 BIOSYNEX AMPLIQUICK SARS-CoV-23 réf.98/79 BIOSYNEX AMPLIQUICK STI Panel I3 réf. BIOSYNEX C. difficile GDH BIOSYNEX COMBO ADENO/ROTA BSS98/79 BIOSYNEX COMBO COVID-FLU BSS98/79 BIOSYNEX COVID-19 Ag BSS98/79 BIOSYNEX CryptoPS2 réf. BIOSYNEX DENGUE Ab BSS98/79 BIOSYNEX DENGUE Ag BSS98/79 BIOSYNEX DENGUE COMBO BSS98/79 BIOSYNEX Legionella pneumophila BSS98/79 BIOSYNEX Legionella pneumophila BSX98/79 BIOSYNEX RSVTOP BSS98/79 BIOSYNEX S.pneumoniae98/79 BIOSYNEX S.pneumoniae BSX98/79 BIOSYNEX Strep A98/79 BIOSYNEX Strep A BSX98/79 CHLAMYTOP98/79 Control Set for rapid SARS-CoV-2 PCR98/79 Contrôle positif TETANUS98/79 easyTETANOTOP98/79 H. Pylori positive control98/79 IMMUNOQUICK NoRotAdeno98/79 IMMUNOQUICK Norovirus98/79 INFLUENZATOP BSS98/79 MALARIA Control98/79 Negative control swab98/79 Norovirus GI Positive Control98/79 NOROVIRUS GII positive Control98/79 PALUTOP +4 OPTIMA98/79 Positive control swab Adenovirus & Rotavirus SW401998/79 Positive control swab COVID-19 Ag98/79 Procise Stool Collection Kit2 réf. PYLORITOP Ab BSS98/79 PYLORITOP AG98/79 STREPTATEST2 réf.98/79 TETANOTOP98/79 TETANOTOP BSX98/79 BIOSYNEX AMPLIFLASH GBS (plus commercialisé) Ksmart D-DIMER98/79 (plus commercialisé) Ksmart D-DIMER + Controls98/79 (plus commercialisé) SYPHILITOP98/79 (plus commercialisé)	A, B, C IVDR, 98/79	Présent sur le marché en France Site web reglementaire@biosynex.com Fiche EUDAMED Signaler une erreur
Alba Bioscience FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	United Kingdom (ex Northern Ireland)	ALBAcheck® - BGS SIMULATED WHOLE BLOOD CONTROLS Z48998/79 ALBAclone® Anti-A Z00198/79 ALBAclone® Anti-A,B Z02198/79 ALBAclone® Anti-B Z01198/79 ALBAclone® Anti-c Z08398/79 45 autres ALBAclone® Anti-D alpha Z03198/79 ALBAclone® Anti-D blend Monoclonal IgM/IgG Z04198/79 ALBAclone® Anti-D optimum Z03998/79 ALBAclone® Anti-E Z07398/79 ALBAclone® Anti-Fya Z15298/79 ALBAclone® Anti-Fyb Z15498/79 ALBAclone® Anti-human C3 Z36098/79 ALBAclone® Anti-Jka Z16298/79 ALBAclone® Anti-Jkb Z16698/79 ALBAclone® Anti-k (cellano) Z13798/79 ALBAclone® Anti-Lea Z21298/79 ALBAclone® Anti-Leb Z21798/79 ALBAclone® Anti-M Z17198/79 ALBAclone® Anti-N Z17698/79 ALBAclone® Anti-P1 Z20298/79 ALBAclone® Anti-S Z18298/79 ALBAcyte® IgG Sensitised Reagent Red Cells Z44198/79 ALBAcyte® Reagent Red Cells A1 Z40198/79 ALBAcyte® Reagent Red Cells A2 Z40698/79 ALBAcyte® Reagent Red Cells B Z41198/79 ALBAcyte® Reagent Red Cells for Antibody Identification (native) Z47198/79 ALBAcyte® Reagent Red Cells for Antibody Identification (papainised) Z47298/79 ALBAcyte® Reagent Red Cells for Antibody Screening, Z45198/79 ALBAcyte® RhD Negative CAT Reagent Red Cells for Antibody Screening Z46698/79 ALBAsera® Anti-Lub Z22398/79 ALBAsera® Anti-s Z18698/79 ALBAsera® Anti-Wra Z23198/79 Anti-A1 LECTIN Z24198/79 Monospecific Anti-Human IgG Z35698/79 ORTHO CONFIDENCE™ 684278598/79 ORTHO™ Anti-Lea 6904497 (FD212B)98/79 ORTHO™ Anti-Leb 6904498 (FD217B)98/79 ORTHO™ Anti-N 6904495 (FD176B)98/79 ORTHO™ Anti-P1 6904496 (FD202B)98/79 ORTHO™ Anti-S 6904490 (FD182B)98/79 ORTHO™ Anti-s 6904491 (FD186B)98/79 ORTHO™ Sera Anti- Fya 6904486 (FD151B)98/79 ORTHO™ Sera Anti- Fyb 6904487 (FD153B)98/79 ORTHO™ Sera Anti-D (DVI) 6904623 (FD039B)98/79 ORTHO™ Sera Anti-D (IAT) 6904493 (FD041B)98/79 ORTHO™ Sera Anti-Jka 6904488 (FD162B)98/79 ORTHO™ Sera Anti-Jkb 6904489 (FD166B)98/79 ORTHO™ Sera Anti-K 6904492 (FD132B)98/79 ORTHO™ Sera Anti-M 6904494 (FD171B)98/79 Polyspecific Anti-Human Globulin Reagent Z35098/79	– 98/79	Présent sur le marché en France Site web regulatory.registrations@alivedx.com Fiche EUDAMED Signaler une erreur
Ameritech Diagnostic Reagent (Jiaxing) Mandataire UE : AR Experts B.V. (Pays-Bas) et 1 autre	Chine	Exacto-85879598/79 PreventID Strep A R34-11298/79 PreventID Strep B R66-11298/79 R10-11098/79 R10-11698/79 45 autres R102-11098/79 R102-11298/79 R102-11498/79 R108-11098/79 R108-11298/79 R109-11298/79 R11-11098/79 R11-11698/79 R118-11698/79 R13-11098/79 R13-11698/79 R16-11098/79 R16-11298/79 R18-11098/79 R18-11298/79 R18-11698/79 R19-11098/79 R19-11298/79 R200-11298/79 R310-11298/79 R330-11298/79 R34-11098/79 R34-11298/79 R40-11098/79 R40-1122 réf.98/79 R402-11298/79 R40S-11098/79 R40S-11298/79 R44-11298/79 R66-11098/79 R66-1122 réf.98/79 R70-11098/79 R70-11298/79 R70-11698/79 R84-11098/79 R84-11298/79 R85-11098/79 R85-11298/79 R89-11098/79 R89-11298/79 R90-11298/79 R92-11098/79 R92-11298/79 R92-11698/79 R98-11298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Genegeo Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	12-DDL 12-DHL 12-DRF 12-DRS 12-DWL 45 autres 8P-DFL Automatic Hematology Analyzer DX-100 Automatic Hematology Analyzer DX-100P Automatic Hematology Analyzer DX-100R Automatic Hematology Analyzer DX-100W Automatic Hematology Analyzer DX-12098/79 Automatic Hematology Analyzer DX-120C98/79 Automatic Hematology Analyzer DX-120CR98/79 Automatic Hematology Analyzer DX-120R98/79 Automatic Hematology Analyzer DX-120S98/79 Automatic Hematology Analyzer DX-120SR98/79 Automatic Hematology Analyzer DX-60 Automatic Hematology Analyzer DX-60i Automatic Hematology Analyzer DX-60P Automatic Hematology Analyzer DX-898/79 Automatic Hematology Analyzer DX-80 Automatic Hematology Analyzer DX-80C Automatic Hematology Analyzer DX-80S Automatic Hematology Analyzer DX-8i98/79 Automatic Hematology Analyzer DX-8P98/79 Automatic Hematology Analyzer DX-8P298/79 Automatic Hematology Analyzer DX-8P2i98/79 Automatic Hematology Analyzer DX-8P398/79 Cleaning Solution DCC2 réf. CS DCS Diluent for Hematology Analysis 10-DRS3 réf. DX-9000 DXS2 réf. Fluorescent Dye for Hematology Analysis 10-DDF3 réf. Fluorescent Dye for Hematology Analysis 10-DPF3 réf. Fluorescent Dye for Hematology Analysis 10-DRF3 réf. Fluorescent Dye for Hematology Analysis 10-DTF3 réf. Fluorescent Dye for Hematology Analysis 10-DWF3 réf. Fluorescent Dye for Hematology Analysis 6-ODF3 réf. Fluorescent Dye for Hematology Analysis 8-DFF3 réf. GE-DXS Lysing Reagent for Hematology Analysis 10-DDL3 réf. Lysing Reagent for Hematology Analysis 10-DHL3 réf. Lysing Reagent for Hematology Analysis 10-DPL3 réf. Lysing Reagent for Hematology Analysis 10-DWL3 réf. Lysing Reagent for Hematology Analysis 6-ODL3 réf. Lysing Reagent for Hematology Analysis 6-OHB3 réf. Lysing Reagent for Hematology Analysis 8-DFL3 réf. Lysing Reagent for Hematology Analysis 8-WHB2 réf.	A IVDR, 98/79	sales@genegeo.com Fiche EUDAMED Signaler une erreur
Jiangsu Macro & Micro-Test Med-Tech FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 2 autres	Chine	14 Kinds of Genitourinary Tract Infection Pathogen Nucleic Acid Detection Kit (Fluorescence PCR)98/79 14 Kinds of Respiratory Pathogens Combined Nucleic Acid Detection Kit (Fluorescence PCR)98/79 14 Types of High-risk Human Papillomavirus (16/18 Typing) Nucleic Acid Detection Kit (Fluorescence PCR)98/79 15 Types of High-risk Human Papillomavirus E6/E7 Gene mRNA Detection Kit (Fluorescence PCR)98/79 17 Types of Human Papillomavirus (16/18/6/11/44 Typing) Nucleic Acid Detection Kit (Fluorescence PCR)98/79 45 autres 18 Types of High-risk Human Papilloma Virus (16/18 Typing) Nucleic Acid Detection Kit (Fluorescence PCR)98/79 4 Kinds of Respiratory Viruses Nucleic Acid Detection Kit (Fluorescence PCR)98/79 COVID-19 /Flu A &B/ RSV/ADV Ag Combo Rapid Test HWTS-RT065A3 réf. COVID-19/ Flu A&B Ag Rapid Test HWTS-RT200A3 réf. D-Dimer Test Kit (Fluorescence Immunoassay)98/79 Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography) 1 test/kit98/79 Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography) 20 tests/kit98/79 Enterovirus Universal, EV71 and CoxA16 Nucleic Acid Detection Kit (Fluorescence PCR)98/79 Freeze-dried 14 Types of Human Papillomavirus Nucleic Acid Typing Detection Kit (Fluorescence PCR)98/79 Freeze-dried Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR)98/79 Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT176A3 réf. Freeze-dried Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)98/79 Freeze-dried Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)98/79 Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 -Subpackage 48 tests/kit98/79 Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 50 tests/kit98/79 Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) 50 tests/kit98/79 Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)-Subpackage 48 tests/kit98/79 Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT177A3 réf. Helicobacter Pylori and Toxin Nucleic Acid Detection Kit (Fluorescence PCR)98/79 Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR)98/79 IL-6 Test Kit (Fluorescence Immunoassay)98/79 Jiangsu Macro & Micro-Test Med-Tech Co., Ltd Type Ⅰ: 50 tests/ kit3 réf. Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. HWTS-EV032A3 réf. Macro & Micro-Test Fluorescence Immunoassay Analyzer HWTS IF 1003 réf. Mycobacterium Tuberculosis Isoniazid Resistance Mutation Detection Kit(Melting Curve)98/79 Mycobacterium Tuberculosis Nucleic Acid and Rifampicin Resistance Detection Kit (Melting Curve)98/79 Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)98/79 Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescence PCR)98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Candida Albicans 50 tests/kit98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Dengue virus98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Enterovirus98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Influenza A virus98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Novel Coronavirus (SARS-CoV-2) 16 tests/kit98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Plasmodium 50 tests/kit98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for SARS-CoV-2 16 tests/kit98/79 Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR) 50 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 24 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 25 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 48 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 50tests/kit98/79 Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 50 tests/kit98/79 RSV/ADV Ag Rapid Test HWTS-RT201A3 réf. SARS-CoV-2 Variant B.1.617.2 Rapid Identification Kit (Fluorescence PCR) 50 tests/kit98/79 SARS-CoV-2, Respiratory Syncytium, and Influenza A&B Antigen Combined Detection Kit(Latex Method)98/79 SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) 50 tests/kit98/79	A, B, C IVDR, 98/79	marketing@hongweitest.com Fiche EUDAMED Signaler une erreur
Lorne Laboratories Mandataire UE : Advena Limited (Malte)	United Kingdom (ex Northern Ireland)	A.H.G Elite (Clear) AHG Antibody Reagents98/79 A.H.G Elite (Green) AHG Antibody Reagents98/79 Anti-A Monoclonal ABO Monoclonal Antibody Reagents98/79 Anti-A,B Monoclonal ABO Monoclonal Antibody Reagents98/79 Anti-A1 Lectin Lectin Antibody Reagents98/79 45 autres Anti-B Monoclonal ABO Monoclonal Antibody Reagents98/79 Anti-C Monoclonal Rhesus Monoclonal Antibody Reagents2 réf.98/79 Anti-C+D+E Monoclonal Rhesus Monoclonal Antibody Reagents98/79 Anti-C3d Monoclonal Rare Phenotype Antibody Reagents98/79 Anti-Cw Monoclonal Rare Phenotype Antibody Reagents98/79 Anti-D Clone 1 Monoclonal Rhesus Monoclonal Antibody Reagents98/79 Anti-D Clone 2 Monoclonal Rhesus Monoclonal Antibody Reagents98/79 Anti-D Duoclone Monoclonal Rhesus Monoclonal Antibody Reagents98/79 Anti-Dia Polyclonal Rare Phenotype Antibody Reagents98/79 Anti-E Monoclonal Rhesus Monoclonal Antibody Reagents2 réf.98/79 Anti-Fya Monoclonal Duffy Antibody Reagents98/79 Anti-Fyb Polyclonal Duffy Antibody Reagents98/79 Anti-H Lectin Lectin Antibody Reagents98/79 Anti-Human IgG (Clear) AHG Antibody Reagents98/79 Anti-Human IgG (Green) AHG Antibody Reagents98/79 Anti-Jka Monoclonal Kidd Monoclonal Antibody Reagents98/79 Anti-Jkb Monoclonal Kidd Monoclonal Antibody Reagents98/79 Anti-k (Cellano) Monoclonal Rare Phenotype Antibody Reagents98/79 Anti-K Monoclonal Kell Monoclonal Reagent98/79 Anti-Kpa Polyclonal Rare Phenotype Antibody Reagents98/79 Anti-Kpb Polyclonal Rare Phenotype Antibody Reagents98/79 Anti-Lea Monoclonal Rare Phenotype Antibody Reagents98/79 Anti-Leb Monoclonal Rare Phenotype Antibody Reagents98/79 Anti-Lua Polyclonal Rare Phenotype Antibody Reagents98/79 Anti-Lub Polyclonal Rare Phenotype Antibody Reagents98/79 Anti-M Monoclonal Rare Phenotype Antibody Reagents98/79 Anti-N Lectin Lectin Antibody Reagents98/79 Anti-P1 Monoclonal Rare Phenotype Antibody Reagents98/79 Anti-S Monoclonal Rare Phenotype Antibody Reagents2 réf.98/79 Brucella abortus Rapid Agglutination Febrile Antigen Kits98/79 Brucella melitensis Rapid Agglutination Febrile Antigen Kits98/79 Proteus OX19 Rapid Agglutination Febrile Antigen Kits98/79 Proteus OX2 Rapid Agglutination Febrile Antigen Kits98/79 Proteus OXK Rapid Agglutination Febrile Antigen Kits98/79 Rose Bengal Rapid Agglutination Febrile Antigen Kits98/79 RPR Carbon Antigen Rapid Agglutination Syphilis Kits98/79 RPR Carbon Kit Rapid Agglutination Syphilis Kits2 réf.98/79 Salmonella Paratyphi AH Rapid Agglutination Febrile Antigen Kits98/79 Salmonella Paratyphi AO Rapid Agglutination Febrile Antigen Kits98/79 Salmonella Paratyphi BH Rapid Agglutination Febrile Antigen Kits98/79 Salmonella Paratyphi BO Rapid Agglutination Febrile Antigen Kits98/79 Salmonella Paratyphi CH Rapid Agglutination Febrile Antigen Kits98/79 Salmonella Paratyphi CO Rapid Agglutination Febrile Antigen Kits98/79 Salmonella Typhi H Rapid Agglutination Febrile Antigen Kits98/79 Salmonella Typhi O Rapid Agglutination Febrile Antigen Kits98/79	– 98/79	Site web info@lornelabs.com Fiche EUDAMED Signaler une erreur
RAL Diagnostics FDA	France	Acid Mayer hemalum 709380-1000 Carbolic toluidine blue 320130-1000 EA50 Papanicolaou solution 367600-1000 Eosin solution 363200-0100 Eosin, 1% in aqueous solution 312740-1000 45 autres Giemsa R solution Giemsa Solution for SP automated systems 75030SX1000 Giemsa solution for stainers 320450-2500 Giemsa stain 709260-1000 Harris hematoxylin 361070-1000 Kit HistoPerls 361850-0000 Kit HémaPerls 362800-0000 Kit Myeloperoxydase 361610-0000 Kit RAL StainBox BBM 360400-0000 Kit RAL StainBox MCDh 360300-0000 Kit Ral Stainer MCDh Kit Vita-Eosine 380420-0000 Light green 361700-0100 May Grünwald stain 709760-1000 May-Grunwald Solution for SP automated systems 75010SX2500 May-Grünwald solution3 réf. May-Grünwald solution for stainers 320830-2500 Mayer hemalum 320550-10002 réf. MCDh 2 313570-25003 réf. MCDh 3 313560-25003 réf. MCDh 4 313600-25002 réf. MCDh 4 concentrate 313610-1000 MCDh Zero S1 for SP Automated Systems 75020SX5000 MCDh Zero S2 for SP Automated Systems 75021SX2500 MCDh Zero S3 for SP Automated Systems 75022SX7010 MCDh Zero S4 for SP Automated Systems 75023SX7010 Modified MCDh2 313585-2500 Nigrosin solution 363210-0100 Nuclear red solution 320910-0100 OG6 Papanicolaou solution 361630-1000 Pyronin, 0,2% in aqueous solution 361800-0125 R1 - Kit RAL StainBox BBM 313595-0250 R2 - Kit RAL StainBox BBM 3135752A2502 réf. R4 - Kit RAL StainBox BBM 313565-0250 R5 - Kit RAL StainBox BBM 313605-0250 RAL Stainer RAL Stainer 2 RAL TB Stainer Saffron in alcoholic solution 369200-1000 Schiff reagent 320680-1000 Shorr solution 361100-1000 Wright Giemsa Solution for SP automated systems 75080SX2500 Wright solution 320400-2500 Wright solution for SP Automated systems 75090SX2500 Wright-Giemsa stain RAL 330211-2500	A IVDR	Présent sur le marché en France Site web info@ral-diagnostics.fr Fiche EUDAMED Signaler une erreur
Ayset	Turquie	AYSET5 réf.98/79 AYSET 1 ml 9NC Sodium Citrate %3,2 Coagulation Blood Collection Tube98/79 AYSET 1 ml K3E K3EDTA Blood Collection Tube98/79 AYSET 1,8 ml 9NC Sodium Citrate %3,2 Coagulation Blood Collection Tube98/79 AYSET 10 ml CAT Clot Activator Blood Collection Tube98/79 44 autres AYSET 10 ml Z No Additive Blood Collection Tube98/79 AYSET 2 ml 9NC Sodium Citrate %3,2 Coagulation Blood Collection Tube98/79 AYSET 2 ml CAT Clot Activator Blood Collection Tube98/79 AYSET 2 ml CAT Gel & Clot Activator Blood Collection Tube98/79 AYSET 2 ml K2E K2EDTA Blood Collection Tube98/79 AYSET 2 ml K3E K3EDTA Blood Collection Tube98/79 AYSET 2 ml Z No Additive Blood Collection Tube98/79 AYSET 2,5 ml 9NC Sodium Citrate %3,2 Coagulation Blood Collection Tube98/79 AYSET 2,7 ml 9NC Sodium Citrate %3,2 Coagulation Blood Collection Tube98/79 AYSET 3 ml 9NC Sodium Citrate %3,2 Coagulation Blood Collection Tube98/79 AYSET 3 ml CAT Clot Activator Blood Collection Tube98/79 AYSET 3 ml CAT Gel&Clot Activator Blood Collection Tube98/79 AYSET 3 ml K2E K2EDTA Blood Collection Tube98/79 AYSET 3 ml K3E K3EDTA Blood Collection Tube98/79 AYSET 3,5 ml CAT Gel&Clot Activator Blood Collection Tube98/79 AYSET 4 ml CAT Clot Activator Blood Collection Tube98/79 AYSET 4 ml CAT Gel&Clot Activator Blood Collection Tube98/79 AYSET 4 ml K2E K2EDTA & GEL Blood Collection Tube98/79 AYSET 4 ml K2E K2EDTA Blood Collection Tube98/79 AYSET 4 ml K3E K3EDTA Blood Collection Tube98/79 AYSET 4 ml Z No Additive Blood Collection Tube98/79 AYSET 4,5 ml K3E K3EDTA Blood Collection Tube98/79 AYSET 5 ml CAT Clot Activator Blood Collection Tube98/79 AYSET 5 ml CAT Gel & Thrombin Blood Collection Tube98/79 AYSET 5 ml CAT Gel&Clot Activator Blood Collection Tube98/79 AYSET 5 ml K3E K3EDTA Blood Collection Tube98/79 AYSET 5 ml Z No Additive Blood Collection Tube98/79 AYSET 5,5 ml CAT Gel & Clot Activator Blood Collection Tube98/79 AYSET 6 ml CAT Clot Activator Blood Collection Tube98/79 AYSET 6 ml CAT Gel & Clot Activator Blood Collection Tube98/79 AYSET 6 ml K2E K2EDTA Blood Collection Tube98/79 AYSET 6 ml K3E K3EDTA Blood Collection Tube98/79 AYSET 6 ml Z No Additive Blood Collection Tube98/79 AYSET 7 ml CAT Clot Activator Blood Collection Tube98/79 AYSET 7 ml K3E K3EDTA Blood Collection Tube98/79 AYSET 8 ml CAT Clot Activator Blood Collection Tube98/79 AYSET 8 ml CAT Gel & Clot Activator Blood Collection Tube98/79 AYSET 8,5 ml CAT Gel & Clot Activator Blood Collection Tube98/79 AYSET 9 ml CAT Clot Activator Blood Collection Tube98/79 AYSET 9 ml CAT Gel & Clot Activator Blood Collection Tube98/79 AYSET 9 ml K2E K2EDTA & GEL Blood Collection Tube98/79 AYSET 9 ml K2E K2EDTA Blood Collection Tube98/79 AYSET 9 ml K3E K3EDTA Blood Collection Tube98/79 AYSET 9 ml Z No Additive Blood Collection Tube98/79	– 98/79	Site web info@ayset.com Fiche EUDAMED Signaler une erreur
Bdbiosciences FDA Mandataire UE : Becton Dickinson Ireland Limited (Irlande)	États-Unis	BD FACSDiva CS&T IVD Beads (50 tests)2 réf. BD FACSDUET2 réf. BD FACSLYRIC3 réf. BD LEUCOCOUNT4 réf. BD MULTI-CHECK3 réf. 44 autres BD Multi-Check CD4 Low Controls3 réf. BD MULTITEST BD MULTITEST BD TRUCOUNT BD MULTITEST BD TRUCOUNT BD Multitest™ CD3/CD16+CD56/CD45/CD19 with BD Trucount™ Tubes BD MULTITEST BD TRUCOUNT BD Multitest™ CD3/CD8/CD45/CD4 with BD Trucount™ Tubes BD Multitest™ 6-Color TBNK BD Multitest™ 6-Color TBNK with BD Trucount™ Tubes BD Multitest™ CD3/CD16+CD56/CD45/CD19 BD ONEFLOW4 réf. BD TRITEST BD TRUCOUNT "BD Tritest™ CD3/CD4/CD45 with BD Trucount™ Tubes" BD TRITEST BD TRUCOUNT BD Tritest™ CD4/CD8/CD3 with BD Trucount™ Tubes BD Tritest™ CD3/CD4/CD45 CYTOGNOS CD38 Single Color Reagents3 réf. FACS 7-C Setup Bead FC Beads 8-Color Kit for BD OneFlow™ Horizon CD138 Single Color Reagents3 réf. Horizon CD27 Single Color Reagents3 réf. Horizon CD279 Single Color Reagent Horizon CD3 Single Color Reagents3 réf. Horizon CD45RA Single Color Reagents3 réf. Horizon CD81 Single Color Reagent Not Applicable10 réf. Not Applicable Anti-TCR-α/β (WT31) single color reagent Not Applicable Anti-TCR-γ/δ (11F2) single color reagent Not Applicable BD® Anti-Kappa (TB 28-2)3 réf. Not Applicable BD® CD10 (HI10a)3 réf. Not Applicable BD® CD193 réf. Not Applicable BD® CD20 (L27)3 réf. Not Applicable BD® CD22 (S-HCL-1)3 réf. Not Applicable BD® CD23 (EBVCS-5)2 réf. Not Applicable BD® CD45 (2D1)3 réf. Not Applicable BD® CD79b (SN8)3 réf. Not Applicable BD® FMC7 Not Applicable CD152 Single Color Reagent Not Applicable CD1a Single Color Reagent Not Applicable CD2 Single Color Reagents3 réf. Not Applicable CD25 Single Color Reagents3 réf. Not Applicable CD34 Single Color Reagents3 réf. Not Applicable CD4 Single Color Reagents3 réf. Not Applicable CD5 Single Color Reagents3 réf. Not Applicable CD56 Single Color Reagents3 réf. Not Applicable CD57 Single Color Reagent Not Applicable CD79a Single Color Reagents3 réf. Not Applicable CD8 Single Color Reagents3 réf.	A, B, C IVDR	Site web EUDAMEDenquiries@bd.com Fiche EUDAMED Signaler une erreur
Linear FDA	Espagne	ALTHEA ALTHEA XL Automatic Coagulometer Analyzer APTT98/79 ARES Aura POCT CLIA Analyzer 44 autres CERES - Coagulation Analyzer (2 Channels) Clonatest2 réf.98/79 Cromatest16 réf.98/79 Cromatest Plasma Control Level 12 réf.98/79 Cromatest Plasma Control Level 22 réf.98/79 Cromatetst98/79 Fibrinogen98/79 i-FOB Stool Collection Tube IRIA JUNO Automatic eCLIA Analyzer KROMA Automatic Clinical Chemistry Analyzer KROMA iT Automatic Immunological Analyzer KROMA Plus Automatic Clinical Chemistry Analyzer KROMA Plus iT Automatic Immunological Analyzer LENA 16 EDTA ESR autoanalyzer LENA 32 EDTA ESR autoanalyzer LENA NE ESR autoanalyzer LIDA 300 Automatic Clinical Chemistry Analyzer LIDA-300 Automatic Clinical Analyzer LIDA 500 Automatic Clinical Chemistry Analyzer LIDA-500 Automatic Clinical Analyzer LIDA 800 Automatic Clinical Chemistry Analyzer NEOS-32 XT Nucleic Acid Extractor System NEOS-48 qPCR Real-Time PCR System 8435287395006 NEOS-96 qPCR Real-Time PCR System. 6 Channels NEOS-96 XT Nucleic Acid Extractor System NEOS-9NEOS-96 qPCR Real-Time PCR System. 4 Channels Plus sed auto PT-HS98/79 Saliva collectors. Paper-poly pouch package Saliva collectors. With medium. Blister package Saliva collectors. With medium. Paper-poly pouch package2 réf. STEL-3 Cleaner 1 L STEL-3 Diluent 20 L STEL-3 Extra Cleaner 100 mL STEL-3 Lyser 0,5 L STEL-5 autoloader diluent 20L STEL-5 autoloader probe cleanser 50mL STEL-5 Diff Lyse 0,5 L STEL-5 LH Lyser 200 mL STEL-5 PLUS LD Lyser 1L STEL-5 autoloader LD Lyser 1L STEL-5 PLUS LH Lyser 200mL STEL-5 autoloader LH Lyser 200mL STEL-5 series Diluent 20 L STEL-5 Diluent 20 L STEL-5 series Extra Cleaner 50 mL STEL-5 Extra Cleaner 50 mL THERMA NE ESR autoanalyzer Visualsed ESR Rack	A IVDR, 98/79	Site web info@linear.es Fiche EUDAMED Signaler une erreur
Richard-Allan Scientific Mandataire UE : Epredia Netherlands B.V. (Pays-Bas)	États-Unis	1% Acetic Acid Solution3 réf. 10% Neutral Buffered Formalin Prefilled Container3 réf. 10% Neutral Buffered Formalin Solvents3 réf. 100% Dehydrant3 réf. 37% Formaldehyde3 réf. 44 autres Acid Fast Bacillus Stain Kit - Blue Secondary Stain3 réf. Acid Fast Bacillus Stain Kit - Green Secondary Stain2 réf. Alcian Blue pH 2.5 Periodic Acid-Schiff Stain Kit3 réf. Alcoholic Hematoxylin Solution3 réf. Ammonium Hydroxide Solution (28-30%)3 réf. Amyloid Stain Kit3 réf. Aniline Blue Stain Solution3 réf. Antibody Diluent OP Quanto Aqua Mount3 réf. Biopsy Cassette I3 réf. Bluing Reagent3 réf. Cal-Rite™3 réf. Cell-Fixx™3 réf. Chromic Acid Solution (5%)3 réf. Citrate Buffer for HIER3 réf. Citrus Clearing Solvent3 réf. ClearVue™ Mountant3 réf. Cryochrome™ Blue3 réf. Crystal Violet Solution3 réf. Cyto-Stain™3 réf. Cytocool™ II2 réf. DAB Quanto2 réf. Dewax and HIER Buffer H3 réf. Eosin Y Alcoholic3 réf. FITC Protein Blocking Agent (PBA)3 réf. Giemsa Stain3 réf. Gill 1 Hematoxylin3 réf. Gomori’s Trichrome Stain - Green Collagen2 réf. Gum Mastic Solution3 réf. Hematoxylin 12 réf. Histoplast IM3 réf. Hydrochloric Acid Solution (20%)3 réf. Kwik-Diff™ Solution 13 réf. Mark-It™ Tissue Marking Dye Black3 réf. Methyl Green-Pyronin Y Stain Solution Modified Grocott’s Methenamine Silver Stain Kit2 réf. Modified Wright Stain Pack2 réf. Mucicarmine Stain Kit2 réf. PapSpin™ Collection Fluid3 réf. Rapid-Chrome™ H&E Frozen Section Staining Kit2 réf. Rapid-Chrome™ Papanicolaou Staining Kit Reticulocyte Stain Tissue Specimen Bags3 réf. UltraVision Quanto Detection System HRP DAB3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Shenzhen Comen Medical Instruments FDA Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Automatic Hematology Analyzer CH850098/79 Automatic Hematology Analyzer CH8500CRP98/79 Automatic Hematology Analyzer CH850198/79 Automatic Hematology Analyzer CH850298/79 Automatic Hematology Analyzer CH860098/79 44 autres Automatic Hematology Analyzer CH8600CRP98/79 Automatic Hematology Analyzer CH860198/79 Automatic Hematology Analyzer CH8601CRP98/79 Automatic Hematology Analyzer CH860298/79 Automatic Hematology Analyzer CH8602CRP98/79 Hematology Analyzer Diluent Model：3D，Packing Specifications：10L98/79 Hematology Analyzer Diluent Model：3D，Packing Specifications：20L98/79 Hematology Analyzer Diluent Model：5D，Specification：10L98/79 Hematology Analyzer Diluent Model：5D，Specification：20L98/79 Hematology Analyzer LYSE Model：3LHD，Packing Specifications： 500ml×498/79 Hematology Analyzer LYSE Model：3LHD，Packing Specifications：200ml98/79 Hematology Analyzer LYSE Model：3LHD，Packing Specifications：500ml98/79 Hematology Analyzer LYSE Model：3LHD，Packing Specifications：500ml×298/79 Hematology Analyzer LYSE Model：5LDA，Specification：1000mL98/79 Hematology Analyzer LYSE Model：5LDA，Specification：1000mL×498/79 Hematology Analyzer LYSE Model：5LDA，Specification：200mL98/79 Hematology Analyzer LYSE Model：5LDA，Specification：4L98/79 Hematology Analyzer LYSE Model：5LDB，Specification：200mL98/79 Hematology Analyzer LYSE Model：5LDB，Specification：500mL98/79 Hematology Analyzer LYSE Model：5LDB，Specification：500mL×498/79 Hematology Analyzer LYSE Model：5LDS，Packing Specifications：200ml98/79 Hematology Analyzer LYSE Model：5LDS，Packing Specifications：500ml98/79 Hematology Analyzer LYSE Model：5LDS，Packing Specifications：500ml×298/79 Hematology Analyzer LYSE Model：5LHS，Packing Specifications： 200ml×498/79 Hematology Analyzer LYSE Model：5LHS，Packing Specifications：200ml98/79 Hematology Analyzer LYSE Model：5LHS，Packing Specifications：200ml×298/79 Hematology Analyzer LYSE Model：5LH，Specification：200mL98/79 Hematology Analyzer LYSE Model：5LH，Specification：4L98/79 Hematology Analyzer LYSE Model：5LH，Specification：500mL98/79 Hematology Analyzer LYSE Model：5LH，Specification：500mL×498/79 Hematology Calibrator Model：CH-CAL，Specification:3mL×198/79 Hematology Calibrator Model：CH-CAL，Specification:3mL×298/79 Hematology Calibrator Model：CH-CAL，Specification:3mL×398/79 Hematology Control Model：CH-5QC，High value(H):3mL×198/79 Hematology Control Model：CH-5QC，High value(H):3mL×298/79 Hematology Control Model：CH-5QC，High value(H):3mL×398/79 Hematology Control Model：CH-5QC，Low value(L):3mL×198/79 Hematology Control Model：CH-5QC，Low value(L):3mL×298/79 Hematology Control Model：CH-5QC，Low value(L):3mL×398/79 Hematology Control Model：CH-5QC，Normal value (N):3mL×198/79 Hematology Control Model：CH-5QC，Normal value (N):3mL×298/79 Hematology Control Model：CH-5QC，Normal value (N):3mL×398/79 Probe Cleanser 50ml98/79 Probe Cleanser Model：Cleanser，Specification:50mL98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Shenzhen New Industries Biomedical Engineering FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Bypass Module 1 SATLARS T83 réf. Centrifuge Module I SATLARS mini-T83 réf. Hemolumi APTT (Clotting Assay)10 réf.98/79 Hemolumi AT III (Chromogenic Substrate Assay)10 réf.98/79 Hemolumi Automated coagulation analyzer 44 autres Hemolumi Coagulation Calibrators4 réf.98/79 Hemolumi D-Dimer (Latex)8 réf.98/79 Hemolumi D-Dimer Calibrators4 réf.98/79 Hemolumi FDP (Latex)8 réf.98/79 Hemolumi FDP Calibrators4 réf.98/79 Hemolumi Fibrinogen (Clotting Assay)10 réf.98/79 Hemolumi PT (Clotting Assay)10 réf.98/79 Hemolumi TT (Clotting Assay)10 réf.98/79 MAGLUMI 800 Fully-auto chemiluminescence immunoassay analyzer MAGLUMI Adenovirus IgM (CLIA)3 réf. MAGLUMI Anti-Dengue Virus IgG (CLIA) Controls MAGLUMI Anti-Dengue Virus IgM (CLIA) Controls MAGLUMI Anti-HAV (CLIA) Controls MAGLUMI Chlamydia pneumoniae IgG (CLIA) Controls MAGLUMI Chlamydia pneumoniae IgM (CLIA) Controls MAGLUMI CMV IgG (CLIA) Controls MAGLUMI Coxsackievirus B IgM (CLIA)3 réf. MAGLUMI Dengue virus NS1 Antigen (CLIA) Controls MAGLUMI EBV EA IgA (CLIA) Controls MAGLUMI EBV EA IgG (CLIA) Controls MAGLUMI EBV NA IgA (CLIA) Controls MAGLUMI EBV VCA IgA (CLIA) Controls MAGLUMI Fully-auto chemiluminescence immunoassay analyzer MAGLUMI X102 réf. MAGLUMI H.pylori IgM (CLIA) Controls MAGLUMI HEV IgG (CLIA) Controls MAGLUMI HEV IgM (CLIA) Controls MAGLUMI HSV-1 IgM (CLIA) Controls MAGLUMI HSV-1/2 IgM (CLIA) Controls MAGLUMI HSV-2 IgM (CLIA) Controls MAGLUMI Human Parainfluenza Virus IgM (CLIA)3 réf. MAGLUMI Influenza A Virus IgM (CLIA)3 réf. MAGLUMI Influenza B Virus IgM (CLIA)3 réf. MAGLUMI Legionella pneumophila IgM (CLIA)3 réf. MAGLUMI Mycoplasma pneumoniae IgG (CLIA) Controls MAGLUMI Mycoplasma pneumoniae IgM (CLIA) Controls MAGLUMI Reaction Cup MAGLUMI Reaction Module MAGLUMI Respiratory Syncytial Virus IgM (CLIA)3 réf. MAGLUMI Tip MAGLUMI Toxo IgG (CLIA) Controls MAGLUMI Waste Bag2 réf. MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer MAGLUMI X6 Fully-auto chemiluminescence immunoassay analyzer MAGLUMI X8 Fully-auto chemiluminescence immunoassay analyzer	A, B, C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Ab Analitica	Italie	AMPLIQUALITY HCV TYPE PLUS3 réf. AMPLIQUALITY HPV-TYPE EXPRESS v3.02 réf.98/79 FERTILITY CUSTOM SERVICE 00-06R-5098/79 FERTILITY DECON TEST98/79 FERTILITY HISTON COLOR TEST98/79 43 autres FERTILITY LIFE TEST98/79 FERTILITY ROUND CELL TEST 00-05R-5098/79 FERTILITY SWELLING TEST98/79 GENEQUALITY 2050 GENEQUALITY 2050 Extraction C GENEQUALITY 2050 Extraction P GENEQUALITY X120 PATHOGEN KIT IC 05-79-A2 réf. REALQUALITY Aspergillus4 réf.98/79 REALQUALITY InFLU-Typing2 réf.98/79 REALQUALITY RQ-ADENO4 réf.98/79 REALQUALITY RQ-ADENO STANDARD2 réf.98/79 REALQUALITY RQ-BKV4 réf.98/79 REALQUALITY RQ-BKV STANDARD2 réf.98/79 REALQUALITY RQ-CMV4 réf.98/79 REALQUALITY RQ-CMV STANDARD2 réf.98/79 REALQUALITY RQ-EBV4 réf.98/79 REALQUALITY RQ-EBV STANDARD2 réf.98/79 REALQUALITY RQ-ENTERO8 réf.98/79 REALQUALITY RQ-ENTERO STANDARD2 réf.98/79 REALQUALITY RQ-HHV 6 STANDARD2 réf.98/79 REALQUALITY RQ-HHV 74 réf.98/79 REALQUALITY RQ-HHV 7 STANDARD2 réf.98/79 REALQUALITY RQ-HHV 84 réf.98/79 REALQUALITY RQ-HHV 8 STANDARD2 réf.98/79 REALQUALITY RQ-HPV HR Multiplex4 réf.98/79 REALQUALITY RQ-HPV HR/LR Multiplex6 réf.98/79 REALQUALITY RQ-HPV Screen4 réf.98/79 REALQUALITY RQ-HSV 1 STANDARD2 réf.98/79 REALQUALITY RQ-HSV 2 STANDARD2 réf.98/79 REALQUALITY RQ-JCV STANDARD2 réf.98/79 REALQUALITY RQ-MBT COMPLEX4 réf.98/79 REALQUALITY RQ-MBT COMPLEX STANDARD98/79 REALQUALITY RQ-Multi HPV Detection6 réf.98/79 REALQUALITY RQ-PARVO B194 réf.98/79 REALQUALITY RQ-PARVO B19 STANDARD2 réf.98/79 REALQUALITY RQ-STI CT6 réf.98/79 REALQUALITY RQ-TOXO4 réf.98/79 REALQUALITY RQ-VZV STANDARD2 réf.98/79 REALQUALITY RS-HHV 64 réf.98/79 REALQUALITY RS-HSV 14 réf.98/79 REALQUALITY RS-HSV 24 réf.98/79 REALQUALITY RS-VZV4 réf.98/79	A, C IVDR, 98/79	customersupport@abanalitica.it Fiche EUDAMED Signaler une erreur
Aconbio Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	ACON HIV 1/2/O Tri-line Rapid Test Cassette (Serum/Plasma/Whole blood)3 réf. ACON SARS-CoV-2 IgG/IgM Rapid Test2 réf.98/79 FIAflex5 réf.98/79 FIAflex Dengue NS1 Ag FIA Test98/79 FIAflex IL-6 FIA Test98/79 43 autres FIAflex SARS-CoV-2 & Influenza A/B Ag Combo FIA98/79 FIAflex SARS-CoV-2 Antigen FIA98/79 Flowflex25 réf.98/79 Flowflex Dengue NS1 Ag & IgG/IgM Combo Rapid Test Cassette (Serum/Plasma/Whole Blood)98/79 Flowflex Dengue NS1 Ag FIA Test98/79 Flowflex EV71 IgM Rapid Test98/79 Flowflex IL-6 FIA Test98/79 Flowflex SARS-CoV-2 & Flu A/B & RSV & Adenovirus Antigen Combo Rapid Test98/79 Flowflex SARS-CoV-2 & Influenza A/B Ag Combo FIA98/79 Flowflex SARS-CoV-2 & Influenza A/B Ag Combo Rapid Test4 réf.98/79 Flowflex SARS-CoV-2 Antigen FIA98/79 Flowflex SARS-CoV-2 Antigen Rapid Test4 réf.98/79 Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)2 réf.98/79 Flowflex SARS-CoV-2 Antigen Rapid Test Slim2 réf.98/79 Influenza A/B Rapid Test (Self-Testing) L031-1193598/79 Mission Capillary Transfer Tubes CCA-1013 réf. Mission Capillary Transfer Tubes CCA-1032 réf. Mission CCC-17198/79 Mission CCS-1712 réf.98/79 Mission Expert U120 Smart Urine Analyzer2 réf. Mission Expert U500 Urine Analyzer3 réf. Mission HA-3602 réf.98/79 Mission HA-56098/79 Mission U120 Smart Urine Analyzer2 réf. Mission U500 Urine Analyzer3 réf. On Call OGM-1512 réf. On Call OGM-1914 réf. On Call OGM-5413 réf. On Call Extra Blood Glucose Meter OGM-1913 réf.98/79 On Call EZ II Blood Glucose Meter OGM-15198/79 On Call MultiPro Analyzer OGM-2212 réf. On Call OGM-2114 réf. On Call OGM-2124 réf. On Call Plus Blood Glucose Meter OGM-5412 réf.98/79 On Call Sure Blood Glucose Meter OGM-2113 réf.98/79 On Call Sure Sync Blood Glucose Meter OGM-2123 réf.98/79 Promotor Nucleic Acid (DNA) Extraction Kit3 réf. Promotor Nucleic Acid (RNA) Extraction Kit3 réf. Promotor Nucleic Acid Extraction Kit Promotor Viral DNA/RNA Isolation Kit2 réf. Promotor Viral Nucleic Acid Isolation Kit Promotor Whole Blood Genomic DNA Extraction Kit2 réf. Quik-Check7 réf.98/79	A, C, D IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Getein FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Akso EV/CA16/EV71 Real-time RT-PCR Kit Akso HPV Real-time PCR Kit Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit Anti-TP Fast Test Kit (Immunofluorescence Assay)8 réf.98/79 D-Dimer Fast Test Kit (Immunofluorescence Assay)9 réf. 43 autres D-Dimer Reagent Kit (Immunoturbidimetric Method)98/79 Dengue IgG/IgM Antibody Fast Test Kit (Immunofluorescence Assay)7 réf.98/79 Dengue NS1 Ag Fast Test Kit (Immunofluorescence Assay)7 réf.98/79 Getein 1150 Immunofluorescence Quantitative Analyzer Getein 1200 Immunofluorescence Quantitative Analyzer Getein 1600 Immunofluorescence Quantitative Analyzer H. pylori Antibody Fast Test Kit (Immunofluorescence Assay)7 réf.98/79 H. pylori Antigen Fast Test Kit (Immunofluorescence Assay)7 réf. H. pylori Fast Test Kit (Immunofluorescence Assay)98/79 H.pylori Antigen Control QC02398/79 HSV-Ⅰ IgG Control (CLIA)98/79 HSV-Ⅰ IgM Control (CLIA)98/79 HSV-Ⅱ IgG Control (CLIA)98/79 HSV-Ⅱ IgM Control (CLIA)98/79 IL-6 Control98/79 IL-6 Fast Test Kit (Immunofluorescence Assay)8 réf. Influenza A/B Antigen Fast Test Kit (Immunofluorescence Assay)7 réf.98/79 Influenza A/B Rapid Test CG2059 MAGICL D-Dimer (CLIA)98/79 MAGICL DD (CLIA)98/79 MAGICL Dengue Virus NS1 Antigen (CLIA)98/79 MAGICL FDP (CLIA)98/79 MAGICL HSV-I IgG (CLIA)2 réf.98/79 MAGICL HSV-I IgM (CLIA)2 réf.98/79 MAGICL HSV-II IgG (CLIA)2 réf.98/79 MAGICL HSV-II IgM (CLIA)2 réf.98/79 MAGICL IL-10 (CLIA)2 réf.98/79 MAGICL IL-1β (CLIA)2 réf.98/79 MAGICL IL-2R (CLIA)2 réf.98/79 MAGICL IL-6 (CLIA)2 réf. MAGICL IL-8 (CLIA)2 réf.98/79 MAGICL PIC (CLIA)2 réf.98/79 MAGICL Syphilis (CLIA) MAGICL t-PAIC (CLIA)2 réf.98/79 MAGICL TAT (CLIA)2 réf.98/79 MAGICL TB-IGRA (CLIA) MAGICL TM (CLIA)2 réf.98/79 MAGICL TNF-α (CLIA)2 réf.98/79 Malaria P.f/P.v Antigen Fast Test Kit (Immunofluorescence Assay)3 réf.98/79 Metis 6000 Modular System (Integrated Clinical Chemistry and Immunochemistry) RSV Fast Test Kit (Immunofluorescence Assay)98/79 SARS-CoV-2 Antigen Fast Test Kit (Immunofluorescence Assay)7 réf.98/79 TNF-α Control (CLIA)98/79	A, B, C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
KenDor Technology (Zhejiang) Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Centrifuge tube D10013 réf. Culture plate98/79 Culture plate F1003-F98/79 Culture plate F1003-V98/79 Culture plate F100498/79 43 autres Culture plate F100898/79 Culture plate F102198/79 Disposable Urine Collection Tube19 réf.98/79 Disposable Vacuum Blood Tube37 réf.98/79 Swab (swab with media) G1026198/79 Swab (swab with media) G1026298/79 Swab (swab with media) G10263.2 réf.98/79 Swab (swab with media) G1026498/79 Swab (swab with media) G1026598/79 Test tube G100198/79 Test tube G100298/79 Test tube G100398/79 Test tube G100498/79 Test tube G100598/79 Test tube G100698/79 Test tube G100798/79 Test tube G100998/79 Test tube G101098/79 Test tube G101198/79 Test tube G101298/79 Test tube G101398/79 Test tube G101698/79 Test tube G101798/79 Test tube G1017-198/79 Test tube G1017-1498/79 Test tube G1017-298/79 Test tube G1017-398/79 Test tube G1017-498/79 Test tube G101998/79 Test tube G102098/79 Test tube G102198/79 Test tube G102598/79 Test tube G102698/79 Test tube G1026-6CC98/79 Test tube G1026-8CC98/79 Test tube G102798/79 Test tube G103098/79 Test tube G103198/79 Test tube G103598/79 Test tube G1102198/79 Tube with swab G102298/79 Tube with swab G1029FN98/79 Tube with swab G1029FT98/79	A IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Bosonbio FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	Chemiluminescence Immunoassay Analyzer2 réf. D-Dimer assay (CLIA)98/79 D-Dimer Test (FIA)98/79 Dengue IgG/IgM Combo Test (FIA)98/79 Dengue NS1 Antigen Test (FIA)98/79 42 autres Helicobacter Pylori IgG assay (CLIA)98/79 Influenza A + B Antigen Test (FIA)98/79 PIC assay (CLIA)98/79 Rapid Chikungunya IgG/IgM Combo Test Card 1N27C298/79 Rapid D-Dimer Test Card 1M21C298/79 Rapid Dengue IgG/IgM Combo Test Card 1N04C298/79 Rapid Dengue NS1 Antigen and IgG/IgM Duo Panel Test Card 1N24C298/79 Rapid Dengue NS1 Antigen Test Card 1N23C298/79 Rapid Flu A+B/RSV Antigen Test Card98/79 Rapid Flu A+B/RSV/ADV Antigen Test Card98/79 Rapid H.Pylori Antibody Test Card 1O02C298/79 Rapid H.Pylori Antigen Test Card (3mm) 1O03C4298/79 Rapid H.Pylori Antigen Test Card 1O03C498/79 Rapid HAV IgG/IgM Combo Test Card 1H16C298/79 Rapid Influenza A Antigen Test Card 1N17C598/79 Rapid Influenza A+B Antigen Test Card 1N18C598/79 Rapid Legionella Urinary Antigen Test Card 1O05C398/79 Rapid Malaria pan Antigen Test Card 1Q05C298/79 Rapid Malaria pf Antigen Test Card 1Q06C298/79 Rapid Malaria pf/pan Antigen Test Card 1Q10C298/79 Rapid Malaria pf/pv Antigen Test Card 1Q07C298/79 Rapid Mycoplasma Pneumoniae Antigen Test 1O26C5-1-EU,1O26C5-20-EU98/79 Rapid Respiratory Syncytial Virus Antigen Test Card 1N26C598/79 Rapid SARS-CoV-2 Antigen Test Card3 réf. Rapid SARS-CoV-2 Antigen Test Card 1N40C5-2598/79 Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card 1N45C598/79 Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card 1N45C5-198/79 Rapid SARS-CoV-2/Flu A+B/RSV/ADV Antigen Test Card 1N44C598/79 Rapid SARS-CoV-2/Flu A+B/RSV/ADV Antigen Test Card 1N44C5-198/79 Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card 1N41C5-1S-CE3 réf. Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card 1N41C5-2598/79 Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card 1N41C5-2798/79 Rapid Strep A Test Card 1O08C598/79 Rapid Strep A Test Card 1O08C5-198/79 Rapid Syphilis Antibody Test Card 1N02C298/79 Rapid Syphilis Antibody Test Strip 1N02S298/79 Rapid Zika Virus IgG/IgM Combo Test Card 1N28C298/79 Respiratory Syncytial Virus Antigen Test (FIA)98/79 SARS-CoV-2 Antigen Test (FIA)98/79 SARS-CoV-2 Neutralizing Antibody Test Card 1N42C298/79 Thrombin-Antithrombin III Complex assay (CLIA)98/79 Treponema Pallidum Antibody assay (CLIA)98/79	A, C IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Denizbiyokimya	Turquie	INNOVIQURE D-dimer Reagent Kit 100T98/79 INNOVIQURE D-dimer Reagent Kit 200T98/79 INNOVIQURE D-dimer Reagent Kit 400T98/79 INNOVIQURE HAV Ab - Reagent CALIBRATORS98/79 INNOVIQURE HAV Ab Reagent Kit 100T98/79 42 autres INNOVIQURE HAV Ab Reagent Kit 200T98/79 INNOVIQURE HAV Ab Reagent Kit 400T98/79 INNOVIQURE HAV IgM - Reagent CALIBRATORS98/79 INNOVIQURE HAV IgM Reagent Kit 100T98/79 INNOVIQURE HAV IgM Reagent Kit 200T98/79 INNOVIQURE HAV IgM Reagent Kit 400T98/79 INNOVIQURE HBc Ab - Reagent CALIBRATORS98/79 INNOVIQURE HBc Ab Reagent Kit 100T98/79 INNOVIQURE HBc Ab Reagent Kit 200T98/79 INNOVIQURE HBc Ab Reagent Kit 400T98/79 INNOVIQURE HBc IgM - Reagent CALIBRATORS98/79 INNOVIQURE HBc IgM Reagent Kit 100T98/79 INNOVIQURE HBc IgM Reagent Kit 200T98/79 INNOVIQURE HBc IgM Reagent Kit 400T98/79 INNOVIQURE HBe Ab - Reagent CALIBRATORS98/79 INNOVIQURE HBe Ag - Reagent CALIBRATORS98/79 INNOVIQURE HBe Ag Reagent Kit 100T98/79 INNOVIQURE HBe Ag Reagent Kit 200T98/79 INNOVIQURE HBe Ag Reagent Kit 400T98/79 INNOVIQURE HBs Ab - Reagent CALIBRATORS98/79 INNOVIQURE HBs Ab Reagent Kit 100T98/79 INNOVIQURE HBs Ab Reagent Kit 200T98/79 INNOVIQURE HBs Ab Reagent Kit 400T98/79 INNOVIQURE HBs Ag Reagent Kit 100T98/79 INNOVIQURE HBs Ag Reagent Kit 200T98/79 INNOVIQURE HBs Ag Reagent Kit 400T98/79 INNOVIQURE HCV Ab - Reagent CALIBRATORS98/79 INNOVIQURE HCV Ab Reagent Kit 100T98/79 INNOVIQURE HCV Ab Reagent Kit 200T98/79 INNOVIQURE HCV Ab Reagent Kit 400T98/79 INNOVIQURE HIV 1/2 Ab - Reagent CALIBRATORS98/79 INNOVIQURE HIV 1/2 Ab Reagent Kit 100T98/79 INNOVIQURE HIV 1/2 Ab Reagent Kit 200T98/79 INNOVIQURE HIV 1/2 Ab Reagent Kit 400T98/79 INNOVIQURE HIV Combo Ag/Ab - Reagent CALIBRATORS98/79 INNOVIQURE HIV Combo Ag/Ab Reagent Kit 100T98/79 INNOVIQURE HIV Combo Ag/Ab Reagent Kit 400T98/79 INNOVIQURE HTLV I/II Ab - Reagent CALIBRATORS98/79 INNOVIQURE HTLV I/II Ab Reagent Kit 100T98/79 INNOVIQURE Syphilis Reagent Kit 100T98/79 INNOVIQURE Syphilis Reagent Kit 200T98/79 INNOVIQURE Syphilis Reagent Kit 400T98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Medikal Olusum Sanayi Ve Ticaret Sirketi	Turquie	10% Neutral Buffered Formaldehyde 5L 24 HOURS URINE COLLECTION CONTAINER 2.5 LT AMBER3 réf. 37-40% Neutral Buffered Formaldehyde 5L EA 50 1000mL EA 50 250mL 40 autres EA 50 500mL Elastic Van Giesson 100 Test Embedding Cassette with Lid Embedding Cassette without Lid Eosin Y 1% 1000mL Eosin Y 1% 250mL Eosin Y 1% 500mL Faeces Container 15mL3 réf. Giemsa Solution 250mL Harris’ Hematoxylin 1000mL Harris’ Hematoxylin 250mL Harris’ Hematoxylin 500mL Inoculation Loop 1 µl2 réf. Isopropyl Alcohol 5L Masson Trichrome (Light Green) 100 Test Masson Trichrome 100 Test Masson Trichrome Solution 1000mL May Grunwald 1000mL May Grunwald 250mL May Grunwald 500mL Mayer's Hematoxylin 1000mL Mayer's Hematoxylin 500mL Methyl Green Pyronin 100 Test Methylene Blue 1000mL Orange G 1000mL Orange G 250mL Orange G 500mL Petri Dish 120mm3 réf. Prefilled Formalin Containers 100mL3 réf. Saffron Solution 1000mL Specimen Container 1000mL Test Tube with Cap BPKT00001 Toluidine blue O 100 Test Toluidine blue O 1000mL Toluidine blue O 250mL Toluidine blue O 500mL Urinal Bottle 750mL Urine Container 100mL3 réf. Van Giesson 100 Test Verhoeff’s Elastic Stain Kit 100 Test	I, A IVDR, MDR	Site web info@moslab.com Fiche EUDAMED Signaler une erreur
Microprofit Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)2 réf. Dengue Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)4 réf.98/79 Dengue IgG/IgM Antibody Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)4 réf.98/79 Fluorescent Biological Microscope H.Pylori Antibody (H.p Ab) Diagnostic Kit (Immunochromatographic Assay)2 réf.98/79 40 autres Helicobacter pylori Antigen (Hp-Ag) Diagnostic Kit (Immunochromatographic Assay)2 réf.98/79 Herpes Simplex Virus 1 IgG(HSV-1-IgG)Diagnostic Kit (Immunochromatographic Assay)2 réf.98/79 Herpes Simplex Virus I IgM(HSV-I-IgM)Diagnostic Kit ( Immunochromatographic Assay)2 réf.98/79 Herpes Simplex Virus II IgG(HSV-II-IgG)Diagnostic Kit ( Immunochromatographic Assay)2 réf.98/79 Herpes Simplex Virus II IgM(HSV-II-IgM)Diagnostic Kit ( Immunochromatographic Assay)2 réf.98/79 Herpes Simplex Virus-II (HSV-II) Antigen Test Kit(Immunofluorescence)98/79 HP-Ag control98/79 Interleukin-6 (IL-6) Diagnostic Kit(Immunochromatographic Assay)2 réf.98/79 Inverted Biological Microscope Malaria Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)4 réf.98/79 Malaria Pf/ Pv Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79 Malaria Pf/ Pv Antigen Test Kit (Immunochromatographic Assay)2 réf.98/79 N. Gonorrhea Test kit(Colloidal Gold Chromatographic Immunoassay)2 réf.98/79 Respiratory 13 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79 Respiratory 9 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79 Respiratory Bacteria & M.P 6 Antigen Combo Test Kit (Immunochromatographic Assay)2 réf.98/79 Respiratory Virus, Bacteria & M.P 10 Antigen Combo Test Kit (Immunochromatographic Assay)2 réf.98/79 Respiratory Virus, Bacteria & M.p 11 Antigen Combo Test Kit (Immunochromatographic Assay)2 réf.98/79 Respiratory Virus, Bacteria & M.P 14 Antigen Combo Test Kit (Immunochromatographic Assay)2 réf.98/79 S.p/L.p/S.aureus/Kpn/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79 S.p/L.p/S.aureus/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79 SARS-CoV-2 & Influenza A/B & RSV /ADV/hMPV Antigen Combo Test Control98/79 SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Control98/79 SARS-CoV-2 & Influenza A/B & RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79 SARS-CoV-2 & Influenza A/B Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)98/79 SARS-CoV-2 Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay)98/79 SARS-CoV-2 Antibody Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 Antigen Test Control98/79 SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)(Saliva)98/79 SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay)98/79 SARS-CoV-2 Neutralizing Antibody Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay)3 réf.98/79 SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2/RhV/PIV & Influenza A/B & RSV /ADV/hMPV Antigen Combo Test Control98/79 SARS-CoV-2/RhV/PIV & Influenza A/B & RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79 SARS-CoV-2/RhV/PIV/Influenza A/B / RSV/ADV/hMPV/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79 SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay)98/79 Strep A antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79	A, C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
OSANG Healthcare FDA Mandataire UE : Obelis s.a. (Belgique)	Corée du Sud	adia System OG-SH03-AD (D48531)2 réf. CLOVER A1c Analyzer IGM-0023M CLOVER A1c Expert Analyzer IHM-0005M CLOVER A1c Self Analyzer IGM-002398/79 EASYGLUCO Auto-coding Blood Glucose Monitoring System for self-testing INFM22ACZ98/79 40 autres EASYGLUCO Auto-coding Blood Glucose Monitoring System for self-testing INFM22AIT98/79 EASYGLUCO Auto-coding Meter OG-SX01-EG3 réf. ELEMENT Blood Glucose Monitoring System for self-testing INFM21A98/79 ELEMENT Blood Glucose Monitoring System for self-testing INFM21ACZ98/79 ELEMENT Blood Glucose Monitoring System for self-testing INFM21APT98/79 EXADEMIN® Fast Blood Glucose Monitoring System for self-testing INFM003AIT98/79 Examedin® FAST Meter OG-SH01-GL3 réf. FINETEST Auto-coding premium Blood Glucose Monitoring System for self-testing INFM16B98/79 FINETEST Auto-coding premium Blood Glucose Monitoring System for self-testing INFM16BICZ98/79 FINETEST Auto-coding premium Blood Glucose Monitoring System for self-testing INFSS16B98/79 FINETEST Auto-coding premium Meter OG-SX01-FP3 réf. Finetest Lite Meter OG-SH01-FL3 réf. GeneFinder STDI( CT/NG/UU) Multiplex Real-time PCR kit IFMR-0398/79 GlucoCheck Excellent System OG-SX03-EX (21514)2 réf. GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing INFCL001A98/79 GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing INFM001ACZ98/79 GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing INFM001ASK98/79 GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing INFM22A98/79 GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing INFM22ASV98/79 GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing INFS22ARU98/79 GLUCOLAB Auto-coding Meter OG-SX01-LBS-23 réf. GluNEO Blood Glucose Monitoring System for self-testing INFM001A98/79 GluNEO Dual Blood Glucose/Blood β-Ketone Monitoring System OG-SH01-GD3 réf. GluNEO H Lite Blood Glucose Monitoring System OG-SH01-HL2 réf. GluNEO H OG-SH01-GH3 réf. GluNEO Lite Blood Glucose Monitoring System for self-testing D4853198/79 GluNEO Lite Blood Glucose Monitoring System for self-testing INFCH001L98/79 GluNEO Lite Blood Glucose Monitoring System for self-testing INFCL001L98/79 GluNEO plus Blood Glucose Monitoring System for self-testing INFCH003K98/79 GluNEO plus Blood Glucose Monitoring System for self-testing INFCN001LPO98/79 GluNEO plus Blood Glucose Monitoring System for self-testing INFCN003APT98/79 GluNEO plus Blood Glucose Monitoring System for self-testing INFS003KG98/79 GluNEO plus Blood Glucose Monitoring System for self-testing INFSS003KIT98/79 GluNEO Plus Meter OG-SH01-GPS-23 réf. Healthpro S Meter OG-SX01-HES-23 réf. HemoCue HbA1c 501 Analyzer IGM-0026B98/79 HemoCue HbA1c 501 Analyzer IGM-0026BM Oh'Care Lite Blood Glucose Monitoring System for self-testing INFCH003A98/79 Oh'Care Lite Blood Glucose Monitoring System for self-testing INFS001LBG98/79 Oh'Care Lite Blood Glucose Monitoring System for self-testing INFSS003A98/79	A, C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Carloerbareagents	France	CARLO ERBA Reagents18 réf. CARLO ERBA Reagents Eosin Y 0.5% solution alcoholic CARLO ERBA Reagents Eosin Y 1% solution acqueous CARLO ERBA Reagents Formaldehyde 10% v/v according to Lillie4 réf. CARLO ERBA Reagents Formaldehyde 4% w/v buffered at pH 6.914 réf. 39 autres CARLO ERBA Reagents Formaldehyde 4% w/v buffered at pH 6.9 - 10L CARLO ERBA Reagents Formaldehyde 4% w/v buffered at pH 6.9 - 1L CARLO ERBA Reagents Formaldehyde 4% w/v buffered at pH 6.9 - 5L CARLO ERBA Reagents Formaldehyde 4% w/v buffered at pH 6.9 RS Histology 120 mL CARLO ERBA Reagents Formaldehyde 4% w/v buffered at pH 6.9 RS Histology 30mL CARLO ERBA Reagents Giemsa's reagent RS 100ml x 6 CARLO ERBA Reagents Giemsa's reagent RS 4 x 2.5L CARLO ERBA Reagents Giemsa's reagent RS 500ml x 6 CARLO ERBA Reagents Giemsa's reagent RS ml 100 CARLO ERBA Reagents Giemsa's reagent RS ml 2500 CARLO ERBA Reagents Giemsa's reagent RS ml 500 CARLO ERBA Reagents Haemalum reagent solution for microscopy RS 1L CARLO ERBA Reagents Hematoxylin solution according to Mayer - RS For histology - 100mL CARLO ERBA Reagents Hematoxylin solution according to Mayer - RS For histology - 1L CARLO ERBA Reagents May Grünwald reagent RS 2.5L CARLO ERBA Reagents May Grünwald reagent RS 4 x 2.5 L CARLO ERBA Reagents May Grünwald reagent RS 500 mL CARLO ERBA Reagents May Grünwald reagent RS 6 x 100 mL CARLO ERBA Reagents May Grünwald reagent RS 6 x 500 mL CARLO ERBA Reagents Papanicolaou Haematoxylin solution according to Harris RS 1L CARLO ERBA Reagents Papanicolaou Haematoxylin solution according to Harris RS 2.5 L CARLO ERBA Reagents Papanicolaou Haematoxylin solution according to Harris RS 4 x 2.5 L CARLO ERBA Reagents Papanicolaou Haematoxylin solution according to Harris RS 500 mL CARLO ERBA Reagents Papanicolaou Haematoxylin solution according to Harris RS 6 x 1 L CARLO ERBA Reagents Papanicolaou Haematoxylin solution according to Harris RS 6 x 500 mL CARLO ERBA Reagents Papanicolaou solution EA 50 RS 1L CARLO ERBA Reagents Papanicolaou solution EA 50 RS 2.5L CARLO ERBA Reagents Papanicolaou solution EA 50 RS 4 x 2.5L CARLO ERBA Reagents Papanicolaou solution EA 50 RS 500 mL CARLO ERBA Reagents Papanicolaou solution EA 50 RS 6 x 1L CARLO ERBA Reagents Papanicolaou solution EA 50 RS 6 x 500 mL CARLO ERBA Reagents Papanicolaou solution OG 6 RS 2.5 L CARLO ERBA Reagents Papanicolaou solution OG 6 RS 4 x 2.5L CARLO ERBA Reagents Papanicolaou solution OG 6 RS 500 mL CARLO ERBA Reagents Papanicolaou solution OG 6 RS 6 x 500 mL CARLO ERBA Reagents PAPANICOLAOU SOLUTION OG 6 RS ml 1000x6 CARLO ERBA Reagents Papanicolaou solution OG 6 RS ML1000 CARLO ERBA Reagents Paraffin 56-58°C - Erbaplast (without DMSO) CARLO REAGENTS Reagents Formaldehyde 4% w/v buffered at pH 6.9	A IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Vazyme Mandataire UE : Caretechion GmbH (Allemagne) et 3 autres	Chine	2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based） C6603C98/79 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit CD302-0298/79 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit CD312-0298/79 Automatic Chemiluminescence Immunoassay Analyzer Elf S260 , Elf S2902 réf. Automatic Fluorescence Immunoassay Analyzer QD-S2000 39 autres Automatic Nucleic Acids Extraction Instrument VNP-32YL Cell-Free DNA Collection Tube BH106ME-C1-XY、BH106ME-C12 réf. D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2402CC98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2402CL98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2402CV98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2403CC98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2403CV98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2404CC98/79 DNA/RNA Extraction Kit RM301-013 réf. Fluorescence Immune Analyzer QD-S900 Full-automatic Nucleic Acids Extraction Instrument VNP-96 High-throughput Virus DNA/RNA Nucleic Acid Extraction Kit RM502ME Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography) C4402CC98/79 Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography) C4402CL98/79 Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography) C4402CL, C4403CV, C4402CV, C4402CC, C4404CC, C4403CC98/79 Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography) C4403CC98/79 Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography) C4403CV98/79 Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography) C4404CC98/79 Logilet Arbovirus Panel DAB01M98/79 Logilet Gastrointestinal Panel DGI02M98/79 Logilet HPV Panel VD401198/79 Logilet Hr-HPV Panel DHPV01M98/79 Logilet Logicore System Logilet Meningitis/Encephalitis Panel DME02M98/79 Logilet MTB/RIF Panel DTB01M98/79 Logilet Respiratory Pathogen Panel VD101198/79 Logilet Respiratory/Sore Throat (R/ST) Test Panel DUR01M98/79 Logilet Sexual Health Test Panel DSTI01M98/79 Logilet STl Panel VD402198/79 Quality Control Kit for Logilet HPV Panel QC401198/79 Quality Control Kit for Logilet Respiratory Pathogen Panel Quality Control Kit for Logilet STl Panel QC402198/79 Quantum Dot Fluorescence Immune Analyzer QD-S600 Real-Time Fluorescence Quantitative PCR System Turbo16 Real-Time Quantitative Thermal Cycler FMR3 SARS-CoV-2 and Influenza A/B Virus Antigen Combined Detection Kit (Colloidal Gold-Based)98/79 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) C8611C98/79 Universal DNA/RNA Extraction Kit ECM01ME-01 Vazyme Hybrid System2 réf.	A, B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Qiagen FDA Mandataire UE : QIAGEN GmbH (Allemagne)	Allemagne, États-Unis	artus CMV QS-RGQ Kit98/79 artus CMV RG PCR Kit2 réf.98/79 artus EBV QS-RGQ Kit98/79 artus EBV RG PCR Kit2 réf.98/79 artus HBV QS-RGQ Kit2 réf.98/79 40 autres artus HBV RG PCR Kit2 réf.98/79 artus HSV-1/2 QS-RGQ Kit98/79 artus HSV-1/2 RG PCR Kit2 réf.98/79 EZ1 DSP DNA Blood Kit EZ1 DSP Virus Kit EZ2 Connect MDx Hybrid Capture System Microplate Heater 1 Hybrid Capture System Multi-Specimen Tube Vortexer 2 QFT-Plus 2 Plate Kit ELISA2 réf. QFT-Plus Dispenser Pack3 réf. QIAamp DSP DNA Blood Mini Kit QIAamp DSP DNA FFPE Tissue Kit QIAamp DSP Virus Kit QIAamp DSP Virus Spin Kit QIAcube Connect MDx QIAcuityDx Four QIAstat-Dx Analytical Module3 réf. QIAstat-Dx BCID GN Plus AMR Panel QIAstat-Dx BCID GPF Plus AMR Panel QIAstat-Dx Gastrointestinal Panel 22 réf. QIAstat-Dx Meningitis/Encephalitis (ME) Panel2 réf. QIAstat-Dx Respiratory SARS-CoV-2 Panel2 réf. QIAstat-Dx Rise QIAsymphony AS QIAsymphony Connect QIAsymphony DSP DNA Midi Kit2 réf. QIAsymphony DSP DNA Virus/Pathogen Midi Kit2 réf. QIAsymphony SP QuantiFERON CMV Blood Collection Tubes Single Patient Pack98/79 QuantiFERON Monitor 2 Plate Kit ELISA98/79 QuantiFERON Monitor 2 Plate Kit ELISA QuantiFERON CMV 2 Plate kit ELISA98/79 QuantiFERON Monitor Blood Collection Tubes98/79 QuantiFERON Monitor LyoSpheres98/79 Rapid Capture System RNeasy DSP FFPE Kit RNeasy DSP Midi Kit RNeasy DSP MinElute Cleanup Kit Rotor-Gene Q MDx 5Plex3 réf. careHPV Test Kit98/79 (plus commercialisé) careHPV Test Shaker (plus commercialisé)	A, C IVDR, 98/79	Présent sur le marché en France Site web info@qiagen.com Fiche EUDAMED Signaler une erreur
Diagnostics	Belgique, Espagne	APTT (Act. Thromboplastine Time) HC0010098/79 Autoplak3 réf. Bacterial Antigen polyvalent control + 590198/79 Bacterial Antigen polyvalent control - 590298/79 Bacterial Antigens BA-SPEC98/79 38 autres Ball dispenser CY0033 réf. Brucella abortus 509198/79 Brucella melitensis 509298/79 Calibrator Fibr/PT HC0060098/79 Cleaner 1L CY006-R0398/79 Coagulation Control HC0050098/79 CYANCyte Reagent pack for 400 t CY010-RP98/79 CYANElite 290 CY0152 réf. CYANHemato 380 CY01798/79 CYANStrip Mini CY011 Diluent 20L CY006-R0198/79 Fibrinogen HC0030098/79 Giemsa HS003 - HS0042 réf. H. Pylori 33398/79 Harris' Hematoxylin HS006 - HS007 - HS0093 réf. Hematology Calibrator CY010-C0198/79 Hematology Controls L/N/H CY010-C0298/79 Hypoclean (100mL) CY010-R0498/79 Hypoclean 1L CY006-R0498/79 Hypoclean CC 100ml CY006-R0698/79 Lyse for CYANHemato 380 CY017-R0298/79 Opticlean (100mL) CY010-R0598/79 Proteus OX19 511198/79 Proteus OX2 510198/79 Proteus OXK 512198/79 PT Prothrombin Time HC0020098/79 Quick Panoptic Conc. (1:10) HS005 Rose Bengal 2220298/79 Salmonella paratyphi AH 501198/79 Salmonella paratyphi AO 502198/79 Salmonella paratyphi BH 503198/79 Salmonella paratyphi BO 504198/79 Salmonella paratyphi CH 505198/79 Salmonella paratyphi CO 506198/79 Salmonella typhi H 507198/79 Salmonella typhi O 508198/79 Syphilis Ab Rapid C 35398/79 Wright HS023	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Hightopbio FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne) et 1 autre	Chine	96T/Box 480T/Box98/79 Adenovirus (Adv) IgG Antibody ELISA Test Kit98/79 Adenovirus (Adv) IgM Antibody ELISA Test Kit98/79 Antibodies to Hepatitis A Virus (HAV) IgM ELISA Test Kit (Serum/Plasma)98/79 Antibodies to Hepatitis E Virus (HEV) IgM ELISA Test Kit (Serum/Plasma)98/79 38 autres Antibodies to Herpes Simplex Virus I IgG Test Kit (ELISA)98/79 Antibodies to Herpes Simplex Virus I IgM Test Kit (ELISA)98/79 Antibodies to Herpes Simplex Virus II IgG Test Kit (ELISA)98/79 Antibodies to Herpes Simplex Virus II IgM Test Kit (ELISA)98/79 Antibodies to Mycobacterium Tuberculosis(TB) IgM ELISA Test Kit98/79 Antibodies to Treponema Pallidum (TP) ELISA Test Kit (Serum/Plasma)98/79 Brucella IgG Antibody ELISA Test Kit98/79 Brucella IgM Antibody ELISA Test Kit98/79 Card type9 réf.98/79 Card type, Card box type6 réf.98/79 CMV Cytomegalovirus Antibody IgG Rapid Test (Colloidal Gold)98/79 CMV Cytomegalovirus Antibody IgM/IgG Rapid Test Kit (Colloidal Gold)98/79 Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold)98/79 D-dimer Reagent Kit (Microparticles Chemiluminescent Immunoassay)98/79 Dengue IgG ELISA Test Kit98/79 Dengue IgM ELISA Test Kit98/79 Diagnostic Kit for Influenza A virus RNA (Fluorescence RT-PCR)98/79 Epidemic Hemorrhagic Fever (EHF) IgM Antibody Enzyme Immunoassay Test Kit98/79 Epstein-Barr Virus IgG Antibody ELISA Test Kit98/79 Epstein-Barr Virus IgM Antibody ELISA Test Kit98/79 Flu A+B/MP Antigen Rapid Test98/79 Helicobacter pylori (H.P) Antigen ELISA Test Kit (Feces)98/79 Influenza A Antigen Rapid Test H1919-21S98/79 Influenza B Antigen Rapid Test H1918-21S98/79 Malaria P.f (HRP2, pLDH) Rapid Test98/79 Malaria P.f/P.v/Pan Rapid Test H1433-41W98/79 Measles Virus (MV) IgM Antibody ELISA Test Kit98/79 Measles Virus(MV) IgG Antibody ELISA Test Kit98/79 Mpox Virus Antigen Rapid Test H200S98/79 Respiratory Syncytial Virus (RSV) IgG Antibody ELISA Test Kit98/79 Respiratory Syncytial Virus (RSV) IgM Antibody ELISA Test Kit98/79 RV Rubella Antibodies IgG Rapid Test Kit (Colloidal Gold)98/79 RV Rubella Antibodies IgM Rapid Test Kit(Colloidal Gold)98/79 SARS-CoV-2 Antigen Rapid Test98/79 Strep A Antigen Rapid Test (Immunochromatography)98/79 Streptococcus Pneumoniae Antigen Rapid Test98/79 Syphilis TP Reagent Kit（Microparticles Chemiluminescent Immunoassay）98/79 TB Igra ELISA Test Kit98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Orgentec	Allemagne	Alegria Alegria 2 Alegria Negative Control Alegria Positive Control Anti-B. pertussis Toxin IgA ORG 916A98/79 38 autres Anti-B. pertussis Toxin IgG ORG 916G98/79 Anti-Borrelia IgG98/79 Anti-Borrelia IgG Liquor98/79 Anti-Borrelia IgM Abs.98/79 Anti-Borrelia IgM Liquor98/79 Anti-Chlamydia pneumoniae IgA ORG 907A98/79 Anti-Chlamydia pneumoniae IgG ORG 907G98/79 Anti-Chlamydia pneumoniae IgM Abs.98/79 Anti-Chlamydia trachomatis IgA ORG 906A98/79 Anti-Chlamydia trachomatis IgG ORG 906G98/79 Anti-Chlamydia trachomatis IgM Abs.98/79 Anti-EBV (EBNA-1) IgG98/79 Anti-EBV (VCA) IgG ORG 901G98/79 Anti-EBV (VCA) IgM Abs.98/79 Anti-Helicobacter pylori IgA ORG 917A98/79 Anti-Helicobacter pylori IgG ORG 917G98/79 Anti-Hepatitis E Virus IgG ORG 921G98/79 Anti-Hepatitis E Virus IgM Abs.98/79 Anti-HSV-1 IgG98/79 Anti-HSV-1 IgM Abs.98/79 Anti-HSV-1/2 IgG98/79 Anti-HSV-1/2 IgM Abs.98/79 Anti-HSV-2 IgG98/79 Anti-HSV-2 IgM Abs.98/79 Anti-Measles Virus IgG ORG 909G98/79 Anti-Measles Virus IgM Abs.98/79 Anti-Mumps Virus IgG ORG 908G98/79 Anti-Mumps Virus IgM Abs.98/79 Anti-Mycoplasma pneumoniae IgA ORG 915A98/79 Anti-Mycoplasma pneumoniae IgG ORG 915G98/79 Anti-Mycoplasma pneumoniae IgM Abs.98/79 Anti-Parvovirus B19 IgG98/79 Anti-Parvovirus B19 IgM Abs.98/79 Anti-VZV IgG ORG 914G98/79 Anti-VZV IgM Abs.98/79 Anti-Yersinia IgA ORG 913A98/79 Anti-Yersinia IgG ORG 913G98/79 Stool Extraction Tubes ORG 282	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Anhui Sinic Laboratory Medicine Technology Mandataire UE : MedPath GmbH (Allemagne)	Chine	Vacuum Tube blacdflj-103 réf. Vacuum Tube blcnj-103 réf. Vacuum Tube blfhn-103 réf. Vacuum Tube blfhncsj-103 réf. Vacuum Tube blfhnk2-103 réf. 37 autres Vacuum Tube blfhnna2-103 réf. Vacuum Tube blfljcnj-103 réf. Vacuum Tube blfljgsl-103 réf. Vacuum Tube blfljgsn-103 réf. Vacuum Tube blfljk2-103 réf. Vacuum Tube blfljnmsn-103 réf. Vacuum Tube blfljwtjj-103 réf. Vacuum Tube blgsl-103 réf. Vacuum Tube blgsn-103 réf. Vacuum Tube blk2-103 réf. Vacuum Tube blk3-103 réf. Vacuum Tube blmzgask3-103 réf. Vacuum Tube blna2-103 réf. Vacuum Tube blnmsn-1.63 réf. Vacuum Tube blwtjj-103 réf. Vacuum Tube blxc-103 réf. Vacuum Tube petacdflj-103 réf. Vacuum Tube petcnj-103 réf. Vacuum Tube petfhn-103 réf. Vacuum Tube petfhncsj-103 réf. Vacuum Tube petfhnk2-103 réf. Vacuum Tube petfhnna2-103 réf. Vacuum Tube petfljcnj-103 réf. Vacuum Tube petfljgsl-103 réf. Vacuum Tube petfljgsn-103 réf. Vacuum Tube petfljk2-103 réf. Vacuum Tube petfljnmsn-103 réf. Vacuum Tube petfljwtjj-103 réf. Vacuum Tube petgsl-103 réf. Vacuum Tube petgsn-103 réf. Vacuum Tube petk2-103 réf. Vacuum Tube petk3-103 réf. Vacuum Tube petmzgask3-103 réf. Vacuum Tube petna2-103 réf. Vacuum Tube petnmsn-1.63 réf. Vacuum Tube petwttj-103 réf. Vacuum Tube petxc-103 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Biolytical FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Canada	48 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1026-00198/79 48 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1026-00298/79 48 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1026-00398/79 INSTI HCV ANTIBODY TEST 90-1062-001, 90-1062-002, 90-1062-00398/79 INSTI HCV ANTIBODY TEST 90-1062-005 and 90-1062-00698/79 37 autres INSTI HCV Antibody Test Single 90-1062-01298/79 INSTI HCV Test Controls 90-106798/79 INSTI HIV ANTIBODY SELF-TEST 90-1058-001 and 90-1058-00298/79 INSTI HIV ANTIBODY SELF-TEST 90-1123-00198/79 INSTI HIV ANTIBODY SELF-TEST 90-1126-001 and 90-1126-00298/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105098/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105698/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105798/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105898/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105998/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-1059-001 and 90-1059-00298/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-106098/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-1060-001, 90-1060-002, 90-1060-003, and 90-1060-00498/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-106398/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-107698/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-1076-003 and 90-1076-00498/79 INSTI HIV Self Test (no pipette variant, packaged in a box)) 90-1076-005 and 90-1076-00698/79 INSTI HIV Self Test (no pipette variant, packaged in a pouch) 90-1041-001 and 90-1041-00298/79 INSTI HIV Self Test (no pipette variant, packaged in a pouch) 90-1041-003 and 90-1041-01098/79 INSTI HIV Self Test (no pipette variant, packaged in a pouch) 90-1041-00798/79 INSTI HIV Self Test (no pipette variant, packaged in a pouch) 90-1041-014 and 90-1041-01598/79 INSTI HIV Self Test (no pipette variant, packaged in pouch) 90-1041-012 and 90-1041-01398/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-001 and 90-1015-00298/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-003 and 90-1015-00498/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-005 and 90-1015-00698/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-00898/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-00998/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-01098/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-011 and 90-1015-01298/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-013 and 90-1015-01498/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-015 and 90-1015-01698/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-017 and 90-1015-01898/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-102698/79 INSTI HIV-1/HIV-2 Test Controls 90-103698/79 INSTI T. pallidum Test Controls 90-103298/79 INSïl HIV Self Test (no pipette variant, packaged in a box) 90-1056-001 and 90-1056-00298/79 INSïl HIV Self Test (no pipette variant, packaged in a box) 90-1057-001 and 90-1057-00298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Biotical	Espagne	biotical Adenovirus Positive control (1u) / 1 control positivo Adenovirus (sin test rápido)98/79 biotical Adenovirus Positive control (30u) / 30 controles positivos Adenovirus (sin test rápido)98/79 biotical Astrovirus Positive control (1u) / 1 control positivo Astrovirus (sin test rápido)98/79 biotical C. difficile GDH Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile GDH +1 C. Negativo universal)98/79 biotical C. difficile GDH Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile GDH)98/79 37 autres biotical C. difficile GDH Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79 biotical C. difficile GDH Positive control (1u) / 1 control positivo C. difficile GDH (sin test rápido)98/79 biotical C. difficile GDH Positive control (30u)98/79 biotical C. difficile Toxin A Positive control (1u) / 1 control positivo C. difficile Toxins A (sin test rápido)98/79 biotical C. difficile Toxin A Positive control (30u) / 30 controles positivos C. difficile Toxins A (sin test rápido)98/79 biotical C. difficile Toxin B Positive control (1u)98/79 biotical C. difficile Toxin B Positive control (30u) / 30 controles positivos C. difficile Toxins B (sin test rápido)98/79 biotical C. difficile Toxins A + B Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile Toxins A + B +1 C. Negativo universal)98/79 biotical C. difficile Toxins A + B Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile Toxins A + B)98/79 biotical C. difficile Toxins A + B Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79 biotical Campylobacter Positive control (1u) / 1 control positivo Campylobacter (sin test rápido)98/79 biotical Campylobacter Positive control (30u) / 30 controles positivos Campylobacter (sin test rápido)98/79 biotical Crypto Positive control (30u) / 30 controles positivos Crypto (sin test rápido)98/79 biotical E. Coli Positive control (1u) / 1 control positivo E. Coli O157:H7 (sin test rápido)98/79 biotical E. Coli Positive control (30u) / 30 controles positivos E. Coli O157:H7 (sin test rápido)98/79 biotical Enterovirus Positive Control (1u) / 1 control positivo Enterovirus (sin test rápido)98/79 biotical Enterovirus Positive Control (30u) / 30 controles positivos Enterovirus (sin test rápido)98/79 biotical Giardia Positive control (1u) / 1 control positivo Giardia (sin test rápido)98/79 biotical Giardia Positive control (30u)98/79 biotical H. pylori Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo H. pylori +1 C. Negativo universal)98/79 biotical H. pylori Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo H. pylori)98/79 biotical H. pylori Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79 biotical H. pylori Positive control (1u) / 1 control positivo H. pylori (sin test rápido)98/79 biotical H. pylori Positive control (30u) / 30 controles positivos H. pylori (sin test rápido)98/79 biotical Norovirus Gen I Positive control (30u) / 30 controles positivos Norovirus Gen I (sin test rápido)98/79 biotical Norovirus Gen II Positive control (1u) / 1 control positivo Norovirus Gen II (sin test rápido)98/79 biotical Norovirus Gen II Positive control (30u) / kit de 30 unidades de hisopo de control negativo universal98/79 biotical Rotavirus Positive control (1u) / 1 unidad de hisopo de control positivo Rotavirus.98/79 biotical Rotavirus Positive control (30u) / 30 controles positivos Rotavirus (sin test rápido)98/79 biotical S. paratyphi Positive control (1u) / 1 unidad de hisopo de control positivo Salmonella paratyphi.98/79 biotical S. paratyphi Positive control (30u) / 30 controles positivos Salmonella paratyphi (sin test rápido)98/79 biotical Salmonella Positive control (1u) / 1 control positivo Salmonella (sin test rápido)98/79 biotical Salmonella Positive control (30u) / 30 controles positivos Salmonella (sin test rápido)98/79 biotical Y. enterocolitica O:3 Positive control (1u) / 1 control positivo Yersinia enterocolitica O:3 (sin test rápido)98/79 biotical Y. enterocolitica O:3 Positive control (30u) / 30 controles positivos Yersinia enterocolitica O:3 (sin test rápido)98/79 biotical Y. enterocolitica O:9 Positive control (1u) / 1 control positivo Yersinia enterocolitica O:9 (sin test rápido)98/79 biotical Y. enterocolitica O:9 Positive control (30u) / 30 controles positivos Yersinia enterocolitica O:9 (sin test rápido)98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Hybribio Mandataire UE : Emergo Europe B.V. (Pays-Bas) et 3 autres	Chine	1 mL/tube, 24 tubes/box; 1 mL/tube, 48 tubes/box; 1 mL/tube, 96tubes/box; 2 mL/tube, 47tubes/box; 2 mL/tube, 48tubes/box; 2 mL/tube, 96 tubes/box; 3 mL/tube, 48 tubes/box; 3 mL/tube, 96 tubes/box 16 Tests/ Kit, 32 Tests/ Kit, 48 Tests/ Kit, 128 Tests/ Kit, 160 Tests/ Kit, 192 Tests/ Kit3 réf. 16 Tests/ Kit, 48 Tests/ Kit 16 Tests/Kit2 réf.98/79 16 Tests/Kit, 32 Tests/Kit, 48 Tests/Kit, 128Tests/Kit, 160 Tests/Kit, 192 Tests/Kit3 réf. 37 autres 20-HPV Genotype(A) ：16 Tests98/79 20-HPV Genotype(A) ：48 Tests98/79 20-HPV Genotype(A) ：96 Tests98/79 20-HPV Genotype(B) ：16 Tests98/79 20-HPV Genotype(B) ：48 Tests98/79 20-HPV Genotype(B) ：96 Tests98/79 24 Tests/ Kit98/79 30 Tests/ Kit, 24 Tests/ Kit, 6 Tests/ Kit 30 Tests/Kit98/79 32 Tests/Kit98/79 37 HPV GenoArray Diagnostic Kit 30 Tests/Kit98/79 40-HPV Genotype(A+B) ：16 Tests98/79 40-HPV Genotype(A+B) ：48 Tests98/79 40-HPV Genotype(A+B) ：96 Tests98/79 48 Tests/Kit8 réf. 50 tests/kit 6 tests/kit6 réf.98/79 6 Tests/Kit，30 Tests/Ki 60 Tests/Kit98/79 90 Tests/Kit98/79 96 Tests/Kit98/79 Fully Automated Nucleic Acid Extraction and Real-time PCR System HB-IEX96Q HB-2012A HB-IEX96A HB-IEX96S HBHM-3001S HBHM-9000A HBLH-9600A HBLH-Mini96A HBMP-R/96: 16 Tests/ Kit, 96 Tests/ Kit, 192 Tests/ Kit; HBMP-NO-R-A9600-T1: 16 Tests/ Kit, 192 Tests/ Kit; HBMP-NO-R-A9601: 16 Tests/ Kit, 192 Tests/ Kit3 réf. HBNP-4801A HBNP-4803A HBNP-9601A HBNP-ME32A HBPS-9600A HBQW-3200A HHM-3	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
HYPHEN BioMed FDA	France	BIOPHEN™ Abnormal Control Plasma3 réf. BIOPHEN™ Apixaban Calibrator3 réf. BIOPHEN™ Apixaban Control3 réf. BIOPHEN™ Arixtra® Calibrator Fondaparinux Calibrator2 réf. BIOPHEN™ Arixtra® Control Plasma Fondaparinux Control2 réf. 37 autres BIOPHEN™ AT anti-(h)-Xa LRT Antithrombin (AT) activity - AntiXa3 réf. BIOPHEN™ DiXaI Direct Factor Xa inhibitors (DiXaIs) BIOPHEN™ Edoxaban Calibrator3 réf. BIOPHEN™ Edoxaban Control3 réf. BIOPHEN™ FIX Factor IX (FIX) chromogenic3 réf. BIOPHEN™ FVIII Factor VIII (FVIII) chromogenic2 réf. BIOPHEN™ FVIII variant Factor VIII (FVIII) bovine2 réf. BIOPHEN™ Heparin Calibrator2 réf. BIOPHEN™ Heparin LRT Factor Xa (FXa) inhibitors3 réf. BIOPHEN™ LMWH Control C33 réf. BIOPHEN™ Normal Control Plasma Control Normal Plasma3 réf. BIOPHEN™ Orgaran® Calibrator Danaparoid Calibrator2 réf. BIOPHEN™ Orgaran® Control Danaparoid Control2 réf. BIOPHEN™ Protein C LRT Protein C chromogenic LRT BIOPHEN™ Protein C Protein C chromogenic BIOPHEN™ Rivaroxaban Calibrator Low3 réf. BIOPHEN™ Rivaroxaban Control Low3 réf. BIOPHEN™ UFH Calibrator BIOPHEN™ UFH Control C13 réf. Calcium Chloride 0.025M3 réf. CEPHEN™ aPTT2 réf. CEPHEN™ LS aPTT Lupus Sensitive FIBRIPHEN™ LRT3 réf. Hemostasis Hepes Buffer2 réf. Imidazole buffer3 réf. Isotonic Sample Diluent3 réf. LIAPHEN™ vWF: Ag Von Willebrand Factor Antigen (vWF: Ag)2 réf. Platelet Aggregation -ADP AG001K2 réf. Platelet Aggregation -Arachidonic Acid2 réf. Platelet Aggregation -Collagen AG005K2 réf. Platelet Aggregation -Epinephrine2 réf. Platelet Aggregation -Ristocetin AG004K2 réf. Special Calcium Chloride Calcium chloride Heparin neutralizing Special Tris-BSA buffer Tris-NaCl-EDTA buffer, pH 7.85 ZYMUTEST™ HIA (Heparin Induced Antibodies) IgG2 réf. ZYMUTEST™ HIA (Heparin Induced Antibodies) IgGAM2 réf.	A, C IVDR	Présent sur le marché en France Site web info@hyphen-biomed.com Fiche EUDAMED Signaler une erreur
Medicamed	Roumanie	CLORURA DE SODIU 1000gr CLORURA FERICA 10% 2ml KIT COLORATIE GRAM 1000ml KIT COLORATIE GRAM 250ml REACTIV FENILALANINA 5g 37 autres REACTIV OXIDAZA 5gr SER DE CAL 100ml SOLUTIE DE IOD 120ml SUPLIMENT BRUCELLA SUPLIMENT C.N.A (Stafilococi/Streptococi) SUPLIMENT CAMPYLOBACTER BLASER WANG SUPLIMENT CAMPYLOBACTER BUTZLER SUPLIMENT CAMPYLOBACTER C.T.V.A SUPLIMENT CAMPYLOBACTER CCDA SUPLIMENT CAMPYLOBACTER KARMALI SUPLIMENT CAMPYLOBACTER SKIRROW SUPLIMENT CN (PSEUDOMONAS) SUPLIMENT CRESTERE VITALEX cut 10 fiole SUPLIMENT DE CRESTERE LEGIONELLA BCYE cut 10 fiole SUPLIMENT DE CRESTERE PENTRU CAMPYLOBACTER SUPLIMENT DE CRESTERE PENTRU LEGIONELLA cut 10 fiole SUPLIMENT GARDENERELLA cut 10 fiole SUPLIMENT GLICEROL cut 10 fiole SUPLIMENT HAEMOPHILUS cut 10 fiole SUPLIMENT LCAT cut 10 fiole SUPLIMENT LEGIONELLA BMPA cut 10 fiole SUPLIMENT LEGIONELLA GVPC cut 10 fiole SUPLIMENT LEGIONELLA MWY cut 10 fiole SUPLIMENT LISTERIA FRASER cut 10 fiole SUPLIMENT LISTERIA PALCAM pach 10 fiole SUPLIMENT ONPG 1% cut 10 fiole SUPLIMENT PRESTON CAMPYLOBACTER SUPLIMENT SCHAEDLER cut 10 fiole SUPLIMENT SELECTIV MOD VCC cut 10 fiole SUPLIMENT TELURIT DE POTASIU 1% 100ml SUPLIMENT TELURIT DE POTASIU 3.5% 100ml SUPLIMENT TTC 1 % cutie 5x10ml SUPLIMENT UREE 40% 50ml SUPLIMENT V.C.A.T cut 10 fiole SUPLIMENT V.C.N cut 10 fiole SUPLIMENT VITAMINA K 1% 5 x 5ml SUPLIMENT YERSINIA cut 10 fiole	A IVDR	Site web office@medicamed.ro Fiche EUDAMED Signaler une erreur
TIB MOLBIOL Syntheselabor	Allemagne	LightMix®KIT MERS-CoV upE N orf1a LightMix® Kit MERS-CoV upE N orf1a98/79 LightMix®KIT Polyomavirus JC/BK CE98/79 LightMix®KIT Sarbecovirus SARS-CoV-2 LightMix® Modular Sarbecovirus SARS-CoV-298/79 LightMix®KIT U.urealyticum / parvum CE98/79 ModularDx Kit Adenovirus98/79 37 autres ModularDx Kit Adenovirus F98/79 ModularDx Kit Astrovirus98/79 ModularDx Kit Blastocystis98/79 ModularDx Kit Bocavirus 530 LightMix® Modular Bocavirus 53098/79 ModularDx Kit Bocavirus 580 LightMix® Modular Bocavirus 58098/79 ModularDx Kit Campylobacter98/79 ModularDx Kit Chikungunya Virus98/79 ModularDx Kit Cryptosporidium98/79 ModularDx Kit Dengue Virus98/79 ModularDx Kit Dientamoeba98/79 ModularDx Kit Entamoeba histolytica98/79 ModularDx Kit Enterovirus 500 LightMix® Modular Enterovirus 50098/79 ModularDx Kit Enterovirus 640 LightMix® Modular Enterovirus 64098/79 ModularDx Kit Giardia98/79 ModularDx Kit Influenza A98/79 ModularDx Kit Influenza A H1 (H1N1 sw) LightMix® Modular Influenza A H1(H1N1 sw)98/79 ModularDx Kit Influenza B98/79 ModularDx Kit Metapneumovirus98/79 ModularDx Kit Norovirus GG1 Cyan LightMix® Modular Norovirus GG1 Cyan98/79 ModularDx Kit Norovirus GG1 FAM LightMix® Modular Norovirus GG1 FAM98/79 ModularDx Kit Norovirus GG2 FAM LightMix® Modular Norovirus GG2 FAM98/79 ModularDx Kit Parainfluenza 1 LightMix® Modular Parainfluenza 198/79 ModularDx Kit Parainfluenza 2 LightMix® Modular Parainfluenza 298/79 ModularDx Kit Parainfluenza 3 LightMix® Modular Parainfluenza 398/79 ModularDx Kit Parainfluenza 4 LightMix® Modular Parainfluenza 498/79 ModularDx Kit Parechovirus HPeV 530 LightMix® Modular Parechovirus HPeV 53098/79 ModularDx Kit Parechovirus HPeV 640 LightMix® Modular Parechovirus HPeV 64098/79 ModularDx Kit Rotavirus A98/79 ModularDx Kit RSV-A/B98/79 ModularDx Kit Salmonella98/79 ModularDx Kit Shigella / EIEC98/79 ModularDx Kit Trichomonas vaginalis98/79 ModularDx Kit Yersinia enterocolitica98/79 ModularDx Kit Zika Virus 640 LightMix® Modular Zika Virus 64098/79 ModularDx Kit Zika Virus CE98/79 UC-TIB-AdV98/79 UC-TIB-HSV/VZV98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Dialab	Autriche	Abnormal Coagulation Control Plasma T95510198/79 Anti-Syphilis Ab Z0436698/79 Anti-Syphilis Ab Z0936898/79 Antithrombin III 5+16 réf.98/79 Antithrombin III A0051098/79 36 autres DIAQUICK Strep. A Cassette98/79 DLB3 Pack 125H DLB5 Pack 125H HBsAg Sensitive ELISA98/79 HCV Ab Sensitive2 réf.98/79 HIV 1&2 Ab, cut-off2 réf.98/79 HIV 1&2 Ag/Ab2 réf.98/79 IM98/79 LISS Solution B0517898/79 MSPACK 125 HUM MS4 3 DIFF MSPACK HUM MS4 3 DIFF2 réf. MSPACK 125 HUM MS4 5 DIFF MSPACK HUM MS4 5 DIFF2 réf. MSPACK 250 HUM MS9 3 DIFF MSPACK 250 HUM MS9 5 DIFF Photometer DTN-4053 réf. Polyvalent Negative Control98/79 Polyvalent Positive Control98/79 Proteus OX1998/79 Proteus OX298/79 Proteus OXK98/79 Rose Bengal98/79 Rose Bengal Reagent98/79 Salmonella paratyphi AH98/79 Salmonella paratyphi AO98/79 Salmonella paratyphi BH98/79 Salmonella paratyphi BO98/79 Salmonella paratyphi CH98/79 Salmonella paratyphi CO98/79 Salmonella Total Kit98/79 Salmonella typhi H98/79 Salmonella typhi O98/79 Syphilis RPR2 réf.98/79 Syphilis RPR Carbon Reagent98/79 Syphilis RPR Negative Control98/79 Syphilis RPR Positive Control98/79 Syphilis TPHA3 réf.98/79 Syphilis VDRL2 réf.98/79	A IVDR, 98/79	Site web office@dialab.at Fiche EUDAMED Signaler une erreur
Jiangsu Mole Bioscience Mandataire UE : Lotus NL B.V. (Pays-Bas) et 2 autres	Chine	2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)11 réf.98/79 2019-Novel Coronavirus, Influenza A and B Virus Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)3 réf.98/79 2019-Novel Coronavirus, Influenza Virus, Respiratory Syncytial Virus Nucleic Acid Test Kit (Fluorescent Probe-based real-time PCR assay)98/79 Bloodstream Infections Multiplex Real Time PCR Detection Kit2 réf.98/79 Candida auris and Antibiotic-Resistant Strain Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79 36 autres Candida Auris Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79 Clarithromycin, Quinolone-Resistant and Non-Resistant Helicobacter Pylori Nucleic Acid Amplification Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)2 réf.98/79 Clostridium difficile nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)3 réf.98/79 Clostridium Difficile TcdA Gene And TcdB Gene Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79 Dengue Virus Genotyping Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79 Dengue virus nucleic acid test kit (Fluorescent Probe-based Real-time PCR Assay)3 réf.98/79 EV71, CA16 and Other Enteroviral Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79 EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)5 réf.98/79 Flu A/B + COVID-19 Antigen Combo Test Cassette Kit2 réf.98/79 Gastrointestional Infections Multiplex Real Time PCR Detection Kit98/79 H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit3 réf.98/79 Helicobacter Pylori (Hp) Antigen Test Kit98/79 Herpes Simplex Virus Type I and Type II Typing Nucleic Acid Detection Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79 Human Leukocyte Antigen B27 Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79 Human Papillomavirus Nucleic Acid Amplification Test Kit (Fluorescent Probe- Based Real- Time PCR Assay)15 réf.98/79 Human Papillomavirus Nucleic Acid Amplification Test Kit (FluorescentProbe-based Real-time PCR Assay）98/79 Human Respiratory Virus Detection Kit (Fluorescent Probe-Based Real-Time PCR Assay)2 réf.98/79 Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)2 réf.98/79 Influenza A H1N1(2009) Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79 Influenza A&B Rapid Test Cassette R084T020B0C098/79 Influenza A&B Rapid Test Cassette R501T020B0C098/79 Kit de Prueba de Ácido Nucleico del Virus del Dengue (Ensayo de PCR en tiempo real basado en sonda fluorescente)98/79 Monkeypox Virus Nucleic Acid Detection Kit (Fluorescent Probe-based Real-time PCR Assay)98/79 Multi Respiratory Pathogen Real Time PCR Detection Kit5 réf.98/79 Multi-Antibiotic Resistant H.pylori Strain Real Time PCR Detection Kit2 réf.98/79 Mycoplasma Pneumoniae and Macrolides-Resistant Strain Nucleic Acid Test Kit2 réf.98/79 Nucleic Acid Extraction Kit (Boiling Method)3 réf. Nucleic Acid Extraction Kit (Spin Column)3 réf. Nucleic Acid Extraction Kit P01911P20643 réf. Rubella And Measles Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79 Saliva Collection Kit PS01005F04C20103 réf. SARS-CoV-2 Antigen Test Cassette2 réf.98/79 SARS-CoV-2 Realtime PCR Test Kit (Lyophilized)4 réf.98/79 Strep A Antigen Test Kit R226T020B0C098/79 Urological and Reproductive Tract Microbial Nucleic Acid Test Kit(Fluorescent Probe-Based Real-Time PCR Assay)98/79 Zika virus, Dengue virus and Chikungunya virus Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Monobind FDA Mandataire UE : AR Experts B.V. (Pays-Bas)	États-Unis	Anti-H. Pylori IgA AccuBind ELISA Kit - 192 wells 1625-300B98/79 Anti-H. Pylori IgA AccuBind ELISA Kit - 96 wells 1625-300A98/79 Anti-H. Pylori IgA AccuLite CLIA Kit - 192 wells 1675-300B98/79 Anti-H. Pylori IgA AccuLite CLIA Kit - 96 wells 1675-300A98/79 Anti-H. Pylori IgG AccuBind® ELISA Test System 1425-300A98/79 36 autres Anti-H. Pylori IgG AccuBind® ELISA Test System 1425-300B98/79 Anti-H. Pylori IgG AccuLite CLIA Kit - 192 wells 1475-300B98/79 Anti-H. Pylori IgG AccuLite CLIA Kit - 96 wells 1475-300A98/79 Anti-H. Pylori IgM AccuBind ELISA Kit - 192 wells 1525-300B98/79 Anti-H. Pylori IgM AccuBind ELISA Kit - 96 wells 1525-300A98/79 Anti-H. Pylori IgM AccuLite CLIA Kit - 192 wells 1575-300B98/79 Anti-H. Pylori IgM AccuLite CLIA Kit - 96 wells 1575-300A98/79 Anti-SARS-CoV-2 IgA AccuBind ELISA Kit - 192 wells 11825-300B98/79 Anti-SARS-CoV-2 IgA AccuBind ELISA Kit - 96 wells 11825-300A98/79 Anti-SARS-CoV-2 IgA AccuLite CLIA Kit - 192 wells 11875-300B98/79 Anti-SARS-CoV-2 IgA AccuLite CLIA Kit - 96 wells 11875-300A98/79 Anti-SARS-CoV-2 IgG AccuBind ELISA Kit - 192 wells 11925-300B98/79 Anti-SARS-CoV-2 IgG AccuBind ELISA Kit - 96 wells 11925-300A98/79 Anti-SARS-CoV-2 IgG AccuLite CLIA Kit - 192 wells 11975-300B98/79 Anti-SARS-CoV-2 IgG AccuLite CLIA Kit - 96 wells 11975-300A98/79 Anti-SARS-CoV-2 IgM AccuBind ELISA Kit - 192 wells 11725-300B98/79 Anti-SARS-CoV-2 IgM AccuBind ELISA Kit - 96 wells 11725-300A98/79 Anti-SARS-CoV-2 IgM AccuLite CLIA Kit - 192 wells 11775-300B98/79 Anti-SARS-CoV-2 IgM AccuLite CLIA Kit - 96 wells 11775-300A98/79 Anti-SARS-CoV-2 S1-RBD IgG (COVID-19 S1-RBD IgG) AccuBind® ELISA Test System 12525-300B98/79 Anti-SARS-CoV-2 S1-RBD IgG AccuBind ELISA Kit - 96 wells 12525-300A98/79 D-Dimer AccuBind ELISA Kit - 192 wells 12025-300B98/79 D-Dimer AccuBind ELISA Kit - 96 wells 12025-300A98/79 D-Dimer AccuLite CLIA Kit - 192 wells 12075-300B98/79 D-Dimer AccuLite CLIA Kit - 96 wells 12075-300A98/79 IL-6 AccuBind ELISA Kit - 192 wells 13225-300B98/79 IL-6 AccuBind ELISA Kit - 96 wells 13225-300A98/79 IL-6 AccuLite CLIA Kit - 192 wells 13275-300B98/79 IL-6 AccuLite CLIA Kit - 96 wells 13275-300A98/79 IN006 IN006-2 IN006-3 IN008 IN009 IN010 IN013	A IVDR, 98/79	Site web info@monobind.com Fiche EUDAMED Signaler une erreur
Spinreact	Espagne	22% SEROLOGICAL ALBUMIN No98/79 30% SEROLOGICAL ALBUMIN No98/79 Anti-A Monoclonal Anti-A+B Monoclonal98/79 Anti-B Monoclonal98/79 36 autres Anti-C monoclonal2 réf.98/79 Anti-C+D+E monoclonal98/79 Anti-D IgG + IgM Monoclonal98/79 Anti-E monoclonal2 réf.98/79 Anti-human globulin polyspecific No98/79 Anti-Kell Monoclonal98/79 APTT No98/79 ATHROM-III NO6 réf.98/79 BACTERIAL ANTIGENS No45 réf.98/79 CALPRO-TURBI STOOL COLLECTION TUBE COAGULATION CAL No98/79 COAGULATION CONTROL N No98/79 COAGULATION CONTROL P No98/79 D-DIMER98/79 D-DIMER CAL 098/79 D-DIMER CONTROL 098/79 D-DIMER MD170923198/79 DIL-5 Diluent reagent Spincell 5 Series FIBRINOGEN2 réf.98/79 FOB-TURBI STOOL COLLECTION TUBE HEMOGLOBIN No98/79 LYS-3 Lyse reagent Spincell 3 series2 réf. LYS-5 Lyse reagent Spincell 5 series PT No5 réf.98/79 ROSE BENGAL No98/79 RPR-CARBON -CONTROL + No98/79 RPR-CARBON No3 réf.98/79 SHEA-5 Sheat reagent Spincell 5 series SPIN XL SPIN XS SPINCELL 3 No98/79 SPINCELL 3n No98/79 SPINCELL 5 Compact No98/79 SPINCELL 5 Plus98/79 TPHA No98/79 VDRL No2 réf.98/79	A, D IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Technogenetics FDA	Italie	AL1200 analyzer 120 IDS Borrelia Control Set IDS Borrelia IgG IDS Borrelia IgM IDS CMV Avidity Control Set 36 autres IDS CMV Control Set IDS CMV IgG IDS CMV IgG Avidity IDS CMV IgM IDS EBV Control Set IDS EBV EA IgG IDS EBV EBNA-1 IgG IDS EBV VCA IgG IDS EBV VCA IgM IDS HSV 1 IgG IDS HSV 1/2 IgG Control Set IDS HSV 1/2 IgM IDS HSV 1/2 IgM Control Set IDS HSV 2 IgG IDS Measles IgG IDS Measles IgM IDS MMV IgG Control Set IDS MMV IgM Control Set IDS Mumps IgG IDS Mumps IgM IDS Parvovirus B19 Control Set IDS Parvovirus B19 IgG IDS Parvovirus B19 IgM IDS Rubella Avidity Control Set IDS Rubella Control Set IDS Rubella IgG IDS Rubella IgM IDS Tetanus IgG IDS Tetanus IgG Control Set IDS TOXO Avidity Control Set IDS TOXO Control Set IDS TOXO IgG IDS TOXO IgG Avidity IDS TOXO IgM IDS VZV IgG IDS VZV IgM	A, B, C IVDR	Site web QA@TECHNOGENETICS.IT Fiche EUDAMED Signaler une erreur
Viramed FDA	Allemagne	Bordetella pertussis ViraChip IgA Antigen Coated Wells Bordetella Antibodies2 réf. Bordetella pertussis ViraChip IgA Deca Kit3 réf. Bordetella pertussis ViraChip IgA Positive Control3 réf. Borrelia All-In-One ViraChip AP-Anti-Human Conjugate Lyme Antibodies2 réf. Borrelia All-In-One ViraChip Deca Kit2 réf. 36 autres Borrelia All-In-One ViraChip Negative Control2 réf. Borrelia ViraChip IgG Antigen Coated Wells Lyme IgG Antibodies Borrelia ViraChip IgG Deca Kit2 réf. Borrelia ViraChip IgG Positive Control2 réf. Borrelia ViraChip IgM Antigen Coated Wells Lyme IgM Antibodies Borrelia ViraChip IgM Deca Kit2 réf. Borrelia ViraChip IgM Positive Control CMV ViraChip IgG Antigen Coated Wells CMV IgG Antibodies2 réf. CMV ViraChip IgG Deca Kit2 réf. CMV ViraChip IgG Positive Control3 réf. CMV ViraChip IgM Antigen Coated Wells CMV IgM Antibodies2 réf. CMV ViraChip IgM Deca Kit2 réf. CMV ViraChip IgM Positive Control2 réf. EBV ViraChip IgG Antigen Coated Wells EBV IgG Antibodies EBV ViraChip IgG Deca Kit2 réf. EBV ViraChip IgG Positive Control3 réf. EBV ViraChip IgM Antigen Coated Wells EBV IgM Antibodies EBV ViraChip IgM Deca Kit2 réf. EBV ViraChip IgM Positive Control2 réf. Helicobacter ViraChip IgA Antigen Coated Wells Helicobacter Antibodies2 réf. Helicobacter ViraChip IgA Deca Kit3 réf. Helicobacter ViraChip IgA Positive Control3 réf. Treponema + VDRL ViraChip IgG Antigen Coated Wells Syphilis IgG Antibodies2 réf. Treponema + VDRL ViraChip IgG Deca Kit2 réf. Treponema + VDRL ViraChip IgG Positive Control3 réf. Treponema + VDRL ViraChip IgM Antigen Coated Wells Syphilis IgM Antibodies2 réf. Treponema + VDRL ViraChip IgM Deca Kit2 réf. Treponema + VDRL ViraChip IgM Positive Control2 réf. ViraCam3 réf. ViraChip Chromogen / Substrate Solution2 réf. ViraChip Sample Buffer3 réf. ViraChip Wash Buffer Plus3 réf. ViraChip® AP-Anti-Human IgA Conjugate3 réf. Yersinia ViraChip IgA Deca Kit3 réf. Yersinia ViraChip IgA Positive Control3 réf. Yersinia ViraChip IgA,IgM Antigen Coated Wells Yersinia Antibodies2 réf.	A, B, C IVDR	Site web Fiche EUDAMED Signaler une erreur
Aesku FDA	Allemagne	AESKUBLOTS® Borrelia-G98/79 AESKUBLOTS® Borrelia-M98/79 AESKULISA® Cytomegalovirus IgG98/79 AESKULISA® Cytomegalovirus IgM98/79 AESKULISA® Toxoplasma gondii IgM98/79 35 autres AESKULISA® Annexin V-GM98/79 AESKULISA® Borrelia-G98/79 AESKULISA® Borrelia-M98/79 AESKULISA® Cholin-GM98/79 AESKULISA® Clostridium tetani IgG98/79 AESKULISA® Ethanolamine-A98/79 AESKULISA® Ethanolamine-GM98/79 AESKULISA® Free Protein S98/79 AESKULISA® Herpes Simplex Virus 1 (gG1) IgG98/79 AESKULISA® Herpes Simplex Virus 1/2 IgG98/79 AESKULISA® Herpes Simplex Virus 1/2 IgM98/79 AESKULISA® Herpes Simplex Virus 2 (gG2) IgG98/79 AESKULISA® HiT II98/79 AESKULISA® HiT II Check98/79 AESKULISA® Inositol-GM98/79 AESKULISA® Measles Virus IgG98/79 AESKULISA® Measles Virus IgM98/79 AESKULISA® Parvovirus B19 IgG98/79 AESKULISA® Parvovirus B19 IgM98/79 AESKULISA® Phospholipid-8Pro-A98/79 AESKULISA® Phospholipid-8Pro-GM98/79 AESKULISA® Phospholipid-Screen98/79 AESKULISA® Phospholipid-Screen-A98/79 AESKULISA® Phospholipid-Screen-GM98/79 AESKULISA® Protein C98/79 AESKULISA® Protein S98/79 AESKULISA® Rubella Virus IgG98/79 AESKULISA® Rubella Virus IgM98/79 AESKULISA® Sphingomyelin-GM98/79 AESKULISA® Thrombin-Check98/79 AESKULISA® Thrombin-GM98/79 AESKULISA® Toxoplasma gondii IgG98/79 AESKULISA® Varicella-Zoster Virus IgG98/79 AESKULISA® Varicella-Zoster Virus IgM98/79 AESKUSLIDES® COUNTERSTAIN (Evans Blue 0.2%)98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Aichek FDA Mandataire UE : Medunion S.L. (Espagne) et 1 autre	Chine	AI 1000 AI 1600,AI 1610,AI 1620,AI 1630 AI 2600, AI 2610, AI 2620, AI 2660, AI 26802 réf. AI 510F AI 600 35 autres Anti-HAV Hepatitis A Virus Antibody (CLIA)98/79 Anti-HAV IgM Hepatitis A Virus IgM Antibody (CLIA)98/79 Anti-TP Treponema Pallidum Antibody (CLIA)98/79 Automatic Chemiluminescence lmmunoanalyzer AI 8200, AI 8210,AI 8260 COVID-19 Antigen Rapid Test98/79 COVID-19 IgG/IgM Rapid Test98/79 COVID-19&Influenza A+B Antigen Rapid Test98/79 COVID-19/ InfluenzaA+B/RSV Antigen Combo Rapid Test COVID-19/ Influenza A+B/RSV Antigen Combo Rapid Test98/79 COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 COVID-19/Influenza A+B/RSV/Adenovirus/MP Antigen Combo Rapid Test98/79 D-Dimer Rapid Test D-D-D02a98/79 D-Dimer (CLIA)98/79 D-Dimer Test Kit FIA98/79 Dengue IgG/IgM Rapid Test DEAB-D02a98/79 Dengue IgG/IgM/NS1 Combo Rapid Test98/79 Dengue NS1 Rapid Test98/79 H. Pylori Antibody Rapid Test HP-D02a, HP-D01a98/79 H. Pylori Antigen Rapid Test HP-F02a98/79 Hp Ab Helicobacter Pylori Antibody (CLIA)98/79 HSV - 1 IgG Herpes Simplex Virus Type 1 IgG Antibody (CLIA)98/79 HSV - 2 IgG Herpes Simplex Virus Type 2 IgG Antibody (CLIA)98/79 IL-6 Interleukin-6 (CLIA)98/79 Influenza A+B Antigen Rapid Test FLU-B22b98/79 Malaria P.f. Antigen Rapid Test MAL-D02a98/79 Malaria P.f./P.an. Rapid Test MAL-D22a98/79 Malaria P.f./P.v. Rapid Test MAL-D22b98/79 PIC Plasmin-α2-Plasmin Inhibitor Complex (CLIA)98/79 Respiratory Syncytial Virus (RSV) Antigen Rapid Test RSV-B02b98/79 Rotavirus/Adenovirus Antigen Combo Rapid Test RAV-F22a98/79 Salmonella typhi & Salmonellaparatyphi Antigen Combo Rapid Test98/79 Strep A Antigen Rapid Test STA-B02b98/79 Strep B Antigen Rapid Test STB-K02a98/79 Syphilis Antibody Rapid Test SYP-D02a, SYP-D01a98/79 TAT Thrombin-Antithrombin III Complex (CLIA)98/79 tPAI·C Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)98/79	A IVDR, 98/79	ra.rep@aichek.com Fiche EUDAMED Signaler une erreur
Hain Lifescience	Allemagne	FluoroLyse VER 1.0 FluoroType® BKV HT VER 1.0 FluoroType® CT VER 1.098/79 FluoroType® HSV VER 1.098/79 FluoroType® MRSA VER 3.0 35 autres FluoroType® MTB VER 1.098/79 FluoroType® MTBDR VER 2.0 FluoroType® Mycobacteria VER 1.098/79 FluoroType® SARS-CoV-2/Flu/RSV VER 1.098/79 FluoroType® STI VER 1.098/79 GENERIC HBV VIRAL LOAD VER 2.0 GENERIC HIV-1 VIRAL LOAD VER 2.0 GenoLyse VER 1.0 GenoType CMdirect VER 1.098/79 GenoType HelicoDR VER 1.098/79 GenoType LepraeDR VER 1.098/79 GenoType MRSA VER 3.098/79 GenoType MTBC VER 1.X98/79 GenoType MTBDRplus VER 2.02 réf. GenoType MTBDRsl VER 2.02 réf.98/79 GenoType Mycobacterium AS VER 1.098/79 GenoType Mycobacterium CM VER 2.02 réf.98/79 GenoType NTM-DR VER 1.098/79 GT-Blot 48 GXT Blood Extraction Kit VER 2.0 GXT NA Extraction Kit VER 1.0 GXT96 X2 Extraction Kit VER 1.0 GXT96 X3 Extraction Kit VER 1.0 Inactivation Set VER 1.0 Liquefaction Set VER 1.0 LiquidArray® Gastrointestinal VER 1.0 LiquidArray® Gastrointestinal VER 2.0 LiquidArray® MTB-XDR VER 1.0 Proteinase K Set VER 1.0 Reagent Set for DNA•STRIP Kits SpheroLyse VER 1.0 Stool Buffer VER 1.0 SW Set VER 1.0 TwinCubator X2 Cartridge VER 1.0	A, C, D IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
AccuBioTech Mandataire UE : MDSS GmbH (Allemagne)	Chine	Accu-Tell® Clostridium difficile GDH Cassette (Feces)98/79 Accu-Tell® Chagas Cassette(Whole Blood/Serum/Plasma)98/79 Accu-Tell® Chagas Strip (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Chikungunya IgG/IgM Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Clostridium difficile GDH +Toxin A+ Toxin B Combo Cassette (Feces)98/79 34 autres Accu-Tell® Clostridium difficile Toxin A+ Toxin B Combo Cassette (Feces)98/79 Accu-Tell® D-Dimer Cassette (Whole Blood/Plasma/Serum)98/79 Accu-Tell® D-Dimer Strip (Whole Blood/Plasma/Serum)98/79 Accu-Tell® Dengue IgG/IgM Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Dengue IgG/IgM/NS1 Combo Cassette (Serum/Plasma)98/79 Accu-Tell® Dengue IgG/IgM/NS1 Combo Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Dengue NS1 Antigen Cassette (Serum/Plasma)98/79 Accu-Tell® Dengue NS1 Antigen Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Entamoeba histolytica Strip (Feces)98/79 Accu-Tell® Entamoeba Histolytica Cassette (Feces)98/79 Accu-Tell® Giardia lamblia Cassette (Feces)98/79 Accu-Tell® Giardia lamblia Strip (Feces)98/79 Accu-Tell® H. pylori Antigen Cassette (Feces)98/79 Accu-Tell® H. pylori IgG Cassette(Serum/Plasma)98/79 Accu-Tell® H. pylori IgG Strip (Whole Blood/Serum/Plasma)98/79 Accu-Tell® H. pylori IgG/IgM/IgA Cassette(Whole Blood/Serum/Plasma)98/79 Accu-Tell® H. pylori IgG/IgM/IgA Strip （Whole Blood/Serum/Plasma)98/79 Accu-Tell® Influenza A+B Cassette (Swab/Nasal Aspirate)98/79 Accu-Tell® Influenza A+B Strip (Swab/ Nasal Aspirate)98/79 Accu-Tell® Legionella Pneumophila Antigen Cassette (Urine)98/79 Accu-Tell® Malaria P.f. Cassette(Whole Blood)98/79 Accu-Tell® Malaria P.f./P.v. Cassette(Whole Blood)98/79 Accu-Tell® Norovirus Cassette (Feces)98/79 Accu-Tell® RSV Antigen Cassette (Swab)98/79 Accu-Tell® Strep A Cassette (Throat Swab)98/79 Accu-tell® Strep A Strip (Throat Swab)98/79 Accu-Tell® Syphilis Cassette (Serum/Plasma)98/79 Accu-Tell® Syphilis Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Syphilis Strip (Serum/Plasma)98/79 Accu-Tell® Syphilis Strip (Whole Blood/Serum/Plasma)98/79 Accu-Tell®H. pylori IgG Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell®Malaria p.f./p.v./pan Cassette(Whole Blood)98/79 Accu-Tell®Malaria P.f./Pan Cassette(Whole Blood)98/79 Accu-Tell®Malaria P.f./Pan Strip(Whole Blood)98/79	– 98/79	sales@accubiotech.com Fiche EUDAMED Signaler une erreur
Genrui Biotech FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	225 tests98/79 25 tests98/79 50T/Kit98/79 Auto Chemiluminescence Analyzer MT120S, MT120 Auto Chemiluminescence Immunoassay Analyzer MT60, MT60S2 réf. 34 autres Auto Chemistry Analyzer GS100 Auto Chemistry Analyzer GS300Plus, GS480A2 réf. Auto Hematology Analyzer KT-62, KT-60, KT-40, KT-422 réf. Auto Hematology Analyzer KT-630098/79 Coagulation Analyzer CA51, CA52, CA543 réf. D-Dimer Detection Kit (Nephelometry)98/79 D-Dimer Detection Kit (Nephelometry) 225 tests98/79 D-Dimer Detection Kit (Nephelometry) 25 tests98/79 D-Dimer test kit (Immunofluorescence) 25T/kit98/79 E-Z Cleanser FA20 Fully-auto Specific Protein Analyzer PA120 Fully-auto Specific Protein Analyzer PA480，PA2402 réf. GE30098/79 Interleukin 6 (IL-6) Quality Control98/79 Interleukin 6 (IL-6) Test Kit (Immunofluorescence) 25T/kit98/79 Interleukin 6 (IL-6) Test Kit (Immunofluorescence) 50T/Kit98/79 KT-4098/79 KT-6098/79 KT-650098/79 KT-651098/79 KT-660098/79 KT-661098/79 KT-800098/79 KT03 Diluent please see UDI-DI for details2 réf. KT03 Lyse Solution Please see UDI-DIs for details.2 réf. KT05 DIFF Lyse Please see UDI-DIs for details2 réf. KT05/KT05A LD Lyse2 réf. KT05A DIL Diluent KT05A LH Lyse Please see UDI-DIs for details3 réf. Probe Cleanser4 réf. Quantitative lmmunoassay Analyzer FA30, FA31 Quantitative lmmunoassay Analyzer FA50 Specific Protein Analyzer PA50, PA542 réf.	A, B IVDR, 98/79	Présent sur le marché en France Site web service@genrui-bio.com Fiche EUDAMED Signaler une erreur
Grifols FDA Mandataire UE : Diagnostic Grifols, S.A. (Espagne)	Espagne, Suisse, États-Unis	Anti-C3d Anti-Cw Mono-Type Dual Anti-Dia Dual Anti-H for DG Gel Anti-H Mono-Type 34 autres Anti-k (Cellano) Mono-Type Anti-Kpa Dual Anti-Kpb Dual Anti-Lea for DG Gel Anti-Lea Mono-Type Anti-Leb for DG Gel Anti-Leb Mono-Type Anti-Lua98/79 Anti-Lua for DG Gel Anti-Lub Mono-Type Dual Anti-M Mono-Type Dual Anti-N (LN3/MN879) Mono-Type Anti-P1 Mono-Type Dual Anti-S Mono-Type2 réf. Bromelase 3098/79 Data-Cyte Extend 0.8% DG Gel Confirm D DG Gel DC Scan DG Gel DC Scan Plus DG Reader Net DG Spin DG Therm DG-Papain98/79 Diego(a)-Cyte 0.8% Diego(a)-Cyte 3% Enlisst-II Erytra Erytra Eflexis Mi(a)-Cyte 0.8% Procleix Panther System2 réf. Serascan Diana Dia Specific Albumin 22% Specific Albumin 30% WADiana Compact	A, C, D IVDR, 98/79	Présent sur le marché en France Site web regulatoryaffairs_dxbu@grifols.com Fiche EUDAMED Signaler une erreur
Suzhou TianLong Biotechnology FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	Andes virus (ANDV) Nucleic Acid Detection Kit (Fluorescence PCR Method)2 réf.98/79 Astrovirus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Avian Influenza Virus H7 Universal/HPAI-H7/N9 Subtype RNA Detection Kit (Fluorescence PCR Method)98/79 Bacillus Pertussis Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Dengue Virus Genotyping (I/II/III/IV) Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 34 autres EB Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)2 réf.98/79 Ebola Virus (Zaire) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Enterovirus Universal RNA Detection Kit (Fluorescence PCR Method)98/79 Escherichia Coli DNA Detection Kit (Fluorescence PCR Method)98/79 Group B Streptococcus (GBS) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Hantaan Virus/Seoul Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Herpes Simplex Virus (HSV) II Nucleic Acid Detection Kit (Fluorescence PCR Method)2 réf.98/79 Human Adenovirus (Ad) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Human Influenza Virus A/B & Respiratory Syncytial Virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Human Influenza Virus A/B / Respiratory Syncytial Virus/SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Human Influenza Virus B (Yamagata&Victoria) and A (H1&H3) Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Human Influenza Virus B Genotyping (Yamagata&Victoria) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Human Metapneumovirus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Influenza A/B Virus RNA Detection Kit (Fluorescence PCR Method)98/79 Influenza A/Influenza B/Respiratory Syncytial Virus (RSV) Nucleic Acid Detection Kit (Fluorescence PCR Method-0.1mL Pre-filled)98/79 Legionella Pneumophila Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Listeria Monocytogenes DNA Detection Kit (Fluorescence PCR Method)98/79 Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Neisseria Gonorrhoeae (NG) Nucleic Acid Detection Kit (Fluorescence PCR Method)2 réf.98/79 Norovirus (NoV) Genotype GI/GII Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Respiratory 12 Types Virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Respiratory 15 Types Virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method-0.2mL Pre-filled)98/79 Respiratory Syncytial Virus Genotype A/B Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Respiratory Syncytial Virus Universal RNA Detection Kit (Fluorescence PCR Method)98/79 Respiratory Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Respiratory Virus Nucleic Acid Detection Kit (Fluorescence PCR Method; Pre-filled)98/79 Respiratory 17 Types Pathogen Multiplex Nucleic Acid Detection Kit (Fluorescence PCR Method; Freeze-dried)98/79 Respiratory 7 Types Pathogen Multiplex Nucleic Acid Detection Kit (Fluorescence PCR Method; Freeze-dried)98/79 Rotavirus Genotype A/B/C Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Rotavirus Universal RNA Detection Kit (Fluorescence PCR Method)98/79 Salmonella DNA Detection Kit (Fluorescence PCR Method)98/79 Salmonella Enterica/Shigella Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Staphylococcus Aureus DNA Detection Kit (Fluorescence PCR Method)98/79 ZiKa Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Becton Dickinson FDA Mandataire UE : Becton Dickinson Ireland Limited (Irlande)	États-Unis	A-LINE3 réf. BACTEC7 réf. BBL SENSI-DISC BD BBL™ Sensi-Disc™ 12- Place Self-Tamping Dispenser BBL SENSI-DISC BD BBL™ Sensi-Disc™ 6- Place Self-Tamping Dispenser BBL SENSI-DISC BD BBL™ Sensi-Disc™ 8- Place Self-Tamping Dispenser 33 autres BBL SENSI-DISC BD BBL™ Sensi-Disc™ Single Dispenser, 1 Each BBL SENSI-DISC BD BBL™ Sensi-Disc™ Single Dispenser, 6 Each BD BACTEC™ FX40 Instrument BD BACTEC™ FX40 System Software BD PhoenixSpec BD Respiratory Viral Panel-SCV2 for BD MAX™ System BD SurePath™ Collection Vial Kit 500 BD Vacutainer® Boric Acid Sodium Borate/Formate C&S Urine Tube98/79 BD Vacutainer® C&S Boric Acid Sodium Borate/Formate3 réf.98/79 BD Vacutainer® EDTA Blood Collection Tube98/79 BD Vacutainer® K3E Aprotinin Blood Collection Tube BD Vacutainer® RST Blood Collection Tube98/79 BD Vacutainer® SST™ Blood Collection Tube98/79 BD Vacutainer® Urinalysis Preservative Plus Urine Tube3 réf.98/79 BD Vacutainer® Urinalysis Preservative Tube98/79 BD Vacutainer® Urine Collection Cup98/79 BD Vacutainer® Z (No Additive) Plus Urine Tube98/79 BD Vacutainer® Z (No Additive) Plus Urine Tube-Conical2 réf.98/79 COR CYTORICH3 réf. MAX6 réf. MGIT Microtainer3 réf. MiniDraw2 réf. Not Applicable3 réf. Onclarity8 réf. Onclarity COR SurePath Totalys2 réf. Vacutainer21 réf. Vacutainer Barricor3 réf. Vacutainer PPT7 réf.98/79 VIPER	A, B, C IVDR, 98/79	Présent sur le marché en France Site web eudamedenquiries@bd.com Fiche EUDAMED Signaler une erreur
Cowingene Mandataire UE : MedPath GmbH (Allemagne)	Chine	Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit98/79 Cowingene Dengue Virus Detection Kit98/79 Cowingene Dengue Virus I/II/III/IV Detection Kit98/79 Cowingene Dengue Virus, Zika Virus and Chikungunya Virus Detection Kit98/79 Cowingene Diarrhea Virus Panel 6 Detection Kit98/79 33 autres Cowingene DNA/RNA Extraction Kit Cowingene Enterovirus Universal, EV71 and CoxA16 Detection Kit98/79 Cowingene Epstein-Barr Virus (EBV) Detection Kit98/79 Cowingene Group B Streptococcus Detection Kit98/79 Cowingene Herpes Simplex Virus 1/2 Detection Kit98/79 Cowingene HPV (2+12) Detection Kit98/79 Cowingene HPV (2+16) Detection Kit98/79 Cowingene HPV 15 E6/E7 Gene mRNA Detection Kit98/79 Cowingene HPV 15 Genotyping Detection Kit98/79 Cowingene HPV 16/18/45 Detection Kit98/79 Cowingene HPV 28 Genotyping Detection Kit98/79 Cowingene HPV 6/11 Detection Kit98/79 Cowingene HPV Genotyping Detection Kit98/79 Cowingene HPV Genotyping Pro Detection Kit98/79 Cowingene Influenza A/B and RSV Detection Kit98/79 Cowingene Monkeypox Virus Detection Kit98/79 Cowingene Monkeypox Virus Typing Detection Kit98/79 Cowingene MTB and NTM Detection Kit98/79 Cowingene Mycobacterium Tuberculosis Detection Kit98/79 Cowingene Mycoplasma Genitalium and Mycoplasma Hominis Detection Kit98/79 Cowingene Parvovirus B19 Detection Kit98/79 Cowingene Respiratory Pathogen Panel 21 Detection Kit98/79 Cowingene Respiratory Pathogen Panel Detection Kit98/79 Cowingene Respiratory Pathogen Panel Pro Detection Kit98/79 Cowingene Sample Release Reagent Cowingene SARS-CoV-2 & Influenza A/B Detection Kit98/79 Cowingene STI Multiplex Detection Kit98/79 Cowingene Varicella-Zoster Virus (VZV) Detection Kit98/79 Cowingene Viral DNA/RNA Column2 réf. Cwingene STI Multiplex Pro Detection Kit98/79 NATBox System SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method)98/79 SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography)98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Diagreat Mandataire UE : MedNet EC-REP GmbH (Allemagne) et 1 autre	Chine	2019-nCoV Antigen Rapid Test Kit 25 tests/box 2019-nCoV IgG Antibody Determination Kit 25 tests/box 2019-nCoV IgG/gM Antibody Rapid Test Kit 25 tests/box 2019-nCoV IgM Antibody Determination Kit 25 tests/box 25 tests/box 32 autres Acid Cleaning Solution 100mL×1 Alkaline Cleaning Solution 100mL×1 Automatic Chemiluminescence Immunoassay Analyzer DF100/DF100i Chemiluminescent Substrate 100mL×12 réf. Chemiluminescent Wash Solution 0 .5L×12 réf. D-Dimer CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box D-Dimer Determination Kit (Fluorescence Immunochromatographic Assay) 25 tests Dengue IgG/IgM Rapid Test Kit 25 tests/box Dengue NS1 Antigen & IgG/IgM Combo Rapid Test Kit 25 tests/box Dengue NS1 Antigen Rapid Test Kit 25 tests/box Group A Streptococcus Antigen Rapid Test Kit 25 tests/box Group B Streptococcus Antigen Rapid Test Kit 25 tests/box H. pylori Ag Determination Kit (Fluorescence Immunochromatographic Assay) 25 tests/box H. pylori Ag Rapid Test Kit 25 tests/box H.pylori Antibody Rapid Test Kit 25 tests/box Influenza A/B Antigen Rapid Test Kit 25 tests/box Interleukin-10 CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box Interleukin-1β CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box Interleukin-2 Receptor CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box Interleukin-6 CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box Interleukin-6 Determination Kit (Fluorescence Immunochromatographic Assay) 25 tests Interleukin-8 CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box Malaria P.f Antigen Rapid Test Kit 25 tests/box Malaria P.f/P.v Antigen Combo Rapid Test Kit 25 tests/box Malaria P.f/Pan Antigen Combo Rapid Test Kit 25 tests/box Mycoplasma Pneumoniae IgM Rapid Test Kit 25 tests/box PV and HB Combo Rapid Test Kit 25 tests/box Syphilis Antibody Rapid Test Kit 25 tests/box TB IgG/IgM Rapid Test Kit 25 tests/box Typhoid IgG/IgM Rapid Test Kit 25 tests/box Whole Blood Sample Extraction Reagent SF004 α Tumor Necrosis Factor CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box	A, B, C IVDR	Site web info@diagreat.com Fiche EUDAMED Signaler une erreur
Gensurebio Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Adenovirus Ag Rapid Test P202398/79 C.difficile GDH + Toxin A/B Combo Rapid Test P240898/79 C.difficile GDH Rapid Test P240998/79 C.difficile Toxin A/B Rapid Test P241098/79 Candida Albicans/Gardnerella Vaginalis/Trichomonas Vaginalis Ag Rapid Test P203298/79 32 autres Chikungunya IgG/IgM Ab Rapid Test P205498/79 COVID-19 Ag Rapid Test P200498/79 COVID-19 IgG+IgM Rapid Test P200298/79 COVID-19/Flu A+B Ag Rapid Test P2007C01, P2007C02, P2007C05, P2007C203 réf. COVID-19/Flu A+B/RSV/hMPV Ag Rapid Test P209798/79 COVID-19/Flu A+B/RSV/Radv/M.p Ag Rapid Test P209698/79 COVID-19/FluA+B/RSV/Radv/hMPV/M.p Ag Rapid Test P208598/79 COVID-19/FluA+B/RSV/Radv/hMPV/M.p/PIV Ag Rapid Test P208898/79 COVID-19/FluA+B/RSV/Radv/hMPV/PIV/hRV Ag Rapid Test P208798/79 COVID-19/RSV/Flu A+B Ag Rapid Test P2081C01, P2081C02, P2081C05, P2081C20.3 réf. COVID-19/RSV/Radv/Flu A/B Ag Rapid Test P203998/79 COVID-19/RSV/Radv/hMPV/Flu A+B Ag Rapid Test P208498/79 COVID-19/RSV/Radv/M.P/hMPV/hRV/Flu A+B Ag Rapid Test P208698/79 COVID19/FluA+B/RSV+Radv/hMPV+hRV/PIV/M.p Ag Rapid Test P208998/79 Dengue Virus Ab Rapid Test P204298/79 DIAGOTEC Strep A Rapid Test3 réf. EuroGen Flu A+B Ag Rapid Test3 réf. Group B Streptococcus (GBS) Ag Rapid Test P202798/79 H. pylori (HP) Ag Rapid Test P202098/79 H.pylori Ab (HP Ab) Rapid Test P202198/79 M. pneumoniae Antigen Rapid Test P208398/79 M. pneumoniae IgM/IgG Antibody Rapid Test P208298/79 Malaria P.f/P.v Antigen Rapid Test P204098/79 Malaria Pf/Pan Rapid Test P204198/79 Neisseria Gonorrhoeae Ag Rapid Test P204598/79 Norovirus Ag Rapid Test P202698/79 Respiratory Syncytial Virus (RSV) Rapid Test P200898/79 Rotavirus Ag Rapid Test P202298/79 RSV/Radv/Flu A+B Antigen Rapid Test P209098/79 Sinocare Strep A FIA KIT98/79 Strep A/COVID-19 Antigen Rapid Test P230398/79 Strep A/COVID-19/Flu A+B Ag Rapid Test P230498/79	C IVDR, 98/79	Site web info@gensurebio.com Fiche EUDAMED Signaler une erreur
Sclavo	Italie	APTT-E K3000205098/79 D DIMER GREEN K3000408BK98/79 DETERGENT SOLUTION G523237403 réf. FATTOE I PLASMA IMMUNODEPLETO K2910579098/79 FATTORE PLASMA IMMUNODEPLETO K2910579798/79 32 autres FATTORE IX PLASMA IMMUNODEPLETO K2910579498/79 FATTORE V PLASMA IMMUNODEPLETO K2910579198/79 FATTORE VII PLASMA IMMUNODEPLETO K2910579298/79 FATTORE VIII PLASMA IMMUNODEPLETO K2910579398/79 FATTORE X - PLASMA IMMUNODEPLETO K2910579598/79 FATTORE XI PLASMA IMMUNODEPLETO K2910579698/79 GIEMSA G54350250 K2900518598/79 K2900530198/79 LAC CONFIRM K3001100698/79 LAC SCREEN K3001000698/79 MAY GRUNWALD G54350150 PROTEINA C CROMOGENICA K2910554398/79 PROTEINA S LIBERA K2900552598/79 Sclavo %PT Direct INR Kit K2900549098/79 Sclavo Abnormal Control Plasma Kit K2900530298/79 Sclavo Antithrombin (Factor Xa) Kit K2900500098/79 Sclavo APTT-S Kit K2900555898/79 Sclavo APTT-S Kit K2900555998/79 Sclavo Auto D-Dimer High Control Kit K2910551098/79 Sclavo Auto D-Dimer Kit K2910550198/79 Sclavo Auto D-Dimer Low Control Kit K2910550998/79 Sclavo Cloruro di Calcio 0.025M K25001902 SCLAVO CLOT 4 Sclavo Fibrinogen Kit K2905376298/79 Sclavo Fibrinogen Kit K2905376598/79 SCLAVO PT READY QUICK K2900500598/79 Sclavo PT-HRTF Kit K2900600898/79 Sclavo PT-HRTF Kit K2900601898/79 SCLAVO SED 10 V0120211098/79 SCLAVO TT KIT K2900539298/79 SYSCLEAN G54350350	A IVDR, 98/79	qa@sclavo.it Fiche EUDAMED Signaler une erreur
Shenzhen Drawray Biotech Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	1000 pcs/bag,2 bags/box 30 Tests/kit 5 Tests/kit 20 Tests/kit2 réf. D-Dimer 20 tests/kit98/79 D-Dimer 5 tests/kit98/79 32 autres iStar 2000-A/ iStar 2000-B/ iStar 2000-C3 réf. iStar 500 iStar-D-dimer 30 Tests98/79 iStar-D-dimer Ⅱ 25 Tests/kit98/79 iStar-D-dimer Ⅱ 2×25 Tests/kit98/79 iStar-D-dimer Ⅱ 2×50 Tests/kit98/79 iStar-D-dimer Ⅱ 30 Tests/kit98/79 iStar-FDP 25 Tests/kit98/79 iStar-FDP 2×25 Tests/kit98/79 iStar-FDP 2×50 Tests/kit98/79 iStar-FDP 30 Tests/kit98/79 iStar-IL-6 30 Tests98/79 iStar-IL-6 Ⅱ 25 Tests/kit98/79 iStar-IL-6 Ⅱ 2×25 Tests/kit98/79 iStar-IL-6 Ⅱ 2×50 Tests/kit98/79 iStar-IL-6 Ⅱ 30 Tests/kit98/79 iStar-PIC 25 Tests/kit98/79 iStar-PIC 2×25 Tests/kit98/79 iStar-PIC 2×50 Tests/kit98/79 iStar-PIC 30 Tests/kit98/79 iStar-t-PAIC 25 Tests/kit98/79 iStar-t-PAIC 2×25 Tests/kit98/79 iStar-t-PAIC 2×50 Tests/kit98/79 iStar-t-PAIC 30 Tests/kit98/79 iStar-TAT 25 Tests/kit98/79 iStar-TAT 2×25 Tests/kit98/79 iStar-TAT 2×50 Tests/kit98/79 iStar-TAT 30 Tests/kit98/79 Unicorn-D-dimer 20 Tests/kit98/79 Unicorn-D-dimer 5 Tests/kit98/79 Unicorn-IL-6 20 Tests/kit2 réf.98/79 Unicorn-IL-6 5 Tests/kit2 réf.98/79	A, C IVDR, 98/79	Site web info@szdrawray.com Fiche EUDAMED Signaler une erreur
Antitoxin	Allemagne	ABO-trol® forte II or Medtrokarte NK498/79 ABO-trol® forte plus98/79 AHG serum blend98/79 Anti-A monoclonal, IgM clone: Birma-198/79 Anti-AB monoclonal, IgM clones: ES-15, ES-498/79 31 autres Anti-B monoclonal, IgM clone: LB-298/79 Anti-C monoclonal, human IgM clone: MS-27398/79 Anti-c monoclonal, human IgM clone: MS-3398/79 Anti-c monoclonal, human IgM clone: MS-3598/79 Anti-C monoclonal, human IgM clones: MS-24, P3X25513G898/79 Anti-CDE monoclonal, human IgM + IgG clones: MS-24, MS-201, MS-80, MS-2698/79 Anti-D blend monoclonal, human IgG+IgM clones: MS-26, TH-2898/79 Anti-D monoclonal, human IgM clone: P3x6198/79 Anti-D monoclonal, human IgM clone: RUM-198/79 Anti-E monoclonal, human IgM clones: MS-12, MS-26098/79 Anti-e monoclonal, human IgM clones: MS-16, MS-21, MS-6398/79 Anti-E monoclonal, human IgM clones: MS-258, 90698/79 Anti-e monoclonal, human IgM clones: MS-62, MS-6998/79 Anti-Fya Coombs-reactive, polyclonal, human98/79 Anti-Fya for card method Coombs-reactive, polyclonal, human98/79 Anti-Fyb Coombs-reactive, polyclonal, human98/79 Anti-Fyb for card method Coombs-reactive, polyclonal, human98/79 Anti-Jka Coombs-reactive, polyclonal, human98/79 Anti-Jka for card method, Coombs-reactive, polyclonal, human98/79 Anti-Jka for card method, monoclonal, human IgM clone: MS-1598/79 Anti-Jka monoclonal, human IgM clone: MS-1598/79 Anti-Jkb Coombs-reactive, polyclonal, human98/79 Anti-Jkb for card method, Coombs-reactive, polyclonal, human98/79 Anti-Jkb for card method, monoclonal, human IgM clone: MS-898/79 Anti-Jkb monoclonal, human IgM clone: MS-898/79 Anti-Jsb for card method monocolonal, IgG - 01.244-0298/79 Anti-K (KEL1) Coombs-reactive, polyclonal, human98/79 Anti-K (KEL1) monoclonal, human IgM clone: AEK-498/79 Anti-K (KEL1) monoclonal, human IgM clone: MS-5698/79 Anti-Leb for card method monoclonal, human clone: P3F234MD498/79 Anti-P1 for card method monoclonal, human IgM clone: P3NIL10098/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Spectrum For Diagnostic Industries Joint Stock Mandataire UE : MDSS GmbH (Allemagne)	Égypte	"S.typhi-S.paratyphi "A Direct Antigen Detection98/79 APTT Reagent98/79 APTT Reagent (SP-UNICELIN)2 réf.98/79 Brucella A/M5 réf.98/79 Brucella Abortus98/79 31 autres Brucella Combo2 réf.98/79 Brucella Melitensis98/79 Brucella Rose Bengal98/79 CMV IgG/IgM Rapid Test-Cassette98/79 D-Dimer Turbi Latex7 réf.98/79 FIBRINOGEN98/79 FIBRINOGEN Immuno - Turbidimetry98/79 FIBRINOGEN-LS Clauss Clotting Time Method2 réf.98/79 G6PD98/79 G6PD - single reagent98/79 Glucose-6-Phosphate dehydrogenase (G-6-PD)98/79 H. pylori Ab Rapid Test Cassette (Serum, Plasma and Whole Blood)98/79 H. pylori Ab Test98/79 H. pylori Ag Rapid Test Cassette (Fecal Specimen)98/79 H. pylori Ag Test98/79 Haemoglobin (Ready To Use)3 réf.98/79 Haemoglobin (Single Reagent)2 réf.98/79 Haemoglobin Drabkin's Solution2 réf.98/79 Hemoglobin (Ready-To-Use)Drabkin’s Solution2 réf.98/79 Malaria Antigen Test Card2 réf.98/79 Plasma control set For coagulation Assays98/79 PT Reagent (SP-Normoplastin)2 réf.98/79 PT Reagent ISI 1.052 réf.98/79 PT Reagent ISI 1.52 réf.98/79 Recoplastin ISI 1.0 PT Reagent4 réf.98/79 Rose Bengal Brucella Antigen4 réf.98/79 RPR Syphilis Test4 réf.98/79 S. Typhi/Para Typhi A Antigen2 réf.98/79 Typhoid IgG/IgM Rapid Test-Cassette98/79 Typhoid Rapid Test Cassette (Serum/Plasma/Whole Blood)98/79 Widal Test (Salmonella Ab)13 réf.98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Aitbiotech Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Singapour	30010798/79 30010898/79 30014298/79 30014398/79 30014498/79 30 autres 30015598/79 30015698/79 30018598/79 30018698/79 30022198/79 30022298/79 30026798/79 30026898/79 30027598/79 30027698/79 302011 302012 302013 302014 800505 800507 800580 800581 800582 800700 800702 800705 800800 800814 800827 800841 800941 800945 800971 801001	A IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Beijing Jinwofu Bioengineering Technology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Candida Albican (Ca) Ag Rapid Test98/79 Candida albicans，Trichomonas vaginalis，Gardnerella Antigen combined Test Kit98/79 Chagas Ab Rapid Test P2211098/79 D-Dime Test98/79 Dengue Ag+IgG/IgM Rapid Test P220122598/79 30 autres Ebola Antigen Rapid Test P221140198/79 Enterovirus 71 IgM Antibody Test Kit98/79 Flu A/B Ag Combo Test98/79 Gastric Helicobacter pylori (HP) polypeptide antigen Test kit98/79 Group A Streptococcus Antigen Test Kit98/79 Group B Streptococcus Antigen Test Kit98/79 HAV Ag One Step Rapid Test98/79 HAV lgM Rapid Test98/79 Helicobacter Pylori (HP) Urease Antibody Detection Kit98/79 Interleukin 6 (IL-6) Test98/79 JWF2 réf.98/79 JWF HPV Antigen Test Kit98/79 JWF Human Metapneumovirus (hMPV) Antigen Rapid test98/79 JWF® Dengue NS1 Ag Rapid Test98/79 JWF® EV 71/C A16 IgM Antibody Test Kit98/79 JWF® Helicobacter Pylori (HP) IgM/IgG Combo Test Kit98/79 Leishmania IgGIgM Ab Combo Rapid Test98/79 Malaria Pf/Pv Ag Test Kit98/79 Mononucleosis Rapid Test P2220372598/79 Mycoplasma pneumoniae IgG Antibody Test Kit P220062598/79 Mycoplasma pneumoniae IgM Antibody Test Kit P220052598/79 Neisseria gonorrhoeae Antigen Test Kit P220022598/79 Norovirus Antigen Test Kit P220262598/79 Respiratory Syncytial Virus (RSV) Rapid Test P2209598/79 Salmonella Antigen Test kit P220242598/79 Treponema pallidum antibodyTest Kit98/79 Trichomonas Vaginalis (Tv) Ag Rapid Test98/79 Tuberculosis Antibody Test Kit98/79 Tumour Necrosis Factor ALPHA (TNFALPHA) Test98/79 Typhoid IgG/IgM Combo Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bio-Optica Milano FDA	Italie	10% neutral buffered formalin (ready to use)3 réf. 10% neutral buffered formalin Fixatives for histology3 réf. ACID PHOSPHATASE Stain 05-06002/L3 réf. AUS240 B-Cyto microscope slides 50 pcs 30 autres B-Mount ISO 250 ml Mezzi di montaggio per istologia e citologia3 réf. B-Print C B-PRO450 Open2 réf. BCP1702 réf. BEC150 Bench Tech 1303 réf. Bio Mount HM3 réf. BIOPSY CASSETTE II3 réf. Bouin 1 flacone da 1 litro Fissativi per istologia Chemical Cabinet 12002 réf. CONTAINERS3 réf. Coverglasses3 réf. CVR909 Dual Cytocuvette - medium absorption2 réf. Embedding cassettes for histology for printers3 réf. Endokit KIT FOR THE CORRECT ORIENTING OF ENDOSCOPIC BIOPSIES2 réf. Eosin Y 1% aqueous solution3 réf. Formalin concentrate - 10 l2 réf. Giemsa Pappenheim3 réf. Immersion oil for optical microscope2 réf. MGG Quick Stain2 réf. Microscope slides3 réf. Mount Quick aqueous MULTIPURPOSE CONTAINERS3 réf. PC800 Hot plate for histology Reattivo di Schiff Feulgen 1 flacone da 250 ml Soluzioni coloranti per istologia SVF100 Oven for histology2 réf. Transport bags Bags for transport of biological samples TRIMMING TECH 1803 réf. WB 1002 réf.	A IVDR	Site web info@bio-optica.it Fiche EUDAMED Signaler une erreur
Bio-Rad FDA	France	Access HCV Ab V3 B3345898/79 Access HCV Ab V3 Calibrators B3345998/79 Access HCV Ab V3 QC B3346098/79 Access HIV combo V2 C2843098/79 Access HIV combo V2 Calibrators C2843198/79 30 autres Access HIV combo V2 QC C2843298/79 Access HIV combo V2 QC plus C4357698/79 CONCENTRATED WASHING SOLUTION (20X) EVOLIS2 réf. Geenius HIV 1/2 Confirmatory Assay 7246098/79 Geenius HIV 1/2 Confirmatory Controls 7232998/79 Geenius Reader IPS Pastorex Meningitis3 réf. Pastorex Staph-Plus2 réf. Pastorex Strep3 réf. Platelia Aspergillus Ag Platelia Aspergillus IgG Platelia Aspergillus IgG Negative & Positive controls Platelia Candida Ab Plus Platelia Candida Ab Plus Negative & Positive controls Platelia Candida Ag Plus Platelia Dengue NS1 Ag EIA Microplate Dengue NS1 Ag Platelia Rubella IgG Platelia Rubella IgM Platelia Toxo IgG Platelia Toxo IgG Avidity Platelia Toxo IgM PR 4100 PW 40 - Microplate Washer RPR2 réf. Syphilis Total Ab 7253098/79 Syphilis Total Ab 7253198/79 TPHA 7250398/79 TPHA 7250498/79	A, B, C IVDR, 98/79	Présent sur le marché en France Site web contact@bio-rad.com Fiche EUDAMED Signaler une erreur
Bioantibody Biotechnology Mandataire UE : Medunion S.L. (Espagne)	Chine	D-Dimer (DD) Rapid Quantitative Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79 D-Dimer (DD) Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 D-Dimer (DD) Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79 Dengue IgM/IgG Antibody Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79 Dengue IgM/IgG Antibody Rapid Quantitative Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79 30 autres Dengue IgM/IgG Antibody Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 Dengue IgM/IgG/NS1 Combo Rapid Test Kit (Lateral Chromatography) 1 Tests/Kit98/79 Dengue IgM/IgG/NS1 Combo Rapid Test Kit (Lateral Chromatography) 25 Tests/Kit98/79 Dengue IgM/IgG/NS1 Combo Rapid Test Kit (Lateral Chromatography) 5 Tests/Kit98/79 Dengue NS1 Antigen Rapid Quantitative Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79 Dengue NS1 Antigen Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 Dengue NS1 Antigen Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79 H. Pylori Antigen Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 H. Pylori Antigen Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79 H. Pylori Antigen Rapid Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79 Handheld Urine Analyzer BK150 Hematology Analyzer BK160 Influenza A&B Antigen Rapid Test Kit (Immunochromatographic Assay) 1 Test/Kit98/79 Influenza A&B Antigen Rapid Test Kit (Immunochromatographic Assay) 25 Tests/Kit98/79 Influenza A&B Antigen Rapid Test Kit (Immunochromatographic Assay) 5 Tests/Kit98/79 RSV Antigen Rapid Test Kit(Lateral Chromatography) 1 Test/Kit98/79 RSV Antigen Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 RSV Antigen Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV & MP Antigen Combo Rapid Test Kit(Lateral Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV & MP Antigen Combo Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV & MP Antigen Combo Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79 SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) 25 Tests/Kit98/79 SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) 5 Tests/Kit98/79 Syphilis Rapid Quantitative Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79 Syphilis Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 Syphilis Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Chronolab	Espagne	APTT, R1 5 x 4 mL, R2 5 x 4 mL98/79 Brucella abortus, 1 x 5 mL98/79 Brucella abortus, 20 x 5 mL98/79 Brucella mellitensis, 1 x 5 mL98/79 Brucella mellitensis, 20 x 5 mL98/79 30 autres Coagulation calibrator, 4 x 1 mL98/79 Coagulation control N, 4 x 1 mL98/79 Coagulation control P, 4 x 1 mL98/79 Fibrinogen, R1 8 x 2 mL, R2 1 x 100 mL, R3 1 x 3.5 mL98/79 Hemoglobin 50X, R: 4 x 5 mL, CAL: 1 x 1 mL98/79 Proteus OX19, 1 x 5 mL98/79 Proteus OX19, 20 x 5 mL98/79 Proteus OX2, 1 x 5 mL98/79 Proteus OX2, 20 x 5 mL98/79 Proteus OXK, 1 x 5 mL98/79 Proteus OXK, 20 x 5 mL98/79 Prothrombin Time, 4 x 4 mL98/79 Rose Bengal, 100 tests98/79 Salmonella Paratyphi AH, 1 x 5 mL98/79 Salmonella Paratyphi AH, 20 x 5 mL98/79 Salmonella Paratyphi AO, 1 x 5 mL98/79 Salmonella Paratyphi AO, 20 x 5 mL98/79 Salmonella Paratyphi BH, 1 x 5 mL98/79 Salmonella Paratyphi BH, 20 x 5 mL98/79 Salmonella Paratyphi BO, 1 x 5 mL98/79 Salmonella Paratyphi BO, 20 x 5 mL98/79 Salmonella Paratyphi CH, 1 x 5 mL98/79 Salmonella Paratyphi CH, 20 x 5 mL98/79 Salmonella Paratyphi CO, 1 x 5 mL98/79 Salmonella Paratyphi CO, 20 x 5 mL98/79 Salmonella Typhi H, 1 x 5 mL98/79 Salmonella Typhi H, 20 x 5 mL98/79 Salmonella Typhi O, 1 x 5 mL98/79 Salmonella Typhi O, 20 x 5 mL98/79 TPHA, 200 tests98/79	– 98/79	Site web info@chronolab.com Fiche EUDAMED Signaler une erreur
HEALSTONE Biotech FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Canada	Chikungunya IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCHK(IgM)-402a98/79 Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid) GCCr(Ag)-402a98/79 Dengue IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(ab)-402c98/79 Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(NS)-402c98/79 Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(NS)-402d98/79 30 autres Dengue NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN-425a98/79 Gonorrhea Rapid Test Cassette (Swab) GCGON-502b98/79 H. pylori Ab Rapid Test Cassette (Serum/Plasma) GCHP-302a98/79 H. pylori Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHP-402a98/79 H. pylori Ag Rapid Test Cassette (Feces) GCHP-602a98/79 HAV IgM Rapid Test Cassette (Serum/Plasma) GCHAV(IgM)-302Ba98/79 Human Papillomavirus E7 Protein Rapid Test Cassette (Swab) GCHPV-502a98/79 Human Parainfluenza Virus Type I / III and Adenovirus Detection Kit (Fluorescence PCR) APA0198/79 Influenza A/ B and Respiratory Syncytial Virus Detection Kit (Fluorescence PCR) AFR0198/79 Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pv)-402a98/79 Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pan)-402a98/79 Ocular viral Detection Kit (Fluorescence PCR) AOPV0198/79 One Step Chikungunya Ag Test Cassette (Whole Blood/Serum/Plasma) GCCHK-402a98/79 One Step Microalbumin Test Cassette (Urine) GIHSA-102a98/79 Rapid Human Adenovirus DNA Test RADV0198/79 Rapid Influenza A/B RNA test RFLU0198/79 Rapid Respiratory Syncytial Virus RNA Test RRSV0198/79 Rapid SARS-CoV-2 RNA test RCOV0198/79 SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR) ACAB0198/79 SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR) ACAB0298/79 SARS-CoV-2 & Omicron Variants Detection Kit (Fluorescence PCR) ACOV0898/79 SARS-CoV-2 Detection Kit (Direct Fluorescence PCR) ACOV0198/79 SARS-CoV-2 Detection Kit (Direct Fluorescence PCR) ACOV0298/79 SARS-CoV-2 Detection Kit (Fluorescence RT-PCR) ACOV0398/79 SARS-CoV-2 K417N/E484K Mutations Detection Kit (Fluorescence PCR) ACOV0598/79 SARS-CoV-2 N501Y/HV69-70del Mutations Detection Kit (Fluorescence PCR) ACOV0498/79 Syphilis Ab Rapid Test Cassette (Serum/Plasma) GCSYP-302a98/79 Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma) GCTB-302a98/79 Vaginal pH Rapid Test Cassette (Swab) VPH-502a98/79 Zika NS1 Ag Rapid Test Cassette (Whole blood/Serum/Plasma) GCZIK(NS1)-402a98/79	– 98/79	sales@orientgene.com Fiche EUDAMED Signaler une erreur
Mpbio FDA Mandataire UE : MP Biomedicals Germany GmbH (Allemagne)	Allemagne, Singapour	AutoScan PRO 4.0 Dengue NS1 Antigen Rapid Test98/79 Diagnostic Kit for D-Dimer 07CTNL502598/79 Immunofluorescence Analyzer MPQuanti™ MP Diagnostics ASSURE H. pylori Antigen Rapid Test98/79 30 autres MP Diagnostics ASSURE H. pylori Rapid Test98/79 MP Diagnostics HBsAg ELISA 4.1 23470-096 (96 wells)98/79 MP Diagnostics HBsAg ELISA 4.1 23470-480 (480 wells)98/79 MP Diagnostics Helico Blot 2.198/79 MP Diagnostics Helico Blot 2.1 MP Diagnostic Helico Blot 2.198/79 MP Diagnostics HEV ELISA98/79 MP Diagnostics HEV ELISA 4.098/79 MP Diagnostics HEV lgM ELISA 3.098/79 MP Diagnostics HIV Ag/Ab Combo ELISA 4.0 23040-09698/79 MP Diagnostics HIV Ag/Ab Combo ELISA 4.0 23040-48098/79 MP Diagnostics MULTISURE HIV 1/2 Confirmatory Test98/79 MP Diagnostics MULTISURE HIV 1/2 Confirmatory Test Controls98/79 MP Diagnostics MULTISURE HIV Rapid Test98/79 MP Diagnostics MULTISURE® Dengue Ab/Ag Rapid Test98/79 Rapid 2019-nCoV IgG/IgM Combo Test Card98/79 Rapid Dengue NS1 Antigen Test Card98/79 Rapid H.pylori Antigen Test Card98/79 Rapid Influenza A + B Antigen Test Card98/79 Rapid Influenza A Antigen Test Card98/79 Rapid Salmonella typhi IgG/IgM Combo Test Card2 réf.98/79 Rapid SARS-CoV-2 Antigen Test Card2 réf.98/79 Rapid SARS-CoV-2 Antigen Test Card (1 Test Box)98/79 Rapid SARS-CoV-2 Antigen Test Card (1 test per box NL)98/79 Rapid SARS-CoV-2 Antigen Test Card (20 tests per box)98/79 Rapid SARS-CoV-2 Antigen Test Card (5 tests per box)98/79 Rapid SARS-CoV-2 Antigen Test Card (5 tests per box, NL)98/79 Rapid SARS-CoV-2 Antigen Test Card (7 tests per box)98/79 Rapid SARS-CoV-2 Antigen Test Card (8 tests per box)98/79 Rapid SARS-CoV-2 Influenza A+B Antigen Duo Test Card98/79 Rapid Zika Virus IgG/IgM Combo Test Card2 réf.98/79	A IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Oxoid FDA Mandataire UE : Thermo Fisher Diagnostics B.V. (Pays-Bas)	United Kingdom (ex Northern Ireland)	AMPLIFIED IDEIA HP STAR KIT CRYPTOCOCCUS ANTIGEN LATEX TEST KIT R30851501 DRYSPOT E. COLI O157 DRYSPOT LEGIONELLA PNEUMOPHILA 13 réf. E. COLI O157 TEST KIT 30 autres EXTRACTION ENZYME DR0593G IMAGEN Adenovirus98/79 IMAGEN CHLAMYDIA KIT IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDE IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPE 1 and 2 IMAGEN hMPV98/79 IMAGEN hMPV Positive Control Slide98/79 IMAGEN HSV POSITIVE CONTROL SLIDE IMAGEN Influenza Virus A and B98/79 IMAGEN Parainfluenza Virus Types 1, 2 and 32 réf.98/79 IMAGEN Respiratory Syncytial Virus (RSV)98/79 IMAGEN TEFLON COATED SLIDES (100/BOX) Infectious Mononucleosis Test Kit DR0780M98/79 LEGIONELLA LATEX TEST DR0800M LEGIONELLA PNEUMO GROUP 13 réf. OXOID SALMONELLA PATHODXTRA POSITIVE CONTROL PATHODXTRA STREP GROUP A LATEX3 réf. PATHODXTRA STREP GROUPING KIT POLYVALENT POSITIVE CONTROL DR0592G ProSpecT C. difficle Toxin A/B Microplate Assay98/79 ProSpecT Campylobacter Microplate Assay98/79 ProSpecT Entamoeba histolytica Microplate Assay98/79 PROSPECT GIARDIA / CRYPTOSPORIDIUM MICROPLATE ASSAY2 réf. PROSPECT GIARDIA MICROPLATE ASSAY ProSpecT Rotavirus Microplate Assay98/79 PROSPECT WASH BUFFER RAPID HP STAR LATERAL FLOW KIT STREPTOCOCCAL GROUPING KIT DR0585A STREPTOCOCCAL GROUPING REAGENT A DR0586G3 réf.	A, B, C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Progenie molecular S.L.U	Espagne	RealCycler ADNV-ABI3298/79 RealCycler ADNV-UX98/79 RealCycler ADVQ98/79 RealCycler AURI-ABI3298/79 RealCycler AURI-UX98/79 30 autres RealCycler AURQ98/79 RealCycler B19Q98/79 RealCycler BBUR-ABI3298/79 RealCycler BBUR-UX98/79 RealCycler BHOLPP-ABI3298/79 RealCycler BHOLPP-UX98/79 RealCycler BKVQ98/79 RealCycler BOAD-ABI3298/79 RealCycler BOAD-UX98/79 RealCycler BORD-ABI3298/79 RealCycler BORD-UX98/79 RealCycler BORDETEL-P1-ST198/79 RealCycler BPAQ98/79 RealCycler BPEQ98/79 RealCycler CDIF-ABI3298/79 RealCycler CDIF-UX98/79 RealCycler CHAG-ABI3298/79 RealCycler CHAG-UX98/79 RealCycler CORO-ABI32 v.6.298/79 RealCycler CORO-UX v.6.298/79 RealCycler COROFLUR-ABI3298/79 RealCycler COROFLUR-UX98/79 RealCycler COXI-ABI3298/79 RealCycler COXI-UX98/79 RealCycler DONO-ABI3298/79 RealCycler DONO-UX98/79 RealCycler EBAR-ABI3298/79 RealCycler EBAR-UX98/79 RealCycler EBVQ98/79 RealCycler ECSALI-UX98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Titolchimica	Italie	BLU ALCIAN 8 GX2 réf. BLU CRESIL BRILLANTE BOUIN fissativo CARAZZI EMALLUME CYTOBIOLOGIC FLUID (ROSSO)2 réf. 30 autres CYTOBIOLOGIC URINE (VERDE)2 réf. EOSINA GIALLASTRA 0,5% ALCOLICA2 réf. EOSINA GIALLASTRA 1% ACQUOSA FISSATIVO B5 FORMALINA 10% v/v (4% p/v)3 réf. GIEMSA REAGENTE3 réf. KIT ROSSO CONGO KIT ZIEHL NEELSEN LOEFFLER BLU METILENE SOLUZIONE MAY GRUNWALD REAGENTE3 réf. MAYER EMALLUME3 réf. MAYER EMALLUME modificato MONTANTE PTX UNIVERSALE 10% MONTANTE SINTETICO PER VETRINI2 réf. MONTANTE SINTETICO PER VETRINI metodo con isoparaffina2 réf. OLIO DI IMMERSIONE PAPANICOLAOU ARANCIO G (SOLUZIONE OG6)3 réf. PAPANICOLAOU ARANCIO II SOLUZIONE3 réf. PAPANICOLAOU EMATOSSILINA sec. GILL ( I )2 réf. PAPANICOLAOU EMATOSSILINA sec. GILL ( II )2 réf. PAPANICOLAOU EMATOSSILINA sec. GILL ( III ) PAPANICOLAOU EMATOSSILINA sec. HARRIS3 réf. PAPANICOLAOU SOLUZIONE EA 503 réf. Papanicolaou Soluzione EA653 réf. PARAFFINA GOCCE PF 56-58 per uso istologico PERLS KIT SCHIFF REAGENTE PER ISTOLOGIA2 réf. STERNHEIMER-MALBIN colorante per microscopia3 réf. SUDAN soluzione alcolica satura ZIEHL-NEELSEN FUCSINA FENICATA2 réf.	A IVDR	Site web info@titolchimica.it Fiche EUDAMED Signaler une erreur
C-Luminary Biotechnology Mandataire UE : Share info GmbH (Allemagne) et 1 autre	Chine	Cuvettes 2000 Pcs/Box Folate Releasing Agent 3.65 mL/Vial Sample Processing Solution 50mL/Vial2 réf. Sharay (1-3)-β-D-Glucan (CLIA)98/79 Sharay (1-3)-β-D-Glucan (CLIA) R1+R398/79 30 autres Sharay Cytokine Profile (CLIA) Model 10: Sharay IFN-γ2 réf.98/79 Sharay Cytokine Profile (CLIA) Model 10: TNF-α2 réf.98/79 Sharay Cytokine Profile (CLIA) Model 11: Sharay TNF-α98/79 Sharay Cytokine Profile (CLIA) Model 12: Sharay IFN-α2 réf.98/79 Sharay Cytokine Profile (CLIA) Model 1: IL-1β2 réf.98/79 Sharay Cytokine Profile (CLIA) Model 1: Sharay IL-1β98/79 Sharay Cytokine Profile (CLIA) Model 2: IL-22 réf.98/79 Sharay Cytokine Profile (CLIA) Model 2: Sharay IL-298/79 Sharay Cytokine Profile (CLIA) Model 3: IL-42 réf.98/79 Sharay Cytokine Profile (CLIA) Model 3: Sharay IL-498/79 Sharay Cytokine Profile (CLIA) Model 4: IL-52 réf.98/79 Sharay Cytokine Profile (CLIA) Model 4: Sharay IL-598/79 Sharay Cytokine Profile (CLIA) Model 5: IL-62 réf.98/79 Sharay Cytokine Profile (CLIA) Model 5: Sharay IL-698/79 Sharay Cytokine Profile (CLIA) Model 6: IL-82 réf.98/79 Sharay Cytokine Profile (CLIA) Model 6: Sharay IL-898/79 Sharay Cytokine Profile (CLIA) Model 7: IL-102 réf.98/79 Sharay Cytokine Profile (CLIA) Model 7: Sharay IL-1098/79 Sharay Cytokine Profile (CLIA) Model 8: IL-12p7098/79 Sharay Cytokine Profile (CLIA) Model 8: Sharay IL-12p7098/79 Sharay Cytokine Profile (CLIA) Model 9: IL-172 réf.98/79 Sharay Cytokine Profile (CLIA) Model 9: Sharay IL-1798/79 Sharay D-Dimer(CLIA)98/79 Sharay FDP (CLIA)98/79 Sharay IL-2R (CLIA)2 réf.98/79 Sharay PIC (CLIA)98/79 Sharay t-PAIC (CLIA)98/79 Sharay TAT (CLIA)98/79 Vitamin B12 Releasing Agent 3.65 mL/Vial Sharay IL-6 (CLIA)98/79 (plus commercialisé)	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
3Bblackbio Mandataire UE : Wellkang Ltd (Irlande du Nord)	Inde	TRUPCR® Bacterial / Fungal DNA Extraction Kit2 réf. TRUPCR® Bacterial DNA Extraction Kit2 réf. TRUPCR® Blood DNA Extraction Kit2 réf. TRUPCR® Blood RNA Extraction Kit TRUPCR® BS DNA Extraction Kit 29 autres TRUPCR® CMV QT Kit3 réf. TRUPCR® FFPE Tissue DNA Extraction Kit TRUPCR® Influenza A/B & RSV with SARS-CoV-2 RT qPCR Kit3 réf. TRUPCR® Leptospira Detection Kit3 réf. TRUPCR® Magbead Blood DNA Extraction Kit TRUPCR® Magbead FFPE Tissue DNA Extraction Kit2 réf. TRUPCR® Magbead MTB/NTM DNA Extraction Kit2 réf. TRUPCR® Magbead Tissue DNA Extraction Kit2 réf. TRUPCR® Magbead Total Nucleic Acid Extraction Kit2 réf. TRUPCR® Magbead Total Viral Nucleic Acid Extraction Kit2 réf. TRUPCR® Magbead Viral RNA Extraction Kit2 réf. TRUPCR® Meningitis Panel Kit3 réf. TRUPCR® MTB/NTM DNA Extraction Kit TRUPCR® MTBC OneStep Nested Kit3 réf. TRUPCR® Neuro Panel Kit3 réf. TRUPCR® Panel Extraction Kit TRUPCR® Respiratory Pathogen Panel Kit3 réf. TRUPCR® SARS-CoV-2 RT qPCR Kit TRUPCR® STD Panel Kit3 réf. TRUPCR® Tissue DNA Extraction Kit TRUPCR® TORCH Panel Kit3 réf. TRUPCR® Total Nucleic Acid Extraction Kit4 réf. TRUPCR® Total Nucleic Acid Extraction Kit (500ul) TRUPCR® Total Viral Nucleic Acid Extraction Kit (500ul)98/79 TRUPCR® Total Nucleic Acid Extraction Kit (500µl) TRUPCR® Total Viral Nucleic Acid Extraction Kit (500µl) TRUPCR® Total Viral Nucleic Acid Extraction Kit2 réf. TRUPCR® Toxoplasma Real-Time PCR Detection Kit3 réf. TRUPCR® Tropical Fever Panel Kit3 réf. TRUPCR® Viral RNA Extraction Kit2 réf. TRUPCRÂ® Flu Panel with RSV detection Kit3 réf.	A, B, C IVDR, 98/79	Site web info@3bblackbio.com Fiche EUDAMED Signaler une erreur
Hangzhou Immuno Biotech Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	Adenovirus Antigen Rapid Test HADV026G98/79 Borrelia Burgdorferi Antibody Rapid Test98/79 Brucella IgG/IgM Antibody Rapid Test HBRU039T98/79 Campylobacter Antigen Rapid Test HCP032G98/79 Chagas IgG/IgM Rapid Test HCHA011T98/79 29 autres Chikungunya IgG/IgM Rapid Test HCHI012T98/79 Chlamydia Antigen Rapid Test HCT024G98/79 Clostridium difficile Antigen Rapid Tes98/79 Clostridium dificile GDH, Toxin A and Toxin B Combo Rapid Test98/79 Dengue IgG/IgM And NS1 Combo Rapid Test98/79 Dengue IgG/IgM Rapid Test HDEN005T98/79 Dengue NS1 Antigen Rapid Test98/79 Ebola Virus Nucleic Acid Detection Kit PEB00198/79 Giardia Lamblia Antigen Rapid Test HGIA030G98/79 Gonorrhea Antigen Rapid Test98/79 H. pylori Antigen Rapid Test HHP033G98/79 Herpes Simplex Virus HSV1/2 IgG/IgM Rapid Test Cat.No.:HHSV074T98/79 Human Papilloma Virus (HPV) Antigen Rapid Test HHPV071G98/79 Influenza A Antigen Rapid Test HFLU015GA98/79 Influenza A+B Antigen Combo Test HFLU014GAB98/79 Leishmania IgG/IgM Rapid Test HLSH003T98/79 Leptospira IgG/IgM Rapid Test HLEP002T98/79 Lyme Borrelia IgG/IgM Rapid Test98/79 Malaria P.f./Pan Antigen Rapid Test HMAL013G98/79 Norovirus Antigen Rapid Test HNV029G98/79 Respiratory Syncytial Virus Antigen Rapid Test HRSV022G98/79 Rotavirus Antigen Rapid Test HROTA027G98/79 Salmonella Typhi Antigen Rapid Test98/79 Strep A Antigen Rapid Test HSTR034GA98/79 Syphilis Antibody Rapid Test HTP063T98/79 Tuberculosis IgG/IgM Rapid Test98/79 Zika Virus IgG/IgM And NS1 Combo Test98/79 Zika virus IgG/IgM Rapid Test :HZIK009T98/79 Zika virus NS1 Antigen Rapid Test98/79	– 98/79	info@jgbiotech.com Fiche EUDAMED Signaler une erreur
LifeGlobal Group FDA Mandataire UE : CooperSurgical Distribution B.V. (Pays-Bas)	États-Unis	A700-23093/42 CCLS-08293/42 Coda A700-11593/42 Coda Air® 800 A800-00893/42 Coda Air® 900: A900-00993/42 29 autres Coda Air® CCSK-90093/42 Coda GCAU-11593/42 Coda GCAU-23093/42 CodaAir® 900 A900-10993/42 Coda® Aero® CAFK-90093/42 Coda® Aero® GCAF-00193/42 Coda® Aero® GCAF-00293/42 Coda® Aero® GCAF-70293/42 Coda® C2IU-01093/42 Coda® CAPP-11593/42 Coda® CAPP-23093/42 Coda® CCTA-08193/42 Coda® CCTS-08193/42 Coda® CIPR-00193/42 Coda® CPMA-03593/42 Coda® CPMS-03593/42 Coda® CXBL-00193/42 Coda® Eco GEAK-150093/42 Coda® Eco GECO-11593/42 Coda® Eco GECO-23093/42 Coda® Eco GELT-11593/42 Coda® Eco GELT-23093/42 Coda® Eco GESA-150093/42 Coda® GCIF-00193/42 Coda® GCIU-01093/42 Coda® lnline® GILC-03593/42 Coda® lnline® GMAG-04593/42 Coda® Lo-Boy® CCLA-08293/42 Coda® Xtra lnline® CXGR-00193/42	I 93/42	Ra@coopersurgical.com Fiche EUDAMED Signaler une erreur
Lifescan FDA Mandataire UE : LifeScan Deutschland GmbH (Allemagne)	Suisse	OneTouch Select Plus Flex 02435498/79 OneTouch Select Plus Flex 0243550198/79 OneTouch Select Plus Flex 02435698/79 OneTouch Select Plus Flex 02435798/79 OneTouch Select Plus Flex 02437298/79 29 autres OneTouch SelectPlus 02320898/79 OneTouch SelectPlus 02320998/79 OneTouch SelectPlus 02321098/79 OneTouch SelectPlus 02321198/79 OneTouch SelectPlus 02321698/79 OneTouch SelectPlus 02376498/79 OneTouch SelectPlus 02376798/79 OneTouch SelectPlus 02376898/79 OneTouch SelectPlus 02376998/79 OneTouch SelectPlus Flex 02341498/79 OneTouch SelectPlus Flex 02341698/79 OneTouch SelectPlus Flex 02341898/79 OneTouch SelectPlus Flex 02342098/79 OneTouch SelectPlus Flex 02352098/79 OneTouch Ultra Plus Reflect 02393998/79 OneTouch Ultra Plus Reflect 02394098/79 OneTouch Verio Flex 02318398/79 OneTouch Verio Flex 02318898/79 OneTouch Verio Flex 02319098/79 OneTouch Verio Reflect 02390898/79 OneTouch Verio Reflect 02390998/79 OneTouch Verio Reflect 02391098/79 OneTouch Verio Reflect 02391198/79 OneTouch Verio Reflect 02391398/79 OneTouch Verio Reflect 02391698/79 OneTouch Verio Reflect 02391798/79 OneTouch Verio Reflect 02392098/79 OneTouch Verio Reflect 02405498/79 OneTouch Verio Reflect 02407698/79	– 98/79	Présent sur le marché en France info@lifescan.ch Fiche EUDAMED Signaler une erreur
Molbio Diagnostics Mandataire UE : QbD RepS BV (Belgique)	Inde	STABILYSE Prep Free 90101PF05, 90101PF20, 90101PF25, 90101PF503 réf. Truemix COVID-19 70143000898/79 Truemix COVID-19 70143002498/79 Truemix COVID-19 70143004898/79 Truemix COVID-19 70143009698/79 29 autres Truenat COVID-19 60143000598/79 Truenat COVID-19 60143002098/79 Truenat COVID-19 60143002598/79 Truenat COVID-19 60143005098/79 Truenat CT/NG 601160005, 601160020, 601160025, 601160050, 601160100, 6011602003 réf. Truenat Influenza A/B 60120000598/79 Truenat Influenza A/B 60120002098/79 Truenat Influenza A/B 60120002598/79 Truenat Influenza A/B 60120005098/79 Truenat LTS 60140000598/79 Truenat LTS 60140002098/79 Truenat LTS 60140002598/79 Truenat LTS 60140005098/79 Truenat Malaria Pv/Pf 60101002098/79 Truenat Malaria Pv/Pf 60101005098/79 Truenat MTB Plus 60113000598/79 Truenat MTB Plus 60113002098/79 Truenat MTB Plus 60113002598/79 Truenat MTB Plus 60113005098/79 Truenat MTB-RIF Dx 60121000598/79 Truenat MTB-RIF Dx 60121002098/79 Truenat MTB-RIF Dx 60121002598/79 Truenat MTB-RIF Dx 60121005098/79 Truenat® Malaria Pv/Pf 60101000598/79 Truenat® Malaria Pv/Pf 60101002598/79 Trueprep AUTO MTB Sample Pre-treatment Pack 60204AS05, 60204AS20, 60204AS25, 60204AS503 réf. Trueprep AUTO Universal Cartridge Based Sample Prep Kit 60203AR25, 60203AR502 réf. Trueprep AUTO Universal Sample Pre-treatment Pack 60205AB05, 60205AB20, 60205AB25, 60205AB503 réf. Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Kit 60207AR50	A, C IVDR, 98/79	Site web customersupport@molbiodiagnostics.com Fiche EUDAMED Signaler une erreur
Sigma-Aldrich Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	AMYLOID STAIN, CONGO RED HT60-1KT AUTOMATED WRIGHT STAIN SET WSHT-1SET CARBOL FUCHSIN SOLUTION HT70 and HT803 réf. ELASTIC STAIN HT25A-1KT EOSIN Y SOLUTION ALCOHOLIC HT1103 réf. 29 autres FETAL HEMOGLOBIN Kit 285C-1KT and 285D-1KT2 réf. FONTANA-MASSON KIT HT200-1KT GIEMSA STAIN, MODIFIED GS and MG3 réf. GRAM STAIN KIT FOR FILMS HT90A-1KT and HT90T-1KT2 réf. HARRIS HEMATOXYLIN SOLUTION, MODIFIED HHS3 réf. HEMATOXYLIN SOLUTION, GILL NO 1 GHS3 réf. IRON STAIN HT20-1KT LEUCOCYTE ALKALINE PHOSPHATASE KIT 86C-1KT and 86R-1KT2 réf. Leukocyte Acid Phosphatase (TRAP) Kit 386A-1KT Leukocyte Acid Phosphatase (TRAP) Kit 387 387A-1KT Leukocyte Alkaline Phosphatase Kit 85L1 85L1-1KT and 85L2-1KT2 réf. LEUKOCYTE NAPHTHOL AS-D CHLOROACETATE (SPECIFIC ESTERASE) KIT 90A1-1KT and 90C2-1KT2 réf. LEUKOCYTE NAPHTHOL AS-D CHLOROACETATE (SPECIFIC ESTERASE) KIT 91A-1KT and 91C-1KT2 réf. Leukocyte Peroxidase (Myeloperoxidase) Kit 390 390A-1KT Leukocyte Peroxidase (Myeloperoxidase) Kit 391 391A-1KT MAYERS HEMATOXYLIN SOLUTION MHS3 réf. MUCICARMINE STOCK SOLUTION HT302 réf. PAPANICOLAOU STAIN EA 50 HT403 réf. Periodic Acid-Schiff (PAS) Staining System 395 395B-1KT RETICULOCYTE STAIN R4132-120ML RETICULUM STAIN KIT HT102A-1KT SCOTT'S TAP WATER SUBSTITUTE CONCENTRATE S5134-6X100ML SILVER STAIN HT100A-1KT Sudan Black B Staining System 380B-1KT TRICHROME STAIN (MASSON) HT15-1KT TRICHROME STAIN AB SOLUTION HT102 réf. WEIGERTS IRON HEMATOXYLIN SET HT1079-1SET WRIGHT STAIN, MODIFIED WG / WS3 réf. α-NAPHTHYL BUTYRATE ESTERASE, KIT, PART 1 181B-1KT	A IVDR	Présent sur le marché en France Site web customer.caredesk@milliporesigma.com Fiche EUDAMED Signaler une erreur
Trinitybiotech FDA Mandataire UE : TrinityBiotech (Irlande)	États-Unis	Bartels Legionella Urinary Antigen Test Kit B1029-44098/79 Bio-Rad Malaria EIA Test Kit 7252698/79 Bio-Rad Malaria EIA Test Kit 7252898/79 Bio-Stat Syphilis EIA Test Kit YY6012698/79 Captia EBNA-1 IgG Test Kit 232580098/79 29 autres Captia EBNA-1 IgG Test Kit 232580198/79 Captia EBV EA-D IgG Test Kit 232500098/79 Captia EBV EA-D IgG Test Kit 232500198/79 Captia EBV VCA (P-18) IgG Test Kit 232470098/79 Captia EBV VCA (P-18) IgG Test Kit 232470198/79 Captia EBV VCA IgG Test Kit 232570098/79 Captia EBV-VCA IgM Test Kit 232576098/79 Captia EBV-VCA IgM Test Kit 232576198/79 Captia H. pylori IgA Test Kit 232643098/79 Captia H. pylori IgG Test Kit 234640098/79 Captia H. pylori IgG Test Kit 234640198/79 Captia HSV 1 IgM Test Kit 232546098/79 Captia HSV 2 IgM Test Kit 232556098/79 Captia HSV Combined IgM Test Kit 232666098/79 Captia Legionella pneumophila IgG/IgM Test Kit 234698098/79 Captia Malaria EIA Test Kit 232247198/79 Captia NMT Syphilis IgM EIA 232936098/79 Captia Syphilis (T. pallidum) IgG Test Kit 800-96098/79 Captia Syphilis (T. pallidum) IgG Test Kit 800-97098/79 Captia Syphilis TA EIA Test Kit 232217098/79 Captia Syphilis TA EIA Test Kit 232217198/79 Captia™ Cytomegalovirus IgM kit 232526098/79 Captia™ Cytomegalovirus IgM kit 232526198/79 Captia™ Malaria EIA98/79 Platelia EB-NA-1 IgG Test Kit 7293998/79 Platelia EBV-EA-D IgG Test Kit 7293898/79 Platelia EBV-VCA IgG Test Kit 7293798/79 Platelia EBV-VCA IgM Test Kit 7293698/79 Syphilis IgM EIA Test Kit 7252098/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Arkray FDA Mandataire UE : ARKRAY Europe, B.V. (Pays-Bas) et 1 autre	Inde, Japon	ADAMS A1c (HA-8180)98/79 ADAMS A1c (HA-8180T)3 réf. ADAMS A1c (HA-8180V)3 réf. ADAMS A1c (HA-8190V)2 réf. ADAMS A1c (HA-8380V)98/79 32 autres ADAMS A1c Lite (HA-8380V) AUTION ELEVEN (AE-4020)6 réf. AUTION EYE (AI-4510)98/79 AUTION MAX (AX-4030)3 réf.98/79 AUTION MAX (AX-4060)3 réf.98/79 AutionIDaten (AE-4070)3 réf. Crystal Crystal 58IC104-25, 58IC104-50 Crystal Dengue NS1 GLUCOCARD S (GT-7110)5 réf.98/79 GLUCOCARD S onyx (GT-7120)6 réf.98/79 GLUCOCARD W (GT-7210)7 réf.98/79 OSMO STATION (OM-6050)3 réf.98/79 OSMO STATION (OM-6060)3 réf.98/79 OSMO STATION 2 (OM-6070)98/79 PARAHIT-F VER. 1.0 Rapid Test for P. falciparum Malaria Device PocketChem BA (PA-4140)3 réf. PocketChem UA (PU-4010)8 réf. SPOTCHEM D-01 (SD-3810)2 réf. SPOTCHEM D-02 (SD-4810)2 réf. SPOTCHEM D-03 (SD-4820)2 réf. SpotChem D-Concept 2c (SD-4830) SpotChem D-Concept 2e (SD-4840) SPOTCHEM EL (SE-1520)4 réf. SpotChem EL 2 (SE-1530) SPOTCHEM EZ (SP-4430)3 réf. The Lab 001 (CE-8810)2 réf. The Lab 004 (DB-3910) GLUCOCARD SM (GT-7120)2 réf.98/79 (plus commercialisé) GLUCOCARD Vital (GT-1050)98/79 (plus commercialisé) GLUCOCARD X-meter (GT-1910)98/79 (plus commercialisé) GLUCOCARD X-mini plus (GT-1960)3 réf.98/79 (plus commercialisé)	A, B, C IVDR, 98/79	Présent sur le marché en France Site web support_arkrayeurope@arkray.co.jp Fiche EUDAMED Signaler une erreur
Autobio FDA Mandataire UE : Obelis s.a. (Belgique)	Chine	AutoBC 450 AutoBC 450 AutoBC 450 Series-SL3 réf. AutoChem B2000 AutoChem B2200 AutoChem B2600 AutoChem B28003 réf. AutoChem B861(With ISE Module) AutoChem B861(Without ISE Module)2 réf. Autof ms1000 Autof ms1600 31 autres Autof ms2000 Autof ms2600 Autof ms600 Autof ms800 AutoFlex 120 AutoFlex 120Se2 réf. AutoFluid Autolas X-1 Centrifuge CT Autolas X-1 Series AutoLumo S900 AutoLumo S920 AutoLumo S960 AutoLumo S9803 réf. Automatic Luminescence Immunoassay Analyzer AutoLumo A1800, AutoLumo A1820, AutoLumo A1860, AutoLumo A18803 réf. Automatic Luminescence Immunoassay Analyzer AutoLumo A2000Plus Automatic Luminescence Immunoassay Analyzer AutoLumo A6000、AutoLumo A6200、AutoLumo A6600、AutoLumo A68003 réf. AutoMimo 1200 AutoMimo R8 AutoMimo Z1 AutoMolec 1600 AutoMolec 3000 AutoMolec 1600 AutoStreak S1800; AutoStreak S1800S2 réf. BC60 Plus BC60， BC60 Se，BC60-120， BC60-180，BC60-240，BC60-300，BC60-3603 réf. M1600-PCR Tube M1600-Tip Tray M3000-PCR Tube M3000-Tip Tray Reaction Vessel CMO0601 Reaction Vessel（box) CMO0701 Sample Management Module SDM SDM AutoBes X Series-SL (plus commercialisé) AutoBes X, AutoBes X-R2 réf. (plus commercialisé) BC120 Plus, BC120 Plus-240, BC120 Plus-6003 réf. (plus commercialisé)	A, C IVDR	Site web Fiche EUDAMED Signaler une erreur
Accumaxlab Mandataire UE : mdi Europa GmbH (Allemagne)	Inde	ACT-005-B-S98/79 ACT-005-B-S-A98/79 ACT-005-B-S-C98/79 ACT-005-L-B-S98/79 ACT-017-B-S98/79 29 autres ACT-017-B-S-A98/79 ACT-017-B-S-C (C= GREEN/ ORANGE/ PINK/ RED/ YELLOW/ VIOLET)98/79 ACT-017-L-B-S98/79 ACT-020-B-S98/79 ACT-020-B-S-A98/79 ACT-020-B-S-C (C= GREEN/ ORANGE/ PINK/ RED/ YELLOW/ VIOLET)98/79 ACT-020-L-B-S98/79 ACT-15-B-S98/79 ACT-15-R-S98/79 ACT-15-S-W98/79 ACT-50-B98/79 ACT-50-B-S98/79 ACT-50-K-B98/79 ACT-50-K-B-S98/79 ACT-50-K-S-W98/79 ACT-50-R98/79 ACT-50-R-S98/79 ACT-50-S-W98/79 CENTRIFUGE iFuge D06 Clinical Centrifuge iFuge C4000NXT iFuge CS03 NXT iFuge CS2P NXT iFuge CYTO iFuge D08 iFuge GC 12 iFuge GC12 iFuge HCT NXT iFuge UC02 iFuge UC02R iFuge CS04 NXT (plus commercialisé)	A IVDR, 98/79	Site web compliance@accumaxlab.com Fiche EUDAMED Signaler une erreur
BeijingModern GaoDa Biotechnology Mandataire UE : Medunion S.L. (Espagne)	Chine	1 T/kit3 réf.98/79 1 Test/Kit2 réf.98/79 10 T/kit98/79 10 test /kit98/79 10 Tests/Kit98/79 28 autres 100 test /kit98/79 100 Tests/Kit98/79 100T/kit6 réf.98/79 15 T/kit3 réf.98/79 15T/kit2 réf.98/79 1T/kit3 réf.98/79 20 test /kit98/79 20 Tests/Kit98/79 20T/kit98/79 25 test/kit98/79 40 T/kit4 réf.98/79 40 test /kit98/79 40 Tests/Kit98/79 40T/kit2 réf.98/79 5 T/kit2 réf.98/79 5T/kit2 réf.98/79 Cassette： 1T/kit2 réf.98/79 Cassette：100T/kit2 réf.98/79 Cassette：15T/kit2 réf.98/79 Cassette：40T/kit2 réf.98/79 Cassette：5T/kit2 réf.98/79 Strip： 1000T/kit98/79 Strip：1 T/bag2 réf.98/79 Strip：100 T/kit98/79 Strip：1000 T/kit98/79 Strip：100T/kit98/79 Strip：25T/canister2 réf.98/79 Strip：50T/ kit2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chengdu Legend-Tec Technology Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Anti-Human CD3 Antibody APC2 réf.98/79 Anti-Human CD3 Antibody APC-Cy72 réf.98/79 Anti-Human CD3 Antibody BV4212 réf.98/79 Anti-Human CD3 Antibody BV5102 réf.98/79 Anti-Human CD3 Antibody BV6052 réf.98/79 28 autres Anti-Human CD3 Antibody BV6502 réf.98/79 Anti-Human CD3 Antibody BV7112 réf.98/79 Anti-Human CD3 Antibody BV7502 réf.98/79 Anti-Human CD3 Antibody FITC2 réf.98/79 Anti-Human CD3 Antibody PE2 réf.98/79 Anti-Human CD3 Antibody PE-Cy72 réf.98/79 Anti-Human CD3 Antibody PerCP2 réf.98/79 Anti-Human CD3 Antibody PerCP-Cy5.52 réf.98/79 Anti-Human CD3 Antibody V4502 réf.98/79 Anti-Human CD4 Antibody APC2 réf.98/79 Anti-Human CD4 Antibody APC-AF7002 réf.98/79 Anti-Human CD4 Antibody APC-Cy72 réf.98/79 Anti-Human CD4 Antibody BV4212 réf.98/79 Anti-Human CD4 Antibody BV5102 réf.98/79 Anti-Human CD4 Antibody BV6052 réf.98/79 Anti-Human CD4 Antibody BV6502 réf.98/79 Anti-Human CD4 Antibody BV7112 réf.98/79 Anti-Human CD4 Antibody BV7862 réf.98/79 Anti-Human CD4 Antibody FITC2 réf.98/79 Anti-Human CD4 Antibody Pacific Blue2 réf.98/79 Anti-Human CD4 Antibody PE2 réf.98/79 Anti-Human CD4 Antibody PE-Cy72 réf.98/79 Anti-Human CD4 Antibody PerCP2 réf.98/79 Anti-Human CD4 Antibody PerCP-Cy5.52 réf.98/79 Anti-Human CD8 Antibody APC2 réf.98/79 Anti-Human CD8 Antibody APC-Cy72 réf.98/79 Anti-Human CD8 Antibody FITC2 réf.98/79 Anti-Human CD8 Antibody PE4 réf.98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Dispomed For Manufacturing Medical Laboratory Supplies Mandataire UE : EUROMED Authorized Services Kft (Hongrie)	Égypte	Dispomed Petri dish 10001 Dispomed Petri dish 10002 Dispomed Petri Dish 10003 Dispomed Urine cup 20001 Dispomed Urine cup 20002 28 autres Dispovac Gel 3.5ml 51503 Dispovac Glucose tube (Sod. Fluoride + k2 EDTA) 2ml 54102 Dispovac Glucose tube (Sod. Fluoride + k2 EDTA) 4ml 54104 Dispovac Glucose tube 2ml 54002 Dispovac Glucose tube 4ml 54004 Dispovac k2 1ml 52201 Dispovac k2 2ml 52202 Dispovac k2 3ml 52203 Dispovac k2 4ml 52204 Dispovac k3 1ml 52301 Dispovac k3 2ml 52302 Dispovac k3 3ml 52303 Dispovac k3 4ml 52304 Dispovac LH 2ml 56002 Dispovac LH 4ml 56004 Dispovac NAH 2ml 56102 Dispovac NAH 4ml 56104 Dispovac No additive 1ml 50001 Dispovac No additive 2ml 50002 Dispovac No additive 4ml 50004 Dispovac Serum 1ml 51001 Dispovac Serum 2ml 51002 Dispovac Serum 4ml 51004 Dispovac sodium citrate 3.2% 53001 Dispovac sodium citrate for ESR 2ml 55002 ProLab Petri dish 10011 ProLab Petri dish 10012 ProLab Urine cup 20011	A IVDR	Fiche EUDAMED Signaler une erreur
E-LAB Biological Science & Technology Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Auto Chemiluminescence Immunoassay Analyzer IA120, IA121, IA122, IA150, IA151, IA152, IA180, IA181, IA182, IA1200, IA201, IA2023 réf. Auto Chemistry Analyzer : BT-600L, BT-610L, BT-620L, BT-630L, BT-800L, BT-810L, BT-820L, BT-830L3 réf. Auto Chemistry Analyzer AS-800, AS-600, AS-480, AS-450, AS-380, AS-350, AS-280, AS-240,AS-160, AS-120, ES-480, ES-400, ES-380, ES-320, ES-2003 réf. Auto Chemistry Analyzer BT-120,BT-120P,BT-120M,BT-160,BT-160P,BT-160M,BT-200,BT-200P,BT-200M,BT-240,BT-240P,BT-240M,BT-300,BT-300P,BT-300M,BT-330,BT-330P,BT-330M3 réf. Auto Chemistry Analyzer BT-200L、BT-210L、BT-220L、BT-240L、BT-260L、BT-280L、BT-300L、BT-310L、BT-320L、BT-340L、BT-360L、BT-380L、BT-400L、BT-410L、BT-420L、BT-440L、BT-460L、BT-480L3 réf. 28 autres Auto Coagulation Analyzer CL-1200, CL-1200l, CL-1150, CL-1150l, CL-1100, CL-1100l, CL-650, CL-650l, CL-600, CL-600l, CL-550, CL-550l3 réf. Auto Hematology Analyzer EC-2098/79 Auto Hematology Analyzer EC-2198/79 Auto Hematology Analyzer EC-2898/79 Auto Hematology Analyzer EC-3098/79 Auto Hematology Analyzer EC-3198/79 Auto Hematology Analyzer EC-3698/79 Auto Hematology Analyzer EC-3898/79 Auto Hematology Analyzer EC-38A98/79 Auto Hematology Analyzer EC-38B98/79 Auto Hematology Analyzer EC-51098/79 Auto Hematology Analyzer EC-51198/79 Auto Hematology Analyzer EC-51298/79 Auto Hematology Analyzer EC-51398/79 Auto Hematology Analyzer EC-51498/79 Auto Hematology Analyzer EC-51598/79 Auto Hematology Analyzer EC-51698/79 Auto Hematology Analyzer EC-51798/79 Auto Hematology Analyzer EC-51898/79 Auto Hematology Analyzer EC-51998/79 Hematology Analyzer Diluent E5-D 20L×1,10L×1,5.5L×2,5.5L×13 réf. Hematology Analyzer Diluent 20L×1，10L×1，5.5L×2，5.5L×13 réf. Hematology Analyzer Lyse E5-LH 200mL×4,200mL×1,100mL×4,100mL×13 réf. Hematology Analyzer Lyse 200ml×4，100ml×4，500ml×1，250ml×1 ，100ml×13 réf. Hematology Analyzer Lyse E5-DIFF 500mL×4，500mL×2，500mL×13 réf. Probe Cleanser 50mLx1,17mL×122 réf. Semi-Auto Chemistry Analyzer ES-105、ES-104、ES-103、ES-102、ES-101C、ES-100P、ES-100C、ES-90C、ES-903 réf. Semi-Auto Coagulation Analyzer CL100, CL200, CL4003 réf.	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Hologic FDA Mandataire UE : Hologic BV (Belgique)	États-Unis	Aptima Assay Fluids3 réf. Aptima Cervical Specimen Collection and Transport Kit3 réf. Aptima Chlamydia trachomatis Assay Aptima CMV Quant Assay3 réf. Aptima Combo 2 Assay2 réf. 28 autres Aptima Controls Kit Aptima CV/TV Assay3 réf. Aptima DBS Extraction Buffer3 réf. Aptima HBV Quant Assay3 réf. Aptima HCV Quant Dx Assay3 réf. Aptima Herpes Simplex Viruses 1 & 2 Assay2 réf. Aptima HIV-1 Quant Dx Assay3 réf. Aptima HPV 16 18/45 Genotype Assay2 réf. Aptima HPV Assay3 réf. Aptima Mycoplasma genitalium Assay2 réf. Aptima Neisseria gonorrhoeae Aptima SARS-CoV-2 Assay2 réf. Aptima Trichomonas vaginalis Assay3 réf. Cellient Automated Cell Block System Filter Cassette Kit3 réf. Compass Stainer Panther Fusion AdV/hMPV/RV Assay2 réf. Panther Fusion Flu A/B/RSV Assay2 réf. Panther Fusion GBS Assay2 réf. Panther Fusion GI Bacterial Assay2 réf. Panther Fusion GI Expanded Bacterial Assay2 réf. Panther Fusion Internal Control-B3 réf. Panther Fusion MRSA Assay2 réf. Panther Fusion Paraflu Assay2 réf. Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay2 réf. ThinPrep Arcless Microscope Slides3 réf. ThinPrep Integrated Imager2 réf. ThinPrep Stain Bluing II Solution3 réf. Tomcat Instrument	A, B, C, D IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Kangjian FDA Mandataire UE : Humiss Beratung GmbH (Allemagne) et 2 autres	Chine	A4 réf. ACD tube, trisodium citrate/citric acid/glucose3 réf. B5 réf. blood coagulation test tube, trisodium citrate3 réf. blood glucose test tube, heparin lithium/fluoride3 réf. 28 autres blood glucose test tube, heparin sodium/fluoride3 réf. blood glucose test tube, K2-EDTA/fluoride3 réf. blood glucose test tube, K3-EDTA/fluoride3 réf. blood glucose test tube, Na2-EDTA/fluoride3 réf. blood glucose test tube. oxalate/fluoride3 réf. blood routine examination tube, K2-EDTA3 réf. blood routine examination tube, K3-EDTA3 réf. blood routine examination tube, Na2-EDTA3 réf. blood sedimentation test tube, trisodium citrate3 réf. Capillary Blood Collection Tube3 réf. cell preparation tube, heparin lithium/glucose/gel3 réf. cell preparation tube, heparin sodium/glucose/gel3 réf. cell preparation tube, trisodium citrate/glucose/gel3 réf. clot activator tube3 réf. DNA preservation tube, DNA solution3 réf. gel & clot activator tube3 réf. heparin tube, heparin lithium3 réf. heparin tube, heparin lithium/gel3 réf. heparin tube, heparin sodium3 réf. heparin tube, heparin sodium/gel3 réf. KJLC-I no additive tube3 réf. PPT tube, K2-EDTA/gel3 réf. PPT tube, K3-EDTA/gel3 réf. PPT tube, Na2-EDTA/gel3 réf. saliva collection and preservation system98/79 SPS tube, SPS solution/Saline solution3 réf. Type B	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Nordic Biomarker	Suède	Control Level 12 réf. Control Level 22 réf. D-Dimer Calibrator K50452 réf. D-Dimer Control High SC109K D-Dimer Control Low SC108K 28 autres D-Dimer Latex LRT3 réf. D-Dimer PBS Diluent2 réf. MRX Antithrombin98/79 MRX Antithrombin Calibrator98/79 MRX APTT2 réf. MRX Blue D-dimer MRX Blue Free Protein S98/79 MRX Calcium Chloride3 réf. MRX D-dimer DDU Calibrator MRX FDP Clear Calibrator Set98/79 MRX Fib Clauss98/79 MRX Fib Clauss Calibrator98/79 MRX Free Protein S Calibrator98/79 MRX Green D-dimer MRX Green FDP98/79 MRX Green vWF Antigen98/79 MRX Laboratory Water MRX Protein C98/79 MRX Protein C Calibrator98/79 MRX PT Buffer3 réf. MRX PT Quick98/79 MRX PT Quick (INR) Calibrator Set98/79 MRX Red Free Protein S98/79 MRX Sample Diluent2 réf. MRX Specialty Abnormal Control MRX Specialty Normal Control MRX Thrombin Time98/79 MRX vWF Antigen Calibrator98/79	A, C IVDR, 98/79	Site web info@nordicbiomarker.com Fiche EUDAMED Signaler une erreur
Quimica Clinica Aplicada	Espagne	AGS. FEB. SALMONELLA, CTRL+98/79 Alcian Blue (1 x 250 mL) Alcoholic Eosin 1% (1 x 1000 mL)3 réf. ANTIGENOS FEBRILES: CONTROL POSITIVO PROTEUS98/79 ANTITROMBINA III98/79 28 autres Antígenos Febriles: Control Positivo Brucella98/79 B5 FIXATIVE (1 x 1000mL)3 réf. BRUCELLA ABORTUS98/79 BRUCELLA MELITENSIS98/79 CALIBRADOR DE COAGULACIÓN98/79 Carazzi’s Hematoxylin (1 x 1000 mL)3 réf. CITRATO SODICO 3.2%3 réf. CONTROLES DE COAGULACIÓN98/79 FIBRINÓGENO98/79 Giemsa (1 x 1000 mL)3 réf. HEMOSCANN®2 réf.98/79 LEISHMAN STAIN (1x125mL) Masson’s Trichrome stain (5 x 250mL)3 réf. MAY-GRÜNWALD (1 x 1000 mL)3 réf. Myeloperoxidase (330 mL) Nuclear Fast Red 0,1%2 réf. Papanicolaou EA-36 (1 x 1000 mL)3 réf. PARAFFIN DMSO PEARLS2 réf. PAS (SOLUCIÓN AC. PERIODICO 0,5%) PERIODIC ACID SOLUTION 0.5% PLASMASCANN® LIQUIDO2 réf.98/79 PROTEUS OX 1998/79 QUICK PANOPTIC CONCENTRATED 1:10 (3 x 100 mL)3 réf. ROSA DE BENGALA98/79 Schiff's Reagent (1 x 500mL) Shorr’s stain (1 x 500 mL) Sudan Black kit (2 x 100mL) TINCIÓN SEDIMENTO URINARIO WRIGHT (1 x 1000 mL)2 réf.	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Tellgencorp Mandataire UE : MedNet EC-REP GmbH (Allemagne) et 1 autre	Chine	Aspergillus Galactomannan (GM) Assay Kit (CLIA)（)18 réf.98/79 D-Dimer（CLIA)8 réf.98/79 Dengue Virus 1-4/Zika Virus/Chikungunya Virus Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Dengue Virus Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Dengue Virus/Zika Virus/ Chikungunya Virus Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 28 autres EVU/CoxA16 and EV71 Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 FDP (CLIA)12 réf.98/79 Fungus (1-3)-β-D-glucan Assay Kit (CLIA)12 réf.98/79 HPV 2+1298/79 HPV 5+998/79 HPV15 Genotyping Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Human Papillomavirus Nucleic Acid Detection and 16/18 Typing Kit based on Cartridge Real-Time PCR Platform98/79 IL-6 (CLIA)8 réf.98/79 Interleukin-1 β Assay Kit（CLIA）12 réf.98/79 Interleukin-10 Assay Kit（CLIA）12 réf.98/79 Interleukin-12p70 Assay Kit（CLIA）12 réf.98/79 Interleukin-17A Assay Kit（CLIA）12 réf.98/79 Interleukin-2 Assay Kit（CLIA）12 réf.98/79 Interleukin-4 Assay Kit（CLIA）12 réf.98/79 Interleukin-5 Assay Kit（CLIA）12 réf.98/79 Interleukin-8 Assay Kit（CLIA）12 réf.98/79 MTB/RIF Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 MTB/XDR Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Mycobacterium tuberculosis Complex Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Mycobacterium tuberculosis Complex, Mycobacterium avium Complex and Mycobacterium abscessus Complex Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Mycobacterium tuberculosis, Haemophilus influenzae and Streptococcus pneumoniae Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 PIC (CLIA)12 réf.98/79 SARS-CoV-2 /Influenza A/Influenza B/RSV Nucleic Acid Detection Kit98/79 SARS-CoV-2 /Influenza A/Influenza B/RSV/ADV/MP/MPV Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 TAT(CLIA)12 réf.98/79 TellgenplexTM HPV27 genotyping Assay98/79 TM-7 (CLIA)12 réf.98/79 Tumour Necrosis Factor-α Assay Kit（CLIA）11 réf.98/79	– 98/79	Site web sales@tellgen.com Fiche EUDAMED Signaler une erreur
InTec PRODUCTS Mandataire UE : MedNet EC-REP GmbH (Allemagne) et 1 autre	Chine	69361558COVID19-AG-BE**X5 ITP1601398/79 AQ+ COVID-19 Ag Rapid Test ITP160424 réf.98/79 AQ+ COVID-19 Ag Rapid Test ITP1604498/79 AQ+ COVID-19 Ag Rapid Test ITP16044-TC25-98/79 AQ+Rapid SARS-CoV-19/ Flu Combo Test ITP160503 réf.98/79 31 autres COVID-19/FluA&B/RSV Ag Combo Rapid Test ITP18260398/79 ITP01152-TC4098/79 ITP01153-TC1098/79 ITP02153-TC1098/79 ITP02153-TC4098/79 ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test ITP710023 réf.98/79 ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST ITP030042 réf.98/79 One Step Dengue NS1 Ag Test ITP7100398/79 ONE STEP H. pylori Ag Test ITP100032 réf.98/79 ONE STEP H. pylori Ag Test ITP1021398/79 ONE STEP Malaria(p.f.) Test ITP110022 réf.98/79 ONE STEP Malaria(p.f/p.v) Tri-line Test ITP110032 réf.98/79 Rapid Anti-H.Pylori Test ITP100022 réf.98/79 Rapid Anti-H.Pylori Test ITP102122 réf.98/79 Rapid Anti-HEV-IgM Test ITP0911012 réf.98/79 Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test ITP710044 réf.98/79 Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test ITP7100598/79 Rapid Flu A Test ITP08100198/79 Rapid Flu A/B Test ITP08100398/79 Rapid Flu B Test ITP08100298/79 Rapid Malaria Test (P.f/Pan) ITP110052 réf.98/79 Rapid Mycoplasma Pneumoniae IgM test ITP1500198/79 Rapid Rota-Adenovirus Combo Test ITP1400398/79 Rapid Rotavirus Test ITP1400198/79 Rapid SARS-CoV-2 Antigen Test ITP160103 réf.98/79 Rapid SARS-CoV-2 Antigen Test ITP1601398/79 W0105040601 ITP1400298/79 ITP01152-TC2598/79 (plus commercialisé) ITP01153-TC4098/79 (plus commercialisé) ITP02152-TC2598/79 (plus commercialisé) ITP02152-TC4098/79 (plus commercialisé)	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Amos Scientific Pty Mandataire UE : Luxus Lebenswelt GmbH (Allemagne)	Australie	AVTP2500 Carousel Tissue Processor ATP200 Cryo Console AEC380-C Cryo Console TEC2800-C Drying Oven ADO260 27 autres Embedding Center AEC380 Embedding Center AEC380-M Embedding Center TEC2800-M Fully-automatic Cryostat Microtome AST550 Fully-automatic Cryostat Microtome AST580 Fully-automatic Rotary Microtome AEM480 Grossing Station TST1200 Immunohistochemistry Stainer AISH620 Laser Cassette Printer EM400 Laser Cassette Printer EM600 Laser Slide Printer SM100 Manual Microtome AMR400 Paraffin Reservoir AEC380-PR Paraffin Trimmer APT290 Semi-automatic Cryostat Microtome AST500 Semi-automatic Cryostat Microtome AST560 Semi-automatic Rotary Microtome AEM450 Semi-automatic Rotary Microtome AEM460 Slide Dryer ASD220 Slide Dryer TEC2602 Slide Stainer AMSS330 Slide Stainer ASS190 TEC2800 Thermal Console TEC2800-T Tissue Processor ATP140 Water Bath - Slide Driver TEC2500 Water Bath AWB210	A IVDR	info@amos-scientific.com Fiche EUDAMED Signaler une erreur
Biolabo	France	BE APTT K APTT Kaolin + CaCl23 réf. BE APTT SL APTT Silica + CaCl23 réf. BE Cal Ref Reference Plasma2 réf. BE Cal Set Calibration Plasma PT Prothrombin Time Standard Set2 réf. BE Clean SOLEA 1003 réf. 27 autres BE DDimer D-DIMER Turbidimetric Immunoassay3 réf. BE DDTrol 1 DDimer Plasma low D-DIMER Controls3 réf. BE Factor II Deficient Plasma FII2 réf. BE Factor IX Deficient Plasma FIX2 réf. BE Factor V Deficient Plasma FV2 réf. BE Factor VII Deficient Plasma FVII2 réf. BE Factor VIII Deficient Plasma FVIII2 réf. BE Factor X Deficient Plasma FX2 réf. BE Factor XI Deficient Plasma FXI2 réf. BE Factor XII Deficient Plasma FXII2 réf. BE FIB Thrombin Kaolin + Buffer Fibrinogen Reagents3 réf. BE Owren Buffer2 réf. BE PT HI Thromboplastin high ISI Prothrombin Time (High ISI)3 réf. BE PT LI Thromboplastin low ISI Prothrombin Time (Low ISI)3 réf. BE Trol 1 Plasma Level 1 CONTROL PLASMAS with coagulation factors3 réf. BE TT Thrombin Time2 réf. BIO SOLEA 2 - COAGULOMETER 2 CHANNELS, including accessories2 réf. CALCIUM CHLORIDE 0.025M CHLORURE DE CALCIUM 0,025M Cleaning Solution for TIA3 réf. CONTROL PLASMA Level 1 CONTROL PLASMAS without coagulation factors3 réf. HAEMOGLOBIN Colorimetric Method (Cyanmethemoglobin) HbA1c Control Set HbA1c Standard Set KENZA 240ISE - AUTOMATIC BIOCHEMISTRY ANALYSER with ISE Module, including accessories KENZA 240TX2 réf. KENZA 450ISE - AUTOMATIC BIOCHEMISTRY ANALYSER with ISE Module, including accessories KENZA 450TX3 réf. KENZA MAX BioChemisTry PHOTOMETER KENZA ONE - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories	A, B, C IVDR	Présent sur le marché en France support@biolabo.fr Fiche EUDAMED Signaler une erreur
Hangzhou Danwei Biotechnology FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	101A0108EY98/79 101A0113EY98/79 101A0201EY,101A0201ED98/79 101A0202EY98/79 101A0204EY98/79 27 autres 101A0205EY，101A0205ED98/79 101A0207EY,101A0207ED98/79 101A0209EY98/79 101A0211EY，101A0211ED98/79 101A0216EY ，101A0216EYD98/79 101A0217EY98/79 ACAB01,ACAB0298/79 ACOV03,ACOV03D98/79 AFR01,AFR01D98/79 AMPV01，AMPV01D98/79 APA01,APA01D98/79 ASTD130198/79 CDGV01A-AHG4E98/79 CDGVZK01-AHG4E98/79 CGBS01A-AHG4E98/79 CGBSZK01A-AHG4E98/79 CGCT01A-AHG4E98/79 CMTB01A-AHG4E98/79 CMTBMDR01A-AHG4E98/79 CMTBMDRZK01-AHG4E98/79 CMTBRIF01A-AHG4E98/79 CMTBRIFZK01-AHG4E98/79 CRTI601A-AHG4E98/79 CRTI701A-AHG4E98/79 SNCE01-ADW48,SNCE01-ADW9698/79 SNCE05-ADW4898/79 SNCE07-ADW50E98/79	– 98/79	ra.danwei@danwei-bio.com Fiche EUDAMED Signaler une erreur
HLB Life Science FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Corée du Sud	10ul capillary tube3 réf. 10ul Capillary tube (Blue line)2 réf. 20ul capillary tube3 réf. 5ul capillary tube3 réf. Capillary tube 10/20ul (Blue/Black, 2 line)2 réf. 27 autres Capillary tube 5ul, 10ul(Black, 2 line)3 réf. Easy sample collector 20ul2 réf. Easy sample collector 20ul (PS)2 réf. Ezi Tube+ 10ul3 réf. Ezi Tube+ 20ul2 réf. Ezi Tube+ 35ul3 réf. Ezi Tube+ 5ul2 réf. Fixed Volume Dropper 300ul3 réf. Fixed Volume Dropper 600ul3 réf. Inverted cup 61mm3 réf. Inverted cup 61mm(Blue)2 réf. Inverted cup 80mm3 réf. Inverted cup 80mm Mini-tip R type 10ul (with silicone plunger)3 réf. Mini-tip 10ul(non-heparin, with plunger)2 réf. Mini-tip 20ul(non-heparin, with plunger) Mini-tip Q type 10ul (without plunger)3 réf. Mini-tip Q type 10ul – Hydrophilic3 réf. Mini-tip Q type 10ul – Hydrophilic(Blue)3 réf. Mini-tip Q type 10ul – Hydrophilic(Blue, Neck STR)3 réf. Mini-tip Q type 20ul (without plunger)2 réf. Mini-tip Q type 20ul – Hydrophilic3 réf. Mini-tip Q type 20ul – Hydrophilic(Blue)3 réf. Mini-tip Q type 20ul – Hydrophilic(Blue, Neck STR)3 réf. Mini-tip QP type 10ul (with plunger)2 réf. Mini-tip QP type 20ul (with plunger)2 réf. Mini-tip R type 20ul (with silicone plunger)2 réf. Mini-tip R type 50ul (with silicone plunger)2 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Isiabio Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Adenovirus Antigen Rapid Test Kit (QDs Immunofluorescence Method) ADV-QD2 réf.98/79 Aspergillus Galactomannan Rapid Test Kit (QDs Immunofluorescence Method) Aspergillus GM-QD98/79 Aspergillus IgG Antibody Rapid Test Kit (QDs Immunofluorescence Method) Aspergillus IgG-QD98/79 Candida IgG Antibody Rapid Test Kit (QDs Immunofluorescence Method) Candida IgG-QD98/79 Control For Adenovirus antigen ADV-CONTROL98/79 27 autres Control For Cryptococcus 048Z98/79 Control For Flu A/B antigen98/79 Control For Helicobacter Pylori (H.Pylori) H.Pylori Ag-CONTROL 099Z98/79 Control For Respiratory Syncytial Virus (RSV) antigen 057Z98/79 Control For SARS-CoV-2 Antigen SARS-CoV-2-CONTROL98/79 Cryptococcus Antigen Rapid Test Kit (QDs Immunofluorescence Method) Cryptococcus-QD98/79 D-dimer Rapid Test Kit (QDs Immunofluorescence Method) D-dimer-QD98/79 D-Dimer Test Kit (CLIA Method)98/79 Dengue Virus IgM/IgG Test Kit（FIA） DENV IgM/IgG-FIA98/79 Dengue Virus NS1 Test Kit（FIA） DENV NS1-FIA98/79 Fibrinogen Degradation Product (FDP) Test Kit (CLIA Method)98/79 H.Pylori IgG-CLIA98/79 Helicobacter Pylori (H.Pylori) antibody Rapid Test Kit (QDs Immunofluorescence Method) HP Ab-QD98/79 Helicobacter Pylori (H.Pylori) Antigen Rapid Test Kit (QDs Immunofluorescence Method) H.Pylori Ag-QD98/79 Helicobacter Pylori (H.Pylori) Antigen Rapid Test Kit (QDs Immunofluorescence Method) HP Ag-QD98/79 Helicobacter Pylori (H.Pylori) Typing Test Kit (QDs Immunofluorescence Method) H.Pylori Typing-QD98/79 Helicobacter Pylori (H.Pylori) Typing Test kit (QDs Immunofluorescence Method) HP Typing-QD98/79 HP IgG Test Kit (CLIA Method)98/79 HP Typing Test Kit (CLIA Method)98/79 Influenza A/B (Flu A/B) virus antigen Rapid Test Kit (QDs Immunofluorescence Method) Flu A/B-QD2 réf.98/79 Interleukin 6 (IL-6) Rapid Test Kit (QDs Immunofluorescence Method) IL-6-QD98/79 Interleukin 6 (IL-6) Test Kit (CLIA Method) IL-6-CLIA98/79 Plasmin-α2-Plasmin Inhibitor Complex (PIC) Test Kit (CLIA Method)98/79 Respiratory Syncytial Virus (RSV) Antigen Rapid Test Kit (QDs Immunofluorescence Method) RSV-QD2 réf.98/79 SARS-CoV-2 Antigen Rapid Test Kit (QDs Immunofluorescence Method) SARS-CoV-2-QD98/79 Thrombin-Antithrombin Ⅲ complex (TAT) Test Kit (CLIA Method)98/79 Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (tPAIC) Test Kit (CLIA Method)98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Keyubio Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	KEYU Automatic Urine Analysis System KU-280098/79 KEYU Automatic Urine Analysis System KU-300098/79 KEYU Cryptosporidium Antigen Test Kit (Colloidal Gold Method) CRY-Ⅰ98/79 KEYU Dry Chemistry Urine Analyzer3 réf. KEYU Entamoeba histolytica Antigen Test Kit (Colloidal Gold Method)98/79 27 autres KEYU Fluorescent Immunoassay Analyzer FI-650S KEYU H. Pylori Rapid Rapid Test (Colloidal Gold) HP-R-F98/79 KEYU H. Pylori Rapid Rapid Test (Colloidal Gold) HP-R-G98/79 KEYU H. Pylori Rapid Test Kit (Colloidal gold method) HP-I98/79 KEYU H. Pylori Rapid Test Kit (Colloidal gold method) HP-II98/79 KEYU H. Pylori Rapid Test Kit (Colloidal gold method) HP-III98/79 KEYU H.pylori Antigen Test Kit (Fluorescence Immunochromatography) HP-F-Ⅰ98/79 KEYU H.pylori Antigen Test Kit (Fluorescence Immunochromatography) HP-F-Ⅱ98/79 KEYU Norovirus Antigen Test Kit (Colloidal gold method) NV-I98/79 KEYU Norovirus Antigen Test Kit (Colloidal gold method) NV-II98/79 KEYU ParaFloat™ Intestinal Parasite Concentrator (Ova) KU-F05-II KEYU ParaSpin™ Intestinal Parasite Concentrator KU-F05-I KEYU ParaSpin™ Intestinal Parasite Concentrator KU-F05-IV KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method) ARV-I98/79 KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method) ARV-II98/79 KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method) ARV-III98/79 KEYU Rotavirus Group A Antigen Rapid Test (Colloidal Gold) RV-R-F98/79 KEYU Rotavirus Group A Antigen Rapid Test (Colloidal Gold) RV-R-G98/79 KEYU Sample Collection Container3 réf. KEYU Sample Collection Cup3 réf. KEYU Sample Collection Tube4 réf. KEYU Urine Sample Collection Tube2 réf. KEYU Urine Sediment Analyzer KU-200098/79 KEYU Urine Sediment Analyzer KU-2000B98/79 KEYU Urine Sediment Analyzer KU-60098/79 KEYU Urine Sediment Analyzer KU-600A98/79 KEYU Urine Sediment Analyzer UM-3098/79	A IVDR, 98/79	Site web export@keyubio.com Fiche EUDAMED Signaler une erreur
Sejoy FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	Adenovirus Rapid Test (Feces) Cassette98/79 BG-201 Blood Glucose Monitoring System98/79 Blood Glucose Monitoring system BG-70798/79 Blood Glucose Monitoring system BG-713t Ease98/79 Dengue IgG/IgM Rapid Test Device Cassette98/79 27 autres Dengue IgG／IgM／NS1 Combo Rapid Test Cassette98/79 Dengue NS1 Antigen Rapid Test Cassette98/79 H.pylori Antibody Rapid Test Cassette98/79 Hemoglobin Monitoring control solution HC-10198/79 Hemoglobin Test Strip HS-10198/79 Influenza A+B Rapid Test Cassette98/79 ISIRA-944598/79 ISIRAH-965598/79 Malaria P.f ＆P.v Rapid Test (Whole Blood) Cassette98/79 Malaria P.f ＆Pan Rapid Test (whole blood) Cassette98/79 Malaria Plasmodium Falciparum Rapid Test (whole blood) Cassette98/79 SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test Cassette98/79 SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test COIF-52298/79 SARS-CoV-2 & Influenza A/B & Respiratory Syncytial Virus & HMPV Antigen Combo Test Kit98/79 Sejoy BG-709g98/79 SEJOY Blood Glucose Monitoring System BG-20198/79 SEJOY Blood Glucose Monitoring System BG-201 (100S)98/79 SEJOY Blood Glucose Monitoring System BG-201 (50S)98/79 SEJOY Blood Glucose Monitoring System BG-202 （BLU）98/79 SEJOY Blood Glucose Monitoring System BG-20398/79 SEJOY Blood Glucose Monitoring System BG-709 Blood Glucose Monitoring System98/79 SEJOY Blood Glucose Monitoring System BG-709 （50S）98/79 SEJOY Blood Glucose Monitoring System BG-710b98/79 SEJOY Blood Glusose Monitoring system BG-20298/79 Strep A Rapid Test ISTA-811298/79 Syphilis Antibody Rapid Test Cassette,Strip98/79 Typhoid IgG/IgM Rapid Test Cassette98/79	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Seramun	Allemagne	Seraline® Anti-Borrelia-8 IgG2 réf.98/79 Seraline® Anti-Borrelia-8 IgM2 réf.98/79 Seraline® Anti-Helicobacter-6 IgA98/79 Seraline® Anti-Helicobacter-6 IgG98/79 Seraline® Anti-Yersinia-6 IgA2 réf.98/79 27 autres Seraline® Anti-Yersinia-6 IgG2 réf.98/79 SeraSpot® Anti-Borrelia IgG3 réf. SeraSpot® Anti-Borrelia IgM3 réf. SeraSpot® Anti-Borrelia-10 IgG3 réf.98/79 SeraSpot® Anti-Borrelia-10 IgM3 réf.98/79 SeraSpot® Anti-EBV-3 IgM2 réf.98/79 SeraSpot® Anti-EBV-4 IgG2 réf.98/79 SeraSpot® Anti-Helicobacter-6 IgA2 réf.98/79 SeraSpot® Anti-Helicobacter-6 IgG2 réf.98/79 SeraSpot® Anti-Parvovirus-5 IgM2 réf.98/79 SeraSpot® Anti-Parvovirus-6 IgG2 réf.98/79 SeraSpot® Anti-Treponema-4 IgG2 réf.98/79 SeraSpot® Anti-Treponema-4 IgM2 réf.98/79 SeraSpot® Anti-Yersinia-6 IgA2 réf.98/79 SeraSpot® Anti-Yersinia-6 IgG2 réf.98/79 Serazym® Adenovirus98/79 Serazym® Astrovirus98/79 Serazym® Campylobacter98/79 Serazym® Clostridium difficile GDH98/79 Serazym® Clostridium difficile Toxin A+B98/79 Serazym® Cryptosporidium parvum98/79 Serazym® Entamoeba histolytica98/79 Serazym® Giardia98/79 Serazym® H. pylori 2nd Gen.98/79 Serazym® Norovirus98/79 Serazym® Rotavirus98/79 Serazym® Verotoxin 1+298/79	B IVDR, 98/79	info@seramun.com Fiche EUDAMED Signaler une erreur
Bioneer FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	AccuPower® HBV Quant Kit (ExiStation™ FA 96) AccuPower® HCV Quant Kit (ExiStation™ FA 96) AccuPower® HIV-1 Quant Kit (ExiStation™ FA 96) AccuPower® HIV-1 Quantitative RT-PCR Kit98/79 AccuPrep® Dx Viral RNA Extraction Kit 26 autres Exicycler™ 962 réf. ExiCycler™ V5 3843 réf. ExiPrep ™ 48 Viral RNA Kit ExiPrep™48 Viral RNA Kit ExiPrep™ 48 Genomic DNA Kit ExiPrep™48 Genomic DNA Kit ExiPrep™ 48 SF Genomic DNA Kit ExiPrep™ 48 SF Mycobacteria Genomic DNA Kit ExiPrep™ 48 SF Viral DNA/RNA Kit ExiPrep™ 48 Viral DNA/RNA Kit ExiPrep™ 96 Genomic DNA Kit ExiPrep™ 96 Viral DNA/RNA Kit ExiPrep™ Dx Bacteria Genomic DNA Kit ExiPrep™ Dx Blood Genomic DNA Kit ExiPrep™ Dx Blood Viral DNA Kit ExiPrep™ Dx Mycobacteria Genomic DNA Kit ExiPrep™ Dx SF Mycobacteria Genomic DNA Kit ExiPrep™ Dx Viral DNA Kit ExiPrep™ Dx Viral DNA/RNA Kit ExiPrep™ Dx Viral RNA Kit ExiPrep™16 Dx ExiPrep™48 Dx ExiPrep™96 Lite ExiStation™ FA 384 ExiStation™ FA 96/3842 réf. ExiStation™ FA DNA/RNA Kit (V2) ExiStation™ FA DNA/RNA Kit (V3) IRON-qPCR™ MagListo™ 5M Viral DNA/RNA Extraction Kit	A, D IVDR, 98/79	Site web sales@bioneer.com Fiche EUDAMED Signaler une erreur
Changsha Yingtai Instrument FDA Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	CDL7M cytoprep-1 cytoprep-2 DDL6 DL6MB 26 autres DL8M GL10 GL12 GL21M TD4 TD4A TD4B TD4C TD4N TD5 TD5A TD5B TD6 TD6C TDL5 TDL5A TDL5M TG18A TG20 TGL16 TGL16E TGL18 TGL20 TGM12 TGW16 TXK4	A IVDR	Fiche EUDAMED Signaler une erreur
Edan FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Blood Gas and Chemistry Analyzer i152 réf. Blood Gas and Chemistry Analyzer i20 Blood Gas and Chemistry Analyzer i200598/79 Blood Gas and Chemistry Analyzer i5002 réf. Blood Sampler6 réf. 26 autres Cleaner HC310 Cleaner HC600 Diluent HD310 Diluent HD600 Diluent HD93R Hematology Analyzer H30 Pro3 réf. Hematology Analyzer H604 réf. Hematology Analyzer H6698/79 Hematology Analyzer H66S98/79 Hematology Analyzer H68S98/79 Hematology Analyzer H69S98/79 Hematology Analyzer H803 réf. Hematology Analyzer H903 réf. Hematology Calibrator ED-CAL PLUS Hematology Control ED-30D Hematology Control ED-30D Control N98/79 Hematology Control ED-60D Hematology Control ED-60D Control H98/79 Hematology Control ED-90D Lyse HL310 Lyse HL600 Lyse HL610 Lyse HL620 Lyse HL90H Lyse HL91D Lyse HL92N	A, B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Medlab-Products	Pologne	Ezy z oczkiem o poj. 10µl i igłą, z ABS, granatowe, pakowane po 20szt - sterylne98/79 Ezy z oczkiem o poj. 10µl i igłą, z ABS, granatowe, pakowane po 20szt w pudełko z dozownikiem - sterylne98/79 Ezy z oczkiem o poj. 10µl, z PS, niebieskie, pakowane po 10szt - sterylne98/79 Ezy z oczkiem o poj. 10µl, z PS, niebieskie, pakowane po 10szt w pudełko z dozownikiem - sterylne98/79 Ezy z oczkiem o poj. 10µl, z PS, niebieskie, pakowane po 1szt - sterylne98/79 26 autres Ezy z oczkiem o poj. 10µl, z PS, niebieskie, pakowane po 1szt w pudełko z dozownikiem - sterylne98/79 Ezy z oczkiem o poj. 10µl, z PS, niebieskie, pakowane po 20szt - sterylne98/79 Ezy z oczkiem o poj. 10µl, z PS, niebieskie, pakowane po 20szt w pudełko z dozownikiem - sterylne98/79 Ezy z oczkiem o poj. 1µl i igłą, z ABS, kremowe, pakowane po 20szt - sterylne98/79 Ezy z oczkiem o poj. 1µl i igłą, z ABS, kremowe, pakowane po 20szt w pudełko z dozownikiem - sterylne W0503030298/79 Ezy z oczkiem o poj. 1µl, z PS, żółte, pakowane po 10szt - sterylne98/79 Ezy z oczkiem o poj. 1µl, z PS, żółte, pakowane po 10szt w pudełko z dozownikiem - sterylne98/79 Ezy z oczkiem o poj. 1µl, z PS, żółte, pakowane po 1szt - sterylne98/79 Ezy z oczkiem o poj. 1µl, z PS, żółte, pakowane po 1szt w pudełko z dozownikiem - sterylne98/79 Ezy z oczkiem o poj. 1µl, z PS, żółte, pakowane po 20szt - sterylne98/79 Ezy z oczkiem o poj. 1µl, z PS, żółte, pakowane po 20szt w pudełko z dozownikiem - sterylne98/79 Granulat do separacji surowicy - 1000g3 réf. Końcówki o poj. do 1000µl, typu Eppendorf, klasa Economy, bezbarwne3 réf. Pojemniki o poj.120ml z PP, z podziałką i polem do opisu, bez zakrętki3 réf. Probówka na 2,5ml krwi, z heparyną Li3 réf. Probówki (śr. 1255mm) do koagulologii na 0,9ml krwi, z nalepką3 réf. Probówki (śr. 13100mm) na 5ml krwi, z granulatem do szybkiego wykrzepiania3 réf. Probówki (śr.12*55mm) na 1ml krwi, z EDTA-K2, z przekłuwalnym korkiem, z nalepką3 réf. Probówki do glukozy na 1,8ml krwi3 réf. Probówki do OB na 1,6ml krwi3 réf. Probówki na 100µl krwi, z EDTA-K2, z kapilarą3 réf. Probówki na 120µl krwi do zliczania retikulocytów Probówki okrągłodenne, o poj. 11ml, śr. 16 mm, dł. 100mm, z polipropylenu (PP)3 réf. Szalki Petriego o śr. 90mm i wys. 16mm, bez wentylacji, aseptyczne3 réf. Szkiełka nakrywkowe 18x18mm i gr.: 0,15mm3 réf. Szkiełka nakrywkowe 20x26mm z ciętymi krawędziami do kamer2 réf.	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Nanjing Norman Biological Technology Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	Cuvette 504pcs/bag D-Dimer Test Kit (Chemiluminescence) 100tests/box98/79 D-Dimer Test Kit (Chemiluminescence) 50tests/box98/79 D-Dimer Test Kit (Chemiluminescence) 50×2tests/box98/79 D-Dimer Test Kit (Immunofluorescence) 25 Tests /Box98/79 26 autres D-Dimer Test Kit (Immunoturbidimetry) 50tests/box98/79 FI-1200 Fibrin (proto) Degradation Product (FDP) Test Kit (Immunofluorescence) 25 Tests /Box98/79 Interleukin 6 (IL-6) Test Kit (Chemiluminescence) 100tests/box98/79 Interleukin 6 (IL-6) Test Kit (Chemiluminescence) 50tests/box98/79 Interleukin 6 (IL-6) Test Kit (Chemiluminescence) 50×2tests/box98/79 Interleukin 6 (IL-6) Test Kit (Immunofluorescence) 25 Tests /Box98/79 Interleukin-10(IL-10) Test Kit (Chemiluminescence) 100tests/box98/79 Interleukin-10(IL-10) Test Kit (Chemiluminescence) 50tests/box98/79 Interleukin-10(IL-10) Test Kit (Chemiluminescence) 50×2tests/box98/79 Interleukin-1β(IL-1β) Test Kit (Chemiluminescence) 100tests/box98/79 Interleukin-1β(IL-1β) Test Kit (Chemiluminescence) 50tests/box98/79 Interleukin-1β(IL-1β) Test Kit (Chemiluminescence) 50×2tests/box98/79 Interleukin-2 Receptor(IL-2R) Test Kit (Chemiluminescence) 100tests/box98/79 Interleukin-2 Receptor(IL-2R) Test Kit (Chemiluminescence) 50tests/box98/79 Interleukin-2 Receptor(IL-2R) Test Kit (Chemiluminescence) 50×2tests/box98/79 Interleukin-8(IL-8) Test Kit (Chemiluminescence) 100tests/box98/79 Interleukin-8(IL-8) Test Kit (Chemiluminescence) 50tests/box98/79 Interleukin-8(IL-8) Test Kit (Chemiluminescence) 50×2tests/box98/79 NORMAN-CL211,NRM411-S7 NORMAN-CL211A NRM-FI-1000 NRM411 Tumor Necrosis Factor (TNF) Test Kit (Chemiluminescence) 100tests/box98/79 Tumor Necrosis Factor (TNF) Test Kit (Chemiluminescence) 50tests/box98/79 Tumor Necrosis Factor (TNF) Test Kit (Chemiluminescence) 50×2tests/box98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Xiamen Zeesan Biotech FDA Mandataire UE : JOYSUN GROUP S.L.U (Espagne) et 1 autre	Chine	DNA Extraction Kit (Lab-Aid 896)3 réf. High Risk HPV Genotyping Assay (MMCA)98/79 High Risk HPV Genotyping Kit (Sanity 2.0)98/79 Lab-Aid 808 Nucleic Acid Extraction System3 réf. Low Risk HPV Genotyping Assay98/79 26 autres Low Risk HPV Genotyping Kit (Sanity 2.0)98/79 MDR-TB Test Kit (MMCA)98/79 MDR-TB Test Kit (Sanity 2.0)98/79 MeltArray High Risk HPV Genotyping Assay98/79 MeltArray High Risk HPV Genotyping Assay (Sanity)98/79 MTB Test Kit98/79 MTB Test Kit (Sanity 2.0)98/79 MTB/EMB Test Kit (MMCA)98/79 MTB/FQ Test Kit (MMCA)98/79 MTB/MDR Test Kit (Sanity 2.0)98/79 MTB/PZA Test Kit98/79 MTB/SL Test Kit (MMCA)98/79 MTB/STR Test Kit (MMCA)98/79 Mycobacteria Identification Kit (MMCA)98/79 Mycobacteria Identification Kit (Sanity 2.0)98/79 Respiratory Pathogen Panel (RPP3D)98/79 Respiratory Pathogen Panel (RPP40D)98/79 Respiratory Pathogen Panel (RPP4D)98/79 Saliva DNA Sample Collection Kit2 réf. Sanity 2.0 System3 réf. Sanity-2 Respiratory Pathogen Panel (RPP22)98/79 Sanity-2 Respiratory Pathogen Panel (RPP3)98/79 Sanity-2 Respiratory Pathogen Panel (RPP4)98/79 Sanity-2 Respiratory Pathogen Panel (RPP40)98/79 SARS-CoV-2 Test Kit98/79 SARS-CoV-2 Test Kit (Sanity 2.0)4 réf.98/79	A IVDR, 98/79	info@zsandx.com Fiche EUDAMED Signaler une erreur
Tosoh FDA Mandataire UE : Tosoh Europe N.V. (Belgique)	Belgique, Japon	AIA-900 19tray Sorter AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-3603 réf. AIA-PACK D-Dimer CONTROL SET98/79 AIA-PACK Homocysteine CONTROL SET98/79 Automated TRCR Real-time Monitor TRCReady-80 CL AIA-PACK CMV IgG ADJUSTER SET98/79 32 autres CL AIA-PACK CMV IgG TEST CUP98/79 CL AIA-PACK CMV IgM ADJUSTER SET2 réf. CL AIA-PACK D-Dimer ADJUSTER SET98/79 CL AIA-PACK D-Dimer TEST CUP98/79 CL AIA-PACK Rubella IgG ADJUSTER SET98/79 CL AIA-PACK Rubella IgG TEST CUP98/79 CL AIA-PACK Rubella IgM ADJUSTER SET2 réf. CL AIA-PACK Toxo IgG ADJUSTER SET98/79 CL AIA-PACK Toxo IgG TEST CUP98/79 CL AIA-PACK Toxo IgM ADJUSTER SET2 réf. GR F&A2 Calibrator Set GR01 β-Thalassemia Elution Buffer No. 13 réf. Hemolysis Collection System 10 µL Hemolysis Stability Solution 6 x 100 ml ST AIA-PACK D-Dimer98/79 ST AIA-PACK D-Dimer CALIBRATOR SET98/79 ST AIA-PACK D-Dimer SAMPLE DILUTING SOLUTION98/79 ST AIA-PACK Homocysteine98/79 ST AIA-PACK Homocysteine CALIBRATOR SET98/79 ST AIA-PACK Homocysteine PRETREATMENT SET98/79 ST AIA-PACK Homocysteine SAMPLE DILUTING SOLUTION98/79 TRCR Purification Kit TRCReady MTB98/79 TSKgel GR01 β-Thal. CL AIA-PACK SARS-CoV-2-Ag ADJUSTER SET98/79 (plus commercialisé) CL AIA-PACK SARS-CoV-2-Ag CONTROL SET98/79 (plus commercialisé) CL AIA-PACK SARS-CoV-2-Ag SAMPLE TREATMENT SOLUTION98/79 (plus commercialisé) CL AIA-PACK SARS-CoV-2-Ag TEST CUP98/79 (plus commercialisé) G7 HSi Elution Buffer No.1 (S)98/79 (plus commercialisé) G7 HSi Elution Buffer No.2 (S)98/79 (plus commercialisé) G7 HSi Elution Buffer No.3 (S)98/79 (plus commercialisé) Hemoglobin F&A2 Calibrator98/79 (plus commercialisé)	A, B, C IVDR, 98/79	Présent sur le marché en France Site web csc@tosoh.co.jp Fiche EUDAMED Signaler une erreur
Anicrin	Italie	12 x 75 provetta cilindrica in PS3 réf. Ansa calibrata 10 µl - in sacchetti da 1 pz - sterile98/79 Ansa calibrata 10 µl - in sacchetti da 5 pz - sterile98/79 Contenitore coprologia 18 ml con spatola - sterile98/79 Contenitore coprologia 18 ml con spatola involucro singolo - sterile Contenitore coprologia 18 ml con spatola sterile98/79 24 autres Contenitore coprologia 18 ml PS con spatola2 réf. Piastra per micrometodi 96 pozzetti fondo piatto in confezione singola - sterile Piastre per micrometodi a 96 pozzetti sterili98/79 Piastra per micrometodi 96 pozzetti fondo U in confezione singola - sterile Piastre per micrometodi a 96 pozzetti sterili98/79 Piastra per micrometodi 96 pozzetti fondo U con coperchio assemblato in confezione singola - sterile Piastre per micrometodi a 96 pozzetti sterili98/79 Piastra per micrometodi 96 pozzetti fondo U con coperchio assemblato in confezione singola Piastre per micrometodi a 96 pozzetti / 96-well microplates3 réf. Piastra per micrometodi 96 pozzetti fondo V in confezione singola - sterile Piastre per micrometodi a 96 pozzetti sterili98/79 Piastra Petri 120x120 mm quadra per Antibiogramma3 réf. Piastra Petri Ø 100 mm ventilata - sterile98/79 Piastra Petri Ø 120 mm senza tacche - sterile98/79 Piastra Petri Ø 150 mm ventilata - sterile98/79 Piastra Petri Ø 55 mm senza tacche - sterile98/79 Piastra Petri Ø 55 mm tipo Contact - doppio sacco - sterile98/79 Piastra Petri Ø 55 mm tipo Contact autobloccante - doppio sacco - sterile98/79 Piastra Petri Ø 55 mm ventilata - sterile98/79 Piastra Petri Ø 60 mm senza tacche - sterile98/79 Piastra Petri Ø 60 mm ventilata - sterile98/79 Piastra Petri Ø 90 mm 3 settori ventilata - sterile98/79 Piastra Petri Ø 90 mm h14mm ventilata - sterile98/79 Piastra Petri Ø 90 mm h14mm ventilata 8 tacche - sterile98/79 Piastra Petri Ø 90 mm h14mm ventilata 8 tacche con divisori- sterile98/79 Piastra Petri Ø 90 mm h14mm ventilata con divisori- sterile98/79 Piastra Petri Ø 90 mm senza tacche h14mm - sterile98/79 Piastra Petri Ø 90 mm tipo Contact - sterile98/79 Piastra Petri Ø 90 mm ventilata h15mm - sterile98/79	A IVDR, 98/79	Site web info@anicrin.com Fiche EUDAMED Signaler une erreur
Cesna	Turquie	BACTERIAL PATHOGEN DETECTION KIT FIA ANALİZÖR (FIA ANALYZER) GASTROENTERITIS SCREENING KIT GASTROINTESTINAL BACTERIAL PANEL V2 GASTROINTESTINAL PARASITE PANEL CSNP025 24 autres GASTROINTESTINAL VIRAL PANEL CSNP027 GASTROİNTESTİNAL BAKTERİ PANELİ V1 GASTROINTESTINAL BACTERIAL PANEL V1 H.PYLORI AB HIZLI TESTİ H.PYLORI AG HIZLI TESTİ IFA OKUYUCUSU INFLUENZA A-B, H1N1 DETECTION KIT INFLUENZA-A,B DETECTION KIT CSNP016 RESPIRATORY PATHOGEN PANEL DETECTION KIT CSNMP120 RESPIRATORY PATHOGENS PANEL (RPP) MAXI RESPIRATORY PATHOGENS PANEL (RPP) MIDI RESPIRATORY PATHOGENS PANEL (RPP) MINI RESPIRATORY PATHOGENS SCREENING 24P KIT RESPIRATORY VIRAL BASIC SCREENING KIT CSNMP048 RSV HIZLI TEST KİTİ SARS-CoV-2/FLU/RSV DETECTION KIT SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) – B TESPİT KİTİ SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) – TEŞHİS KİTİ SOLUNUM YOLU PATOJENLERİ PANELİ (RPP) MIDI SOLUNUM YOLU PATOJENLERİ PANELİ (RPP) MİNİ SOLUNUM YOLU PATOJENLERİ PANELİ (RPP) MİNİ EKSTRA SOLUNUM YOLU PATOJENLERİ PANELİ (RPP)MAXI STREP HIZLI TEST KİTİ KONTROLÜ TOKSİN A/B HIZLI TEST KİTİ URINARY TRACT INFECTIONS KIT CSNUT001	A, B IVDR	Site web info@cesna.com.tr Fiche EUDAMED Signaler une erreur
Hysenbiotech Mandataire UE : Medunion S.L. (Espagne)	Corée du Sud	Adenovirus Rapid Test Cassette HIAD-60298/79 Arbovirus Multiplex Detection Kit98/79 Blood Pathogens and Drug Resistance Genes Digital PCR Detection Kit98/79 Blood Pathogens and Drug Resistance Genes Digital PCR Detection Kit Plus98/79 cfNDA-P1 24 autres Dengue IgG/IgM Rapid Test Cassette HIDC-402A98/79 Dengue NS1 Rapid Test Cassette98/79 Drug Resistance Genes Digital PCR Detection Kit98/79 Fungal Digital PCR Detection Kit98/79 Gastrointestinal Pathogens Multiplex Detection Kit MAA-17E98/79 Gastrointestinal Pathogens Nucleic acid Detection Kit (Microfluic Chip)98/79 H. pylori Antibody Rapid Test Cassette/Strip HIHP-402/HIHP-40198/79 H. pylori Antigen Rapid Test Cassette HIHPG-60298/79 Human Herpesvirus Digital PCR Detection Kit98/79 HysenD30H HysenDx 200 Influenza A+B Rapid Test Cassette HIFL-52298/79 Lower Respiratory Pathogens Multiplex Detection Kit MLR-19E98/79 Malaria P.f./Pan Rapid Test Cassette HIMPN-40298/79 Meningitis/Encephalitis (ME) Pathogens Multiplex Detection Kit98/79 Multiplex Infection Pathogens & Resistance Genes Detection Kit DMIR0198/79 Respiratory Pathogens Multiplex Detection Kit MUR-24E98/79 Rotavirus Rapid Test Cassette HIRO-60298/79 Sexually Transmitted Disease (STD) Pathogen Multiplex Detection Kit98/79 Sexually Transmitted Disease (STD) Pathogens Multiplex Detection Kit98/79 Sexually Transmitted Disease (STD) Pathogens Multiplex Detection Kit II98/79 Strep A Rapid Test Cassette/Strip HISTA-502/HISTA-50198/79 Syphilis Rapid Test Cassette/Strip HISY-402/HISY-40198/79 Tropical Pathogens Multiplex Detection Kit MAA-1898/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Jiangsu Qitian Gene biotechnology Mandataire UE : JOYSUN GROUP S.L.U (Espagne) et 1 autre	Chine	Bacillus anthracis Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 Brucella Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 COVID-19 Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）3 réf.98/79 Ebola virus Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 23 autres Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 Japanese Encephalitis Virus Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 Listeria Monocytogenes Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 Mpox Virus Nucleic Acid Detection Kit（Fluorescent RAA)3 réf.98/79 Plasmodium Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 RAA Nucleic Acid Amplication Kit2 réf. RAA Nucleic Acid Amplication Kit(Fluorescent Method)2 réf. RAA Nucleic Acid Amplication Kit(Test Strip Method)2 réf. RT-RAA Nucleic Acid Amplication Kit2 réf. RT-RAA Nucleic Acid Amplication Kit(Fluorescent Method)2 réf. RT-RAA Nucleic Acid Amplication Kit(Test Strip Method)2 réf. Salmonella Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 SARS-CoV-2 Nucleic Acid Detection Kit98/79 Schistosoma Haematobium Nucleic Acid Detection Kit（Fluorescent RAA)3 réf.98/79 Schistosoma Mansoni Nucleic Acid Detection Kit（Fluorescent RAA)3 réf.98/79 Staphylococcus Aureus Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 V1-D/R-64JⅠ3 réf. V2-D/R-64J3 réf. Vibrio Cholerae Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 Vibrio Parahemolyticus Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 Yellow Fever Virus Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 Yersinia Pestis Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79 Zika Virus Nucleic Acid Detection Kit（Isothermal Amplification)3 réf.98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Kogene Mandataire UE : Obelis s.a. (Belgique)	Corée du Sud	PowerChek™ 18 RV Panel Kit98/79 PowerChek™ 20 Bacterial Panel Kit98/79 PowerChek™ Adeno / Astro / Rota Real-time PCR Kit98/79 PowerChek™ Adenovirus / Bocavirus Real-time PCR Kit98/79 PowerChek™ Coronavirus 229E / OC43 / NL63 / HKU1 Real-time PCR Kit Ver.1.098/79 23 autres PowerChek™ Influenza A&B, RSV Multiplex Real-time PCR Kit98/79 PowerChek™ Influenza B (Victoria & Yamagata) Real-time PCR Kit Ver.1.198/79 PowerChek™ Measles virus Real-time PCR Kit Ver.1.02 réf.98/79 PowerChek™ MeV / MeVA Multiplex Real-time PCR Kit98/79 PowerChek™ MTB/NTM Real-time PCR Kit98/79 PowerChek™ Mumps Real-time PCR Kit Ver.1.198/79 PowerChek™ Norovirus GI / GII Multiplex Real-time PCR Kit98/79 PowerChek™ Parainfluenza Virus 1/2/3 Real-time PCR Kit98/79 PowerChek™ RSV A & B/HMV Real-time PCR Kit98/79 PowerChek™ Salmonella Triplex Real-time PCR Kit98/79 PowerChek™ SARS-CoV-2 Advanced Real-time PCR Kit98/79 PowerChek™ SARS-CoV-2 Real-time PCR Kit98/79 PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit2 réf.98/79 PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit98/79 PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II3 réf.98/79 PowerChek™ STI Multiplex Real-time PCR Kit Ⅲ2 réf.98/79 PowerChek™ STI Multiplex Real-time PCR KitⅡ2 réf.98/79 PowerChek™ ZIKV / DENV / CHIKV Multiplex Real-time PCR Kit2 réf.98/79 PowerEXP™ 48LH PowerPrep™ Pathogen NA Extraction Kit EXP2 réf. PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0 PowerPrep™ Viral NA Extraction Kit EXP2 réf. PowerPrep™ Whole blood NA Extraction Kit EXP2 réf.	A IVDR, 98/79	Site web info@kogene.co.kr Fiche EUDAMED Signaler une erreur
Nexlab Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	Mycoplasma hominis Real-time PCR Kit ITSZ09400198/79 Neisseria gonorrhoeae Real-time PCR Kit ITSZ09000198/79 POCBio COVID-19/Flu A&B Combo Rapid Test LATR04-C2598/79 POCBio COVID-19/FluA/FluB/RSV 4 in 1 Rapid Test LATR05-C2598/79 POCBio Dengue IgM/IgG Rapid Test LATT02-C2598/79 23 autres POCBio Dengue IgM/IgG Rapid Test LATT02-C5098/79 POCBio Dengue NS1 and IgM/IgG Combo Rapid Test LATT07-C2598/79 POCBio Dengue NS1 Antigen Rapid Test LATT01-C2598/79 POCBio Dengue NS1 Antigen Rapid Test LATT01-C5098/79 POCBio Flu A/B Rapid Test LATR01-C2598/79 POCBio H.Pylori Antibody Rapid Test LATG01-C2598/79 POCBio H.Pylori Antibody Rapid Test LATG01-C5098/79 POCBio H.Pylori Antigen Rapid Test LATG02-C2598/79 POCBio Malaria Pf Rapid Test LATT03-C2598/79 POCBio Malaria Pf Rapid Test LATT03-C5098/79 POCBio Malaria Pf/Pan Rapid Test LATT05-C2598/79 POCBio Malaria Pf/Pan Rapid Test LATT05-C5098/79 POCBio Malaria Pf/Pv Rapid Test LATT04-C2598/79 POCBio Malaria Pf/Pv Rapid Test LATT04-C5098/79 POCBio Mycobacterium Tuberculosis (TB) Antibody Rapid Test LATR02-C5098/79 POCBio Rota/Adenovirus Combo Rapid Test LATG03-C2598/79 POCBio S.Typhi/Paratyphi Ag Combo Rapid Test LATG04-C2598/79 POCBio SARS-CoV-2 Antigen Rapid Test LATR03-C2598/79 POCBio Syphilis Antibody Rapid Test LATB04-C2598/79 POCBio Syphilis Antibody Rapid Test LATB04-C5098/79 POCBio Typhoid IgM/IgG Rapid Test LATT06-C2598/79 POCBio Typhoid IgM/IgG Rapid Test LATT06-C5098/79 Ureaplasma urealyticum Real-time PCR Kit ITSZ09200198/79	– 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Ortho-Clinical Diagnostics Dba Quidel Mandataire UE : MDSS GmbH (Allemagne) et 1 autre	États-Unis	D3 Chlamydia Antigen Control Slides98/79 D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit98/79 D3 DFA Metapneumovirus Identification Kit98/79 D3 Enterovirus Reagent Duo Pack98/79 D3 hMPV Antigen Control Slides98/79 23 autres D3 IFA Enterovirus Identification Kit98/79 D3 RSV Antigen Control Slides98/79 Lyra Adenovirus Assay98/79 Lyra Direct C. difficile Assay98/79 Lyra Direct SARS-CoV-298/79 Lyra Direct Strep Assay98/79 Lyra Influenza A+B Assay98/79 Lyra Parainfluenza Virus Assay98/79 Lyra RSV+HMPV Assay98/79 Lyra SARS-CoV-2 Assay98/79 Quidel Molecular C. difficile Control Set98/79 Quidel Digital Heat Block Quidel Molecular Adenovirus Control Set98/79 Quidel Molecular Influenza A+B Control Set98/79 Quidel Molecular Parainfluenza Virus Control Set98/79 Quidel Molecular RSV+hMPV Control Set98/79 Quidel Molecular Step A+G Control Set98/79 Savanna Instrument Savanna RVP Control Set98/79 Savanna RVP Control Set (1-set)98/79 Savanna RVP Control Set (4-set)98/79 Savanna RVP4 Assay98/79 Solana Instrument	A IVDR, 98/79	Site web PRRC@quidelortho.com Fiche EUDAMED Signaler une erreur
Taiwan Advanced Nanotech FDA Mandataire UE : mdi Europa GmbH (Allemagne)	Taïwan	611 series3 réf. 612 series3 réf. 615 series3 réf. 61C series3 réf. 61E series3 réf. 23 autres 61F series3 réf. 61G series3 réf. 61H series3 réf. 61P series3 réf. 621 series3 réf. 622 series3 réf. 635 series3 réf. 63F series3 réf. 665 series3 réf. 66P-MS series3 réf. 685 series3 réf. 6K2 series3 réf. 6SC series3 réf. 6ST series3 réf. 6T2 series3 réf. 6TF series3 réf. Maelstrom 24102 réf. Maelstrom 48102 réf. Maelstrom 8 Autostage3 réf. Maelstrom 96002 réf. Maelstrom 96102 réf. Maelstrom 9610 LH SLA-E13200	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Biologicals Quality Control	Pays-Bas	P0048 ViraQ Negative3 réf. P0063 ViraQ HCV Check 1252 réf. P0064 ViraQ HIV-1 Check 1252 réf. P0065 ViraQ HBV Check 1252 réf. P0067 ViraQ HCV Trend 252 réf. 22 autres P0068 ViraQ HIV-1 Trend 25 P0077 SeraQ TPHA Syphilis2 réf. P0078 SeraQ ARCHITECT2 réf. P0154 ViraQ HBV Trend 502 réf. P0179 SeraQ Elecsys2 réf. P0180 SeraQ LIAISON2 réf. P0237 SeraQ LIAISON Syphilis2 réf. P0247 ViraQ WNV Check 1253 réf. P0259 SeraQ Murex2 réf. P0260 SeraQ Murex Syphilis2 réf. P0264 ViraQ HEV Check 1253 réf. P0266 ViraQ Parvo B19/HAV Check3 réf. P0267 SeraQ TPHA Syphilis V22 réf. P0273 ViraQ Multi-Marker Check 752 réf. P0309 SeraQ BIO-RAD2 réf. P0312 SeraQ Elecsys Syphilis2 réf. P0313 SeraQ BIO-RAD Syphilis2 réf. P0317 SeraQ Alinity Syphilis2 réf. P0318 ViraQ HIV-2 Check 1253 réf. P0320 SeraQ Alinity V22 réf. P0374 SeraQ Alinity V32 réf. P0386 SeraQ Alinity V42 réf.	B IVDR	Site web info@bioqcontrol.com Fiche EUDAMED Signaler une erreur
Gmt Sarl	France	AUTO HEMATOLOGY ANALYZER OX - 360 OX360CLOSED98/79 AUTO HEMATOLOGY ANALYZER OX - 360 OX360OPEN98/79 AUTO HEMATOLOGY ANALYZER OX - 560 OX56098/79 AUTO HEMATOLOGY ANALYZER OX - 580 OX58098/79 AUTO HEMATOLOGY ANALYZER OX 560 - RET OX560RET2 réf.98/79 22 autres BIOCHEMISTRY ANALYZER AX - 200CLOSED AX200OPEN, AX200CLOSED BIOCHEMISTRY ANALYZER AX - 300CLOSED AX300OPEN, AX300CLOSED, AX400OPEN, AX400CLOSED2 réf. CLE-P Cleanser 500.05 Cleaner 360.5, Cleaner 360.12 réf. Coagulation Analyzer CX - 040 CX200, CX260, CX380, CX0403 réf. Concentrated Cleaner 360.02, Concentrated Cleaner 360.012 réf. Detergent 20 RET DIL-A Diluent 580.20 DIL-C Diluent 560.20 Diluent 20 RET Diluent 360.20, Diluent 360.52 réf. LYA-1 Lyse 580.5, LYA-1 Lyse2 réf. LYA-2 Lyse 580.51, LYA-2 Lyse2 réf. LYA-3 Lyse 580.1, LYA-3 Lyse2 réf. LYC-1 Lyse 560.2, LYC-1 Lyse 560.012 réf. LYC-2 Lyse 560.5, LYC-2 Lyse 560.22 réf. Lyse 1 RET Lyse 360.05, Lyse 360.032 réf. Probe Cleaner 360.01, Probe Cleaner 360.0052 réf. Probe Cleaner RET Sheath 20 RET Stain RET OR50T0020	A IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Microgenics FDA Mandataire UE : B·R·A·H·M·S GmbH (Allemagne)	États-Unis	96005098/79 96005198/79 96049998/79 96050098/79 96050198/79 22 autres 96060098/79 96123098/79 96123198/79 96124098/79 96124198/79 96124298/79 962000A98/79 96300198/79 96300298/79 96300398/79 96400198/79 96400298/79 96400398/79 96460098/79 96500198/79 96500298/79 96500398/79 96714698/79 96715098/79 96715198/79 96903298/79 OraTrust Oral Fluid Collection System B400017642 réf.	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Seamaty Mandataire UE : GRZAN GmbH (Allemagne) et 1 autre	Chine	AI Morphology analyzer SA1 Auto Chemistry Analyzer SMT-10A Auto Chemistry Analyzer SMT-120 Auto Dry Biochemistry Analyzer SD1 Auto Dry Biochemistry Analyzer SD1080 22 autres Auto Dry Biochemistry Analyzer SD3 Automatic Hematology Analyzer SMT-30 Automatic Hematology Analyzer SMT-30 Pro Automatic Hematology Analyzer SMT-50 Automatic Hematology Analyzer SMT-60 Blood gas & Electrolyte Analyzer SG1 Cleaner SMT-5C(50ml/200mL)2 réf. Diluent SMT-3D（5L、10L、20L）3 réf. Diluent SMT-5D(5L、10L、20L)3 réf. Fully Automated Chemiluminescence Immunoassay Analyzer SC200 Lyse SMT-3L（50ml、100mL、 200ml、250ml 、500mL、1L）3 réf. Lyse SMT-5L-D（50ml、100mL、 200ml、250ml 、500mL、1L）3 réf. Lyse SMT-5L-H（50ml、100mL、 200ml、250ml 、500mL、1L）3 réf. POCT Electrolyte Analyzer SE1 Seamaty SD1、SD32 réf. Seamaty SE1 Seamaty SG1 Seamaty SMT-120 Semi-automatic Biochemistry Analyzer SMT-70 Semi-automatic Biochemistry Analyzer SMT-70A VCHEMY S® EVO EVO-A01 VEGA-001	A IVDR	Fiche EUDAMED Signaler une erreur
Taidoc FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Taïwan	Clever Check TD-4116 Glucometru98/79 Clever Check TD-4116 Sistem pentru monitorizarea glucozei în sânge98/79 CLEVER CHECK TD-4125 Sistem pentru monitorizarea glicemiei98/79 Everchek Max Blood Glucose Monitoring System TD-418398/79 FORA COMFORT plus G30a98/79 22 autres FORA Diamond GD5098/79 Gluceofine Pro Blutzucker-Mess-System TD-418398/79 GLUCO TEST DUO Blutzuckermessger.Starterset mg/dl98/79 GLUCO TEST DUO Blutzuckermessger.Starterset mg/dl Messgerät98/79 GLUCO TEST DUO Blutzuckermessger.Starterset mmol/l98/79 GLUCO TEST DUO Blutzuckermessger.Starterset mmol/l Messgerät98/79 GLUCO TEST DUO Pro Set Blutzuckermessgerät mg/dl98/79 GLUCO TEST DUO Pro Set Blutzuckermessgerät mmol/l98/79 GLUCO TEST Plus 10 Set mg/dl98/79 GLUCO TEST Plus 10 Set mg/dl Messgerät98/79 GLUCO TEST Plus 10 Set mmol/l98/79 GLUCO TEST Plus 10 Set mmol/l Messgerät98/79 GlucoX Blood Glucose Monitoring System98/79 GlucoX TD-418398/79 mini SYSTÉM NA MERANIE HLADINY GLUKÓZY V KRVI98/79 Next PRO Glukomer98/79 Next SYSTÉM NA MONITOROVANIE GLUKÓZY V KRVI98/79 TD GLUCO Blood Glucose Monitoring System TD-427798/79 Uright TD-412598/79 Uright TD-426698/79 Uright TD-427798/79 XPER Technology Procheck Advance Multi-Functional Monitoring System98/79	– 98/79	Présent sur le marché en France Site web sales@taidoc.com Fiche EUDAMED Signaler une erreur
Dakewe FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	6250 Cryostat Microtome 6250, CT520, CT6203 réf. 7109030A Microscope Slides 7109030A, 7109040A2 réf. Automatic Tissue Processor HP300, HP300Plus, HP-HUGO3 réf. CK20 Antibody Reagent2 réf.98/79 CS500 Glass Coverslipper 21 autres Cytokeratin Pan Antibody Reagent2 réf.98/79 DKWAS001A Adhesion Microscope Slides DP260 Slide Stainer DP360, DP2602 réf. Embedding Cassette C-0A-00, C-0B-01, C-0B-00, C-1-00, C-1-02, C-1-01, C00, C01, C02, C033 réf. Eosin Staining Solution Alcohol-soluble; Water-soluble2 réf. Giemsa Staining Solution2 réf. Glass Coverslipper CS600 Harris Hematoxylin-Eosin Staining Solution HD Immunochromogenic Reagent3 réf. Immunochromogenic Reagent HI3 réf. Ki-67 Antibody Reagent2 réf.98/79 Microscope Cover Galss CG0121019，CG00210192 réf. Mounting Medium NB-30, NB-1002 réf. Mounting Medium QD-20 MT1 Rotary Microtome NS20 Fully Automated IHC Stainer NS40, NS202 réf. O.C.T. Compound p63 Antibody Reagent98/79 Papanicolaou Staining Solution EA50 SMA Antibody Reagent98/79	A IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Norgen Biotek Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Canada	Blood Genomic DNA Isolation Mini Kit Dx Cryptosporidium TaqMan RT-PCR Kit Dx EBV TaqMan PCR Kit Dx EZ Collect Stool Nucleic Acid Collection and Preservation Device Dx EZCollect Saliva DNA Device Dx 21 autres EZCollect Saliva RNA Device Dx FFPE DNA Purification Kit Dx FFPE RNA Purification Kit Dx FFPE RNA/DNA Purification Plis Kit Giardia intestinalis TaqMan RT-PCR Kit Dx JCV TaqMan PCR Kit Dx NoV TaqMan RT-PCR Kit Dx Plasma/Serum Cell-Free Circulating Purification Kit Dx3 réf. Plasma/Serum Circulating and Exosomal RNA Purification Kit Dx (Slurry Format) Plasma/Serum Circulating DNA Purification Mini Kit Dx (Slurry Format) Saliva DNA Collection and Preservation Devices Dx Saliva DNA Isolation Kit Dx Saliva RNA Collection and Preservation Devices Dx Saliva/Swab RNA Purification Kit Dx2 réf. Stool DNA Isolation Kit Dx Stool Nucleic Acid Collection and Preservation Devices Dx Stool Total RNA Purification Kit Dx Total RNA Purification Kit Dx3 réf. Urine DNA Isolation Kit Dx Urine Nucleic Acid Collection and Preservation System Dx Urine Total RNA Purification Maxi Kit Dx (Slurry Format)	A, B IVDR	Site web regulatory@norgenbiotek.com Fiche EUDAMED Signaler une erreur
Operon FDA	Espagne	CONTROL POSITIVO EN SECO CAMPYLOBACTER / CAMPYLOBACTER DRY POSITIVE CONTROL 9.230.XXX.12.ZZZ98/79 Control positivo en seco Crypto-Giardia-Entamoeba / Crypto-Giardia-Entamoeba Dry Positive Control 9.144.011.12.000 CONTROL POSITIVO EN SECO GDH-TOXINS / DRY GDH-TOXINS POSITIVE CONTROL 9.065.XXX.12.ZZZ CONTROL POSITIVO EN SECO H.PYL-TF \|\| H.PYL-TF DRY POSITIVE CONTROL 9.231.XXX.12.ZZZ CONTROL POSITIVO EN SECO ROTA-ADENO-NORO \|\| DRY POSITIVE CONTROL ROTA-ADENO-NORO 9.050.XXX.12.ZZZ 21 autres CONTROL POSITIVO EN SECO SARS-CoV-2/Flu A+B / SARS-CoV-2/Flu A+B DRY POSITIVE CONTROL 9.242.XXX.12.ZZZ CONTROL POSITIVO STREP PNEUMO-LEGIO / STREP PNEUMO-LEGIO POSITIVE CONTROL 9.108.XXX.37.ZZZ98/79 High + Low PapillomaStrip 3.148.XXX.YY.ZZZ98/79 High PapillomaStrip 3.146.XXX.YY.ZZZ98/79 Real Respiratory Bacterial Panel 2 (B. pertussis, B. parapertussis, B. holmesii) 5.182.XXX.YY.ZZZ2 réf. Real SARS-CoV-2/Flu/RSV 5.237.XXX.88.ZZZ98/79 Respiratory Bacterial Panel Strip 3.095.XXX.YY.ZZZ98/79 S. PneumoStrip 3.165.XXX.YY.ZZZ98/79 Simple / Stick Strep A 9.134.XXX.YY.ZZZ3 réf. SIMPLE 2A-Bdiff / STICK 2A-Bdiff 9.038.XXX.YY.ZZZ98/79 Simple AG SARS-CoV-2 / Flu A+B 9.242.XXX.YY.ZZZ3 réf. Simple Flu A+B 9.080.XX.YYY.ZZZ3 réf. SIMPLE GDH / STICK GDH 9.045.XXX.YY.ZZZ3 réf. Simple GDH-Toxins 9.065.XXX.YY.ZZZ3 réf. Simple H.pyl / Stick H.pyl 9.076.XXX.YY.ZZZ98/79 SIMPLE Legio pneumo / STICK Legio pneumo 9.106.XXX.YY.ZZZ98/79 Simple RSV 9.064.XXX.YY.ZZZ3 réf. Simple RSV-Flu A+B 9.081.XXX.YY.ZZZ3 réf. SIMPLE Strep pneumo / STICK Strep pneumo 9.107.XXX.YY.ZZZ98/79 STD Panel Strip 3.150.XXX.YY.ZZZ98/79 VIRAPID® HELICOBACTER PYLORI/TRANSFERRIN Ag 9.231.XXX.YY.ZZZ3 réf.	B IVDR, 98/79	Site web infoeudamed@operon.es Fiche EUDAMED Signaler une erreur
Phasescientific FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Hong Kong	INDICAID™ Candida/Trichomonas Vaginalis/Gardnerella Vaginalis Rapid Antigen Test98/79 INDICAID™ Dengue Virus Rapid Antibody Test98/79 INDICAID™ GASTROINTESTINAL 3-in-1 Rapid Antigen Test98/79 INDICAID™ Hand Foot And Mouth Disease Rapid Antibody Test98/79 INDICAID™ Helicobacter pylori Rapid Antigen Test98/79 21 autres INDICAID™ Helicobacter pylori Rapid IgG Antibody Test98/79 INDICAID™ HPV Virus Staining Test98/79 INDICAID™ Human Papillomavirus Nucleic Acid Test (Urine, Gene sequencing technology)98/79 INDICAID™ Human Papillomavirus Nucleic Acid Test (Urine, PCR-fluorescent probe method)98/79 INDICAID™ Human Papillomavirus Nucleic Acid Test (vaginal or cervical swab, PCR-fluorescent probe method)98/79 INDICAID™ Multiple Respiratory Pathogen Rapid Antigen Test98/79 INDICAID™ Pertussis Rapid Antibody Test98/79 INDICAID™ Respiratory 12-in-1 Rapid Antigen Test98/79 INDICAID™ Respiratory 12-in-1 Rapid Antigen Test (Children Edition)98/79 INDICAID™ Respiratory 5-in-1 Rapid Antigen Test98/79 INDICAID™ Respiratory 6-in-1 Rapid Antigen Test98/79 INDICAID™ Respiratory 8-in-1 Rapid Antigen Test98/79 INDICAID™ Respiratory Syncytial Virus Rapid Antigen Test98/79 INDICAID™ Rotavirus/Adenovirus Rapid Antigen Test98/79 INDICAID™ Strep A Rapid Antigen Test98/79 INDICAID™ Vaginal Discharge Analysis Test Strip98/79 INDICAID™Dengue Virus Rapid NS1 Antigen Test98/79 INDICAID™Norovirus Rapid Antigen Test98/79 INDICAID™Strep B Rapid Antigen Test98/79 INDICAID™Treponema Pallidum Rapid Antibody Test98/79 P0098, P009998/79	– 98/79	Site web info@phasesci.com Fiche EUDAMED Signaler une erreur
Qnostics Mandataire UE : WMDE B.V. (Pays-Bas)	United Kingdom (ex Northern Ireland)	Qnostics Ltd Adenovirus (ADV) Analytical Q Panel98/79 Qnostics Ltd Adenovirus (ADV) Molecular Q Control98/79 Qnostics Ltd Adenovirus (ADV) Molecular Q Panel98/79 Qnostics Ltd BK Virus (BKV) Analytical Q Panel98/79 Qnostics Ltd BK Virus (BKV) Molecular Q Control98/79 21 autres Qnostics Ltd BK Virus (BKV) Molecular Q Panel98/79 Qnostics Ltd Epstein-Barr Virus (EBV) Analytical Q Panel98/79 Qnostics Ltd Epstein-Barr Virus (EBV) Molecular Q Control98/79 Qnostics Ltd Epstein-Barr Virus (EBV) Molecular Q Panel98/79 Qnostics Ltd Herpes Simplex Virus 1 (HSV1) Analytical Q Panel98/79 Qnostics Ltd Herpes Simplex Virus 1 (HSV1) Molecular Q Control98/79 Qnostics Ltd Herpes Simplex Virus 1 (HSV1) Molecular Q Panel98/79 Qnostics Ltd Herpes Simplex Virus 2 (HSV2) Analytical Q Panel98/79 Qnostics Ltd Herpes Simplex Virus 2 (HSV2) Molecular Q Control98/79 Qnostics Ltd Herpes Simplex Virus 2 (HSV2) Molecular Q Panel98/79 Qnostics Ltd Influenza B virus (INFB) Molecular Q Control98/79 Qnostics Ltd JC Virus (JCV) Molecular Q Control98/79 Qnostics Ltd Respiratory Syncytial Virus A (RSVA) Molecular Q Control98/79 Qnostics Ltd Severe acute respiratory syndrome coronavirus 2 (SCV2) Analytical Q Panel98/79 Qnostics Ltd Severe acute respiratory syndrome coronavirus 2 (SCV2) Molecular Q Control98/79 Qnostics Ltd Severe acute respiratory syndrome coronavirus 2 (SCV2) Molecular Q Panel98/79 Qnostics Ltd Varicella Zoster Virus (VZV) Analytical Q Panel98/79 Qnostics Ltd Varicella Zoster Virus (VZV) Molecular Q Control98/79 Qnostics Ltd Varicella Zoster Virus (VZV) Molecular Q Panel98/79 Qnostics Ltd. Influenza A virus (INFA) Molecular Q Control98/79 Qnostics Ltd. JC Virus (JCV) Molecular Q Panel98/79	– 98/79	quality@qnostics.com Fiche EUDAMED Signaler une erreur
Realytech Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	Anti-Treponema Pallidum(Anti-TP) Assay Reagent Kit (CMIA) C2KJ00198/79 D-Dimer Rapid Test Device (Colloidal Gold) B010216D98/79 D-Dimer Rapid Test Device (Colloidal Gold) B011016D98/79 Dengue NS1 Antigen (DEN NS1 Ag) Assay Reagent Kit (CMIA) C2KJ00298/79 Herpes Simplex Virus -Ⅰ IgG (HSV-Ⅰ IgG) Assay Reagent Kit (CMIA) C2KL00198/79 21 autres Herpes Simplex Virus -Ⅰ IgM (HSV-Ⅰ IgM) Assay Reagent Kit (CMIA) C2KL01198/79 Herpes Simplex Virus -Ⅰ/Ⅱ IgG (HSV-Ⅰ/Ⅱ IgG) Assay Reagent Kit (CMIA) C2KL00998/79 Herpes Simplex Virus -Ⅰ/Ⅱ IgM (HSV-Ⅰ/Ⅱ IgM) Assay Reagent Kit (CMIA) C2KL01098/79 Herpes Simplex Virus -Ⅱ IgM (HSV-Ⅱ IgM) Assay Reagent Kit (CMIA) C2KL01298/79 Herpes Simplex Virus-Ⅱ IgG(HSV-Ⅱ IgG) Assay Reagent Kit(CMIA) C2KL00298/79 HPV IgM Rapid Test Device K410216D98/79 Influenza A&B Rapid Test K251316T98/79 Interleukin-6 (IL-6) Assay Reagent Kit (CMIA) C2KF00298/79 M.Pneumonia Antigen Rapid Test Device K681416D98/79 M.Pneumonia IgG/IgM Rapid Test Device K670216D98/79 Malaria Ag P.f (HRP-Ⅱ) Assay Reagent Kit (CMIA) C2KJ00398/79 Malaria P.f. Rapid Test Device K270916D98/79 Malaria P.f./P.v. Rapid Test Device K280916D98/79 Malaria P.f./Pan Antigen Rapid Test Device K290916D98/79 Mycoplasma pneumoniae IgG antibody Assay Reagent Kit (CMIA) C2KJ01498/79 Mycoplasma pneumoniae IgM antibody Assay Reagent Kit (CMIA) C2KJ01598/79 RSV Rapid Test Device K311416D98/79 S.typhi Antigen Rapid Test Device K360416D98/79 The IL-6 Rapid Test A060201T98/79 The L.pn Rapid Test Device K780316D98/79 Typhoid IgG/IgM Rapid Test K370216T98/79	– 98/79	Site web info@realytech.com Fiche EUDAMED Signaler une erreur
Wheisman Medical Technology Mandataire UE : Umedwings Netherlands B.V. (Pays-Bas)	Chine	Auto 3-part Hematology Analyzer AC 31098/79 Auto 3-part Hematology Analyzer AC31698/79 Auto 3-part Hematology Analyzer AC33098/79 Auto 3-part Hematology Analyzer AC33698/79 Auto 5-part Hematology Analyzer AC 61098/79 21 autres Auto 5-part Hematology Analyzer AC 61698/79 Auto 5-part Hematology Analyzer AC 63098/79 Auto 5-part Hematology Analyzer AC 63698/79 Hematology Calibrator L-CAL：3mL×198/79 Hematology Control L-3D： High: 2.5mL/Vial98/79 Hematology Control L-3D： Mix: 2.5mL/Vial98/79 Hematology Control L-3D：Low: 2.5mL/Vial98/79 Hematology Control L-3D：Normal: 2.5mL/Vial98/79 Hematology Control L-5D：High: 3mL/Vial98/79 Hematology Control L-5D：Low: 3mL/Vial98/79 Hematology Control L-5D：Mix: 3mL/Vial98/79 Hematology Control L-5D：Normal: 3mL/Vial98/79 Hematology Reagent - Diluent 2L, 5L, 10L, 20L3 réf. Hematology Reagent - Diluent W-31D：2L, 5L, 10L, 20L3 réf. Hematology Reagent - Lyse W-31L：250mL、250mL×3、500mL、500mL×3、1L3 réf. Hematology Reagent - Lyse W-61LD：250mL、250mL×3、500mL、500mL×3、1L3 réf. Hematology Reagent - Lyse W-61LH：250mL、250mL×3、500mL、500mL×3、1L3 réf. Hematology Reagent - Lyse W-62LD： 250mL, 500mL, 500mL×4, 1L 1L×43 réf. Hematology Reagent - Lyse W-63LD1： 200mL, 500mL, 1L, 1L×43 réf. Hematology Reagent - Lyse W-63LD2： 100mL, 250mL, 500mL, 500mL×43 réf. Hematology Reagent - Probe Cleanser 50mL、50mL×22 réf.	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Wizbiotech Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	Diagnostic Kit for Antibody Subtype to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)98/79 Diagnostic Kit for Antibody to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)98/79 Diagnostic Kit for Antibody to Helicobacter Pylori(Colloidal Gold)98/79 Diagnostic Kit for Antigen to Adenoviruses (Colloidal Gold)98/79 Diagnostic Kit for Antigen to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)98/79 21 autres Diagnostic Kit for Antigen to Helicobacter Pylori (Latex)98/79 Diagnostic Kit for Antigen to Rotavirus (Latex)98/79 Diagnostic Kit for Antigen to Rotavirus/Adenoviruses (Latex)98/79 Diagnostic Kit for IgM Antibody to C. pneumoniae(Colloidal Gold)98/79 Diagnostic Kit for IgM Antibody to Mycoplasma Pneumoniae (Colloidal Gold)98/79 Diagnostic Kit for Interleukin-6 (Fluorescence Immunochromatographic Assay)98/79 Diagnostic Kit for Antibody to Treponema Pallidum(Colloidal Gold)98/79 Diagnostic Kit for Antigen to Norovirus (Colloidal Gold)98/79 Diagnostic Kit for Antigen to Respiratory Syncytial Virus (Colloidal Gold)98/79 Malaria (P.F) Rapid Test (Colloidal Gold)98/79 Malaria P.F/P.V Rapid Test (Colloidal Gold)98/79 Malaria P.F/Pan Rapid Test(Colloidal Gold)98/79 SARS-CoV-2 Ab Rapid Test (Colloidal Gold)98/79 SARS-CoV-2 Antigen Rapid Test98/79 SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)98/79 SARS-CoV-2 Antigen Rapid Test (Saliva)98/79 SARS-CoV-2 Antigen Rapid Test (Sputum/Saliva/Stool)98/79 SARS-CoV-2 Neutralizing Antibodies Test98/79 Type A, Type B98/79 Type A, Type B, Type C98/79 WIZ-A101	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Yanengbio Mandataire UE : Obelis s.a. (Belgique)	Chine	Automatic Hybridization System YN-H48 Automatic Integrated Nucleic Acid Analyzer YN-AHR3210 DD Nucleic Acid Dye Fully Automated Nucleic Acid Amplification Hybridization Analyzer YN-HR9600pro Group B Streptococcus Nucleic Acid Detection Kit (Real-Time PCR)98/79 21 autres Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis)98/79 Human Papillomavirus Genotyping Kit for 15 Types (PCR-Reverse Dot Blot)98/79 Human Papillomavirus Genotyping Kit for 18 Types (PCR-Reverse Dot Blot)98/79 Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot)2 réf.98/79 Human Papillomavirus Nucleic Acid Detection and HPV16/18 Genotyping Kit (PCR-Fluorescence Probing)98/79 Nucleic Acid Extraction Reagent Human Whole Blood DNA (Spin-Column) Nucleic Acid Extraction Reagent MCP-16C, MCP-96C, MCP-100F, MCP-96E Nucleic Acid Extraction Reagent MEB-16C, MEB-96C, MEB-100F, MEB-16D, MEB-96D Nucleic Acid Extraction Reagent MEG-16C, MEG-96C, MEG-100F Nucleic Acid Extraction Reagent MES-16C, MES-96C, MES-100F Nucleic Acid Extraction Reagent MNP-16C, MNP-96C, MNP-100F, MNP-96E Nucleic Acid Extraction Reagent MNS-16C; MNS-48F Nucleic Acid Extraction Reagent Pathogen DNA (Spin-Column) Nucleic Acid Extraction Reagent QIA p16/ Ki-67 dual stain cytology kit DS Respiratory Pathogens Combo Testing Kit98/79 Sample Pretreatment Kit for DNA Methylation Test BS Sample Pretreatment Kit for DNA Methylation Test MBS-16C; MBS-48F Stool Collection Tube FPS Urine Collection Tube UPF Urine Collection Tube UPS	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
YASEE BioMedical FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	Blood Glucose Meter AC-30198/79 Blood Glucose Meter AC-30398/79 Blood Glucose Meter AC-30798/79 Blood Glucose Meter AC-30898/79 Blood Glucose Meter AC-3092 réf.98/79 21 autres Blood Glucose Meter GLM-732 réf.98/79 Blood Glucose Meter GLM-7598/79 Blood glucose meter GLM-7698/79 Blood Glucose Meter GLM-772 réf.98/79 Blood Glucose Meter GLM-7898/79 BLOOD GLUCOSE METER GLM-7998/79 Blood Glucose Monitoring System AC-30198/79 Blood Glucose Monitoring System AC-30398/79 Blood Glucose Monitoring System AC-30598/79 Blood Glucose Monitoring System AC-30798/79 Blood Glucose Monitoring System AC-30898/79 Blood Glucose Monitoring System AC-30998/79 Blood Glucose Monitoring System GLM-7398/79 Blood Glucose Monitoring System GLM-7598/79 Blood Glucose Monitoring System GLM-7698/79 Blood Glucose Monitoring System GLM-7798/79 Blood Glucose Monitoring System GLM-7898/79 Blood Glucose Monitoring System GLM-7998/79 Glucómetro GLM-7398/79 Lancing device YS-CXB3 W0201060102 AC-30598/79	I MDR, 98/79	Fiche EUDAMED Signaler une erreur
Diatron FDA	Hongrie	3 Hematology Scan Aquarius 3 Hematology Analyzer3 réf. 5 Hematology Scope Hematology analyzer3 réf. Abacus 380 Hematology Analyzer3 réf. Abacus Junior 30 Hematology Analyzer2 réf. Aquila Hematology Analyzer2 réf. 20 autres Atellica DT 250 analyzer Chemistry Analyzer2 réf. Autopak 300 Clinical Chemistry Autoanalyzer Clinilcal Chemistry analyzers3 réf. Diacon 3 Hematology Control HIGH Level DN35003-SET98/79 Diacon 3 Hematology Control LOW Level DN35001-SET98/79 Diacon 3 Hematology Control Normal DN35002-SET98/79 Diacon 3 Hematology Control Set (2L-2N-2H) DN35004-KIT98/79 Diacon 5 Hematology Control HIGH Level DN55003-SET98/79 Diacon 5 Hematology Control LOW Level DN55001-SET98/79 Diacon 5 Hematology Control NORMAL Level DN55002-SET98/79 Diacon 5 Hematology Control Set (2L-2N-2H) DN55004-KIT98/79 Diatrocal Hematology Calibrator DL30001-SET98/79 Diatro•3P Reagent Smart Pack DRP07498/79 Diatro•Cleaner D5012 réf. Diatro•Diff-5P D30298/79 Diatro•Dil-5P D15198/79 Diatro•Dil-DIFF D10198/79 Diatro•Hypoclean CC D801 Diatro•Hypoclean D701 Diatro•Lyse-5P D30198/79 Diatro•Lyse-DIFF D20198/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Genobio Pharmaceutical FDA Mandataire UE : Caretechion GmbH (Allemagne) et 2 autres	Chine	Aspergillus Galactomanan ELISA Detection Kit98/79 Aspergillus Galactomannan Detection K-Set (Lateral Flow Assay)98/79 Aspergillus Galactomannan Detection Kit (CLIA)98/79 Aspergillus IgG Antibody Detection K-Set(Lateral Flow Assay)98/79 Aspergillus IgG Antibody Detection Kit (CLIA)98/79 20 autres Aspergillus IgM Antibody Detection K-Set(CLIA)98/79 Aspergillus Molecular Detection Kit (Real-time PCR)2 réf.98/79 Candida auris Molecular Detection Kit (Real-time PCR) FCUPCR-2598/79 Candida auris Molecular Detection Kit (Real-time PCR) FCUPCR-5098/79 Candida IgG Antibody Detection Kit (CLIA)98/79 Candida Mannan Detection Kit (CLIA)98/79 Candida Mannan IgM Antibody Detection K-Set(CLIA) CMCLIA-0198/79 Candida Molecular Detection Kit (Real-time PCR)2 réf.98/79 Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay)2 réf.98/79 Cryptococcal Capsular Polysaccharide Detection Kit (CLIA)98/79 Cryptococcus Molecular Detection Kit (Real-time PCR) FCPCR-2598/79 Cryptococcus Molecular Detection Kit (Real-time PCR) FCPCR-5098/79 Full-Automatic Chemiluminescence Immunoassay System Fully Automatic Kinetic Tube Reader Fungus (1-3)-β-D-Glucan Detection Kit (CLIA)98/79 Immunochromatography Analyzer Influenza A&B Antigen Rapid Test (Colloidal Gold) VILFA-0198/79 Influenza A&B Antigen Rapid Test (Colloidal Gold) VILFA-2098/79 Monkeypox Virus Molecular Detection Kit (Real-time PCR)2 réf.98/79 Pneumocystis Molecular Detection Kit (Real-time PCR)2 réf.98/79	A IVDR, 98/79	Site web marketing@era-bio.com Fiche EUDAMED Signaler une erreur
Arcdia	Finlande	mariPOC® Adenovirus gastrointestinal test reagent98/79 mariPOC® Adenovirus respiratory test reagent98/79 mariPOC® Campylobacter spp. test reagent98/79 mariPOC® CDI test plate98/79 mariPOC® Clostridium difficile GDH test reagent98/79 21 autres mariPOC® Clostridium difficile Toxin A/B test reagent98/79 mariPOC® Extraction solution A mariPOC® Extraction solution B mariPOC® Group A streptococcus test reagent98/79 mariPOC® Human bocavirus test reagent98/79 mariPOC® Human coronavirus OC43 test reagent98/79 mariPOC® Human metapneumovirus test reagent98/79 mariPOC® Inactivation solution mariPOC® Influenza A virus test reagent98/79 mariPOC® Influenza B virus test reagent98/79 mariPOC® Norovirus GI test reagent98/79 mariPOC® Norovirus GII.4 test reagent98/79 mariPOC® Parainfluenza virus 1 test reagent98/79 mariPOC® Parainfluenza virus 2 test reagent98/79 mariPOC® Parainfluenza virus 3 test reagent98/79 mariPOC® Pneumococcus respiratory test reagent98/79 mariPOC® Respiratory syncytial virus test reagent98/79 mariPOC® Rotavirus test reagent98/79 mariPOC® SARS-CoV-2 test reagent98/79 mariPOC® Quick combi test plate (plus commercialisé) mariPOC® RTI combi test plate (plus commercialisé)	A IVDR, 98/79	Site web office@arcdia.com Fiche EUDAMED Signaler une erreur
SD Biosensor FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud, Inde	Q-NCOV-07G4 réf. STANDARD™ F H. pylori Ag FIA F-HPY-01 STANDARD™ F Legionella Ag FIA FLGN01G STANDARD™ F S. pneumo & Legio Combo Ag Control C-F-PNLG-01C STANDARD™ GlucoNavii® GDH Blood Glucose Monitoring System 01GM3098/79 20 autres STANDARD™ H. pylori Ag Control C-HPY-01 STANDARD™ i Wash buffer i-WBF-01 STANDARD™ i1000 STANDARD™ i2000 STANDARD™ Legionella Ag Control C-LGN01G STANDARD™ M10 C. difficile BT M10-CBT-01 STANDARD™ M10 C. difficile M10-CDF-0198/79 STANDARD™ M10 Console M10-01S2 réf. STANDARD™ M10 Flu/RSV/SARS-CoV-2 M10-CVFR-0198/79 STANDARD™ M10 Flu/RSV/SARS-CoV-2 M10-CVFR-02 STANDARD™ M10 Hr-HPV M10-HPV-02 STANDARD™ M10 MRSA/SA M10-MRSA-01 STANDARD™ M10 MTB-RIF/INH M10-MTB-02 STANDARD™ M10 SARS-CoV-2 M-NCOV-0398/79 STANDARD™ M10 Sputum Pretreatment Kit M10-SPTP-01 STANDARD™ M10 STI Panel M10-STI-01 STANDARD™ M10 Stool Pretreatment kit M10-STP-01 STANDARD™ Q COVID-19 Ag Home Test Q-NCOV-03G3 réf. STANDARD™ Q HCV Ab Test QHCV01B2 réf. STANDARD Q Malaria P.f/P.v Ag RK025-40 (plus commercialisé)	A, B, C, D IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
3Klab	Turquie	1 UL ÖZE UCU E-BEAM STERİL98/79 10 UL ÖZE UCU E-BEAM STERİL98/79 100 ML İDRAR KABI ASEPTİK98/79 100 ML İDRAR KABI E-BEAM STERİL98/79 100 ML İDRAR KABI NON-STERİL 19 autres 120MM PETRİ KABI ASEPTİK98/79 120MM PETRİ KABI E-BEAM STERİL98/79 150MM PETRİ KABI ASEPTİK98/79 150MM PETRİ KABI E-BEAM STERİL98/79 6015 MM PETRİ E-BEAM STERİL98/79 60ML ENTEGRE ASEPTİK İDRAR KABI98/79 60ML ENTEGRE NON STERİL İDRAR KABI 60MM PETRİ ASEPTİK STERİL 6015 MM PETRİ ASEPTİK STERİL98/79 60MM PETRİ GAMMA STERİL 6015 MM PETRİ GAMMA STERİL98/79 9015 BÖLMELİ PETRİ ASEPTİK98/79 9015 BÖLMELİ PETRİ E-BEAM STERİL98/79 9015 PETRİ KABI ASEPTİK98/79 90*15 PETRİ KABI E-BEAM STERİL98/79 90MM İKİ BÖLMELİ PETRİ KABI ASEPTİK STERİL98/79 90MM İKİ BÖLMELİ PETRİ KABI E-BEAM STERİL98/79 90MM PETRİ KABI ASEPTİK STERİL98/79 90MM PETRİ KABI E-BEAM STERİL98/79 RODAK PETRİ KABI E-BEAM STERİL98/79 RODAK PETRİ KABI GAMMA STERİL98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Ablsa	Luxembourg	DeepChek® Assay INTEGRASE Genotyping and Drug Resistance V1.X98/79 DeepChek® Assay INTEGRASE Sequencing V1.X98/79 DeepChek® Assay PROTEASE / REVERSE TRANSCRIPTASE Genotyping and Drug Resistance V1.X98/79 DeepChek® Assay PROTEASE / REVERSE TRANSCRIPTASE Sequencing V1.X98/79 DeepChek® Assay Whole Genome HIV-1 Genotyping V1.X98/79 19 autres UltraGene Assay SARS-CoV-298/79 UltraGene Assay Combo 4 Screening V2.X (1000 tests)98/79 UltraGene Assay Combo 4 Screening V2.X (50 tests)98/79 UltraGene Assay FLU/HRSV (32 tests)98/79 UltraGene Assay FLU/HRSV (64 tests)98/79 UltraGene Assay Respiratory pathogens 21 (32 tests)98/79 UltraGene Assay Respiratory pathogens 21 (64 tests)98/79 UltraGene Assay SARS-CoV-2 PrimeChek V3 (1000 tests, liquid)98/79 UltraGene Assay SARS-CoV-2 PrimeChek V3 (50 tests, liquid)98/79 UltraGene Assay SARS-CoV-2 PrimeChek V3 (96 tests, lyophilized)98/79 UltraGene Assay SARS-CoV-2 VOC Screening & Determination V1.X98/79 UltraGene Assay SARS-CoV-2 Universalis V2.X (1000 tests)98/79 UltraGene Assay SARS-CoV-2 Universalis V2.X (50 tests)98/79 UltraGene Assay Stool parasites (32 tests)98/79 UltraGene Assay Stool parasites (64 tests)98/79 UltraGene Assay Vesicular rash (32 tests)98/79 UltraGene Assay Vesicular rash (64 tests)98/79 UltraGene Assay Viral meningitis (32 tests)98/79 UltraGene Assay Viral meningitis (64 tests)98/79	– 98/79	Site web contact@ablsa.com Fiche EUDAMED Signaler une erreur
Advanced Molecular Diagnostics Mandataire UE : Advena Limited (Malte)	United Kingdom (ex Northern Ireland)	ZENA MAX BK Virus Real Time PCR Detection Kit98/79 ZENA MAX Dengue Virus Real Time PCR Detection Kit98/79 ZENA MAX EBV Epstein-Barr Real Time PCR Detection Kit98/79 ZENA MAX H. pylori Real Time PCR Detection Kit98/79 ZENA MAX Hepatitis A Virus Real Time PCR Detection Kit98/79 19 autres ZENA MAX Hepatitis E Virus Real Time PCR Detection Kit98/79 ZENA MAX HSV Type 1/2 Real Time PCR Detection Kit98/79 ZENA MAX Human Adenovirus (HAdV) Real Time PCR Detection Kit98/79 ZENA MAX Human Herpesvirus 6 (HHV-6) Real Time PCR Detection Kit98/79 ZENA MAX Human Herpesvirus 8 (HHV-8) Real Time PCR Detection Kit98/79 ZENA MAX Influenza A(H1N1)pdm09 Real Time PCR Detection Kit98/79 ZENA MAX Measles Virus Real Time PCR Detection Kit98/79 ZENA MAX Mumps Virus (MuV) Real Time PCR Detection Kit98/79 ZENA MAX Mycobacterium Tuberculosis Real Time PCR Detection Kit98/79 ZENA MAX Papillomavirus (HPV) Type 16 and 18 Real Time PCR Detection Kit98/79 ZENA MAX Papillomavirus (HPV) Type 6 and 11 Real Time PCR Detection Kit98/79 ZENA MAX Parvovirus B19 Real Time PCR Detection Kit98/79 ZENA MAX Respiratory Panel 1 SARS-CoV-2, Influenza A and B Real Time PCR Detection Kit98/79 ZENA MAX Respiratory Panel 2 SARS-CoV-2, Influenza A & B and RSB A&B Real Time PCR Detection Kit98/79 ZENA MAX Respiratory Panel 3 SARS-CoV-2, Influenza A&B and H1N1 Real Time PCR Detection Kit98/79 ZENA MAX Respiratory Panel 4 SARS-CoV-2 and Coronavirus (HKU1, NL63, OC43, 229E)98/79 ZENA MAX Toxoplasma gondii Real Time PCR Detection Kit98/79 ZENA MAX Varicella-Zoster Virus (VZV) Real Time PCR Detection Kit98/79 ZENA MAX Yersinia Pestis Real Time PCR Detection Kit98/79	– 98/79	Site web info@am-diagnostics.co.uk Fiche EUDAMED Signaler une erreur
Andreas Hettich FDA	Allemagne	BOECO HC-240 - 100-127V/50-60Hz 180198/79 BOECO HC-240 - 200-240V/50-60Hz 180198/79 EBA 200 - 100V-127V/50-60Hz 1800, 18023 réf. EBA 200, 100-127V/50-60Hz, (MD) 18102 réf. EBA 270, 100-127V 50-60Hz 23002 réf. 19 autres EBA 280 S, 100-127V /50-60Hz 1101, 11023 réf. HAEMATOKRIT 200 - 100-127V/50-60HZ 180198/79 HAEMATOKRIT 200 - 200-240V/50-60HZ 180198/79 HettCube 200, 100-120V, 50/60 Hz 62000, 62005, 64000, 64005, 66000, 660053 réf. MIKRO 185 - 100-127V/50-60Hz 12032 réf. MIKRO 2.0 (IVD), 100-240V/50-60Hz 2404, 24062 réf. MIKRO 200 - 100-127V/50-60Hz 2400, 24053 réf. MIKRO 220 R, 100-127V/60Hz 2200, 22053 réf. MIKRO 220 Robotic 100-127V/50-60Hz 23502 réf. ROTANTA 460 R, 100-127V 60Hz 100V 50Hz 5650, 5660, 5670, 56753 réf. ROTANTA 460 Robotic, 100V 50-60Hz 56803 réf. ROTINA 380 R, 110-127V 60Hz 1701, 17063 réf. ROTINA 380 RC Robotic 3700, 37043 réf. ROTINA 420 R, 100-127V 60Hz, 100V 50Hz 4701, 47063 réf. ROTIXA 500 RS, 208V 60Hz 49503 réf. ROTO SILENTA 630 RS 50053 réf. ROTOFIX 32 A, 100-127V 50-60Hz, (MD) 12072 réf. ROTOFIX 32A, 100-127V 50-60Hz 12063 réf. UNIVERSAL 320 R, 115-127V 60Hz 1401, 14063 réf.	IIa, A IVDR, MDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Eurobio Scientific	France	Bleu Trypan 4,0%2 réf. EBX GI Helminths3 réf.98/79 EBX GI Pretreatment EBE-092 EBX GI Protozoans3 réf.98/79 EurobioPlex Bartonella3 réf.98/79 19 autres EurobioPlex BK Virus3 réf.98/79 EurobioPlex BK virus / JC virus3 réf.98/79 EurobioPlex Bordetella pertussis et parapertussis3 réf.98/79 EurobioPlex Coxiella Burnetii3 réf.98/79 EurobioPlex Dengue 12343 réf.98/79 EurobioPlex FluCoSyn EBX-0425 réf.98/79 EurobioPlex HHV6-HHV83 réf.98/79 EurobioPlex JC Virus3 réf.98/79 EurobioPlex Méningite bactérienne communautaire2 réf.98/79 EurobioPlex Méningite bactérienne materno-foetale2 réf.98/79 EurobioPlex Parvovirus B193 réf.98/79 EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)3 réf.98/79 EurobioPlex Zika Virus3 réf.98/79 Lymphocyte separation medium CMSMSL01-013 réf. Milieu Essentiel Minimum de Eagle3 réf. Milieu Essentiel Minimum De Eagle modifié Par Dulbecco2 réf. Milieu L15 de Leibovitz2 réf. Milieux RPMI 1640 Milieu RPMI 16403 réf. MYCOKIT SERO98/79	A IVDR, 98/79	Présent sur le marché en France reglementaire@eurobio-scientific.com Fiche EUDAMED Signaler une erreur
Hebei Xinle Sci&Tech FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Single-use Containers for Human Capillary Blood Specimen Collection Clot Activator3 réf. Single-use Containers for Human Capillary Blood Specimen Collection Gel and Clot Activator3 réf. Single-use Containers for Human Capillary Blood Specimen Collection K2EDTA3 réf. Single-use Containers for Human Capillary Blood Specimen Collection K3EDTA3 réf. Single-use Containers for Human Capillary Blood Specimen Collection Lithium Heparin3 réf. 19 autres Single-use Containers for Human Capillary Blood Specimen Collection No Additive3 réf. Single-use Containers for Human Capillary Blood Specimen Collection Sodium Fluoride/K2EDTA3 réf. Single-use Containers for Human Capillary Blood Specimen Collection Sodium Heparin3 réf. Single-use Containers for Human Venous Blood Specimen Collection 4NC Sodium Citrate3 réf. Single-use Containers for Human Venous Blood Specimen Collection 9NC Sodium Citrate3 réf. Single-use Containers for Human Venous Blood Specimen Collection Acid Citrate Dextrose3 réf. Single-use Containers for Human Venous Blood Specimen Collection ccfDNA Tube3 réf. Single-use Containers for Human Venous Blood Specimen Collection Clot Activator3 réf. Single-use Containers for Human Venous Blood Specimen Collection Gel and Clot Activator3 réf. Single-use Containers for Human Venous Blood Specimen Collection Gel and K2EDTA3 réf. Single-use Containers for Human Venous Blood Specimen Collection Gel and Lithium Heparin3 réf. Single-use Containers for Human Venous Blood Specimen Collection K2EDTA3 réf. Single-use Containers for Human Venous Blood Specimen Collection K3EDTA3 réf. Single-use Containers for Human Venous Blood Specimen Collection Lithium Heparin3 réf. Single-use Containers for Human Venous Blood Specimen Collection No Additive3 réf. Single-use Containers for Human Venous Blood Specimen Collection Sodium Fluoride/ K2EDTA3 réf. Single-use Containers for Human Venous Blood Specimen Collection Sodium Fluoride/ Lithium Heparin3 réf. Single-use Containers for Human Venous Blood Specimen Collection Sodium Fluoride/ Potassium Oxalate3 réf. Single-use Containers for Human Venous Blood Specimen Collection Sodium Heparin3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Illumaxbio Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	Automated CLEIA system DNK-MiniCL16 Automated CLEIA system DNK-MiniCL8 Automated CLEIA system lumiflx16 Automated CLEIA system lumiflx16s Automated CLEIA system lumilite8 19 autres Automated CLEIA system lumilite8s Automated Multiplex Immunoassay System P16 Automated Multiplex Immunoassay System P16s Automated Multiplex Immunoassay System P8 Automated Multiplex Immunoassay System P8e Automated Multiplex Immunoassay System P8n Automated Multiplex Immunoassay System P8s D-Dimer Assay Kit(Chemiluminescent Immunoassay) 24 strips/box98/79 D-Dimer Assay Kit(Chemiluminescent Immunoassay) 48 strips/box98/79 Fibrinogen Degradation Products Assay Kit (Chemiluminescent Immunoassay) 24 strips/box98/79 Fibrinogen Degradation Products Assay Kit (Chemiluminescent Immunoassay) 48 strips/box98/79 Interleukin-6 Assay Kit(Chemiluminescent Immunoassay) 24 strips/box98/79 Interleukin-6 Assay Kit(Chemiluminescent Immunoassay) 48 strips/box98/79 Plasmin-α2 Plasmin inhibitor Complex Assay Kit (Chemiluminescent Immunoassay) 24 strips/box98/79 Plasmin-α2 Plasmin inhibitor Complex Assay Kit (Chemiluminescent Immunoassay) 48 strips/box98/79 Thrombin-Antithrombin Ⅲ Complex Assay Kit (Chemiluminescent Immunoassay) 24 strips/box98/79 Thrombin-Antithrombin Ⅲ Complex Assay Kit (Chemiluminescent Immunoassay) 48 strips/box98/79 tissue Plasminogen Activator-plasminogenactivator Inhibitor-1 Complex Complex Assay Kit (Chemiluminescent Immunoassay) 24 strips/box98/79 tissue Plasminogen Activator-plasminogenactivator Inhibitor-1 Complex Complex Assay Kit (Chemiluminescent Immunoassay) 48 strips/box98/79	A IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Shandon Diagnostics FDA Mandataire UE : Epredia Netherlands B.V. (Pays-Bas)	United Kingdom (ex Northern Ireland)	12ml VIAL WITH CAP KIT3 réf. 5 Litre Reagent bottle - Empty (set of 6 bottles)3 réf. ADAPTER F JUNG CTM6 Coverslipper3 réf. BASKET AND CARRIER3 réf. BASKET DIVIDER ASSY3 réf. 19 autres BASKET STAND COMPLETE A792000013 réf. Bionet Cassettes - Aqua3 réf. CABLE A810000043 réf. Cool-Cut HM 355S Rotary Microtome3 réf. Cryostar NX50 HOP HC Cryostar NX50 Cryostat3 réf. Cryostar NX70 HOMP Cryostar NX70 Cryostat3 réf. Cytospin 4 Cytocentrifuge3 réf. Epredia E1000 Dx Digital Pathology Solution EVAPORATION COVER3 réf. Histoplast 10kg2 réf. HM 325 HM325 Rotary Microtome3 réf. HM 430 Sliding Microtome2 réf. HM 450 Sliding Microtome HM340E Rotary Microtome3 réf. HM525 NX HC HM525 NX Cryostat3 réf. Manual Unloaded Screwdriver3 réf. PARAFIN BATH STP120 Tissue Processor3 réf. PT Module Shandon™ PapSpin™	A IVDR	Fiche EUDAMED Signaler une erreur
Biohermes FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	A1C EZ 2.098/79 A1C EZ 2.0 BT98/79 A1C EZ Auto 4 W98/79 A1C-EXP M1198/79 A1C-EXP M1298/79 18 autres BF C063 réf.98/79 BF S065 réf.98/79 BF S215 réf.98/79 BH6098/79 BH60G98/79 GM 1.02 réf.98/79 GM 4.098/79 GM 4.12 réf.98/79 GM 5.098/79 GM 5.12 réf.98/79 GM 6.098/79 GM 6.12 réf.98/79 GM 7.098/79 GM 7.12 réf.98/79 GM 8.098/79 GM 8.12 réf.98/79 GM 9.098/79 GM 9.12 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Clongene FDA Mandataire UE : HUMISS TRADING S. L. (Espagne) et 1 autre	Chine	D-Dimer FIA CfDDg00298/79 D-Dimer Rapid Test CDDg00298/79 Dengue IgG/IgM Rapid Test Cassette (WB/S/P) IDAB421298/79 Dengue IgG/IgM-NS1 Combo Rapid Test Cassette (WB/S/P) IDEN432598/79 Dengue NS1 Antigen Rapid Tests IDAG4001, IDAG400298/79 18 autres H.pylori Antibody Rapid Tests IHPB4001, IHPB400298/79 H.pylori Antigen Rapid Test Cassette (Feces) IrHPG600298/79 HPV 18 High-Risk with 16/18 Genotyping PCR Test Kit IHPVk0Ns98/79 IL-6 FIA YfILS400298/79 Influenza A+B Rapid Test IFLUn212, IFLUn21898/79 Influenza A/B & RSV RT-PCR Test Kit IRP53Na98/79 Legionella pneumophila Antigen Rapid Test ILP100298/79 Malaria P.f Antigen Rapid Test Cassette (WB) IPFGi00298/79 Malaria P.f/P.v Antigen Rapid Test Cassette (WB) IFVGi2198/79 Malaria P.f/Pan Antigen Rapid Test Cassette (WB) IFPGi212, IFPGi21898/79 Malaria Pan Antigen Rapid Test Cassette (WB) IPANi00298/79 Monkeypox Virus Antigen Rapid Test IMPX000298/79 Monkeypox Virus PCR Test Kit IMPX00Na98/79 RSV Antigen Rapid Test Cassette (Swab) IRSVn002, IRSVn00898/79 SARS-CoV-2 & Influenza A/B RT-PCR Test Kit IID53Na98/79 Streptococcus pneumoniae Antigen Rapid Test ISP100298/79 Strep A Rapid Tests ISAp001 ISAp002 ISAp00898/79 Syphilis Rapid Tests ITP4001, ITP400298/79	– 98/79	Site web marketing@clongene.com Fiche EUDAMED Signaler une erreur
Meridian Bioscience FDA Mandataire UE : Meridian Bioscience Europe S.r.l. (Italie)	États-Unis	Alethia Alethia Chlamydia Alethia CMV Alethia CMV External Controls alethia® Gonorrhea 18 autres alethia® Group B Streptococcus alethia® Group B Streptococcus External Control Kit alethia® HSV 1&2 alethia® HSV 1&2 External Control Kit alethia® Malaria alethia® Malaria External Control Kit alethia® Pertussis alethia® Pertussis External Control Kit M-Prep DNA Sample Preparation Para-Pak EcoFix Para-Pak® 10% Formalin Para-Pak® C&S Para-Pak® Clean Vial Para-Pak® CON-Trate® Tubes & Caps Para-Pak® SAF Para-Pak® Zn-PVA Revogene® Revogene® Mock Pie	A, C IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach	Pologne	Konserwowane Krwinki Wzorcowe do identyfikacji przeciwciał98/79 Konserwowane Krwinki Wzorcowe do identyfikacji przeciwciał PLUS98/79 Konserwowane Krwinki Wzorcowe do układu ABO98/79 Konserwowane Krwinki Wzorcowe do układu ABO I98/79 Konserwowane Krwinki Wzorcowe do wykrywania przeciwciał98/79 18 autres LISS-L standaryzowany roztwór soli o niskiej sile jonowej do badań serologicznych LISS-M (low ionic strenght solution medium) jest roztworem soli o niskiej sile jonowej, wystandaryzowanych wartościach pH i osmolalności, stosowany jest do przemywania i sporządzania zawiesin krwinek czerwonych Odczynnik anty-IgG98/79 Papaina ST98/79 PBS zbuforowany fizjolicziczny roztwór soli do badań serogicznych pH 6,9 (2litry) PBS – buffered salt solution pH 6,93 réf. PEG roztwór glikolu polietylenowego do pośredniego testu antyglobulinowego Standaryzowane Krwinki Wzorcowe do układu ABO98/79 Standaryzowane Krwinki Wzorcowe O RhD+ opłaszczone przeciwciałami anty-D98/79 Standaryzowane Krwinki Wzorcowe O RhD+ opłaszczone przeciwciałami anty-D GOTOWE DO UŻYTKU98/79 Standaryzowane Krwinki Wzorcowe opłaszczone do kontroli BTA98/79 Standaryzowane Krwinki Wzorcowe typ LISS-VERA do wykrywania przeciwciał98/79 Standaryzowane Krwinki Wzorcowe typ PBS-VERA do układu ABO98/79 Surowica Antyglobulinowa Poliwalentna (10x10ml) Polyvalent anti-human globulin serum (10x10ml)98/79 Surowica Antyglobulinowa Poliwalentna (10x5ml) Polyvalent anti-human globulin serum (10x5ml)98/79 Surowica Antyglobulinowa Poliwalentna (1x5ml) Polyvalent anti-human globulin serum (1x5ml)98/79 Surowica Grupy AB Zestaw Próbek Kontrolnych do codziennej kontroli odczynników diagnostycznych i krwinek wzorcowych do układu ABO i RhD ZPK I98/79 Zestaw Próbek Kontrolnych ZPK98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
TECO Medical Instruments, Production + Trading	Allemagne	BioSystems COAX 1 Coatron X generic product group3 réf. Blue D-Dimer LC98/79 Coatron A4 Coatron A generic product group3 réf. Red D-Dimer D2010-01298/79 TECal DD98/79 18 autres TECal N98/79 TEChrom98/79 TEClot APTT-S98/79 TEClot Factor II Deficient Plasma98/79 TEClot Factor IX Deficient Plasma98/79 TEClot Factor V Deficient Plasma98/79 TEClot Factor VII Deficient Plasma98/79 TEClot Factor VIII Deficient Plasma98/79 TEClot Factor X Deficient Plasma98/79 TEClot Factor XI Deficient Plasma98/79 TEClot Factor XII Deficient Plasma98/79 TEClot FIB2 réf.98/79 TEClot PT-B98/79 TEClot PT-S3 réf.98/79 TEClot TT98/79 TEControl A98/79 TEControl A Plus98/79 TEControl N98/79	A IVDR, 98/79	Site web info@teco-medical.com Fiche EUDAMED Signaler une erreur
Biocare Medical Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	Helicobacter pylori [EPR10353] CM383C98/79 Helicobacter pylori [EPR10353] IP383G1098/79 Helicobacter pylori [EPR10353] OPAI383T6098/79 Helicobacter pylori [EPR10353] PM383AA98/79 Helicobacter pylori [EPR10353] PM383H98/79 19 autres Helicobacter pylori [EPR10353] PM383L98/79 Herpes Simplex Virus 1&2 (HSV1&2) API108AA98/79 HPV-16 (CAMVIR-1) ACI186C98/79 Ki-67 [MIB-1] ALI3156G798/79 Ki-67 [MIB-1] API3156AA98/79 Ki-67 [MIB-1] API3156H98/79 Ki-67 [MIB-1] AVI3156G98/79 Ki-67 [MIB-1] OPAI3156T6098/79 MCM2 + TOP2A API3181AA98/79 MCM2 + TOP2A API3181H98/79 MLH1 AVI220G98/79 MLH1 CM220AK98/79 MLH1 CM220BK98/79 MLH1 CM220CK98/79 MLH1 IPI220G1098/79 MLH1 OPAI220T6098/79 MLH1 PM220AA98/79 MCM2 + TOP2A OPAI3181T6098/79 (plus commercialisé) MLH1 PM220H98/79 (plus commercialisé)	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Iline Microsystems FDA	Espagne	microINR Chips CHB0025AA98/79 microINR Chips CHB0025AB98/79 microINR Chips CHB0025AB-1098/79 microINR Chips CHB0025AC98/79 microINR Chips CHB0025AU98/79 17 autres microINR EasyControl EKA0005UU98/79 microINR Expert Kit KTP0001AA microINR kit KTA0001AA98/79 microINR kit KTA0001AB98/79 microINR kit KTA0001AC98/79 microINR kit KTA0001AU98/79 microINR kit KTA0001AZ98/79 microINR kit KTA0001PL98/79 microINR kit KTB0001AA98/79 microINR kit KTB0001AB98/79 microINR kit KTB0001AU98/79 microINR kit KTB0001AZ98/79 microINR kit KTB0001PL98/79 microINR Link kit KTD0001AA98/79 microINR Link Kit KTD0001AB98/79 microINR Link kit KTE0001AA98/79 microINR Link kit KTE0001AB98/79	A IVDR, 98/79	eudamed@ilinemicrosystems.com Fiche EUDAMED Signaler une erreur
Sentinel FDA	Italie	CALiaGold® pierceTube CALiaGold® Tube FOB Gold Tube NG FOB Gold Tube Screen2 réf. FOB Gold® Tube Screen BE-VLG 17 autres PANLiaGold™ pierceTube PANLiaGold™ Tube PYLiaGold™ pierceTube PYLiaGold™ Tube SENTiFIT® FOB Gold® Collection Tube SENTiFIT® FOB Gold® Tube Screen Israel SENTiFIT® pierceTube4 réf. SENTiNAT® 200 Pathomag Extraction Kit SENTiNAT® X48 Pathomag Extraction kit STAT-NAT® DNA Mix STAT-NAT® DNA Mix Flex STAT-NAT® DNA/RNA Pathogen extraction kit STAT-NAT® Pathomag extraction kit STAT-NAT® RNA Mix STAT-NAT® SN200 CMV CMV 1 STAT-NAT® SN200 DNA Mix STAT-NAT® Total DNA/RNA extraction kit	A, C IVDR	Site web Fiche EUDAMED Signaler une erreur
Synthgene (Yixing) Health Technology Mandataire UE : MedPath GmbH (Allemagne)	Chine	Bacterial vaginosis Rapid Test Kit (Colloidal gold method)98/79 Candida Albicans Antigen Rapid Test Kit (Colloidal gold method)98/79 Dengue IgG/IgM Rapid Test Kit (Colloidal gold method)98/79 Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal gold method)98/79 Dengue NS1 Rapid Test Kit (Colloidal gold method)98/79 17 autres FluA/FluB Antigen Rapid Test Kit (Colloidal gold method)98/79 H. Pylori Antibody Rapid Test Kit(Colloidal gold method)98/79 H. Pylori Antigen Rapid Test Kit CR00798/79 HPV Rapid Test kit FK00698/79 Malaria Antibody Rapid Test Kit (Colloidal gold method)98/79 Malaria Antigen Rapid Test Kit (Colloidal gold method)98/79 Malaria pf/pan Rapid Test Kit(Colloidal gold method)98/79 Malaria pf/pv Antigen Rapid Test Kit (Colloidal gold method)98/79 Monkeypox Virus Antibody Rapid Test Kit CR01598/79 Monkeypox Virus Antigen Rapid Test Kit CR01798/79 Neisseria Gonorrhoeae Antigen Rapid Test Kit(Colloidal gold method)98/79 RSV Antigen Rapid Test Kit(Colloidal gold method)98/79 Strep A Antigen Rapid Test Kit (Colloidal gold method)98/79 Strep B Antigen Rapid Test Kit(Colloidal gold method)98/79 Syphilis (TP) Antibody Rapid Test Kit98/79 Trichomonas Vaginalis Antigen Rapid Test Kit (Colloidal gold method)98/79 Trichomonas/Candida Antigen Combo Rapid Test Kit (Colloidal gold method)98/79	– 98/79	sales@syngenebio.com Fiche EUDAMED Signaler une erreur
Citest Diagnostics Mandataire UE : VidaQuick Biotech S.L. (Espagne)	Canada	Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICD-635B98/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICD-635B(CT)98/79 Dry-type Fluorescent Immunoassay Analyzer (Single Channel) Fluorescence Immunoassay Analyzer3 réf. H. pylori Antibody Rapid Test Cassette IHP-302(CT)98/79 16 autres H.pylori Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) IHP-40298/79 H.pylori Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) IHP-402(CT)98/79 H.pylori Antigen Rapid Test Cassette (Feces) IHP-60298/79 H.pylori Antigen Rapid Test Cassette (Feces) IHP-602(CT)98/79 Influenza A+B Rapid Test Cassette (Swab/Nasal Aspirate)98/79 Influenza A+B Rapid Test Cassette IIN-502(CT)98/79 MONO Rapid Test Cassette (WB/S/P)98/79 Mycoplasma pneumoniae IgM Test Cassette (Whole Blood/Serum/Plasma)98/79 RSV Rapid Test (Nasopharyngeal swab/Nasal Aspirate)98/79 RSV Rapid Test Cassette IRS-502(CT)98/79 S. pneumoniae Antigen Rapid Test Cassette ISP-102(CT)98/79 Strep A Rapid Test Cassette (Throat Swab)98/79 Strep A Rapid Test Cassette IST-502(CT)98/79 Streptococcus pneumoniae Test Cassette (Urine/Cerebral Spinal Fluid)98/79 Syphilis Rapid Test Cassette (WB/S/P)98/79 Syphilis Rapid Test Cassette ISY-402(CT)98/79	A IVDR, 98/79	ra02@citestdiagnostics.com Fiche EUDAMED Signaler une erreur
Diagon	Hongrie	Abacus Abaclean3 réf. CELL CLENZ Cellaclean3 réf. Cellagon 3 Hematology Analyzer2 réf. Cellagon 5 Pro Hematology Analyzer 16 autres Coag 2D coagulometer Coag 4D Plus coagulometer Coag 4D coagulometer3 réf. Coag D Cuvettes2 réf. Coag L automated coagulometer2 réf. Coag M automated coagulometer Coag S Coagulometer Coag XL automated coagulometer2 réf. Dia-Blue Panoptic Dia-CaCl22 réf. Dia-Fix Panoptic Dia-IMIDAZOL Dia-PT 1098/79 Dia-Red Panoptic Dia-Rinse Panoptic Dia-Rinse-CD 1.6 Dia-Rinse-CD 3.53 réf. HemOcular Slide Reader	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Giesse Diagnostics	Italie	Antitrombina III 670498/79 D-Dimero 673798/79 Fibrinogeno 780498/79 IgA 671198/79 IgG 671098/79 16 autres IgM 671298/79 Mononucleosi Infettiva 774698/79 Rosa Bengala 780298/79 Rosa Bengala 7802/5098/79 RPR Carbon 701098/79 RPR Carbon 701198/79 Salmonella Paratyphi AH 505098/79 Salmonella Paratyphi AO 506098/79 Salmonella Paratyphi BH 504098/79 Salmonella Paratyphi BO 509698/79 Salmonella Paratyphi CH 509798/79 Salmonella Paratyphi CO 509898/79 Salmonella Typhi H 507098/79 Salmonella Typhi O 508098/79 TPHA 202998/79 VDRL 780098/79	– 98/79	Site web info@giessediagnostics.com Fiche EUDAMED Signaler une erreur
Hunan Ehome Health Technology Mandataire UE : Medunion S.L. (Espagne) et 1 autre	Chine	Auto Hematology Analyzer EHBT-7598/79 Auto Hemotology Analyzer VXELL FIVE Stellar98/79 Automated Hematology Analyzer O-Cyte 1, O-Cyte 2, O-Cyte 3, O-Cyte 4, O-Cyte 5, O-Cyte 6, O-Cyte 7, O-Cyte 8, O-Cyte 998/79 Calibrator for Hematology Analyzer YH-CA50298/79 Cleaning Solution YH-HC301 16 autres D-Dimer Rapid Test Kit HU-RE-F07F04500198/79 D-Dimer Rapid Test Kit HU-RE-F07F04500298/79 Disposable Capillary Blood Collection Tube YH-CX200 Hematology Analyzer EHBT-25 Hematology Analyzer Vxell Hematology Analyzers Control kit YH-QC50098/79 Hematology Reagent Kit YH-HC300 IL-6 Rapid Quantitative Test2 réf.98/79 Kit for Sample Processing for Hematology Analysis VXELL FIVE Kit for Sample Processing for Hematology Analysis YH-HC200 Kit for Sample Processing for Hematology Analyzer Vxell Kit for Sample Processing for Hematology Analyzer YH-HC101 Lithography Quality Control Kit YH-QC100 Multi-functional Analyzer EHBT-50 Multi-functional Analyzer VXELL FIVE YH-CA50098/79	A IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Kaltek	Italie	ANSA AD AGO NI-CR3 réf. ANTIDOPING TEST TUBE WITH SEAL3 réf. ARMADIO ASPIRATO CLEAN BOX V/120 BASE MOULD IN ACCIAIO PER MEGACASSETTE3 réf. BIOPSI CASSETTA ARANCIO3 réf. 16 autres CAPPA ASPIRANTE CON TAVOLO DI SUPPORTO ATTREZZATO - GREEN ECO FLUX V/130 V/1503 réf. CASSETTINA C/ COPERCHIO A PARTE AZZURRA3 réf. CONTENITORE FECI PP TAPPO A VITE CON PALETTA 60 ml CONTENITORI PER CAMPIONI ISTOLOGICI2 réf. CYTO CUVETTA PLURIUSO3 réf. CYTOKIT 3 CON SOLUZIONE ALCOLICA3 réf. DIF STAIN KIT 3 X 250 ml3 réf. EMBED 503 CENTRALINA PER INCLUSIONE DI PARAFFINA FORMALDEIDE 4% per Tissue Filling pH 7,2-7,4 FORMALDEIDE AL 4% HISBATH 42 réf. INCLUSORI PARAFFINA BIANCHI3 réf. PIASTRA FREDDA CP 503 SACCHETTI DOPPI PER TRASPORTO CAMPIONI “BIOHAZARD” 160 x 170 mm3 réf. STAMPANTE PER CASSETTE LASER STRETCH A PIASTRA ASCIUGAVETRINI VETRINI KOLORFROST MOLATI CON BANDA BIANCA 50 x 76 VETRINI PORTAOGGETTO XILMOUNT MONTANTE PER VETRINI 100 ml3 réf.	A IVDR	info@kaltek.it Fiche EUDAMED Signaler une erreur
Meril Diagnostics FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Inde	CLZCCR-04 FloQuant™ Fluorescence Immunoassay Analyzer3 réf. HIVFIND HIVSST-013 réf. HIVWBS-01 HIVWBS-02 HIVWBS-03 HIVWBS-043 réf. HPBELI-0398/79 16 autres MBTREK-01 MBTREK-023 réf. MEGRA Detergent DETCCR-04 DETCCR-052 réf. MEGRA Diluent BDTCCR-023 réf. MEGRA Lyse -FDT CLYCCR-033 réf. Merilisa HPBELI-0698/79 Merilisa HPBELI-0798/79 Merilyzer AutoQuant 200 Excelus FAACNQ-053 réf. Merilyzer CelQuant 3603 réf. Merilyzer ClotQuant 4 CGCCAQ-012 réf. Merilyzer LumiQuant™ LQ1002 réf. MerilyzerCliniQuant SAACNM-012 réf. MERISCREEN HCV RPDHCV-01 RPDHCV-032 réf. MERISCREEN HVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 HVWRPD-08 HVWRPD-09 HVWRPD-10 HVWRPD-11 HVWRPD-123 réf. MERISCREEN RPDHBV-01 RPDHBV-032 réf. SAAEIQ-07 SAAEIW-03	A, D IVDR, 98/79	Site web ram.kanoje@merillife.com Fiche EUDAMED Signaler une erreur
Syscanbio Mandataire UE : Obelis s.a. (Belgique)	Chine	Activated Partial Thromboplastin Time (APTT) Reagent(Ellagic Acid) Coagulation Analyzer2 réf.98/79 Antithrombin III Assay Kit Coagulation Analyzer Ci-AT-1298/79 Antithrombin III Assay Kit Coagulation Analyzer Ci-AT-2498/79 Antithrombin III Assay Kit Coagulation Analyzer CP-AT-100098/79 Antithrombin III Control Coagulation Analyzer ATIII-0198/79 16 autres Antithrombin III Control Coagulation Analyzer ATIII-0298/79 Coagulation Analyzer Ci-APTT-10E98/79 Coagulation Control Plasma Coagulation Analyzer CONP-I-0198/79 Coagulation Control Plasma Coagulation Analyzer CONP-II-0198/79 D-Dimer Assay Kit Coagulation Analyzer Ci-DD-1298/79 D-Dimer Assay Kit Coagulation Analyzer Ci-DD-2498/79 D-Dimer Assay Kit Coagulation Analyzer CP-DD-100098/79 D-Dimer Control Coagulation Analyzer ATIII-0198/79 D-Dimer Control Coagulation Analyzer DDI-0198/79 D-Dimer Control Coagulation Analyzer DDII-0198/79 Fibrin Degradation Product (FDP) Assay Kit Coagulation Analyzer2 réf.98/79 Fibrin Degradation Product (FDP) Control Coagulation Analyzer2 réf.98/79 Fibrinogen Reference Plasma Coagulation Analyzer STD-FIB-0198/79 Prothrombin Time (PT) Reagent Coagulation Analyzer2 réf.98/79 Thrombin Reagent (for Fbg assay) Coagulation Analyzer3 réf.98/79 Thrombin Time (TT) Reagent Coagulation Analyzer3 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Xenta Biomedical Science FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	COVID-19 Antigen Rapid Detection Kit (Nasal Swab)2 réf.98/79 COVID-19 Antigen Rapid Detection Kit (NP Swab)2 réf.98/79 COVID-19 Antigen Rapid Detection Kit (Saliva Lollipop)2 réf.98/79 COVID-19 Antigen Rapid Detection Kit (Saliva)2 réf.98/79 COVID-19 Antigen Rapid Detection Kit (Throat Swab)2 réf.98/79 16 autres D-Dimer Detection Kit (Fluorescent Immune Chromatography)2 réf.98/79 D-Dimer Rapid Quantitative Test XRDL007A105OS98/79 D-Dimer Rapid Quantitative Test XRDL007A120OS98/79 Fibrin and Fibrinogen Degradation Products (FDP) Rapid Quantitative Test2 réf.98/79 IFA & IFB & COVID-19 Antigen Joint Detection Kit (Immunochromatography Assay)2 réf.98/79 IFA & IFB Antigen Joint Detection Kit (Immunochromatography Assay)2 réf.98/79 IL-6 Detection Kit (Fluorescent Immune Chromatography)2 réf.98/79 Interleukin-6 (IL-6) Rapid Quantitative Test2 réf.98/79 Malaria Antigen P.f Detection Reagent (Colloidal Gold method)2 réf.98/79 Malaria Antigen P.f/P.v Detection Reagent (Colloidal Gold method)2 réf.98/79 Malaria Antigen P.f/Pan Detection Reagent (Colloidal Gold method)2 réf.98/79 Plasmin-α2-Plasmin Inhibitor Complex (PIC) Rapid Quantitative Test2 réf.98/79 Plasminogen (PLG) Rapid Quantitative Test2 réf.98/79 TB Specific Cell Immune Response Detection Kit2 réf.98/79 Thrombin-Antithrombin Ⅲ Complex (TAT) Rapid Quantitative Test2 réf.98/79 Tissue-Type Plasminogen Activator Inhibitor-1 Complex (t-PAIC) Rapid Quantitative Test2 réf.98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
ZOVEC diagnostics	Allemagne	DETERGENT Z-RDE5RP98/79 DILUENT2 réf.98/79 LYSE98/79 LYSE SOLUTION98/79 PROBE CLEANER98/79 16 autres Reticulocyte Tube Z-RR5RP98/79 SHEATH Z-RS5RP98/79 Z-ELITE Electrolyte Analyzer with Na/K/Cl analytes98/79 Z-ELITE Li98/79 Z-ELITE Pro+98/79 Z-GEM 398/79 Z-GEM 52 réf.98/79 Z-GEM 5 DILUENT2 réf.98/79 Z-GEM 5 Lyse 198/79 Z-GEM 5 Lyse 1A98/79 Z-GEM 5 Lyse 298/79 Z-GEM 5 Lyse 2A98/79 Z-GEM 5 Lyse 3A98/79 Z-GEM 5R+98/79 Z-GEM CLEANSER98/79 Z-Hb Confirm98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Orasure FDA Mandataire UE : QbD RepS BV (Belgique)	États-Unis	OraQuick HCV Rapid Antibody Test 1001-027098/79 OraQuick HCV Rapid Antibody Test 1001-027498/79 OraQuick HCV Rapid Antibody Test 3001-214198/79 OraQuick HIV Self-Test 1001-060098/79 OraQuick HIV Self-Test 1001-0600U98/79 19 autres OraQuick HIV Self-Test 1001-060198/79 OraQuick HIV Self-Test 1001-0601U98/79 OraQuick HIV Self-Test 1001-060298/79 OraQuick HIV Self-Test 1001-0602U98/79 OraQuick HIV Self-Test 1001-060398/79 OraQuick HIV Self-Test 1001-0603U98/79 OraQuick HIV Self-Test 1001-062798/79 OraQuick HIV Self-Test 1001-0627U98/79 OraQuick HIV Self-Test 1001-062898/79 OraQuick HIV Self-Test 1001-0628U98/79 OraQuick HIV Self-Test 1001-062998/79 OraQuick HIV Self-Test 1001-0629U98/79 OraQuick HIV Self-Test 1001-063098/79 OraQuick HIV Self-Test 1001-0630U98/79 OraQuick® HCV Rapid Antibody Test Kit Controls 1001-027898/79 OraQuick HCV Rapid Antibody Test 1001-037098/79 (plus commercialisé) OraQuick HCV Rapid Antibody Test 1001-037198/79 (plus commercialisé) OraQuick HIV Self-Test 1001-070698/79 (plus commercialisé) OraQuick HIV Self-Test 1001-0706U98/79 (plus commercialisé)	– 98/79	Présent sur le marché en France Site web customercare@orasure.com Fiche EUDAMED Signaler une erreur
Cormay	Pologne	ACCENT M3202 réf. ACCENT MC2402 réf. AURYX 90 D-dimer STAT Reagent Kit2 réf.98/79 AURYX 90 IL-6 Reagent Kit2 réf.98/79 Chemistry Analyzer ACCENT-4002 réf. 15 autres Chemistry Analyzer Model: ACCENT S1202 réf. CLEANER2 réf. DILUENT5 réf. ENZYMATIC CLEANER FORTE HAEM 12 CONTROL H98/79 HAEM 12 CONTROL L98/79 HAEM 12 CONTROL N98/79 HAEM 8 CONTROL H98/79 HAEM 8 CONTROL L98/79 HAEM 8 CONTROL N98/79 Immunoassay System AURYX 90 LYSING REAGENT CN FREE3 réf. LYSING REAGENT KX21 CN FREE URI-TEX URI-TEX 300	A IVDR, 98/79	regulatory_affairs@cormay.com Fiche EUDAMED Signaler une erreur
DiaMex	Allemagne	Optitrol Blue3 réf. Optitrol Green3 réf. Optitrol HEPA-13 réf. Optitrol HEPR-13 réf. Optitrol HIV 23 réf. 15 autres Optitrol HIVp243 réf. Optitrol NAT HBV Screening No2 réf. Optitrol NAT HBV Viral Load2 réf. Optitrol NAT HCV Screening Optitrol NAT HCV Viral Load2 réf. Optitrol NAT HEV2 réf. Optitrol NAT HIV Screening2 réf. Optitrol NAT HIV Viral Load2 réf. Optitrol NAT HIV-22 réf. Optitrol NAT NEG2 réf. Optitrol NAT Triplex2 réf. Optitrol Orange3 réf. Optitrol Red3 réf. Optitrol SeroNeg3 réf. Optitrol Yellow3 réf.	B IVDR	Site web Fiche EUDAMED Signaler une erreur
Gama	Tchéquie	Kónická odměrka na moč 100 ml3 réf. Mikrotitrační destička dělená P - dvojstrip3 réf. Mikrotitrační destička P2 réf. Mikrotitrační destička Terasakiho Petriho miska Ø 903 réf. 15 autres Petriho miska Ø 60 mm pro tkáňové kultury Petriho misky 60 mm pro tkáňové kultury98/79 Petriho miska Ø 90 mm - sterilní EO98/79 Petriho miska Ø 90 mm - sterilní R98/79 Petriho miska Ø 90 mm AP3 réf. Petriho miska Ø 90 mm sterilní - R - EN98/79 Zkumavka 10 ccm PP - sterilní98/79 Zkumavka 10 ccm PS - sterilní98/79 Zkumavka 10 ccm PS - sterilní - zátka 49330798/79 Zkumavka 10 ccm PS - sterilní bez zátky98/79 Zkumavka 15 ccm PP - sterilní98/79 Zkumavka 15 ccm PS - sterilní98/79 Zkumavka 15 ccm PS - sterilní - zelená zátka98/79 Zkumavka 15 ccm PS - sterilní - zátka 49330698/79 Zkumavka 15 ccm PS - sterilní bez zátky98/79 Zkumavka 15 ccm PS - sterilní bez zátky VB98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Goldsite Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Automatic HPLC HbA1c Analyzer GSH-50 Automatic HPLC HbA1c Analyzer GSH-60 FIA Go D-Dimer Kit98/79 G-3DIL Diluent G-3LHB Lyse 15 autres GBA-1000 Glycated Hemoglobin Analyzer A1c Go GPP-100 D-Dimer Kit98/79 HbA2 & HbF & HbA1c Calibrator98/79 HbA2 & HbF & HbA1c Control2 réf.98/79 Kemilo D-Dimer Kit98/79 Kemilo IL-6 Kit98/79 Monkeypox Virus Real-time PCR Kit3 réf.98/79 Nephstar AT3 Kit98/79 Nephstar D-Dimer Kit98/79 Omlipo AT3 Kit98/79 Omlipo D-Dimer Kit98/79 SARS-CoV-2 & Influenza A/B & RSV Antigen Kit (Colloidal Gold)3 réf.98/79 SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing)4 réf.98/79 SARS-CoV2 & Influenza A/B Antigen Kit (Colloidal Gold)3 réf.98/79	A IVDR, 98/79	Site web export@goldsite.com.cn Fiche EUDAMED Signaler une erreur
Ingenetix	Autriche	BactoReal® Kit Bordetella Multiplex98/79 BactoReal® Kit E. coli & Klebsiella98/79 BactoReal® Kit H. pylori ClariRes98/79 BactoReal® Kit Listeria monocytogenes98/79 BactoReal® Kit P. aeruginosa & Enterobacter spp.98/79 15 autres BactoReal® Kit S. pneumoniae & Streptococcus spp.98/79 BactoReal® Kit Staphylococcus spp. & S. aureus98/79 BactoReal® Kit Streptococcus pneumoniae98/79 BactoReal® Kit vanA & Enterococcus spp.98/79 MycoReal® Kit Aspergillus98/79 MycoReal® Kit Candida & A. fumigatus98/79 MycoReal® Kit Pneumocystis98/79 ParoReal® Kit Acanthamoeba T498/79 ViroReal® Kit Adenovirus98/79 ViroReal® Kit Enterovirus98/79 ViroReal® Kit Influenza A/B98/79 ViroReal® Kit Metapneumovirus98/79 ViroReal® Kit Parainfluenzavirus98/79 ViroReal® Kit Rhinovirus (A, B, C)98/79 ViroReal® Kit RSV (A & B)98/79	– 98/79	Site web office@ingenetix.com Fiche EUDAMED Signaler une erreur
Lituo Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Automated Sampling System LTS-AS3000 BV Diagnostic Kit (Sialidase Assay)98/79 Cell Preservative Solution Model I, Model II3 réf. EA-503 réf. EA50/OG6 Combo3 réf. 15 autres Fecal Specimen Collection & Storage Tube Model I, Model Ⅱ,Model Ⅲ,Model IV3 réf. Feces Analysis & Processing System LTS-E300 Feces Analysis&Processing LTS-E100 Glass Slide LTC210101 Gram Stain Kit Model Ⅰ, Model Ⅱ, Model Ⅲ, Model Ⅳ, Model Ⅴ3 réf. Gram Stain Slides LTA090101 HE Stain Kit Hematoxylin3 réf. Iodine Solution（Lugol's Solution）3 réf. Leucorrhoea Staining Solution3 réf. LTS-AS96、 LTS-AS96A、 LTS-AS303 réf. OG-63 réf. Pap Stain Kit Type A: 250ml3/Kit, 500ml3/Kit, 1L3/Kit; Type B: 250ml2/Kit, 500m12/Kit, 1L2/Kit; Type C: 250ml2/Kit, 500m12/Kit, 1L*2/Kit3 réf. Stainer LTS-RS1080 Tips LTC260102	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Mpw	Pologne	CYTO base and insert3 réf. CYTO set Laboratory centrifuge MPW M-BASIC 100V/50-60Hz3 réf. Laboratory centrifuge MPW M-DIAGNOSTIC 100V/50-60Hz3 réf. Laboratory centrifuge MPW M-SCIENCE 100V/50-60Hz3 réf. 15 autres Laboratory centrifuge MPW M-UNIVERSAL 100V/50-60Hz3 réf. Laboratory centrifuge MPW-260 100V/50-60Hz3 réf. Laboratory centrifuge MPW-351e 100V/50-60Hz3 réf. Laboratory centrifuge MPW-352 100V/50-60Hz3 réf. Laboratory centrifuge MPW-380 100V/50-60Hz3 réf. Laboratory centrifuge MPW-54 100V/50-60Hz3 réf. Laboratory centrifuge MPW-54s 100V/50-60Hz3 réf. Laboratory centrifuge MPW-55 100-230V/50-60Hz Laboratory centrifuge MPW-56 100-230V/50-60Hz Refrigerated and heated laboratory centrifuge MPW-260RH 100V/60Hz3 réf. Refrigerated and heated laboratory centrifuge MPW-352RH 100V/60Hz3 réf. Refrigerated laboratory centrifuge MPW-150R 100V/60Hz3 réf. Refrigerated laboratory centrifuge MPW-260R3 réf. Refrigerated laboratory centrifuge MPW-352R 100V/60Hz3 réf. Refrigerated laboratory centrifuge MPW-380R 100V/60Hz3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
MTD Diagnostics	Italie	Antithrombin III Antibody TB116098/79 Diluent 3 Diff H398/79 Diluent 30 Diff H398/79 Diluent 5 Diff H598/79 Diluent 60 Diff H598/79 15 autres Diluent M-SYS98/79 Homocysteine LS HP98/79 ITALO M98/79 Lyse 3 Diff H398/79 Lyse 30 Diff H398/79 Lyse 5 Diff H598/79 Lyse 60 Diff H598/79 Lyse 60 LH Diff H598/79 Probe Cleaner 3 Diff H398/79 Probe Cleaner 30 Diff H398/79 Probe Cleaner 5 Diff H598/79 Probe Cleaner 60 Diff H598/79 Rinse 3 Diff H398/79 Rinse 5 Diff H598/79 Sheath 5 Diff H598/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
NORMA Instruments Zártkörűen Működő Részvénytársaság	Hongrie	Autosampler NG accessory unit for automated sample vial loading3 réf. H3-Check Complete control blood set for 3-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials NormaCont3+ KIT K13 réf. H3-Compact 100 Norma-iRP313 réf. H3/5-CAL calibrator for Hemolyzer® hematology analyzers NormaCal3 calibrator2 réf. H3/5-Hypoclean2 réf. 15 autres H5-Check Complete control blood set for 5-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials NormaCont5+ control blood set for 5-part differential hematology analyzers3 réf. H5-Compact 100 Norma-iRP513 réf. H5-Compact 100-O Norma-iRP51 OP3 réf. H5-Opticlean2 réf. Hemolyzer® 3 NG automated 3-part differential hematology analyzer Norma Icon-33 réf. Hemolyzer® 5 NG automated 5-part differential hematology analyzer with closed sampling method Norma Icon-53 réf. Hemolyzer® 5 NG Open automated 5-part differential hematology analyzer with open sampling method Norma Icon-5 OP3 réf. Norma i3LAB automated 3-part differential hematology analyzer2 réf. Norma-iClean5 Norma-iDil3 Norma-iDil5 Norma-iLyse3 Norma-iLyse5 Norma-iRP20 Norma-iRP212 réf. Norma-iSol32 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Sichuan Orienter Biotechnology Mandataire UE : Lotus NL B.V. (Pays-Bas) et 2 autres	Chine	Alpha Tumor Necrosis Factor (TNFα) Assay Kit (Chemiluminescent Immunoassay) 2×50 test/box Calibrator:0.5mL×298/79 Automatic Chemiluminescence Immunoassay Analyzer LA 2000 Automatic Chemiluminescence Immunoassay Analyzer LA 3000 Automatic Chemistry Analyzer CA2000 D-Dimer (D-D) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 15 autres Fibrin Degradation Products (FDP) Assay Kit (Chemiluminescent Immunoassay) /2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 Helicobacter Pylori Urease Antibody (Urease Ab) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 Interferon Alpha (IFNα) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 Interferon Gamma (IFNγ) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 Interferon-Gamma Release Assay for Mycobacterium tuberculosis Test Kit (Chemiluminescent Immunoassay) 16 Serving/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 Interleukin -10 (IL-10) Assay Kit (Chemiluminescent Immunoassay) 2×50 test/box Calibrator:0.5mL×298/79 Interleukin -17A (IL-17A) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 Interleukin -4 (IL-4) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 Interleukin -8 (IL-8) Assay Kit (Chemiluminescent Immunoassay) 2×50 test/box Calibrator:0.5mL×298/79 Interleukin-1β (IL-1β) Assay Kit (Chemiluminescent Immunoassay) 2×50 test/box Calibrator:0.5mL×298/79 Interleukin-2 Receptor (IL-2R) Assay Kit (Chemiluminescent Immunoassay) 2×50 test/box Calibrator:0.5mL×298/79 Pneumatic Tube System ST10 Sample Collection Tube 400 Branch/Box t-PAIC Assay Kit(Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 Thrombin-Antithrombin Ⅲ complex(TAT) Assay Kit(Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79	A IVDR, 98/79	Site web info@orienterglobal.com Fiche EUDAMED Signaler une erreur
Biotecnica	Italie	ANALIZZATORE CHIM-CLIN. CB350i BT 3000 PLUS3 réf. ANTITHROMBIN III TURB 61098/79 AS660 S/I AUTOLYSER3 réf. AUTOLYSER 4504 réf. 15 autres AUTOLYSER ISE3 réf. BT 15006 réf. BT 1500i3 réf. BT 16004 réf. BT 3000 PLUS S/ISE-BC BT 3000 PLUS SENZA ISE3 réf. BT 35003 réf. BT 3500 S/ISE3 réf. BT 3600 S/I BT 37004 réf. BT 4500S S/ISE3 réf. BT 4500V3 réf. BT15i3 réf. CB250-B-G HOMOCYSTEINE 55398/79 BT 3600 (plus commercialisé)	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
77 Elektronika Műszeripari Kft	Hongrie	Automated urine chemistry analyzer - LabUMat 2 family4 réf.98/79 Automated urine sediment analyzer - UriSed 2 family98/79 AutoSense Voice kit3 réf.98/79 Dcont ETALON3 réf. Dcont ETALON B kit98/79 14 autres Dcont ETALON kit3 réf.98/79 Dcont MONDA kit2 réf.98/79 Dcont NOVUM kit2 réf.98/79 DocUReader 2 Pro3 réf. LabUMat 2 PRO Automated urine chemistry analyzer - LabUMat 2 family2 réf.98/79 LabUReader Plus 22 réf. SensoCard set2 réf.98/79 Sensolite Nova Plus set2 réf.98/79 Sensolite Nova set2 réf.98/79 UC-MAX Automated urine chemistry analyzer - LabUMat 2 family3 réf.98/79 Urilyzer Auto Evo Automated urine chemistry analyzer - LabUMat 2 family98/79 Urilyzer Cell98/79 UriSed 3 PRO Automated urine sediment analyzer - UriSed 3 family98/79 UriSed mini98/79	A, C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Autobio Diagnostics FDA Mandataire UE : QbD RepS BV (Belgique)	Chine	AutoLumo B19 IgG Calibrators AutoLumo analyzer3 réf. AutoLumo B19 IgM Calibrators AutoLumo analyzer3 réf. AutoLumo IL-6 Calibrators AutoLumo Analyzer3 réf. CMV IgG CLIA Microparticles Autolumo analyzer3 réf. CMV IgM CLIA Microparticles Autolumo analyzer3 réf. 14 autres EA IgG CLIA Microparticles2 réf.98/79 HSV-1 IgG CLIA Microparticles Autolumo analyzer3 réf. HSV-1 IgM CLIA Microparticles Autolumo analyzer3 réf. HSV-2 IgG CLIA Microparticles Autolumo analyzer3 réf. HSV-2 IgM CLIA Microparticles Autolumo analyzer3 réf. NA IgG CLIA Microparticles2 réf.98/79 Rubella IgG CLIA Microparticles Autolumo analyzer3 réf. Rubella IgM CLIA Microparticles Autolumo analyzer3 réf. ToRCH IgG Control AutoLumo analyzer3 réf. ToRCH IgM Control AutoLumo analyzer3 réf. Toxo IgG CLIA Microparticles Autolumo analyzer3 réf. Toxo IgM CLIA Microparticles Autoluno analyzer3 réf. VCA IgG CLIA Microparticles2 réf.98/79 VCA IgM CLIA Microparticles2 réf.98/79	C IVDR, 98/79	info@autobio-diagnostics.com Fiche EUDAMED Signaler une erreur
Bio-Rad Medical Diagnostics	Allemagne	Anti-C3 Anti-C3d Anti-C4 Anti-Dia (DI1) Anti-IgG 14 autres Anti-IgM Anti-Kpa (KEL3) Anti-Kpb (KEL4) Anti-Lua (LU1) Anti-Wra (DI3) Rinderalbumin 22% Seraclone Anti-H (H1) Seraclone Anti-Lea (LE1) Seraclone Anti-Lub (LU2) Seraclone Anti-M (MNS1) Seraclone Anti-N (MNS2) Seraclone Anti-P1 (P1) Seraclone Anti-S (MNS3) Seraclone Anti-s (MNS4)	A, C IVDR	Site web contact@bio-rad.com Fiche EUDAMED Signaler une erreur
BioFynder Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	United Kingdom (ex Northern Ireland)	TruAna TA100 TruCell98/79 TruCell TC100 TruCell TC600 TruDerma98/79 14 autres TruGlyc TG100 TruHemo7 réf.98/79 TruHemo TH100 TruLyta TL100 TruOx TX100 TruReno TR100 TruUri TU100 TruVue24 réf.98/79 TruVue COVID-19 Antigen Rapid Test (LFA)98/79 TruVue COVID-19& Influenza A +B Antigen Combo Rapid Test (LFA)98/79 TruVue Dengue IgG/IgM/ NS1 Combo Rapid Test (LFA)98/79 TruVue Dengue NS1 Ag Rapid Test (LFA)98/79 TruVue TV100 TruVue TV600	A IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Genekam	Allemagne	D0003-DNA-Positive Control for Borrrelia burgdorferi98/79 D0007-DNA Positive Control for Leptospira98/79 D0046-cDNA positive-Control for Influenza Virus H598/79 FR001-Leptospira pathogenic (Realtime PCR-Kit)98/79 FR004-Bordetella pertussis (Realtime PCR-Kit)98/79 14 autres FR006-FluHunter: Avian Influenza Virus H5N1 (Realtime PCR-Kit)98/79 FR013a-Mycobacterium tuberculosis-Doubel Check (Ready to use Realtime PCR-Kit)98/79 FR015-Epstein-Barr Virus (Ready to use Realtime PCR-Kit)98/79 FR024-Human Herpes Simplex Virus 1 & 2 -Multiplex (Ready to use Realtime PCR-Kit)98/79 FR074-Dengue Fever Virus -(Realtime PCR-Kit)98/79 FR118-Human specific DNA-Internal Control (Realtime PCR-Kit) FR325-Zika Virus-Single Check (Realtime PCR-Kit)98/79 FR799-Identification of human specific ß-Actin K017a-Leptospira pathogenic (Ready to use PCR-Kit)98/79 K025-Identification of human specific DNA98/79 K063-Brucella abortus-Ready to use PCR-Kit98/79 K201-Plasmodium falciparum98/79 K404-Plasmodium vivax98/79 K740-Detection of Borrelia burgdorferi98/79	A IVDR, 98/79	Site web office@genekam.de Fiche EUDAMED Signaler une erreur
Haemokinesis Mandataire UE : Compliance Management Solutions Europe LTD (Bulgarie)	Australie	DAY Anti-A1 lectin 11001-198/79 DAY Anti-Cw MS-11098/79 DAY Anti-H lectin98/79 DAY Anti-k P3A118OL6798/79 DAY Anti-Lea P3N20V398/79 14 autres DAY Anti-Leb P3F234MD498/79 DAY Anti-Lub LU298/79 DAY Anti-M LM110/14098/79 DAY Anti-N LN398/79 DAY Anti-P1 65098/79 DAY Anti-S MS-9498/79 DAY Anti-s P3BER98/79 DAY Bromelin Reagent DAY LISS Diluent DAYmate S 209030-198/79 STARGEL10 CENTRIFUGE STARGEL10 SATELLITE READER98/79 STARGEL10 STAR SOLUTION STATUS1 Solution	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Limingbio Mandataire UE : Wellkang Ltd (Irlande du Nord)	Chine	StrongStep® Candida albicans antigen Rapid Test 20 Tests/box98/79 StrongStep® Cryptococcal Antigen Rapid Test 20 Tests/box98/79 StrongStep® H.pylori Antigen Rapid Test 20 Tests/box98/79 StrongStep® Influenza A Antigen Rapid Test 20 Tests/box98/79 StrongStep® Influenza A/ B Combo Antigen Rapid Test 20 Tests/box98/79 14 autres StrongStep® Influenza A/B & RSV Multiplex Real-Time PCR Kit 96 Tests/box98/79 StrongStep® Influenza A/B Multiplex RT-qPCR Kit 96 Tests/box98/79 StrongStep® Neisseria gonorrhoeae Antigen Rapid Test 20 Tests/box98/79 StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes) 96 Tests/box98/79 Strongstep® Nucleic acid extraction kit(magnetic beads method) 100 Tests/box98/79 StrongStep® Salmonella Antigen Rapid Test 20 Tests/box98/79 StrongStep® SARS-CoV-2 & Influenza A/B Multiplex Real-Time PCR Kit 96 Tests/box98/79 StrongStep® Screening test for Cervical Pre-cancer and Cancer 20 Tests/box98/79 StrongStep® Strep A Antigen Rapid Test 20 Tests/box98/79 StrongStep® Strep B Antigen Rapid Test 20 Tests/box98/79 StrongStep® System Device for SARS-CoV-2 & Influenza A/ B Combo Antigen Rapid Test 20 Tests/box98/79 StrongStep® System Device for SARS-CoV-2,Influenza A/B & RSV Combo Antigen Rapid Test 20 Tests/box98/79 StrongStep® Trichomonas Vaginalis Antigen Rapid Test 20 Tests/box98/79 StrongStep®SARS-CoV-2 Antigen Rapid Test 25 Tests/box98/79	– 98/79	Site web sales@limingbio.com Fiche EUDAMED Signaler une erreur
MedicalSystem Biotechnology FDA Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Automated Hematology Analyzer Diluent DIL-A Automated Hematology Analyzer Diluent DIL-C Automated Hematology Analyzer Diluent DIL-E Automated Hematology Analyzer Diluent MS-5DIL Automated Hematology Analyzer Lyse LYA-1, LYA-2, LYA-33 réf. 14 autres Automated Hematology Analyzer Lyse LYC-1, LYC-22 réf. Automated Hematology Analyzer Lyse LYE-1 Automated Hematology Analyzer Lyse MS-5LD Automated Hematology Analyzer Lyse MS-5LH Cleanser CLE-P D-Dimer Control 1×0.5mL98/79 D-Dimer Kit (Latex-Enhanced Immunoturbidimetric Method) 48mL（R1:1×36mL+R2:1×12mL）98/79 Fibrinogen Degradation Product Kit (Latex-Enhanced Immunoturbidimetric Method) 48ml（R1:1×36ml+R2:1×12ml）98/79 Fibrinogen Kit (Immunoturbidimetric Method) 60ml（R1:1×45ml+R2:1×15ml）98/79 Glucose-6-Phosphate Dehydrogenase Kit (Kinetic Method) 52mL(R1:1×45 mL+R2:1×7 mL);Hemolysis Reagent:3×100 mL98/79 Influenza A+B Rapid Test Cassette 1T98/79 Interleukin-6 Kit(CLIA) 100T98/79 Nucleic Acid Extraction or Purification Reagent NAEPR Treponema Pallidum Antibodies Kit(CLIA) 100T98/79	A IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Meus FDA	Italie	171703 réf. EMOPLASTIK 185573 réf. SEKURPLAST14 réf.98/79 STERILE TEST TUBES AND CONTAINERS40 réf.98/79 STERILE TEST TUBES AND CONTAINERS 17002G98/79 14 autres STERILE TEST TUBES AND CONTAINERS 17002R98/79 STERILE TEST TUBES AND CONTAINERS 17050G98/79 STERILE TEST TUBES AND CONTAINERS 18007BC98/79 STERILE TEST TUBES AND CONTAINERS 18007BL98/79 STERILE TEST TUBES AND CONTAINERS 18007S98/79 STERILE TEST TUBES AND CONTAINERS 18007VC98/79 STERILE TEST TUBES AND CONTAINERS 18011S98/79 STERILE TEST TUBES AND CONTAINERS 18015S98/79 STERILE TEST TUBES AND CONTAINERS 180321S98/79 STERILE TEST TUBES AND CONTAINERS 18303S98/79 STERILE TEST TUBES AND CONTAINERS 18307GL98/79 STERILE TEST TUBES AND CONTAINERS 18307S98/79 STERILE TEST TUBES AND CONTAINERS 18417S98/79 STERILE TEST TUBES AND CONTAINERS B1952098/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Orphée Mandataire UE : PZ CORMAY Spółka Akcyjna (Pologne)	Suisse	Auto Hematology Analyzer MYTHIC 3CRP98/79 CLEANER FOR MYTHIC 22 DILUENT FOR MYTHIC 22 MYT-3CRP98/79 MYT-3CRP CAL98/79 14 autres MYT-3CRP N98/79 Myt-3D3 réf.98/79 Myt-5D2 réf.98/79 Myt-CAL98/79 MYTHIC 1898/79 Mythic 18 Cyanide free Lytic solution2 réf. Mythic 18 Diluent2 réf. Mythic 18-22 Enzymatic Cleaning Solution MYTHIC 3CRP Cleaner MYTHIC 3CRP Diluent2 réf. MYTHIC 3CRP Lysing Reagent2 réf. MYTHIC 6098/79 MYTHIC 7098/79 OnlyOne	A IVDR, 98/79	ra@orphee-medical.com Fiche EUDAMED Signaler une erreur
Randox FDA	Irlande du Nord	Capillary Blood Sample Collection Kit A SCK10672 Capillary Blood Sample Collection Kit B SCK10673 Capillary Blood Sample Collection Kit C SCK10674 Capillary Blood Sample Collection Kit D SCK10719 evidence MULTISTAT 14 autres HAEMATOLOGY CONTROL - LEVEL 1,2,3 (HAEM CNTL - LEVEL 1,2,3) Home Blood Sample Collection Kit EV4460 Home Saliva Collection Kit SCK10654 Microbiome Home Sample Collection Kit Premium Capillary Blood Sample Collection Kit Randox Discovery RX daytona plus (with ISE)2 réf. RX imola RX modena RX monaco SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL POSITIVE)3 réf. SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)2 réf. SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +)3 réf. UNIVERSAL FAECAL SAMPLE COLLECTION KIT SCK10693	A, B IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
ZeptoMetrix FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	NATtrol™ Chlamydia trachomatis (CT) Positive Control NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Control NATtrol™ Clostridium difficile Negative Control NATtrol™ Clostridium difficile Positive Control NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control 14 autres NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control NATtrol™ Group B Streptococcus (GBS) Negative Control NATtrol™ Group B Streptococcus (GBS) Positive Control NATtrol™ Influenza A/B Positive Control NATtrol™ Influenza/RSV Negative Control NATtrol™ Methicillin-Resistant Staphylococcus aureus (MRSA) Positive Control NATtrol™ MRSA/SA Negative Control NATtrol™ Neisseria gonorrhoeae (NG) Positive Control NATtrol™ Norovirus GI/GII Positive Control NATtrol™ Norovirus Negative Control NATtrol™ RSV Positive Control NATtrol™ Staphylococcus aureus (SA) Positive Control NATtrol™ T.vaginalis Negative Control NATtrol™ Trichomonas vaginalis (T. vaginalis) Positive Control	B IVDR	Site web Fiche EUDAMED Signaler une erreur
Ardentbiomed Mandataire UE : MedPath GmbH (Allemagne)	Chine	Disposable Sterile Evacuated Blood Collection Tubes Acid citrate dextrose solution A3 réf. Disposable Sterile Evacuated Blood Collection Tubes Acid citrate dextrose solution B3 réf. Disposable Sterile Evacuated Blood Collection Tubes Blood Cell Blood Collection Tube3 réf. Disposable Sterile Evacuated Blood Collection Tubes Cell-Free DNA Blood Collection Tube3 réf. Disposable Sterile Evacuated Blood Collection Tubes Cell-Free RNA Blood Collection Tube3 réf. 13 autres Disposable Sterile Evacuated Blood Collection Tubes Clot activator3 réf. Disposable Sterile Evacuated Blood Collection Tubes Clot activator with gel3 réf. Disposable Sterile Evacuated Blood Collection Tubes EDTA.K23 réf. Disposable Sterile Evacuated Blood Collection Tubes EDTA.K33 réf. Disposable Sterile Evacuated Blood Collection Tubes Fluoride EDTA.K23 réf. Disposable Sterile Evacuated Blood Collection Tubes Fluoride oxalate3 réf. Disposable Sterile Evacuated Blood Collection Tubes Lithium heparin3 réf. Disposable Sterile Evacuated Blood Collection Tubes No additive3 réf. Disposable Sterile Evacuated Blood Collection Tubes Sodium heparin3 réf. Disposable Sterile Evacuated Blood Collection Tubes Trisodium citrate 4:13 réf. Disposable Sterile Evacuated Blood Collection Tubes Trisodium citrate 9:13 réf. Disposable Sterile Evacuated Blood Collection Tubes Trisodium citrate 9:1 with gel3 réf. Disposable Sterile Evacuated Blood Collection Tubes Whole Blood Cell RNA Blood Collection Tube3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Kalians Mandataire UE : MDSS GmbH (Allemagne)	Égypte	Brucella A, Brucella M D-801 00198/79 Brucella A, Brucella M D-802 00198/79 D-Dimer Turbi Latex98/79 Fibrinogen-LS Clauss Clotting Time Method98/79 Glucose-6-Phosphate Dehydrogenase (G-6-PD) Quantitative Assay98/79 13 autres H. pylori Ab Rapid Test Cassette (Serum, Plasma and Whole Blood) D-793 00198/79 H. pylori Ag Rapid Test Cassette (Fecal Specimen)98/79 Haemoglobin (Ready-To-Use) Drabkin's Solution4 réf.98/79 Haemoglobin (Single Reagent) Drabkin’s Solution2 réf.98/79 Haemoglobin Drabkin’s Solution2 réf.98/79 Liquid PT Reagent ISI 1.03 réf.98/79 Malaria Antigen Test (Whole Blood) For Plasmodium falciparum & vivax98/79 PT Reagent ISI 1.53 réf.98/79 PTT Reagent98/79 Rose Bengal Brucella Antigen2 réf.98/79 RPR Syphilis Test98/79 Typhoid IgG/IgM Rapid Test- Cassette98/79 Widal Test (Salmonella Ab)10 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Nanjing Synthgene Medical Technology FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	Adenovirus Rapid Test Kit (Colloidal gold method) CR03598/79 Candida Albicans Antigen Rapid Test Kit (Colloidal gold method) CR02598/79 Chikungunya Fever IgG/IgM Antibody Test Kit (Colloidal Gold Method)98/79 D-Dimer Rapid Test Kit (Colloidal gold method) XJ00298/79 D-Dimer Rapid Test Kit (Quantum Dot Fluorescence Immunoassay) XJ00598/79 13 autres Dengue NS1 Rapid Test Kit (Colloidal gold method) CR02298/79 Giardia Lamblia Rapid Test Kit (Colloidal gold method) CR03498/79 H. Pylori Antigen Rapid Test Kit CR00705001HKS3 réf. HSV 12 Antigen Rapid Test Kit (Colloidal gold method) CR03098/79 IL-6 Rapid Test Kit (Quantum Dot Fluorescence Immunoassay) CR03898/79 Malaria pf/pan Rapid Test Kit (Colloidal gold method) CR01898/79 Malaria pf/pv Antigen Rapid Test Kit (Colloidal gold method) CR00298/79 Neisseria Gonorrhoeae Antigen Rapid Test Kit (Colloidal gold method) CR02498/79 Rotavirus Antigen Rapid Test Kit (Colloidal gold method) CR03298/79 Salmonella Antigen Rapid Test Kit (Colloidal gold method) CR03398/79 Strep A Antigen Rapid Test Kit (Colloidal gold method) CR02398/79 Strep B Antigen Rapid Test Kit (Colloidal gold method) CR02998/79 Trichomonas Vaginalis Antigen Rapid Test Kit (Colloidal gold method) CR02698/79	C IVDR, 98/79	Site web sales@syngenebio.com Fiche EUDAMED Signaler une erreur
Pilotgene Mandataire UE : Medunion S.L. (Espagne)	Chine	Automated Digital PCR System AD3207 Automated Nucleic Acid Detection Reaction Construction System AP10 Digital PCR Universal Kit dPCR Digital PCR Workstation DW3200 EM98/79 13 autres FS98/79 HHV98/79 Integrated Digital PCR Instrument Pilot1200 MP2198/79 Nucleic Acid Extraction or Purification Reagent CF12 réf. Nucleic Acid Extraction or Purification Reagent Easy-CF2 Nucleic Acid Extraction or Purification Reagent TF1 P1198/79 RP0198/79 SC98/79 TB0198/79 Tip Tip Box TIP-P-3-4	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Reetoo Mandataire UE : Umedwings Netherlands B.V. (Pays-Bas)	Chine	100 tests/kit BD3000 BF820198/79 BF8201P, BF8202P98/79 Canaly-100, Canaly-200, Canaly-30098/79 13 autres D-Dimer Test Kit (Fluorescence Immunochromatographic Assay)98/79 EFT-B98/79 Influenza & SARS-CoV-2 Antigen Combo Test Kit（Colloidal Gold Immunochromatographic Assay)98/79 Influenza A&B Antigen Test kit(Colloidal Gold Immunochromatographic Assay)98/79 Interleukin-6 (IL-6) Test Kit (Fluorescence Immunochromatographic Assay)98/79 Multitest Card2 réf. RC-CAL，RC-CAL RET98/79 RQ-6D，RQ-NRBC，RQ-RET，RQ-BF98/79 RT-i1000, RT-i1100, RT-i1200, RT-i130098/79 RT-U600 RT-U600, RT-U610, RT-U620, RT-U63098/79 Sanaly-100，Sanaly-200，Sanaly-30098/79 U-200	A IVDR, 98/79	Présent sur le marché en France Site web service@reetoo.com.cn Fiche EUDAMED Signaler une erreur
Singuway Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	COVID-19 Antigen Test Kit (Colloidal Gold) (Cassette)98/79 Detection Kit for Adenovirus Nucleic Acids (PCR-Fluorescence Probing) ADV001-4898/79 Detection Kit For Coronavirus Disease 2019 (COVID-19) (PCR Fluorescence Probe)98/79 Detection Kit for Influenza A Virus, Influenza B Virus and Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing)98/79 Detection Kit for Monkeypox Virus(PCR Fluorescence Probing)98/79 13 autres Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing) TB001-4898/79 Detection Kit for Plasmodium Falciparum (PCR Fluorescence Probing) PF001-4898/79 Detection Kit for Respiratory Syncytial Virus RNA (PCR Fluorescence Probing)98/79 Fluorescence Immunoassay Analyzer FluoreMini Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit(PCR Fluorescent Probe Method) TB002-4898/79 Nucleic Acid Detection Kit for High-risk Human Papillomavirus (PCR-Fluorescence Probing)98/79 Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing) HPV002-4898/79 Nucleic Acid Detection Kit for Human Metapneumovirus (PCR-Fluorescence Probing)98/79 Nucleic Acid Extraction Reagents(Magnetic Bead) T-16,T-32,T-48,T-64,T-96,T-200,T-9603 réf. Nucleic Acid Extraction Reagents(Magnetic Bead) TM-363 réf. Nucleic Acid Releaser (For PCR) SR05050, SR10050, SR05080, SR10080,SR05100, SR10100, SR50001, SR100001, SR5L01, SR20L01 Real-time PCR Quantitative Analyzer AccuRa Mini Real-time PCR Quantitative Analyzer AccuRa32	A IVDR, 98/79	Présent sur le marché en France sales@singuway.com Fiche EUDAMED Signaler une erreur
Thermofisher FDA Mandataire UE : Life Technologies Europe B.V. (Pays-Bas)	Finlande, Lituanie, États-Unis	Ailex AS-2450 Analyzer Interface Module3 réf. D-Dimer D-Dimer Calibration Set D-Dimer Control D-Dimer Control High 13 autres Dynabeads HLA Class I2 réf.98/79 Dynabeads HLA Class II2 réf.98/79 HIV-1 Genotyping Kit A5440198/79 INDIKO3 réf. Indiko Ultra3 réf. MagMax Dx Viral/Pathogen NA Isolation Kit (A52735, A52736)2 réf. MagMax Viral/Pathogen II Nucleic Acid Isolation Kit A48383 MULTICELL CUVETTES TaqPath™ 1-Step Multiplex Master Mix (No ROX)2 réf.98/79 TaqPath™ COVID-19 Control2 réf.98/79 TaqPath™ COVID-19 Control Dilution Buffer98/79 TaqPath™ COVID-19 RT-PCR Kit2 réf.98/79 Tencell Cuvettes	A, C IVDR, 98/79	Présent sur le marché en France Site web info.baltics@thermofisher.com Fiche EUDAMED Signaler une erreur
AIDA	Allemagne	Annexin V-GM98/79 Borrelia IgG98/79 Borrelia IgM98/79 Choline-GM98/79 Ethanolamin-A98/79 12 autres Ethanolamin-GM98/79 Free Protein S98/79 HiT II98/79 HiT II Check98/79 Inositol-GM98/79 Phospholipid Screen-GM98/79 Phospholipid-Screen98/79 Protein C98/79 Protein S98/79 Sphingomyelin98/79 Thrombin-Check98/79 Thrombin-GM98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Anhui Formaster Biosci Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Adenovirus Rapid Test (Feces) IAD-301398/79 Dengue Ab and Ag Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IDEC-502398/79 Gonorrhea Rapid Test (Swab) WGO-101398/79 H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma) IHP-501398/79 H. pylori Antigen Rapid Test (Feces) IHP-301398/79 12 autres HAV Rapid Test Cassette (Serum/Plasma) IHA-601398/79 Influenza A&B Rapid Test IIN-102398/79 Influenza A&B/Adeno/RSV/COVID-19 Antigen98/79 Influenza A&B/Adeno/RSV/COVID-19/MP Antigen Rapid Test98/79 Influenza A&B/COVID-19 Antigen Combo Rapid Test98/79 Influenza A&B/RSV/COVID-19 Antigen Rapid Test98/79 NORO (Norovirus) Rapid Test (Feces)98/79 Rotavirus Rapid Test (Feces) IRO-301398/79 RSV Rapid Test IRS-101398/79 Strep A Rapid Test (Swab) ISA-101398/79 Strep B Rapid Test (Swab) ISB-101398/79 Syphilis Rapid Test (Whole Blood/Serum/Plasma) ISY-501398/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Astra Biotech	Allemagne	Chlamydia trachomatis PCR kit (Form F)3 réf.98/79 Chlamydia trachomatis PCR kit (Form S)3 réf.98/79 Chlamydia trachomatis PCR kit (Form T)3 réf.98/79 Magnetic DNA / RNA Auto Extraction kit Magnetic DNA/RNA Auto Extraction kit (Form P1) 12 autres Magnetic Plus DNA/RNA Auto Extraction kit Magnetic Plus DNA/RNA Auto Extraction kit (Form P1) Multi DNA Extraction kit Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form F)3 réf.98/79 Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form S)3 réf.98/79 Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form T)3 réf.98/79 Neisseria gonorrhoeae PCR kit3 réf.98/79 Prime DNA/RNA Extraction kit Trichomonas vaginalis PCR kit3 réf.98/79 Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form F)3 réf.98/79 Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form S)2 réf.98/79 Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form T)3 réf.98/79	A IVDR, 98/79	Site web info@astrabiotech.de Fiche EUDAMED Signaler une erreur
Biosystems FDA	Espagne	[AUTOANALYZER] BA2002 réf. [AUTOANALYZER] BA4002 réf. [RANDOM ACCESS ANALYZER] A153 réf. [RANDOM ACCESS ANALYZER] A25 ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)3 réf.98/79 12 autres ANTI-PHOSPHOLIPID IgG/IgM (APLA)98/79 BIOSYSTEMS MIRA D-DIMER2 réf.98/79 D-DIMER CONTROLS I / II98/79 D-DIMER STANDARD98/79 FIBRINOGEN3 réf.98/79 FIBRINOGEN CONTROL PLASMA98/79 FIBRINOGEN STANDARD98/79 OPEN STOOL COLLECTION TUBE REACTION ROTOR RPR-CARBON2 réf.98/79 STOOL COLLECTION TUBE2 réf.	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Cellomics (Shenzhen) Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Cell Sorter Circulating epithelial cell detection kit IFCP0100 Circulating epithelial cell detection kit IFCP0101 CTC100 Pro Digital PCR Reader 12 autres Disposable Cell Filter Immuno-Chromogenic Reagent IFCP00013 réf. Immuno-Chromogenic Reagent IFCP0005 Immuno-Chromogenic Reagent IFCP0006 Immuno-Chromogenic Reagent IFCP0007 Immuno-Chromogenic Reagent IFCP0010 Immuno-Chromogenic Reagent IFCP0011 Immuno-Chromogenic Reagent IFCP0013 Immuno-Chromogenic Reagent IFYC0040 Immuno-Chromogenic Reagent IFYC0041 Immuno-Chromogenic Reagent IFYC0042 Immuno-Chromogenic Reagent IFYC0043	A, C IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
CellSolutions FDA Mandataire UE : CellSolutions GmbH (Allemagne)	États-Unis	CellSolutions BestPrep General Cytology Preservative (1L) CellSolutions BestPrep General Cytology Preservative (500x10mL) CellSolutions BestPrep General Cytology Preservative C-101 (200x10mL) CellSolutions BestPrep General Cytology Preservative C-101 (4x1L) CellSolutions BestPrep General Cytology Preservative C-101(50x10mL) 12 autres CellSolutions Blue Preservative (1L) CellSolutions Blue Preservative (4x1L) CellSolutions Density Reagent (1L) CellSolutions Density Reagent (4x1L) CellSolutions F50 General Cytology Preservative (1L) CellSolutions F50 General Cytology Preservative (200x10mL) CellSolutions F50 General Cytology Preservative (4x1L) CellSolutions F50 General Cytology Preservative (500x10mL) CellSolutions F50 General Cytology Preservative (50x10mL) CellSolutions Red Lytic General Cytology Preservative (1L) CellSolutions Red Lytic General Cytology Preservative (25x40mL) CellSolutions Red Lytic General Cytology Preservative (4x1L)	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Diapro	Italie	anti-HCV ELISA 5127498/79 Dengue virus NS1 Ag98/79 DIA.CHEMILUX HSV 2 IgM RAHSV2M.CE98/79 DIA500 DP5 EBV DNA Quantitation (QT) EBVDNAQT.CE98/79 12 autres ENTEROVIRUS ONE-STEP ENTERONE.CE98/79 HBsAg ultra sens ELISA 5104998/79 HEV IgM EVM.CE98/79 HEV RNA QUANTITATION (QT) HEVONEQT.CE98/79 HIV Ag/Ab ELISA 5121498/79 HSV1 DNA Quantitation (QT) HSV1DNAQT.CE98/79 JCV DNA Quantitation (QT) JCVDNAQT.CE98/79 ORPHIA Chemiluminescence Immunoassay Analyzer2 réf. Parvovirus B19 IgM PARVOM.CE98/79 SYPH IgM SIM.CE98/79 Syphilis Screen ELISA 5100498/79 ZIKV IgM ZIKVM.CE98/79	A IVDR, 98/79	Site web info@diapro.it Fiche EUDAMED Signaler une erreur
Dynamiker Mandataire UE : JOYSUN GROUP S.L.U (Espagne) et 1 autre	Chine	100 tests14 réf.98/79 12 tests/kit98/79 20 tests9 réf.98/79 20 tests (A)98/79 200 tests14 réf.98/79 12 autres 24 tests5 réf.98/79 24 tests/kit10 réf.98/79 40 tests98/79 40 tests/kit (A)98/79 48 tests9 réf.98/79 48 tests/kit11 réf.98/79 50 tests5 réf.98/79 50 tests/kit3 réf.98/79 50 tests/kit (A)98/79 96 tests3 réf.98/79 96 tests/kit98/79 DNK-2103-198/79	– 98/79	Site web marketing@dynamiker.com Fiche EUDAMED Signaler une erreur
Evident FDA Mandataire UE : Evident Europe GmbH (Allemagne)	Japon	BX432 réf. BX462 réf. BX532 réf. BX632 réf. CKX532 réf. 12 autres CX233 réf. CX333 réf. CX433 réf. IX733 réf. IX832 réf. IX853 réf. SZ513 réf. SZ613 réf. SZX103 réf. SZX163 réf. SZX72 réf. VS-M1-IVD2 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Jiangsu Q-Array Mandataire UE : Caretechion GmbH (Allemagne)	Chine	Adenovirus & Rhinovirus & mycoplasma pneumoniae Nucleic Acid Detection Kit (Fluorescence PCR )5 réf.98/79 Bordetella pertussis and Mycoplasma pneumoniae Nucleic Acid Multiplex Detection Kit (Fluorescence PCR)98/79 Dengue virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR)98/79 Enterovirus, enterovirus 71 and coxsackie virus A 16 NucleicAcid Detection Kit (Fluorescence PCR)98/79 Full-Automatic Nucleic Acid Extraction and Purification Instrument MN-9600B 12 autres Influenza A&B Nucleic Acid Detection Kit(RNA Amplification Lateral Flow)3 réf.98/79 Influenza A/B & RSV Nucleic Acid Multiplex Detection Kit(Fluorescence PCR)5 réf.98/79 Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR)2 réf.98/79 Mycobacterium tuberculosis/Rifampicin resistant mutation Detection Kit (Fluorescence PCR )98/79 Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Latex Chromatography)98/79 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescence PCR)98/79 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RNA Amplification Lateral Flow)98/79 Nucleic Acid Extraction and Purification Kit (Magnetic Bead Method) Q012-96 Plasmodium Nucleic Acid Multiplex Detection Kit (Fluorescence PCR )98/79 QA Nucleic Acid Extraction Kit(Magnetic Bead Method)3 réf. Real-time Quantitative Thermal Cycler MA-688，MA-1610Q，MA-1620Q，MA-1630Q，MA-1640Q3 réf. Ureaplasma urealyticum, Mycoplasma hominis, Mycoplasma genitalium Nucleic Acid Multiplex Detection Kit (Fluorescence PCR)98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
KH Medical Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	CHAMP Malaria P.f Kit98/79 RADI Brucella spp Detection KIT98/79 RADI Chikungunya Detection Kit98/79 RADI Dengue Virus Detection Kit98/79 RADI Ebola Virus Detection Kit98/79 12 autres RADI FAST Flu-SC2-RSV Detection Kit98/79 RADI FAST Influenza A/B Detection Kit98/79 RADI FAST RSV A/B Detection Kit98/79 RADI Kala-azar (Leishmania) Detection KIT98/79 RADI Malaria Detection Kit98/79 RADI PCR RADI Salmonella spp Detection KIT98/79 RADI Shigella spp Detection KIT98/79 RADI West nile virus Detection Kit98/79 RADICHAMP RADIONE2 réf. RADIPREP3 réf.	A IVDR, 98/79	Site web info@khmedical.co.kr Fiche EUDAMED Signaler une erreur
Roche FDA	Allemagne	Accu-Chek® Active meter3 réf. CoaguChek INRange9 réf. CoaguChek XS PT Test PST10 réf. CoaguChek XS System98/79 cobas lumira SARS-CoV-2 Ag Ultra4 réf. 12 autres cobas lumira SARS-CoV-2 Ag Ultra QC2 réf. Elecsys Anti-HBs II2 réf. Elecsys HTLV-I/II3 réf. Elecsys IGRA TB PreciControl HTLV PreciControl HTLV-I/II VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody2 réf. VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody2 réf. VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody2 réf. VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody2 réf. VENTANA anti-PMS2 (SP487) Mouse Monoclonal Primary Antibody VENTANA PD-L1 (SP263) Assay	B, C, D IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Shenzhen Superbio Technology FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	CLIA FDP Control98/79 D-Dimer Assay Kit CLIA2 réf.98/79 Diagnostic Kit for D-Dimer (DD) (Time-resolved Fluorescence Immunochromatographic Assay)98/79 Diagnostic Kit for Interleukin-6(IL-6)(Time-resolved Fluorescence Immunochromatographic Assay)98/79 FDP Assay kit CLIA2 réf.98/79 12 autres HCY Assay kit CLIA2 réf.98/79 IL-6 Assay Kit CLIA2 réf.98/79 InFluA/InFluB Ag Rapid Test (Immunochromatography Assay)98/79 Monkeypox Virus (MPxV) Antigen Quality Control2 réf.98/79 ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test (Colloidal Gold)2 réf.98/79 ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)2 réf.98/79 ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold)2 réf.98/79 PIC Assay kit CLIA2 réf.98/79 Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Fluorescence Immunochromatographic Assay)98/79 Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Immunochromatography Assay)98/79 TAT Assay kit CLIA2 réf.98/79 tPAIC Assay kit CLIA2 réf.98/79	– 98/79	info@sup-bio.com Fiche EUDAMED Signaler une erreur
Targetingone Mandataire UE : Medunion S.L. (Espagne) et 1 autre	Chine	Blood pathogens and drug resistance genes digital PCR detection kit BP01-Y2498/79 Blood pathogens and drug resistance genes real-time PCR detection kit BP03-Y2498/79 C10 easyPCR System Chip Reader R1 Chip Reader R2 12 autres D20 D30 Automatic Digital PCR System D50 Automatic Digital PCR System Drop Maker M1 EBV nucleic acid digital PCR detection kit EB01-Q2498/79 EBV nucleic acid digital PCR detection kit EB01-Y2498/79 High-risk HPV genotyping real-time PCR detection kit PV02-1Y2498/79 HPV nucleic acid real-time PCR detection kit PV01-1Y3298/79 HPV nucleic acid real-time PCR detection kit PV01-2Y3298/79 Pathogens nucleic acid digital PCR detection kit BP02-Y2498/79 Transplant-related pathogen nucleic acids digital PCR detection kit TP01-Q2498/79 Transplant-related pathogen nucleic acids digital PCR detection kit TP01-Y2498/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Wiener Laboratorios SAIC FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Argentine	APTT ellagic2 réf.98/79 APTTest ellágico98/79 Chagatest ELISA lisado2 réf.98/79 Chagatest ELISA recombinante v.4.02 réf.98/79 CM 160 M-23003 réf. 29 autres Coagulation Calibrator2 réf.98/79 Control Plasma Normal98/79 Control Plasma Pathologic98/79 e32 Fibrinogen98/79 Fibrinógeno98/79 Plasma Control Normal98/79 Prothrombin Time98/79 Prothrombin Time plus2 réf.98/79 Soluplastin3 réf.98/79 Thrombin Time98/79 Albúmina bovina 30% (plus commercialisé) Anticoagulante TP (plus commercialisé) APTTest98/79 (plus commercialisé) Chrom ATIII98/79 (plus commercialisé) Chrom Protein C98/79 (plus commercialisé) CM 160i M-23003 réf. (plus commercialisé) Coagulation Control N98/79 (plus commercialisé) Coagulation Control P98/79 (plus commercialisé) Factor IX Deficient Plasma98/79 (plus commercialisé) Factor VIII Deficient Plasma98/79 (plus commercialisé) Imidazole buffer (plus commercialisé) Plasma Control Patológico98/79 (plus commercialisé) Tiempo de Trombina98/79 (plus commercialisé) WL 19 E-Z Cleanser AA (plus commercialisé) WL 19 Rinse AA2 réf. (plus commercialisé) WL Diluent2 réf. (plus commercialisé) WL Lyse2 réf. (plus commercialisé) WL Probe Cleanser (plus commercialisé)	A IVDR, 98/79	Site web marketing@wiener-lab.com Fiche EUDAMED Signaler une erreur
Abon Biopharm(Hangzhou) Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Chine	Chlamydia Rapid Test Device (Swab/Urine) ICH-50298/79 Clearview™ Strep A Dipstick 2 IST-50198/79 Clearview™ One Step H.pylori Antigen Test Device (Feces) IHP-60298/79 Clearview™ Strep A Cassette 2 IST-50298/79 ICH-50298/79 11 autres IHBsg-40298/79 IHC-30298/79 IHI-T40298/79 IHP-30298/79 IHP-40298/79 IHP-60298/79 IIN-50198/79 IST-50198/79 IST-50298/79 ISY-U40198/79 ISY-U40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Aidian FDA	Finlande	Protein Calibrator Set98/79 Protein Control98/79 QuikRead CRP Control98/79 QuikRead go CRP Control98/79 QuikRead go CRP Control Low98/79 11 autres QuikRead go CRP Control Set98/79 QuikRead go Hb 10 µl Control98/79 QuikRead go Hb Control98/79 QuikRead go HbA1c98/79 QuikRead go HbA1c Control Set98/79 QuikRead go Instrument3 réf. QuikRead go Plus Instrument3 réf. QuikRead go Strep A98/79 QuikRead go Strep A Extraction Tubes QuikRead iFOB Sampling Set Urine Albumin Control98/79	A IVDR, 98/79	Site web eudamed@aidian.eu Fiche EUDAMED Signaler une erreur
Biomaxima	Pologne	Auto Analizator Biochemiczny BM 200 Auto Chemistry Analyser BM 200 Auto Analizator Biochemiczny BM 300 Auto Chemistry Analyser BM 300 Clostridium difficile GDH kasetki 20 szt2 réf. Clostridium difficile GDH+A+B kas. 20szt Denga Ab/Ag / Dengue Ab/Ag 11 autres Dengue - kasetki 20 szt. Dengue NS1 kasetki 20 szt. H. pylori Ab - kasetki 20 szt. H. pylori Ag w kale - kasetki 20 szt. Influenza A+B kas. 20 szt. Malaria P.f./Pan 1-352-K02098/79 Mononukleoza / Mononucleosis RPR Carbon (+kontrola / +control) RPR Carbon bez kontroli 100 ozn.2 réf. RSV + Adeno-resp. - kasetki 20 szt. RSV - kasetki 20 szt. Syfilis / Syphilis Syfilis kasetki 40 szt.2 réf.	A, B, C IVDR, 98/79	Site web info@biomaxima.com Fiche EUDAMED Signaler une erreur
Daan Gene Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	20 tests/kit3 réf.98/79 24 tests/kit7 réf.98/79 48 tests/kit3 réf.98/79 Auto FICA-300 Automatic Nucleic Acid Extraction Instrument Swift96，Stream SP96，Ballet X33 réf. 11 autres Large package, 10 tests/kit4 réf.98/79 Large package, 20 tests/kit6 réf.98/79 Large package, 24 tests/kit3 réf.98/79 Large package, 48 tests/kit14 réf.98/79 NAE16 Nucleic Acid Extraction Instrument Smart32 ，Smart32plus Rapid Detection System T-elfie Real-time PCR Detection System Lava96 Single tube, 10 tests/kit6 réf.98/79 Single tube, 20 tests/kit11 réf.98/79 Single tube, 48 tests/kit98/79	A IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
DNA-Technology, Research & Production Mandataire UE : Obelis s.a. (Belgique)	Russie	DTprime II 4M13 réf. DTstream 12L13 réf. PREP-CITO DBS DNA Extraction Kit, Package N PREP-GS DNA Extraction Kit3 réf. PREP-MB DWP DNA/RNA Extraction Kit, Package A3 réf. 11 autres PREP-MB MAX DNA Extraction Kit, Package A2 réf. PREP-MB-DBS DWP DNA Extraction Kit, package N3 réf. PREP-MB-RAPID II DNA Extraction Kit, Package A3 réf. PREP-NA DNA/RNA Extraction Kit3 réf. PREP-NA-FET DNA Extraction Kit PREP-NA-S DNA/RNA Extraction Kit PREP-OPTIMA DNA Extraction Kit. Package N3 réf. PREP-PK Kit for sample pretreatment while processing of nucleic acids isolation, Set № 12 réf. PREP-RAPID DNA Extraction Kit2 réf. Real-time PCR instrument DTlite 4S12 réf. Real-time PCR instrument DTprime 4M13 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Flmedical FDA	Italie	PROMED2 réf. PROMED 2115098/79 PROMED 21150-S10098/79 PROMED 211500198/79 PROMED 211500398/79 11 autres PROMED 211500598/79 PROMED 211500798/79 PROMED 21150ARC98/79 PROMED 2115198/79 PROMED 2115298/79 PROMED 2115398/79 PROMED 2115498/79 PROMED 2115598/79 PROMED 2115898/79 PROMED 2115998/79 URINTAINER 25032	A IVDR, 98/79	Site web info@flmedical.com Fiche EUDAMED Signaler une erreur
Hartbio FDA Mandataire UE : Amstermed UK Ltd (Irlande du Nord)	United Kingdom (ex Northern Ireland)	Hart Biologicals HB-5502-FG98/79 Hart Biologicals HB-5504-FG98/79 Hart Biologicals HB-5506-FG98/79 Hart Biologicals HB-5508-FG98/79 Hart Biologicals HB-5509-FG98/79 11 autres Hart Biologicals HB-5511-FG98/79 Hart Biologicals HB-5514-FG98/79 Hart Biologicals HB-5515-FG98/79 Hart Biologicals HB-5533-FG98/79 Hart Biologicals HB-5548-FG98/79 Hart Biologicals HB-5613-FG98/79 Hart Biologicals HB-5614-FG98/79 Hart Biologicals HB-5615-FG98/79 Hart Biologicals HB-5616-FG98/79 Hart Biologicals HB-5617-FG98/79 Hart Biologicals HB-5618-FG98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Henan Tuoren Medical Technology Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Disposable Vacuum Blood Collection Tube Coagulant3 réf. Disposable Vacuum Blood Collection Tube Coagulant/separation gel3 réf. Disposable Vacuum Blood Collection Tube EDTA/sodium fluoride3 réf. Disposable Vacuum Blood Collection Tube K2E/separation gel3 réf. Disposable Vacuum Blood Collection Tube K2EDTA3 réf. 11 autres Disposable Vacuum Blood Collection Tube K3E/separation gel3 réf. Disposable Vacuum Blood Collection Tube K3EDTA3 réf. Disposable Vacuum Blood Collection Tube Lithium heparin3 réf. Disposable Vacuum Blood Collection Tube Lithium heparin/separation gel3 réf. Disposable Vacuum Blood Collection Tube Na2EDTA3 réf. Disposable Vacuum Blood Collection Tube No Additive3 réf. Disposable Vacuum Blood Collection Tube Sodium heparin3 réf. Disposable Vacuum Blood Collection Tube Sodium heparin/separation gel3 réf. Disposable Vacuum Blood Collection Tube Sodium heparin/sodium fluoride3 réf. Disposable Vacuum Blood Collection Tube Sodium citrate 4:13 réf. Disposable Vacuum Blood Collection Tube Sodium citrate 9:13 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Increcare FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Chemiluminescence Immunoassay Analyzer Shine i1110 Chemiluminescence Immunoassay Analyzer Shine i16900 Chemiluminescence Immunoassay Analyzer Shine i1920 Chemiluminescence Immunoassay Analyzer Shine i3900 Chemiluminescence Immunoassay Analyzer Shine i3910 11 autres Chemiluminescence Immunoassay Analyzer Shine i3920 Chemiluminescence Immunoassay Analyzer Shine i6910 Chemiluminescence Immunoassay Analyzer Shine i8900 Chemiluminescence Immunoassay Analyzer Shine i9910 shine i1900 shine i1910 Shine i2110 shine i2900 Shine i2910 shine i2920 shine i2930	A IVDR	Fiche EUDAMED Signaler une erreur
Jiangsu CoWin Biotech Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Blood RNA Storage Tube (Plus) CWX027M C. difficile GDH and toxin A/B detection kit CWX315M98/79 Cell-Free DNA Storage Tube(Glass) CWX001M2 réf. Cell-Free DNA Storage Tube(PET) CWX003M2 réf. CWX005M/CWX006M2 réf. 11 autres CWX005M/CWX006M/CWX007M/CWX008M3 réf. CWX006M-H CWX007M/CWX008M2 réf. CWX021S/CWX021M/CWX024M3 réf. CWX022M CWX023S/CWX023M/CWX023L3 réf. CWX026M CWX101S/CWX101M2 réf. CWX102S/CWX103S/CWX103S-BR/CWX103S-ZY/CWX103S-SLD/CWX104S/CWX104S-BR/CWX104S-ZY/CWX104S-M3 réf. CWX112S CWX901/CWX902/CWX9033 réf.	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
LTA	Italie	Brucella abortus Micro 5x10 ml98/79 Brucella melitensis Micro 5x10 ml98/79 Brucella TOTAL Micro 5x10 ml98/79 Salmonella paratyphi A TOTAL Micro 5x10 ml98/79 Salmonella paratyphi AH Micro 5x10 ml98/79 11 autres Salmonella paratyphi AO Micro 5x10 ml98/79 Salmonella paratyphi B TOTAL Micro 5x10 ml98/79 Salmonella paratyphi BH Micro 5x10 ml98/79 Salmonella paratyphi BO Micro 5x10 ml98/79 Salmonella paratyphi C TOTAL Micro 5x10 ml98/79 Salmonella paratyphi CH Micro 5x10 ml98/79 Salmonella paratyphi CO Micro 5x10 ml98/79 Salmonella typhi H Micro 5x10 ml98/79 Salmonella typhi O Micro 5x10 ml98/79 Syphilis TPHA 100 Tests98/79 Syphilis TPHA 200 Tests98/79	– 98/79	Site web office@ltaonline.it Fiche EUDAMED Signaler une erreur
NanoEntek FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	ADAM-rWBC2 réf. ADAM-rWBC HT ADAMII BioTracer™ Dengue Combo Rapid Card98/79 BioTracer™ Dengue IgG/IgM Rapid Card98/79 11 autres BioTracer™ Dengue NS1 Ag Rapid Card98/79 BioTracer™ Influenza A&B Rapid Card98/79 BioTracer™ Influenza A&B Test98/79 COVID-19 IgG/IgM Control LQ98/79 COVID-19 Neutralization Ab Control LQ98/79 COVID-19 SP Control LQ98/79 FIC-CGSW COVID-19 Ag positive control swab, Negative control swab98/79 FREND 2.02 réf. FREND D-Dimer98/79 FREND FLU A&B98/79 Influenza A&B control swab FIC-FLSW98/79	A IVDR, 98/79	Présent sur le marché en France Site web eudamed@nanoentek.com Fiche EUDAMED Signaler une erreur
Optika Microscopes	Italie	B-1000 B-150 B-190 B-290 B-380 11 autres B-510 B-60 B-800 IM-300 IM-5 IM-7 SFX SLX SZ SZP SZR-180	A IVDR	Fiche EUDAMED Signaler une erreur
r2 Diagnostics FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	États-Unis	Emicizumab Calibrator98/79 Emicizumab Controls98/79 FibroTek Fibrinogen kit98/79 LupoTek Correctin VL98/79 LupoTek Detectin VL98/79 11 autres LupoTek KCT98/79 NoFact IX98/79 NoFact VIII98/79 Phospholin ES2 réf.98/79 Phosphoplastin RL2 réf.98/79 PlasmaCon L198/79 PlasmaCon L298/79 PlasmaCon LA98/79 PlasmaCon N98/79 T-Tek98/79 ThromboTek PSe98/79	– 98/79	Site web qa@r2diagnostics.com Fiche EUDAMED Signaler une erreur
Reagena	Finlande	Eosin solution 100072 Etanolifiksatiivi 50 % V/V, sis. eosiinia (120 x 10 ml) 102354SC3 réf. Formalin 10 % (1 L), phosphate buffered pH 7,2 incl. 4 % formaldehyde 1022563 réf. Formalin 10 % in sample container (120 x 30 ml), phosphate buffered pH 7,2 incl. 4 % formaldehyde 102256SC3 réf. GEWF solution 102448 11 autres Giemsa solution 100119 May-Grünwald solution 1002112 réf. Mayer's hematoxylin solution 100210 PEG-ethanol cytology fixative (120 x 10 ml) 105028SC2 réf. Reageana DOBRAVA-HANTAAN IgG EIA98/79 Reagena C6 LYME IgM/IgG EIA98/79 Reagena DOBRAVA-HANTAAN IgM EIA98/79 Reagena PUUMALA IgG EIA98/79 Reagena PUUMALA IgM EIA98/79 Reastain Urine 140345 Weigert-Van Gieson Staining Kit 102538	A IVDR, 98/79	Site web info@reagena.com Fiche EUDAMED Signaler une erreur
Rrmechatronics FDA	Pays-Bas	Interrliner XN1 FRL 230V3 réf. RPI-ECO21 230V Starrsed Cleaning Agent Starrsed Control Level A - Blister 6*QRR 0490022 réf. Starrsed CR 10L 11 autres Starrsed Diluent Starrsed Disinfectant Starrsed DL 10L Starrsed ILXS 220-240 Vac Starrsed NSTA 230V/240V Starrsed PC 500 ml Starrsed Rinse Solution 10L2 réf. Starrsed RS 230V Beckman Coulter DXH-8003 réf. Starrsed Saline Starrsed TL 230V Starrsed X-Clean	A IVDR	Site web support@rrmechatronics.com Fiche EUDAMED Signaler une erreur
Seleo	Italie	Adalya 4098/79 Adalya 40 IFE98/79 AFSC Haemoglobin control98/79 Hemoglobin A2 elevated control98/79 Hemoglobin A2 normal control98/79 11 autres Hemoglobin electrophoresis kit 100 tests 4 samples98/79 Hemoglobin electrophoresis kit 200 tests98/79 Hemoglobin electrophoresis kit 200 tests 4 samples98/79 Hemoglobin electrophoresis kit 80 tests98/79 Immunofixation electrophoresis kit 25 tests98/79 Microphor98/79 Miniclot 0498/79 Miniphor 0898/79 Miniphor TS98/79 Picophor98/79 Selvet 2498/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Suzhou Shengtian Biotechnology Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	Disposable Vacuum Blood Collection Tube SZG01 Disposable Vacuum Blood Collection Tube SZG02 Disposable Vacuum Blood Collection Tube SZG03 Disposable Vacuum Blood Collection Tube SZG04 Disposable Vacuum Blood Collection Tube SZG05 11 autres Disposable Vacuum Blood Collection Tube SZG06 Disposable Vacuum Blood Collection Tube SZG07 Disposable Vacuum Blood Collection Tube SZG08 Oral Fluid Collection Kit STGJ01 Oral Fluid Collection Kit STGJ02 Oral Fluid Collection Kit STGJ03 Oral Fluid Collection Kit STGJ04 Oral Fluid Collection Tube STGJ0101 Oral Fluid Collection Tube STGJ0201 Oral Fluid Collection Tube STGJ0301 Oral Fluid Collection Tube STGJ0401	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Techlab FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	C. DIFF CHEK -602 réf.98/79 C. DIFF QUIK CHEK98/79 C. DIFF QUIK CHEK COMPLETE2 réf. C. DIFFICILE TOX A/B II2 réf.98/79 C. DIFFICILE TOX-B TEST98/79 11 autres CAMPYLOBACTER CHEK98/79 CAMPYLOBACTER QUIK CHEK98/79 CRYPTOSPORIDIUM II98/79 E. HISTOLYTICA II T501798/79 E. HISTOLYTICA QUIK CHEK98/79 GIARDIA II PT501298/79 H. PYLORI CHEK98/79 H. PYLORI QUIK CHEK98/79 SHIGA TOXIN CHEK98/79 SHIGA TOXIN QUIK CHEK TOX A/B QUIK CHEK98/79	B IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Ortho-Clinical Diagnostics Rochester Mandataire UE : Ortho-Clinical Diagnostics France (France)	États-Unis	FS Cuvettes VITROS ORTHO BLISS (4 x 50 ml bottles) VITROS2 réf. VITROS 3600 Immunodiagnostic System2 réf. VITROS 4600 Chemistry System2 réf. VITROS 5600 Integrated System2 réf. 11 autres VITROS Chemistry Products HCY 2 Reagent98/79 VITROS ECI IMMUNODIAGNOSTIC SYSTEM2 réf. VITROS FS MicroTips VITROS Microsample Cups VITROS MicroTips VITROS Products FS MicroTip Bulk VITROS VersaTips VITROS XT 3400 VITROS XT 76002 réf. VITROS XT3400 VersaTip Tray ORTHO Antibody Enhancement Solution VITROS (plus commercialisé)	A IVDR, 98/79	Présent sur le marché en France Site web PRRC@quidelortho.com Fiche EUDAMED Signaler une erreur
Anbio Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	Anbio Anbio Dengue NS1 Ag&IgG/IgM Rapid Test Kit98/79 Anti-HP Rapid Test Kit A0208200298/79 BOIRON A10013001D98/79 D-Dimer Rapid Test Kit A0200800298/79 10 autres Dengue IgM/IgG Rapid Test Kit A1000400198/79 Dengue NS1 Rapid Test Kit98/79 Group A Streptococcus Test Kit A0216700298/79 HbA1c Rapid Test Kit98/79 HP Rapid Test Kit A0208100298/79 IL-6 Rapid Test Kit A0201400298/79 Influenza A/B Rapid Test Kit A0210500298/79 Malaria (Pf/Pv) Rapid Test Kit A0208300298/79 RSV Ag Rapid Test Kit A0210800298/79 SHA-100, SHA-200	A IVDR, 98/79	Présent sur le marché en France info@anbio.com Fiche EUDAMED Signaler une erreur
AVE Science & Technology FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	1mL/bottle, 3mL/bottle, 5mL/bottle, 10mL/bottle, 15mL/bottle, 20mL/bottle, 30mL/bottle, 50mL/bottle, 100mL/bottle, 200mL/bottle, 500mL/bottle. 1piece/box, 5 pieces/box, 25 pieces /box, 50 pieces /box, 100 pieces /box.98/79 3 bottles/set (5mL/bottle, 10mL/bottle, 25mL/bottle, 40mL/bottle, 50mL/bottle, 100mL/bottle, 150mL/bottle, 200mL/bottle, 250mL/bottle, 500mL/bottle, 1000mL/bottle). AVE-YG01. 50 pieces/box, 200 pieces/box. 50mL4, 100mL4, 250mL4. 10 autres 5mL/bottle, 10mL/bottle, 25mL/bottle, 40mL/bottle, 50mL/bottle, 100mL/bottle, 150mL/bottle, 200mL/bottle, 250mL/bottle. AVE-FA01. AVE-762A, AVE-762C, AVE-762D, AVE-764A, AVE-764B, AVE-764C, AVE-766, etc.98/79 AVE-772, AVE-772A, AVE-772B, AVE-772C, AVE-773, AVE-773A, AVE-773B, AVE-773C, AVE-774, AVE-774A, AVE-774B, AVE-774C, AVE-775, AVE-775A, AVE-775B, AVE-775C98/79 AVE-FA01. 40pieces/box, 200pieces/box. AVE-FC01, AVE-FC02, AVE-FC03. AVE-MA01H, AVE-MA01M, AVE-MB01H, AVE-MB01M, AVE-MB02H, AVE-MB02M, AVE-MB03H, AVE-MB03M, AVE-MC01H, AVE-MC01M, AVE-MC02H, AVE-MC02M, AVE-MD01H, AVE-MD01M. AVE-NYB-01, AVE-NYB-02. AVE-TR100, AVE-TR100A, AVE-TR100B, AVE-TR100C, AVE-TR100D, AVE-TR200, AVE-TR200A, AVE-TR200B, AVE-TR200C, AVE-TR200D. EA50: 50mL3, 100mL3, 250mL3; EA65: 50mL3, 100mL3, 250mL3. Type I: 100mL2; Type II: 250mL2; Type III: 250mL4; Type IV: 250mL3; Type V: 250mL6; Type VI: 100mL3; Type VII: 100mL6.	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Bgi	Danemark	4800T98/79 BGI 1 test/kit2 réf. BGI 1 tube/kit BGI 10 tests/kit4 réf.98/79 BGI 25 tests/kit4 réf.98/79 10 autres BGI 32tests BGI 48 tests BGI 5 tests/kit4 réf.98/79 BGI 50 tests/kit6 réf.98/79 BGI 50 tests/package98/79 BGI one test per collection kit BGI PBC20， PBC20A， PBC22， PBC22A，PBC20 Plus, PBC20A Plus，PBC22 Plus，PBC22A Plus3 réf. BGI SI-POCT-02 Nucleic Acid Extraction Kit 96 tests Seq-hpv-1, Seq-hpv-298/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Celnovte Mandataire UE : Umedwings Netherlands B.V. (Pays-Bas)	Chine	AB-PAS stain kit Acid-fast stain kit Alcian Blue stain kit Congo red stain kit HS22092 réf. Elastic fiber stain kit HS2210 10 autres Fully Automatic IHC Staining System CNT360-M13 réf. Fully Automatic Immunohistochemistry Stainer CNT300 Fully Automatic Immunohistochemistry Stainer CNT330 Helicobacter pylori stain kit HS2206 Iron stain kit HS2202 Methenamine sliver stain kit3 réf. Mucicarmine stain kit Periodic acid Schiff-PAS stain kit Primary Antibody Diluent Trichrome-Masson stain kit2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Credo Diagnostics Biomedical Pte Taiwan Branch Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Taïwan	VitaPCR Flu A&B Assay98/79 VitaPCR Flu A&B External Control Set98/79 VitaPCR Flu/RSV Assay98/79 VitaPCR Influenza/SARS-CoV-2 (Flu/SC2) Assay98/79 VitaPCR Instrument 10 autres VitaPCR RSV External Control Set98/79 VitaPCR SARS-CoV-2 Assay98/79 VitaPCR SARS-CoV-2 External Control Set98/79 VitaPCR SARS-CoV-2 Gen 2 Assay98/79 VitaPCR SARS-CoV-2 Gen 2 External Control Set VitaPCR SARS-CoV-2 Gen2 External Control Set98/79 VitaPCR Strep A Assay98/79 VitaSIRO solo HPV Assay98/79 VitaSIRO solo Instrument VitaSIRO solo SARS-CoV-2/Flu/RSV Assay98/79 VitaSIRO solo SARS-CoV-2/Flu/RSV External Control Set98/79	A IVDR, 98/79	service@credodxbiomed.com Fiche EUDAMED Signaler une erreur
Ddk Italia	Italie	Acetate buffered formalin3 réf. Acid alcohol solution3 réf. Acridine orange for plasmodium and DNA3 réf. Afog stain solution3 réf. AgNOR3 réf. 10 autres Albumine glicerinate3 réf. Blocstore 9 container for 450 block3 réf. Blue cresyl brilliant Ddclear (D-Limonene)3 réf. Denatured ethyl alcohol 99A3 réf. Eosin for sperm vitality3 réf. Gentian violet phenic solution3 réf. Giemsa L (stock solution)3 réf. HC1 pH 8.0 buffer3 réf. Tissue marking dyes black3 réf.	A IVDR	info@ddkitalia.com Fiche EUDAMED Signaler une erreur
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH	Allemagne	PoET B19V98/79 PoET Extraction PoET HAV98/79 PoET HBV98/79 PoET HCV98/79 10 autres PoET HEV98/79 PoET HEV Positive Control98/79 PoET HIV98/79 PoET Instrument PoET Internal Control98/79 PoET Master Positive Control98/79 PoET Negative Control98/79 PoET Prep Reagent PoET WNV98/79 PoET WNV Positive Control98/79	A IVDR, 98/79	Site web info@gfeblut.de Fiche EUDAMED Signaler une erreur
Hitachi High-Tech FDA Mandataire UE : Roche Diagnostics GmbH (Allemagne)	Japon	ACU for cobas 8100 cobas 8100 automated workflow series cobas 8000 c 701 Module cobas 8000 modular analyzer series cobas 8000 c 702 Module cobas 8000 modular analyzer series cobas 8000 ISE 1800 Module cobas 8000 modular analyzer series cobas 8000 ISE 900 Module cobas 8000 modular analyzer series 10 autres cobas c 303 analytical unit cobas pure integrated solutions cobas c 311 analyzer cobas c 503 analytical unit cobas pro integrated solutions cobas c 513 analyzer cobas e 402 analytical unit cobas pure integrated solutions cobas e 411 analyzer (disk system) cobas e 411 analyzer (rack system) cobas e 801 analytical unit cobas 8000 modular analyzer series cobas e 801 MSB/MSBL cobas 8000 modular analyzer series cobas pro ISE analytical unit cobas pro integrated solutions	A IVDR	ra-contact.aj@hitachi-hightech.com Fiche EUDAMED Signaler une erreur
Iontek	Turquie	Fluorion BKV QNP 1.0 Real-Time PCR Kit98/79 Fluorion CMV QNP 3.0 Real-Time PCR Kit98/79 Fluorion Covidenza Plus QLP 1.0 Real-Time PCR Kit98/79 Fluorion Covidenza Plus QLP 2.0 Real-Time PCR Kit98/79 Fluorion Covidenza Plus QLP 3.0 Real-Time PCR Kit98/79 10 autres Fluorion Covidenza QLP 1.0 Real-Time PCR Kit98/79 Fluorion EBV QNP 1.0 EBV Real-Time PCR Kit98/79 Fluorion HBV QNP 2.0 Real-Time PCR Kit98/79 Fluorion HCV QNP 2.1 Real-Time PCR98/79 Fluorion HDV QNP 1.0 Real-Time PCR Kit98/79 Fluorion HIV-1 QNP 1.1 Real-Time PCR Kit98/79 Fluorion Influenza A/B QLP 1.0 Real-Time PCR Kit98/79 Fluorion MTBC QLP 2.1 Real-Time PCR Kit98/79 Fluorion Rhinovirus QLP 1.0 Real-Time PCR Kit98/79 Fluorion RSV QLP 1.0 Real-Time PCR Kit98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Labnovation Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	Automated HbA1c Analyzer2 réf. Dengue IgG/IgM Antibody Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Dengue NS1 Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Dengue NS1&IgG/lgM Rapid Test (Immunochromatography) 20 Tests/Kit98/79 Fully Automated HbA1c Analyzer6 réf. 10 autres H. Pylori Antibody Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 H. Pylori Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Influenza A/B Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Malaria P.f (HRP-2) Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Malaria P.f (HRP-2)/P.v (LDH)/Pan (LDH) Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Monkeypox Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 POCT HbA1c Analyzer3 réf. SARS-CoV-2 Antigen and Influenza A/B Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Treponema Pallidum Antibody Rapid Test kit (Immunochromatography) 20 Tests/Kit98/79	A IVDR, 98/79	Site web info@labnovation.com Fiche EUDAMED Signaler une erreur
Labsystems Diagnostics FDA	Finlande	Biocard Chlamydia pneumoniae IgM98/79 Biocard Helicobacter pylori IgG98/79 Biocard Mycoplasma pneumoniae IgM 3-035-00098/79 Biocard™ H pylori IgG Home 3-018-20098/79 Chlamydia pneumoniae IgA EIA98/79 10 autres Chlamydia pneumoniae IgG EIA98/79 Chlamydia pneumoniae IgM EIA 611132098/79 Chlamydia trachomatis IgA EIA98/79 Chlamydia trachomatis IgG EIA98/79 MYCOPLASMA PNEUMONIAE IgA EIA98/79 MYCOPLASMA PNEUMONIAE IgG EIA98/79 Mycoplasma pneumoniae IgM EIA98/79 Neonatal Toxoplasma gondii IgM FEIA98/79 NS Reader 5420100 NS2400 5400200	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Lysunbio FDA Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	BGM-10198/79 LYSUN BGM-103N98/79 LYSUN BHM-202 LYSUN CRP-W21-1(25PCS)98/79 LYSUN DEG-P21（25PCS）98/79 10 autres LYSUN DIM-W21（25PCS）98/79 LYSUN FLU-S21（25PCS）98/79 LYSUN Gon-102（25PCS）98/79 LYSUN HAV-W21-GM（25PCS）98/79 LYSUN HP-F21（25PCS）98/79 LYSUN MAL-W21- FV（25PCS）98/79 LYSUN SAL-F21(25PCS)98/79 LYSUN STP-S21（25PCS）98/79 LYSUN SYP-W21（25PCS）98/79 LYSUN TYP-P21（25PCS）98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Ningbo High-Tech Bluesky Manufactory & Trading FDA Mandataire UE : Wellkang Ltd (Irlande du Nord)	Chine	BS0097HQ BS0100J BS0106J-T2 réf. BS0110J BS0113J 10 autres BS0270J BS0308J BS0342J BS0557J BS0788J BS1250J BS1384J BS1386J BS9008J PILL BOX	I MDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Shenzhen Chenghui Medical Technology Mandataire UE : HUMISS TRADING S. L. (Espagne)	Chine	Arboviral Pathogen Nucleic Acid Detection Kit 1.198/79 Arboviral Pathogen Nucleic Acid Detection Kit 2.198/79 Blood Culture Pathogen and Antimicrobial Resistance Gene (G+&Fungi&AMR) Nucleic Acid Detection Kit 1.198/79 Blood Culture Pathogen and Antimicrobial Resistance Gene (G-&AMR) Nucleic Acid Detection Kit 1.198/79 Gastrointestinal Tract Pathogen Nucleic Acid Detection Kit 1.198/79 10 autres Human Papillomavirus (HPV) Nucleic Acid Typing Detection Kit 1.198/79 Human Papillomavirus (HPV) Nucleic Acid Typing Detection Kit 2.198/79 Lower Respiratory Tract Pathogen and Antimicrobial Resistance Gene Nucleic Acid Detection Kit 1.198/79 Malaria Pathogen Nucleic Acid Detection Kit 1.198/79 Malaria Pathogen Nucleic Acid Detection Kit 2.198/79 Meningitis Pathogen Nucleic Acid Detection Kit 1.198/79 Reproductive Tract Pathogen Nucleic Acid Detection Kit 2.198/79 Reproductive Tract Pathogen Nucleic Acid Detection Kit1.198/79 Respiratory Tract Pathogen Test Kit 2.198/79 Upper Respiratory Tract Pathogen Nucleic Acid Detection Kit (Fluorescent PCR-Chip Method)	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Verbiese	France	Fixateur de Duboscq-Brasil dans 60 ml - 20 ml Fixateur par mélange Formol tamponné pbs 4 % - 10 ml / 20 ml Formol tamponné pbs 4 % dans flacon 20 ml Formol tamponné pbs 4 % - 10 ml / 40 ml Formol tamponné pbs 4 % dans flacon 40 ml Formol tamponné pbs 4 % - 100 ml / 180 ml Formol tamponné pbs 4 % dans flacon 180 ml3 réf. 10 autres Formol tamponné pbs 4 % - 150 ml / 250 ml Formol tamponné pbs 4 % dans flacon 250 ml Formol tamponné pbs 4 % - 20 ml / 60 ml Formol tamponné pbs 4 % dans flacon 60 ml3 réf. Formol tamponné pbs 4 % - 250 ml / 500 ml Formol tamponné pbs 4 % dans flacon 500 ml Formol tamponné pbs 4 % - 500 ml / 1000 ml Formol tamponné pbs 4 % dans flacon 1000 ml Formol tamponné pbs 4 % - 60 ml / 125 ml Formol tamponné pbs 4 % dans flacon 125 ml2 réf. Formol tamponné pbs 4 % dans flacon 3000 ml Formol tamponné pbs 4 % rosé dans flacon 60 ml Formol tamponné pbs 4 % tube 6 ml - 5 ml Formol tamponné pbs 4 % dans flacon 6 ml VERBIESE3 réf. VERBIESE Formol tamponné pbs 4 % en solution3 réf.	A IVDR	Présent sur le marché en France Site web contact@verbiese.fr Fiche EUDAMED Signaler une erreur
Zhejiang QL Biotech Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	QINGLI Device (IHP-402)98/79 QINGLI Device(IAD-602)98/79 QINGLI Device:20 Test/Kit40 réf.98/79 QINGLI Device:20 Test/Kit, Strip: 25Test/Kit QINGLI IHP-60298/79 10 autres QINGLI IRO-60298/79 QINGLI IST-501 (Strip) / IST-502 (Device)98/79 QINGLI Strip (IHP-401)98/79 QINGLI Strip(IAD-601)98/79 QINGLI Strip(IHP-601)98/79 QINGLI Strip(IRO-601)98/79 QINGLI Strip(ISY-401)98/79 QINGLI Strip: 25Test/Kit98/79 QINGLI Strip: 25Tests/Kit31 réf.98/79 Strep A Rapid Test Device IST-502s	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Hangzhou Genesis Biodetection Biocontrol FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	C. difficile GDH & Toxin A+B Combo Rapid Test P22111598/79 C. difficile GDH & Toxin A/B Combo Rapid Test P22110998/79 Calprotectin Rapid Test P22110598/79 Dengue IgG/IgM Rapid Test Device P23110698/79 EBNA IgG Rapid Test P23111798/79 14 autres EBV-VCA IgG Rapid Test P23111698/79 Flu A+B Antigen Rapid Test Device P21210298/79 Flu A+B Antigen Rapid Test P21100298/79 H. pylori Antibody Rapid Test P22110398/79 Legionella Antigen Rapid Test Device P24111098/79 Mycoplasma pneumoniae IgG/IgM Rapid Test P23111098/79 RSV Antigen Rapid Test Device P21211298/79 Strep B Antigen Rapid Test P28100398/79 Treponema Pallidum Antibody Rapid Test P23111198/79 Dengue IgG/IgM/NS1 Combo Rapid Test Device P23110598/79 (plus commercialisé) Dengue NS1 Rapid Test Device P23110498/79 (plus commercialisé) Malaria Pf Antigen Rapid Test Device P23110798/79 (plus commercialisé) Malaria Pf/Pan Antigen Rapid Test Device P23110998/79 (plus commercialisé) Malaria Pf/Pv Antigen Rapid Test Device P23110898/79 (plus commercialisé)	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Sinocare FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 2 autres	Chine	D-Dimer Reagent Kit 2N00198/79 FHhub Safe AQ Smart, Safe AQ Voice, Safe AQ Air3 réf. Hematology Reagent Kit Prothrombin Time Reagent Kit 1S00198/79 Safe AQ pro Ⅰ, Safe AQ pro Ⅱ, Safe AQ pro Ⅲ; Safe AQ maxⅠ, Safe AQ max Ⅱ, Safe AQ max Ⅲ98/79 10 autres Safe AQ proⅠ98/79 Safe AQ Smart98/79 Safe AQ Voice98/79 Safe-Accu2 réf.98/79 Safe-Accu298/79 Safe AQ max Ⅲ98/79 Sinocare H102 Air ，H1013 réf. Sinocare Safe-Accu98/79 SLX-120 Lipid and Blood Glucose Analyzer98/79 Sinocare98/79 (plus commercialisé)	A, B, C IVDR, 98/79	RA@sinocare.com Fiche EUDAMED Signaler une erreur
AFI Centrifuge	France	AFI 230V / 50Hz IVD QBD REGINA AFI ELLA Ventilated centrifuge, 230V IVD AFI ISA Reversible Centrifuge, 230V IVD AFI LINA Refrigerated centrifuge for IVD application, 230V 50-60Hz AFI LINA Ventilated centrifuge, 230V IVD 9 autres AFI LISA Refrigerated Centrifuge, 230V IVD AFI LISA Ventilated Centrifuge, 230V IVD AFI LOREENA Floor Standing Refrigerated Centrifuge, 230V IVD AFI LOREENA Refrigerated Centrifuge, 230V IVD AFI LOREENA Ventilated Centrifuge, 230V IVD AFI SIRENA Refrigerated Centrifuge, 230V IVD ISA Refrigerated 230V ISA Refrigerated Centrifuge, 230V IVD ISA VENTILATED 230V ISA Ventilated Centrifuge, 230V IVD LISA Reversible centrifuge, 230V IVD	A IVDR	Présent sur le marché en France Site web contact@afigroups.com Fiche EUDAMED Signaler une erreur
ALS Life Sciences Portugal	Portugal	InviMag® Blood DNA Mini Kit/ IG InviMag® Universal Kit/ IG InviMag® Universal Kit/ KF962 réf. InviSorb® Spin Blood Mini Kit (250)2 réf. InviSorb® Spin Universal Kit (250)2 réf. 9 autres InviTrap® Spin Universal RNA Mini Kit (250)2 réf. PSP® SalivaGene DNA Kit (250)2 réf. PSP® Spin Stool DNA Basic Kit (250)2 réf. RTP® Pathogen Kit (250)2 réf. SalivaGene® Collector SalivaGene® Swab Comfort Stool Catcher (250)2 réf. Stool Collection Tubes with DNA Stabilizer (250)2 réf. Stool Collection Tubes with DNA Stabilizer (w/ Stool Catcher) (250)2 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Beijing Wantai Biological Pharmacy Enterprise Mandataire UE : QbD RepS BV (Belgique)	Chine	AiD HIV 1+2 Ag/Ab ELISA Plus2 réf.98/79 AiDTM HBsAg ELISA2 réf.98/79 AiD anti-HCV ELISA Plus2 réf.98/79 AiD anti-HIV 1+2 ELISA2 réf.98/79 Rapid Test for Antibody to Syphilis (Colloidal Gold Device)2 réf.98/79 9 autres Rapid Test for IgM Antibody to Hepatitis A Virus (Colloidal Gold Device)2 réf.98/79 Rapid Test for IgM Antibody to Hepatitis E Virus (Colloidal Gold Device)98/79 Rotavirus Group A Diagnostic Kit (Colloidal Gold Device)2 réf.98/79 WANTAI anti-TP ELISA98/79 WANTAI HAV-IgM ELISA98/79 WANTAI HEV-Ag ELISA Plus98/79 WANTAI HEV-IgG ELISA98/79 WANTAI HEV-IgM ELISA98/79 WANTAI TB-IGRA98/79	– 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Challenbio Mandataire UE : MedPath GmbH (Allemagne)	Chine	Cytosteller DX02 Cytosteller DX01 Cytosteller DX03 Cytosteller DX04 Cytosteller DX05 9 autres Cytosteller DX06 Cytosteller DX07 Cytosteller DX08 Flow Cytometer6 réf. Flow Cytometer CytoStellar AX01 Flow Cytometer CytoStellar AX02 Flow Cytometer CytoStellar AX03 Flow Cytometer CytoStellar AX04 IsFlower QC Beads2 réf.	A IVDR	sale@challenbio.com Fiche EUDAMED Signaler une erreur
Epsbio FDA Mandataire UE : Obelis s.a. (Belgique)	Taïwan	EasyMax MU Self Monitoring Blood Glucose System4 réf.98/79 EasyMax Neu Self Monitoring Blood Glucose System EM25 réf.98/79 EasyMax Voice Self Monitoring Blood Glucose System EMV 3.15 réf.98/79 EASYMAX® Tag Self Monitoring Blood Glucose System EM Tag7 réf.98/79 EASYMAX® Tag Blood Glucose Monitoring System EMTAG2 réf. 9 autres EASYMAX® Tag Blood Glucose Meter2 réf. lisubel®check LB-EMV3 Blood Glucose Meter EMV 3.198/79 lisubel®check LB-EMV3 Self Monitoring Blood Glucose System EMV 3.198/79 saneo® SV-GD 01 Blood Glucose Meter EM Tag98/79 saneo® SV-GD 01 Self-Monitoring Blood Glucose System EM Tag98/79 smartLAB® genie Blood Glucose Meter EasyPlus mini R598/79 smartLAB® genie Self Monitoring Blood Glucose System EasyPlus mini R598/79 SOMA® be Blood Glucose Meter EasyMax MU2 réf.98/79 SOMA® be Self Monitoring Blood Glucose System EasyMax MU2 réf.98/79	C IVDR, 98/79	Présent sur le marché en France Site web info@epsbio.com.tw Fiche EUDAMED Signaler une erreur
Especialidades Médicas Myr FDA	Espagne	Myr EC 350 Myr EC 350-1 Myr EC 350-2 Myr EC 500 Myr EC 500-1 9 autres Myr EC 500-2 Myr EC 500-3 Myr M-240 Myr M-250 Myr S-30H Myr SS-30 Myr STP 120-1 Myr STP 120-2 Myr STP 120-3	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Guangzhou KOFA Biotechnology Mandataire UE : Medunion S.L. (Espagne)	Chine	D-Dimer CLIA8 réf.98/79 D-Dimer Immunofluorescence Assay6 réf.98/79 FDP CLIA8 réf.98/79 Fully automatic chemiluminescence immunoassay analyzer Please see UDI-DI for detail3 réf. IL-10 CLIA8 réf.98/79 9 autres IL-1β CLIA8 réf.98/79 IL-2R CLIA8 réf.98/79 IL-6 CLIA8 réf.98/79 IL-6 Immunofluorescence Assay6 réf.98/79 IL-8 CLIA8 réf.98/79 PIC CLIA8 réf.98/79 t-PAIC CLIA7 réf.98/79 TAT CLIA8 réf.98/79 TNF-α CLIA8 réf.98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Institut de Biotechnologies Jacques Boy	France	Anti-A monoclonal (clone 26A2)98/79 Anti-AB monoclonal (clones 152D12+9113D10)98/79 Anti-B monoclonal (clone B2A22)98/79 Anti-C (Clone MS-24)98/79 Anti-c (clone MS-33)98/79 9 autres Anti-D IgG+IgM (clones TH28+MS-26)98/79 Anti-D IgM (clone MS-201)98/79 Anti-e (clones MS-16+MS-21+MS-63)98/79 Anti-E (clones MS-80+MS-258)98/79 Anti-Kell (clone MS-56)98/79 DAT-QC C3b-C3d98/79 DAT-QC IgG98/79 Hématies tests à 2,5% pour épreuve plasmatique98/79 Témoin négatif salin (TNS)98/79	– 98/79	Présent sur le marché en France Site web contact@ibjb.fr Fiche EUDAMED Signaler une erreur
Jiangsu Confidence Medical Technology Mandataire UE : JOYSUN GROUP S.L.U (Espagne)	Chine	25 tests/kit (including calibration)98/79 D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)6 réf.98/79 Interleukin-10 (IL-10) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)11 réf.98/79 Interleukin-12p70 (IL-12p70) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)12 réf.98/79 Interleukin-17A (IL-17A) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)12 réf.98/79 9 autres Interleukin-17F (IL-17F) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)11 réf.98/79 Interleukin-1β (IL-1β ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)11 réf.98/79 Interleukin-2 (IL-2 ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)12 réf.98/79 Interleukin-2R (IL-2R ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)10 réf.98/79 Interleukin-4 (IL-4 ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)11 réf.98/79 Interleukin-5 (IL-5 ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)12 réf.98/79 Interleukin-6 (IL-6) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)6 réf.98/79 Interleukin-6 (IL-6) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)11 réf.98/79 Interleukin-8 (IL-8) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)12 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Medconn FDA Mandataire UE : JOYSUN GROUP S.L.U (Espagne) et 2 autres	Chine	Auto Chemistry Analyzer MC-200 Automatic Chemiluminescence Immunoassay Analyzer M2 Automatic Chemiluminescence Immunoassay Analyzer MI mini 90 Automatic Hematology Analyzer MH 60 Pro98/79 Automatic Hematology Analyzer MH 60X98/79 9 autres Blood Gas Analyzer Afresh H1 D-Dimer Reagent Kit 100 Tests/kit98/79 D-Dimer Reagent Kit 50 Tests/kit98/79 Fully Automated Coagulation Analyzer MCA-300 M3 M3 Pro MC-240 MH 60 Automatic Hematology Analyzer98/79 NOVEOS X	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Nano Diagnosis for Health Biotech (Guangzhou) Mandataire UE : MedPath GmbH (Allemagne) et 1 autre	Chine	Covid-19 + Influenza A/B + RSV Combo Rapid Test98/79 Covid-19 + Influenza A/B Combo Rapid Test98/79 Dengue IgG/IgM Rapid Test DENAB-0298/79 Dengue NS1 + IgG/IgM Combo Rapid Test98/79 Dengue NS1 Antigen Rapid Test98/79 9 autres Fluorescence immunoassay analyzer H.Pylori Antibody Rapid Test HPAB-0298/79 H.Pylori Antigen Rapid Test HPAG-01、HPAG-0298/79 Malaria P.f./P.v. Rapid Test MALAC1-0298/79 Malaria P.f./P.v./Pan Rapid Test MALAC3-0298/79 Malaria P.f./Pan Rapid Test MALAC2-0298/79 One Minute Drug Analyzer Syphilis Rapid Test SYP-01、SYP-0298/79 Tuberculosis (TB) Rapid Test98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Nihon Kohden FDA Mandataire UE : NIHON KOHDEN EUROPE GmbH (Allemagne)	Inde, Japon	"D-dimer Calibrator DD-CAL" "D-dimer Control DD-QC" Celltac chemi D-dimer DD-421W Celltac chemi Rinse solution -RN-410VH Cleanac 3 MEK 620H3 réf. 9 autres CLEANAC MEK-5203 réf. Diluent2 réf. HEMATOLOGY CONTROL for reticulocyte MK-RE13 réf. HEMATOLOGY CONTROL+CRP MK-3CH3 réf. HEMOLYNAC 310- MK-310WH2 réf. HEMOLYNAC 5-MEK-910H2 réf. Hemolynac･310 MK-310W3 réf. Hemolynac･510 MK-510W ISOTONAC･3 MEK-6403 réf.	A, B, C IVDR	Présent sur le marché en France Site web information@db.nkc.co.jp Fiche EUDAMED Signaler une erreur
Ortho-Clinical Diagnostics Raritan Mandataire UE : Ortho-Clinical Diagnostics France (France)	États-Unis	ORTHO VISION Analyzer - BioVue VITROS2 réf. ORTHO VISION Max Analyzer – Certified VITROS2 réf. VITROS Anti-A1 Lectin (Anti-ABO4)98/79 VITROS Anti-C (Anti- RH2) (Monoclonal) BioClone98/79 VITROS Anti-c (Anti-RH4) (Monoclonal) BioClone98/79 9 autres VITROS Anti-D (RH1) IgM + IgG BioClone98/79 VITROS Anti-E (Anti-RH3) (Monoclonal) BioClone98/79 VITROS Anti-e (RH5) Monoclonal IgM Blend (human) BioClone for Slide, Tube and Microplate Tests98/79 VITROS ORTHO A2 Cells98/79 VITROS ORTHO HCV 3.0 ELISA Test System with Enhanced SAVe2 réf.98/79 VITROS ORTHO HCV 3.0 ELISA Test System with Enhanced SAVe (Sample Addition Verification)98/79 VITROS RESOLVE Panel B98/79 VITROS SELECTOGEN2 réf.98/79 VITROS SURGISCREEN2 réf.98/79	A IVDR, 98/79	Présent sur le marché en France Site web PRRC@quidelortho.com Fiche EUDAMED Signaler une erreur
Pluslife Mandataire UE : Kingsmead Service B.V. (Pays-Bas) et 3 autres	Chine	Influenza A/Influenza B/RSV Nucleic Acid Test Card98/79 Mini Dock PM001 MiniDock MTB Test MiniDock Ultra PM001 Ultra Mycobacterium Tuberculosis Nucleic Acid Assay Control2 réf. 9 autres Pluslife Dock Pro 8 PM008 Pluslife Mycoplasma Pneumoniae Card98/79 Pluslife RSV Card98/79 Pluslife SARS-CoV-2 Card SARS-CoV-2 Nucleic Acid Testing Card98/79 Pluslife SARS-CoV-2/Influenza A/Influenza B Card SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Test Card98/79 Pluslife Strep A Card98/79 SARS-CoV-2/Influenza A/Influenza B/RSV Nucleic Acid Assay Control98/79 SARS-CoV-2/Influenza A/Influenza B/RSV Nucleic Acid Test Card98/79 Strep A Nucleic Acid Assay Control CRM1010402-198/79	A, C IVDR, 98/79	Site web ra@pluslife.com Fiche EUDAMED Signaler une erreur
Remel Europe FDA Mandataire UE : Thermo Fisher Diagnostics B.V. (Pays-Bas)	United Kingdom (ex Northern Ireland)	PATHODX HERPES TYPING CONTROL SLIDES PATHODX HERPES TYPING KIT PATHODX STREP A GROUPING LATEX3 réf. PATHODX STREP GROUPING KIT PATHODX STREP GROUPING UNIVERSAL KIT2 réf. 9 autres ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay98/79 STREPTEX2 réf. STREPTEX LATEX A3 réf. STREPTEX RAPID Wellcogen H influenzae b98/79 Wellcogen N. meningitdis B/E.coli K198/79 Wellcogen N. meningitidis ACY W13598/79 Wellcogen S pneumoniae98/79 Wellcogen Strep B98/79	C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Sunbiote Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Imidazole Buffer Solution2 réf. UG1200 UG1210 UG2400 UG2410 9 autres UG2500 UG2510 UG500 UP1500 UP3000 UP5000 UP5500 UR6000 UR8000	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Ukinbio Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Automatic Biochemical Analyzer UKCA 2000 / UKCA 3000 / UKCA 6500 / UKCA 88003 réf. Fluorescence Immunochromatographic Analyzer iTest F100 / iTest F101 / iTest F800 / iTest F20003 réf. Glycohemoglobin Analyzer UKGH-20098/79 Glycohemoglobin Analyzer UKGH-31098/79 Hematology Analyzer Huma 300098/79 9 autres Hematology Analyzer Huma 3000s98/79 Hematology Analyzer Huma 500098/79 Hematology Analyzer Huma 5000s98/79 Hematology Analyzer Huma mini98/79 Hematology Testing Pack HT 300 / HT5002 réf. Microplate ELISA Reader UKMR 480 / UKMR 960 / UKMR 20003 réf. Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit (PCR- Fluorescence Probing ) TB001FD98/79 Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing) HPV002FD98/79 Real-Time PCR Fluorescent Quantitative Analyzer UKRT Qube / UKRT Mini / UKRT 320 / UKRT 9603 réf.	A IVDR, 98/79	sales@ukinbio.com Fiche EUDAMED Signaler une erreur
Álvarez Redondo	Espagne	Biocen 22 CE 146IVD2 réf. Bioprocen 22 R CE 223IVD2 réf. Consul 22 CE 226IVD3 réf. Consul 23 CE 269IVD3 réf. Cyto 1 CE 254IVD2 réf. 9 autres Cyto 22 CE 261IVD2 réf. Digicen 21 CE 110IVD3 réf. Digicen 22 CE 257IVD3 réf. Digtor 22 CE 228IVD3 réf. Dilitcen 22R CE 221IVD2 réf. Magnus CE 230IVD3 réf. MICROCEN 24 CE 202IVD Plasma 22 CE 156IVD Unicen 21 CE 126IVD2 réf.	A IVDR	Site web info@ortoalresa.com Fiche EUDAMED Signaler une erreur
3D Biomedicine Science & Technology FDA Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	100 Tests/kit3 réf.98/79 50 tests/kit2 réf.98/79 64 Tests/kit 64Test/Kit3 réf. 64Tests/kit2 réf. 8 autres 96A Automated Viral DNA/RNA Isolation Kit2 réf. ANDiS 350 ANDiS 360 ANDiS 396 ANDiS 500 ANDiS MTB Detection Kit 32tests/kit98/79 ANDiS MTB RIF/INH Resistance Detection Kit 300000000030698/79 Human Papillomavirus（HPV）DNA Diagnostic Kit 50 tests/kit98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Aptaca FDA	Italie	"24 ORE"DA 2500 ML TIPO BOTTI LIA IN PE CON ETICHETTA3 réf. Bottiglia per urine "24 ore" da 2.500ml, graduata, con tappo, tappino e manico3 réf. Cassetta inclusione arancione CASSETTE PER INCLUSIONE E SACCHETTI PER LA PROCESSAZIONE ISTOLOGICA - BASI MOULD NON STERILI3 réf. Ciotoline per Ciba Corning Express 550 e Plus, in PS, 0,8ml3 réf. CONT.COPROL. 60 ML 35X70 PP T/VITE NON INSERITO +ETICH.3 réf. 8 autres Contenitore feci 60 ml tappo rosso a vite e paletta3 réf. Contenitori per espettorato, da 60ml, PS, senza tappo, Ø60 x 34 mm3 réf. Coperchi per piastre per micrometodi3 réf. CUVETTE PER COAGULOMETRO tipo SIGMA® AMELUNG® KC4 DELTA™3 réf. Granuli separatori in PS confezione da 1 Kg Provette con anticoagulanti e separatori di siero non sterili3 réf. Piastre di Petri Ø 100 mm, con ventilazione, asettiche3 réf. PROVETTE CILINDR. 10 ML 16X100 PS GRAD. C/BORDO C/TAPPO Provette non sterili3 réf. Vetrino per sedimento urinario3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
CareDx FDA Mandataire UE : QbD RepS BV (Belgique)	Australie, Suède	AlloSeq Tx3 réf. AlloSeq Tx 17(24) Set A98/79 AlloSeq Tx 17(24) Set B98/79 AlloSeq Tx 17(96) Set A98/79 AlloSeq Tx 17(96) Set B98/79 8 autres AlloSeq Tx 9(96) Set A98/79 AlloSeq Tx 9(96) Set B98/79 Oelrup SSP98/79 Olerup QTYPE 112 réf.98/79 Olerup QTYPE LC480 II Cal Plate98/79 OLerup SSP167 réf.98/79 QTYPE2 réf. QTYPE Colour Compensation Plate	A, C IVDR, 98/79	Site web regulatory-au@gendx.com Fiche EUDAMED Signaler une erreur
CellPath FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	United Kingdom (ex Northern Ireland)	10% ACETIC ZINC FORMALIN 10% FORMAL SALINE - 120ml - CELLSTOR POT3 réf. CELLSTOR - 10L - 10% NEUTRAL BUFFERED FORMALIN3 réf. CELLSTOR – 20L – 100% NEUTRAL BUFFERED FORMALIN CONCENTRATE CELLWAX PLUS (P) - 4 x 2.5Kg3 réf. 8 autres CLARITEX COVERSLIPS No 1.0 22 x 22mm3 réf. DPX (PHTHALATE FREE) MOUNTING MEDIUM - 1L3 réf. EOSIN Y STAIN 1% (ALCOHOLIC) - 1L3 réf. HAEMATOXYLIN ‘Z’ STAIN – 1L3 réf. PAPANICOLAOU EA50 STAIN (ORTHO) - 1L3 réf. PAPANICOLAOU OG6 STAIN (ORTHO) - 1L3 réf. XMARK FIX - 250ML3 réf. XYLENE - 5L	A IVDR	Site web info@cellpath.com Fiche EUDAMED Signaler une erreur
Cube Dx	Autriche	GINA 5003 réf. hybcell Bacteria DNA xB98/79 hybcell Fungi DNA xB98/79 hybcell Pathogens DNA xB98/79 hyborg Dx RED22 réf. 8 autres IPC98/79 LINA PCR-Box Bacteria98/79 PCR-Box Bacteria 48rx-s98/79 PCR-Box Fungi98/79 PCR-Box Fungi 48rx-s98/79 PCR-Box IPC98/79 PCR-Box Resistance2 réf.98/79	A IVDR, 98/79	Site web info@cubedx.com Fiche EUDAMED Signaler une erreur
Diaglobal	Allemagne	Erythroctes Photometer98/79 Erythrocyten Diaglobal Photometer98/79 Erytrocten Eckküvetten98/79 Erytrocyten Kontrolle Diaglobal Photometer98/79 Haemoglobin HB 442A98/79 8 autres Hämatokrit Diaglobal Photometer98/79 Hämglobin Diaglobal Photometer98/79 Hämoglobin 2500 ml Flasche98/79 Hämoglobin 500 mL Flasche98/79 Hämoglobin Diaglobal Photometer2 réf.98/79 Hämoglobin Eck-Küvetten Photometer98/79 Hämoglobin Eckküvetten98/79 Hämoglobin Kontrolle Diaglobal Photometer98/79	– 98/79	Site web info@diaglobal.de Fiche EUDAMED Signaler une erreur
Eppendorf FDA	Allemagne	Centrifuge 5418 R Centrifuge 5418R Centrifuge 54202 réf. Centrifuge 5425 R Centrifuge 5425R3 réf. Centrifuge 5425; Centrifuge 5425R3 réf. Centrifuge 5427R3 réf. 8 autres Centrifuge 5430; Centrifuge 5430R3 réf. Centrifuge 5702R; Centrifuge 5702RH; Centrifuge 57023 réf. Centrifuge 5804; Centrifuge 5804R; Centrifuge 5810; Centrifuge 5810R3 réf. Centrifuge 5811 R3 réf. Centrifuge 5910Ri3 réf. Centrifuge 5920R3 réf. Centrifuge MiniSpin2 réf. SpinPro 6 R2 réf.	A IVDR	Présent sur le marché en France RA.Corporate@eppendorf.de Fiche EUDAMED Signaler une erreur
Hotgen FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	D-Dimer test (Chemiluminescence Immunoassay) Please see the IFU Dengue IgM/IgG Rapid test (Colloidal Gold) Please see the IFU2 réf. Glycosylated Hemoglobin test (Chemiluminescence Immunoassay) Please see the IFU Interferon Gamma Chemiluminescence Immunoassay Kit (CLIA) Please see the IFU98/79 Interferon-γ test (Chemiluminescence Immunoassay) Please see the IFU 8 autres Interleukin 10 Chemiluminescence Immunoassay Kit (CLIA) Please see the IFU98/79 Interleukin 1β Chemiluminescence Immunoassay Kit (CLIA) Please see the IFU98/79 Interleukin 2 Chemiluminescence Immunoassay Kit (CLIA) Please see the IFU98/79 Interleukin 8 Chemiluminescence Immunoassay Kit (CLIA) Please see the IFU98/79 Interleukin-6 test (Up-converting Phosphor Technology ) Please see the IFU98/79 Interleukin-6 test (Chemiluminescence Immunoassay) Please see the IFU One Step Syphilis Anti-TP Test (Colloidal Gold) Please see the IFU2 réf. Tumor Necrosis Factor Alpha Chemiluminescence Immunoassay Kit (CLIA) Please see the IFU98/79	B, C IVDR, 98/79	service@hotgen.com.cn Fiche EUDAMED Signaler une erreur
Ing. Petr Švec - PENTA s.r.o	Tchéquie	BOUIN ROZTOK DRABKIN ROZTOK DUSIČNAN STŘÍBRNÝ p.a. FORMALDEHYD 4% PUFROVANÝ pH 7,2-7,4 GIEMSA-ROMANOWSKI roztok 8 autres HAEMATOXYLIN EHRLICH HAEMATOXYLIN HARRIS HAEMATOXYLIN MAYER MAY-GRÜNWALD roztok MUCIKARMÍN WEIGERT ROZTOK ZKOUMADLO EOSINOVÝ ROZTOK ČERVEŇ KONGO indikátor	A IVDR	Site web info@pentachemicals.eu Fiche EUDAMED Signaler une erreur
Labex Canada Mandataire UE : Obelis s.a. (Belgique)	Canada	Labax Canada 5mL, 100mL, 1L Labax Canada Ready to use 6mL98/79 Labex Canada 100 tests/pouch Labex Canada 100mL Labex Canada 100tests/box4 réf. 8 autres Labex Canada 1L Labex Canada 3mL Labex Canada 5mL, 100mL, 1L Labex Canada Concentrated 1.0mL116 réf.98/79 Labex Canada LC-AS20 Labex Canada LC-AS88-E Labex Canada Ready to use 6mL113 réf.98/79 W01030709 Ready to use 6mL2 réf.98/79	A IVDR, 98/79	Site web info@labexcanada.com Fiche EUDAMED Signaler une erreur
Ortho-Clinical Diagnostics Summers Ridge San Diego Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	QuickVue Dipstick Strep A 25-Test Kit2 réf.98/79 QuickVue Dipstick Strep A 50-Test Kit2 réf.98/79 QuickVue In-Line Strep A Test3 réf.98/79 QuickVue Influenza A+B Test2 réf.98/79 QuickVue RSV98/79 8 autres Sofia 2 C. difficile FIA98/79 Sofia 2 Flu + SARS Antigen FIA98/79 Sofia Influenza A+B FIA2 réf.98/79 Sofia Legionella FIA98/79 Sofia RSV 25T2 réf.98/79 Sofia S. pneumoniae FIA98/79 Sofia SARS FIA98/79 Sofia Strep A+ FIA 25T2 réf.98/79	– 98/79	Site web PRRC@quidelortho.com Fiche EUDAMED Signaler une erreur
Redcell	Turquie	Bromelin Solution RCBS10 Cell ID 1198/79 Cell Reverse A1B98/79 Cell Screen 1-2-398/79 Comp / Cross98/79 8 autres Forward / Reverse98/79 Forward / Reverse Donor98/79 Forward AB Plus98/79 Forward ABO Patient98/79 LISS Diluent2 réf. Newborn98/79 Rh Phenotype98/79 Rh Phenotype Plus98/79	A IVDR, 98/79	Site web info@redcell.com.tr Fiche EUDAMED Signaler une erreur
Steellex Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	10010198/79 10×10ml98/79 10×2ml2 réf.98/79 10×5ml2 réf.98/79 L1 10×1ml98/79 8 autres L2 101mL98/79 R1:510ml R2:330ml98/79 R1:510ml R2:510ml98/79 R1:52ml R2:330ml98/79 R1:52ml R2:52ml2 réf.98/79 R1:54ml R2:54ml98/79 R1:55ml R2:330ml98/79 R1:55ml R2:5*5ml98/79	– 98/79	info@steellex.com Fiche EUDAMED Signaler une erreur
Yvsolab	Belgique	5 L ALCOOL ISO-PROPYLIQUE PUR / UN RECIPIENT EN PLASTIQUE 5 L ISOPROPANOL3 réf. 5 L FORMALDEHYDE 4 % / TAMPONNEE / PH NEUTRALE / RECIPIENT EN PLASTIQUE Formaldehyde 4% 5L3 réf. 5 L METHANOL PUR / UN RECIPIENT EN PLASTIQUE3 réf. 5 L TOLUENE PUR / UN RECIPIENT EN PLASTIQUE2 réf. 5 L XYLEEN ZUIVER / UN RECIPIENT IN PLASTIEK2 réf. 8 autres Formaldehyde 4% 10L Formaldehyde 4% 10ml Formaldehyde 4% 1L Formaldehyde 4% 30ml Formamdehyde 4% 60ml USI - YB - 10mlF4% USI - YC - 100mlF4% USI - YD - 30mlF4%	A IVDR	Site web info@yvsolab.be Fiche EUDAMED Signaler une erreur
Ailex Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	150Tests98/79 200Tests98/79 AH-600 Automated Glycohemoglobin Analyzer AH-600 Calibrator 1～2：2×0.1mL98/79 9 autres Calibrator 1～2：2×0.2mL98/79 Control1～2：2×0.2mL98/79 Control1～2：4×0.2mL98/79 Eluent1: 800mL×1bag98/79 Eluent2: 800mL×1bag98/79 Eluent3: 800mL×1bag98/79 Hemolysis & Wash Solution:2L×1bottle98/79 AILEX AS-1450 (plus commercialisé) AILEX AS-690 (plus commercialisé)	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Aikang MedTech FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Aigel Mini Automated Blood Grouping Analyzer Aigel Series6 réf. Automated Blood Grouping Analyzer Metis Series3 réf. Automated Chemiluminescence Immunoassay Analyzer Lumimate 300A Automatic Elisa Analyzer URANUS AE Series3 réf. 7 autres Blood group card centrifuge2 réf. Chemiluminescence Immunoassay Analyzer C 900 Chemiluminescence Immunoassay Analyzer CLIA-mate Series2 réf. Fluorescent Immunoanalyzer YFA 100 Full Automatic Sample Transfer Processing System AiStar 670, AiStar 7702 réf. Nucleic Acid Extracting System AiNA32 Nucleic Acid Extracting System AiNP 96	A IVDR	Fiche EUDAMED Signaler une erreur
Artronlab FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Canada	Acmex Hepatitis B Surface Antigen (HBsAg) Test Cassette2 réf. Acmex Hepatitis C Virus (HCV) Antibody Test Cassette2 réf. Acmex Human Immunodeficiency Virus 1/2 (HIV1/2) Antibody Test Cassette2 réf. Acmex Treponema Pallidum (TP) Antibody Test Cassette2 réf. Artron Dengue NS1 Antigen Test Cassette98/79 7 autres Artron Helicobacter Pylori (HP) Antibody Test cassette98/79 Artron Helicobacter pylori (HP) Antigen Test Cassette98/79 Artron Hepatitis B Virus Surface Antigen (HBsAg) Test Cassette98/79 Artron Hepatitis C Virus (HCV) Antibody Test cassette98/79 Artron Human lmmunodeficiency Virus 1/2 (HMl2l Antibody Test Cassette98/79 Artron One Step Treponema Pallidum (TP) Antibody Test Cassette2 réf.98/79 Artron One Step Treponema Pallidum (TP) Antibody Test Strip98/79	C, D IVDR, 98/79	Site web info@artronlab.com Fiche EUDAMED Signaler une erreur
Cofoe FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	blood glucose meter CGH09，CGH10，CGH11，CGH25，CGH302 réf. Blood Glucose Meter GKF-B0198/79 Blood Glucose Meter GKF-B01-C98/79 Blood Glucose Meter KF-A0298/79 Blood Glucose Meter KF-A02-C98/79 7 autres Blood Glucose Meter KF-A0498/79 Blood Glucose Meter KF-A04-C98/79 Blood Glucose Meter KF-A0698/79 Blood Glucose Meter KF-A06-C98/79 Blood Glucose Meter KF-A0898/79 Blood Glucose Meter KF-A08-C98/79 Blood glucose meter KF-B12, GKF-B01, KF-B06, KF-B07, KF-B09, KF-B102 réf.	C IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Drucker Diagnostics FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	Boost 4 IVD Centrifuge DASH Flex 6 IVD Centrifuge QBC AccuTube 100 Test Kit QBC Autoread Plus Dry Hematology Analyzer98/79 QBC Autoread Plus System - Dry Hematology Analyzer and Capillary Tube Centrifuge98/79 7 autres QBC Capillary Blood Tube, 100 Test Kit2 réf. QBC Capillary Centrifuge2 réf. QBC STAR98/79 QBC STAR Tube, 100 Test Kit2 réf. QBC STAR, Refurbished98/79 QBC Venous Blood Tube, 100 Test Kit2 réf. Refurbished QBC Autoread Plus Dry Hematology Analyzer98/79	A IVDR, 98/79	Site web regulatory@druckerdiagnostics.com Fiche EUDAMED Signaler une erreur
Eurotrol FDA	Pays-Bas	Hb 301 Control High98/79 Hb 301 Control Low98/79 Hb 301 Control Normal98/79 HemoTrol Duo High98/79 HemoTrol Duo Low98/79 7 autres HemoTrol Duo Normal98/79 HemoTrol High (Level 3)2 réf.98/79 HemoTrol Low (Level 1)2 réf.98/79 HemoTrol Normal (Level 2)2 réf.98/79 Plasma/Low Hb Control '1.0'98/79 Plasma/Low Hb Control '20.0'98/79 Plasma/Low Hb Control '5.0'98/79	– 98/79	Site web office@eurotrol.com Fiche EUDAMED Signaler une erreur
FlashDx Shenzhen Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Arbovirus Panel (ENA) ABVP8E-1098/79 Automated Nucleic Acid Detection System FlashDx-1000-E Automated PCR Analysis System FlashDx® sSPRT™ 4T3 réf. CRE Test CRE-P5-1098/79 GBS Test GBS-P1-1098/79 7 autres MRSA/SA Test B-MARSA-10NU98/79 Respiratory Panel 1.0 RP1-P10-1098/79 Respiratory Panel 1.1 RP-P10-1098/79 Respiratory Panel 2 RP2-P7-1098/79 SARS-CoV-2 Test CoV2-1098/79 SARS-CoV-2 Test CoV2-2098/79 SARS-CoV-2/FluA/FluB/RSV Test Cov2P4-1098/79	A IVDR, 98/79	info@flash-dx.com Fiche EUDAMED Signaler une erreur
Genesignbio Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne) et 1 autre	Chine	1 test/kit35 réf.98/79 25 tests/kit34 réf.98/79 GeneSign Chikungunya Antigen Rapid Test 1 test/kit98/79 GeneSign Chikungunya Antigen Rapid Test 25 tests/kit98/79 GeneSign Chikungunya IgG/IgM Rapid Test 1 test/kit98/79 7 autres GeneSign Chikungunya IgG/IgM Rapid Test 25 tests/kit98/79 GeneSign Dengue NS1/ZIKA/CHIKV Antigen Rapid Test 1 test/kit98/79 GeneSign Dengue NS1/ZIKA/CHIKV Antigen Rapid Test 25 tests/kit98/79 GeneSign HSV-I IgM/IgG Rapid Test 1 test/kit98/79 GeneSign HSV-I IgM/IgG Rapid Test 25 tests/kit98/79 GeneSign Malaria P.f/P.v Ab Rapid Test 1 test/kit98/79 GeneSign Malaria P.f/P.v Ab Rapid Test 25 tests/kit98/79	– 98/79	info@genesignbio.com Fiche EUDAMED Signaler une erreur
Hamiltoncompany FDA Mandataire UE : Johner Medical GmbH (Allemagne)	États-Unis	1000 µL Tips, Conductive, Filter, ISCC PLUS BioCir 757023 réf. 1ML VOL TIPS FLTR STRL (3840) 23594098/79 300UL CORE TIPS STACK STERI 23598598/79 300UL TIPS FLTR STERILE-5760 23593898/79 50UL CORE TIPS STACK STERI 23598798/79 7 autres CASE,COND,SING,1ML,FILT,STER 23526398/79 CASE,COND,SING,300UL,FILT,STER 23526198/79 CASE,COND,SING,50UL,FILT,STER 23526098/79 CO-RE TIPS(50UL)FIL STERILE 23597998/79 CO-RE TIPS,4 ML,FLTR STERILE 18402398/79 CO-RE TIPS,5 ML,STERILE 18402298/79 CT,1ML,FIL,3.20MM,MOD,STER 23584298/79	A IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
IBL International	Allemagne	Borrelia + VlsE IgG ELISA98/79 Borrelia 14kDa + OspC IgM ELISA98/79 Chagas (Trypanosoma cruzi) IgG ELISA98/79 Cholin IgG/IgM ELISA98/79 Fecal Helicobacter pylori-Antigen ELISA98/79 7 autres Haemophilus influenzae B IgG ELISA98/79 Helicobacter pylori IgA ELISA98/79 Helicobacter pylori IgG ELISA98/79 Helicobacter pylori IgM ELISA98/79 SaliCap Set2 réf. sInterleukin-2-Receptor ELISA TBE virus (FSME) IgG ELISA98/79	A, B IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Irvine Scientific FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	CHANG AMNIO 99473-100mL98/79 CHANG Marrow 91031-100mL98/79 CHANG Marrow 91031-500mL98/79 CHANG Medium 91004-100mL98/79 CHANG MEDIUM 91004-500mL98/79 7 autres CHANG MEDIUM 91005-100mL98/79 CHANG MEDIUM 99404-100mL98/79 CHANG MEDIUM C100-90mL98/79 CHANG MEDIUM C106-14mL98/79 CHANG MEDIUM T105-100mL98/79 CHANG MEDIUM T105-500mL98/79 COLCEMID 9311-10mL98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Leica Microsystems CMS FDA	Allemagne	DM IL LED3 réf. DM10002 réf. DM20002 réf. DM25002 réf. DM30002 réf. 7 autres DM4 B2 réf. DM6 B2 réf. DMi13 réf. DMi83 réf. LMD7 MATEO TL IVD GLOBAL VISORIA B IVD GLOBAL	A IVDR	Fiche EUDAMED Signaler une erreur
Lingen Precision Medical Products (Shanghai) Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Labtub3 réf. Labtub Clot activator and Separate Gel3 réf. Labtub EDTA and Sodium Fluoride2 réf. Labtub K2EDTA3 réf. Labtub K2EDTA/Separate Gel2 réf. 7 autres Labtub K3EDTA3 réf. Labtub Lithium Heparin3 réf. Labtub Lithium Heparin/Separate Gel Labtub No additive2 réf. Labtub Sodium Citrate (1:4) Labtub Sodium Citrate (1:9)3 réf. Labtub Sodium Heparin2 réf.	A IVDR	Présent sur le marché en France info@labtub.com Fiche EUDAMED Signaler une erreur
Medical Scientific Equipment	France	Blue Force 12L R 400V/50-60Hz BF12 HAWK Laboratory Centrifuge Cellsep 6/720R 230V/50-60Hz Laboratory Centrifuge Falcon 6/300 230V/50Hz Laboratory Centrifuge Falcon 6/300R 230V/50Hz 7 autres Laboratory Centrifuge Harrier 230V/50Hz Laboratory Centrifuge Harrier R 230V/50Hz Laboratory Centrifuge Hawk R 230V/50Hz Laboratory centrifuge Kestrel CENTRIFUGE IVD AC Laboratory Centrifuge MicroCentaur R 230V/50Hz Laboratory Centrifuge Owl 110-220V/50-60Hz MICROCENTAUR	A IVDR	Présent sur le marché en France Site web info@mse-sas.fr Fiche EUDAMED Signaler une erreur
Microbio Mandataire UE : Qualrep Services B.V. (Pays-Bas)	Australie	InfectID-BSI B1 Bacterial Detection Kit MRB50098/79 InfectID-BSI B2 Bacterial Detection Kit MRB60098/79 InfectID-BSI B3 Bacterial Detection Kit MRB70098/79 InfectID-BSI B4 Bacterial Detection Kit MRB80098/79 InfectID-BSI B5 Bacterial Detection Kit MRB90098/79 7 autres InfectID-BSI B6 Bacterial Detection Kit MRB100098/79 InfectID-BSI Bacterial and Yeast Assay Kit MRB130098/79 InfectID-BSI Bacterial and Yeast Assay Kit MRB1300.598/79 InfectID-BSI Bacterial and Yeast Combined Detection Kit MRB40098/79 InfectID-BSI Y1 Yeast Detection Kit MRB140098/79 InfectID-BSI Y2 Yeast Detection Kit MRB120098/79 InfectID-BSI Y3 Yeast Detection Kit MRB150098/79	– 98/79	Site web info@microbio.com.au Fiche EUDAMED Signaler une erreur
Nasmeddiagnostic Mandataire UE : AF Pharma Service Europe SL (Espagne)	Inde	Blood Collection Tube - ACD (Acid Citrate Dextrose) Blood Collection Tube - Clot Activator3 réf. Blood Collection Tube - Gel+ Clot Activator3 réf. Blood Collection Tube - K2 EDTA3 réf. Blood Collection Tube - K3 EDTA3 réf. 7 autres Blood Collection Tube - Lithium Heparin3 réf. Blood Collection Tube - No Additives3 réf. Blood Collection Tube - Sodium Citrate 3.2%3 réf. Blood Collection Tube - Sodium Citrate 3.8%3 réf. Blood Collection Tube - Sodium Fluoride3 réf. Blood Collection Tube - Sodium Heparin (Vacuum) (2ML)(PET)3 réf. Blood collection tube -Plethora Cell- Free DNA tubes (Vacuum)	A IVDR	Fiche EUDAMED Signaler une erreur
One Lambda FDA Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	AllType NGS Library Prep Kit3 réf. AllType™ FASTplex™ NGS 11 Kit (Box 2 of 2) ALL-FAST11LF2 réf. AllType™ FASTplex™ NGS 11 Loci Kit – 48 (Box 1 of 2) ALL-FAST11L C1qScreen Class I Positive Control C1qScreen™ C1q3 réf. FlowPRA™ Class I Positive Control3 réf. 7 autres HybriType™ HLA Plus 18 Loci Flex Kit – 4 Enrichments HYB18LF3 réf. LABScreen™ MICA Single Antigen - Group 13 réf. LABScreen™ Multi LABType™ CWD Class I A Locus Typing Test - 20 tests3 réf. LABType™ SSO Class I A Locus Typing Test3 réf. LinkSēq HLA-ABC 384 Typing Kit3 réf. SeCore GSSP3 réf.	C IVDR	Site web Fiche EUDAMED Signaler une erreur
Reagen Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	COVID-19 & Influenza A/B Antigen Combo Test Kit98/79 Eleven Respiratory Pathogens Antigen Rapid Test Kit 20T98/79 Eleven Respiratory Pathogens Antigen Rapid Test Kit （NPS) 20T98/79 Nine Respiratory Pathogens Antigen Rapid Test Kit 1T98/79 Nine Respiratory Pathogens Antigen Rapid Test Kit 20T98/79 7 autres SARS-CoV-2/RSV&Flu A/B Antigen Rapid Test Kit 1T98/79 SARS-CoV-2/RSV&Flu A/B Antigen Rapid Test Kit 20T98/79 SARS-CoV-2/RSV/ADV/MP&Flu A/B Antigen Rapid Test Kit 1T98/79 SARS-CoV-2/RSV/ADV/MP&Flu A/B Antigen Rapid Test Kit 20T98/79 Ten Respiratory Pathogens Antigen Rapid Test Kit 1T98/79 Ten Respiratory Pathogens Antigen Rapid Test Kit 20T98/79 Twelve Respiratory Pathogens Antigen Rapid Test Kit 1T98/79	– 98/79	Site web info@reagenus.com Fiche EUDAMED Signaler une erreur
RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi	Turquie	RTA CMV Real Time PCR Kit2 réf.98/79 RTA CMV Real Time PCR Kit, v2.03 réf.98/79 RTA HBV Real Time PCR Kit 25 tests/ kit98/79 RTA HBV Real Time PCR Kit v2.03 réf.98/79 RTA HCV Real Time PCR Kit2 réf.98/79 7 autres RTA HCV Real Time PCR Kit, v2.03 réf.98/79 RTA HIV-1 Real Time PCR Kit2 réf.98/79 RTA HIV-1 Real Time PCR Kit v2.03 réf.98/79 RTA MB VIRAL NUCLEIC ACID ISOLATION KIT (12 Tests) 12 Tests/ Kit, 24 Tests/ Kit, 48 Tests/ Kit3 réf. RTA TOTAL NUCLEIC ACID EXTRACTION KIT 16 Tests/ Kit, 48 Tests/ Kit, 96 Tests/ Kit3 réf. RTA VIRAL NUCLEIC ACID ISOLATION KIT (100 TESTS) 50 tests/ kit, 100 tests/ kit2 réf. RTA VIRAL RNA ISOLATION KIT (100 TESTS) 50 Tests, 100 Tests2 réf.	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Sakura Seiki Mandataire UE : Sakura Finetek Europe B.V. (Pays-Bas)	Japon	Cyto-Tek CF-12E Histo-Tek VP1 Tissue-Tek AutoTEC AutoTEC a120 Tissue-Tek Film Film-E2 Tissue-Tek Genie 7 autres Tissue-Tek Glas g2-E2 Tissue-Tek Prisma Prisma-P-ED Tissue-Tek Prisma Prisma-P-ES Tissue-Tek TEC 6-CM-E2 Tissue-Tek TEC 6-EM-E2 Tissue-Tek VIP VIP 6 AI-E2 Tissue-Tek Xpress Xpress x120	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Shanghai BioGerm Medical Technology Mandataire UE : MedNet EC-REP GmbH (Allemagne) et 2 autres	Chine	6-in-1 Respiratory Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/kit98/79 Diagnostic Kit for 2019-nCoV Antigen (Colloidal Gold) 20 Tests/kit98/79 Diagnostic Kit for 2019-nCoV Antigen (Colloidal Gold) 50 Tests/kit98/79 Influenza A/B & RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 tests/kit Sampling tube with 0.75mL Lysis Buffer98/79 Influenza A/B & RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 tests/kit Sampling tube with 2.5mL Lysis Buffer98/79 7 autres Influenza A/B Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/kit98/79 Norovirus Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/kit98/79 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/ kit98/79 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 96 tests/ kit98/79 Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 Tests/Kit;2 réf.98/79 Nucleic acid extraction and purification kit 96 tests/ kit2 réf. Respiratory Syncytial Virus/HumanParainfluenza Virus /Human Rhinovirus Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 tests/kit98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Widufit	Allemagne	D-dimers Rapid Test WIB-DIM-K98/79 STREP A Rapid Test WIB-SA-K98/79 STREP A Rapid Test WIB-SA-S98/79 STREP B Rapid Test B-SB98/79 STREP B Rapid Test B-SB-K98/79 7 autres STREP B Rapid Test B-SB-S98/79 STREP B Rapid Test WIB-SB-K98/79 STREP B Rapid Test WIB-SB-S98/79 WiduMed D-Dimer Test2 réf.98/79 WiduMed Strep A Kassettentest98/79 WiduMed Strep A Streifentest98/79 WiduMed Strep B Kassettentest98/79	– 98/79	Site web info@widufit.de Fiche EUDAMED Signaler une erreur
Xi An Tianlong Science Technology FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Aurora PANA X6 Genesy Gentier 48E, Gentier 48R, Gentier 96E, Gentier 96T, Gentier 96R, Gentier Mini, Gentier mini+, Gentier X3E, Gentier X3R, Gentier X3S, Gentier X3C, FLUORITE, PowerAmp96™ Dx3 réf. Gentier Sp96E, Gentier Sp96R, Gentier Sp96X, Gentier Sp96V, Gentier Sp384E, Gentier Sp384R3 réf. iGenebox 3A 7 autres Npex 96 Nucleic Acid Extraction System Libex, GeneRotex 24, GeneRotex 48, GeneRotex 96, GeneFlex 16, GeneFlex 32, GeneFlex 48, GeneFlex 96, GeneFlex 192, Npex 192, PowerEXP™ 323 réf. PANA 9600S, PANA 9600X, PANA 3200S, PANA 3200S+3 réf. Panall 8000 Panall X1600 Rhodonite VIRPLEX 8 VX8S	A IVDR	Fiche EUDAMED Signaler une erreur
Adaltis	Italie	AMPLIlab98/79 EIAgen Detect HIV Combo Kit ++M52108131C98/79 EIAgen HBsAg Kit98/79 EIAgen HCV Ab (v.4) Kit ++M52107106LG98/79 EIAgen Syphilis Ab Kit98/79 6 autres eLab98/79 EXTRALAB98/79 MDXlab98/79 MOLgen Universal Extraction Kit98/79 NEXgen98/79 PLab (Personal LAB)98/79	– 98/79	Présent sur le marché en France Site web info@adaltis.net Fiche EUDAMED Signaler une erreur
Beijing Lepu Medical Technology Mandataire UE : Lepu Medical (Europe) Cooperatief U.A. (Pays-Bas)	Chine	Blood Glucose Monitoring Meters Poctor 80098/79 CFMS LEPU-8800 CFMS LEPU-8880 Colloidal Gold Immunochromatograpic Assay Analyzer LEPU Quant 800 COX-1 Platelet Aggregation Test Reagent Card (Turbidimetry) 10 tests/kit98/79 6 autres Dry Biochemical Analyzer MBM001 P2Y12 Receptor Platelet Aggregation Test Reagent Card (Turbidimetry) 10 tests/kit98/79 Real-Time PCR System Lepgen-96 SARS-COV-2 Antigen Rapid Tests for Self-Testing CG361098/79 Urine Analyzer UAM1411 Urine Analyzer UAM1412	A IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Biochemical Systems International	Italie	Aria Blood Glucose Systems Kit - English98/79 Aria Glucometer98/79 Aria Kit98/79 Aria Kit - Italiano98/79 OGCare Glucometer - ITA98/79 6 autres OGCare Kit98/79 OGCare Kit (mmol/L) - ENG98/79 OGCare Kit (mmol/L) - HU98/79 OGCare Kit - ENG98/79 OGCare Kit - Free Sample - Kit98/79 OGCare Kit - GRK98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Biocomma Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Biocomma BNP027-5E Biocomma CC01E Biocomma NAES-32 Biocomma NAES-48 Biocomma NAES-96 6 autres Biocomma NAES-96Plus Biocomma NAES-DC48 Biocomma NAES-DC96 Biocomma NAES-N96 Biocomma Type A (contain preservation medium)3 réf. Biocomma XSB001E3 réf.	A IVDR	Site web sales@biocomma.cn Fiche EUDAMED Signaler une erreur
BioFire Diagnostics FDA Mandataire UE : bioMérieux SA (France)	États-Unis	BIOFIRE FILMARRAY GI1.1 Panel2 réf. BioFire® Blood Culture Identification 2 (BCID2) Panel2 réf. BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel BioFire® Joint Infection (JI) Panel2 réf. BioFire® Respiratory Panel 2.1 plus (RP2.1 plus) 6 autres BIOFIRE® FILMARRAY® Pneumonia Panel plus2 réf. FilmArray® 2.0 Instrument FilmArray® Gastrointestinal (GI) Panel2 réf. FilmArray® Meningitis/Encephalitis (ME) Panel2 réf. FilmArray® Torch System2 réf. SpotFire®2 réf.	A, B, C, D IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Guangzhou Improve Medical Instruments FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	ESR-30 IMPROMINI® Blood Collection Tube Citrate 9NC 1.0 mL IMPROMINI® Capillary Blood Collection Tube Clot Activator Tube;Gel & Clot Activator Tube4 réf. IMPROMINI® Capillary Blood Collection Tube Lithium Heparin Tube;Sodium Heparin Tube;Glucose Tube;EDTA.K2 Tube;EDTA.K3 Tube;Gel& EDTA.K2 Tube;Gel & Lithium Heparin Tube;Gel& Sodium Heparin Tube6 réf. IMPROVACUTER® Evacuated Blood Collection Tube Cell Free DNA Tube 6 autres IMPROVACUTER® Evacuated Blood Collection Tube Clot Activator Tube;Gel & Clot Activator Tube8 réf. IMPROVACUTER® Evacuated Blood Collection Tube EDTA.K2 Tube;EDTA.K3 Tube;Citrate Tube or Trisodium Citrate Tube;ESR Tube;Sodium Heparin Tube;Lithium Heparin Tube;Glucose Tube;Fluoride/Oxalate Tube ;Gel & EDTA.K2 Tube;Gel & Lithium Heparin Tube;Gel & Sodium Heparin Tube32 réf. IMPROVACUTER® Evacuated Blood Collection Tube No Additive Tube4 réf. IMPROVACUTER® Evacuated Blood Collection Tube Thrombin tube;Gel & Thrombin tube3 réf. IMPROVACUTER® Urine Collection Tube UA No Additive Tube2 réf. IMPROVACUTER® Urine Collection Tube UA Preservative Tube;Urine Culture Preservative Tube3 réf.98/79	A IVDR, 98/79	ra@improve-medical.com Fiche EUDAMED Signaler une erreur
Hangzhou Zhunxin Biotechnology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	HA-00298/79 HA-00898/79 HA-01098/79 HA-01198/79 HA-01298/79 6 autres HA-01698/79 HA-01798/79 HA-01998/79 HA-02298/79 HA-02398/79 Nucleic Acid Amplification Analyzer AIMDX 1800	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Jiangsu Rongye Technology FDA Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Blood collection tubes Coagulant Blood collection tubes Heparin Lithium RY-BCT-07 Blood collection tubes Heparin Sodium RY-BCT-06 Blood collection tubes K2-EDTA Blood collection tubes K3-EDTA 6 autres Blood collection tubes No additive RY-BCT-01 Blood collection tubes Potassium oxalate / sodium fluoride RY-BCT-09 Blood collection tubes Potassium oxalate RY-BCT-08 Blood collection tubes Separation gel RY-BCT-11 Blood collection tubes Trisodium citrate(4:1) Blood collection tubes Trisodium citrate(9:1)	A IVDR	Fiche EUDAMED Signaler une erreur
Ldbio Diagnostics	France	ASPERGILLUS ICT IgG-IgM2 réf.98/79 ASPERGILLUS WB IgG3 réf.98/79 CHAGAS WB IgG3 réf.98/79 ECHINOCOCCUS WB IgG3 réf.98/79 FASCIOLA ES WB IgG3 réf.98/79 6 autres LDBIO TOXO II IgG3 réf. LDBIO TOXO II IgM3 réf. LEISHMANIA WB IgG3 réf.98/79 SCHISTO II WB IgG3 réf.98/79 SCHISTOSOMA ICT IgG-IgM2 réf.98/79 TOXOPLASMA ICT IgG-IgM2 réf.98/79	C IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Lordsmark Mandataire UE : Obelis s.a. (Belgique)	Inde	LordsMed 3 Part Haematology Analyser LM001 LordsMed 5-Part Auto Hematology Analyzer LM002 LordsMed CLIA Reader LM007 LordsMed Diluent LM008 LordsMed Fully Auto Biochemistry Analyzer (200 TPH) LM005 6 autres LordsMed Fully Auto Biochemistry Analyzer (400 TPH) LM004 LordsMed Lyse LM010 LordsMed Probe Cleaner LM011 LordsMed Rinse LM009 LordsMed Semi Auto biochemistry Analyzer LM003 LordsMed Urine Analyser LM006	A IVDR	Site web Fiche EUDAMED Signaler une erreur
MagBio Genomics FDA Mandataire UE : CEpartner4U (Pays-Bas)	États-Unis	HighPrep PCR - DX (1 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (100 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (1000 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (250 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (5 mL) Device for post-PCR and post-enzymatic reaction clean-up 6 autres HighPrep PCR - DX (50 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (500 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep Viral DNA & RNA Kit - DX (20 preps) Kit for viral RNA and DNA isolation HighPrep Viral DNA & RNA Kit - DX (384 preps) Kit for viral RNA and DNA isolation HighPrep Viral DNA & RNA Kit - DX (3840 preps) Kit for viral RNA and DNA isolation HighPrep Viral DNA & RNA Kit - DX (96 preps) Kit for viral RNA and DNA isolation	A IVDR	Site web info@magbiogenomics.com Fiche EUDAMED Signaler une erreur
Medite FDA	Allemagne	ACS 7203 réf. COP 303 réf. COT 20.0003 réf. Cryostat M6303 réf. Heated Forceps, 0.5 mm3 réf. 6 autres Microtome A5503 réf. OTS 40.15203 réf. TDO Sahara3 réf. TES 99.23 réf. TPC 15.400 DUO3 réf. USE 332 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Milestone FDA	Italie	10-GL-22-15 FLASHFREEZE3 réf. BNS R16MC DecalMATE KIT3 réf. BPSPADS4mmBK MAGNUS3 réf. DREAMBLADES 35HH HISTODREAM M3 réf. EGROSS PRO-X3 réf. 6 autres FineFIX2 réf. FineFIX Module3 réf. FORMALIN2 réf. GPR/K KOS3 réf. HISTODREAM CM HISTODREAM EW3 réf. HISTODREAM S3 réf.	A IVDR	Site web marketing@milestonemedsrl.com Fiche EUDAMED Signaler une erreur
Nhs FDA Mandataire UE : Quality First International OÜ (Estonie)	United Kingdom (ex Northern Ireland)	PR01298/79 PR01498/79 PR01598/79 PR02298/79 PR03398/79 6 autres PR03498/79 PR03598/79 PR03698/79 PR04498/79 PR04598/79 PR04698/79	– 98/79	Fiche EUDAMED Signaler une erreur
PRIMA Lab Mandataire UE : QbD RepS BV (Belgique)	Suisse	800062-x98/79 Autotest Helicobacter pylori98/79 Autotest HIV 1/298/79 Dr. Max Helicobacter pylori test 800017-x98/79 GetTested HIV TEST98/79 6 autres GetTested STREP A TEST98/79 HIV 1/2 SELF-TEST98/79 Horny Hive HIV Selbsttest98/79 PRIMA HOME TEST HIV 1/2 SELF-TEST98/79 TEST AUTODIAGNOSTICO HELICOBACTER PYLORI98/79 Veneris Test rapid HIV 1&298/79	– 98/79	quality@primahometest.com Fiche EUDAMED Signaler une erreur
Sanquin Reagents FDA	Pays-Bas	Anti-Fyb AGT method98/79 Anti-s AGT method98/79 Anti-Wra AGT method98/79 Cellbind A1 reagent red cells98/79 Cellbind B reagent red cells98/79 6 autres Cellbind DILUENT Makropanel 1698/79 PeliControl98/79 Pelikloon anti-D enhanced (lgM)monoclonal98/79 Pelikloon anti-e (IgM) monoclonal98/79 Pelikloon anti-Fya (IgG) monoclonal AGT method98/79	A IVDR, 98/79	Site web info@essange-reagents.nl Fiche EUDAMED Signaler une erreur
Shenzhen YOUYI Bioscience Mandataire UE : Medunion S.L. (Espagne) et 1 autre	Chine	EUYI 16 HPV genotypes Detection kit R4898/79 EUYI Cyto-Preservative Solution YY05 EUYI High-Risk HPV Test R4898/79 EUYI HPV Genotyping Kit Plus R2598/79 EUYI HPV Genotyping Kit R2598/79 6 autres EUYI IP-10 Rapid Test for MTB R4898/79 EUYI MTB DNA Test R4898/79 EUYI Nucleic Acid Extraction Reagent (Manual method)2 réf. EUYI p16/Ki-67 Dual Staining kit (immunocytochemical method) YY014 réf. EUYI Pap Staining Kit2 réf. Molecular Hybridizer MH48	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Slee FDA	Allemagne	Covertec CUT 4062 CUT 5062 CUT 6062 MPS 1 6 autres MPS C MPS CX MPS P MPS W MTP Paraffin Wax Embedding Centre MPS P2	A IVDR	Fiche EUDAMED Signaler une erreur
Vellap	Allemagne	Cleartest D-Dimer98/79 Cleartest Influenza A+B98/79 Cleartest Strep A2 réf.98/79 IDEAL Influenza A+B98/79 IDEAL Strep A98/79 6 autres TOP D-Dimer C3 0501-5-MTU98/79 TOP Strep A2 réf.98/79 VELLAP D-Dimer3 réf. VELLAP Influenza A/B98/79 VELLAP Legionella98/79 VELLAP Strep A98/79	C IVDR, 98/79	info@vellap.de Fiche EUDAMED Signaler une erreur
Vitromed FDA	Allemagne	- V-ROUNDTUBE2 réf.98/79 V- CULTUREDISH3 réf.98/79 V-4 WELLDISH98/79 V-CENTERWELL98/79 V-CONICALTUBE98/79 6 autres V-ICSIDISH98/79 V-SEROLOGICAL Pipet3 réf.98/79 V-SPERM MOPRHO SLIDE V-TIP V-TIP-100098/79 V-TIP V-TIP-20098/79 V-TRANSFER PIPET98/79	A IVDR, 98/79	Site web info@vitromed.com Fiche EUDAMED Signaler une erreur
Wwhsbio Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	25Tests/kit98/79 Diagnostic Kit for D-Dimer (Immunochromatographic assay) 20Tests/Kit98/79 Diagnostic Kit for D-Dimer（Immunochromatographic assay） 25Tests/Kit98/79 Diagnostic Kit for Interleukin-6 (Immunochromatographic assay) 20Tests/Kit98/79 Diagnostic Kit for Interleukin-6（Immunochromatographic assay） 25Tests/Kit98/79 6 autres Dry Fluoroimmunoassay Analyzer NIR-1000 Dry Fluoroimmunoassay Analyzer NIR-2000 Helicobacter Pylori（HP）Antigen Rapid Quantitative Test（Fluorescence Immunoassay） 25Tests/Kit98/79 Helicobacter Pylori（HP）IgG Antibody Rapid Quantitative Test（Fluorescence Immunoassay） 25Tests/Kit98/79 Influenza A/B（Flu A/B）Antigen Rapid Test Kit（Colloidal Gold） 25Tests/Kit98/79 SARS-CoV-2 Antigen Rapid Test Kit（Colloidal Gold） 25Tests/Kit98/79	A IVDR, 98/79	Présent sur le marché en France Site web info@wwhsbio.com Fiche EUDAMED Signaler une erreur
Zetmedikal	Turquie	SARS-CoV-2 IgG/IgM Rapid Antibody Test98/79 SOFTEC Dengue NS1 Rapid Test Kit98/79 SOFTEC Dengue NS1/IgG/IgM Combo Rapid Test Kit SFDNCB4098/79 SOFTEC H.Pylori Antigen test98/79 SOFTEC Hepatitis E Virus (HEV) IgG/IgM Rapid Test Kit SFHEV4098/79 6 autres SOFTEC Magic-Auto Whole Blood DNA/RNA Isolation Kit ZT-MAWB98/79 SOFTEC Malaria P.f/P.v Rapid Test Kit98/79 SOFTEC SARS-CoV-2 Antigen Rapid Test (Nasal Swab)98/79 SOFTEC SARS-CoV-2 Neutralizing Antibody Rapid Test98/79 SOFTEC Syphilis Rapid Test Kit (Cassette) SFSPRT4098/79 SOFTEC Tuberculosis Rapid Test Kit SFTB4098/79	– 98/79	Site web info@zetmedikal.com Fiche EUDAMED Signaler une erreur
General Life Biotechnology FDA Mandataire UE : MDSS GmbH (Allemagne)	Taïwan	BeneCheck Blood Glucose Monitoring System VSG010-298/79 BeneCheck Blood Glucose Monitoring System VSG01D-298/79 BeneCheck Hb Hemoglobin Control Solution BK-CSH3098/79 BeneCheck Hb Hemoglobin Control Solution BK-CSH3198/79 BeneCheck Hb Hemoglobin Control Solution BK-CSH3298/79 7 autres BeneCheck Hb Hemoglobin Test Strip BK-H298/79 BeneCheck Supreme Blood Glucose Monitoring System BX-SG0098/79 BeneCheck Supreme Blood Glucose Monitoring System BX-SG0D98/79 BeneCheck Uni Blood Glucose Monitoring System BSG010-298/79 BeneCheck Uni Blood Glucose Monitoring System BSG01D-298/79 BeneCheck Plus Pro Glucose Monitoring System BKM21-2-A98/79 (plus commercialisé) BeneCheck Plus pro Glucose Monitoring System BKM21-2-B98/79 (plus commercialisé)	– 98/79	Site web service@glbiotech.com.tw Fiche EUDAMED Signaler une erreur
Aaz Productions Le Materiel Biomedical	France	ALL IN QUADRIPLEX®98/79 autotest COVID-VIRO ALL IN®5 réf.98/79 autotest COVID-VIRO®9 réf.98/79 autotest VIH® 2nd GENERATION3 réf. COV-GRIP98/79 5 autres COVID-VIRO98/79 SYPHILIS ALL IN® TR-SYP-00198/79 TetaQuick98/79 TROD'ANGINE2 réf.98/79 TROD'DENGUE98/79	D IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Abacus Diagnostica	Finlande	GenomEra HSV 1/2, VZV + EV Assay Kit CDX-1702 réf.98/79 GenomEra Norovirus Assay kit CDX-1002 réf.98/79 GenomEra® C. difficile Assay Kit CDX-403 réf.98/79 GenomEra® C. difficile Control Set CDX-20-56198/79 GenomEra® GBS Assay Kit CDX-602 réf.98/79 5 autres GenomEra® MRSA/SA AC Assay Kit CDX-30-052 réf.98/79 GenomEra® MRSA/SA Multi Swab Assay Kit CDX-30-0298/79 GenomEra® S. pneumoniae Assay Kit CDX-702 réf.98/79 GenomEra® SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit CDX-1602 réf.98/79 GenomEra® SARS-CoV-2, Flu A/B + RSV Assay Kit CDX-1402 réf.98/79	– 98/79	info@abacusdiagnostica.com Fiche EUDAMED Signaler une erreur
Abiores Technology (Beijing) Mandataire UE : Medunion S.L. (Espagne) et 2 autres	Chine	(MP) Mycoplasma Pneumoniae Test Strip & Cassette98/79 Blood Glucose Test Meters S915598/79 Influenza A Virus and Influenza B Virus RNA Diagnostic Kit (Fluorescence PCR) Cassette98/79 Monkeypox Virus Ag Test Strip & Cassette AB331-2098/79 Monkeypox Virus Fluorescence PCR Kit Cassette98/79 5 autres Monkeypox Virus Fluorescence PCR Kit（Direct qPCR） Cassette98/79 Monkeypox Virus IgM/IgG Ab Test Strip & Cassette AB330-2098/79 Respiratory Syncytial Virus RNA Diagnostic Kit (Fluorescence PCR) Cassette98/79 SARS-CoV-2(COVID-19) Fluorescence PCR Kit Cassette98/79 ZiKA IgG/IgM Test Strip & Cassette AB220-2098/79	– 98/79	Fiche EUDAMED Signaler une erreur
Biobase Diagnostic Technology (Shandong) Mandataire UE : Luxus Lebenswelt GmbH (Allemagne)	Chine	Automatic Chemiluminescence Immunoassay Analyzer3 réf. Biobase COVID-19 Antigen Rapid Test 20 Tests/kit98/79 Biobase COVID-19 Antigen Rapid Test 25 Tests/kit98/79 Cleaning Liquid DR1101 Monkeypox Virus Real Time PCR Kit 50 rxns/kit98/79 5 autres Nucleic Acid Extraction Kit ZD001 Sample Diluent Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay） 100 Tests/kit98/79 Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay） 200 Tests/kit98/79 Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay） 50 Tests/kit98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
BioChain (Beijing) Science & Technology Mandataire UE : Medunion S.L. (Espagne)	Chine	1 test/kit98/79 10 tests/kit2 réf.98/79 100 tests/kit98/79 20 servings / box2 réf.98/79 20 tests/kit2 réf.98/79 5 autres 24 Tests/Kit2 réf.98/79 5 tests/kit2 réf.98/79 50 tests/kit98/79 GD-020 METHYSMART-12S	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Chengdu Puth Medical Technology Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Vacuum Blood Colection Tube Gel Tube3 réf. Vacuum Blood Collection Tube 4NC Tube3 réf. Vacuum Blood Collection Tube 9NC Tube3 réf. Vacuum Blood Collection Tube ACD Tube3 réf. Vacuum Blood Collection Tube Clot activator Tube3 réf. 5 autres Vacuum Blood Collection Tube EDTA Tube3 réf. Vacuum Blood Collection Tube Heparin Tube3 réf. Vacuum Blood Collection Tube No additive Tube3 réf. Vacuum Blood Collection Tube PPT Tube3 réf. Vacuum Blood Collection Tube Sodium fluoride Tube3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Engelbrecht	Allemagne	AUTOMAT-STAR Deckgläser 24x60a1,0 mm rein-weiß, Stärke 1 (0,13-0,17 mm)3 réf. CellPot 1000ml gefüllt mit Formaldehyd 4% phosphatgepuffert, Etikett mit Gefahrensymbolen aufgeklebt Probengefäße gefüllt mit Formaldehyd 4% phosphatgepuffert, Etikett mit Gefahrensymbolen aufgeklebt3 réf. Innenröhrchen 100x16 mm gefüllt mit Formaldehyd 4% phosphatgepuffert, Etikett mit Gefahrensymbolen aufgeklebt Probengefäß gefüllt mit Formaldehyd 4% phosphatgepuffert, Etikett mit Gefahrensymbolen aufgeklebt3 réf. Objektträger Beschriftungsfeld BLAU, Ecken 45° geschliffen3 réf. Objektträger Mattrand 15 mm, Kanten geschnitten3 réf. 5 autres Probengefäß 76x21 mm gefüllt mit Formaldehyd 4% phosphatgepuffert, Etikett mit Gefahrensymbolen aufgeklebt Probengefäße gefüllt mit Formaldehyd 4% phosphatgepuffert, Etikett mit Gefahrensymbolen aufgeklebt2 réf. Schraubdose 100 ml gefüllt mit Formaldehyd 4% phosphatgepuffert, Etikett mit Gefahrensymbolen aufgeklebt Schraubdose gefüllt mit Formaldehyd 4% phosphatgepuffert, Etikett mit Gefahrensymbolen aufgeklebt3 réf. Schraubdose 1250 ml weiß PP, Schraubdeckel mit Dichteinlage, gefüllt mit Formaldehyd 4% phosphatgepuffert, Etikett mit Gefahrensymbolen aufgeklebt Schraubdose weiß, Schraubdeckel mit Dichteinlage, gefüllt mit Formaldehyd 4% phosphatgepuffert, Etikett mit Gefahrensymbolen aufgeklebt Standarddose rund, HDPE 1.000 ml, schwarzer Schraubdeckel mit PE-Dichteinlage, gefüllt mit Formaldehyd 4% phosphatgepuffert, Etikett mit Gefahrensymbolen aufgeklebt Standarddose rund, HDPE schwarzer Schraubdeckel mit PE-Dichteinlage, gefüllt mit Formaldehyd 4% phosphatgepuffert, Etikett mit Gefahrensymbolen aufgeklebt3 réf. Weithalsfass 10,4 Ltr., gefüllt mit Formaldehyd 4% phosphatgepuffert, Etikett mit Gefahrensymbolen aufgeklebt Weithalsfass gefüllt mit Formaldehyd 4% phosphatgepuffert3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Eschweiler	Allemagne	ESCHWEILER combiline 2 combiline 2 BGA98/79 ESCHWEILER combiline 2 combiline 2 BGA + E98/79 ESCHWEILER combiline 2 combiline 2 BGA + E + M98/79 ESCHWEILER combiline 2 combiline 2 BGA + M98/79 ESCHWEILER combiline 2 combiline 2 ISE98/79 5 autres ESCHWEILER modular pro 2 modular pro BGA98/79 ESCHWEILER modular pro 2 modular pro BGA + E98/79 ESCHWEILER modular pro 2 modular pro BGA + E + M98/79 ESCHWEILER modular pro 2 modular pro BGA + M98/79 ESCHWEILER Sensor tHb98/79	– 98/79	Site web info@eschweiler-kiel.de Fiche EUDAMED Signaler une erreur
Eurospital FDA	Italie	Cleaning Solution3 réf. EasyCal Helori98/79 EasyCal Turbo-Universal Eu-King's STAR Eu-Mag DNA/RNA extraction 5 autres Helori FAST98/79 Helori Turbo98/79 Helori Urease Myp-test IgA98/79 Myp-test IgM98/79	A, B IVDR, 98/79	regulatory@eurospital.it Fiche EUDAMED Signaler une erreur
Genmark	Turquie	geneMAP Borrelia Detection Kit, 50T98/79 geneMAP HPV HR & 6 /11 Genotyping Kit, 50T98/79 geneMAP MTB Detection Kit, 100T98/79 geneMAP MTB/MDR Detection Kit, 50T98/79 geneMAP MTB/NTM Detection Kit, 100T98/79 5 autres geneMAP MTB/XDR Detection Kit, 25T98/79 geneMAP Respiratory Master Panel, 50T98/79 geneMAP Respiratory Viral Panel 2 (2019-nCoV, Inf A/B, RSV A/B),100T98/79 geneMAP Respiratory Viral Panel 3 (2019-nCoV, Inf A/B),100T98/79 geneMAP™ Blood RNA Kit	A IVDR, 98/79	Site web info@genmark.com.tr Fiche EUDAMED Signaler une erreur
Genotropy	France	AIO-RHD FETAL DNA KIT (1050)98/79 AIO-RHD FETAL DNA KIT (1200)98/79 AIO-RHD FETAL DNA KIT (1350)98/79 AIO-RHD FETAL DNA KIT (150)98/79 AIO-RHD FETAL DNA KIT (1500)98/79 5 autres AIO-RHD FETAL DNA KIT (300)98/79 AIO-RHD FETAL DNA KIT (450)98/79 AIO-RHD FETAL DNA KIT (600)98/79 AIO-RHD FETAL DNA KIT (750)98/79 AIO-RHD FETAL DNA KIT (900)98/79	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Medicon Hellas FDA	Greece	CUVETTE CLEANER D-DIMER3 réf. G-6-PDH98/79 MEDI DETERGENT 3D3 réf. MEDI DILUENT 5 autres MEDI SHEATH MEDICLEAN3 réf. MEDILYSE 3D2 réf. MEDILYSE DIFF3 réf. MEDITON DIFF	A, C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Micropointbio Mandataire UE : Obelis s.a. (Belgique)	Chine	mLabs® D-Dimer M101-09100198/79 qLabs® APTT Liquid Control QS-9-CL Pro98/79 qLabs® APTT Test Strips QS-9 Pro98/79 qLabs® Coag Panel 2 Liquid Control QS-4-CL Pro98/79 qLabs® FIB Controls Level 1 QS-18-CLN98/79 5 autres qLabs® FIB Controls Level 2 QS-18-CLP98/79 qLabs® Multi-level Coag Controls QS-6-CL Pro98/79 qLabs® PT-INR Liquid Control QS-1-CL Pro98/79 qLabs® PT-INR Owren (Dry) Test Strips QS-298/79 qLabs® PT-INR Owren (Dry) Test Strips QS-2 Pro98/79	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Precision System Science FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Japon	geneLEAD VIII geneLEAD VIII Consumable Set geneLEAD VIII PCR Reaction Cassette Set geneLEAD VIII PCR Reagent Cassette Set geneLEAD XXIV 5 autres MagDEA Dx MV Ⅱ MagDEA Dx SV magLEAD 12gC magLEAD 12gC LiNK3 réf. magLEAD Consumable kit	A IVDR	service@pss.co.jp Fiche EUDAMED Signaler une erreur
Pushkang Mandataire UE : MedPath GmbH (Allemagne) et 1 autre	Chine	150tests98/79 1ml*102 réf.98/79 60 tests98/79 Automated Chemistry Analyzer MS200 CBC Assay Kit HE5010198/79 5 autres Chemistry Analyzer MS100 Coagulation Analyzer MC100 MI200 MU500 PB30	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Realmindbio Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	MCL60 Reagents (Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit98/79 Reagents (Calibrator 1x1mL/bottle and Control 2x1mL/bottle ) 100tests/kit98/79 Reagents (Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit98/79 Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit98/79 5 autres Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit11 réf.98/79 Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit98/79 Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit98/79 Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit98/79 Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Senlo Mandataire UE : Umedwings Netherlands B.V. (Pays-Bas)	Chine	Automatic Chemistry Analyzer S100 Automatic Chemistry Analyzer S100A Automatic Chemistry Analyzer S150 Automatic Chemistry Analyzer S150A Automatic Chemistry Analyzer S160 5 autres Automatic Chemistry Analyzer S160A Automatic Chemistry Analyzer S240 Automatic Chemistry Analyzer S240A Automatic Chemistry Analyzer S400 Automatic Chemistry Analyzer S400A	A IVDR	Site web sales@senlo.com.cn Fiche EUDAMED Signaler une erreur
Shandong Aosaite Medical Devices Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Clot activator (2ml, 3ml, 4ml, 5ml, 6ml, 7ml, 8ml, 9ml)3 réf. EDTAK2 (1ml,2ml,3ml,4ml,5ml,6ml,7ml,8ml,9ml)3 réf. EDTAK3 (2ml,3ml,4ml,5ml,6ml,7ml,8ml,9ml)3 réf. Gel&Clot activator (2ml, 3ml, 4ml, 5ml, 6ml, 7ml, 8ml)3 réf. Glucose(Fluoride Sodium + EDTA2NA)(2ml,3ml,4ml,5ml,6ml)3 réf. 5 autres Lithium heparin (2ml,3ml,4ml,5ml,6ml,7ml,8ml,9ml)3 réf. Plain (3ml, 4ml, 5ml, 6ml, 7ml, 8ml, 9ml, 10ml)3 réf. Sodium heparin (2ml,3ml,4ml,5ml,6ml,7ml,8ml,9ml,10ml)3 réf. Trisodium citrate 4NC (1.6ml, 2ml, 3ml, 4ml, 5ml, 6ml, 7ml, 8ml, 9ml)3 réf. Trisodium citrate 9NC (2ml,3ml,4ml,5ml)3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Shimadzu FDA Mandataire UE : Shimadzu Europa GmbH (Allemagne)	Japon	APCI-805098/79 CLAM-2030 CL98/79 CLAM-2040 CL Fully Automated Sample Preparation Module for LCMS LabSolutions LC CL Add PDA98/79 LabSolutions LC CL Multi LC98/79 5 autres LabSolutions LCMS CL version 1.198/79 LCMS-8045 CL Liquid Chromatograph Mass Spectrometer3 réf. LCMS-8050 CL98/79 LCMS-8060 CL98/79 Nexera CL HPLC SYSTEM HIGH PERFORMANCE LIQUID CHROMATOGRAPH	A IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Singclean Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	FASUAL COVID-19 Test kit (Colloidal Gold Method)98/79 Singclean Cassette：1 test/box2 réf.98/79 Singclean Cassette：10 tests/box2 réf.98/79 Singclean Cassette：20 tests/box2 réf.98/79 Singclean Cassette：5 tests/box2 réf.98/79 5 autres Singclean® COVID-19 Antigen Test kit (Colloidal Gold Method)4 réf.98/79 Singclean® COVID-19 IgG Test kit (Colloidal Gold Method)2 réf.98/79 Singclean® COVID-19 IgM Test kit (Colloidal Gold Method)4 réf.98/79 Singclean® COVID-19 Neutralizing Antibody Test Kit(Colloidal Gold)4 réf.98/79 Singclean® COVID-19 Test kit (Colloidal Gold Method)6 réf.98/79	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Suzhou Cyrunfeh Medical Devices Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Blood Collection Tubes CRF Vacuum Blood Collection Tube -Cell-Free DNA Collection Tubes2 réf. Vacuum Blood Collection Tube -Coagulation Test Tubes2 réf. Vacuum Blood Collection Tube -ESR Test Tubes2 réf. 5 autres Vacuum Blood Collection Tube -Heparin Tubes-Heparin lithium2 réf. Vacuum Blood Collection Tube -Heparin Tubes-Heparin Sodium 350640 Vacuum Blood Collection Tube -Routine Blood Tubes-K2EDTA3 réf. Vacuum Blood Collection Tube -Separating Gel Procoagulant Tubes2 réf. Vacuum Blood Collection Tube for Blood Specimen Collection-No Additive Tubes	A IVDR	Fiche EUDAMED Signaler une erreur
Tisenc Mandataire UE : QbD RepS BV (Belgique) et 1 autre	Chine	Tisenc D-Dimer (CLIA)4 réf.98/79 Tisenc Dengue Virus IgG Antibody (CLIA)4 réf.98/79 Tisenc Dengue Virus IgM Antibody (CLIA)4 réf.98/79 Tisenc Dengue Virus NS1 Antigen (CLIA)4 réf.98/79 Tisenc Interleukin-6 (CLIA)4 réf.98/79 5 autres Wondfo D-Dimer (CLIA)4 réf.98/79 Wondfo Dengue Virus IgG Antibody (CLIA)4 réf.98/79 Wondfo Dengue Virus IgM Antibody (CLIA)4 réf.98/79 Wondfo Dengue Virus NS1 Antigen (CLIA)4 réf.98/79 Wondfo Interleukin-6 (CLIA)4 réf.98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Tysonbio FDA Mandataire UE : MDSS GmbH (Allemagne)	Taïwan	JS100 Blood Glucose Monitoring System (Standard Plus) (CE)98/79 JS100 Blood Glucose Test Strips (50T) (CE)98/79 plusMED fasTTest98/79 Rossmax HS2003 réf.98/79 Soludiab LGLMV-0298/79 5 autres Soludiab LGLMV-BT-0198/79 Spengler JT100 Blood Glucose Monitoring System (CE)98/79 Spengler JT100 Blood Glucose Test Strips (50T) (CE)98/79 Spengler JT100 Control Solution (Level 2) (CE)98/79 Spengler TB10098/79	– 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
VMRD FDA Mandataire UE : MediMark Europe Sarl. (France)	États-Unis	Fuller Laboratories by VMRD Q-Fever MIF IgG Antibody Kit QG-12098/79 Fuller Laboratories by VMRD Q-Fever MIF IgM Antibody Kit QM-12098/79 Fuller Laboratories by VMRD Rickettsia (conorii / typhi) Screen MIF IgG Antibody Kit R21G-12098/79 Fuller Laboratories by VMRD Rickettsia (conorii / typhi) Screen MIF IgM Antibody Kit R21M-12098/79 Fuller Laboratories By VMRD Rickettsia conorii IFA IgG Antibody Kit RCG-12098/79 5 autres Fuller Laboratories by VMRD Rickettsia rickettsii IFA IgG Antibody Kit RRG-12098/79 Fuller Laboratories by VMRD Rickettsia typhi EIA IgG Antibody Kit RTG-96K98/79 Fuller Laboratories by VMRD Spotted Fever Rickettsia EIA IgG Antibody Kit SFG-96K98/79 Fuller Laboratories by VMRD Spotted Fever Rickettsia EIA IgM Antibody Kit RRM-96K98/79 Fuller Laboratories by VMRD Typhus Group Rickettsia EIA IgM Antibody Kit RTM-96K98/79	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Ascensia FDA Mandataire UE : Ascensia Diabetes Care Italy Srl (Italie)	Suisse	Contour® Care CCARE-M-XXXXYY3 réf. Contour® Next98/79 Contour® Next CNEXT-M-XXXXYY3 réf. Contour® Next One CNO-M-XXXXYY3 réf. Contour® Plus Blue CPB-M-XXXXYY 5 autres Contour® Plus CPLUS-M-XXXXYY3 réf. Contour® Plus Elite CPE-M-XXXXYY3 réf. Contour® Plus One CPO-M-XXXXYY2 réf. Contour® XT3 réf.98/79 Contour® Fit COFIT-M-XXXXYY (plus commercialisé)	C IVDR, 98/79	Présent sur le marché en France Site web EUDAMED-info@ascensia.com Fiche EUDAMED Signaler une erreur
Daltonbio Mandataire UE : MedPath GmbH (Allemagne) et 2 autres	Chine	/98/79 DH3 High-Risk HPV DNA Test3 réf. Helicobacter Pylori Antigen Detection Kit (Immunochromatographic Method)98/79 High Risk Human Papillomavirus (Type 16, 18) Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79 Influenza A Virus Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79 5 autres Influenza A/B Virus Antigen Detection Kit (Immunochromatographic Method)98/79 Influenza B Virus Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79 Low Risk Human Papillomavirus (Type 6, 11) Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79 Neisseria Gonorrhoeae Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79 High Risk Human Papillomavirus (HPV) Genotyping System98/79 (plus commercialisé)	C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Avioq Bio-tech Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	1 Test/Kit98/79 2 Tests/Kit98/79 20 Tests/Kit98/79 24 Tests/Kit98/79 25 Tests/Kit98/79 4 autres 40 Tests/Kit98/79 48 Tests/Kit98/79 5 Tests/Kit98/79 96 Tests/Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Biyosistem	Turquie	BASEMOULD 10X10X53 réf. Biopsy Foam, Blue2 réf. Bluing Reagent Solution, 1000 ml2 réf. Double Cytology Funnel, 2 Irregular with White Filter3 réf. HistoCool Freezer Spray, 200 ml OCT Plus3 réf. 4 autres HMD Tissue Marking Dye, 3 Color Set, 30 ml3 réf. Paraffin Wax 56-58 °C, 1 Kg HistoPlus3 réf. SecurePot Specimen Container, 100 ml3 réf. Thermal Ribbon (for PrintMate) for Cassette Printer3 réf.	A IVDR	Site web info@biyosistem.com.tr Fiche EUDAMED Signaler une erreur
Centre Europeen De Biotechnologie	France	F2000BNE24H F2000F2700NST242 réf. F500BNECANST FP60PSSGACBO FP60ACBOSTE98/79 PC150BSG PC150STE98/79 PC150BSGER PC150STE98/79 4 autres PC150NST2 réf. PC150SG PC150STE98/79 PC150SGER PC150STE98/79 PC150SGERLABOUEST PC150STE98/79	A IVDR, 98/79	Présent sur le marché en France contact@ceb-angers.fr Fiche EUDAMED Signaler une erreur
Concepta Diagnostics	United Kingdom (ex Northern Ireland)	Blood Sample Collection Kit (Gold) T12000 Blood Sample Collection Kit (Lavender) T15000 Boots Blood Sample Collection Kit – Gold & Lavender Tube (Home Use – Single Test) Boots Blood Sample Collection Kit – Gold Tube (Home Use Single Test) MyHealthChecked B5000 4 autres MyHealthChecked B6000 Retest Blood Kit (Gold & Lavender) Retest Blood Kit (Single Gold) Retest Blood Kit (Single Lavender)	I, IIa MDR	Site web info@conceptaivd.com Fiche EUDAMED Signaler une erreur
Deltalab	Espagne	CONJ. 2x300705, 2x705722 +VASO RECIPIENTES PARA LA RECOGIDA DE ORINA - URINE COLLECTION CONTAINERS3 réf. CUERPO FRASCO PP 30ML RECIPIENTES PARA LA RECOGIDA DE MUESTRAS Y/U ORINA - SAMPLES AND / OR URINE COLLECTION CONTAINERS3 réf. FRASCO ORINA 24 HORAS 3L MARRON CON CANULA LARGA RECIPIENTES PARA LA RECOGIDA DE ORINA - URINE COLLECTION CONTAINERS3 réf. FRASCO PARA VACÍO 120 ML PP B/U CONTENEDORES PARA MUESTRAS ESTÉRILES - GENERAL SPECIMEN CONTAINER STERILES98/79 FRASCO PARA VACÍO 120 ML PP CONTENEDORES PARA MUESTRAS ESTÉRILES - GENERAL SPECIMEN CONTAINER STERILES98/79 4 autres FRASCO SIS. VACIO 60 ML PP T/AMARILLO B/U CONTENEDORES PARA MUESTRAS ESTÉRILES - GENERAL SPECIMEN CONTAINER STERILES98/79 FRASCO SIS. VACIO 60 ML PP T/PREC. AMARILLO CONTENEDORES PARA MUESTRAS ESTÉRILES - GENERAL SPECIMEN CONTAINER STERILES98/79 FRASCO VACIO 60 ML PP AMARILLO B/U CONTENEDORES PARA MUESTRAS ESTÉRILES - GENERAL SPECIMEN CONTAINER STERILES98/79 PIPETA VIDRIO VSG 0-180 mm RECIPIENTES PARA LA RECOGIDA DE SANGRE - BLOOD COLLECTION DEVICES3 réf.	A IVDR, 98/79	Présent sur le marché en France Site web info@deltalabgroup.com Fiche EUDAMED Signaler une erreur
DiagCor Life Science Mandataire UE : Medunion S.L. (Espagne) et 1 autre	Hong Kong	24 tests98/79 48 tests3 réf.98/79 92002 9200798/79 9200898/79 4 autres 9202998/79 92031 92033 GenoQuest HPV 24 Genotyping qPCR Assay 48 tests98/79	A IVDR, 98/79	QARA@diagcorlifescience.com Fiche EUDAMED Signaler une erreur
Diasia FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	1 Test/kit98/79 10 Tests/kit98/79 100 Tests/kit5 réf.98/79 25 Tests/kit5 réf.98/79 5 Tests/kit98/79 4 autres 50 Tests/kit6 réf.98/79 Speedry Chem2 réf. Speedry UR WBC Colour Agent	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Furuno FDA Mandataire UE : MedEnvoy Global BV (Pays-Bas)	Japon	Clinical Chemistry Analyzer CA-270 with ISE Clinical Chemistry Analyzer CA-270 without ISE Clinical Chemistry Analyzer CA-310 with ISE Clinical Chemistry Analyzer CA-310 without ISE Clinical Chemistry Analyzer CA-400 with ISE 4 autres Clinical Chemistry Analyzer CA-400 without ISE Clinical Chemistry Analyzer CA-800 with ISE Clinical Chemistry Analyzer CA-800 without ISE SENTiFIT ®800 Analyzer	A IVDR	Site web Fiche EUDAMED Signaler une erreur
GC Medical Science Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	GENEDIA Multi Influenza Ag Rapid Test Kit98/79 GENEDIA W COVID-19 Ag3 réf.98/79 GENEDIA W COVID-19 Ag External Control Swab98/79 GREENCARE A1c Analyzer RT-10098/79 Greencare Flu 2 Influenza A&B Ag98/79 4 autres Performa A1c Analyzer RT-100 PocketChem A1c Advanced RT-10098/79 QDx A1c Advance RT-10098/79 respons® A1c Analyzer RT-10098/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
GenDx FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine, États-Unis	GENEYE® Influenza Virus （FluA/B）ERA Assay98/79 GENEYE® Mycoplasma Pneumoniae Assay98/79 GENEYE® Respiratory Syncytial Virus（RSV）ERA Assay98/79 ImmunoFLOW Mycoplasma IgM Control98/79 ImmunoFLOW Mycoplasma pneumoniae98/79 4 autres ImmunoFLOW Negative Control - Mycoplasma IgM98/79 ImmunoWELL JCV IgG Test98/79 ImmunoWELL Mycoplasma Pneumoniae (IgG Antibody)98/79 ImmunoWELL Mycoplasma Pneumoniae (IgM Antibody)98/79	– 98/79	Présent sur le marché en France Site web orders@genbio.com Fiche EUDAMED Signaler une erreur
Genemind Mandataire UE : Medunion S.L. (Espagne) et 1 autre	Chine	Automatic sampler X-bot 16 FASTASeq 300 Dx G Tube,10 mL GeneMind2 réf. GeneMind 96 tests/kit2 réf.98/79 4 autres GeneMind PET 10mL,50 tubes/box；GL 10mL,50 tubes/box2 réf. GenoLab M Dx Single Molecule DNA Sequencer GenoCare 1600 SURFSeq 5000 Dx	A IVDR, 98/79	regulatoryaffairs@genemind.com Fiche EUDAMED Signaler une erreur
Haimen Shengbang Laboratory Equipment FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	10ml , 20ml , 30ml , 40ml , 60ml , 70ml , 80ml , 90ml, 100ml, 120ml 10ul98/79 13x75mm 13x100mm 16x100mm 13x75mm with boric acid 13x100mm with boric acid 16x100mm with boric acid3 réf. 150ml , 250ml , 500ml , 1000ml 1slides , 2slides, 3slides, 5slides , 12slides , 25slides, 50slides , 100slides 4 autres 30ml98/79 90-9009, 90-9210, 90-9250 , 90-9381 , 90-9081 , 90-9100, 90-9200 , 90-9025 , 90-1536, 90-5016 , 90-2281, 90-2200, 90-2381, 90-2300 , 90-5281 , 90-5200, 90-1200, 90-1281 , 90-1300 , 90-1381 , 98-4127, 98-4227, etc 90ml embedding cassette(square hole) embedding cassette(rectangle hole) embedding cassette(rectangle hole-two part)3 réf.	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Hunan Michael Laboratory Instrument Mandataire UE : Humiss International B.V. (Pays-Bas)	Chine	Medical Centrifuge BYL-5R Medical Centrifuge DL-5M, DL-6MB, GR-800C, GR-10C Medical Centrifuge KC-50X, KC-500B, KC-550B, KC-40T, KC-42F Medical Centrifuge KC-60X, KC-600B, XJ-8, XJ-6 Medical Centrifuge TD5, TD4 4 autres Medical Centrifuge TD5A,TD5B Medical Centrifuge TDZ5-WS, TDZ4-WS, MK540, MK450 Medical Centrifuge VL-200R, TGL-16M, TGL-20M, HK-16R Medical Centrifuge VL-6B, VL-200B, TG16-WS, TG20-WS, TG16W, HK-16C	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Kingcreate Mandataire UE : Kingsmead Service B.V. (Pays-Bas) et 1 autre	Chine	HPV Genotyping Kit (18 Types) 48 Tests/Kit HPV Genotyping Kit Specification A: 1 test/tube, 24 tests/box98/79 HPV Genotyping Kit Specification B: 8 tests/strip, 24 tests/box98/79 HPV Genotyping Kit Specification C: 8 tests/strip, 24 tests/box98/79 Pathogen Nucleic Acid Extraction Kit 2×16 tests/kit 4 autres Respiratory Pathogens Detection Kit Specification A:1 test/tube, 24 tests/box98/79 Respiratory Pathogens Detection Kit Specification B: 8 tests/strip,24 tests/box98/79 Respiratory Pathogens Detection Kit Specification C: 8 tests/strip,24 tests/box98/79 Type A: 100 tests/kit Type B: 24 tests/kit Type B: 48 tests/kit Type B: 96 tests/kit Type C: 96 tests/kit Type D: 6×16 tests/kit3 réf.	A, C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Konsung FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	D-Dimer Test Kit (Immunofluorescence Method)98/79 HBC-3A3 réf.98/79 HCU01, HCU022 réf. Helicobacter pylori Antibody (IgG) Test Kit (Colloidal Gold)98/79 Helicobacter pylori Antigen Test kit (Colloidal Gold)2 réf.98/79 4 autres Influenza A&B Rapid Test Kit (Colloidal Gold)2 réf.98/79 Konsung C1013 réf. Konsung WBC-298/79 Konsung WBC-598/79	A IVDR, 98/79	info@konsung.com Fiche EUDAMED Signaler une erreur
Lumatas FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas) et 1 autre	États-Unis	DAB Away Kit Hematoxylin Solution Lumatas Titan Autostainer Lumatas Titan S Autostainer Titan AP Fast Red 30mL Kit Titan AP Fast Red 30 mL Kit 4 autres Titan Double Stain Kit Titan HRP DAB 30 mL Kit Titan Prime Universal AP Polymer Detection Kit with Fast Red Titan Prime Universal HRP Polymer Detection Kit with DAB	A IVDR	Fiche EUDAMED Signaler une erreur
Nanjing Leading Medical Technology Mandataire UE : Medunion S.L. (Espagne)	Chine	1 Test/Bag98/79 1 Test/Box98/79 101.6 mL98/79 25 Tests/Box98/79 50 Tests/Box98/79 4 autres 50.8 mL98/79 level 12 réf.98/79 level 1+level 22 réf.98/79 level 22 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Ningbo Dasky Life Science FDA Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	TS10000H TS1000H TS100H TS10H TS1H 4 autres TS200H TS20H TS5000H TS50H	A IVDR	Présent sur le marché en France Site web sale@daskymed.com Fiche EUDAMED Signaler une erreur
Ortho-Clinical Diagnostics FDA Mandataire UE : Ortho-Clinical Diagnostics France (France)	United Kingdom (ex Northern Ireland)	Anti-Human Globulin Anti-lgG, -C3d; polyspecific (Rabbit and Murine Monoclonal) (Green) Ortho BioVue System (Poly Cassette) VITROS2 réf. Anti-Human Globulin Anti-lgG (Rabbit) Anti-Human Globulin Anti-C3b, -C3d (Monoclonal) Control Ortho BioVue System (DAT/IDAT Cassette) VITROS Anti-Human Globulin Anti-lgG (Rabbit) (Green) Ortho BioVue System (IgG Cassette) VITROS2 réf. Anti-Human Globulin Anti-lgG, -C3d; polyspecific (Rabbit and Murine Monoclonal) (Green) Neutral Solution Ortho BioVue System (Poly/Neutral Cassette) VITROS2 réf. Bovine Albumin 22% VITROS2 réf. 4 autres Neutral Ortho BioVue System (Neutral Cassette) VITROS2 réf. ORTHO BROMELIN MT6 VITROS ORTHO Optix™ Reader (BioVue) VITROS VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Extraction Buffer	A, C IVDR	Présent sur le marché en France Site web PRRC@quidelortho.com Fiche EUDAMED Signaler une erreur
PentaBase	Danemark	BasePurifier™ 32 Nucleic Acid Extraction System 32 Oscillating Rods BasePurifier™ 48 Large Volume Nucleic Acid Extraction System 48 Rotating Rods BasePurifier™ 96 Nucleic Acid Extraction System 96 Rotating Rods BaseTyper™ 16.2 Portable Real-Time PCR System BaseTyper™ 48.4 Quiet HRM Real-Time PCR System 4 autres BaseTyper™ 96.4 Flexible Real-Time PCR System BaseTyper™ 96.6 Flexible Real-Time PCR System CoviFLU98/79 RespiDetect98/79	A IVDR, 98/79	Site web info@pentabase.com Fiche EUDAMED Signaler une erreur
pfm medical FDA	Allemagne	Accu-Cut® SRM™ 500 UCC3 réf. Adapter fixed3 réf. pfm Cassette Trimming System CTS 500 pfm Forceps EWF 600 pfm Mobile Cooling System MCS 400 4 autres pfm Rotary 3004 M3 réf. pfm Slide 4004 M2 réf. pfm Stretching Table 1100 Samui Kühlplatte (115/127 VAC)2 réf.	A IVDR	Présent sur le marché en France Site web info@pfmmedical.com Fiche EUDAMED Signaler une erreur
Ral Tecnica Para El Laboratorio	Espagne	CLIMA JR CLIMA MC 15 CLIMA MC15 CLIMA PLUS CLOT 12B Coagulómetro Semi-automático CLOT 2B CLOTTY Coagulómetro semi-automático 4 autres COAGULOMETER RA000200 SCANION Densitometer SRA 48 M STARDUST MC 15	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Seekxbio Mandataire UE : GRZAN GROUP SL (Espagne)	Chine	Activated Clotting Time Cartridge(ACT) CK20133 réf.98/79 Coagulation Analyzer CK2002 réf. Coagulation Panel Cartridge CK20013 réf.98/79 Coagulation Panel Cartridge CK20023 réf.98/79 Coagulation Panel Cartridge CK20033 réf.98/79 4 autres Coagulation Panel Cartridge CK20043 réf.98/79 NeoCoag Coagulation Test Strip Neo1013 réf.98/79 NeoCoag Coagulation Test Strip Neo1023 réf.98/79 NeoCoag Pro	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Shandong Bohong Gene Technology Mandataire UE : Luxus Lebenswelt GmbH (Allemagne)	Chine	5-Part Auto Hematology Analyzer BH-HA610, BH-HA510, BH-HA630, BH-HA640, BH-HA650, etc.3 réf. Automatic Urine Analyzer BH-QNY series2 réf. Disposable Virus Sampling Tube2 réf. Hematology Analyzer BH-HA3103 réf. Nucleic Acid Extraction Kit BH002 4 autres Nucleic Acid Extractor BH003 Real-time PCR System LEIA series2 réf. Thermal Cycler BH0052 réf. Urine Analyzer BH-NY01, BH-NY01S2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Shijiazhuang Yuanding Medical Device FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Single-use Containers for Venous Blood Specimen Collection 4NC Sodium Citrate2 réf. Single-use Containers for Venous Blood Specimen Collection 9NC Sodium Citrate3 réf. Single-use Containers for Venous Blood Specimen Collection Clot Activator3 réf. Single-use Containers for Venous Blood Specimen Collection Gel and Clot Activator3 réf. Single-use Containers for Venous Blood Specimen Collection K2EDTA3 réf. 4 autres Single-use Containers for Venous Blood Specimen Collection Lithium Heparin3 réf. Single-use Containers for Venous Blood Specimen Collection No Additive3 réf. Single-use Containers for Venous Blood Specimen Collection Sodium Fluoride/K2EDTA3 réf. Single-use Containers for Venous Blood Specimen Collection Sodium Heparin3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Solveco	Suède	Blåsfix Formaldehyd 35% Formaldehyd 4 % obuffrad Formaldehyd 4% med Fosfatbuffert Formaldehyd 7% i vatten 200L Returfat 4 autres GEWF - Lösning SolvClear Urifix Xylen	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Tigsun Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	1 test3 réf.98/79 10 tests3 réf.98/79 100 tests3 réf.98/79 20 tests3 réf.98/79 25 tests3 réf.98/79 4 autres 40 tests3 réf.98/79 5 tests3 réf.98/79 50 tests3 réf.98/79 80 tests3 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Vwr FDA	Belgique, France	Coverquick 1000 Q Path3 réf. Easyfix Q Path3 réf. Eosin Y alcoholic 0,2% Q Path3 réf. Formaldehyde 4% Pink Q Path / FORMALINE 10% (PINK)3 réf. PARAFFIN NORMAL Q PATH3 réf. 4 autres Q Path Containers 150 mL Blue cap3 réf. Q Path Fixative Ethanol Q Path Macrostar I3 réf. VWR Urine Collection Bottle - Sterile7 réf.98/79	A IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Weinkauf Medizintechnik	Allemagne	Formalin Dispenser HP105 LS72 Para Cooler3 réf. Paraffin Dispenser 4 autres RWECC TP12 TP14 Waterbath3 réf.	A IVDR	Site web info@weinkauf-medizintechnik.de Fiche EUDAMED Signaler une erreur
General Biologicals Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Taïwan	ANTICORASE B-96 (TMB)98/79 ANTICORASE MB-96 (TMB)98/79 ANTISURASE B-96 (TMB)98/79 ANTISURASE B-96 II (TMB)98/79 GB HIV Ag-Ab COMB2 réf.98/79 4 autres GBC Chemiluminescence Analyzer (Non-Sterile) GBC CLi120 NANBASE C-96 V4.02 réf.98/79 SURASE B-96 (TMB)2 réf.98/79 ANTISURGEN B98/79 (plus commercialisé)	A IVDR, 98/79	sales.group@gbc.com.tw Fiche EUDAMED Signaler une erreur
Pharmasave	Roumanie	"TRUSSA" fara gel 59447590690082 réf. ADYA Green Pharma ADYA Green Pharma - KIT COPROCULTURA KIT COPROCULTURA simplu, fara gel DR MAX Kit coprocultura cu gel cary blair2 réf. DR.MAX --KIT COPROCULTURA KIT COPROCULTURA simplu, fara gel 4 autres MASTERLAB PHARMASAVE2 réf. TERM OK2 réf. "TRUSSA"98/79 (plus commercialisé)	A IVDR, 98/79	OFFICE@PHARMASAVE.RO Fiche EUDAMED Signaler une erreur
Anchor Diagnostics	Allemagne	Anchor C. difficile PCR Kit98/79 ANCHOR CMV PCR Kit2 réf. Anchor EBV PCR Kit98/79 Anchor HSV 1/2 PCR Kit98/79 Anchor Influenza A/B PCR Kit98/79 3 autres Anchor Norovirus PCR Kit98/79 Anchor SARS-CoV-2 PCR Kit v2.098/79 Anchor VZV PCR Kit98/79	C IVDR, 98/79	info@anchor-diagnostics.com Fiche EUDAMED Signaler une erreur
Association Of Medicine Analytics Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Russie	AMA DENT98/79 AMA RUT Expert98/79 AMA RUT Pro (48 in blocks)98/79 AMA RUT Pro (block of 24)98/79 AMA VENERA98/79 3 autres HELIC ABT Reader indicator tube kit (1 pcs)98/79 HELIC ABT Reader indicator tube kit (30 pcs)98/79 HELIC ABT Reader indicator tube kit (50 pcs)98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
B&E Bio-Technology FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	CellCleaner (Detergent Rinse) CellLyse Electrolyte Analyzer CBS-300, CBS-301, CBS-400, CBS-401, CBS-500, CBS-501, CBS-30, CBS-40, CBS-50, CBS-3, CBS-4, CBS-5, KS-401, KS-4023 réf. G20, G21, G60, G802 réf. Glycated Hemoglobin Analyzer G2098/79 3 autres Glycated Hemoglobin Analyzer G20, G2198/79 HbA1c Level 1: 0.1ml×1; Level 2: 0.1ml×198/79 Sheath-Sys,Sheath-Ruby,Sheath-XN3 réf.	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Beaverbio Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	BeaverBeads™ Blood DNA Kit 70423 BeaverBeads™ Circulating DNA Kit 70404 BeaverBeads™ Multi Sample RNA Kit 70418 BeaverBeads™ Saliva DNA Kit 70405 BeaverBeads™ Stool DNARNA Kit 70411 3 autres BeaverBeads™ Viral DNA RNA Kit 70406 BEAVER™ Cell Free DNA Tubes 43803 Saliva Collector 43806	A IVDR	Présent sur le marché en France sales@beaverbio.com Fiche EUDAMED Signaler une erreur
Beiantmed Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	HE6008 HE6010 HE6108 HE6110 HE6130 3 autres HE6130L HE6130P HE7230	A IVDR	Fiche EUDAMED Signaler une erreur
BioGnost	Croatie	A.F.O.G. kit, 6x100 mL3 réf. Acridine Orange boja u prahu, C.I. 46005, 25 g3 réf. Bio-Diff 1 RTU reagens, 100 mL3 réf. BioMount Aqua, 100 mL3 réf. BioWax 52/54, 1 kg3 réf. 3 autres BM Fixative One, 1 L3 réf. DAB Chromogen kit, for 1250 tests3 réf. LeukoGnost ACP, za 50 testiranja3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Bioland FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Blood Glucose Meter G-425-298/79 Blood Glucose Meter G-425-398/79 Blood Glucose Meter G-427B98/79 Blood Glucose Meter G-427B,G-425-22 réf. Blood glucose monitor kit G-425-398/79 3 autres Blood Glucose Monitoring Kit G-425-398/79 Blood Glucose Monitoring System G-425-298/79 Blood Glucose Monitoring System G-425-398/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Bordier FDA Mandataire UE : Leman Diagnostics SARL (France)	Suisse	Aspergillus fumigatus IgG ELISA98/79 Echinococcus granulosus IgG ELISA Echinococcus multilocularis (Em18) IgG ELISA Echinococcus multilocularis (Em2-Em18) IgG ELISA98/79 Entamoeba histolytica IgG ELISA98/79 3 autres Fasciola hepatica IgG ELISA Leishmania infantum IgG ELISA98/79 Schistosoma mansoni IgG ELISA	B IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Caltag FDA Mandataire UE : Advena Limited (Malte)	United Kingdom (ex Northern Ireland)	TransFix and TransFix Sample Storage Tubes3 réf. TransFix CSF Sample Storage Tube3 réf. TransFix/EDTA 3 mL Vacuum Blood Collection Tubes (1 Tube)98/79 TransFix/EDTA 3 mL Vacuum Blood Collection Tubes (2 tubes)98/79 TransFix/EDTA 3 mL Vacuum Blood Collection Tubes (50 tubes)98/79 3 autres TransFix/EDTA 9 mL Vacuum Blood Collection Tubes (1 Tube)98/79 TransFix/EDTA 9 mL Vacuum Blood Collection Tubes (2 tubes)98/79 TransFix/EDTA 9 mL Vacuum Blood Collection Tubes (50 tubes)98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Diagnostic Systems	Allemagne	abia HBs Ag DK.013.01.398/79 abia HBs Ag DK.013.05.398/79 abia HEV IgG DK.029.01.398/79 abia HEV IgG DK.029.05.398/79 abia HEV IgM DK.030.01.398/79 3 autres abia HEV IgM DK.030.05.398/79 abia HIV AgAb DK.003.01.398/79 abia HIV AgAb DK.003.05.398/79	– 98/79	Site web info@ab-ds.de Fiche EUDAMED Signaler une erreur
Dutch Diagnostics	Pays-Bas	Chagas Test98/79 Chikungunya IgG/IgM Test98/79 Dengue IgG/IgM Test98/79 H.Pylori Ab Test2 réf.98/79 H.Pylori Ag Test98/79 3 autres Influenza A+B Test3 réf.98/79 Strep A Test3 réf.98/79 TMS Strep A2 réf.98/79	– 98/79	Site web info@dutch-diagnostics.com Fiche EUDAMED Signaler une erreur
Dyonmed	Greece	DyonCDA98/79 DyonDimer (D-Dimer)98/79 DyonHpAb triple98/79 DyonHpsA98/79 DyonMono98/79 3 autres DyonStrepA-strip98/79 Pylori test (1 test/box)98/79 Pylori test (10 tests/box)98/79	– 98/79	Site web customerservice@dyonmedical.com Fiche EUDAMED Signaler une erreur
Eiken FDA Mandataire UE : Advena Limited (Malte) et 1 autre	Japon	Loopamp(TM) PURE DNA Extraction Kit Loopamp™ Malaria Pan Detection Kit2 réf. Loopamp™ Malaria Pf Detection Kit Loopamp™ Malaria Pv Detection Kit Loopamp™ MTBC Detection Kit 3 autres OC-Auto Sampling Bottle 3 (VCPZ25)3 réf. OC-Light™ S FIT Sampling Bottles OC-SENSOR Ceres OC Equipment Family3 réf.	A, C IVDR	Présent sur le marché en France regulatoryaffairs@eiken.co.jp Fiche EUDAMED Signaler une erreur
FRIZ Biochem	Allemagne	COVID-19 direct RT-PCR GastroVir1 direct RT-PCR GastroVir2 direct RT-PCR res2plex direct PCR res3plex direct PCR res1plex direct PCR 3 autres res4plex direct RT-PCR Ax, Bx, Cx3 réf. res5plex direct RT-PCR res6plex direct RT-PCR	B IVDR	Site web info@frizbiochem.de Fiche EUDAMED Signaler une erreur
Genetree Mandataire UE : Obelis s.a. (Belgique)	Corée du Sud	NamuPlex™ GNT-2013-1 NamuPlex™ Q005A NamuPlex™ Q006A98/79 NamuPlex™ Q016A98/79 NamuPlex™ Q021A 3 autres NamuPlex™ Q022A NamuPlex™ Q023A NamuPlex™ Q024A	B, C IVDR, 98/79	Présent sur le marché en France Site web ra@genetree.co.kr Fiche EUDAMED Signaler une erreur
Hospitex	Italie	Centrifuge T16-50 CYTOfast CytoCentrifuge3 réf. CYTOfast Kit Urine - Eco StandAlone - 3x20 ml3 réf. CYTOfast PLUS Puntali 5ml - 250 pz CYTOfast Stainer 3 autres CYTOfast Vetrini - Special Coated - 72 pz Ematossilina di Harris 500 ml Soluzione CYTOfast - 1 lt3 réf.	A IVDR	Site web info@hospitex.com Fiche EUDAMED Signaler une erreur
Hunan Kangxin Biotechnology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	D-dimer Kit (Microfluidic Fluorescent Immunoassay)98/79 Dengue IgG & IgM Antibody Kit (Microfluidic Fluorescent Immunoassay)98/79 Dengue Virus Antigen Kit (Microfluidic Fluorescent Immunoassay)98/79 Helicobacter Pylori Antibody Kit (Microfluidic Fluorescent Immunoassay)98/79 Helicobacter Pylori Antigen Kit (Microfluidic Fluorescent Immunoassay)98/79 3 autres Influenza A/B & RSV Antigen Kit (Microfluidic Fluorescent Immunoassay)98/79 Interleukin-6 Kit (Microfluidic Fluorescent Immunoassay)98/79 Treponema Pallidum Antibody Kit (Microfluidic Fluorescent Immunoassay)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
inno-train Diagnostik	Allemagne	Lymphodex 500 ml2 réf. Lyophilized Rabbit Complement 1 ml98/79 Lyophilized Rabbit Complement 3 ml98/79 Lyophilized Rabbit Complement 5×1 ml98/79 Rabbit Complement 100 ml98/79 3 autres Rabbit Complement 5 × 2 ml98/79 Rabbit Complement 5 × 3 ml98/79 Rabbit Complement, frozen 5 × 1 ml98/79	A IVDR, 98/79	Site web info@inno-train.de Fiche EUDAMED Signaler une erreur
Instrumentation Laboratory FDA	Italie	ILab Aries w/o ISE 000160258302 ILab Aries with ISE 000160258304 ILab Taurus refurbished w/o ISE 230V 00001070301R ILab Taurus refurbished with ISE 230V 00001070302R ILab Taurus with ISE 120V 00001070304 3 autres ILab Taurus with ISE 230V 00001070302 ILab Taurus without ISE 120V 00001070303 ILab Taurus without ISE 230V 00001070301	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Laboveritas	Lettonie	Express Genetics DNA 0018 ExtraMag 1000 0020 Laboveritas 475104263LVE00156T VeriLab Express DNA 0014 VeriLab ExtraMag 500 0019 3 autres Verilab GMag 0012 VeriLab UMag Verilab USorb 0011	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Opta-Tech	Pologne	LAB40 FL3 réf. LAB50 FL Mikroskop Biologiczny OPTA-TECH serii LAB 503 réf. MB2003 réf. Mikroskop Biologiczny OPTA-TECH serii MB-5 MB5 Mikroskop Stereoskopowy OPTA-TECH serii SK 3 autres Mikroskop Stereoskopowy OPTA-TECH serii STX 12 MW50 FL Mikroskop Odwrócony OPTA-TECH serii MW 502 réf. SZKIEŁKA PODSTAWOWE DO DRUKAREK KRAWĘDZIE SZLIFOWANE - NAROŻNIKI 45° - KOLOR BIAŁY3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Pentapharm FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Suisse	APCr APCr Controls Batroxobin Time Pefaclot® UFH Controls98/79 Pefaclot® UFH98/79 3 autres Pefakit® APC-R Factor V Leiden Controls98/79 Pefakit® APC-R Faktor V Leiden98/79 Pefakit® Reptilase® Time98/79	B IVDR, 98/79	Site web RA@pentapharm.com Fiche EUDAMED Signaler une erreur
Rocgene FDA Mandataire UE : Medunion S.L. (Espagne) et 1 autre	Chine	10 tests/kit17 réf.98/79 10200602G 50 tests/kit17 réf.98/79 Archimed Mini 16 Archimed X4 3 autres Archimed X6 ArchiPure 96 Pro iFIND S2 、iFIND S4 、iFIND S83 réf.	A IVDR, 98/79	sale@rocgene.com Fiche EUDAMED Signaler une erreur
Roll	Italie	904763 réf. PP CYLINDRICAL TEST TUBES 16X100 MM 10 ML WITH RIM3 réf. STERILE 150 ML CONTAINER98/79 STERILE 60 ML CONTAINER98/79 STERILE CONTAINER2 réf.98/79 3 autres STERILE CONTAINER 150 ML98/79 STERILE CONTAINER 60 ML98/79 URINE CONTAINER WITH COLLECTION DEVICE98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
sebia FDA	France	A1C/CE - CAPILLARY BLOOD SAMPLE KIT (A) CAPILLARYS 3 DBS CAPILLARYS 3 OCTA CAPILLARYS 3 TERA CAPILLARYS 3 TERA TLA 3 autres GELSCAN HYDRASYS 2 SCAN FOCUSING MINICAP FLEX-PIERCING	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Shanghai THAN Medical Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	B8001,B8001-1, B8001-2, B8002, B8002-1, B8002-2, B6001,B6002, B6001-1, B6001-2, B6002-1, B6002-2, ET01,ET01-1, ET01-2, ET02, ET02-1, ET02-2, MS01,MS01-1, MS01-2, MS02, MS02-1, MS02-2, CS01, CS01-1, CS01-2, CS02, CS02-1, CS02-23 réf. BM10、BM202 réf. CP 9XX (00, 09, 10, 19, 20, 29, 30, 39, 40, 49, 50, 59)2 réf. CP450L、CP550L、CP650L、CP750L、CP850L3 réf. M8001, M8002, M8003, M8004, M8005, M6001,M6002, M6003, M6004, M6005,M8001-1, M8001-2, M8002-1, M8002-2, M8003-1, M8003-2, M6001-1, M6001-2, M6002-1, M6002-2, M6003-1, M6003-2, MC01, MC02, MC01-1, MC01-2, MC02-1, MC02-2, BC01, etc.3 réf. 3 autres SM10 SP 6XX (00, 06, 10, 16, 20, 26, 30, 36, 40, 46), SP 8XX (00, 10, 20, 30)3 réf. SP100L, SP200L, SP100R, SP200R, SP220L , SP110L, SP110R, SP220R, SP108L, SP208L, SP108R, SP208R, SP118L,SP118R, SP228R,SP228L MSP100L, MSP100R, MSP200L, MSP200R, MSP110L, MSP220L, MSP110R,MSP120R, SP101L, SP201L, SP101R, SP102R3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Shenzhen Kang Sheng Bao Bio-Technology Mandataire UE : QbD RepS BV (Belgique)	Chine	D-Dimer Rapid Detect98/79 Flu A & Flu B Rapid Test98/79 Flu A Rapid Test98/79 Flu B Rapid Test98/79 H.pylori Ab Rapid Test98/79 3 autres H.pylori Ag Rapid Test98/79 RSV Rapid Test98/79 Strep A Rapid Test98/79	– 98/79	Site web info@ksbbiotech.com Fiche EUDAMED Signaler une erreur
SpeeDx FDA Mandataire UE : MedEnvoy Global BV (Pays-Bas)	Australie	PlexPCR Colour Compensation 1.0 PlexPCR Flu/RSV/SARS-CoV-2 1.0 PlexPCR RespiVirus (610) 1.03 réf. PLexPCR VHS (LC480) 1.03 réf. Positive Control Flu/RSV/SARS 1.0 3 autres Positive Control HSV/VZV/TP 1.0 ResistancePlus GC (550) 1.03 réf. ResistancePlus MG 1.03 réf.	A, B, C IVDR	Site web regulatory@speedx.com.au Fiche EUDAMED Signaler une erreur
Streck FDA Mandataire UE : MediMark Europe Sarl. (France)	États-Unis	Cell-Free DNA BCT3 réf. Cell-Free DNA BCT CE3 réf. Para 12 Plus3 réf. Streck 2124313 réf. Streck 2135593 réf. 3 autres Streck 2187503 réf. Streck 2254803 réf. Streck Cell Preservative3 réf.	A, B IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Vitrex Medical A S FDA	Danemark	Blood Gas Capillary Tube Capillary Tube End-to-End Pipette4 réf. Micro Haematocrit Capillary Tube6 réf. Micro Haematocrit Capillary Tubes 3 autres Plastic Blood Capillary Tube Plastic Micro Haematocrit Capillary Tube3 réf. Precalibrated Pipette6 réf.	A IVDR	Site web info@vitrexmg.com Fiche EUDAMED Signaler une erreur
Wallac	Finlande	AutoDELFIA Automatic Immunoassay System2 réf. DELFIA Xpress GSP, Genetic Screening Processor Migele Gel Electrophoresis Unit (IVD) RESOLVE Hb FASC Control Kit98/79 3 autres Vanadis Core Vanadis Extract Vanadis View	A IVDR, 98/79	Site web regulatoryaffairs.turku@revvity.com Fiche EUDAMED Signaler une erreur
Wuhan MGI Tech Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	DNB Loader MGIDL-T7 Genetic Sequencer DNBSEQ-G400 DNBSEQ-G50, DNBSEQ-G400, DNBSEQ-T7, DNBSEQ-G99, DNBSEQ-G99A, HELICON® G400, HELICON® G503 réf. HPV DNA Extraction Kit HD01T-96 Nucleic Acid Extraction Kit BDT-864 T-1728, T-96, OP02-32, VDR03P-32, VDR02P-96, VDR03P-96, SD01T-96, SD01T-1536, FDP-32, CDP-32, CDT-192, CDT-25, CDT-48, CDT-50, BDT-864, BDT-96, MD01T-96, WDT-96, WDT-8643 réf. Saliva Sample Collection Kit SSC022 réf. 3 autres Sample Collection and Release Reagent SCR-100 Sample Transfer Processing System MGISTP-3000 MGISTP-7000, MGISTP-3000, STP-B10003 réf. Stool Collection Kit GSC02-I-15, GSC02-I-302 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Youpubiotech Mandataire UE : MedPath GmbH (Allemagne)	Chine	Blood Collection Tube Centrifuge Disposable Petri Dish Disposable Pipette Tip Disposable Stool Container 3 autres Disposable Urine Container Special Blood Collection Tube Sputum Container	A IVDR	ra@youpubiotech.com Fiche EUDAMED Signaler une erreur
Zhuhai Shineway Biotech Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	AutoPoc MDx Hand-held Nucleic Acid Detection Analyzer SWSI-023 réf. IPOCT-01 MC42-P01 Nucleic Acid Release Reagent NARR-01 3 autres PCR Nucleic Acid Analyzer SWM-01 Real-time PCR Nucleic Acid Detection System SWM-02 SW-RCA-0198/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Zhuhai DL Biotech Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Auto Blood Culture System BT120 Auto Blood Culture System BT180 Auto Blood Culture System BT24 Auto Blood Culture System BT240 Auto Blood Culture System BT48 7 autres Auto Blood Culture System BT60 Fully auto blood culture analysis system BT Station 3020 Auto Stainer DL-DYE-ACID-16 (plus commercialisé) Auto Stainer DL-DYE-ACID-8 (plus commercialisé) Auto Stainer DL-DYE-GA-32 (plus commercialisé) Auto Stainer DL-DYE-GR-16 (plus commercialisé) Auto Stainer DL-DYE-GR-8 (plus commercialisé)	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Gc Medis Mandataire UE : Obelis s.a. (Belgique)	Corée du Sud	CERA-CHEK™ 3 in 1 GHL Blood Glucose, Hemoglobin, Lactate Monitoring System M 40098/79 CERA-CHEK™ 3 in 1 GHL Hemoglobin Control Solution M 40098/79 CERA-CHEK™ 3 in 1 GHL Hemoglobin Test Strip M 40098/79 CERA-CHEK™ 1070 Blood Glucose Monitoring System G 30098/79 CERA-CHEK™ 1Code Blood Glucose Monitoring System G 40098/79 5 autres CERA-CHEK™ Hb Plus Hemoglobin Control Solution H 40098/79 CERA-CHEK™ Hb Plus Hemoglobin Test Strip H 40098/79 CERA-STAT™ 2000 Analyzer CS 200098/79 (plus commercialisé) CERA-STAT™ 4000 Analyzer CS 400098/79 (plus commercialisé) LabonaCheck™ A1c HbA1c Analyzer MH 20098/79 (plus commercialisé)	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Innodx Mandataire UE : QbD RepS BV (Belgique)	Chine	HAV Ab CLIA2 réf.98/79 HAV IgM CLIA2 réf.98/79 HEV IgG CLIA2 réf.98/79 HEV IgM CLIA2 réf.98/79 IL-6 CLIA2 réf.98/79 3 autres TB-IGRA CLIA2 réf. TP Ab CLIA2 réf.98/79 INNODX TB-IGRA CMIA2 réf.98/79 (plus commercialisé)	C IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
3Dhistech	Hongrie	PANNORAMIC 1000 DX Digital Scanner3 réf. PANNORAMIC 150 DX Digital Scanner PANNORAMIC 250 Flash III DX Digital Scanner3 réf. PANNORAMIC 480 DX Digital Scanner3 réf. PANNORAMIC 75 DX Digital Scanner 2 autres PANNORAMIC Flash DESK DX Digital Scanner2 réf. PANNORAMIC MIDI III DX Digital Scanner	A IVDR	Présent sur le marché en France Site web info@3dhistech.com Fiche EUDAMED Signaler une erreur
Accriva Diagnostics FDA Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	Avoximeter AVOX1000E-INT98/79 GEM® Hemochron® 100 System 000GH100 Hemochron™ Signature Elite Hemochron™ Signature Elite ELITEINT VerifyNow™ System 70068 2 autres VerifyNow™ System 85062 VerifyNow™ System 86000	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Avantor Performance Materials Poland FDA	Pologne	Cervix Spray Fixative 12 X 125 ML HDPE CyMet 22 CN Free3 réf. Diluid™ 100 Plus3 réf. Formaldehyde 3,8 - 4,2%,3 réf. Hypochlorite NR3 réf. 2 autres Phosphate Buffered Saline2 réf. UltraKitt3 réf.	A IVDR	Présent sur le marché en France Site web regulatory.pl@avantorsciences.com Fiche EUDAMED Signaler une erreur
Biokit FDA	Espagne	D-Dimer 01R10013 réf. HemosIL AcuStar VWF:CB 0009802044 HemosIL FDP3 réf. HemosIL HIT- Ab(PF4-H) Controls2 réf. HemosIL VWF:RCo 0020300900 2 autres monogen kit 150 tests2 réf. Quantia D-Dimer3 réf.	B, C IVDR	Fiche EUDAMED Signaler une erreur
Capitalbiotech Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	12 tests/kit98/79 20 tests /kit98/79 24 tests/kit98/79 32 tests/kit98/79 32tests/kit98/79 2 autres 48 tests/kit98/79 96 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Cepheid FDA Mandataire UE : Cepheid AB (Suède)	Suède, États-Unis	GeneXpert5 réf. Xpert®25 réf. Xpert® HIV-1 Qual XC98/79 Xpert® HIV-1 Viral Load XC98/79 Xpert® Xpress CoV-2 plus98/79 2 autres Xpert® Xpress CoV-2/Flu/RSV plus98/79 Xpert® Xpress SARS-CoV-298/79	A, B, C IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Chemtronbio Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 2 autres	Chine	Cassette 8022C98/79 Chemtrue ®® Influenza A+B Antigen Combo Rapid Test (Lateral Flow)98/79 Chlamydia Trachomatis Rapid Test 8001C01P25 Chlamydia Trachomatis Rapid Test Cassette 8001C98/79 HP Ag H.pylori Antigen Rapid Test 2 autres Influenza A+B Antigen Combo Rapid Test 8062C01 Influenza A+B Antigen Combo Rapid Test Cassette 8010C98/79	B, C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Chengwumedical Mandataire UE : MedPath GmbH (Allemagne) et 1 autre	Chine	0.2ml,0.25ml,0.5ml,1ml3 réf. 0.2ml、0.5ml、1ml、2ml、3ml、5ml、10ml3 réf. 15ml,20ml,30ml,40ml,50ml,60ml,100ml,120ml,125ml3 réf. 15ml、20ml 、30ml、40ml、50ml、60ml、100ml、120ml、125ml3 réf. Disposable Vacuum Blood Collection Tube30 réf. 2 autres No Additive, Clot Activator, Gel & Clot Activator, Sodium Citrate (1:4), Sodium Citrate (1:9), Sodium/Lithium Heparin, EDTA K2/K3, Sodium Fluoride3 réf. Saliva Kit 001;Saliva Kit 002;Saliva Kit Without VTM 001;Saliva Kit Without VTM 002;Full Saliva Kit;Saliva Kit without VTM.3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
CorDx FDA Mandataire UE : Medunion S.L. (Espagne)	États-Unis	CorDx Respiratory Antigen Combo Rapid Test (ADV/RSV + PIV/HMPV) Cassette CorDx Respiratory Antigen Combo Rapid Test (ADV/RSV) Cassette CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID + ADV/RSV + PIV/HMPV) Cassette CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID + ADV/RSV) Cassette CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID + PIV/HMPV) Cassette 2 autres CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID) Cassette CorDx Respiratory Antigen Combo Rapid Test (PIV/HMPV) Cassette	C IVDR	Fiche EUDAMED Signaler une erreur
Cornley Mandataire UE : Caretechion GmbH (Allemagne) et 1 autre	Chine	AFT-300、AFT-400、AFT-500、PR703、PR705、K-Lite3、K-Lite5、PR-C、AFT-C、KLite-C3 réf. AFT-800A、AFT-800B、AFT-800D、AFT-800E、AFT-800F、AFT-800G、AFT-800H3 réf. BG-800A、BG-800B、BG-800、BG-800AQ、BG-800BQ、BG-8000、BG-800E3 réf. Gaslite80A、Gaslite80B、Gaslite80、Gaslite80AQ、Gaslite80BQ、Gaslite80Q、Gaslite80E3 réf. K-Lite8A、K-Lite8B、K-Lite8D、K-Lite8E、K-Lite8F、K-Lite8G、K-Lite8H、K-Lite83 réf. 2 autres MINI ISE Vitagas 5E98/79	A IVDR, 98/79	Site web sales@cornley.com Fiche EUDAMED Signaler une erreur
Coyotebio Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	FlashDetect17 réf.98/79 FlashDetect Flash10 FlashDetect Flash20 FlashDetect Nano FlashDetectTM SARS-CoV-2&Flu A&Flu B&RSV External Quality Control98/79 2 autres FlashDetect™ LyocartE Enterovirus 71 Assay98/79 FlashDetect™ LyocartE HSV-1&HSV-2 Assay2 réf.98/79	A IVDR, 98/79	sales@coyotebio.com Fiche EUDAMED Signaler une erreur
DAS	Italie	AP-BLOT ELITE AP16 IF BLOT ELITE AP16 IF ELITE2 réf. AP22 ELITE2 réf. AP22 IF BLOT ELITE 2 autres AP22 IF ELITE2 réf. PLATE READER OR-9710220	A IVDR	Site web quality@dasitaly.com Fiche EUDAMED Signaler une erreur
Diatrust FDA Mandataire UE : Wellkang Ltd (Irlande du Nord)	Chine	DiaTrust3 réf. DiaTrust CB01,CB02,CB03,CB11,CB12,CB13,CB50,CB51,CB60,CB61,CC21,CC22,CC23,CE21,CE22,CE23,CE31,CE32,CE33,CH21,CH22,CH23,CH24,CS01,CS02,CS03,CS11,CS12,CS13,CS40,CS41,CS60,CS61.2 réf. DiaTrust CT210,CT220,CT310,CT320,CT410,CT420,CT510,CT511,FC000,FC001,FC002,FC201,FC202,FC203,FC204,FC320,FC324,FC325,FC326,FC340,FC360,FC390,RS01,SC0501,SC0601,SC0602,SC0603,SC0604,SC0605,SC0701,SC0702,SC0703,SC0704,SC0705,SC0706,SC0707,SC08012 réf. DiaTrust CT605,CT615,CT620,CT625,CT626,TC01,TC02,TC03,TC05,TC06,TC07,TC08,TC09,TC10,TC11,TC12,TC13,TC19,TC40,TC410,TC411,TC41,TC412,TC413,TC420,TC42,TC421,TC422,TC423,TC450,TC451,TC452,TC460,TC461,TC462,TC470,TC471,TC472,TC480,TC481,TC482,TC483,TC484,TC485,TC491 DiaTrust FT10,FT11,FT12,FT14,FT16,FT17,FT20,FT21,FT22,FT24,FT26,FT27,FT50,FT51,FT52,FT53,FT54,FT56,FT57,FT58,FT60,FT61,FT62,FT63,FT64,FT66,FT67,FT68,FT914,FT924,FT954,FT964,PT01,PT02,PT04,PT05,PT07,PT08,PT09,PT11,PT12,PT13,PT14,PT15,PT16,PT17,PT18,PT20,PT22,PT26 2 autres DiaTrust PD550,PD551,PD552,PD553,PD554,PD555,PD556,PD557,PD558,PD560,PD561,PD5623 réf. PlasDispo	A IVDR	Fiche EUDAMED Signaler une erreur
Dynodx Mandataire UE : HUMISS TRADING S. L. (Espagne)	Chine	1 test/box,98/79 10 test/box98/79 100 test/box98/79 20 test/box98/79 25 test/box,98/79 2 autres 50 test/box98/79 CBCR type, CBC type98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Eurolyser	Autriche	CUBE-S Analyser (700/546) D-Dimer control kit ST150098/79 D-Dimer test kit (16 tests)98/79 D-Dimer test kit (6 tests)98/79 iFOB collector kit (32 pcs, incl. collection paper) 2 autres PT (INR) control kit98/79 PT (INR) test kit (32 tests)98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Guangzhou LBP Medicine Science & Technology Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	100 tests/kit 100 tests/kit 200 tests/kit2 réf. 300 tests/kit 300 tests/kit 600 tests/kit 900 tests/kit3 réf. 60 tests/kit 150 tests/kit 600 tests/kit3 réf. 2 autres Hyper S9 Hyper S5 ( 99-121V) Hyper S5 ( 198-242V)3 réf. LBP-6612 (99-121V) LBP-6612 (198-242V)2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Hecin Mandataire UE : Share info GmbH (Allemagne)	Chine	AccuProbe Influenza A Virus PCR Kit3 réf. AccuProbe Influenza A/B Virus PCR Kit3 réf. AccuProbe Influenza B Virus PCR Kit3 réf. AccuProbe RSV PCR Kit3 réf. COVID-19/Flu A&B Rapid Antigen Test3 réf. 2 autres HCPlex RSV PCR Kit3 réf. Influenza A&B Rapid Antigen Test RJ05-13 réf.	B IVDR	Fiche EUDAMED Signaler une erreur
I.S.E. - Societa' A Responsabilita' Limitata - Sistemi Intelligenti Elettronici	Italie	AUTOANALYZER MOD. HEMO ONE p/n 11154-10-A AUTOANALYZER MOD. MIURA 200 DA (31 Rgt Pos) p/n 10997-00-A2 réf. AUTOANALYZER MOD. MIURA 200 SA (31 Rgt Pos) p/n 11025-00-A2 réf. AUTOANALYZER MOD. MIURA DA (59 Smp Pos) p/n 10001-02-A2 réf. AUTOANALYZER MOD. MIURA ONE (15 Smp Pos) p/n 10750-02-A2 réf. 2 autres Hemo One+, Universal stool extraction tubes Plate with Miura reading cuvettes 200 pcs/pack2 réf.	A IVDR	Site web info@logotech-ise.com Fiche EUDAMED Signaler une erreur
Inbios FDA Mandataire UE : AR Experts B.V. (Pays-Bas)	États-Unis	CHIKjj Detect™ IgG ELISA98/79 CHIKjj Detect™ IgM ELISA98/79 Dengue NS1 Detect™ Rapid Test98/79 DENV Detect™ IgG ELISA98/79 DENV Detect™ IgM Capture ELISA98/79 2 autres DENV Detect™ NS1 ELISA98/79 West Nile Detect™ IgM Capture ELISA98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Jiangsu Xinkang Medical Instrument Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	XINKANG2 réf. XINKANG 1-12ml XINKANG 10-10000ul XINKANG 75*25mm XINKANG 8003 réf. 2 autres XINKANG φ13-16mm XINKANG φ60-150mm	A IVDR	Fiche EUDAMED Signaler une erreur
Jiangxi Aicare Medical Technology FDA Mandataire UE : Caretechion GmbH (Allemagne)	Chine	Blood Glucose Meter A60698/79 Blood Glucose Meter A60898/79 Blood Glucose Meter A60998/79 Blood Glucose Meter A61298/79 Blood Glucose Meter W332 réf.98/79 2 autres Blood Glucose Meter W3798/79 Blood glucose meters W4098/79	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Kamiya Biomedical FDA Mandataire UE : Advena Limited (Malte)	États-Unis	Coagulation Control K204C-10M3 réf. K-ASSAY Factor XIII Calibrator KAI-106C98/79 K-ASSAY Factor XIII Control K135C-10M98/79 K-ASSAY Factor XIII KAI-10598/79 K-ASSAY H. pylori Calibrator KAI-241C98/79 2 autres K-ASSAY H. pylori Control K242C-2M98/79 K-ASSAY H. pylori KAI-24098/79	B IVDR, 98/79	Présent sur le marché en France Site web info@k-assay.com Fiche EUDAMED Signaler une erreur
Katsura Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Taïwan	Katsura Biological Coporation 310111 Katsura Biological Coporation 310211 Katsura Biological Coporation 310311 Katsura Biological Coporation 320211 Katsura Biological Coporation 320311 2 autres Katsura Biological Coporation A-20-M03201 Katsura Biological Coporation S2R16B	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Kurin FDA Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	D-PIV1293/42 DJ-PIV1293/42 M-PIV1293/42 S-PIV493/42 SJ-PIV493/42 2 autres T-PIV1293/42 TJ-PIV1293/42	IIa 93/42	Site web Fiche EUDAMED Signaler une erreur
Life Technologies Holdings Pte Mandataire UE : Life Technologies Europe B.V. (Pays-Bas)	Singapour	3500 Dx Genetic Analyzer Applied Biosystems™ 3500 Dx/3500xL Dx Genetic Analyzers2 réf. Applied Biosystems™ SeqStudio™ 24 Flex Dx Genetic Analyzer2 réf. Ion OneTouch™ Dx Instrument3 réf. Ion Torrent™ Genexus™ Dx Integrated Sequencer3 réf. QuantStudio™ 5 Dx Real‑Time PCR Instrument (96-Well 0.2ml Block) QuantStudio™ 5 Dx Real-Time PCR System and Accessories2 réf. 2 autres QuantStudio™ 7 Pro Dx 384-Well Block QuantStudio™ 7 Pro Dx Real-Time PCR Instrument and Accessories3 réf. VeritiPro™ Dx Thermal Cycler	A IVDR	Fiche EUDAMED Signaler une erreur
Margomed	Pologne	APTECZKA ABC Pojemnik na mocz STERYLNY 100 ml Sterile urine container98/79 APTEO Pojemnk sterylny na mocz 100 ml Sterile urine container98/79 DOZ MED Pojemnik na mocz 100 ml sterylny Sterile urine container98/79 Non sterile urine container Novama U-CUP Pojemnik sterylny na mocz Sterile urine container98/79 2 autres Sterile urine container98/79 Świat Zdrowia Pojemnik sterylny na mocz Sterile urine container98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Micras	Italie	Antibody diluent 500 ml Staining solutions and reagents not dangerous3 réf. Blood Quick stain 500 ml Reagent and staining solutions for histology and cytology3 réf. Bouin 500 ml Fixatives3 réf. Cover Mount 8 x 500 ml Mounting media for microscopy3 réf. Coverglasses 24 x 50 Microscope slides and coverglasses3 réf. 2 autres Eosin Nigrosin 100 ml3 réf. Gill 1 Hematoxylin 20 l3 réf.	A IVDR	info@micras.it Fiche EUDAMED Signaler une erreur
Ningbo HEALTH Gene Technologies Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	A-32 A-32min A-96 ES400 HPV Genotyping Kit (PCR capillary analysis) (F650)98/79 2 autres HPV Genotyping Kit (PCR-Capillary Electrophoresis Fragment Analysis) (F488)98/79 L-20	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
PaxGenBio Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	PaxView DNA Extraction Kit V0101 PaxView HPV16/18/Others MPCR-ULFA Kit V030198/79 PaxView HPV16/HPV18 MPCR-ULFA Kit V033098/79 PaxView HPV20 Genotyping MPCR-ULFA Kit V032498/79 PaxView TB MPCR-ULFA Kit V043198/79 2 autres PaxView TB/NTM MPCR-ULFA Kit V040198/79 PaxView® SARS-CoV-2 real-time RT-PCR Kit R050298/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Plasticerveira - Transformação de Plástico, Lda	Portugal	Contenedor de orina 120ml c/adap. vacío, ind. Individuais 120ml3 réf. Contenedor de orina 60ml c/adap. vacío, ind. Individuais 60ml3 réf. Contenedor de orina c/canula 2Lt. marron Bote 2L3 réf. Contenedor de orina c/canula 3Lt. Marron Bote 3L3 réf. Kit de orina c/ tampa vacuo c/1 tubo s/conservante Kits 120ml3 réf. 2 autres Kit de recogida de orina, vaso blando c/1 tubo redondo Kit recogida de orina 60ml c/adap. vacío c/ 2 tubos, borico y normal Kits 60ml3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Pro-med (Beijing) Technology Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	1 test/kit98/79 10 tests/kit98/79 25 tests/kit98/79 5 tests/kit98/79 50 tests/kit98/79 2 autres ST-1000 Thrombelastograph General Cup Kit 1 test/kit98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Sanowa PlastoTec	Allemagne	Bio Net 2 Embedding cassette - beige (loose)3 réf. Bio Net 2 embedding cassette LMB aqua - stacked3 réf. Bio-Link embedding cassette - aubergine (loose)3 réf. Bio-Link V embedding cassette beige - stacked3 réf. Biopsie embedding cassette beige - stacked3 réf. 2 autres Standard embedding cassette - beige (loose)3 réf. Standard embedding cassette LMB - stacked3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Scytek FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	Acetate Buffer Solution, pH 8.0 1000 mL3 réf. Actin, Alpha-Smooth Muscle; Clone 1A4 (Concentrate) 1 mL3 réf. Aqueous Mount (Low Viscosity) 1000 mL3 réf. BCIP/INT Solution3 réf. Bouin's Fluid 1 Gal.3 réf. 2 autres Giemsa Stain Kit (May-Grunwald) 1 kit(s)3 réf. PolyTek Anti-Mouse Polymerized Alk-Phos 1000 mL3 réf.	A, C IVDR	Site web Fiche EUDAMED Signaler une erreur
Serosep FDA	Irlande	EntericBio Gastro Panel 2 EBGP2A-v398/79 EntericBio® Clostridioides difficile EBCDA-V298/79 EntericBio® Dx EBGPDx98/79 EntericBio® Dx plate EBGPDx-ROC98/79 EntericBio® Viral Panel 1 EPVP198/79 2 autres EntericBio® Viral Panel 3 EBVP398/79 Serosep 50μl filter tips 9111004.657	A IVDR, 98/79	Site web info@serosep.com Fiche EUDAMED Signaler une erreur
Shanghai LeChen Biotechnology Mandataire UE : Everbiz GmbH (Autriche)	Chine	CP-AS-Ⅱ CP-G-08 CP-II CP-II-32 CP-SP-02 2 autres YQ-MSL-01 YQ-MSZ-01	A IVDR	Fiche EUDAMED Signaler une erreur
Shenzhen Dake Medical Technology Mandataire UE : HyperCert Limited B.V. (Pays-Bas) et 1 autre	Chine	Automatic Glycohemoglobin Analyzer Bright h600, Bright h600Pro, Bright h600Max, Bright h800, Bright h800Pro, Bright h800Max, Bright h1200, Bright h1200Pro, Bright h1200Max3 réf. Bright i60 Series (including Bright i30, Bright i36, Bright i38, Bright i39,Bright i60, Bright i66, Bright i68, Bright i69 models); Bright i100 Series (includingBright i100, Bright i160, Bright i180, Bright i190 models); etc2 réf. D-Dimer Assay kit Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 réf. Interleukin-6 Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 réf. Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 réf. 2 autres Thrombin-antithrombin Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 réf. Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 réf.	A, B, C IVDR	Fiche EUDAMED Signaler une erreur
Sterilin Mandataire UE : NUNC A/S (Danemark)	United Kingdom (ex Northern Ireland)	100ML CONT PTD LAB D/BAG I/W98/79 250ML CONT PTD LABEL D/BAG I/W98/79 250ML CONTAINER NO LABEL IRRAD98/79 250ML CONTAINER PLAIN LABEL IR98/79 30ML PTD LAB D/BAG I/W IRR98/79 2 autres 30ML UNI CONT RED CAP T/PK IRR98/79 30ML UNI NO LBL RED QS CAP IRR98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Strumed FDA Mandataire UE : Amstermed B.V. (Pays-Bas)	Inde	cLOT XPLOR98/79 iNFLA QUICK98/79 iNFLA QUICK Model No. : Pro ED120 - 40 Wells does not have internal mixer, ProMx ED120 - 40 Wells comes with an internal mixer98/79 iNFLA QUICK PRO ED3098/79 iNFLA QUICK SC4098/79 2 autres iNSTA XPLOR® P98/79 uRI QUICK98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Wesailbio Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	D-Dimer Test Kit (Immunofluorescence) 20 tests/kit98/79 Handheld Colloidalgold Analyzer WS-Si1400 Handheld Immunofluorescence Analyzer WS-Si1300 Immunofluorescence Analyzer WS-Mi6000 Immunofluorescence Analyzer WS-Si1000 2 autres Immunofluorescence Analyzer WS-Si1500 Interleukin-6 Test Kit (Immunofluorescence) 20 tests/kit98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
XEMA Mandataire UE : Polmed.de Beata Rozwadowska (Allemagne)	Russie	Aspergillus IgG EIA98/79 GalMAg EIA98/79 Giardia lamblia Total Ab EIA98/79 H. pylori IgG EIA98/79 H. pylori IgM EIA98/79 2 autres Mycoplasma IgG EIA98/79 Ureaplasma IgG EIA98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Xi'An Huawei Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Bacteria Genomic DNA Purification Kit 20T/Box (Pre-filled), 5T/Plate × 4plates 64T/Box (Pre-filled), 16T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips3 réf. Blood Genomic DNA Purification Kit 20T/Box (Pre-filled), 5T/Plate × 4plates 64T/Box (Pre-filled), 16T/Plate × 4plates 40T/Box (Pre-filled), 10T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips3 réf. HPV Genomic DNA Purification Kit 20T/Box (Pre-filled), 5T/Plate × 4plates 64T/Box (Pre-filled), 16T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips3 réf. Magnetic Bead DNA/RNA Purification Kit 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips 40T/Box (Pre-filled), 10T/Plate × 4plates 20T/Box (Pre-filled), 5T/Plate × 4plates 64T/Box (Pre-filled), 16T/Plate × 4plates3 réf. Magnetic Bead DNA/RNA Purification Kit 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips 64T/Box (Pre-filled), 16T/Plate × 4plates 40T/Box (Pre-filled), 10T/Plate × 4plates 20T/Box (Pre-filled), 5T/Plate × 4plates3 réf. 2 autres Magnetic Bead DNA/RNA Purification Kit 64T/Box (Pre-filled), 16T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips2 réf. Magnetic Bead DNA/RNA Purification Kit 64T/Box (Pre-filled), 16T/Plate × 4plates 32T/Box (Pre-filled), 8T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
YD Diagnostics FDA Mandataire UE : CARE diagnostica Laborreagenzien GmbH (Allemagne) et 1 autre	Corée du Sud	EASYPREP Preservative solution(GYN), EASYPREP Preservative solution(NON-GYN)2 réf. EASYPREP® URiSCAN Optima URiSCAN PluScope URiSCAN Tracking System, URiSCAN PluScope ver2 URiSCAN Tracking System98/79 URiSCAN PluScope, URiSCAN PluScope ver298/79 2 autres URiSCAN PRO URiSCAN Super+	A IVDR, 98/79	Site web admin@yd-diagnostics.com Fiche EUDAMED Signaler une erreur
Yzymedical Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	ATM/p53/13q14/RB1/CSP12 gene Probe Detection Kit (fluorescence in situ hybridization )98/79 GLP13/GLP21/CSP18/GLPX/CSPY Probe (fluorescence in situ hybridization )98/79 HER-2 DNA Probe Kit (fluorescence in situ hybridization )98/79 i(17q) gene Probe Detection Kit (fluorescence in situ hybridization )98/79 IGH Dual Color Break Apart Probe (fluorescence in situ hybridization )98/79 2 autres PML/RARA Gene Fusion Probe Detection Kit (fluorescence in situ hybridization )98/79 ROS1 Dual Color Break Apart Probe (fluorescence in situ hybridization )98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Genetic Signatures FDA Mandataire UE : mdi Europa GmbH (Allemagne)	Australie	EasyScreen8 réf.98/79 EasyScreen ® Pan Enteric Detection Kit PE001 Panel B98/79 EasyScreen™98/79 EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001 - Panel A)98/79 EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001)4 réf.98/79 3 autres EasyScreen™ Sample Processing Kit3 réf. EasyScreen Respiratory Pathogen Detection Kit (RP007)98/79 (plus commercialisé) EasyScreen® SARS CoV-2 Detection Kit98/79 (plus commercialisé)	A IVDR, 98/79	Site web RAQA@geneticsignatures.com Fiche EUDAMED Signaler une erreur
Suzhou Sym-Bio Lifescience Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Chine	48 tests 50 tests Pre-NAT II (SY61-EI) Pre-NAT II SY61 Pre-NAT II SY61-01 3 autres SuperFlex2 réf. Level 1: 0.75mL×4, Level 2: 0.75mL×498/79 (plus commercialisé) SuperFlex Interleukin-6 Kit98/79 (plus commercialisé)	A, C IVDR, 98/79	quality.taicang@revvity.com Fiche EUDAMED Signaler une erreur
Zymo Research FDA Mandataire UE : DAVID Catherine Elisabeth Marie (France)	États-Unis	DNA/RNA Sample Collection Kit R2000-A DNA/RNA Shield Fecal Collection Tube (with Beads) - DX (1 tube/pk) R1101-E3 réf. DNA/RNA Shield SafeCollect Saliva Collection Kit R1160-E3 réf. EZ DNA Methylation-Lightning Kit (200 rxns) D5030-E3 réf. Quick-DNA-RNA™ HT - Dx (1000 preps) R2140-E3 réf. 3 autres ZymoBIOMICS 96 MagBead DNA Kit (Lysis Rack) D4302-E3 réf. EZ-96 DNA Methylation-Lightning Kit (Deep-Well) - 2 x 96 Rxns D5033-E (plus commercialisé) EZ-96 DNA Methylation-Lightning Kit (Shallow-Well) -2 x 96 Rxns D5032-E (plus commercialisé)	A IVDR	Présent sur le marché en France info@zymoresearch.com Fiche EUDAMED Signaler une erreur
Atomo Diagnostics Mandataire UE : QbD RepS BV (Belgique)	Australie	ARST001-0298/79 ARST001-0498/79 ARST001-0598/79 Newfoundland HIV Self Test NFLD001-0198/79 NFLD001-0298/79 2 autres NFLD001-0398/79 Simplitude ByMe Galileo Platform2 réf.98/79 (plus commercialisé)	– 98/79	Site web info@atomodiagnostics.com Fiche EUDAMED Signaler une erreur
Zeiss FDA Mandataire UE : Carl Zeiss Microscopy GmbH (Allemagne)	Allemagne, Chine	Axio Imager.Z2 clinical3 réf. Axio Observer 5 clinical3 réf. Axioscope 5 / Axioscope 7/ Axiolab 5 / Primostar 3 / Primostar 13 réf. Axiovert 5 / Primovert / Axio Vert.A1/Axiovert 73 réf. Stemi 3052 réf. 2 autres ZEISS Axioscan 73 réf. Axio Zoom.V163 réf. (plus commercialisé)	A IVDR	Présent sur le marché en France Site web regulatoryaffairs.microscopy@zeiss.com Fiche EUDAMED Signaler une erreur
"Bio-Ksel"	Pologne	Automatyczny analizator koagulologiczny bioksel 6000 Automatyczny analizator koagulologiczny bioksel 6100 Automatyczny analizator koagulologiczny bioksel 8000 Bio-Ksel PT plus98/79 Koagulometr CC-4000 1 autre Kuweta Chrom	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Amsino FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	AMSure® Mucus Trap AS7940093/42 AMSure® Mucus Trap AS7980093/42 AMSure® Specimen Container AMSure® Specimen Container AS34093/42 AMSure® Specimen Container AS34193/42 1 autre AMSure® Specimen Cup AS34593/42	I MDR, 93/42	Fiche EUDAMED Signaler une erreur
Aperbio Technologies (Suzhou) Mandataire UE : Medunion S.L. (Espagne)	Chine	Auto 12 Dx AutoRuby Dx Kingwell 96 Dx Pangaea 3fast/4fast/5fast/6fast3 réf. Pangaea Super 8 Pro Dx 1 autre qMate mini Dx	A IVDR	Fiche EUDAMED Signaler une erreur
Bioendo Mandataire UE : JOYSUN GROUP S.L.U (Espagne)	Chine	Intelligent Fully Automatic Endotoxin And MAT Detection Robot System (Phoenix Q Series) Phoenix Q5 Intelligent Fully Automatic Endotoxin Detection Robot System (Qilin Endomaster Series) Limulus Amebocyte Lysate (Gel Method)3 réf. Pyrogen Test Kit (Monocyte Activation Test, MAT) rCR Endotoxin Test Kit (Recombinant Cascade Reagents Chromogenic Assay) 1 autre rFC Endotoxin Test Kit (Recombinant Factor C Fluorometric Assay)	A IVDR	sale@bioendo.com Fiche EUDAMED Signaler une erreur
Biohit FDA	Finlande	BIOHIT Extraction tubes BIOHIT FAEX Sample System2 réf. BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 Control98/79 BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 UFT3004 réf.98/79 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 IgG98/79 1 autre 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 quick test98/79	A IVDR, 98/79	Site web info@biohit.fi Fiche EUDAMED Signaler une erreur
Boen Healthcare FDA Mandataire UE : Everbiz GmbH (Autriche)	Chine	95Kpa Specimen Transport Bag2 réf. Biohazard Autoclave Bag Filtered Universal Pipette Tips Microscope Cover Glass 1818mm, 2020mm, 2222mm, 2424mm, 2432mm, 2240mm, 2440mm, 2250mm, 2450mm, 2260mm, 24*60mm, etc Microscope Slide 1 autre Microscope Slide Box 1piece2 réf.	I, A IVDR, MDR	Site web Fiche EUDAMED Signaler une erreur
Bruker FDA	Allemagne	MALDI Biotyper sirius IVD System MALDI Biotyper sirius one IVD System MALDI Biotyper-BD sirius IVD System MALDI Biotyper-BD sirius one IVD System Micro-Dx2 réf.98/79 1 autre SepsiTest-UMD2 réf.98/79	A IVDR, 98/79	Présent sur le marché en France Site web info.md@bruker.com Fiche EUDAMED Signaler une erreur
Citotest FDA Mandataire UE : Obelis s.a. (Belgique) et 1 autre	Chine	CITOGLAS3 réf. CITOGLAS Glass10 réf. CITOSWAB2 réf. CITOTEST7 réf. CITOTEST plastic6 réf. 1 autre CITOTEST white particles3 réf.	I, A IVDR, MDR	Site web info@citotest.com Fiche EUDAMED Signaler une erreur
Codisan	Italie	Contenitore per analisi coprologiche2 réf. Contenitore per analisi coprologiche in astuccio Contenitore per analisi urine 120ml3 réf. Contenitore per analisi urine 120ml in astuccio Provetta per analisi urine 10ml 1 autre Sacchetto per trasporto campioni - Arancio3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
CTK Biotech FDA Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	Aria H. pylori Ab Combo Rapid Test R0191C3 réf. Aria Influenza A/B Ag Rapid Test R0187C2 réf. Aria RSV Ag Rapid Test R0186C2 réf. Aria® Dengue Ag Rapid Test R0063C3 réf. Aria® H. pylori Ag Rapid Test R0192C3 réf. 1 autre Aria® Syphilis Ab Combo Rapid Test R0031C3 réf.	B, C IVDR	Site web info@ctkbiotech.com Fiche EUDAMED Signaler une erreur
Dynex	Tchéquie	AdvanSure AlloView 1.13 réf. ADVANSURE ALLOVIEW 2.0 DYNABLOT AUTOMATIC V43 réf. DYNABLOT 442 réf. DYNABLOT COMFORT DYNABLOT PLUS2 réf. 1 autre DYNAREAD	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Eaglenos FDA Mandataire UE : MedPath GmbH (Allemagne)	Chine	Blood Gas Analyzer EN102 Blood Glucose and Lactate Meter EN3103 réf. Blood Glucose and Uric Acid Meter EN4103 réf. Blood Glucose and β-ketone Meter EN5103 réf. Multi-functional Monitoring Meter EN6003 réf. 1 autre P1	A IVDR	Fiche EUDAMED Signaler une erreur
Fanttest Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	1 test/kit9 réf.98/79 20 tests/kit98/79 25 tests/kit22 réf.98/79 50 tests/kit98/79 Cassette(25 tests/kit)98/79 1 autre ICP-32598/79	– 98/79	info@fanttest.com Fiche EUDAMED Signaler une erreur
Fujifilm FDA Mandataire UE : FUJIFILM Healthcare Europe GmbH (Allemagne) et 1 autre	Japon	BC Tip 1000-R 995-05001, 991-051012 réf. FUJI DRI-CHEM NX10N FUJI DRI-CHEM NX6002 réf. FUJI DRI-CHEM NX7002 réf. LAL Control 993-04201, 997-04101, 995-044013 réf. 1 autre β-Glucan Sample Diluent 999-04301	A, C IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Gonotec	Allemagne	OSMOMAT 300098/79 OSMOMAT 3000 D98/79 OSMOMAT 3000 D-M98/79 OSMOMAT 3000 M98/79 OSMOMAT 3000basic98/79 1 autre OSMOMAT®98/79	– 98/79	Site web contact_gonotec@elitechgroup.com Fiche EUDAMED Signaler une erreur
Guangdong Kindly Medical Device Group FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Blood collection tube10 réf. Capillary Blood Collection Tube5 réf. Single-use Containers for Human Venous Blood Specimen Collection Urinalysis Tube Urine Cup 1 autre Vacuum tube	A IVDR	Fiche EUDAMED Signaler une erreur
Hangzhou HealthSky Biotechnology FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	ATP-96A FCD-5A Healthsky FPA01-AT FPA02-ET FPA02-FT FPA01-ET FPA02-GT FPA01-BT FPA02-MT3 réf. Healtshsky EBMarker-1603 réf. Healtshsky EMarker-11A-S100, EMarker-21A-S1002 réf. 1 autre PSS-05A、PSS-80A、PSS-120A、PSS-160A、PSS-320A、PSS-480A PSS-05B、PSS-80B、PSS-120B、PSS-160B、PSS-320B、PSS-480B3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Helena Biosciences Europe FDA Mandataire UE : Advena Limited (Malte) et 1 autre	United Kingdom (ex Northern Ireland)	Thromboplastin L 5265HL3 réf. UltraCE IFE Diluent UltraCE Maintenance Buffer2 réf. UltraCE Urine Prep V8 Haemoglobin UltraScreen Kit 80110098/79 1 autre V8 UltraCE	A, C IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Inova Diagnostics FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	États-Unis	Aptiva® Multi-Analyte Instrument AP5000 Fecal Extraction Device98/79 NOVA View® Automated Fluorescence Microscope NV2000 QUANTA-Lyser® 3000 ELISA/IFA + Incubator VS3000i QUANTA-Lyser® 3000 ELISA/IFA VS3000 1 autre QUANTA-Lyser® 3000 IFA VS3002	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Intelsint	Italie	AUS2 CVR EFTP ETP FTP-300 FTP300 1 autre TP-300 TP300	A IVDR	Site web info@intelsint.com Fiche EUDAMED Signaler une erreur
Jiangxi Medicalsystem Biological Technology Mandataire UE : Medunion S.L. (Espagne)	Chine	D-Dimer Kit（CLIA） 100T98/79 D-Dimer Kit（CLIA） 50T98/79 Fibrinogen Degradation Product Kit（CLIA） 100T98/79 Fibrinogen Degradation Product Kit（CLIA） 50T98/79 Tumor Necrosis Factor-α Kit（CLIA） 100T98/79 1 autre Tumor Necrosis Factor-α Kit（CLIA） 50T98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Langenbrinck	Allemagne	Histowax with added polymer Plastic containers 08-0001/FE3 réf. Plastic tube volume 12,5 ml , 100x15,7 mm half filled with 4% formaldehyde2 réf. Scintillation Tube volume 20 ml, 58 x 25 mm2 réf. Twist Gefäße befüllt mit 4% Formaldeyd3 réf. 1 autre TWIST-Tube volume 50 ml with blue screw half filled with 4% formaldehyde2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Maine Molecular Quality Controls FDA Mandataire UE : QbD RepS BV (Belgique)	États-Unis	BioFire JI Control Panel M42098/79 BioFire RP2.1/RP2.1plus Control Panel M441 M441-CE98/79 eplex RP2 Control M45198/79 FilmArray BCID2 Control Panel M41698/79 FilmArray GI Control Panel M238 M238-CE 1 autre FilmArray® Pneumonia/Pneumoniaplus Control M34098/79	B IVDR, 98/79	Site web info@mmqci.com Fiche EUDAMED Signaler une erreur
Marfour	Pologne	BioClear NEW3 réf. Koncówki do pipet 5000 µl Pipety Pasteura 1 ml, skal.2 réf. Pojemnik na wycinki chirurgiczne napełniony 10% formaliną w ilości 1800 ml3 réf. Probówka PS 10 ml3 réf. 1 autre Szkiełka mikroskopowe, cięte3 réf.	A IVDR	Site web info@marfour.com.pl Fiche EUDAMED Signaler une erreur
Milenia Biotec	Allemagne	Milenia QuickLine HIT Control98/79 Milenia QuickLine HIT STic EXPERT HIT 2098/79 Milenia QuickLine IL-698/79 STic Expert HIT 598/79 STic EXPERT HIT 5/2098/79 1 autre STic Expert HIT Control98/79	– 98/79	Site web info@milenia-biotec.de Fiche EUDAMED Signaler une erreur
Ndimopoulos	Greece	R&D Diagnostics OSMMR2000-D/10098/79 R&D Diagnostics OSMMR2000-D/30098/79 R&D DIAGNOSTICS OSMMR2000-D/7598/79 R&D DIAGNOSTICS SQMMR125098/79 R&D DIAGNOSTICS SQMMR50098/79 1 autre R&D DIAGNOSTICS SQMMR75098/79	– 98/79	Site web info@ndimopoulos.gr Fiche EUDAMED Signaler une erreur
PathoNostics	Pays-Bas	AsperGenius® 2.0 Resistance TR Multiplex real-time PCR kit PN-20198/79 AsperGenius® 2.0 Species Multiplex real-time PCR kit PN-10198/79 DermaGenius® 2.0 Complete Multiplex real-time PCR kit PN-401 DermaGenius® 3.0 Complete Multiplex real-time PCR kit PN-40298/79 DermaGenius® 3.0 Nail Multiplex real-time PCR kit PN-302 1 autre PathoNostics Extraction kit PN-502	A, B IVDR, 98/79	Site web info@pathonostics.com Fiche EUDAMED Signaler une erreur
Roboscreen	Allemagne	INSTANT Virus RNA/DNA Kit2 réf. INSTANT Virus RNA/DNA Kit - FX3 réf. Rapid INSTANT Virus RNA/DNA Kit – FX RoboGene HBV DNA Quantification Kit 3.03 réf.98/79 RoboGene HCV RNA Quantification Kit 3.03 réf.98/79 1 autre RoboGene HDV RNA Quantification Kit 2.04 réf.98/79	A IVDR, 98/79	Site web info@roboscreen.com Fiche EUDAMED Signaler une erreur
Sakura	Pays-Bas	Tissue-Tek® AutoWrite® Adhesive Ground Edges 90° Clipped Corner Slides, Blue Tissue-Tek® AutoWrite® Non-Adhesive Ground Edges 90° Clipped Corner Slides3 réf. Tissue-Tek® Glas™3 réf. Tissue-Tek® Glas™ Mounting Medium3 réf. Tissue-Tek® O.C.T. Compound Tissue-Tek® Paraffin Wax TEK III3 réf. 1 autre Tissue-Tek® Super Mega-Cassette® White Tissue-Tek® Uni-Cassette® Standard Cassettes3 réf.	A IVDR	Présent sur le marché en France Site web quality@sakura.eu Fiche EUDAMED Signaler une erreur
Sakura Finetek USA Mandataire UE : Sakura Finetek Europe B.V. (Pays-Bas)	États-Unis	Tissue-Tek AutoSection® Tissue-Tek Genie® Controller System3 réf. Tissue-Tek Xpress® Molecular Fixative Solution Pre-Processing Solution3 réf. Tissue-Tek® Cryo3 ® Flex Cryostat, Basic, 230 VAC3 réf. Tissue-Tek® Mega-Cassettes, 6 boxes x 125 cassettes 750, 1 case 1 autre Tissue-Tek® Paraform® Biopsy Cassettes, 13 x 13 mm; 500 cassettes/box3 réf.	A IVDR	Présent sur le marché en France PRRC@sakuraus.com Fiche EUDAMED Signaler une erreur
Shenzhen Channel Biotechnology Mandataire UE : Luxus Lebenswelt GmbH (Allemagne)	Chine	D-Dimer (D-D) Determination Kit (Chemiluminescence Immunoassay) 10 Tests/Kit or 20 Tests/Kit98/79 Intelligent Hematology Analyzer Hemovision Genie 398/79 Intelligent Hematology Analyzer Hemovision Genie 3 Plus98/79 Intelligent Hematology Analyzer Hemovision Genie 598/79 Intelligent Hematology Analyzer Hemovision Genie 5 Plus98/79 1 autre Interleukin-6 (IL-6) Determination Kit (Chemiluminescence Immunoassay) 10 Tests/Kit or 20 Tests/Kit98/79	– 98/79	Site web service.channel@szchenna.com Fiche EUDAMED Signaler une erreur
Shenzhen CoooSeee Biomedical Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	Automatic Hematology Analyzer CH8500CRP CH8501CRP CH8505CRP CH8500 CH8501 CH85023 réf. Hematology Analyzer Diluent DIL, 6DR, DS3 réf. Hematology Analyzer Dye DIFF、RET、WNB、PLT、WPC3 réf. Hematology Analyzer LYSE 3LHD, 5LDA, 5LDB, 5LH, 5LDS, 5LHS, 6LD, 6LH, 6LN3 réf. Probe Cleanser3 réf. 1 autre Sample Diluent CP A3 réf.	A, B IVDR	service@comenbio.com Fiche EUDAMED Signaler une erreur
Suzhou Hokapi Biomedical Engineering Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Automatic Blood Grouping Analyzer SA-120 HOKAPI™ AE-180 HOKAPI™ AE-200 HOKAPI™ CUVETTE3 réf. HOKAPI™ D-DIMER3 réf. 1 autre HOKAPI™ IL-63 réf.	A, C IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Tauns Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Japon	Capilia Flu Neo 10T/Box98/79 Capilia Flu Neo 20T/Box98/79 Capilia RSV Neo 20T/Box98/79 Capilia RSV Neo Test Plate 10T/Box98/79 Capilia TB-Neo Extraction Buffer 20mL/Bottle 1 autre Positive Control Flu98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Tharmac	Allemagne	CellClip Edelstahlclip3 réf. Cellspin III Basis R gekühlt, 220V3 réf. CellStain 15 Grundgerät3 réf. Double Cellfunnel Mehrweg3 réf. ECO Filtercard, Sheet-Version3 réf. 1 autre GynoPrep Verdünnungsflüssigkeit 30 ml3 réf.	A IVDR	Site web info@tharmac.de Fiche EUDAMED Signaler une erreur
Triplex International Biosciences (China) Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	13 Types of High-Risk Human Papillomavirus Nucleic Acid Detection Kit (PCR-Fluorescent Probe）98/79 25 tests/ kit98/79 Dengue NS1 antigen Rapid Test Kit98/79 Group B Streptococcus Nucleic Acid Detection Kit (Fluorescent PCR)98/79 Human Papillomavirus 16 & 18 Nucleic Acid Detection Kit (PCR-Fluorescent Probe)98/79 1 autre Mycobacterium Tuberculosis Nucleic Acid Detection Kit (Fluorescent PCR)98/79	– 98/79	Présent sur le marché en France Site web info@tibchina.com Fiche EUDAMED Signaler une erreur
Vacure Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Beta-haemolytic Group A Streptococcus Nucleic Acid Kit (Fluorescent PCR)98/79 Beta-haemolytic Group B Streptococcus Nucleic Acid Kit (Fluorescent PCR)98/79 Human Papillomavirus Nucleic Acid Kit (Fluorescent PCR)98/79 Multiple-type Respiratory Pathogen Nucleic Acid Kit (Fluorescent PCR)98/79 Neisseria Gonorrhoeae & Ureaplasma Urealyticum kit (Fluorescent PCR)98/79 1 autre Rifampicin-resistant Mycobacterium Tuberculosis Kit (Fluorescent PCR)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Wells Bio Mandataire UE : MDSS GmbH (Allemagne)	Corée du Sud	BGS-E0258298/79 BHP-E0258298/79 BSG-E0258298/79 BSH-E0258298/79 MST-N0508298/79 1 autre MST-N1008298/79	– 98/79	Site web info@wellsbio.net Fiche EUDAMED Signaler une erreur
Genesystem FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	Media:DirectTM Extraction Buffer Swab:DirectTM Extraction Kit, Swab:DirectTM Extraction Kit (2mL) / Trans:DirectTM Extraction Kit2 réf. UF-300 / UF-300P2 réf. UF-340 UF-400 1 autre UF-150 / UF-150E / F-1503 réf. (plus commercialisé)	A IVDR	Site web ra@genesystem.co.kr Fiche EUDAMED Signaler une erreur
Micro Instrument Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Inde	Micro Instrument Co. CLINICO – MD 52 ( BINO) Micro Instrument Co. EXCEL eXCL Nu-20 Micro Instrument Co. EXCEL-MIXCL Micro Instrument Co. Mi-eXCL20 Micro Instrument Co. XECELLENCE MIXCL-31 1 autre Micro Instrument Co. Cx40 (plus commercialisé)	I, A IVDR, MDR	Site web info@mikoindia.com Fiche EUDAMED Signaler une erreur
AD Nucleis	France	AD Nucléis direct SARS-CoV-2_1-step RTCPR 48R98/79 AD Nucléis direct SARS-CoV-2_1-step RTCPR 96R98/79 Extraction and purification kit of NA for blood 14R IVD3 réf. Open lyophilized One-Step qPCR Kit IVD Sequence Evolution IVD2 réf.	A IVDR, 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Addcare FDA Mandataire UE : Lepu Medical (Europe) Cooperatief U.A. (Pays-Bas)	Chine	ADC ELISA 180 ADC ELISA 190 ADC ELISA 200 ADC ELISA 400 DM 801B	A IVDR	Site web sales@addcare.cn Fiche EUDAMED Signaler une erreur
Ademtech	France	60307 60318 60405 60406 60407	B IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Agendia FDA	Pays-Bas	Specimen Collection Kit Specimen Collection Kit Agendia DUS FFPE W/Slides Specimen Collection Kit Agendia ES FFPE W/Slides Specimen Collection Kit Agendia NL FFPE W/Slides Specimen Collection Kit Agendia ROW FFPE W/Slides	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Alwsci Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	Breath Sampling Via C00020983 réf. Breath Sampling Vial3 réf. Breath Sampling Vial C00020113 réf. Breath Sampling Vial C00021303 réf. C0003346, C0003186, C0003507, C0002598, C0003560, C0003561, C0003562, C0003563, C0003564, C0003565, C0003566, C0003567, C0003568, C0003569, C0003570, C00035713 réf.	A IVDR	Présent sur le marché en France Site web marketing@alwsci.com Fiche EUDAMED Signaler une erreur
Ant Medi̇kal İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Turquie	Laborant HPV Genotyping Kit (24) Laborant HPV Genotyping Kit (48) Laborant HPV Genotyping Kit (96) Laborant Omicron VariAnt RT-qPCR Kit Laborant SARS-CoV-2 RT-qPCR Kit	A IVDR	Site web info@antmedical.com Fiche EUDAMED Signaler une erreur
Appolon Bioteck	France	ABility Smart Extract2 réf. ABility STIplex Resist+ RespiGUARD4plex SARS-CoV-2 RT-qPCR DETECTION KIT98/79 Smart GUARD	A, B, C IVDR, 98/79	Présent sur le marché en France Site web contact@appolonbioteck.com Fiche EUDAMED Signaler une erreur
Atom Scientific Mandataire UE : Advena Limited (Malte)	United Kingdom (ex Northern Ireland)	Acetic Acid 0.5% Solution Biological Stain3 réf. Acetic Acid 10% Solution Stains (Histolab)3 réf. Acetic Acid 5% Solution Fixatives (Histolab)3 réf. AFB Stain Kit (Light Green Counterstain)3 réf. Alcoholic Formalin 10% Cytology Fixative Solution3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Avecon Healthcare Mandataire UE : Amstermed B.V. (Pays-Bas)	Inde	AutoMax4 réf. MAXCLEAN MAXCOUNT6 réf. MAXCOUNT BH5603 réf. MAXLYTE	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Azubio Diagnostics Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Pen A46060H11 Pen A47660H11 Pen A48410H11 Pen A49560H11 Pen A4D660H11	C IVDR	Fiche EUDAMED Signaler une erreur
B.P.C. Biosed –	Italie	Automated Biochemistry Analyzer GLOBAL 240 Automated Biochemistry Analyzer < 400 tests/h2 réf. Automated Biochemistry Analyzer GLOBAL 400 Automated Biochemistry Analyzer > 400 tests/h3 réf. EXTRA CLEANING CO40152 réf. KENZA MAX PLUS BioChemisTry PHOTOMETER SOLEA QUICK - COAGULOMETER 1 CHANNEL, including accessories	A IVDR	Site web info@bpcbiosed.it Fiche EUDAMED Signaler une erreur
Becton Dickinson UK FDA Mandataire UE : Becton Dickinson Ireland Limited (Irlande)	United Kingdom (ex Northern Ireland)	BD Vacutainer® EDTA Blood Collection Tube45 réf.98/79 BD Vacutainer® Heparin Blood Collection Tube21 réf.98/79 BD Vacutainer® PST™ II Blood Collection Tube11 réf.98/79 BD Vacutainer® SST™ II Advance Blood Collection Tube39 réf.98/79 BD Vacutainer® Z (No Additive) Plus Urine Tube12 réf.98/79	– 98/79	Présent sur le marché en France Site web eudamedenquiries@bd.com Fiche EUDAMED Signaler une erreur
Beijing Biosynthesis Biotechnology Mandataire UE : Medunion S.L. (Espagne)	Chine	CD20 Antibody Reagent (Immunohistochemistry) Cytokeratin 14 Antibody Reagents (Immunohistochemistry) Mucin 2 Antibody Reagents (Immunohistochemistry) P-53 Tumor Suppressor Protein Antibody Reagent (Immunohistochemistry) Vimentin Antibody Reagent (Immunohistochemistry)	A IVDR	Fiche EUDAMED Signaler une erreur
Bioteke FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	AU1001,AU1001S,AU1001-963 réf. BF4096 BTK-16 BTK-8, BTK-12 réf. ZK1000-1, ZK1500-1, ZK1000-5, ZK1500-2, ZK1500-3, ZK1500-4, ZK1500-53 réf.	A IVDR	Présent sur le marché en France Site web info@bioteke.cn Fiche EUDAMED Signaler une erreur
Boule FDA	Suède	Medonic M-serie Diluent 20L3 réf. Medonic M-series M32 B3 réf. Micro pipette, plastic EDTA 1x100 Swelab Alfa ComboPack 2003 réf. Swelab Alfa Plus Basic3 réf.	A, B IVDR	Site web info@boule.com Fiche EUDAMED Signaler une erreur
B·R·A·H·M·S FDA	Allemagne	B·R·A·H·M·S IL-6 KRYPTOR B·R·A·H·M·S IL-6 KRYPTOR CAL B·R·A·H·M·S IL-6 KRYPTOR QC B·R·A·H·M·S KRYPTOR compact PLUS B·R·A·H·M·S KRYPTOR GOLD	A, C IVDR	Fiche EUDAMED Signaler une erreur
Centralsurgical FDA Mandataire UE : KHANG BAO INTERNATIONAL KFT (Hongrie)	Pakistan	Forceps Jar FJ Instruments Boxes IB Instruments Tray IT Kidney Tray KT Scalar Trays ST	I MDR	Site web Fiche EUDAMED Signaler une erreur
Cerascreen	Allemagne	cerascreen® Candida Test3 réf. cerascreen® Eisen Test3 réf. cerascreen® STI Test3 réf. Cortisol Test3 réf. Zöliakie Test3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
CoaguSense FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	Coag-Sense Control Test Strip Kit - 10 Count 03P69-1098/79 Coag-Sense Prothrombin Time (PT) /INR Monitoring System 00850040656473 Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit 10021898/79 Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit 20020998/79 Coag-Sense® Prothrombin Time (PT) / INR Monitoring System Meter Model P/N 200107; Catalog Number 03P70-01	A, C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Cytecs	Allemagne	CD4 count kit98/79 CD4 count kit - dry98/79 CD4% Kit98/79 CD4% kit - dry98/79 Rapid Fluorescent Malaria Test - UV98/79	– 98/79	Site web info@cytecs.com Fiche EUDAMED Signaler une erreur
Cytogen FDA	Allemagne	Amnioquick98/79 CytogenAmnio2 réf.98/79 CytogenLympho2 réf.98/79 CytogenMarrow2 réf.98/79 CytogenPrena98/79	– 98/79	info@cytogen.net Fiche EUDAMED Signaler une erreur
DFI FDA Mandataire UE : MDSS GmbH (Allemagne)	Corée du Sud	CTBOW Reader 300 CYBOW Reader 3003 réf. CYBOW R-50S3 réf. CYBOW R-600S3 réf. CYBOW R-60S3 réf. UriDoctor R-50S98/79	A IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Elektromed	Pologne	PATHOSOLUTIONS - ClearFix, 1L3 réf. Pathosolutions - Parafina Histopatologiczna Premium 1 kg3 réf. Pathosolutions - Pojemniki do transportu materiału chirurgicznego 100ml3 réf. Pathosolutions - Szkiełka Mikroskopowe Podstawowe, szlifowane krawędzie, lakierowane, kolorowe pole niebieskie3 réf. Pathosolutions Premium - Pojemnik do transportu materiału 15ml2 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Euromex	Pays-Bas	Achios-X Observer bScope Delphi-X Observer iScope Oxion	A IVDR	Site web info@euromex.com Fiche EUDAMED Signaler une erreur
Exbio FDA	Tchéquie	CD34 QuantiFlowEx Kit DryFlowEx TBNK 6-color KOMBITEST B/NK Cell 4-color KOMBITEST T Cell 4-color KOMBITEST TBNK 6-color	C IVDR	Site web info@exbio.cz Fiche EUDAMED Signaler une erreur
FertiPro FDA	Belgique	Blue Collect IB_CD01 DRD Blood DRDB_1 LeucoScreen Plus LEUCO_PLUS3 réf. Spermac Stain - 4x250ml SPS050 / SPS2503 réf. VitalScreen3 réf.	A, B IVDR	Site web info@fertipro.com Fiche EUDAMED Signaler une erreur
Foracare FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Suisse	4SURE SMART98/79 FORA Diamond GD5098/79 FORA Diamond GD50 Blood Glucose Monitoring System98/79 FORA Diamond PRIMA Systém na sledování hladiny cukru v krvi98/79 TESTAmed GlucoCheck ADVANCED98/79	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Globescientific	Pays-Bas	Centrifuge, Clinical, Enhanced3 réf. Centrifuge, Hematocrit, 24-Place Cover Glass3 réf. Diamond White Glass Slides, 25 x 75mm, Charged, 45° Beveled Edges, Safety Corners, White Frosted3 réf. Microscope Slides, Diamond White Glass, 25 x 75mm, 45° Beveled Edges, Clipped Corners, Frosted: 1 End, 1 Side3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Golias	Slovénie	Epruveta 11 x 70mm Test tubes3 réf. Epruveta 12 x 75mm Test tube2 réf. Epruveta za določanje sedimentacije Tube for Urine Sediment Analysis3 réf. Petri dish fi 90mm ster. A Petrijevka fi 90mm K3 réf. Posodica za vzorec s pokrovom 120ml3 réf.	A IVDR	Site web info@golias.si Fiche EUDAMED Signaler une erreur
Guangzhou Biotron Technology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Human Papillomavirus (HPV) 15 Genotype Detection Kit (Fluorescent PCR-Melting Curve Method)2 réf.98/79 Human Papillomavirus (HPV) 31 Genotype Detection Kit (Fluorescent PCR-Melting Curve Method)2 réf.98/79 Human Papillomavirus (HPV) E6/E7 mRNA Genotyping Detection Kit (Fluorescent PCR Melting Curve Method)2 réf.98/79 Respiratory 12-Pathogen Nucleic Acid Detection Kit (Fluorescent PCR Melting Curve Method)2 réf.98/79 Respiratory 15-Pathogen Nucleic Acid Detection Kit (Fluorescent PCR Melting Curve Method)2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hamamatsu Mandataire UE : Hamamatsu Photonics Deutschland GmbH (Allemagne)	Japon	Agilent S540MD Slide Scanner System C17400-51MDEU NanoZoomer S20MD Slide scanner system C16300-21MDEU NanoZoomer S360MD Slide scanner system C13220-21MDEU NanoZoomer S540MD Slide scanner system C17400-21MDEU NanoZoomer S60v2MD Slide scanner system C16600-21MDEU	A IVDR	Site web sales@sys.hpk.co.jp Fiche EUDAMED Signaler une erreur
Hermle Labortechnik FDA	Allemagne	Centrifuge Micro 120V FC5513R IVD FRONTIER 5000 Series3 réf. FC5706P+R97 IVD FRONTIER3 réf. SC 2700 Z 167 M Non-refrigerated Centrifuges3 réf. Z 207 MK3 réf.	A IVDR	Site web info@hermleLT.de Fiche EUDAMED Signaler une erreur
i-SENS FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	i-Smart 30 Electrolyte Analyzer POCEAL001 i-Smart 30 PRO Electrolyte Analyzer POCEAL002 i-Smart 300 Blood Gas Analyzer POCBGAL001 i-SmartCare 10 Blood Gas Analyzer POCBGAL002 mylife Aveo Blood Glucose Meter GM02AAA3 réf.	A, C IVDR	Site web regulatory@i-sens.com Fiche EUDAMED Signaler une erreur
Igenesis Shanghai Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	12 reaction/kit98/79 12 reactions/kit18 réf. Galaxy CT/NG/UU Assay 12 reactions/kit Galaxy Lite3 réf. Influenza A Virus / Influenza B Virus/Respiratory Syncytial Virus Diagnostic Kit (PCR-Fluorescence)98/79	A, C IVDR, 98/79	support@igenesisbio.com Fiche EUDAMED Signaler une erreur
Innovacon Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	456482900098/79 456483900198/79 456484900198/79 456485900098/79 456487900198/79	– 98/79	Fiche EUDAMED Signaler une erreur
Jiangsu Kangjie Medical Devices Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	96Well Filter Tip with Box Embedding Cassette Glass CapillaryTube Microscope Cover Glass Sample Cup	I MDR	Fiche EUDAMED Signaler une erreur
Jinquanmedical Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	"WH-K180,WH-K200,WH-K220,WH-K240,WH-T320, WH-T330,WH-T340,WH-T350,JQ-002,JQ-003,JQ-T200" JQ-AU460,JQ-TS1000,JQ-TS2000,JQ-TS3000 JQ-DS50,JQ-DS60,JQ-DS70,JQ-DS80,JQ-DS90,JQ-DS100,JQ-DS200,JQ-DS300,WH-DR100,WH-DR200,WH-DR300,WH-DR50,WH-DR60,WH-DR70,WH-DR80,WH-DR90 JQ-FAC100，JQ-FAC200，JQ-FAC300，JQ-FAC400 WH-BM100,WH-BM120,WH-BM140,WH-BM160	A IVDR	sales1@jinquanmedical.com Fiche EUDAMED Signaler une erreur
Jokoh Mandataire UE : MDSS GmbH (Allemagne)	Japon	EX-D2 réf. Smart Rate 1098/79 Smart Rate 2098/79 Smart Rate 4098/79 Smart Sed3 réf.	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Junocare Mandataire UE : Humiss International B.V. (Pays-Bas)	Chine	EA/Orange-G Combo Stain2 réf. HEMATOXYLIN Stain2 réf. Precoat Slides4 réf. SUPERPap SUPERPap 480ml2 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Sti	Turquie	CERTAIN7 réf.98/79 CERTIN98/79 LABOQUICK9 réf.98/79 Laboquick LHAB.01 SURELAB6 réf.98/79	B IVDR, 98/79	Site web info@koroglugroup.com Fiche EUDAMED Signaler une erreur
Laborkrone	Allemagne	Blutentnahmeset - Kapillarblutröhrchen iFOBT - Früherkennung von Darmkrebs Mivolis Selbsttest mit Laboranalyse Eisen2 réf. PreNata NIPT Probenahmeset Urin	I, IIa MDR	Site web Fiche EUDAMED Signaler une erreur
Lansionbio Mandataire UE : JOYSUN GROUP S.L.U (Espagne) et 1 autre	Chine	D-Dimer Test Kit (Dry Fluorescence Immunoassay)98/79 FDP Test Kit (Dry Fluorescence Immunoassay)98/79 HCY Test Kit (Dry Fluorescence Immunoassay)98/79 IgE Test Kit (Dry Fluorescence Immunoassay)98/79 IL-6 Test Kit (Dry Fluorescence Immunoassay)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Medical Wire & Equipment Bath Mandataire UE : Advena Limited (Malte)	United Kingdom (ex Northern Ireland)	Microloop8 réf.98/79 Selenite Broth98/79 U-SWAB™ FECAL2 réf.98/79 U-SWAB™ FECAL DRY98/79 U-SWAB™ FECAL DRY– Scoop – 16x100 Vial – Dry98/79	– 98/79	Présent sur le marché en France Site web info@mwe.co.uk Fiche EUDAMED Signaler une erreur
Microbix FDA Mandataire UE : Obelis s.a. (Belgique)	Canada	REDx HPV 16 Positive Control RED-62-163 réf. REDx Mycoplasma genitalium Positive Control RED-63-01 REDx SARS-CoV-2 Negative Control RED-19-013 réf. REDx STI Negative RED-99-M1 REDxFLOQ Respiratory Swab Negative Control RED-S-99-012 réf.	B IVDR	Site web customer.service@microbix.com Fiche EUDAMED Signaler une erreur
Microtrace	Italie	ALLERGIE (IgE Specifiche)2 réf. CALPROTECTINA3 réf. DISBIOSI INTESTINALE3 réf. MTR7023/K INTOLLERANZE ALIMENTARI3 réf. Sistema di raccolta campioni di saliva per invio e analisi di laboratorio - PROFILI ORMONALI3 réf.	A IVDR	Site web office@microtrace.it Fiche EUDAMED Signaler une erreur
Nanjing Superfit I & E Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Superfirt 1.5*75mm red bottle/blue bottle2 réf. Superfirt 10ml/20ml/30ml/40ml/60ml/80ml/100ml /120ml/250ml3 réf. Superfirt 18x18mm,20x20mm,22x22mm,24x24mm, 24x32mm,24x40mm,24x50mm,24x60mm3 réf. Superfirt 7101,7102,7103,7104,7105,7106,7107, 7107-1, 7105-1,7108,7109,7111,7112,71133 réf. Superfirt Square holes/strip holes/round holes/fine square holes/ O rings3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Nantong Mevid Life Scientific Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	CS01-1818,CS01-2020,CS01-2222,CS01-2424,CS01-2432,CS01-2240,CS01-2440,CS01-2450,CS01-2455,CS01-2460,CB01-1818,CB01-2020,CB01-2222,CB01-2424,CB01-2232,CB01-2432,CB01-2440,CB01-2250,CB01-2450,CB01-2455,CB01-2260,CB01-2460,etc EM01-101-16,EM11-102-16,EM01-105-16,EM11-106-16,EM04-104-08,EM11-101-16,EM01-102-17,EM01-102-08,EM01-106-16,EM01-106-02,EM04-103-16,EM01-102-16,EM11-105-16,EM01-106-08,EM04-104-12,EM01-116-16,EM15-116-16,EM11-115-16,EM15-115-12,etc MICROSCOPE SLIDES S101-2001,P101-2001,S105-2001,P105-1001,P105-2001,B105-2001,B105-2002 ,S107-2001,P107-2001,etc2 réf. MO01-0707,MO01-1515 ,MO01-2424,MO01-2430,MO01-2437 ,MO02-0707,MO02-1515,MO02-2424,MO02-2430,MO02-2437 SS112-000,SS103-000,SS010-000,SS020-000	A IVDR	Fiche EUDAMED Signaler une erreur
Natera FDA Mandataire UE : QbD RepS BV (Belgique)	États-Unis	Panorama Prenatal Screen Collection Kit NAT-801141 Prospera Transplant Assessment Collection Kit NAT-802305 Signatera Blood Collection Kit - Plasma for ctDNA NAT-802422 Signatera Blood Collection Kit - Whole blood for germline NAT-802419 Signatera Blood Collection Kit NAT-802296	A IVDR	Site web support@natera.com Fiche EUDAMED Signaler une erreur
Ningbo BESTest Bio-technology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	1 test/kit2 réf.98/79 25 tests/kit2 réf.98/79 5 tests/kit2 réf.98/79 Dengue IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma) 1 test/kit Dengue NS1 Antigen Rapid Test Kit(Colloidal Gold) 1 test/kit	B, C IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Optolane FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	LOAA Analyzer ONPOINT LOAA-M Console LOAA-M Module LAM304-01 LOAA-M POWERBOX LAM306-01 LOAA-M Powerbox System LAM306-01	A IVDR	info@optolane.com Fiche EUDAMED Signaler une erreur
Panreac Química, S.L.U	Espagne	PanReac AppliChem 2510863 réf. PanReac AppliChem 2529313 réf. PanReac AppliChem 253211 PanReac AppliChem 2564623 réf. PanReac AppliChem 256993	A IVDR	Fiche EUDAMED Signaler une erreur
Paul Marienfeld FDA	Allemagne	BGOT 5VT 100x26x3 rw fbk CE3 réf. DG 10 D N.0 V=100 STÜ Superior CE3 réf. DG 10 D N.1 V=100 STÜ Superior CE3 réf. Glaspl 100x75±0,3x1,35 Float fbk oMR V=100 Superior CE3 réf. HistoBond®+Control *K Float weiß V=100 Superior CE3 réf.	A IVDR	Site web info@marienfeld-superior.com Fiche EUDAMED Signaler une erreur
Poweam Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Electrolyte Analyzer EL-1100, EL-1100PLUS, EL-1200, EL-2200, EL-2300，EL-24003 réf. Hematology Analyzer WHY6180，WHY6280，WHY6380，WHY6380S，WHY6580，HA-5000，HA-5500，HA-6000，HA-7006，HA-7003，HA-70043 réf. Microscope 2016, 2016T, 2016L, 2005M, 2005N, 2005T, 2005V, 2005S, M2101, N2101, T2101, V21013 réf. Thermal Cycler WHYA10, WHYA20, WHYA30, Q200A, Q200B, Q200C, G100, WG100, G101, G200, M1601, M1601F, A08, A093 réf. Urine Analyzer WHY120FA, WHY130FA, WHY140FA, WHY160FA, WHY170FA&WHY160FA, WHY170FA3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
PreAnalytiX FDA Mandataire UE : QIAGEN GmbH (Allemagne)	Suisse	PAXgene 761165 PAXgene 762165 PAXgene 768165 PAXgene Blood RNA Kit QIAsymphony PAXgene Blood ccfDNA Kit	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Precision Biosensor FDA Mandataire UE : mdi Europa GmbH (Allemagne)	Corée du Sud	Exdia COVID-19 Ag98/79 Exdia D-dimer98/79 Exdia D-dimer 298/79 Exdia Strep A98/79 PBCheck COVID-19 Ag98/79	– 98/79	Site web info@precision-bio.com Fiche EUDAMED Signaler une erreur
Ravo	Allemagne	Helicobacter pylori p120 (CagA) ELISA98/79 Hemkit Aspergillus IHA98/79 Hemkit Candida IHA98/79 Hemkit Lyme IHA98/79 Leptospiren IHA98/79	– 98/79	Site web info@ravo.de Fiche EUDAMED Signaler une erreur
Remel FDA Mandataire UE : Thermo Fisher Diagnostics B.V. (Pays-Bas)	États-Unis	C. ALBICANS SCREEN R30851401 CRYPTOCOCCUS ANTIGENT LATEX TEST KIT98/79 XPECT C. DIFF TOXIN A/B KT/20TST98/79 XPECT FLU A&B CONTROL 20SWAB/SET KT/2SET98/79 XPECT FLU A&B TEST KIT98/79	B IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Shanghai Rendu Biotechnology Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	AmpSure® Chlamydia Trachomatis (CT) RNA Assay AmpSure® HPV 16/18 Genotype Assay AmpSure® HPV Assay Automatic Nucleic Acid Detection and Analysis System2 réf. RNA033 réf.	A, C IVDR	Fiche EUDAMED Signaler une erreur
Shenzhen AmTech Bioengineering Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	100 tests/kit98/79 2×1 mL (2 levels)98/79 6×1 mL (6 levels)98/79 R1: 2×45 mL, R2: 2×15 mL98/79 ST-280p	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Shenzhen Cinnaray Life Technology Mandataire UE : HUMISS TRADING S. L. (Espagne)	Chine	Cleaning A038500mL3 réf. DiLuent3 réf. Lyse3 réf. M-6FD, M-6FN, M-6FR, M-68FD, M-68FN, M-68FR, 4DS, RET, PLT, WDF, WNR, WPC, FDN-D, FDN-R, Z8 FD, Z8 FN, Z8 FR, DD-5, F-FD, F-FW3 réf. X3000, X3100, X5000, X5100, X5200, X5300, CF9600, CH8600CS, CH8600/CRP, CH8500/CRP, CH8300/CRP3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Shenzhen Everbest Machinery lndustry Mandataire UE : Kingsmead Service B.V. (Pays-Bas) et 1 autre	Chine	Real-Time PCR System FZ-100 Real-Time PCR System FZ-3840 Real-Time PCR System FZ-80 Real-Time PCR System FZ-960 TQ-96	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Shenzhen Huian Biosci Technology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	1T/Kit16 réf.98/79 20T/Kit17 réf.98/79 5T/Kit9 réf.98/79 REF206-00198/79 REF206-02098/79	– 98/79	info@huiantech.com Fiche EUDAMED Signaler une erreur
Shenzhen Sciarray Biotech Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	1 test/ kit98/79 10 tests/ kit98/79 20 tests/ kit98/79 3 tests/ kit98/79 5 tests/ kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Shenzhen Shengqiang Technology Mandataire UE : HUMISS TRADING S. L. (Espagne)	Chine	Innosensia Expert G1A3 réf. Slide Scanning System Innosensia Plus G1A3 réf. Slide Scanning System SQD-12P Slide Scanning System SQD-40P2 réf. Troica ASC	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Sikun Mandataire UE : Obelis s.a. (Belgique)	Chine	Gene Sequencer (Sikun 2000 & Sikun 1000 & Sikun 500 & Sikun 2000 pro & Sikun 1000 pro & Sikun 500 pro)3 réf. Gene Sequencer Sikun Rapid GS 480 Library Prep Consumables(for Library Construction) Full-Skirted PCR Plate, Full-Skirted PCR Plate, Round Deep Well Plate, Squarel Deep Well Plate, 7#Tip, 8#Tip, SIKUN Waste Container, Semi-Skirted PCR Plate, Aluminum Sealing Film, Strip Holder, Reagent Reservoir, PCR Sealing Mat3 réf. Library Prep Consumables(for Nucleic Acid Extraction) 1#Magnetic Bead Sleeves, 2#Magnetic Bead Sleeves2 réf. Library Prep Consumables(for Quality Control) QC Kit, Qubit Assay Tube, 9#Tip3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Sophonix Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Automated Chemiluminescent Immunoassay Analyzing System Aceso 80A2 réf. Automated Chemiluminescent Immunoassay Analyzing System MS-Fast Automated Chemiluminescent Immunoassay Analyzing System MS-Fast pro 160 Automated Chemiluminescent Immunoassay Analyzing System MS-Fast pro 240 Automated Chemiluminescent Immunoassay Analyzing System MS-Fast pro 80	A IVDR	Fiche EUDAMED Signaler une erreur
Sugentech FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	5μL Capillary tube pettyPip S-Blot 3 S-Blot 3 PLUS Surearly SMART	A, B IVDR	ra@sugentech.com Fiche EUDAMED Signaler une erreur
SysCan MedTech (Suzhou) Mandataire UE : Obelis s.a. (Belgique)	Chine	Automatic Coagulation Analyzer AutoCimo C6003 réf. Automatic Coagulation Analyzer AutoCimo C60003 réf. Automatic Coagulation Analyzer Ci-120/Ci-120i/Ci-120x/Ci-120n3 réf. Automatic Coagulation Analyzer Ci-300/Ci-310/Ci-320/Ci-3303 réf. Sample Processing System SSDM16-A2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
TECOmedical Mandataire UE : EUROBIO SCIENTIFIC (France)	Suisse	TECO® Aspergillus Galactomannan ELISA kit98/79 TECO® Fast Aspergillus Galactomannan Ag Lateral Flow Assay98/79 TECO® Fast Candida IgG Ab Lateral Flow Assay98/79 TECO® Fast Candida Mannan Antigen Lateral Flow Assay98/79 TECO® Fast Cryptococcus neoformans Ag Lateral Flow Assay98/79	– 98/79	Site web info@tecomedical.com Fiche EUDAMED Signaler une erreur
Thermo Electron Led Zweigniederlassung Osterode	Allemagne	Themo Scientific Pico 213 réf. Thermo Scientific S2T IVD-MD GP1 Pro3 réf. Thermo Scientific C1FR IVD-MD3 réf. Thermo Scientific Medifuge Thermo Scientific Megafuge ST4 Plus-MD GP4 Pro3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Translite FDA Mandataire UE : E C REP LIMITED (Irlande)	États-Unis	Veinlite EMSPRO VEMSPRO93/42 Veinlite LED+ VLED+93/42 Veinlite LEDX VLEDX93/42 Veinlite NEO VNEO93/42 Veinlite PEDI2 VPEDI293/42	I 93/42	Site web info@veinlite.com Fiche EUDAMED Signaler une erreur
Ventana Medical Systems FDA Mandataire UE : Roche Diagnostics GmbH (Allemagne)	États-Unis	Jones Stain Core Kit Special Stains Eosin CS Special Stains Nuclear Fast Red CS VENTANA CD15 (MMA.P8) Mouse Monoclonal Antibody VENTANA MTAP (SP530) Rabbit Monoclonal Antibody	A, C IVDR	Fiche EUDAMED Signaler une erreur
Viuick Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	VIUICK98/79 VIUICK Diagnostic Kit for Enterovirus type 71/ Coxsackievirus type A16 RNA (Real-Time PCR Method)98/79 VIUICK Diagnostic Kit for Herpes simplex virus type 1/2 DNA (Real-Time PCR Method)98/79 VIUICK Diagnostic Kit for Human Papilloma Virus 14 High-Risk Genotyping DNA (Real-Time PCR Method)98/79 VIUICK Diagnostic Kit for Influenza virus/Respiratory syncytial virus/2019-nCoV RNA (Real-Time PCR Method)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Zhejiang Wantaifu Biotechnology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	Bio-Firm WI-FLU-C82-1098/79 Bio-Firm WI-FLU-C82-2598/79 Bio·Firm WI-MICR-C43A-1098/79 Bio·Firm WI-MICR-C43A-2598/79 Fulscreen WI-FLU-C82A-2598/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Etablissement Francais Du Sang	France	NatQal B19-L NatQal 23 réf. NatQal HBV NatQal 13 réf. SeroQal ALINI 63 réf. Trousse NG-Mix Multiloci98/79 SeroQal MALARIA 10198/79 (plus commercialisé)	B IVDR, 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Grundium	Finlande	Grundium Ocus40 MGU-00003 MGU-00005 Ocus M 20 MGU-30009 Ocus M 40 MGU-30008 Grundium Ocus MGU-00001 (plus commercialisé)	A IVDR	Site web support@grundium.com Fiche EUDAMED Signaler une erreur
PathoFinder	Pays-Bas	RealAccurate® Quadruplex Bordetella PCR Kit PF0975-R98/79 RealAccurate® Quadruplex Corona PCR kit PF0971-R98/79 RealAccurate® Quadruplex Mycobacteria PCR kit PF0920-R98/79 RealAccurate® Quadruplex Parainfluenza PCR kit PF0972-R98/79 RealAccurate® Quadruplex Influenza PCR Kit PF0970-R (plus commercialisé)	B IVDR, 98/79	Site web info@pathofinder.com Fiche EUDAMED Signaler une erreur
Actim FDA	Finlande	Actim® Influenza A&B 32832ETAC98/79 Actim® Influenza A&B 32834ETAC98/79 Actim® Influenza A&B 32836ETAC98/79 Actim® Influenza A&B 32837ETAC98/79	– 98/79	Site web support@actimtest.com Fiche EUDAMED Signaler une erreur
Alifax FDA	Italie	JO-PLUS SI 195.210/THL3 réf. M-SHAKER SI 2301.100 M-SMASHER KIT2 réf. PEN OK	A IVDR	Site web regulatory@alifax.com Fiche EUDAMED Signaler une erreur
Aquisel FDA	Espagne	AQUISFEK SAF 3,3 mL AQUISEL AQUISFEK2 réf. E.S.R. Pipette P-2 for tube 13x75 / 12x86 AQUISEL Erythrocyte Sedimentation Rate Devices3 réf. Plus-Sed auto2 réf. Tube 11x40 - 9NC / 3Na Citrate 3.2% coagulation - 0.5 mL AQUISEL Blood Collection Tubes3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Archem	Turquie	DS DILUENT DS DILUENT Please see UDI-DIs for details. G6PDH REAGENT98/79 PROBE CLEANSER Please see UDI-DIs for details.2 réf.	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Behnk	Allemagne	Thrombo C22 réf. Thrombolyzer Compact X3 réf. Thrombostat3 réf. Thrombotimer 13 réf.	A IVDR	Présent sur le marché en France Site web regulatory@behnk.de Fiche EUDAMED Signaler une erreur
Beijing North Institute of Biotechnology Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	BNIBT RI003C98/79 BNIBT RI003C-2098/79 Microplate Reader NBI 0960E Microplate Washer NBI 0120E	A IVDR, 98/79	info@eugenebio.com Fiche EUDAMED Signaler une erreur
Beijing OriginPoly Bio-Tec Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	(12 tests), (24 tests), (48 tests)3 réf. CISVECO®98/79 CISVECO® 24 tests/kit98/79 CISVECO® 48 tests/kit98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Benoylab Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	18x18mm,20x20mm,22x22mm,24x24mm, 24x32mm,24x40mm,24x50mm,24x60mm 20ml、30ml、40ml、60ml，90ml、100ml、120ml、125ml2 réf. 30ml,40ml,60ml,100ml,120ml 7101、7102、7103、7104、7105、7105-1、7106、7107、7107-1、7108、7109、7110、7111、7112、71132 réf.	A IVDR	Sale02@benoylab.com Fiche EUDAMED Signaler une erreur
Bio-Novum	Pologne	BN SARS CoV 2 Ag Rapid Test98/79 BN SARS CoV 2 IgG/IgM Rapid Test98/79 BN Syphilis Rapid Test98/79 TestiQ	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Boettger	Allemagne	Tube Stool3 réf. Urine Cup with self-adhesive Lid Urine Cups and Screw Caps3 réf. Urine Cups and Snap Caps3 réf.	A IVDR	Site web sales@boettger.com Fiche EUDAMED Signaler une erreur
Bosurebio Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	HC-20198/79 Hemoglobin Control Solution HC-10198/79 Hemoglobin Test Strips BS-10198/79 Urine Analyzer UA-20198/79	– 98/79	Présent sur le marché en France Site web info@bosurebio.com.cn Fiche EUDAMED Signaler une erreur
C.S.A. Service	Italie	Microscope slide box double room VTR052 réf. VTR01 - Microscope slide 7102 VTR02 - Microscope slide 7105 VTR04 - Microscope slide 7107	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Calth Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	AllCheck Dengue Duo Card CHR07 AllCheck Dengue NS1 Ag Card CHR17 Allcheck Influenza A+B CHR0898/79 AllCheck Syphilis Anti-TP CHR20	C IVDR, 98/79	Site web info@thecalth.com Fiche EUDAMED Signaler une erreur
Cellabs Mandataire UE : WMDE B.V. (Pays-Bas)	Australie	Chlamydia CEL IFA (200T)98/79 Chlamydia CEL IFA KC1-50T98/79 Chlamydia CEL PN IFA KC398/79 Chlamydia CEL PN IFA KC3-B98/79	– 98/79	Présent sur le marché en France Site web enquiries@cellabs.com.au Fiche EUDAMED Signaler une erreur
Changchun Chenyu Taikang Medical Laboratory Mandataire UE : MedPath GmbH (Allemagne)	Chine	Automated coagulation analyzer Shine-C900 Automatic Hematology Analyzer TB-30002 réf. Automatic Hematology Analyzer TB-50003 réf. Portable coagulation analyzer Shine-mini	A IVDR	Fiche EUDAMED Signaler une erreur
Contecmed FDA Mandataire UE : Prolinx GmbH (Allemagne)	Chine	Blood Glucose Meter BGM10A，BGM10A-BV，BGM10A-L，BGM10B，BGM10B-BV，BGM10B-L，BGM10C，BGM10C-BV，BGM10C-L，BGM10D，BGM10D-BV，BGM10D-L，BGM10E，BGM10E-BV，BGM10E-L，BGM10F，BGM10F-BV，BGM10F-L，BGM10G，BGM10G-BV，BGM10G-L3 réf. Semi-auto Biochemistry Analyzer BC300 Urine Analyzer BC400 Urine analyzer BC401	A, C IVDR	Présent sur le marché en France Site web pms.qms@contecmed.com Fiche EUDAMED Signaler une erreur
Diagast FDA	France	BROMELINE3 réf. LISS2 réf. PALERM Papain QWALYS	A IVDR	Présent sur le marché en France Site web contact@diagast.com Fiche EUDAMED Signaler une erreur
Diamond Diagnostics FDA Mandataire UE : Diamond Diagnostics Inc. Magyarországi Fióktelepe (Hongrie)	États-Unis	0-DD-PROLYTE Electrolyte analyzer 0-DD-SMARTLYTEPLUS Ion Selective Analyzer 0-DD-CARELYTEPLUS ISE Analyzer 0-DD-Unity	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Diazyme FDA Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	Diazyme D-Dimer Assay2 réf.98/79 Diazyme D-Dimer Calibrator Set98/79 Diazyme D-Dimer Control Set98/79 Diazyme Stool Collection Vial98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
EKF-diagnostic FDA	Allemagne	CompoLab TM Plus2 réf. DiaSpect Control Pack HBT13 réf. Hb-con Set 23 réf. Hemo Control Hemoglobin Microcuvette3 réf.	B IVDR	info@ekf-diagnostic.de Fiche EUDAMED Signaler une erreur
El-Comp Cezary Kostuch	Pologne	pojemnik jałowy na mocz Sterylny pojemnik na mocz 120 ml pojemnik na kał sterylny 20 ml Sterylny pojemnik na kał 20 ml POJEMNIK NIEJAŁOWY NA MOCZ Niesterylny pojemnik na mocz 120 ml UNSTERILE STUHLPROBENBEHÄLTER KAPAZITÄT 20 ML Niesterylny pojemnik na kał 20 ml	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Elisabeth	Tchéquie	EliGene® COVID19 Triple RIC RT98/79 EliGene® Influenza A/B/pandemic LC98/79 EliGene® Mycoplasma pneumoniae UNI98/79 EliGene® STD GAR/URE/MYC RT98/79	– 98/79	Site web info@elisabeth.cz Fiche EUDAMED Signaler une erreur
Fisher Diagnostics A division of Fisher Scientific Mandataire UE : B·R·A·H·M·S GmbH (Allemagne)	États-Unis	100356, J10035698/79 100402, J10040298/79 100403, J10040398/79 100607, J10060798/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
for you eHealth	Allemagne	for you aminogramm3 réf. for you darm-schlank-index3 réf. for you hormon-status frau3 réf. for you plastik test	I, IIa MDR	Site web info@foryouehealth.de Fiche EUDAMED Signaler une erreur
GaDia Mandataire UE : ER Egészségügyi, Kereskedelmi és Szolgáltató Kft. (Hongrie)	Suisse	CandiDia-Antibody98/79 FungaDia-Aspergillus ELISA98/79 FungaDia-Aspergillus Rapid Test98/79 SchistoDia Antibody SCH-02598/79	– 98/79	Présent sur le marché en France Site web info@gadia.net Fiche EUDAMED Signaler une erreur
Genfine Mandataire UE : MedPath GmbH (Allemagne)	Chine	DNA/RNA Extraction Kit(Column) D102：200preps/box3 réf. DNA/RNA Extraction Kit(Magnetic Beads) 101-B: 25preps/box3 réf. Virus DNA/RNA Kit(Column) D501:200preps/box3 réf. Virus DNA/RNA Kit(Magnetic Beads) 502-B: 480preps/box3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Guangdong Hao Jiang Laboratories Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	"HC1：1L、1L×20、5L，HC2：500mL、1L、5L、10L、20L， HC4：500mL、1L、2L、5L、5.5L、10L、20L，HC5：500mL、5L；SKC：1L、10L， WB：1L、5L、10L。C31：50mL、50mL×2、18L。 C2E：100mL、100mL×2" DD5：42mL、42mL×3,4DS：42mL、42mL×3，M68FD：48mL、48mL×4,WNR：82mL、82mL×2，WDF：22mL、22mL×2、42mL、42mL×2，RET：12mL、12mL×2， M60FD：12mL、12mL×4、48mL、48mL×4， M60FN：12mL、12mL×4、48mL、48mL×4，etc HD1：10L、20L，HD2：10L、20L，HD3：5L、10L、20L，HD4：20L，HD5：20L，HD6：20L，D22：20L，52D：5.5L、10L、20L，D86：10L、20L，72D：20L，RD86：20L，SKD：2L、5L、20L，GD5：20L，etc. HL1：400mL、500mL、1L、20L，HL2：15mL、17mL、17mL×18，HL3：1L、5L，HL4：500mL、500mL×3、5L，HL5：500mL、1L， HL7：100mL、500mL、1L，HL8：1L，etc	A IVDR	Fiche EUDAMED Signaler une erreur
Guangdong RunPon Bioscience Mandataire UE : Share info GmbH (Allemagne)	Chine	Automatic Nucleic Acid Detection Analyzer Ideal 30 Automatic Nucleic Acid Detection Analyzer Ideal 36 Automatic Nucleic Acid Detection Analyzer Ideal 66 Real-time PCR Instrument P810	A IVDR	Service_RP@fapon.com Fiche EUDAMED Signaler une erreur
Guangzhou Deaou Gene Technology Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne) et 1 autre	Chine	4 tests/kit5 réf.98/79 8 tests/kit5 réf.98/79 Deaou-ART04 Deaou-RT96	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Guangzhou Xiuwei Technology Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne) et 1 autre	Chine	Laser slide printer XW-JZB-416,XW-JZB-516,XW-JZB-616,XW-JZBD-212 XW-3325, XW-3655, XW-S7120-A、XW-CU1200、 XW-CU1200A, XW-CU1200B, XW-CU1200C, X7 Elite, X7 Elite Pro、X7 Elite X、X7 Elite Plus、X7 Elite Smart、X7 Elite Ascend、X7 Elite S、etc XWM-A, XWM-B、XWM-C、XWM-D、XWM-E、XWM-F、XWM-G、XWM-H、XWM-I、XWM-J、XWM-K、XWM-L、XWM-M、XWM-N, etc XWS-A、XWS-B, XWS-C、XWS-D、XWS-E, XWS-F、Auto ST、Auto STO、Auto STE、Auto STS	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Hangzhou Aokai Biotech Mandataire UE : JOYSUN GROUP S.L.U (Espagne) et 1 autre	Chine	AllDx CS10598/79 AllDx S10598/79 No brand M-GA No brand M-GB	A IVDR, 98/79	info@aokais.com.cn Fiche EUDAMED Signaler une erreur
Hangzhou New Horizon Health Technology Mandataire UE : MedPath GmbH (Allemagne) et 1 autre	Chine	1 Test/ Kit 48 tests/ kit98/79 ColoClear 1 test/kit UU Tube 1 test/ kit	A, C IVDR, 98/79	Site web compliance@nhbio.com.cn Fiche EUDAMED Signaler une erreur
Hebei Sanxin Pharmaceutical Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	D-Dimer Fluorescent Immunochromatographic Assay (FIA) Kit 25 tests per box98/79 Disposable Urine Specimen Sampler Ⅰ 10mL Ⅰ 12mL Ⅰ 10mL Ⅰ 12mL Ⅱ 10mL Ⅱ 12mL Ⅱ 10mL Ⅱ 12mL3 réf. Fluorescent Immunochromatographic Analyzer S-300 IL-6 Fluorescent Immunochromatographic Assay (FIA) Kit 25 tests per box98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
HemoCue FDA	Suède	HemoCue Plasma/Low Hb Microcuvettes3 réf.98/79 HemoCue WBC DIFF Analyzer3 réf. HemoCue WBC DIFF Microcuvettes4 réf.98/79 HemoCue WBC Microcuvettes3 réf.98/79	A IVDR, 98/79	Présent sur le marché en France Site web info@hemocue.se Fiche EUDAMED Signaler une erreur
Hemonart	Turquie	ACT Analyzer ACT instrument98/79 BlacT ACT Test Tube98/79 PlacT ACT Test Tube98/79 Whole Blood Quality Controls98/79	– 98/79	Site web info@hemonart.com Fiche EUDAMED Signaler une erreur
High Technology FDA Mandataire UE : MedEnvoy Global BV (Pays-Bas)	États-Unis	HTI CL-50 Plus HTI CL-500 HTI MicroCC20-Plus HTI MicroCC25-Plus	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Huron Technologies International Mandataire UE : 4 Easy Prrc 2 Smart Mdr, Lda (Portugal)	Canada	SlideVault TISSUESCOPE LE120 TS-LE120 TS-iQ TS-LE	A IVDR	Site web regulatory@hurondigitalpathology.com Fiche EUDAMED Signaler une erreur
Huzhou Jierunxin Biotechnology Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	D-Dimer Test (Fluorescence Immunoassay)98/79 Helicobacter pylori Antigen Test (Colloidal Gold)98/79 Inter-leukin-6 Test (Fluorescence Immunoassay)98/79 Syphilis Antibody Test (Colloidal Gold)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Id Solutions	France	IDTM SARS-CoV-2/Influenza TriplexIDTM SARS-CoV-2/Influenza Triplex IDRESPI-P1-500 (FR) - Boîtes98/79 iSolutions™ Enteric Bacteria & C. difficile Fullplex qPCR IS-ENTBAC-CD-100 (FR) - Boîtes98/79 iSolutions™ Enteric Virus Fullplex qPCR IS-ENTVIR-100 (FR) - Boîtes98/79 iSolutions™ Essential Enteric Bacteria Fullplex qPCR IS-ENTBAC-100 (FR) - Boîtes98/79	– 98/79	Présent sur le marché en France Site web info@id-solutions.fr Fiche EUDAMED Signaler une erreur
igenetech Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Corée du Sud	DiaPOC Dx100 DiaPOC Dx200 MoiM Dx100 MoiM Dx200	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Illumina FDA Mandataire UE : Illumina Netherlands B.V. (Pays-Bas)	États-Unis	Illumina DRAGEN® Server for NextSeq550Dx NextSeq™ 550Dx Instrument2 réf. iScan™Dx MiSeq™Dx Instrument NovaSeq™ 6000Dx Instrument	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Immunotech FDA	France	AQUIOS STEM CD34 Control Cells AQUIOS STEM kit Stem-Kit™ Reagents Stem-Trol Control Cells	C IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Islandpolymer	Allemagne	IPI Pathomat® IPI Pathoslide IPI Pathoslide® 2.0 IPI Pathotape	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Jiezibio Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	10 tests/kit98/79 10tests/kit98/79 JIE-100 JIE-200	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Kangmei Tianhong Biotech (Beijing) Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Diagnostic Kit for Group A Rotavirus (Colloidal Gold) 10 Tests/box98/79 Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR) 12 Tests/kit98/79 Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR) 24 Tests/kit98/79 Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR) 48 Tests/kit98/79	– 98/79	Site web info@kindmay.com Fiche EUDAMED Signaler une erreur
Kolasa Spółka Jawna	Pologne	Barwnik Giemsy (roztwór) 100ml3 réf. EA-36 100ml3 réf. Formaldehyd 10% buforowany (Utrwalacz do badań histologicznych) 1kg3 réf. GRADISOL G Odczynnik do izolowania limfocytów i granulocytów 400ml3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Labpathexperts	Pologne	Microscope Slides, soda-lime white glass, with double frosted labeling field, 90 deg3 réf. Paraffin 54-57 deg C, Blue3 réf. Płyta chłodząca2 réf. Szkiełka mikroskopowe podstawowe ze szkła białego	I, A IVDR, MDR	Site web office@labpathexperts.com Fiche EUDAMED Signaler une erreur
LaCAR MDx Technologies FDA	Belgique	Targeted MS/MS Hemo screening assay J-LS-480PartA98/79 Targeted MS/MS Hemo screening assay J-LS-480PartB98/79 Targeted MS/MS Hemo screening assay J-LS-96PartA98/79 Targeted MS/MS Hemo screening assay J-LS-96PartB98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Life Technologies Grand Island Mandataire UE : Life Technologies Europe B.V. (Pays-Bas)	États-Unis	AmnioMAX C-100 Basal Medium 11269-0163 réf. KaryoMAX Colcemid Solution in HBSS2 réf. MarrowMAX Bone Marrow Medium2 réf. PB-MAX Karyotyping Medium 12557-0132 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Lockcon Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Suisse	Klic urine sample container Klic10 Blood Collection Accessoires Set T Klic10 Blood Collection Accessories Set T Klic10 Blood Collection Accessories AL Urine Vessel 180	IIa, A IVDR, MDR	Site web info@lockcon.ch Fiche EUDAMED Signaler une erreur
Macherey-Nagel FDA	Allemagne	NucleoMag® Dx Pathogen URYXXON® 500 URYXXON® Relax3 réf. URYXXON® Relax (Connect)	A IVDR	Présent sur le marché en France Site web sales@mn-net.com Fiche EUDAMED Signaler une erreur
Macrunbio Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	DS，DR LH，LD，LW MH-300，MH-600，MH-601，MH-609，MH-61098/79 MH-700，MH-710，MH-680，MH-681，MH-690，MH-69198/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Mascia Brunelli	Italie	Coagulase Plasma EDTA MICRO IDENTIFICATION2 réf. HEMOFAST2 réf. MIDI-SYSTEM ECOSAF PARASITOLOGY3 réf. STROMATOL2 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Matsunami Glass Ind FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Japon	APS Adhesive Glass Slide IHC Adhesive Glass Slide3 réf. FF-100 Hematology Glass Slide Fine Frost Preloaded Glass Slide3 réf. MV Glass LBC Adhesive Glass Slide	A IVDR	Fiche EUDAMED Signaler une erreur
Medipak Mandataire UE : AF Pharma Service Europe SL (Espagne)	États-Unis	UVLI Regular Covers3 réf. UVLI Slit-Top Covers3 réf. UVLI Tubing Covers3 réf. UVLI Zip Bags3 réf.	I MDR	info@medipak.com Fiche EUDAMED Signaler une erreur
Molarray Mandataire UE : Caretechion GmbH (Allemagne)	Chine	Full-Automatic Nucleic Acid Extraction and qPCR Analysis System MW-1600BL Portable Nucleic Acid Detection Instrument MAtriX-Mini Portable Nucleic Acid Testing Box Mini-Cube Real-time Quantitative Thermal Cycler MA-6000,P30,MA-3200Q,MA-5000,MA-6000P,MA-9600P,MAtrix-6,MAtrix-43 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Motic FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Motic AE31E AE2000 PX43 BIO3 réf. Motic Panthera E2 Panthera C2 Panthera DL Panthera Cloud PA43 PA53 BIO BA210E BA210LED BA310E BA310LED BA410E 50W BA410E 100W3 réf. MoticEasyScan One MoticEasyScan Pro 1 MoticEasyScan Pro 6 MoticEasyScan Infinity 60 MoticEasyScan Infinity 100 MoticEasyScan Pro 6N MoticEasyScan Infinity 60N MoticEasyScan Infinity 100N3 réf. MoticUltraScan 6 MoticUltraScan FL62 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Newmarket Biomedical FDA Mandataire UE : MDSS GmbH (Allemagne)	United Kingdom (ex Northern Ireland)	NewBio Syphilis EIA TA - 96 Test Kit98/79 Newbio TPHA 1003 réf. NewBio TPHA plus 100 test kit3 réf. PK7400 TP HA Reagent98/79	C IVDR, 98/79	Site web regulatory@new-bio.com Fiche EUDAMED Signaler une erreur
Nihon Kohden Firenze	Italie	Cleanac Detergent3 réf. Hemolynac-310 Lysing reagent for RBC2 réf. Hemolynac-5 Lysing reagent for WBC2 réf. Isotonac-3 Diluent2 réf.	A IVDR	Site web info@nkf.it Fiche EUDAMED Signaler une erreur
NovaGray	France	NovaGray RILA Breast98/79 NovaGray RILA Legacy Breast98/79 NovaGray RILA Legacy Prostate98/79 NovaGray RILA Prostate98/79	– 98/79	Présent sur le marché en France contact@nova-gray.com Fiche EUDAMED Signaler une erreur
Nuclear Laser Medicine	Italie	CHLAMYDIA TRACHOMATIS REAL TIME 2.0 Estrazione rapida di DNA genomico umano GEN-C 3.0 GEN-C Real Time	A, C IVDR	Site web quality@nlm.it Fiche EUDAMED Signaler une erreur
Objective Imaging Mandataire UE : Acorn Regulatory Consultancy Services Ltd (Irlande)	United Kingdom (ex Northern Ireland)	Glissando 20SL A002HR20SL-40-OBJ Glissando Desktop Scanner A002HR-40-OBJ Glissando RS2 Glissando RS20 A002HR-RS20-IVD	A IVDR	Site web Fiche EUDAMED Signaler une erreur
opTricon	Allemagne	Cube Reader3 réf. CubePlus3 réf. Microreader II OP2	A IVDR	Présent sur le marché en France Site web info@optricon.de Fiche EUDAMED Signaler une erreur
Radiometer FDA	Danemark	ABL9 Analyzer -Hardware - no printer AQT90 FLEX Analyzer D941P-240-85x1 safeCLINITUBES Blood Sampler Multipack with heparinized plastic capillaries and accessories. 85 µL, 1 vial of 250 units3 réf. Empty tube kit of 50 empty tubes, for AQT90 FLEX 944-230	A IVDR	Présent sur le marché en France Site web radiometerra_eu@radiometer.dk Fiche EUDAMED Signaler une erreur
Remi Health	Allemagne	Collection Kit 103 réf. Collection Kit 13 Collection Kit 4 STI Standard 5	I, IIa MDR	Site web Fiche EUDAMED Signaler une erreur
Renderbio Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Chemiluminescence Immunoassay Analyzer ICL-6E, ICL-12E Hemostasis Analyzer System IMTEG2 Hemostasis Analyzer System ITEG2, ITEG4, ITEG6, ITEG2+, ITEG4+, ITEG6+ High Throughput Automated Hemostasis Analyzer system IHTEG6, IHTEG12	A IVDR	Fiche EUDAMED Signaler une erreur
Riele	Allemagne	Photometer 40403 réf. Photometer 50102 réf. Photometer 505 Photometer 6802 réf.	A IVDR	Site web info@riele.de Fiche EUDAMED Signaler une erreur
Sakura Finetek Japan Mandataire UE : Sakura Finetek Europe B.V. (Pays-Bas)	Japon	Tissue-Tek® Coverslipping Film Tissue-Tek® Eosin For Prisma (Plus) standard solution reservoir Tissue-Tek® Glas™ Coverslips 24x50mm Tissue-Tek® Hematoxylin 3G For Prisma (Plus) standard solution reservoir	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
SC - Sanguis Counting Kontrollblutherstellungs- und Vertriebs	Allemagne	A-K-FIX Blutgasentnahmesystem steril, ~100 µl - 2,33 x 117 mm, ~100 I.U./ml Lithium-Heparin (balanciert)3 réf. Blutgasentnahmesystem, 1 ml Luer-Lock, ~50 I.U. elektrolytkompensiertes Heparin3 réf. Kapillarblutentnahmesystem, ~100 µl, EDTA-K2, Farbcode: lila3 réf. KBS-Kunststoff-Kapillaren, ~250 µl, EDTA3 réf.	A IVDR	Site web info@sanguis-counting.de Fiche EUDAMED Signaler une erreur
Schebo FDA	Allemagne	ScheBo Hb Smart Patient Set ScheBo Master Quick-Prep ScheBo Quick-Prep ScheBo Quick-Prep XL	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Shenzhen Lvshiyuan Biotechnology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	Flu A & Flu B & COVID-19 Ag Rapid Test Flu A & Flu B & RSV & COVID-19 Ag Rapid Test Kit (Colloidal Gold) HM003A3 SARS‐CoV‐2 Antigen Rapid Test Kit SARS‐CoV‐2 Antigen Rapid Test Kit (Colloidal Gold)	B IVDR	Site web Fiche EUDAMED Signaler une erreur
Shenzhen Uni-medica Technology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Uni-medica 64T, 96T, 384T, 100T, 300T, 1000T, 4800T2 réf. Uni-medica Fluorescent Immunoanalyzer Uni-medica NFAST 96, NFAST 32A2 réf. Uni-medica TypeB 100 tests/kit	A IVDR	Site web marketing@uni-medica.com Fiche EUDAMED Signaler une erreur
Sinopharm Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	0.2ml, 0.25ml, 0.5ml, 1ml 15ml, 20ml, 30ml, 40ml, 50ml, 60ml, 100ml, 120ml, 125ml No Additive, Clot Activator, Gel & Clot Activator, Sodium Citrate (1:4), Sodium Citrate (1:9), Sodium Heparin, Lithium Heparin, EDTA K2, EDTA K3, Sodium Fluoride No Additive, Clot Activator, Gel & Clot Activator, Sodium Citrate 3.8%, Sodium Citrate 3.2%, Sodium Heparin, Lithium Heparin, EDTA K2, EDTA K3, Sodium Fluoride	A IVDR	Fiche EUDAMED Signaler une erreur
Sinseng Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne) et 1 autre	Chine	CAS60 CAS70 CAS80 CAS902 réf. CLS60 Mini 60、CAS100、S120pro、CAS200、CAS300、CAS4002 réf. SXHA610/650/660/680 Diluent; HAS310/330/360/380 Diluent; SXHA610/650/660/680 DIFF Lyse; SXHA610/650/660/680 LH Lyse; HAS310/330/360/380 Lyse; Cleaner3 réf.	A IVDR	service@sinseng.com.cn Fiche EUDAMED Signaler une erreur
Sistat	Turquie	ESR 10 Erythrocyte Sedimentation Rate Analyser ESR 120 Erythrocyte Sedimentation Rate Analyser3 réf. MD-4 Semi Automated Coagulation Analyser OPTO-4 Semi Automated Coagulation Analyser SF-8000 Automated Coagulation Analyser	A IVDR	Site web info@sistat.com.tr Fiche EUDAMED Signaler une erreur
Suntrine Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	Preservation tube 513001 Saliva Sample Collector 904001 Saliva Sample Collector 904201 Viral Tranport Meidum Tube With Swab 903101	A IVDR	Présent sur le marché en France service@suntrine.com Fiche EUDAMED Signaler une erreur
Tem Innovations FDA	Allemagne	ROTEM® delta 200100 ROTEM® sigma 211000 ROTROL N 503-2498/79 ROTROL P 503-2598/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Tianjin Bai Lixin Bio-tech Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	Eosin Stain Hematoxylin and Eosin (H&E) stain Papanicolaou Stain A Hematoxylin Solution Papanicolaou Stain D EA/OG	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Trustmomed Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	TM201-001,TM201-002,TM201-003, TM201-004, TM201-005 TM201-006, TM201-007 TM206-1818,TM206-2020,TM206-2222,TM206-2424,TM206-2232,TM206-2432,TM206-2240,TM206-2440,TM206-2250,TM206-2450, etc TM206-7101,TM206-7102,TM206-7105,TM206-7105-D,TM206-7107-D,TM206-7107-5,TM206-7105SW,TM206-7107SW,TM206-7107B, TM206-7107G, etc TM207-503, TM207-504, TM207-505, TM207-506,TM207-507,TM207-508,TM207-509, TM207-510	A IVDR	sales@trustmomed.com Fiche EUDAMED Signaler une erreur
Visia Lab FDA	Italie	dIFine Automated Microscope dIFine M1 with camera dIFine M1 without camera Zenit FAST98/79	A IVDR, 98/79	Présent sur le marché en France Site web quality@visialab.com Fiche EUDAMED Signaler une erreur
Winnoz Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Taïwan	"Haiim" Vacuum-assisted blood collection system Cassette (Non-sterile) WH-0013 réf. "Haiim" Vacuum-assisted blood collection system Main Device (NPT) WH-002 eGGi Molecular Detection Calibration Strips-Green ED-001; ED-V-B0013 réf. Haiim Vacuum-assisted blood collection system Cassette-X (Non-sterile) WH-0032 réf.	A IVDR	Site web service@winnoz.com Fiche EUDAMED Signaler une erreur
Wizbiosolution Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Corée du Sud	CL0001P1 CL0016 CL2016 W73052-100	A IVDR	Fiche EUDAMED Signaler une erreur
Xiamen Sciendox Biological Technology Mandataire UE : MedPath GmbH (Allemagne)	Chine	Sample Container and Sampling Spoon3 réf. Sciendox ® Extraction Kit for Faecal Nucleic Acid (DNA) Sciendox ® Nucleic acid conversion and purification reagent Sciendox® Feces Sampling and Preservation Tube (DNA)	A IVDR	Fiche EUDAMED Signaler une erreur
Xiaogan Kuohai Medical Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	KH-BE,KH-BF,KH-BL,KH-BJ,KH-BL1，KH-BQ, KH-LQ3000,KH-LQ3100,KH-LQ3300,KH-LQ3500,KH-LQ3600,KH-LQ3700,KH-LQ3900 KUOHAI TECHNOLOGY3 réf. TISSUE SLIDE STAINER KH-S60 KH-S80 KH-S100 KH-S100 KH-S103 KH-S106 KH-S108 KH-F33 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Zentech FDA	Belgique	J-LS-480PartA98/79 J-LS-480PartB98/79 J-LS-96PartA98/79 J-LS-96PartB98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hmdbio FDA Mandataire UE : Luana Med. B.V. (Pays-Bas)	Taïwan	FIABiomed Precisa Blood Glucose Monitoring System98/79 GL GoodLife 001 Blood Glucose Monitoring System98/79 GlucoLeader Enhance Blood Glucose Monitoring System2 réf.98/79 GlucoLeader Enhance 2 Blood Glucose Monitoring System98/79 (plus commercialisé)	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Ae	Irlande	EZGEL EZPRF EZ2K EZPRF EZ4K	IIa MDR	Site web regulatory@ae.expert Fiche EUDAMED Signaler une erreur
Aehealth Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	1 test/kit, 5 tests/kit, 10 tests/kit, 20 tests/kit, 25 tests/kit, 30 tests/kit, 50 tests/kit, 100 tests/kit.98/79 2 x 1 x 0.6 mL98/79 LAFFINITE I, LAFFINITE II, LAFFINITE III, LAFFINITE Mini, LAFFINITE Plus98/79	– 98/79	sales@aehealth.com.cn Fiche EUDAMED Signaler une erreur
Alcor Scientific FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	iSED 112-00101 iSED PRO 112-00120-SYS miniiSED 112-01017	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
AmplexDiagnostics	Allemagne	eazyplex® Candida auris eazyplex® Pneumocystis jirovecii eazySNP C. auris FKS1 S639	C IVDR	info@amplexdiagnostics.de Fiche EUDAMED Signaler une erreur
Anga Anioła Tomasz Anioła	Pologne	Gąbki biopsyjne (cz)3 réf. Kasetki histopatologiczne bez przykrywki (b)3 réf. Przykrywki do kasetek histopatologicznych	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Aucheer Mandataire UE : MedPath GmbH (Allemagne)	Chine	Aucheer iMAGIN 1800 Chemiluminescence Immunoassay Analyzer Aucheer iRaTe 300 Dry fluorescence immunoassay analyzer Aucheer iSort 300 Dry fluorescence immunoassay analyzer	A IVDR	info_office@aucheer.net Fiche EUDAMED Signaler une erreur
Bamed	Tchéquie	Kazeta STANDARD bez víčka, barva bílá3 réf. Kazeta STANDARD bez víčka, Primera, barva bílá3 réf. Kazety UNI BÉŽOVÉ pro laserové tiskárny spojené páskou, víčko zvlášť3 réf.	A IVDR	info@bamed.cz Fiche EUDAMED Signaler une erreur
Bindingsite FDA Mandataire UE : The Binding Site Ireland Limited (Irlande)	United Kingdom (ex Northern Ireland)	EXENT® Analyser IE800 Optilite® Analyser IE700 TENCELL™ Cuvettes IK702	A IVDR	Site web info@bindingsite.com Fiche EUDAMED Signaler une erreur
Bio-Gram Diagnostics FDA	Allemagne	FixOstar - Hema Giemsa JetDye-AF3 réf. JaClean	A IVDR	Site web contact@bio-gram.de Fiche EUDAMED Signaler une erreur
Bioclarma	Italie	Plate PCR AMP98/79 SensiQuant Direct CELL Buffer98/79 SMART SNP Sample Diluent98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Biodatacorp Mandataire UE : mdi Europa GmbH (Allemagne)	États-Unis	Lupus Anticoagulant Confirmation Reagent (LACR) Micro Test Tubes PDQ, Platelet Function Centrifuge Model PDQ	A IVDR	Site web customer.service@biodatacorp.com Fiche EUDAMED Signaler une erreur
Biogenvet	Roumanie	Ansă de însămânțare/inoculare cu buclă dublă, volum calibrat 10µl și 1µl PLACA PETRI Ø 90 Vârf pentru micropipetă automata cu volum cuprins între 20-200 µl	I MDR	contact@biogenvet.ro Fiche EUDAMED Signaler une erreur
BioLegend FDA Mandataire UE : MedEnvoy Global BV (Pays-Bas)	États-Unis	Keratin 14 Polyclonal Antibody, Purified98/79 Keratin 5 Polyclonal Antibody, Purified98/79 Keratin 5 Polyclonal Chicken Antibody, Purified98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Biomed FDA	Allemagne	Hemafix® Blau2 réf. Hemafix® Fixierlösung2 réf. Hemafix® Rot2 réf.	A IVDR	Site web info@biomed.de Fiche EUDAMED Signaler une erreur
Biopanda	Irlande du Nord	Dengue Combo Rapid Test Cassette RAPG-DEC-00198/79 Dengue NS1 Rapid Test Cassette98/79 Malaria P.f. Rapid Test Cassette RAPG-MLR-00198/79	– 98/79	Site web info@biopanda.co.uk Fiche EUDAMED Signaler une erreur
Biosense Mandataire UE : MD&D Alliance GmbH (Allemagne)	Inde	FG00066 - CORALAB ACE HbChek Matrix AutoMini - 40	A IVDR	regulatory.affairs@biosense.in Fiche EUDAMED Signaler une erreur
Biosigma FDA	Italie	CUVETTE / CUVETTES3 réf. HISTOLOGY/BIOPSY PRODUCTS BSI1023 réf. PROVETTE E TAPPI - TEST TUBES AND STOPPERS3 réf.	A IVDR	Site web info@biosigmaeu.com Fiche EUDAMED Signaler une erreur
Bi̇yofen Kurumsal Sağlik Hi̇zmetleri̇ Yazilim Turi̇zm Sanayi̇ Ti̇caret Şti̇	Turquie	SepsiBiyo Modular 120 SepsiBiyo Modular 240 SepsiBiyo Modular 60	A IVDR	Fiche EUDAMED Signaler une erreur
Bonraybio FDA Mandataire UE : MDSS GmbH (Allemagne)	Taïwan	LensHooke® Prestained Morphology Slide CR0 LensHooke® Sperm DNA Fragmentation Rapid Test Kit (SCD Assay) R102 réf. LensHooke® Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay) R11 Plus2 réf.	A IVDR	service@bonraybio.com Fiche EUDAMED Signaler une erreur
BotuAImaging Technology Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	Automated Blood Cell Morphology Analysis System Cygnus-K Automated Malaria Parasite Scanning and Analysis System MalaScope-12 Automated Slide Preparation and Staining System BP-K	A IVDR	Fiche EUDAMED Signaler une erreur
C.P.M. Compagnia Per La Medicina	Italie	D-DIMER I02276/398/79 Fibrinogen‐ONE I021798/79 TRANSPORT SAMPLE ONE MS01430BK1	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Cariad Mandataire UE : PureCE B.V. (Pays-Bas)	Chine	10 Tests/Kit, 20 Tests/Kit4 réf. 10 Tests/Kit, 20 Tests/Kit, 50 Tests/Kit3 réf. 3mL×3, 5mL×3, 10mL×3, 50mL×3, 100mL×3, 500mL×3.3 réf.	A IVDR	Site web support@cariad.com.cn Fiche EUDAMED Signaler une erreur
CLARO-PROM društvo s ograničenom odgovornošću za proizvodnju, trgovinu i usluge	Croatie	10%-tna puferirana otopina formaldehida, 10L 4%-tna puferirana otopina formaldehida3 réf. 37%-tna otopina formaldehida, 1L (plastika)3 réf. Claroplast, 10 kg2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
CleanNA	Pays-Bas	Clean cell free DNA kit CCF-D0384 Clean Quick Viral2 réf. CleanNGS Dx2 réf.	A IVDR	Site web info@cleanna.com Fiche EUDAMED Signaler une erreur
Coei Biotech Mandataire UE : Medunion S.L. (Espagne)	Chine	D-Dimer Rapid Quantitative Test 25 servings/box98/79 H.Pylori Antigen Rapid Detection Test 25 servings/box98/79 hsCRP Rapid Quantitative Test 25 servings/box98/79	– 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Copan Wasp FDA	Italie	Collaborative Station External Loader - Turn Table3 réf. WASP-FLO3 réf.	A IVDR	Site web regulatory.wasp@copangroup.com Fiche EUDAMED Signaler une erreur
Cytochipinc FDA Mandataire UE : Medunion S.L. (Espagne)	États-Unis	CitoCBC Cartridge 121098/79 CitoCBC Control 131098/79 CitoDx CBC Analyzer 1130	A IVDR, 98/79	Présent sur le marché en France quality@cytochipinc.com Fiche EUDAMED Signaler une erreur
D-tek	Belgique	BlueDiver3 réf. BlueDiver Instrument 22 réf. BLUESCAN1/ BlueScan Scanner + DR DOT LIC4/ Dr Dot Software3 réf.	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Dagatron FDA Mandataire UE : BZT-TCP Certification GmbH (Allemagne)	Corée du Sud	AFB(Fluorescence) Stain Reagent Kit3 réf. DAGATRON AT-10003 réf. DAGATRON DX-3003 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Diagenode FDA	Belgique	Panther Fusion Bordetella Assay2 réf. Panther Fusion BKV Quant Assay - BKV Reagent Cartridge2 réf. Panther Fusion EBV Quant Assay3 réf.	B, C IVDR	info@diagenode.com Fiche EUDAMED Signaler une erreur
DiaMed FDA Mandataire UE : Bio-Rad (France)	Suisse	05761_ID-Diluent 2 51051_DiaClon ABD-Confirmation for Donors98/79 52160_DiaClon Antigen Profile II	A, D IVDR, 98/79	Présent sur le marché en France Site web contact@bio-rad.com Fiche EUDAMED Signaler une erreur
Dianabiotech	Tchéquie	DBdirect™ COVID-19 Multiplex RT-PCR Kit2 réf.98/79 DBdirect™ Respiratory panel 1: SARS-CoV-2/Flu/RSV2 réf.98/79 RT-PCR Respiratory panel 1: SARS-CoV-2/Flu/RSV2 réf.98/79	– 98/79	Site web info@dianabiotech.com Fiche EUDAMED Signaler une erreur
Di̇a Pro Tibbi̇ Ürünler San. Ve Ti̇c. A.Ş	Turquie	Across Gel5 réf. ACROSS GEL ACROSS RBC A1/B2 réf. Across System10 réf.	A, D IVDR	Fiche EUDAMED Signaler une erreur
DNA Genotek FDA Mandataire UE : QbD RepS BV (Belgique)	Canada	OMNIgene GUT OMNIgene ORAL2 réf. ORAgene DNA3 réf.	A IVDR	Site web regulatory@dnagenotek.com Fiche EUDAMED Signaler une erreur
Drophil Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	S1002 réf. S200, S260, S280, S2903 réf. S903 réf.	A IVDR	info@drophil.com Fiche EUDAMED Signaler une erreur
Dynex Technologies FDA Mandataire UE : Acorn Regulatory Consultancy Services Ltd (Irlande)	États-Unis	AGILITY3 réf. DEEP WELL STRIPS DS23 réf. DSX Automated ELISA System - Ambient3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Empecs FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine, Corée du Sud	ASUREQUAN Analyzer EMBC-MT01 GH2198/79 MM11002 réf.98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Fujirebio FDA	Belgique	INNO-LiPA HBV Genotyping <20T,CE> 80691 INNO-LiPA HCV 2.0 Amp <20T,CE> 815473 réf. INNO-LiPA HPV Genotyping Extra II <20T,CE> 815342 réf.	C IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
GB Lifecare Mandataire UE : Obelis s.a. (Belgique)	Corée du Sud	Gmate® Origin Blood Glucose Meter PG-310 Gmate® Origin Blood Glucose Monitoring System PG310-003-25 Gmate® Origin Blood Glucose Monitoring System PG310-004-25	C IVDR	Site web Fiche EUDAMED Signaler une erreur
GenBody FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	ConfiGlu G1 Blood Glucose Meter Set BGMGS001 Hemonitor H1 microcuvette HMAC050 HMCT001	A, B, C IVDR	Fiche EUDAMED Signaler une erreur
GeneFirst Mandataire UE : Advena Limited (Malte)	United Kingdom (ex Northern Ireland)	Papilloplex HR HPV Genotyping Kit98/79 Papilloplex® HR-HPV DNA Kit98/79 Papilloplex® HR-HPV mRNA Kit98/79	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
GeneMatrix Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	NeoPlex™ GI-Virus 6 Detection Kit NG0198/79 NeoPlex™ RV-Panel B Detection Kit NR042 réf.98/79 NeoPlex™ TBNTM-5 Detection Kit NR1598/79	– 98/79	Présent sur le marché en France Site web support@genematrix.net Fiche EUDAMED Signaler une erreur
GenMark Diagnostics FDA Mandataire UE : Roche Diagnostics GmbH (Allemagne)	États-Unis	cobas® eplex respiratory pathogen panel 3 (RP3) cobas® eplex system ePlex Instrument	A, B IVDR	regulatory.rmd_international@roche.com Fiche EUDAMED Signaler une erreur
Genomictree Mandataire UE : KTR Europe GmbH (Allemagne)	Corée du Sud	GT NUCLEIC ACID PREP KIT GT-PREP-12 réf. Stool Collection Kit Ⅲ SC03-1 Urine Collection Tube Ⅱ UC02-1	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Gp Medical Devices A S FDA	Danemark	EasySampler Bacteria and Parasites Kit - DA 103 réf. EasySampler Basic 133 réf. EasySampler Mini Kit - Single US 123 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Guangzhou Hearty Expression Medical Technology Mandataire UE : Everbiz GmbH (Allemagne)	Chine	Biological Microscope EN ISO 14971 Fluorescence biomicroscope Immunol Fluorescence Staining Kit	A IVDR	Fiche EUDAMED Signaler une erreur
Guangzhou Naturn Medical Devices Mandataire UE : MedPath GmbH (Allemagne)	Chine	Automated Coverslipper CV6102 réf. Automated Stainer NQ100S3 réf. Ultrasonic tissue processor UT8040,UT8040-C;2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Guilin Royalyze Medical Instrument Mandataire UE : Caretechion GmbH (Allemagne)	Chine	ACCU-ANSWER LBM-0198/79 ACCU-ANSWER LBM-0298/79 MINDMED LBM-0198/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hangzhou Agen Biotechnology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	C000035，C000060，C000100，C000035W，C000060W，C000100W，C001035，C001060，C001100，C001035W，C001060W，C001100W，C010001，etc3 réf. PCR-96-HN-C，PCR-96-HS-C，PCR-96-HS-W-P，PCR-96R-HS-C-P，PCR-96R-HS-R-P，PCR-96R-HS-Y-P，PCR-96R-HS-B-P，PCR-96R-HS-G-P，PCR-96R1-HS-C，PCR-96-LS-W，PCR-96-LN-W，PCR-96-LN-C-P，PCR-96-LF-C-P，PCR-96-LH-C，PCR-96-HH-C，etc3 réf. VT-384-30-RS，VT-384-30-RSL，VTF-384-30-RS，VTF-384-30-RSL，VT-384-70-RS，VT-384-70-RSL，VTF-384-70-RS，VTF-384-70-RSL，VT-250-R，VT-250-RL，VTF-250-RS，VTF-250-RSL，etc3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Hangzhou Bigfish Bio-tech Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E3 réf. BFQP-48、BFQP-96、BFQP-163 réf. FC-96B,FC-96BE,FC-96GE,FC-96D,FC-96G.FC-384G,FC-1536G,FC-48D,FC-48N,FC-48T3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Hangzhou Bio-gener Technology Mandataire UE : MedPath GmbH (Allemagne)	Chine	Micro-Spectrophotometer BGNANO-6013 réf. Nucleic Acid Purification System BGNA-32P Real-Time PCR System3 réf.	A IVDR	info@bio-gener.com Fiche EUDAMED Signaler une erreur
Hangzhou Biobank Bio-technology Mandataire UE : MedPath GmbH (Allemagne)	Chine	Automatic Whole Rack Cryogenic Tubes Capper/Decapper3 réf. Cryogenic Tube BB-CVO0620-PS3 réf. Multi-channel hand-held Screw Cap Recapper3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Hunan AccuBio Biotech Mandataire UE : SUNGO Europe B.V. (Pays-Bas) et 1 autre	Chine	100T6 réf.98/79 1L，10L 50T6 réf.98/79	A IVDR, 98/79	info@hn-accubio.com Fiche EUDAMED Signaler une erreur
Hyris	Italie	bCUBE3 NL SOLUTION (Prefilled) HK043X020 NL SOLUTION HK038X0502 réf.	A IVDR	Site web support@hyris.net Fiche EUDAMED Signaler une erreur
Icarbonx Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	ICX Imager 500 ICX MFA 768B ICX MFA768A	A IVDR	Fiche EUDAMED Signaler une erreur
Imedikers Mandataire UE : Veritas Eston OÜ (Estonie)	Corée du Sud	I-PREP LBC Solution GYN I-PREP Quick Stainer I-PREP2	A IVDR	info@veritaseston.eu Fiche EUDAMED Signaler une erreur
Immunodiagnostic Systems FDA Mandataire UE : Immunodiagnostic Systems SA (Belgique)	United Kingdom (ex Northern Ireland)	IDS i20 IS-910400 IDS-i10 IS-8104003 réf. IDS-i10T IS-810410	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Invitrosco Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	AdvanSure™ i3 TB-IGRA98/79 AdvanSure™ TB-IGRA ELISA98/79 cobas IGRA TB tubes	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Jiangsu Kahotest Citotest Labware Manufacturing Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	30ml/40ml/60ml/100ml/120ml3 réf. 5ml/15ml/30ml/40ml/60ml/100ml/120ml2 réf. Square holes/stripe holes/round holes/fine square holes/O rings2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Jiangsu Medomics Medical Technology FDA Mandataire UE : R Sight B.V. (Pays-Bas) et 1 autre	Chine	Candida albicans/ Trichomonas vaginalis/ Gardnerella vaginalis antigen Combo Test Kit (LFIA)98/79 Candida albicans/ Trichomonas vaginalis/ Gardnerella vaginalis antigen Combo Test Kit (LFIA) 012113-01-02；012113-02-02 ；012113-05-02；012113-20-023 réf. Group A streptococcus Rapid test Kit98/79	C IVDR, 98/79	Site web info@medomics-dx.com Fiche EUDAMED Signaler une erreur
Jiangsu Rongsheng Jiamei Biological Reagent Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Hematology Analyzer Cleaner 20L, 15L, 5.5L, 5L, 1L, 500mL, 100mL, 50mL Hematology Analyzer Diluent 5.5L, 1.5L, 1L, 2L, 4L, 5L, 5.5L, 10L, 15L, 20L Hematology Analyzer Lyse 100mL, 250mL, 500mL, 100mL, 200mL, 300mL, 400mL, 500mL, 850mL, 960mL, 1L, 1.5L, 1.9L, 2L, 3L, 3.8L, 4L, 5L, 9.6L, 10L	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Kangrun Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	Kaeser 20002 réf. Kaeser 6800plus Kaeser 8800	A IVDR	Fiche EUDAMED Signaler une erreur
Kreatech Biotechnology	Pays-Bas	BCL2/IGH t(14;18) Fusion KBI-1060698/79 DEK / NUP214 t(6;9) Fusion KBI-1030698/79 PDGFRB (5q32) Break KBI-1000498/79	– 98/79	Site web QA.Amsterdam@leicabiosystems.com Fiche EUDAMED Signaler une erreur
Labitec	Allemagne	CA-101 CD12-1-17, CD12-2-17, CD12-4-173 réf. Cascade Plus CL1K-093 réf. Cup 4ml for Sample in bag, 2 x 2503 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Ldn	Allemagne	IL-1β-ELISA IL E-300098/79 IL-6-ELISA IL E-320098/79 TNF-α-ELISA IL E-310098/79	– 98/79	Site web regulatory@ldn.de Fiche EUDAMED Signaler une erreur
Leadmanbio Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	CI 1200 Automated Chemiluminescence Immunoassay Analyzer CI 2000S Automated Chemiluminescence Immunoassay Analyzer Treponema Pallidum Antibody（Anti-TP）Assay Kit 100 Tests98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Luminexcorp FDA Mandataire UE : DiaSorin Italia S.p.A. (Italie)	États-Unis	LIAISON PLEX® Chassis2 réf. LIAISON PLEX® Gastrointestinal Flex Assay LIAISON PLEX® Respiratory Flex Assay	A, C IVDR	Site web regulatoryaffairs@luminexcorp.com Fiche EUDAMED Signaler une erreur
Mast Group FDA Mandataire UE : Mast Diagnostica GmbH (Allemagne)	United Kingdom (ex Northern Ireland)	DISCMASTER™ 16 DISPENSER MDD16 DISCMASTER™ 6 DISPENSER MDD DISCMASTER™ 8 DISPENSER MDD8	A IVDR	Site web sales@mastgrp.com Fiche EUDAMED Signaler une erreur
Medical & Biological Laboratories Mandataire UE : QbD RepS BV (Belgique)	Japon	HEXAMATE Factor XIII HEXAMATE Factor XIII - Calibrator HEXAMATE Factor XIII – Control I/II	B IVDR	Fiche EUDAMED Signaler une erreur
Meteromega Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Capillary Tube6 réf. GL100-N, GL86-N, GL73-N3 réf. PL125-N, PL100-N, PL86-N3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Neo-nostics (Suzhou) Bioengineering Mandataire UE : Medunion S.L. (Espagne) et 1 autre	Chine	COVID 19 Antigen Test Kit (Colloidal Gold Method) SVRAG8998/79 Respiratory Infection Test Device(Nasal/Nasopharyngeal/Oropharyngeal/Serum/plasma/ whole blood) RES024298/79 Vaginitis and Sexually Transmitted Infection Test Device(Urogenital Swab/Serum/plasma/whole blood) VAG024398/79	– 98/79	Fiche EUDAMED Signaler une erreur
Ningbo Chiwell Biotechnology FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	CHIWELL CW-1000+CW-800,E2+P8, E3+P3, E5+P5, E9+P9, A8+P8, A4+P4,E1, E4, E2, E3, E6,E7,E8,A1,A2,A3,A4,A5,A6,A7,A9,HE-800,HE-820,HE-860,HE-890,HE-1000,HE-1200,HE-1600,HE-18003 réf. CHIWELL CW-120、CW-600、CW-1000、HD-400i、HD-600i3 réf. CHIWELL CW-180、CW-360、CW-400、CW-400A、CW-400B、CW-420、CW-420A、CW-800、CW-820、CW-860、CW-8803 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Ningbo Trustlab Instruments Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Blood collection tube Clot Activator 4ml3 réf. Cover Glass GT201-1818CE3 réf. Microscope slide GT201-7105	A IVDR	Fiche EUDAMED Signaler une erreur
Noul FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	miLab™ Cartridge CER CCEA98/79 miLab™ Cartridge MAL CMAA98/79 SafeFix CSFA	A IVDR, 98/79	Site web cs@noul.com Fiche EUDAMED Signaler une erreur
Poclight Mandataire UE : HUMISS TRADING S. L. (Espagne)	Chine	D-dimer TestKit (Homogeneous Chemiluminescence Immunoassay)98/79 Interleukin-6 (IL-6) Test Kit (Homogeneous Chemiluminescence Immunoassay)98/79 Krebs von den Lungen 6 (KL-6) Test Kit (Homogeneous Chemiluminescence Immunoassay)98/79	– 98/79	info@poclight.com Fiche EUDAMED Signaler une erreur
Precision BioLogic FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Canada	CRYOcheck26 réf. CRYOcheck Abnormal 1 Reference Control2 réf. CRYOcheck Abnormal 2 Reference Control	C IVDR	Fiche EUDAMED Signaler une erreur
Predicine Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	Predicine Blood Collection Kit PD-SCK30B-007 Predicine Bone Marrow Aspirate (BMA) Collection Kit™ PD-SCK30BM-026 Predicine Urine Collection Kit PD-SCK30U-003	A IVDR	Site web support.us@predicine.com Fiche EUDAMED Signaler une erreur
Premier Medical Mandataire UE : Obelis s.a. (Belgique)	Inde	First Response HBsAg Card Test PI10FRC4 réf.98/79 First Response HCV Card Test PI03FRC4 réf.98/79 First Response HIV 1-2.O Card Test (Version 2.0 PI05FRC4 réf.98/79	– 98/79	Présent sur le marché en France Site web info@premiermedcorp.com Fiche EUDAMED Signaler une erreur
Probatix	Allemagne	SCK_LAN3 réf. SCK_TAP3 réf. SCK_TASSO3 réf.	IIa, A IVDR, MDR	Site web Fiche EUDAMED Signaler une erreur
Proekosrl	Italie	DECOLORANTE DI GRAM 250 ml3 réf. DIFF STAIN QUICK FISSATIVO 250 ml3 réf. DIFF STAIN QUICK KIT IC4002 réf.	A IVDR	Site web info@proekosrl.com Fiche EUDAMED Signaler une erreur
Qingdao MGI Tech Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	DNB loader MGIDL-T20A Genetic Sequencer DNBSEQ-E25 DNBSEQ-E25, DNBSEQ-E25A, DNBSEQ-T20×23 réf. Portable Rapid Nucleic Acid Detector GenCase-S	A IVDR	Fiche EUDAMED Signaler une erreur
Qitan Taike Biotechnology Chengdu Mandataire UE : MedPath GmbH (Allemagne)	Chine	QNome-3841 Nanopore Sequencer QNome-3841hexDx Nanopore Sequencer QPursue-6kDx Nanopore Sequencer	A IVDR	Fiche EUDAMED Signaler une erreur
Reagens Fejlesztő Gyártó És Kereskedelmi Kft	Hongrie	AGGI-LISS Aktív liofilizált papain Bromelin 1000 ml3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
RevoSketch Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Corée du Sud	isoQuarkF2 isoQuarkM4 SS-7010	A IVDR	Site web Fiche EUDAMED Signaler une erreur
RWD Life Science FDA Mandataire UE : WISELINK MEDICAL, S.L.U. (Espagne)	Chine	Cryostat S700、S700A、S709、S710、S711、S712、S713、FS800、FS800A、FS900、FS910、FS920 Frozen Section Embedding Compound FS-EM High-Speed Benchtop Refrigerated Centrifuge 91300	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Samantree FDA Mandataire UE : SamanTree Medical France SASU (France)	Belgique, Suisse	Histolog Scanner Gen III 008 Histolog®️ Dip 005 Histolog®️ Scanner 003	I, A IVDR, MDR	Présent sur le marché en France Site web info@samantree.com Fiche EUDAMED Signaler une erreur
Sekisui Diagnostics FDA Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	OSOM® Mono Test 14598/79 OSOM® RSV/Adeno Control Kit 198E98/79 OSOM® RSV/Adeno Test 197E98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Shanghai Chuangkun Biotech Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	CHK Biotech CHK-3200 CHK-16S CHK-800 CHK Biotech Q1602 Q1604 MQ96 MQ48 CHK Biotech Q9600 Q1600	A IVDR	Fiche EUDAMED Signaler une erreur
Shanghai Kehua Bio-engineering Mandataire UE : QbD RepS BV (Belgique)	Chine	Interleukin-6 Quantitative Detection KIT (Chemiluminescent Immunoassay)98/79 Nucleic Acid Extraction Kit 32 Nucleic Acid Extraction Kit 962 réf. Nucleic Acid Extraction Kit KH-G-M-565-48-CE	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Shanghai Kehua Laboratory System FDA Mandataire UE : Obelis s.a. (Belgique)	Chine	G9800 Automatic Clinical Chemistry Analyzer ZY-400, ZY-450, ZY-460, ZY-480, Polaris c1000, Polaris c1100, Polaris c2000, Polaris c2100, ZY-680, ZY-690, ZY-1200, ZY-1250, ZY-1260, ZY-1280, G9800, ZY-260, ZY-2803 réf. ST-360 Microplate Reader ST-360, ST-380, ST-960, ST-9803 réf. V150 Automatic Chemiluminescence Immunoassay Analyzer	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Shenyang Kingpel Biotech Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	SYD-B2 réf. SYD-K2040; SYD-K2080; SYD-K3080; SYD-K4080; SYD-K4080A; SYD-6010; SYD-4900; SYD-6000; SYD-6010S3 réf. SYD-S30502 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Shenzhen Tailaored Medical Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Automatic Chemiluminescence Analyzer VIT 700 Portable Biochemical Analyzer AUSA 340II-T Portable Biochemical Analyzer H300-D	A IVDR	Fiche EUDAMED Signaler une erreur
Sichuan Shuke Instrument FDA Mandataire UE : JOYSUN GROUP S.L.U (Espagne)	Chine	High Speed Refrigerated Centrifuge TGL-17, TGL-19, TGL-21, TGL-23, TGL-16503 réf. Low Speed Centrifuge TD-4,TD-4Z,TD-5,TD-5Z,TD-400,TD-500,TD-600,TD-5M,TD-6M,TD-450,TD-4B3 réf. Low Speed Refrigerated Centrifuge TDL-5M, TDL-6, TDL-6M3 réf.	A IVDR	sales@shukelab.com Fiche EUDAMED Signaler une erreur
Sidena	France	AQUAREL AQUAREL-1502 AQUAREL-3P Smartcolor AQUAREL-1P	A IVDR	Présent sur le marché en France info@sidena.com Fiche EUDAMED Signaler une erreur
Swiscare Technology Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Taïwan	BG-Pro GM56A98/79 BG-Pro II GM56B98/79 Ecare mini GM2598/79	– 98/79	Fiche EUDAMED Signaler une erreur
Syntesys	Italie	"Easy Tainer Max Plus®" Bottiglia per raccolta urina in 24h, 3L, ambra, con dispositivo per prelievo con provette sottovuoto e sonda 190mm3 réf. "Sekur Tainer" contenitore urina 120ml tappo a vite giallo con dispositivo prelievo da provetta sottovuoto sterile in confezione singola 33125098/79 "Sekur Tainer" Contenitore urina 60 ml tappo a vite giallo con dispositivo per prelievo con provette sottovuoto, sterle, graduato 33122598/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Tianjin Jianbo Biological Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Cryptococcal Antigen Rapid Test Cassette98/79 Cryptococcal Antigen Rapid Test Strip98/79 Detection Kit for IgM/IgG Antibody to Human Brucella (GICA)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Tianjin Mingao Biotechnology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Cassette98/79 Midstream98/79 Strip98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Tmsmedikal	Turquie	PETRI DISHES STERILE M03.01 T20206 URINE CONTAINER 100 ML NON-STERIL	A IVDR	Site web info@tmsmedikal.com Fiche EUDAMED Signaler une erreur
Toda Pharma	France	Toda Dengdiag combo 198/79 Toda Dengdiag combo 1098/79 Toda Dengdiag combo 2098/79	– 98/79	Présent sur le marché en France Site web qualite@todapharma.com Fiche EUDAMED Signaler une erreur
Todylaboratories	Roumanie	ADENOVIRUS RAPID TEST CASSETTE (FECES) C61RT10052 réf. URINE STRIPS READER - 50S2 réf. Vacuum Blood Colection Tubes, Clot Activator, 16x100mm, PET, 8ml3 réf.	A IVDR	Site web contact@todylaboratories.com Fiche EUDAMED Signaler une erreur
Transgen Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	EasyPure® Viral DNA/ RNA Kit ER201 MagicPure® 96 Viral DNA/RNA Kit EC301-96 MagicPure® 32 Viral DNA/RNA Kit EC301-32	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Tridema	Italie	DIAMOND 2 DIAM2014 DIAMOND 4 Diam2026 Diamond DIAM2010	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Typenex FDA Mandataire UE : Qualrep Services B.V. (Pays-Bas)	États-Unis	Smearsafe 00892159002017 Smearsafe BD0101 Typesafe 4R47502 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
VitalScientific FDA	Pays-Bas	Selectra Mach5 6004-301 Selectra ProM 6003-4043 réf. Selectra ProS 6003-5003 réf.	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Wuhan Landing Intelligence Medical FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	LANDING LD Patho 340A LD Cyto2200 LD Patho 320A	A IVDR	Fiche EUDAMED Signaler une erreur
X-ZELL Biotech Pte Mandataire UE : X-ZELL Biotech GmbH (Allemagne)	Singapour	Cryophore™ Ascitic Fluid Cryophore™ Pleural Fluid 1 Cryophore™ Pleural Fluid 3	A IVDR	Site web support@x-zell.com Fiche EUDAMED Signaler une erreur
Yancheng Huida Biotechnology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	7101, 7101A, 7102, 7102A,7103, 7103A, 7104, 7104A, 7105, 705A, 7107, 7107A, 7109, 7109A, HDAS001, HDAS001A, HDAS002, HDAS002A, HDAS003, HDAS003A, HDAS004, HDAS004A, HDAS005, HDAS005A, HDAS016-1, HDAS016-1A, HDAS016-5, HDAS016-5A, etc 7201-IP, 7201-SP, 7201-EP, 7201-OP, 7201-NSP, 7201-X, 7201-L HP2027 HP2028 HP20281 HP2028-1 HP20282 HP20283 HP20284 HP20285 HP20285-1 HP20286 HP20286-1 HP20287 HP20288 HP20289 HP2029 HP20290 HP20291 HP20292 HP20293 HP20294,etc	A IVDR	Fiche EUDAMED Signaler une erreur
Yancheng Jufan Lab Instrument Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	1414mm, 1616mm, 1818mm, 2020mm, 2222mm, 2226mm, 2424mm, 2432mm, 2440mm, 2450mm, 24*60mm 2place, 5place, 10 place, 12 place, 20 place, 25 place, 50 place, 100 place 7101, 7102 , 7103, 7104 , 7105 , 7105-1, 7106, 7107 , 7107-1, 7109 , 7110, 7111	A IVDR	Fiche EUDAMED Signaler une erreur
Yhlo Biotech (Nanjing) Mandataire UE : Medunion S.L. (Espagne)	Chine	Fibrinogen (FIB) Assay Kit (Immunoturbidimetric Method)2 réf.98/79 Helicobacter Pylori Antibody (HP) Assay Kit (Latex-enhanced Immunoturbidimetric Method)2 réf.98/79 Homocysteine (HCY) Assay Kit (Enzymatic Cycling Method)2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Zhejiang Kangshi Medical Devices Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	KS-K2E/SST3 réf. KS-Z (13x75mm; 13x100mm; 16x100mm; 12x60mm; 8x120mm; PET; PP; GLASS), KS-CN (13x75mm; 13x100mm; 16x100mm; 12x60mm; 8x120mm; PET; PP; GLASS), etc KS-Z(No Additive)	A IVDR	Fiche EUDAMED Signaler une erreur
Zhongshan Bio-Tech Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	20 tests/kit98/79 25 tests/kit5 réf.98/79 96 tests/kit4 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Zhongshan Chuangyi Biochemical Engineering Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Cleaning Solution for Hematology Analyzer Compatible SYSMEX, MINDRAY, COULTER, ABBOTT, NIHON KOHDEN, ERMA, MEDONIC, RAYTO, PROCAN, URIT, DIRUI, SWELAB-AC, CIS, DANAM, ABX, ABACUS hematology analyzer. CYB-5200 Automatic Hematology Analyzer CYFIA-2000 Immunofluorescence Reader	A IVDR	Fiche EUDAMED Signaler une erreur
ZKYH AImed Technology （Guangxi） Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	Med-Auto Scan-Pro Med-Auto-Optics-200 Med-Auto-Optics-120 Med-Auto-Optics-80 Med-Sharp Karyo	A IVDR	Fiche EUDAMED Signaler une erreur
Lykon	Allemagne	Food Allergies Test (v3) BT-LH3 réf. Health & Vitality Test (v1) DBS-ADX3 réf. Bloodsugar Test (v3) BT-EDTA2 réf. (plus commercialisé) Cholesterol Test (v3) BT-SG3 réf. (plus commercialisé) Cortisol Test (v3) SW-RO2 réf. (plus commercialisé) 3 autres COVID-19 ANTIKÖRPER (v2) BT-SE (plus commercialisé) Health&Fitness Premium Test (v3) BT-SG-DBS2 réf. (plus commercialisé) Omega-3 Test (v3) DBS2 réf. (plus commercialisé)	I, IIa MDR	quality@lykon.com Fiche EUDAMED Signaler une erreur
Responsebio FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Canada	RAMP 200 (C2100 and C3100) RAMP D-dimer (C1106)98/79 RAMP Total b-hCG Controls - Level 1 (C4003-1)98/79 (plus commercialisé) RAMP Total b-hCG Controls - Level 2 (C4003-2)98/79 (plus commercialisé)	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
-Diagnostics Mandataire UE : mdi Europa GmbH (Allemagne)	États-Unis	Logix Smart ABC (Influenza A/B, SARS-Cov-2) ABC-K-00198/79 Logix Smart MTB Test Kit MTB-K-00798/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
1drop Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	1copy™ COVID-19 qPCR 4plex Kit M2498/79 1copy™ COVID-19/FluA/FluB/RSV qPCR Kit M2598/79	– 98/79	Site web sales@1drop.co.kr Fiche EUDAMED Signaler une erreur
Abaxis FDA Mandataire UE : ABAXIS Europe GmbH (Allemagne)	États-Unis	Piccolo Xpress 1100-10012 réf. Piccolo Xpress 1100-1001R	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Accucise Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Automated Electrochemiluminescence (ECL) Immunoassay Analyzer YnY 2050;YnY 2050d;YnY 2050h3 réf. Automated Electrochemiluminescence (ECL) Immunoassay Analyzer YnY3030	A IVDR	sales@accucise.cn Fiche EUDAMED Signaler une erreur
Acmed FDA Mandataire UE : MedPath GmbH (Allemagne)	Chine	Cover glass 18x18*0.19mm3 réf. Glass slides 7101, 7102, 7103, 7105, 7107, 7109	A IVDR	Fiche EUDAMED Signaler une erreur
Advanced Cell Diagnostics FDA Mandataire UE : QbD RepS BV (Belgique)	États-Unis	RNAscope™ ISH Probe High Risk HPV98/79 RNAscope™ ISH Probe UBC (Positive Control)98/79	– 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Aikang Diagnostics Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	Chemiluminescence Immunoassay Analyzer CLIA-mate 1200, CLIA-mate Plus2 réf. Interleukin 6(IL-6) in vitro diagnostic kit (Chemiluminescent Immunoassay)98/79	A IVDR, 98/79	marketing@aikang-medical.com Fiche EUDAMED Signaler une erreur
Akmedical	Italie	FISSATORE CITOLOGICO VETRINO MOLATO E SABBIATO	A IVDR	commerciale@akmedical.it Fiche EUDAMED Signaler une erreur
Amazingbio Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	Amanilab auto P&D System Amanilab EP201、Amanilab EP202、Amanilab EP101、Amanilab EP102 ULfast Real Time PCR SEP204、SEP208、SEP104、SEP108、SEP116	A IVDR	Fiche EUDAMED Signaler une erreur
AO Vector-Best Mandataire UE : BIORON GmbH (Allemagne)	Russie	RealBest DNA-express RealBest UniMag Universal NA Extraction Kit2 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Apiro	Hongrie	QC1 2011EU QC2 2021EU	C IVDR	Site web info@apiro.eu Fiche EUDAMED Signaler une erreur
ASTA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Corée du Sud	IDSys Elite MicroIDSys Elite98/79	C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Beckman Mandataire UE : Beckman Coulter Ireland Inc. (Irlande)	Inde	ClearLLab Compensation Kit ClearLLab LS Lymphoid Screen Reagent	C IVDR	Site web Fiche EUDAMED Signaler une erreur
Beijing Healthgene Laboratory Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	20 Tests/Kit98/79 COVID-19 Nucleic Acid Detection Kit(Fluorescence PCR)2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bensrl	Italie	CALCIUM CHLORIDE VLR01022 réf. HAEMOSTASIS ANALYZER VLR0201	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Bioanalyse	Turquie	DISPENSER 6 MAGAZINE DSP411002 réf. TRIGGER TRG40200	A IVDR	Site web info@bioanalyse.com Fiche EUDAMED Signaler une erreur
Biocytech Sdn Bhd FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Malaisie	PathTezt Cover Glass 1. CS-36100 2. IS-36100 3. US-36100 4. HS-36100 5. CG-102450 6. GS-25003 réf. PathTezt Dual Filter 1. GF-0825100 2. NGF-0525100 3. UCF-0813100 4. PS-250 5. DF-25083 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Biodetect Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	2019-nCoV Molecular Diagnostic Kit(Fluorescent PCR Test)98/79 Monkeypox Virus Molecular Diagnostic Kit (Fluorescent PCR Test) (Lyophilized)98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Biolis Medical FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Japon	BIOLIS 30i3 réf. Cuvette-8U Reaction Cuvette3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Biomerica FDA Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	GAP IgM Helicobacter pylori ELISA 700698/79 Hp Detect™ Stool Antigen ELISA 708398/79	– 98/79	Site web info@biomerica.com Fiche EUDAMED Signaler une erreur
Bioway Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	Urine Analyzer BW-2003 réf. Urine Sediment Analyzer BW-10003 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Calibrescientific FDA Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	CELL-BOND® Slides, 1 Red Well3 réf. Clean Collection Vials Fecal Fixatives and Transport3 réf.	A IVDR	Présent sur le marché en France Site web regulatory@calibrescientific.com Fiche EUDAMED Signaler une erreur
Callegari	Italie	Centrifuga6000 Clini5	A IVDR	Fiche EUDAMED Signaler une erreur
Campmedica	Roumanie	See Now6 réf. See Now Dengue NS1 antigen98/79	B IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Cangzhou Fukang Medical Supplies Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Plain Tube Clot Activator Tube Sodium Heparin Tube Lithium Heparin Tube EDTAK2 EDTAK3 EDTANa2 Sodium Citrate1:9 Tube 1:4 Sodium Citrate1:4 Tube （EDTA）Sodium Fluoride （EDTA） Tube Sodium Fluoride (Sodium Oxalate) Tube3 réf. Plain Tube,Clot Activator Tube,Sodium Heparin Tube,Lithium Heparin Tube,EDTAK2,EDTAK3,EDTANa2,etc.3 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Canterbury Scientific FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Nouvelle-Zélande	extendSURETM Haemoglobin F and A2 Calibrators HB110SCALAr98/79 extendSURE™ Haemoglobin F and A2 Controls HB110SSBAr98/79	– 98/79	Site web cseymour@canterburyscientific.com Fiche EUDAMED Signaler une erreur
Cavanbio Mandataire UE : HyperCert Limited B.V. (Pays-Bas)	Chine	CAVAN Sampling Tube CST-01/CST-022 réf. Fully Automated Fecal Immunochemical Test Analyzer FIT-1000/1200/1600/18003 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Cell Projects FDA Mandataire UE : Advena Limited (Malte)	United Kingdom (ex Northern Ireland)	12 X GFX Saliva collector (includes funnel, tube filled with 2ml stabilization buffer, cap & instruction manual)3 réf. StoolFix3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Centroiidmeditech Mandataire UE : AF Pharma Service Europe SL (Espagne)	Inde	Centube-Micro3 réf. CENVAC3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Changsha Han Biotechnology Mandataire UE : Medunion S.L. (Espagne)	Chine	Automatic Hematology Analyzer iMC Ge52e Blood Cell Test Reagent JY-05：50 tests/kit	A IVDR	Fiche EUDAMED Signaler une erreur
Chengdu Find Medical Devices Mandataire UE : MedPath GmbH (Allemagne)	Chine	Cell-Free Fetal DNA Library Prepare Kit Nucleic acid extraction or purification reagent N001	A IVDR	Fiche EUDAMED Signaler une erreur
Chengdu One-Chip Biotechnology Mandataire UE : Share info GmbH (Allemagne)	Chine	eTrust® 1 test/kit98/79 eTrust® Semiconductor Gene Sequencer ATGC-4H	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Chengdu Rich Science Industry Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	C.D.Health No additive 0.2ml W050101010202 BLOOD COLLECTION, TUBES WITHOUT ADDITIVES OR SERUM SEPARATOR98/79	A IVDR, 98/79	Qa@cdrich.com Fiche EUDAMED Signaler une erreur
Comedical	Italie	fcd4DNARNA Tubo in vetro per idrolisi3 réf.	A IVDR	Site web info@comedical.biz Fiche EUDAMED Signaler une erreur
Comfit	Italie	CELLA SALME 2 POSTI APERTURA LATERALE TEMPERATURA NORMALE MOTORE MONOBLOCCO CFI 80/2TNMB3 réf. CELLA SALME 3 POSTI APERTURA LATERALE TEMPERATURA NORMALE MOTORE MONOBLOCCO CFI80/3TNMB3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Conlett Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Neo-Vista Vista Plus	I MDR	Fiche EUDAMED Signaler une erreur
CooperSurgical FDA Mandataire UE : CooperSurgical Distribution B.V. (Pays-Bas)	États-Unis	BD SurePath™ 70124-0013 réf. Cytobrush® Plus C01122 réf.	I MDR	RA-CSI@coopersurgical.com Fiche EUDAMED Signaler une erreur
Cupidlimited FDA Mandataire UE : Amstermed B.V. (Pays-Bas)	Inde	CupiKIT2 réf. CupiKIT HIV 1 & 2 Antibody Test Kit	C, D IVDR	Site web qa@cupidlimited.com Fiche EUDAMED Signaler une erreur
Darui Biotechnology Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	100 tests/kit98/79 96 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Delbio Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Taïwan	DELBIO Automated Nucleic Acid Analysis System3 réf. DELBIO GS1 Nucleic Acid Extraction Kit3 réf.	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
devemed FDA	Allemagne	Bone Preparation3 réf. Hand Brush, Brush Dispenser2 réf.	I MDR	Site web info@devemed.de Fiche EUDAMED Signaler une erreur
Diagnostics For Real World FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	États-Unis	SAMBA III SCoV-2/Flu/RSV Test SAMBA III STI Ulcer Panel Test 7000-12	B, C IVDR	Site web ra@drw-ltd.com Fiche EUDAMED Signaler une erreur
Diagnostics For Real World Europe FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	United Kingdom (ex Northern Ireland)	SAMBA III Assay Module I190007AM SAMBA III Tablet Module I190007TM	A IVDR	Site web qa@drw-ltd.com Fiche EUDAMED Signaler une erreur
Diagre Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	48 tests/box98/79 DR-ZTQ001-50 DR-ZTQ001-1002 réf.	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Dlabsci FDA Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	DLAB D2012Plus DLAB DM0412	A IVDR	Présent sur le marché en France info@dlabsci.com Fiche EUDAMED Signaler une erreur
Durviz	Espagne	DANAGEN SALIVA DNA SAMPLE COLLECTION KIT3 réf. REAL GRAHAM TEST SISTEMA DE RECOGIDA PARA DETECCIÓN DE ENTEROBIUS VERMICULARIS3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Dusons Mandataire UE : AF Pharma Service Europe SL (Espagne)	Inde	CLOT ACTIVATOR (Serum separator)- CAT DUVAC3 réf. DURIN2 réf.	A IVDR	Présent sur le marché en France regulatory@dusons.in Fiche EUDAMED Signaler une erreur
Dxterity FDA Mandataire UE : MedEnvoy Global BV (Pays-Bas)	États-Unis	DxCollect Blood Collection Tube (BCT) 45436198/79 DxCollect MicroCollection Device (MCD) 100-00098/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
e-LinkCare Meditech FDA Mandataire UE : Wellkang Ltd (Irlande du Nord)	Chine	UBREATH BA2002 réf.98/79 UBREATH BA80098/79	– 98/79	Fiche EUDAMED Signaler une erreur
EFA Engineering for All Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Israël	RevDx98/79 RevDx Test Chip98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Elitech Microbio	France	E.L.I.H.A TOXO 666102 réf. ELI.H.A Echinococcus 666042 réf.	B, C IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Elmontsrl	Italie	BIO ACTIVA 1203 réf. BLACK ACTIVA TP PLUS 1203 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Enlightening Pallet Industry Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	0.1ML98/79 60ml98/79	– 98/79	Présent sur le marché en France sales02@icnplast.com Fiche EUDAMED Signaler une erreur
Epocal FDA Mandataire UE : Siemens Healthcare Diagnostics Manufacturing Limited (Irlande)	Canada	epoc Care-Fill Capillary Tubes IVDR_69_OTT_DUB-C_A_NPT_BG-EPOC EPOC READER IVDR_69_OTT_DUB-C_A_NPT_INST_BG-EPOC3 réf.	A IVDR	Site web contact@siemens-healthineers.com Fiche EUDAMED Signaler une erreur
Essenlix Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	LA001 UA001	A IVDR	Site web info@essenlix.com.cn Fiche EUDAMED Signaler une erreur
Esteriplas	Portugal	150ml ANAPAT Prefilled, contentores pré-cheios com Formol a 10% tamponado2 réf. 2000083 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Eurosirel FDA	Italie	Primia - Contenitore per urine98/79 Primia - Contenitore per urine con dispositivo di prelievo98/79	– 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Futurlab	Italie	FC20 Plus3 réf. FE26 Electrophoresis Analyzer	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Gangdong Group FDA Mandataire UE : MDSS GmbH (Allemagne)	Corée du Sud	PathoLock™ 10% NBF (130 mL) SINGLE-USE PRE-FILLED SAFETY CONTAINER WITH 10% NEUTRAL BUFFERED FORMALIN, NON-CONTACT MECHANICAL CAP-CLOSURE RELEASE, FOR FIXATION AND TRANSPORT OF HISTOLOGICAL SPECIMENS PathoLock™ 10% NBF (20 mL) SINGLE-USE PRE-FILLED SAFETY CONTAINER WITH 10% NEUTRAL BUFFERED FORMALIN, NON-CONTACT MECHANICAL CAP-CLOSURE RELEASE, FOR FIXATION AND TRANSPORT OF HISTOLOGICAL SPECIMENS	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Gcmedica Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	Mucus Specimen Trap2 réf.93/42 Polyp Trap GC1974A0293/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Geneplus Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Automated Workstation Gene+GIN16 Gene+Box Data Analysis and Management System ED5001	A IVDR	Fiche EUDAMED Signaler une erreur
Genfollower Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Cell scraper：GD00018, GD00025, GD00235, GD00030, Cell lifters：CD00018, CD00215, Spin column：CS00001, CS00033, CS40004, CS60006, CS80008, Syringe Filters:SF012120, SF012135, SF012220, SF012235, SF022120, SF022220, SF022135, SF022235 Pipette tips:E-TR10GL-S, E-RW10GL-S, E-TB10GL, E-RS10GL, E-RS10GL-S, E-TR10GL-L-S, E-RW10GL-L-S, E-TB10GL-L, E-RS10GL-L, E-RS10GL-L-S, E-TR10M-S, E-RW10M-S, E-TB10M, etc	A IVDR	Fiche EUDAMED Signaler une erreur
Gold Probe Diagnostic Biotechnology Mf Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Human Papillomavirus Detection Kit (Multiplex Real-time PCR)98/79 Real time RT-PCR Kit for SARS-2 Flu A Flu B98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Guangdong Zijian Biotechnology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	cfDNA & cfRNA Storage Tube3 réf. Evacuated Blood Collection Tube Serum separation tube(None)1mL,100 tubes/box3 réf.	A IVDR	sales@szzijian.com Fiche EUDAMED Signaler une erreur
Guangzhou Decheng Biotechnology FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	D-Dimer (DD) Rapid Test Kit (Fluorescence Immunochromatographic Assay)98/79 Interleukin-6 (IL-6) Rapid Test Kit (Fluorescence Immunochromatographic Assay)98/79	– 98/79	Site web service@dochekbio.com Fiche EUDAMED Signaler une erreur
Guangzhou Four E’s Healthcare Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	Nucleic Acid Extractor System MultiEx 032 Nucleic Acid Extractor System MultiEx 096	A IVDR	Site web cs4@4e-s.com Fiche EUDAMED Signaler une erreur
Haierbiomedical FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Medical Centrifuge LX-155T500R3 réf. Medical Centrifuge LX-210L750R3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Hailife Mandataire UE : Medunion S.L. (Espagne)	Chine	20 tests/kit, 50 tests/kit2 réf. 20 tests/kit, 50tests/kit2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Haimen Henghui Lab Equipment Manufacturing Factory Mandataire UE : Prolinx GmbH (Allemagne)	Chine	1818 7101	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Hangzhou MiYin Biotechnology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	AUTO-MAGec 32 TQ-XJ-D-032 ；TQ-XQ-R-0323 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Hanhengmed FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	HH-5-B2、HH-5-B3、HH-10-B2、HH-10-B3、HH-10-B4、HH-10-B5、HH-10-B6、HH-10-B83 réf. HH-5、HH-10、HH-5-A2、HH-5-A3、HH-10-A2、HH-10-A3、HH-10-A4、HH-10-A5、HH-10-A6、HH-10-A83 réf.	A IVDR	quality@hanhengmed.com Fiche EUDAMED Signaler une erreur
Helixgen (GUANGZHOU) Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	HGINR-198/79 PT/INR test strip98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hettich FDA Mandataire UE : Andreas Hettich GmbH (Allemagne)	Suisse	ROTOLAVIT II 1008-00 ROTOLAVIT II-S 1008-00S	A IVDR	Présent sur le marché en France Site web info@hettich.ch Fiche EUDAMED Signaler une erreur
Hipro FDA Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	HP-AFS/1 Palm F	A IVDR	Fiche EUDAMED Signaler une erreur
Hisztopatológia Kft	Hongrie	HISTOLS-DAB HISTOLS-Rezisztens AEC2 réf.	A IVDR	Site web info@histopat.hu Fiche EUDAMED Signaler une erreur
Hivis Medical Technology Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	V-198/79 V-500,V-600,V-700,V-800,V-900,V-500MINI,V-4000,V-5000,V-6000	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Hlb Panagene Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	PANAMAX™ 16 PANAMAX™ 48	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Hosmed Grup Medi̇kal Sağlik Hi̇zmetleri̇ Şi̇rketi̇	Turquie	HOSMED PATHGYNE FIX 1022 réf. SepsiBiyo 120	A IVDR	Fiche EUDAMED Signaler une erreur
Hoyotek Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	D-Dimer Rapid Test Kit (Fluorescence Immunochromatographic Assay) Please see the IFU.2 réf.98/79 lnterleukin-6 Rapid Test Kit (Fluorescence Immunochromatographic Assay) Please see the IFU.2 réf.98/79	– 98/79	Site web inquiry@hoyotek.cn Fiche EUDAMED Signaler une erreur
HplanetBio (Shijiazhuang) Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Real-time Fluorescence-based 4-Channel qPCR Instrument JY804 Real-time Fluorescence-based 8-Channel qPCR Instrument JY808	A IVDR	Fiche EUDAMED Signaler une erreur
Hubei V-Medical Products FDA Mandataire UE : RAFFIN MEDICAL (France)	Chine	Cups 60ml，90ml，100ml，120ml，150ml，200ml，250ml，500ml，1000ml3 réf. Dental sponge ES50STERILE	I MDR	Présent sur le marché en France Site web quality-liutao@v-medicalchina.com Fiche EUDAMED Signaler une erreur
Humadx Mandataire UE : Human Gesellschaft für Biochemica und Diagnostica mbH (Allemagne)	Chine	25T2 réf.98/79 HumaCombilyzer	A IVDR, 98/79	service@humadx.com.cn Fiche EUDAMED Signaler une erreur
Hunan Hehao Medical Technology Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Fecal Occult Blood (FOB) Test Kit (LIA)2 réf.98/79 Fecal Occult Blood (FOB) Test Kit (LIA) Hitachi 7020, 7180, Beckman AU680,OC-Sensor IO2 réf.	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Hunan Xiang Yi Laboratory Instrument Development FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	cence CH12R,CH16R,H1750R,HT165R, HT190R,L530R,TGL-16, HT150R,CLT55R,H2500R,CHT210R, H2050R,HT230R,H2100R, HT200R,HT300R,LT60R,HT185R,TGL-16M,TGL-20M, H1850R,H1650R,TGL-16K,L535R,H16R, H1500R,CHT230R,L535R-1,CTK64R,CTK80R, SperryTron 10R, SperryTron, cence TDZ4-WS,TD4,LT53,TD3,L550,TDZ5-WS,L420-A,L500-A,L600-A,XKA-2200, TG12M,TXD3,TDZ4K,CH12R,CH16R,CHT210,HT190,H1850,H1650,TG16-WS, H1750R,HT165R,CL8R,CL5R,CL5 ,DL-6M,HT190R,L530R,HT200,H1750,HT165,H1650K,TGL-16, H1650-W,M16,TD-24K, PRP400,PRP500,L720R-3,etc.3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Inpeco FDA Mandataire UE : QbD RepS BV (Belgique)	Suisse	Accelerator a3600 TLA3 réf. FlexPath Blox FPB	A IVDR	Présent sur le marché en France Regulatory.Affairs@inpeco.com Fiche EUDAMED Signaler une erreur
IQ Products FDA	Pays-Bas	Fetal Cell Count™ kit98/79 FMH QuikQuant98/79	– 98/79	Site web orders@iqproducts.nl Fiche EUDAMED Signaler une erreur
Jiangsu OUKLAB Medical Devices Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	1818mm 2020mm 2222mm 2424mm 2432mm 2240mm 2440mm 2250mm 2450mm 2260mm 24*60mm 7101/7102/7105/7105-1/7107/7107-1/7109 A1/A2/A3/A4/A5	A IVDR	Fiche EUDAMED Signaler une erreur
Jiangsu Yuli Medical Instrument Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	Microscope slides；cover glass with different sizes Mini centrifuge；6-holes；8holes；12-holes；24-holes；48-holes；64-holes；72-holes；96-holes	A IVDR	Fiche EUDAMED Signaler une erreur
Jiangxi Exquisite Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Clot Activator ,2ml,Glass Plain tube (No Additive), EDTA.K2, EDTA.K2/Gel, EDTA.K3, EDTA.Na2, Sodium Citrate 9NC, Sodium Citrate 9NC /Gel, Sodium Citrate 4NC, etc3 réf. Plain tube without additive ,Plain tube with additive	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Joinstar Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	iMatrix Prime Jet-iStar 800	A IVDR	Fiche EUDAMED Signaler une erreur
Lifereal Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	LifeReady 1000 QuantReady K9600	A IVDR	Fiche EUDAMED Signaler une erreur
Liuyang Sanli Medical Technology Development Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	VacuLab5 réf. VacuLab Normal Type	A IVDR	Fiche EUDAMED Signaler une erreur
Luminex Molecular Diagnostics FDA Mandataire UE : DiaSorin Italia S.p.A. (Italie)	Canada	NxTAG® Gastrointestinal Pathogen Panel98/79 NxTAG® Respiratory Pathogen Panel v2	B IVDR, 98/79	Site web regulatoryaffairs@luminexcorp.com Fiche EUDAMED Signaler une erreur
Lybe Scientific	Norvège	NAxtra®3 réf. NAxtra® 2.0 nucleic acid extraction kit3 réf.	A IVDR	Site web contact@lybescientific.com Fiche EUDAMED Signaler une erreur
MacroArray Diagnostics	Autriche	MAX 45k MAX 9k	A IVDR	Site web office@madx.com Fiche EUDAMED Signaler une erreur
Meddo	Roumanie	COPRORECOLTOR CU SPATULA PE COPRORECOLTOR CU SPATULA PS	A IVDR	Site web office@meddo.ro Fiche EUDAMED Signaler une erreur
Medical FDA Mandataire UE : Obelis s.a. (Belgique)	Japon	EXTEL HEMO・AUTO MC Collection Picker3 réf. HM-CODIAM	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Medical Devices Mandataire UE : Obelis s.a. (Belgique)	Pakistan	Adaptor for Disposable Ear Tips EU & US Fitting3 réf. Diagnostic Handle, VISIO 5 "Pulse", PR 3.5V3 réf.	I MDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Medical Electronic Systems Europe FDA	Belgique	QwikCheck DFI Kit98/79 QwikCheck Vitality	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Medico Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	SALIVA COLLECTION KIT MHM-A,MHM-B2 réf. Vacuum blood collection tube MDK- GC013 réf.	A IVDR	info@medicoswab.com Fiche EUDAMED Signaler une erreur
Medilab	Tchéquie	Adhesive Microscope Slides, Positively Charged, Printable, Silane Coated, Ground Edges, Corners 45° - BLUE3 réf. Paraffin Wax - 1 kg3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Megarobo Mandataire UE : MedPath GmbH (Allemagne)	Chine	Automated Liquid Handling Workstation Auflo-A16003 réf. MEGAROBO Liquid Handling Workstation2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
MES Medical Electronic Systems Mandataire UE : Arazy Group GmbH (Allemagne)	Israël	QwikCheck DFI Kit98/79 QwikCheck Vitality Kit	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Miraclean Technology FDA Mandataire UE : Share info GmbH (Allemagne)	Chine	Disposable stool sample collection kit FB-YT01 Saliva Collection Kit TY180, TY180F, TY180D, TY001A, TY001AF, TY001D, TY001B, TY002A-10.0, TY002AF-10.0, TY002AD-10.0, TY002B-10.0, TY003A-5.0, TY003AF-5.0, TY003AD-5.0,TY003B-5.0, TY004A-6.0, TY004AF-6.0, TY004AD-6.0,TY004B-6.03 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Moelab	Allemagne	möLab® D-Dimer Test98/79 möLab® Gonorrhoe Test98/79	– 98/79	Site web info@moelab.de Fiche EUDAMED Signaler une erreur
Monlab	Espagne	H. pylori Ag MonlabTest MO-804001 25 tests98/79 Norovirus MO-804018 20 Tests98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Mr International Healthcare Technology Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	MR HTSH-20003 réf. MR YD-2002 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Nadeemsurgical Mandataire UE : KHANG BAO INTERNATIONAL KFT (Hongrie)	Pakistan	Medium format rectangular tray 30-7726-03 Small rectangular tray 30-7726-01	I MDR	Site web info@nadeemsurgical.com Fiche EUDAMED Signaler une erreur
Nantong Huayun Medical Equipment Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	10ml/20ml/30ml/40ml/60ml/80ml/100ml/120ml/250ml Square holes/strip holes/round holes/fine square holes/ O rings	A IVDR	Fiche EUDAMED Signaler une erreur
Neotech Products FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	NeoGlo® Aqua Transilluminator3 réf. NeoGlo® Disposable Transilluminator - Red Lights2 réf.	I MDR	Site web ra@neotechproducts.com Fiche EUDAMED Signaler une erreur
Nev Yazilim Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇	Turquie	NEVAMAC BC01 NEVAMAC BC02	A IVDR	info@nevasoftai.com Fiche EUDAMED Signaler une erreur
New Erie Scientific Mandataire UE : Epredia Netherlands B.V. (Pays-Bas)	États-Unis	Capillary Gap Microscope Slides3 réf. Cover Slips3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Nichirei Biosciences Mandataire UE : MedEnvoy Global BV (Pays-Bas)	Japon	N-Histofine DAB-3S KIT3 réf. N-Histofine Simple Stain MAX PO (M)3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Ningbo MedicalSystem Biotechnology FDA Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Automated Chemistry Analyzer MS-420P,MS-400P,MS-380P,MS-420,MS-400,MS-380,MS-480,MS-450,MS-520,MS-600,MS-6803 réf. Automated Hematology Analyzer MS-H630	A IVDR	Fiche EUDAMED Signaler une erreur
NTP Nano Tech Projects FDA	Italie	NED-DH NED-DP	A IVDR	info@ntpsrl.biz Fiche EUDAMED Signaler une erreur
Optimedical FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	OPTI CCA -TS Blood Gas Analyzer OPTI CRITICAL CARE ANALYZER - TS (TOUCHSCREEN) OPTI CCA -TS2 Blood Gas Analyzer OPTI CRITICAL CARE ANALYZER - TS2	A IVDR	Site web Fiche EUDAMED Signaler une erreur
OptraSCAN FDA Mandataire UE : AR Experts B.V. (Pays-Bas)	États-Unis	OptraSCAN Digital Pathology System ImagePath OptraSCAN Digital Pathology System OS-Ultra System, OS-Lite System, OS-SiX System, OS-FS System, OS-Fli System3 réf.	A IVDR	Site web info@optrascan.com Fiche EUDAMED Signaler une erreur
Otsukael FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Japon	AA01 NS-Prime	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Oxford Immunotec FDA Mandataire UE : Wallac Oy (Finlande)	United Kingdom (ex Northern Ireland)	LTK.615 T-SPOT.TB TB.300	A, C IVDR	regulatory.oxford@revvity.com Fiche EUDAMED Signaler une erreur
PHC FDA Mandataire UE : PHC Europe B.V. (Pays-Bas)	Japon	Incubator MCO-233AIC-PE3 réf. PATHFAST D-Dimer	I, C IVDR, MDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Philips FDA	Pays-Bas	Pathology Scanner SG300i 1.x - IVD2 réf. Philips IntelliSite Pathology Solution 5.x - IVDR3 réf.	A IVDR	Présent sur le marché en France eudamed@philips.com Fiche EUDAMED Signaler une erreur
Physikit	Allemagne	Allergiekit - Kit für Kapillarblutentnahme At-home capillary blood collection kit2 réf. Buchinger/Wilhelmi Kit für Kapillarblutentnahme3 réf.	IIa MDR	Site web Fiche EUDAMED Signaler une erreur
Pro-Lab Diagnostics UK Mandataire UE : Advena Limited (Malte)	United Kingdom (ex Northern Ireland)	Field's Stain A PL.71233 réf. Rabbit Coagulase Plasma4 réf.98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Pro.Lab FDA	Italie	130413 - BORSA ISOTERMICA ADR PER IL TRASPORTO DI CAMPIONI BIOLOGICI 720201 - BORSA ISOTERMICA ADR PER IL TRASPORTO DI CAMPIONI BIOLOGICI3 réf. 130413/P - BORSA ISOTERMICA ADR PER IL TRASPORTO DI CAMPIONI BIOLOGICI 300422 - BORSA ISOTERMICA ADR PER IL TRASPORTO DI CAMPIONI BIOLOGICI3 réf.	I, A IVDR, MDR	Fiche EUDAMED Signaler une erreur
Promega FDA Mandataire UE : Abbott GmbH (Allemagne)	États-Unis	Abbott mSample Preparation System 04J70-24 Abbott mSample Preparation SystemDNA 06K12-24	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Protia Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	Q-Smart Q-STATION ELITE	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Quidel Cardiovascular FDA Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	Triage D-Dimer2 réf.98/79 Triage MeterPro98/79	– 98/79	Site web PRRC@quidelortho.com Fiche EUDAMED Signaler une erreur
Radon Tibbi̇ Malzemeler İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇	Turquie	Kurşun Çeker Ocak93/42 Su Tankı93/42	I 93/42	Site web info@radonfix.net Fiche EUDAMED Signaler une erreur
Rastin Mandataire UE : Source of Commerce GmbH (Allemagne)	Iran	Rastin HI25 Rastin HI50G	C IVDR	Site web Fiche EUDAMED Signaler une erreur
Regengeek Mandataire UE : MedPath GmbH (Allemagne)	Chine	Mesenchymal Stem Cell Serum-Free Medium2 réf. NK Cell Induction and Expansion Culture Kit2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
ReLIA Biotechnologies (Jiangsu) Mandataire UE : Luxus Lebenswelt GmbH (Allemagne)	Chine	ReLIA6 réf.98/79 ReLIA Interleukin-6 Test (Fluorescence Immunoassay)2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Sacace	Italie	DNA-Sorb-A3 réf. Sa2Res SaCycler-96R Real Time PCR System3 réf.	A IVDR	Site web info@sacace.com Fiche EUDAMED Signaler une erreur
Sanqi Biomedical Shandong Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Interleukin-6 (IL-6) test kit (fluorescence immunochromatography) 3Q-FA1000 Novel Coronavirus Antigen Test Kit(Latex beads) 3Q-FA1000	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Sc Spd Star	Roumanie	COPROCULTOR LIVSANE 30 ML3 réf. UROCULTOR LIVSANE 120 ML UROCULTOR 120 ml3 réf.	A IVDR	Site web OFFICE@SPDGROUP.RO Fiche EUDAMED Signaler une erreur
Scienco Technology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Taïwan	IME-DC DS-22 réf.98/79 SIMCHECK DS-52 réf.98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Sciex FDA Mandataire UE : Leica Microsystems CMS GmbH (Allemagne)	Singapour	Citrine™ QTRAP MS/MS2 réf. QTRAP 4500MD MS/MS System2 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
SD Innovation	France	Glass tubes TH-CV-1000 Stir bars	A IVDR	Présent sur le marché en France contact@sd-innovation.fr Fiche EUDAMED Signaler une erreur
Self-screen	Pays-Bas	HPV-Risk assay QHR1317298/79 QIAscreen HPV PCR test98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Shanghai Howsome Biotechnology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Micro SCANNER Alpha、Micro SCANNER Beta、Micro SCANNER Gamma、Micro SCANNER Delta、Micro SCANNER Epsilon、Micro SCANNER Plus、Micro SCANNER Rainbow Ultra、Micro SCANNER Rainbow Mini、etc Mycob.T Stainer Beta	A IVDR	Fiche EUDAMED Signaler une erreur
Shanghai Sunshore Medical Instruments Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	10ml, 20ml,30ml, 40ml,50ml, 60ml,80ml,90ml,100ml, 120ml,250ml,500ml2 réf. 13x75mm(1-5ml),13x100mm(5-7ml),16x100mm(8-10ml);8x120mm Plain Tube,Pro-coagulation Tube ,Gel&Clot Activator Tube , EDTA Tube,PT Tube,ESR Tube, Heparin Tube, etc	A IVDR	Fiche EUDAMED Signaler une erreur
Shenzhen Huisong Technology Development Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Full Automatic Sample Handling System EL-2600L,EL-2600M,EL-2600H Product Name Nucleic Acid Extraction Kit HH-6160	A IVDR	Fiche EUDAMED Signaler une erreur
Shenzhen Landwind Biomedical Technology Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Landwind LW C100Plus 、LW C100、LW C200T、LW C200E、 LW C400、 LW C360、LW C420、LW C480、LW C600、LW C8003 réf. Landwind LW D658098/79	A IVDR, 98/79	sales@landwindmedical.com Fiche EUDAMED Signaler une erreur
ShenZhen PRS Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	Essential ver. 1.0 Essential ver. 2.0	A IVDR	Fiche EUDAMED Signaler une erreur
Shenzhen YC Biotechnology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	BC-96SA BC-98SA BC-99SA HC-500098/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Shinjin Medics Mandataire UE : Obelis s.a. (Belgique)	Corée du Sud	MESSIAH Gamma Counter MESSIAH R4200	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Sigma Laborzentrifugen FDA	Allemagne	Sigma 1-163 réf. Sigma 8KBS3 réf.	IIa, A IVDR, MDR	Site web info@sigma-zentrifugen.de Fiche EUDAMED Signaler une erreur
Siliconbiosystems FDA Mandataire UE : Menarini Silicon Biosystems S.p.A. (Italie)	États-Unis	CellSave Preservative Tube 790000598/79 CellSave Preservative Tube 95282098/79	– 98/79	Fiche EUDAMED Signaler une erreur
Singlecellbiotech Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	FlowRACS HT300 Univ Raman-Activated Microfluidic Sorter (RAMS) RAMS MM96	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Singleragenomics Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne) et 1 autre	Chine	Nucleic Acid Purification System CaptureRevo NAE24 Nucleic Acid Purification System NAE24 PIus	A IVDR	RA@singleragenomics.com Fiche EUDAMED Signaler une erreur
Skyla Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Taïwan	LINX EVO HB-P022 réf. skyla HI-P01	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Specchiasol	Italie	KIT WELLMICRO GUT TEST PLUS-METAGENOMIC REVOLUTION 99258 WM GUT TEST PLUS METAGENOMIC REVOLUTION 99300	IIa MDR	Fiche EUDAMED Signaler une erreur
Stratec FDA	Allemagne	Gemini Compact Microplate Processor 10041566 KleeYa® Instrument 10108093	A IVDR	Site web info@stratec.com Fiche EUDAMED Signaler une erreur
Sunlant Mandataire UE : MedPath GmbH (Allemagne)	Chine	Automatic Biochip Analyzer Automatic Electrochemiluminescence Immunoassay Analyzer2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Suny (Xiamen) Biotechnology Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	BOIRON COVID-19/Grippe Rapid Antigen Test98/79 BOIRON TEST & CARE Rapid SARS-CoV-2&Flu A&Flu B Antigen Test (Colloidal Gold)/ Nasal Swab98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Sussex Biologicals Mandataire UE : Eurolink Europe Compliance Limited (Irlande)	United Kingdom (ex Northern Ireland)	Phosphate Buffered Saline 10 Litres2 réf. Phosphate Buffered Saline Concentrate 1 x 250ml bottle	A IVDR	Site web info@sussexbiologicals.co.uk Fiche EUDAMED Signaler une erreur
Suzhou Ruiqian Technologies Mandataire UE : Medunion S.L. (Espagne)	Chine	Fully Automated Digital Slide Scanning System WSI-2100;WSI-2200;WSI-24003 réf. Fully Automated Whole Slide Scanning System RQ1000	A IVDR	Fiche EUDAMED Signaler une erreur
Taho Future ( Tianjin ) Biotechnology Mandataire UE : MedPath GmbH (Allemagne)	Chine	Automated Blood Culture System TaiCube 1203 réf. Cleaning Solution MC-Coulter	A IVDR	info@tahobiology.com Fiche EUDAMED Signaler une erreur
Taizhou Kangwei Medical Instrument Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	5ml/10m/12ml/15ml/20ml/25ml/30ml/40ml/60ml/80ml/90ml/100ml/ 120ml/160ml/170ml/180ml/ 250ml/500ml/1L/2L4 réf. Plain tube; Clot activator tube; Sodium Citrate tube:ESR tube; Lithium Heparin tube; Sodium Heparin tube;Gel&Clot activator tube; Glucose tube;EDTA Tube(EDTA-K2/EDTA-K3/EDTA-Na2); PRPtube(ACD/ACD+ Gel/ Sodium Citrate + Gel/ACD+Gel+Biotin/ACD+Gel+HA/ etc3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Taizhou Zecen Biotech Mandataire UE : MedPath GmbH (Allemagne)	Chine	Automatic Biochemistry Analyzer3 réf. Chemiluminescence Immunoassay Analyzer3 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
tascom Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	SimplexTAS 101 Analyzer SimplexTAS 101 Hb Reagent Cartridge98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Tassoinc FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	Tasso+ Amber Plasma K1025-01-EDT3 réf. Tasso-M20 K1001-0293/42	IIa MDR, 93/42	Fiche EUDAMED Signaler une erreur
Terumo FDA Mandataire UE : TERUMO EUROPE N.V. (Belgique)	Japon	MEDISAFE Fit Smile Blood Glucose Meter2 réf.98/79 MEDISAFE FIT Smile Blood Glucose Monitoring System Kits3 réf.98/79	– 98/79	Présent sur le marché en France Eudamed_LAA@terumo.co.jp Fiche EUDAMED Signaler une erreur
TestCard Mandataire UE : CS Life Sciences Europe Ltd (Irlande)	United Kingdom (ex Northern Ireland)	Roche Combur-10 UX StripReader SureScreen Covid/Flu Test Reader	A IVDR	Site web info@testcard.com Fiche EUDAMED Signaler une erreur
Tiangen Mandataire UE : Humiss International B.V. (Pays-Bas)	Chine	TGrinder H24 Tissue Homogenizer OSE-TH-01 TGrinder H24R Tissue Homogenizer OSE-TH-02	A IVDR	Présent sur le marché en France Site web ran.zhang@tiangen.com Fiche EUDAMED Signaler une erreur
Tianjin Bioscience Diagnostic Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	100 TEST/KIT4 réf.98/79 500 TEST/KIT98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Tianjin Dexiang Biotechnology Mandataire UE : Medunion S.L. (Espagne)	Chine	Fully Automated Blood Group Analyzer AI 1000 Fully Automated Blood Group Analyzer DX 8002 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Triolab	Suède	Triomix blue Triomix pink	A IVDR	Site web info@triolab.se Fiche EUDAMED Signaler une erreur
Vecmedical FDA	Espagne	ASMOC BRONCOSCOPIA98/79 ASMOC BRONCOSCOPIA CON CONECTOR98/79	– 98/79	Site web eudamed@vecmedical.com Fiche EUDAMED Signaler une erreur
vivatura	Allemagne	Probenentnahmeset Stuhl Probenentnahmeset Urin	I, IIa MDR	Site web Fiche EUDAMED Signaler une erreur
Waldemar Knittel Glasbearbeitungs	Allemagne	KT Premium Adhesion Microscope Slides3 réf. KT-Premium Cover Glass3 réf.	A IVDR	Site web quality@knittel-glaeser.de Fiche EUDAMED Signaler une erreur
WellMed FDA	Pays-Bas	CryoCompound7 réf. Imsolmount2 réf.	A IVDR	Site web info@wellmed.nl Fiche EUDAMED Signaler une erreur
Whpm FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	Cassette WH-AT-OFLU98/79 One-Step Immunological Fecal Occult Blood Test Strip; Cassette98/79	– 98/79	customerservice@whpm.com.cn Fiche EUDAMED Signaler une erreur
Wuhan BGI Biomedical Engineering Mandataire UE : MedPath GmbH (Allemagne)	Chine	Automatic Chemiluminescence Immunoassay Analyzer GBI-MAP 800Plus Automatic Chemiluminescence Immunoassay Analyzer MAE-1200i	A IVDR	Fiche EUDAMED Signaler une erreur
Wuxi Opulen Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas) et 1 autre	Chine	Real time fluorescence quantitative PCR Device OP-qPCR1600C Real-time Fluorescence Quantitative PCR lnstrument OPqPCR1600	A IVDR	Fiche EUDAMED Signaler une erreur
Wuxi Qitian Biological Science Instrument Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	RAA-F1620 RAA-F1628	A IVDR	Fiche EUDAMED Signaler une erreur
Yali Biotech Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	10 ml, 50 ml, 100 ml. Glass Tube: 5 ml, 10 ml; Pet Tube: 5 ml, 10 ml.	A IVDR	info@yalibiotech.com Fiche EUDAMED Signaler une erreur
Yingmed FDA Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	7-DAY PILL ORGANIZER YM-N014 Tygodniowy pojemnik na leki Depan (okr±g³y) Pill box(7-DAY PILL ORGANIZER, Tygodniowy pojemnik na lekarstwa)	I MDR	Site web info@yingmed.com Fiche EUDAMED Signaler une erreur
ZEUS Scientific FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	FTA-ABS DS Test System FA7001DS98/79 FTA-ABS Test System FA700198/79	– 98/79	Présent sur le marché en France Site web regulatory@zeusscientific.com Fiche EUDAMED Signaler une erreur
Zhejiang Aicor Medical Technology FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	B01, B01-1, B02, B03 , B04 , B05, B06 , B07, B08, B09, B28 , B29, B30 , B46, B473 réf. Pipette Tip, Serological Pipette, Pasteur Pipette, Reagent Bottle, Reservoir. D023 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Zhejiang Gewuzhizhi Biotechnology Mandataire UE : Llins Service & Consulting GmbH (Allemagne) et 1 autre	Chine	Chemiluminescence Immunoassay Analyzer GW2000i Interleukin-8 (IL-8) Test Kit (CLIA) 100Test/Kit98/79	A IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Zhejiang Rongda Bio Technology Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	900091, 900092, 900093, 900094, 900095, 900096, 900097, 900098, 900099900091, 900092, 900093, 900094, 900095, 900096, 900097, 900098, 900099 911011, 911012, 911013, 911014, 911015, 911016, 911017, 911018, 911019	A IVDR	Fiche EUDAMED Signaler une erreur
Zhongshan Ruifu Medical Equipment Technology Mandataire UE : Medunion S.L. (Espagne)	Chine	Automated Immunoblotting Analyzer IB60 Plus-A Automated Immunoblotting Analyzer ImmunoBlot 60	A IVDR	ra@refmedical.net Fiche EUDAMED Signaler une erreur
Zonci Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	Automatic Blood Coagulation Analyzer XL1000e, XL1000, XL3200c, XL3200t, XL3600c, XL3600t, XL3690t, XL120p, XL120T, XL120L, XL120G, XL120R, XL120c, XL120e, XL120s, XL120i, XL1000c, XL1000i, Space, Space1, Space1 plus, XL3690c, XL1000s3 réf. XL40	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Žikplast Žitnik Anja	Slovénie	Epruveta 11 x 55 mm3 réf. Petrijevka fi 90 mm	A IVDR	Fiche EUDAMED Signaler une erreur
Zhejiang Anji Saianfu Biotechnology Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Mycoplasma IgM Rapid Test2 réf.98/79 Adenovirus Ag Rapid Test98/79 (plus commercialisé) Brucellosis Antibody（Brucella Ab）Rapid Test98/79 (plus commercialisé) Candida Albicans/Gardnerella Vaginalis /Trichomonas Vaginalis Combo Rapid Test（Swab）98/79 (plus commercialisé) Chlamydia Rapid Test Device (Swab)98/79 (plus commercialisé) 41 autres Clostridium Difficile Toxin A+B Rapid Test98/79 (plus commercialisé) Clostridium Difficile Toxin AB+GDH Rapid Test98/79 (plus commercialisé) CMV(Cytomegalovirus) IGG IGM Rapid Test98/79 (plus commercialisé) COVID-19 /Flu A&B /RSV /ADENO Ag Combo Rapid Test Cassette (Swab)98/79 (plus commercialisé) COVID-19 /Flu A&B /RSV /ADENO/M.P Ag Combo Rapid Test Cassette (Swab)98/79 (plus commercialisé) COVID-19 /Flu A&B /RSV Ag Combo Rapid Test Cassette (Swab)98/79 (plus commercialisé) COVID-19 AG & INFLUENZA A/B COMBO RAPID TEST98/79 (plus commercialisé) COVID-19 Antigen Rapid Test98/79 (plus commercialisé) COVID-19 IgG IgM Rapid Test Kit98/79 (plus commercialisé) D-dimer Rapid Test98/79 (plus commercialisé) Dengue IgM/IgG Rapid Test98/79 (plus commercialisé) Dengue NS1 Antigen & IgG/IgM Rapid Test（Whole Blood/Serum/Plasma）98/79 (plus commercialisé) Dengue NS1 Rapid Test98/79 (plus commercialisé) Giardia antigen Rapid Test98/79 (plus commercialisé) Gonorrhea Antigen Rapid Test98/79 (plus commercialisé) H. pylori Antibody Rapid Test98/79 (plus commercialisé) H.pylori Antigen Rapid Test98/79 (plus commercialisé) HAV IGG IGM Rapid Test98/79 (plus commercialisé) HPV 16/18 Antigen Rapid Test98/79 (plus commercialisé) HSV IgG/IgM Rapid Test98/79 (plus commercialisé) Influenza A/B Ag Rapid Test98/79 (plus commercialisé) Leishmania IgG IgM Rapid Test98/79 (plus commercialisé) Leptospira IgG IgM Rapid Test98/79 (plus commercialisé) Lyme Ab Rapid Test98/79 (plus commercialisé) Malaria pf/pan One Step Rapid Test98/79 (plus commercialisé) Malaria pf/pv One Step Rapid Test98/79 (plus commercialisé) Monkeypox Antibody Rapid Test (Whole blood/Serum/Plasma)98/79 (plus commercialisé) Monkeypox Antigen Rapid Test98/79 (plus commercialisé) Mycoplasma Antigen Rapid Test98/79 (plus commercialisé) Norovirus Antigen Rapid Test98/79 (plus commercialisé) Parvovirus antigen（CPV Ag/FPV Ag） Rapid Test98/79 (plus commercialisé) Rotavirus Rapid Test98/79 (plus commercialisé) RSV Antigen Rapid Test（Swab）98/79 (plus commercialisé) Strep A Rapid Test98/79 (plus commercialisé) Streptococcus pneumoniae antigen rapid test98/79 (plus commercialisé) TORCH Rapid Test98/79 (plus commercialisé) Treponema Pallidum Antibody Rapid Test98/79 (plus commercialisé) Typhoid IgG/IgM Rapid Test98/79 (plus commercialisé) Typhoid Para Ag Test Device98/79 (plus commercialisé) Typhus IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 (plus commercialisé) Zika Rapid Test98/79 (plus commercialisé)	– 98/79	Fiche EUDAMED Signaler une erreur
YourBio Health FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	TAP 77010293/42 TAP 77120293/42 (plus commercialisé) TAP 77121293/42 (plus commercialisé) TAP 77310293/42 (plus commercialisé) TAP 77311293/42 (plus commercialisé)	IIa 93/42	Site web info@yourbiohealth.com Fiche EUDAMED Signaler une erreur
Lionex	Allemagne	LIOFeron® TB/LTBI3 réf. LIODetect® D-Dimer Rapid Test98/79 (plus commercialisé)	C IVDR, 98/79	Site web info@lionex.de Fiche EUDAMED Signaler une erreur
Salofa FDA	Finlande	Strep A test kit 75-75STREPA-xx98/79 Reader-1-S98/79 (plus commercialisé)	– 98/79	Site web info@salofa.com Fiche EUDAMED Signaler une erreur
2cureX	Danemark	2cx-SC-01	A IVDR	Site web support@2curex.com Fiche EUDAMED Signaler une erreur
77 Elektronika Műszeripari Korlátolt Felelősségű Társaság	Hongrie	Dcont ETALON B Kit3 réf.	IIa MDR	Site web Fiche EUDAMED Signaler une erreur
Abbexa Mandataire UE : Abbexa BV (Pays-Bas)	United Kingdom (ex Northern Ireland)	abx098801	A IVDR	Site web info@abbexa.com Fiche EUDAMED Signaler une erreur
ABI Enterprises Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Pakistan	Teale Tenaculum Forceps	I MDR	Fiche EUDAMED Signaler une erreur
Abionic FDA Mandataire UE : Veranex Germany GmbH (Allemagne)	Suisse	abioSCOPE P01.00007	A IVDR	Site web info@abionic.com Fiche EUDAMED Signaler une erreur
Absology Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	ABOSOL ABSOL-001	A IVDR	Fiche EUDAMED Signaler une erreur
Abviris	Allemagne	Prevo-Check98/79	– 98/79	Site web info@abviris.de Fiche EUDAMED Signaler une erreur
ABW Medizin und Technik	Allemagne	MC 13 réf.	A IVDR	Site web info@abw-medizintechnik.de Fiche EUDAMED Signaler une erreur
Acmexbio Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Acmex Cassette14 réf.98/79	– 98/79	info@acmexbio.com Fiche EUDAMED Signaler une erreur
Addaxbio FDA	Italie	GAF® Fixative 1 l3 réf.	A IVDR	Site web administration@addaxbio.com Fiche EUDAMED Signaler une erreur
Affymetrix Mandataire UE : Life Technologies Europe B.V. (Pays-Bas)	États-Unis	GCDC Dx Installer v1.0 GeneChip™ System 3000Dx v.2 Instrument System3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Agnitio Science &Technology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Taïwan	Agnitio BioIC Analyzer BA-G2000 series/BA-G2012 series/BA400 series/ BA1200 series/BA2400 series3 réf.	A IVDR	Site web contact.us@agnitiost.com Fiche EUDAMED Signaler une erreur
Aiesi	Italie	VETRINI PORTAOGGETTO PER MICROSCOPIO2 réf.	A IVDR	COMMERCIALE@AIESI.IT Fiche EUDAMED Signaler une erreur
Aigene Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Corée du Sud	AIamp Arcus96S, AIamp Arcus96L	A IVDR	Fiche EUDAMED Signaler une erreur
Alere San Diego FDA Mandataire UE : Abbott Rapid Dx International Limited (Irlande)	États-Unis	Cholestech LDX™ Lithium Heparin Capillary Tubes	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Alfresa Pharma FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Japon	Probenahmebehalter A3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Allsheng FDA Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Nucleic acid Extraction and Purification Kit	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Andehealthcare FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	XQZ-03 1mL, XQZ-03 3mL2 réf.	I MDR	Site web Fiche EUDAMED Signaler une erreur
Anhui Wanyi Science Technology Mandataire UE : Eunitor GmbH (Allemagne)	Chine	Real-Time PCR System GT-96	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Anhui Weizhen Bioengineering Technology Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Professional testing B01101M	A IVDR	Fiche EUDAMED Signaler une erreur
Apel Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Japon	Bilirubinmeter3 réf.	A IVDR	Site web sales@apel.co.jp Fiche EUDAMED Signaler une erreur
Apexbio FDA Mandataire UE : Obelis s.a. (Belgique)	Taïwan	Eclipse PLUS	A IVDR	info@apexbio.com Fiche EUDAMED Signaler une erreur
Apexpulp Mandataire UE : Advena Limited (Malte)	Malaisie	Adaptor Urinal Bulbous3 réf.	I MDR	sales@apexpulp.com Fiche EUDAMED Signaler une erreur
Apollo FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	Taïwan	Assaya intelligent analyzer eXpress iaX-2101	A IVDR	Site web info@apollo.bio Fiche EUDAMED Signaler une erreur
AR Instrumed Mandataire UE : AR Instrumed Deutschland GmbH (Allemagne)	Pakistan	AR INSTRUMED 107-335-S3 réf.	I MDR	Site web info@ar-instrumed.com Fiche EUDAMED Signaler une erreur
Arghavan Teb Kavian Mandataire UE : Medisol Technologies S.L. (Espagne)	Iran	ATK HPV	C IVDR	Site web info@atkdiagnostic.com Fiche EUDAMED Signaler une erreur
Arrow Diagnostics	Italie	AD4SEQ HIV-1 SOLUTION V2	C IVDR	Site web info@arrowdiagnostics.it Fiche EUDAMED Signaler une erreur
Arteion	France	sthemA 801	B IVDR	Présent sur le marché en France contact@arteion.com Fiche EUDAMED Signaler une erreur
Ascend Diagnostics Mandataire UE : Advena Limited (Malte)	United Kingdom (ex Northern Ireland)	LEXI MALDI-TOF MASS SPECTROMETER 000000870098/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Asel Tibbi Aletler	Turquie	ASELTECH	I MDR	Site web info@aseltech.com.tr Fiche EUDAMED Signaler une erreur
Athenesedx Mandataire UE : Obelis s.a. (Belgique)	Inde	ALTA Biochemistry Analyzer ADX-230	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Atlas Link Technology FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Chine	Respiratory Antigen Multiple Test Kit C21343 réf.	C IVDR	Site web Fiche EUDAMED Signaler une erreur
Atlascerrahialetler	Turquie	ATLAS	I MDR	Site web Fiche EUDAMED Signaler une erreur
Attomol	Allemagne	attomol® Attosorb 3x96	A IVDR	Site web info@attomol.de Fiche EUDAMED Signaler une erreur
Ayala Sample Kits	Espagne	TUBO PARA RECOGIDA DE AIRE ESPIRADO 100 CAL003, CAL003.1, CAL003.2, CAL003.3, CAL003.4, CAL003.5, CAL003.6, CAL003.7, CAL003.8, CAL003.9, CAL003.10, CAL003.11, CAL003.12, CAL003.13, CAL003.14, CAL003.15, CAL003.16, CAL003.17, CAL003.183 réf.	A IVDR	eudamed.ayalasamplekits@gmail.com Fiche EUDAMED Signaler une erreur
BaSO Biotech Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Taïwan	BaSO Autostainer ( AS-316GH )3 réf.	A IVDR	Site web services@basobiotech.com Fiche EUDAMED Signaler une erreur
Batrik Medical Manufacturing FDA Mandataire UE : Advena Limited (Malte)	Canada	Your First Transport Bags3 réf.	I MDR	Présent sur le marché en France Site web info@surgmed.com Fiche EUDAMED Signaler une erreur
Baybio Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	NE-02-K-12；NE-02-K-12M；NE-02-K-96；NE-02-H-96；NE-02-F-96；NE-12-T-24	A IVDR	Fiche EUDAMED Signaler une erreur
Bd FDA	Pays-Bas	Kiestra5 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Bedfont FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	United Kingdom (ex Northern Ireland)	Gastrocheck Bag	I MDR	Site web Fiche EUDAMED Signaler une erreur
Beijing High-Grade Biotechnology Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	HG2-360	A IVDR	admin@biohighgrade.com Fiche EUDAMED Signaler une erreur
Beijing Kewei Clinical Diagnostic Reagent Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Helicobacter Pylori Antigen Rapid Test Kit (FIA)98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Beijing Microfuture Technology Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	ULSEN ®SARS-CoV-2 Whole Genome Capture Kit Instruction98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Beijing Zhongjian Antai Diagnostic Technology Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Mycoplasma Pneumoniae Antigen Combo Test Cassette: 1 Test/Kit	B IVDR	Fiche EUDAMED Signaler une erreur
Berpu FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	cobas sense venous pipettes 90μL 0.7x9 mm	A IVDR	Fiche EUDAMED Signaler une erreur
Better2Know Mandataire UE : Patient Guard Europe UG (Allemagne)	United Kingdom (ex Northern Ireland)	Better2Know Specimen Receptacles3 réf.	A IVDR	Site web info@better2know.com Fiche EUDAMED Signaler une erreur
Beyotime Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	>200T	A IVDR	Fiche EUDAMED Signaler une erreur
BGI Hangzhou CycloneSEQ Technology Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Genetic Sequencer G100-E	A IVDR	Fiche EUDAMED Signaler une erreur
BGl Biotechnology (Wuhan) Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	1 tube/kit	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Bio-Rad Laboratories FDA Mandataire UE : Bio-Rad (France)	États-Unis	BioPlex 2200 MMRV IgG Control Set BioPlex 2200 MMRV IgG Assay2 réf.	C IVDR	Présent sur le marché en France Site web contact@bio-rad.com Fiche EUDAMED Signaler une erreur
BioArray Solutions FDA Mandataire UE : IMMUCOR Medizinische Diagnostik GmbH (Allemagne)	États-Unis	BioArray Array Imaging System TM (AIS) 400D	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Biobase Biogrand Mandataire UE : Luxus Lebenswelt GmbH (Allemagne)	Chine	Elisa Microplate Reader BK-EL series2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Biocartis FDA	Belgique	Idylla™ Console Idylla™ System3 réf.	A IVDR	Présent sur le marché en France Site web regulatory@biocartis.com Fiche EUDAMED Signaler une erreur
Bioda Diagnostics (Wuhan) Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Bioda	A IVDR	Fiche EUDAMED Signaler une erreur
Bioeuropegmbh	Allemagne	Fortel Ulcer (H. pylori) Screening Test 1005-198/79	– 98/79	Site web info@bioeuropegmbh.com Fiche EUDAMED Signaler une erreur
BioGX FDA	Pays-Bas	BioGX Syphilis - OSR for BD MAX98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Biolab	Hongrie	Széklettartály, 3 részes, postai rendszer	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Biolifeit	Italie	MIDI-SYSTEM ECOSAF3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Biome Diagnostics	Autriche	BiomeCollect	A IVDR	Site web service@biome-dx.com Fiche EUDAMED Signaler une erreur
biomed Dr. Wieser	Autriche	Ledetect96	A IVDR	Site web office@biomed-technics.com Fiche EUDAMED Signaler une erreur
Biomes	Allemagne	SAMPLING.pro - Stool Sample Collection & Stabilisation Kit REF46202 réf.	A IVDR	Site web info@biomes.world Fiche EUDAMED Signaler une erreur
BiopSafe FDA	Danemark	BiopSafe®3 réf.	A IVDR	Site web info@biopsafe.com Fiche EUDAMED Signaler une erreur
biosurfit	Portugal	spinit®2 réf.98/79	– 98/79	info@biosurfit.com Fiche EUDAMED Signaler une erreur
BioView FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Israël	Solo Offline Workstation Duet3 réf.	A IVDR	Site web info@bioview.co.il Fiche EUDAMED Signaler une erreur
Biovis	Allemagne	Atemgas-Set Fruktose-Sorbit-Malabsorption T9293 réf.	A IVDR	ivdr@biovis.de Fiche EUDAMED Signaler une erreur
Bioyuan Mandataire UE : Obelis s.a. (Belgique)	Chine	Coagulation Control refer to IFU14 réf.98/79	– 98/79	ra@bioyuan.cn Fiche EUDAMED Signaler une erreur
Blisscare	Espagne	SBL.PRP.3 KIT	IIa MDR	Site web Fiche EUDAMED Signaler une erreur
Blusense Diagnostics Aps	Danemark	BluBox D6.0	A IVDR	Site web info@blusense-diagnostics.com Fiche EUDAMED Signaler une erreur
Bndhematech Mandataire UE : Umedwings Netherlands B.V. (Pays-Bas)	Chine	BND SteriLink BND-JGJ-02	I MDR	marketing@bndhematech.com Fiche EUDAMED Signaler une erreur
Bournas Medicals	Greece	SOFT CARE LABORATORY SERIES3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Bredlifesci Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Kit for Determination of the DNA Fragmentation level in Spermatozoa (SCD method)2 réf.	A IVDR	info@bredlifesci.com Fiche EUDAMED Signaler une erreur
Brightbiomed Mandataire UE : MedPath GmbH (Allemagne)	Chine	Automatic Nucleic Acid Extraction and Real-Time PCR System2 réf.	A IVDR	info@brightbiomed.com Fiche EUDAMED Signaler une erreur
BSL FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Corée du Sud	CRS-301 ACS-1013 réf.	I MDR	Fiche EUDAMED Signaler une erreur
Calpro	Norvège	EasyExtract CAL0510, CAL0510L	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Candore Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Inde	CANfrag CA-0012 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Cangzhou Shengfeng Plastic Product Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	0.5ml;1ml;2ml;3ml;5ml;10ml;20ml;30ml;40ml;50ml;60ml;80ml;100ml;110ml;130ml;150ml;200ml;300ml;500ml	A IVDR	Fiche EUDAMED Signaler une erreur
Careforu Mandataire UE : Meridius Medical Europe Limited (Irlande)	Corée du Sud	CareBuddy CFU-G198/79	– 98/79	Site web sales@careforu.co.kr Fiche EUDAMED Signaler une erreur
CelltraZone FDA Mandataire UE : Javitech Consulting GmbH (Allemagne)	Corée du Sud	Microscope Slide (Adhesive) ASLIDE002	A IVDR	Site web info@celltrazone.com Fiche EUDAMED Signaler une erreur
Cerca Biotech	Allemagne	RNXtract Kit	A IVDR	Fiche EUDAMED Signaler une erreur
Cespu	Portugal	CESPU Diagnóstico CYTO2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Cetro Medical FDA	Suède	Bottle Uno™ 16402 réf.	I MDR	Site web info@cetromedical.se Fiche EUDAMED Signaler une erreur
Changchun Medicside Medical Technology Mandataire UE : Umedwings Netherlands B.V. (Pays-Bas)	Chine	MA-500 \ CM Series urinalysis System2 réf.	A IVDR	info@mcside.com Fiche EUDAMED Signaler une erreur
Changsha CenLee Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	CenLee Medical Centrifuge： CGF4K,XL6A,PRP4K,PRF4K,PRP5K,PRP6M,PRP6K,PRP400,PRP500,PRP6R,PRP55R,PRP5A,PRP530R,PRP5R,PRP-30S,PRP-20E,SVF-15GU,PRP-30A，etc.	A IVDR	Fiche EUDAMED Signaler une erreur
Changsha Contec Yixin Biotechnology Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	CMS10A3 réf.	C IVDR	Fiche EUDAMED Signaler une erreur
Changsha Xiangzhi Centrifuge Instrument Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	TD4-2	A IVDR	Fiche EUDAMED Signaler une erreur
Changzhou Richgenius Medlab Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	CENTRIFUGE 80-2A3 réf.	A IVDR	info@rich-gen.com Fiche EUDAMED Signaler une erreur
Chengdu Polytech Biological Technology Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	tHb Kit(Colorimetry)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chongqing ME Instruments Technology Mandataire UE : MedPath GmbH (Allemagne)	Chine	Real-time fluorescence quantitative PCR analyzer	A IVDR	Fiche EUDAMED Signaler une erreur
Chongqing NanFang Numerical ControlEquipment Mandataire UE : Medunion S.L. (Espagne)	Chine	ESR Dynamic Analyzer98/79	– 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Chongqing Sanfeng Medical Device Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	coagulation tube 3.6ml (double layer) Tube without additive 3ml3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Chroma Ate FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Taïwan	Chroma ATE GenXplore q4800	A IVDR	Site web info@chromaate.com Fiche EUDAMED Signaler une erreur
Chubio Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Sterile Tube Welder CB303	I MDR	Fiche EUDAMED Signaler une erreur
Cision Vision FDA Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	États-Unis	Cision InVision Imaging System Version 1.0	A IVDR	Fiche EUDAMED Signaler une erreur
Clinical Mandataire UE : MedEnvoy Global BV (Pays-Bas)	United Kingdom (ex Northern Ireland)	UTS Tube 5ml™	A IVDR	Site web info@clinical.design Fiche EUDAMED Signaler une erreur
Clonallon	Irlande du Nord	30ml Disposable Plastic Container3 réf.	I MDR	Site web Fiche EUDAMED Signaler une erreur
CompAI MedTech (Dalian) Mandataire UE : Debao International GmbH (Allemagne)	Chine	Specimen Radiography System	A IVDR	ra@comp-ai.com Fiche EUDAMED Signaler une erreur
Core Technology FDA Mandataire UE : Medunion S.L. (Espagne)	Chine	HAV IgM Test Strip & Cassette B01-1198/79	– 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Cosmosol	Italie	Cosmosol Ghiaccio spray3 réf.	IIa MDR	Site web info@cosmosol-it.com Fiche EUDAMED Signaler une erreur
Creativebio Mandataire UE : Obelis s.a. (Belgique)	Chine	Colosafe	A IVDR	Site web Service@creativebio.cn Fiche EUDAMED Signaler une erreur
Credence Genomics Mandataire UE : Obelis s.a. (Belgique)	Sri Lanka	Bactfast CGNBF001	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Ctcells FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	CTCeptor CTM-C2203	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Cyanagen	Italie	STAR BEADS PATHOGEN DNA/RNA EXTRACTION KIT	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Cytekbio Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	Northern Lights™-CLC NL-CLC3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Cytocell FDA Mandataire UE : Sysmex Europe SE (Allemagne)	United Kingdom (ex Northern Ireland)	DAPI Antifade ES2 réf.	A IVDR	Site web contact@ogt.com Fiche EUDAMED Signaler une erreur
Dainippon Seiki FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Japon	Auto Slide Preparation System AS-410M Global Spec3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Danaus	Italie	Cassetto di recupero DAIA0000030S3 réf.	A IVDR	Site web info@danaus.it Fiche EUDAMED Signaler une erreur
DasLab	Allemagne	Stool Sample Collection Kit	I MDR	Site web contact@daslab.health Fiche EUDAMED Signaler une erreur
Datexim	France	CytoProcessor98/79	– 98/79	Présent sur le marché en France Site web contact@datexim.com Fiche EUDAMED Signaler une erreur
Demeditec FDA	Allemagne	Epstein-Barr Virus (VCA) IgG ELISA98/79	– 98/79	Site web info@demeditec.de Fiche EUDAMED Signaler une erreur
Dermagnostix	Allemagne	PsorX-LabDisk98/79	– 98/79	Site web info@dermagnostix.com Fiche EUDAMED Signaler une erreur
Desitec	Italie	10xBRJ60 BIOREJAR3 réf.	A IVDR	Site web info@desitec.it Fiche EUDAMED Signaler une erreur
Dianext	Italie	Metabiome Kit	A IVDR	Fiche EUDAMED Signaler une erreur
Diatech Pharmacogenetics	Italie	EasyPGX ready HPV	C IVDR	Site web info@diatechpharmacogenetics.com Fiche EUDAMED Signaler une erreur
Dnameter	Tchéquie	DNAmeter2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Doasense	Allemagne	DOASENSE Reader 0002	A IVDR	Site web info@doasense.de Fiche EUDAMED Signaler une erreur
Doctorbox	Allemagne	Probenahme-Set (Stuhl) + Laboranalyse Darmkrebs3 réf.	I MDR	Site web info@doctorbox.de Fiche EUDAMED Signaler une erreur
Doctrinus	Allemagne	Dual-Tube Kit DOC-SKU1-ST2 réf.	IIa MDR	Site web Fiche EUDAMED Signaler une erreur
Domel FDA	Slovénie	CENTRIC 250 IVD Laboratory centrifuge3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Draeger FDA	Allemagne	Dräger DrugTest 5000 Analyzer98/79	– 98/79	Présent sur le marché en France Site web EUDAMED@draeger.com Fiche EUDAMED Signaler une erreur
Dragon Medical FDA Mandataire UE : MedPath GmbH (Allemagne)	Chine	Manual suction pump DW-SP3 réf.	I MDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
DRG Instruments	Allemagne	Fecal Extraction System 2.6	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Drummondsci FDA Mandataire UE : CEpartner4U (Pays-Bas)	États-Unis	10 Microliters MICROSAFE (short), 2000 tubes3 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Dynamic Code	Suède	Dymond tube 001-URI-GuHCl	A IVDR	Site web support@dynamiccode.com Fiche EUDAMED Signaler une erreur
Ecocare	Allemagne	ecocare Home Care Test Kit Vitamin D	IIa MDR	Site web service@ecocare.center Fiche EUDAMED Signaler une erreur
Edna	Turquie	CarciScan HPV PCR Assay for Cervical Cancer Screening Genotyping for HPV16, HPV18 and HPV 45 (CS3), 100 tests98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Eifelfango	Allemagne	Natriumcitrat Lösung 3,13% 10 x 1 ml Natriumcitrat Lösung 3,13% 10x1ml	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Element Biosciences Mandataire UE : QbD RepS BV (Belgique)	États-Unis	AVITI Dx 880-00008	A IVDR	support@elembio.com Fiche EUDAMED Signaler une erreur
Elitbiotech Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Bio-INSTANT FIC-H3	A IVDR	Fiche EUDAMED Signaler une erreur
EntroGen FDA Mandataire UE : TANJA TOPOVSEK S.P. (Slovénie)	États-Unis	Benchbot® 4800	A IVDR	Site web contact@entrogen.com Fiche EUDAMED Signaler une erreur
Epiprobe Mandataire UE : MedPath GmbH (Allemagne)	Chine	Urine Collection Tube A14-12 réf.	A IVDR	service@epiprobe.com Fiche EUDAMED Signaler une erreur
Esco Medical Technologies, UAB FDA	Lituanie	CultureCoin®	IIa MDR	Site web support-medical@escolifesciences.com Fiche EUDAMED Signaler une erreur
Evident Technology Center Europe	Allemagne	VS200-BU-L-V2-IVD VS200-IVD3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Evidentscientific Mandataire UE : Evident Europe GmbH (Allemagne)	États-Unis	pramana CUBIQ3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Excilone	France	PathScan Combi	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
EXIAS Medical	Autriche	EXIAS e\|1 Analyzer	A IVDR	Site web office@exias-medical.com Fiche EUDAMED Signaler une erreur
Factor Medical FDA Mandataire UE : MedEnvoy Global BV (Pays-Bas)	États-Unis	03632 réf.	IIa MDR	Fiche EUDAMED Signaler une erreur
FAR	Italie	HEMOGLOBIN A298/79	– 98/79	order@fardiag.com Fiche EUDAMED Signaler une erreur
Farmasino Mandataire UE : Humiss International B.V. (Pays-Bas)	Chine	Dengue Rapid Test Kit (Colloidal Gold Method)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Feinchemie	Allemagne	Lugols-Lösung	A IVDR	Site web info@feinchemie.de Fiche EUDAMED Signaler une erreur
FFEI Mandataire UE : Eurolink Europe Compliance Limited (Irlande)	United Kingdom (ex Northern Ireland)	08303916001	A IVDR	Site web regulatory@ffei.co.uk Fiche EUDAMED Signaler une erreur
Filling	Allemagne	EUKITT3 réf.	A IVDR	info@orsatec.de Fiche EUDAMED Signaler une erreur
Finess Healthcare Group Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	URINSAMMELBEHÄLTER FN-UC013 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Flash Pathology	Pays-Bas	FS4-A	A IVDR	Site web info@flashpathology.com Fiche EUDAMED Signaler une erreur
Funotec Mandataire UE : GRZAN GROUP SL (Espagne)	Chine	Clinical Chemistry Analyzer(FC-800)	A IVDR	Fiche EUDAMED Signaler une erreur
Gammadis	Italie	Contenitore Sterile Urina 120 ml tappo a vite Coltura delle Urine3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Gaudlitz	Allemagne	simplix stool sample preperation system unfille3 réf.	A IVDR	Site web info@gaudlitz.de Fiche EUDAMED Signaler une erreur
GBUK Group FDA Mandataire UE : Qualrep Services B.V. (Pays-Bas)	United Kingdom (ex Northern Ireland)	pH Reader PHX-act	A IVDR	Site web customerservices@gbukgroup.com Fiche EUDAMED Signaler une erreur
Gencyst	Finlande	Gencyst 4-lokeroinen kudoskasetti GENC-4CH-002	A IVDR	info@gencyst.com Fiche EUDAMED Signaler une erreur
Geneall Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	AllEx™ Mini Viral DNA/RNA Kit 972-048	A IVDR	Site web sales@geneall.com Fiche EUDAMED Signaler une erreur
Geneally Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	model A: Dried Blood Spot Collection model B: Protein Saver model C: Inactivated and Storage model D: Indicating3 réf.	A IVDR	info@geneally.com.cn Fiche EUDAMED Signaler une erreur
Genebiohealth Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	Disposable feces collection and storage tube2 réf.	A IVDR	Site web marketing@genebiohealth.com Fiche EUDAMED Signaler une erreur
Genedrive Mandataire UE : Advena Limited (Malte)	United Kingdom (ex Northern Ireland)	Genedrive® System3 réf.	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Geneus Technologies (Chengdu) Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	G-seq500	A IVDR	Fiche EUDAMED Signaler une erreur
Genhawk (Wuhan) Biotech Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Neisseria meningitidis antisera21 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Gentrend	Tchéquie	Set k odběru kapilární krve	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Geratherm	Allemagne	Geratherm® chlamydia check98/79	– 98/79	Site web info@geratherm.com Fiche EUDAMED Signaler une erreur
Ginevri	Italie	ONE-BEAM BILIRUBINOMETER	A IVDR	Site web mail@ginevri.com Fiche EUDAMED Signaler une erreur
Goodgut	Espagne	Stool Collection Kit (SCK-CRC)3 réf.	A IVDR	Site web info@goodgut.eu Fiche EUDAMED Signaler une erreur
Grant Technology (HK) Mandataire UE : Share info GmbH (Allemagne)	Hong Kong	SepCheck	A IVDR	info@gtech.hk Fiche EUDAMED Signaler une erreur
Guangxihuadu Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Disposable Vacuum Venous Blood Sample Collection Container3 réf.	A IVDR	Sales@guangxihuadu.com Fiche EUDAMED Signaler une erreur
Guangzhou Four E’s Scientific FDA Mandataire UE : Humiss Beratung GmbH (Allemagne)	Chine	MultiEX 024L，MultiEX 016，MultiEX 096P	A IVDR	Fiche EUDAMED Signaler une erreur
Guangzhou Huayue Keju Biotech Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	HuayueKeju BS-450;BS-5002 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Guangzhou Topms Technology Mandataire UE : Share info GmbH (Allemagne)	Chine	TOPMS Insight SQ6000	A IVDR	Fiche EUDAMED Signaler une erreur
Guangzhou Yunrui Medical Technology Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Y-30/Y-348/Y-80/B-48/B-80/Y-30B/Y-48/Y-80B/B-48B/M-30/M-40/M-80/M-90/m-1002 réf.	I MDR	Fiche EUDAMED Signaler une erreur
Guanhong plastic steel products factory Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	GH-USC1 GH-USC2 GH-USC3 GH-USC4	A IVDR	Fiche EUDAMED Signaler une erreur
Guizhou Gaoyi Medical Technology Research Development Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	No additive tube：1mL/2mL/3mL/4mL/5mL/6mL/7mL/8mL/9mL/10mL Procoagulant tube: 1mL/2mL/3mL/4mL/5mL/6mL/7mL/8mL/9mL/10mL Separation gel + procoagulant tube:2ml/3ml/3.5ml/4ml/5ml/6ml/7ml/8ml/8.5ml/9ml/10ml etc	A IVDR	Fiche EUDAMED Signaler une erreur
Gyrozen Mandataire UE : AR Experts B.V. (Pays-Bas)	Corée du Sud	4063 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Haemonetics FDA Mandataire UE : Haemonetics Italia s.r.l (Italie)	Suisse	TEG 6s Hemostasis System	A IVDR	Présent sur le marché en France regulatoryeurope@haemonetics.com Fiche EUDAMED Signaler une erreur
Haimen Rotest Labware Manufacturing Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Square hole/strip hole/round hole/fine square hole/O ring	A IVDR	export@hmrotest.com Fiche EUDAMED Signaler une erreur
Handan FCH Medical Technology Mandataire UE : MedPath GmbH (Allemagne)	Chine	Stool Management Bag FCH-2401	I MDR	Fiche EUDAMED Signaler une erreur
Hangzhou Beiwo Medical Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Pathogen DNA/RNA Purification Kit (Beads) BW-MGD2411-A00 BW-MGD2411-A32 BW-MGD2411-A32-32 BW-MGD2411-A96	A IVDR	Fiche EUDAMED Signaler une erreur
Hangzhou Ciping Medical Devices Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Disposable Vacuum Blood Collection Tubes PT 3.2% /3.8% Sodium Citrate; 10x45mm 0.25ml,0.5ml,1ml; 12x60mm 0.25ml,0.5ml,1ml; 13x75mm 1.8ml,2ml,2.5ml,2.7ml,3ml, 3.2ml,3.6ml,4ml,4.5ml; 13x 100mm 3.6ml, 5ml,5.4ml; 16x100mm 8ml,8.5ml,9ml, ml,8.5ml,9ml,10ml	A IVDR	Fiche EUDAMED Signaler une erreur
Hangzhou DIAN Biotechnology Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	GENEDIAN2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hangzhou Higene Biotechnology Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	FLU A+B Antigen combo Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hangzhou PathoAl Technology Mandataire UE : BioDomi GmbH (Allemagne)	Chine	Automated Digital Microscope Scanner YCS-MSCAN-200A	A IVDR	Fiche EUDAMED Signaler une erreur
Hangzhou Testsea Biotechnology Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Influenza Ag A/B Test RB00798/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hangzhou Yipai Intelligent Technology Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Pathology Slide Scanner MDS-ML1080、MDS-ML3603 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Hangzhou Zheda Dixun Biological Gene Engineering Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	DX-Reader DX-C1	A IVDR	Fiche EUDAMED Signaler une erreur
Hanwooltpc FDA Mandataire UE : Javitech Consulting GmbH (Allemagne)	Corée du Sud	Advansure E3 system3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Happy Innova	Espagne	The Smart Lollipop One	A IVDR	Site web hello@thesmartlollipop.com Fiche EUDAMED Signaler une erreur
Healthy FDA Mandataire UE : AR Experts B.V. (Pays-Bas)	Israël	Dip.io98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Hebei Boxin Recovery Equipment Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	80-1	I MDR	info@boxinhomecare.com Fiche EUDAMED Signaler une erreur
Hebei Chaoran Medical Instruments Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	CHAORAN additive (1, 2, 3, 4, 5, 10ml), Clot activator (1, 2, 3, 4, 5, 10ml), Gel & Clot activator (1, 2, 3, 4, 5, 10ml), EDTA K2, EDTAK3, EDTA-Na2 (1, 2, 3, 4, 5, 6ml), Sodium citrate 4NC (1.6, 2, 3ml), Sodium citrate 9NC (2, 3ml), etc	A IVDR	Fiche EUDAMED Signaler une erreur
Hebei Free Trade Zone Shenghong Medical Devices Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Hebei Free Trade Zone Shenghong Medical Devices Co., Ltd Plain Tube（No Additive）; Clot Activator Tube(Pro-coagulation); Gel&Clot Activator; EDTA K3; EDTA K2; PT Tube (Sodium Citrate 9NC); ESR Tube (Sodium Citrate 4NC); Heparin Lithium; Heparin Sodium; Sodium fluoride/ Potassium Oxalate; etc3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Hebei Kangning Medical Equipment Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Plain tube：1ml、2ml 、3ml、4ml 、5ml、6ml、7 ml、8ml 、9ml、10ml Clot activator Tube：1ml、2ml、 3ml、 4ml、 5ml、 6ml、7 ml、8ml 、9ml、10ml etc3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Hebei Kangweishi Medical Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Plain Tube :（0.5ml/1ml/1.5ml/2ml/2.5ml/3ml/3.5ml/4ml/4.5ml/5ml/5.5ml/6ml/6.5ml/7ml/8ml/9ml/10ml）Clot Activator Tube:（0.5ml/1ml/1.5ml/2ml/2.5ml/3ml/3.5ml/4ml/4.5ml/5ml/5.5ml/6ml/6.5ml/7ml/8ml/9ml/10ml）etc.	I MDR	Fiche EUDAMED Signaler une erreur
Hebei Simaite Medical Devices Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Disposable venous blood sample collection container： No additive (1ml, 2ml, 3ml, 4ml, 5ml, 6ml, 7ml, 8ml, 9ml, 10ml), Clot activator (1ml, 2ml, 3ml, 4ml, 5ml, 6ml, 7ml, 8ml, 9ml, 10ml), Gel & clot activator (2ml, 3ml, 4ml, 5ml, 6ml, 7ml, 8ml, 9ml), etc	A IVDR	Fiche EUDAMED Signaler une erreur
Heng Rong (Xiamen) Plastic Products Mandataire UE : Wellkang Ltd (Irlande du Nord)	Chine	Specimen bag2 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Hessels & Grob	Pays-Bas	PeeSpot	A IVDR	Site web info@hesselsgrob.com Fiche EUDAMED Signaler une erreur
Heytonmed Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	HEYTON 100ml, 200ml, 500ml, 600ml, 750ml, 1000ml, 1500ml, 2000ml without valve, 2000ml T-tap valve, 2000ml push-pull valve, 2000ml twist valve, 500+2000ml, 600+2000ml, 400+2600ml, 500+2600ml, 3000ml, 4000ml, 5000ml	I MDR	Fiche EUDAMED Signaler une erreur
Hidex	Finlande	Hidex GammaDx 425-604	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Hrjbio Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	HRJ-H350	A IVDR	Site web info@hrjbio.com Fiche EUDAMED Signaler une erreur
Huachenyang (Shenzhen) Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	HCY Nucleic Acid Extraction & Purification Kit CY-M002-50, CY-M002-100, CY-M002-200, CY-M002-96, CY-M001-96, CY-M001-50, CY-M001-100, CY-M001-2003 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Huchuang FDA Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	MPZ100	I MDR	Fiche EUDAMED Signaler une erreur
Hunan Biojoint Instrument Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Hunan Biojoint Instrument Co.,Ltd TD4-PRP, TDD4-MC, TD4-MR, TDZ5-WS, TDZ6-WS, TDZ5-SX, DL-4M, TDL-4MC, DD4-M, TD4ZA, TD4Z-XB, TD4ZB, TD4A-WS, TGD20, DD5-XK, TD4, TD4-ZF, DL-5M, TG18, TG16-WS, TG18-WS, etc3 réf.	A IVDR	info@bio-joint.com Fiche EUDAMED Signaler une erreur
Hunan Drawray Biotech Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	iStar 500	A IVDR	info@szdrawray.com Fiche EUDAMED Signaler une erreur
Hunan Labwe Scientific Instruments Mandataire UE : Humiss Beratung GmbH (Allemagne)	Chine	Centrifuge TD4	A IVDR	sales@lab-we.com Fiche EUDAMED Signaler une erreur
Hycor Biomedical FDA Mandataire UE : Advena Limited (Malte)	États-Unis	NOVEOS flex Immunoassay System	A IVDR	Présent sur le marché en France Site web info@hycorbiomedical.com Fiche EUDAMED Signaler une erreur
Hygienx Mandataire UE : Salus Cons Kft. (Hongrie)	Serbie	Sodium Citrate 3,8 %, double walled3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
ID &	Italie	SACCHETTO TASCA DOPPIA SACCHETTI PORTA PROVETTE3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Iki	France	Uriki	A IVDR	Présent sur le marché en France contact@iki-diag.com Fiche EUDAMED Signaler une erreur
Ilabu	Pologne	ILabU zestaw do samodzielnego pobierania próbki: ślina	I MDR	Site web Fiche EUDAMED Signaler une erreur
ImmuChrom	Allemagne	HPLC testkit Homocysteine98/79	– 98/79	info@immuchrom.de Fiche EUDAMED Signaler une erreur
ImmunoDiagnostic Systems France FDA	France	IDS-iSYS Multi-Discipline Automated System IS-3104003 réf.	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Intelligence Artificielle Applications	France	Distributeur de disques ATB - Carré 16 pastilles2 réf.	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Interlab	Italie	INTERLAB G26	A IVDR	Site web Fiche EUDAMED Signaler une erreur
International Biomedical FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	Wee Sight Transilluminator	I MDR	Site web regulatory@int-bio.com Fiche EUDAMED Signaler une erreur
Intron Mandataire UE : Obelis s.a. (Belgique)	Corée du Sud	AutoXT Total gDNA Kit2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Invenio Imaging FDA Mandataire UE : QbD RepS BV (Belgique)	États-Unis	NIO Imaging System	A IVDR	Site web contact@invenio-imaging.com Fiche EUDAMED Signaler une erreur
Itaca	Italie	Contenitore Urina 24h Pharmamentis	A IVDR	info@itacapharma.com Fiche EUDAMED Signaler une erreur
Jazbar International Mandataire UE : KHANG BAO INTERNATIONAL KFT (Hongrie)	Pakistan	Alcohol Lamp al85b	I MDR	Fiche EUDAMED Signaler une erreur
Jeol Mf Mandataire UE : JEOL(Europe)BV AR (Pays-Bas)	Japon	BM Test Acid Solution3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Jiangsu Bojia Biomedical Technology Mandataire UE : MedPath GmbH (Allemagne)	Chine	BJB Rapid Gene Detection System2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Jiangsu Changfeng Medical Industry FDA Mandataire UE : Llins Service & Consulting GmbH (Allemagne)	Chine	no Type A、Type B、Type C	A IVDR	Site web info@changfeng-medical.com Fiche EUDAMED Signaler une erreur
Jiangsu Comeon Medical Apparatus Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	Saliva collector	A IVDR	Fiche EUDAMED Signaler une erreur
Jiangsu Jinzhun Biotech Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	JZ-500,HI-500,JZ-100	A IVDR	Fiche EUDAMED Signaler une erreur
Jiangsu ME Instruments Mandataire UE : MedPath GmbH (Allemagne)	Chine	Automated NGS Library Preparation System	A IVDR	Fiche EUDAMED Signaler une erreur
Jiangsu Kehua Medical Instrument Technology FDA Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	10μL,15μL,20μL,25μL,30μL,35μL,40μL,50μL,60μL,80μL,100μL,120μL,1ml,2ml,3ml, 5ml, 10ml/Single bulb, double bulb, fill line	A IVDR	Présent sur le marché en France info@jskehua.cn Fiche EUDAMED Signaler une erreur
Jiangxi CellGene Biotechnology Mandataire UE : Medunion S.L. (Espagne)	Chine	TBNK Kit with Absolute Counting (Lyophilized Pellets) 50tests/kit98/79	– 98/79	marketing@cell-genebio.com Fiche EUDAMED Signaler une erreur
Jiangxi Hongda Medical Equipment Group FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Vacuum blood collection tubes for single use No additive 1ml2 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Jianlinmedical Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	Urine container JLUC936	I MDR	sales@jianlinmedical.com Fiche EUDAMED Signaler une erreur
Joanlab Mandataire UE : Everbiz GmbH (Allemagne)	Chine	Centrifuge LC-400,LC-400Pro,LC-400P,LC500-8,LC500-12,LC500-6,LC500-18,LC500-24,LC500-MP,LC500-8P,LC500-12P,LC5000H	A IVDR	Fiche EUDAMED Signaler une erreur
JS Medicina Electrónica Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Argentine	Blue & White3 réf.	A IVDR	Site web info@diestroweb.com Fiche EUDAMED Signaler une erreur
K-Med FDA Mandataire UE : MedPath GmbH (Allemagne)	Chine	Urine bag 1000ml3 réf.	I MDR	INFO@K-MED.COM.CN Fiche EUDAMED Signaler une erreur
Karlsson&Novak Medical	Suède	Kit containing Ahlstrom Autocollect 07350167820069	I MDR	Site web info@knmedical.se Fiche EUDAMED Signaler une erreur
Keylights Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Automatic Chemiluminescence Immunoassay Analyzer Venus 100S,Venus 120S,Venus 100H,Venus 120H,BioCLIA 1900,Venus 500,VERCENTRA CS-6000,BioCLIA 69003 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Ki̇bar Dental Tibbi̇ Malzemeleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇	Turquie	GALLANT - PTK-01 - GALLANT BÖLMELİ CAM PETRİ KUTUSU2 réf.	I MDR	Fiche EUDAMED Signaler une erreur
Konan FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Japon	Konan CellChek D CD-15	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Kotsteel Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Pakistan	Kotsteel Private Limited 201/250	I MDR	Site web Fiche EUDAMED Signaler une erreur
Kurabo Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Japon	QuickGene-AutoS DNA Blood Kit	A IVDR	Site web qa@kurabo-grp.com Fiche EUDAMED Signaler une erreur
Lab Diagnostic Systems (SMC) Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Pakistan	R-test Cryptococcus Capsular Polysaccharide Rapid Test 50 Tests98/79	– 98/79	info@ldspak.com Fiche EUDAMED Signaler une erreur
Labco Mandataire UE : Advena Limited (Malte)	United Kingdom (ex Northern Ireland)	12ml Exetainer® Breath Vials3 réf.	A IVDR	Site web enquiries@labco.co.uk Fiche EUDAMED Signaler une erreur
Laboindustria	Italie	Contenitore monouso 5.000ml per pezzi chirurgici, anatomici e istologici con etichetta ref/lotto3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Labonovum	Pays-Bas	Hem-Col4 réf.	A IVDR	Site web info@labonovum.com Fiche EUDAMED Signaler une erreur
Laurypath	France	10% NEUTRAL BUFFERED FORMALIN 10L3 réf.	A IVDR	Présent sur le marché en France Site web contact@laurypath.fr Fiche EUDAMED Signaler une erreur
Leisonbio Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Taïwan	AP-1098/79	– 98/79	Présent sur le marché en France Site web service@leisonbio.com Fiche EUDAMED Signaler une erreur
Lgm International FDA Mandataire UE : Wellkang Ltd (Irlande du Nord)	États-Unis	Liqui-PREP® Collection Vials - 200 60-010	A IVDR	Site web customerservice@lpalp.com Fiche EUDAMED Signaler une erreur
Linhai Chengyuan Glasses FDA Mandataire UE : Debao International GmbH (Allemagne)	Chine	RA, RB, RC, RE, RF, RG, RH, RJ, RL, RM, RN, RO, RP, RQ, RS, RT, RU, RV, RW, AD, AG ,AW, E, G, LA, LAB, LAD, LAM,LH, LN, LP LR, LW, PD, TH, AC, AE, AX, EA, HF, LAC, LAE, LAG, LAY, LB, LBC, LBD, LBE, LBQ, LBG, LD, LE, LG, LO, LQ, LT, LU, LX, LY, LZ, QC, RGA	I MDR	Fiche EUDAMED Signaler une erreur
Linye Health Tech Ningbo Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	Urine bottle LY-MU003 réf.	I MDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Livzondiagnostics FDA Mandataire UE : QbD RepS BV (Belgique)	Chine	100 tests/kit (20×5)；220 tests/kit (55 × 4)2 réf.	C IVDR	Site web ra@livzondiagnostics.com Fiche EUDAMED Signaler une erreur
LM4med	Allemagne	Formaldehyde solution 4% buffered3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Locmedt Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Automatic biochemistry analyzer LOC-200	A IVDR	Fiche EUDAMED Signaler une erreur
Longgene Mandataire UE : MedPath GmbH (Allemagne)	Chine	Real-time qPCR System3 réf.	A IVDR	info@longgene.com Fiche EUDAMED Signaler une erreur
Longlight Technology Mandataire UE : GRZAN GROUP SL (Espagne)	Chine	Sample Preparation System 202001B0FU1003 réf.	A IVDR	marketing@longlightech.com Fiche EUDAMED Signaler une erreur
Lymediagnostics	Hongrie	DualDur98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
magtivio	Pays-Bas	MagSi-DX Pathogen Plus3 réf.	A IVDR	info@magtivio.com Fiche EUDAMED Signaler une erreur
Mark One Surgical Mandataire UE : KHANG BAO INTERNATIONAL KFT (Hongrie)	Pakistan	SPIRIT LAMP 120CC DENTAL Hollowware instruments	I MDR	Site web sales@markonesurgical.com Fiche EUDAMED Signaler une erreur
Masmec FDA	Italie	PRIME MDX	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Mavie	Autriche	MavieMe Saliva Collection Kit MMSAL5	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Mdlsrl FDA	Italie	BIOREJAR	A IVDR	Site web info@mdlsrl.com Fiche EUDAMED Signaler une erreur
MDX Netherlands Diagnostics Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Philippines	MDX HPLCLine 100	A IVDR	Fiche EUDAMED Signaler une erreur
Medicacorp Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	EasyLyte Neo Analyzer	B IVDR	Site web Fiche EUDAMED Signaler une erreur
Medichecks Mandataire UE : CS Life Sciences Europe Ltd (Irlande)	United Kingdom (ex Northern Ireland)	Saliva Sample Collection Kit KSL-COR-ACT2 réf.	A IVDR	Site web qualityandregs@medichecks.com Fiche EUDAMED Signaler une erreur
Medimel Μονοπροσωπη Ικε	Greece	24 HOURS URINE CONTAINER	I MDR	Site web info@medimel.gr Fiche EUDAMED Signaler une erreur
Mediset	Allemagne	Bettbeutel 2000ml	I MDR	Site web info@mediset.de Fiche EUDAMED Signaler une erreur
Medlan	Pologne	Kasetki histopatologiczne znakowane laserowo3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Medspo Mandataire UE : ANTEX MEDI SOLUTION (Allemagne)	Pakistan	Spirit Lamp	I MDR	Site web Fiche EUDAMED Signaler une erreur
MEDx (Suzhou) Translational Medicine Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	30 tests /kit2 réf.98/79	– 98/79	ra@medxtmc.com Fiche EUDAMED Signaler une erreur
Mehrish Mandataire UE : ANTEX MEDI SOLUTION (Allemagne)	Pakistan	Sprit Lamp Double Nut Standard	I MDR	Site web Fiche EUDAMED Signaler une erreur
Menarinidiagnostics	Italie	PRIME MDx DNA/RNA Extraction kit 2 x48 rxn2 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Metzer	Pologne	Hygomed Disposable Dental Trays	I MDR	Site web Fiche EUDAMED Signaler une erreur
Meyosis	Turquie	IV Stand3 réf.	I MDR	Site web info@meyosis.com Fiche EUDAMED Signaler une erreur
Mgitech	Lettonie	Genetic Sequencer DNBSEQ-G400 DNBSEQ-G400, DNBSEQ-G99, DNBSEQ-G99A3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Microviable	Espagne	GUTALIVE	A IVDR	Site web admin@microviable.com Fiche EUDAMED Signaler une erreur
Mikrocerrahialetler	Turquie	MİKRO	I MDR	Site web Fiche EUDAMED Signaler une erreur
Millennium Sciences Mandataire UE : AR Experts B.V. (Pays-Bas)	États-Unis	Cell-VU Microscope Slides and Coverslips3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Miracell FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Corée du Sud	Centrifuge for Cell Processing SMART M-CELL 23 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Mirnax Biosens	Espagne	TMH-01 SISTEMA DE RECOLECCIÓN DE MATERIAL FECAL PARA ANÁLISIS CLÍNICO	A IVDR	info@mirnaxbiosens.com Fiche EUDAMED Signaler une erreur
Molzym	Allemagne	MolYsis-SNplus™ IVD U-300-0122 réf.	A IVDR	info@molzym.com Fiche EUDAMED Signaler une erreur
Mondial	Italie	DT18 - ALDEIDE FORMICA PER ISTOLOGIA3 réf.	A IVDR	Site web info@mondialprod.it Fiche EUDAMED Signaler une erreur
Mongopa Mandataire UE : Share info GmbH (Allemagne)	Chine	BS0872J	I MDR	Fiche EUDAMED Signaler une erreur
Morphlelabs FDA Mandataire UE : Amstermed B.V. (Pays-Bas)	Inde	Robotome 40 RTM	A IVDR	sales@morphlelabs.com Fiche EUDAMED Signaler une erreur
Möller Medical FDA	Allemagne	Docon Seal Blood Donation Sealers2 réf.	I MDR	Site web info@moeller-medical.com Fiche EUDAMED Signaler une erreur
Nanchang Ganda Medical Devices Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Disposable blood collection tubes	A IVDR	Fiche EUDAMED Signaler une erreur
Nantong Shunwei Experimental Equipment Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	10ml/20ml/30ml/40ml/60ml/80ml /100ml/120ml/150ml/200ml/250ml /500ml/1000ml	A IVDR	Fiche EUDAMED Signaler une erreur
Neomed FDA	Italie	Uritainer 16-1800	A IVDR	Site web Fiche EUDAMED Signaler une erreur
nerbe plus	Allemagne	24 Std. Urinssammelflasche2 réf.	A IVDR	Site web info@nerbe-plus.de Fiche EUDAMED Signaler une erreur
Newmars Technologies Kft	Hongrie	1350093/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Newscen Mandataire UE : Wellkang Ltd (Irlande du Nord)	Chine	HIV3-292040170003 réf.	D IVDR	Site web Fiche EUDAMED Signaler une erreur
Next Level	Italie	Alisei Q.S.3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Nightingalehealth	Finlande	Blood Collection Device NGH-03022 réf.	A IVDR	Site web contact@nightingalehealth.com Fiche EUDAMED Signaler une erreur
Nikon FDA Mandataire UE : Nikon Europe B.V. (Pays-Bas)	Japon	ECLIPSE Ci-E	A IVDR	Présent sur le marché en France Regulatory.Affairs@nikon.com Fiche EUDAMED Signaler une erreur
Ningbo Greetmed Medical Instruments FDA Mandataire UE : MedPath GmbH (Allemagne)	Chine	Cooling Gel Patch GT085-120	I MDR	Fiche EUDAMED Signaler une erreur
Noex	Pologne	Płytka Petriego fi 90/0 H16,2 / sterylna, bez wentylacji	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Norsan	Allemagne	NORSAN Fettsäure-Analyse	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Novabone FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	NovaBone Dental Putty Cartridge Dispenser EU360093/42	I 93/42	Site web Fiche EUDAMED Signaler une erreur
Novapro FDA Mandataire UE : Javitech Consulting GmbH (Allemagne)	Corée du Sud	CRYSTE VARISPIN M62 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Novatech Tibbi̇ Ci̇haz Ürünleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇	Turquie	Novacheck Blood Glucose Meter (Glucometer)98/79	– 98/79	Site web info@novadiag.com Fiche EUDAMED Signaler une erreur
Novogenia FDA	Autriche	Novo Saliva Kit VSKP	A IVDR	Site web service@novogenia.com Fiche EUDAMED Signaler une erreur
numares FDA	Allemagne	AXINON® System	A IVDR	info@numares.com Fiche EUDAMED Signaler une erreur
Nüve Sanayi̇ Malzemeleri̇ İmalat Ve Ti̇caret Anoni̇m Şi̇rketi̇	Turquie	NÜVE NF 3000R93/42	IIa 93/42	Site web Fiche EUDAMED Signaler une erreur
OK biotech FDA Mandataire UE : MDSS GmbH (Allemagne)	Taïwan	Solus V2 Blood Glucose Monitoring System 613198/79	– 98/79	Site web service@okbiotech.com Fiche EUDAMED Signaler une erreur
Olgunmedikal	Turquie	LABOSEL9 réf.	A IVDR	info@olgunmedikal.com Fiche EUDAMED Signaler une erreur
Omegametrix	Allemagne	HS-Kit2 réf.	A IVDR	Site web info@omegametrix.eu Fiche EUDAMED Signaler une erreur
Ortho Clinical Diagnostics Biotechnology Development (Shanghai) Mandataire UE : Ortho-Clinical Diagnostics France (France)	Chine	VITROS	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Paitzar Mandataire UE : Metridium OÜ (Estonie)	Iran	Parsian Teb Zaman Python	A IVDR	Présent sur le marché en France Site web info@paitzar.am Fiche EUDAMED Signaler une erreur
Pakkts Mandataire UE : CS Active (Lettonie)	Pakistan	Alcohol lamp	I MDR	Site web info@pakkts.com Fiche EUDAMED Signaler une erreur
PAL Finland	Finlande	Albio CA0101798/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Pamgene	Pays-Bas	IOpener®-Sample Collection Kit 41008	A IVDR	Site web info@pamgene.com Fiche EUDAMED Signaler une erreur
Pathcom Systems FDA Mandataire UE : Hab Gov Strategics Applied Technologies Limited (Malte)	États-Unis	Delta.36 PC9003 réf.	A IVDR	Site web info@pathcomx.com Fiche EUDAMED Signaler une erreur
Paulmurrayplc Mandataire UE : Murrays Health and Beauty Europe Limited (Irlande)	United Kingdom (ex Northern Ireland)	SPECIMEN CONTAINERS2 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
PCL Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Corée du Sud	ATPI03	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Personalgenome FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	PGDx elio tissue complete2 réf.	C IVDR	Site web Fiche EUDAMED Signaler une erreur
Personalis Mandataire UE : QbD RepS BV (Belgique)	États-Unis	Personalis EDTA Blood Collection Kit 102-9892 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Pfaff medical	Allemagne	Seraquick Capillary Cuvettes2 réf.	A IVDR	info@pfaffmedical.de Fiche EUDAMED Signaler une erreur
Phadia FDA	Suède	Phadia 10003 réf.	A IVDR	Site web RegulatoryAffairs.Uppsala.IDD@thermofisher.com Fiche EUDAMED Signaler une erreur
Pharmaline	Turquie	UniPatogen CerviPan HPV qPCR Screening Kit3 réf.	C IVDR	info@pharmaline.com.tr Fiche EUDAMED Signaler une erreur
Pinnacles (Suzhou) Medical Technology Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	PINNACLES KunLun Automatic Chemistry Analyzer KunLun c2800	A IVDR	Fiche EUDAMED Signaler une erreur
Pixcell Medical FDA Mandataire UE : AR Experts B.V. (Pays-Bas)	Israël	HemoScreen 200	B IVDR	Site web info@picxell-medical.com Fiche EUDAMED Signaler une erreur
Plastilab Mandataire UE : CEpartner4U (Pays-Bas)	Lebanon	Petri Dish PD-1402 réf.	A IVDR	Site web info@plastilab.com Fiche EUDAMED Signaler une erreur
PlexBio FDA Mandataire UE : MDSS GmbH (Allemagne)	Taïwan	IntelliPrep Blood GenomicDNA Extraction Kit 830153 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Polycohealthline Mandataire UE : International Associates Auditing & Certification Limited (Irlande)	United Kingdom (ex Northern Ireland)	PIP2598/79	– 98/79	Site web customer.services@polycohealthline.com Fiche EUDAMED Signaler une erreur
Poth Hille & FDA Mandataire UE : Advena Limited (Malte)	United Kingdom (ex Northern Ireland)	Histology Wax3 réf.	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
PreciPoint	Allemagne	iO:M83 réf.	A IVDR	Site web info@precipoint.de Fiche EUDAMED Signaler une erreur
Precision for Medicine FDA Mandataire UE : QbD RepS BV (Belgique)	États-Unis	AAV5 NAb Test Specimen Collection Kit GTKIT80001	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Preox	Allemagne	preOx - HUT Helicobacter Urease Test7 réf.98/79	– 98/79	Site web sales@preox.de Fiche EUDAMED Signaler une erreur
PreTect FDA	Norvège	PreTect X2 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
PrivaPath Diagnostics FDA	Irlande	LetsGetChecked Stool Home Sample Collection Kit	A IVDR	Site web support@letsgetchecked.com Fiche EUDAMED Signaler une erreur
Probe & go Labordiagnostica	Allemagne	Glucose Lösung	A IVDR	Site web info@probe-go.de Fiche EUDAMED Signaler une erreur
ProciseDx FDA Mandataire UE : QbD RepS BV (Belgique)	États-Unis	Procise Stool Collection Kit 49132 réf.	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Proteome Mandataire UE : Propath bv (Belgique)	United Kingdom (ex Northern Ireland)	Formalin3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Pujiang Jianyu Sanitary Products FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Adhesive Bandage 2.5cm400cm/5cm400cm/7.5cm400/10cm400cm	I MDR	Fiche EUDAMED Signaler une erreur
Qingdao Huaren Medical Product Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)5 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Qualigeninc FDA Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	FastPack IP Analyzer	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Quantidx Hong Kong Mandataire UE : MedPath GmbH (Allemagne)	Hong Kong	Real-Time qPCR System2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
QuinTron Instrument FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	BAG, ALVEOSAMPLER, DISCARD, 400ML QT00827-P3 réf.	A IVDR	Site web regulatory@quintron-usa.com Fiche EUDAMED Signaler une erreur
Rajimp Mandataire UE : CS Active (Lettonie)	Pakistan	SPIRIT LAMP DE-2684-2686	I MDR	info@rajimp.com Fiche EUDAMED Signaler une erreur
Raydentinst Mandataire UE : ANTEX MEDI SOLUTION (Allemagne)	Pakistan	SPIRIT LAMP 786-1154 RI	I MDR	Site web info@raydentinst.com Fiche EUDAMED Signaler une erreur
RBCBioscience Mandataire UE : Obelis s.a. (Belgique)	Taïwan	MagCore® Circulating DNA large volume kit3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
REAL Digital International FDA Mandataire UE : Casus Europe B.V. (Pays-Bas)	United Kingdom (ex Northern Ireland)	Faecal Collection Kit with OC-Auto Sampling Bottle3 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Rehaforum	Allemagne	Urinflasche RFM für Frauen, milchig ohne Griff3 réf.	I MDR	Site web info@rehaforum.com Fiche EUDAMED Signaler une erreur
Reingenuity FDA Mandataire UE : Eurolink Europe Compliance Limited (Irlande)	United Kingdom (ex Northern Ireland)	Culture+3 réf.	A IVDR	Site web info@reingenuity.com Fiche EUDAMED Signaler une erreur
Reliance Medical FDA Mandataire UE : Reliance Medical (Ireland) (Irlande)	United Kingdom (ex Northern Ireland)	Alvita Specimen Container 60ML Pack of 103 réf.	A IVDR	Site web regulatory@reliancemedical.co.uk Fiche EUDAMED Signaler une erreur
Reme-D For Laboratory Equipment Chemicals Mandataire UE : Qualitech International B.V. (Pays-Bas)	Égypte	COL-NA Universal DE-01-U	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Revvity FDA Mandataire UE : Wallac Oy (Finlande)	United Kingdom (ex Northern Ireland)	Wizard2 Gamma Counter 2470-00103 réf.	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Rgbio Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	BHP9609	A IVDR	Fiche EUDAMED Signaler une erreur
Rheonova	France	RHEOMUCO V1.098/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Ritter FDA	Allemagne	Conductive tips T 200 µL C-tray3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
RM Life Science Mandataire UE : Javitech Consulting GmbH (Allemagne)	Corée du Sud	RM Coated Slide RMLS-29	A IVDR	Fiche EUDAMED Signaler une erreur
Rocket Medical FDA	United Kingdom (ex Northern Ireland)	FBS Kit - 5 x 100µL Capillary Tubes TF_R012 PP FBS3 réf.	IIa MDR	Site web customerservices@rocketmedical.com Fiche EUDAMED Signaler une erreur
Roylance Scientific Mandataire UE : Casus Europe B.V. (Pays-Bas)	United Kingdom (ex Northern Ireland)	ClearNote	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Runpubio Mandataire UE : R Sight B.V. (Pays-Bas)	Chine	BT Liss	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Sanmen Minsheng Medical Appliances Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Plain Tube; Gel and Clot Activator Tube; Pro-coagulation Tube; PT Tube; EDTA Tube; Sodium Heparin Tube; Lithium Heparin Tube; ESR Tube; Glucose Tube	A IVDR	Fiche EUDAMED Signaler une erreur
Sanway Gene Tech Mandataire UE : Obelis s.a. (Belgique)	Chine	Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)98/79	– 98/79	Présent sur le marché en France Site web info@sansure.com.cn Fiche EUDAMED Signaler une erreur
Screen Italia	Italie	Screen Test FLU A/B SC-0623-2098/79	– 98/79	Site web info@screenitalia.it Fiche EUDAMED Signaler une erreur
Sensacore Mandataire UE : Obelis s.a. (Belgique)	Inde	Ion-Selective Analyzer SCLBL01133 réf.	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Sense Biodetection Mandataire UE : Emergo Europe B.V. (Pays-Bas)	United Kingdom (ex Northern Ireland)	Veros COVID-19 CD0004-SP-10798/79	– 98/79	Site web info@sense-bio.com Fiche EUDAMED Signaler une erreur
Shandong Baiou Medical Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	TDL-600A、DL-1000C、TDL-200、TDL-280、TDL-320、TDL-350、TDL-360、TDL-400、TDL-420、 TDL-450、TDL-5000、TDL-360C、TDL-400C、TDL-500C、 TDL-600C、TDL-36B、etc	A IVDR	Fiche EUDAMED Signaler une erreur
Shandong Chengwu Huabo Medical Equipment Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Clot Activator:1、2、3、4、5、6、7、8、9、10ml Plain Tube:1、2、3、4、5、6、7、8、9、10ml Heparin Sodium:1、2、3、4、5、6、7、8、9、10ml Lithium Heparin:1、2、3、4、5、6、7、8、9、10ml, etc3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Shandong Chengwu Ronghua Biotechnology Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Single-use sampling device2 réf.	I MDR	Fiche EUDAMED Signaler une erreur
Shanghai Bize Import Export Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	SH-150005;SH-150005A;SH-2295;SH-2311;SH-3001;SH-3002;SH-3005; SH-3006; SH-3007; EA169200; EA169201; EA169202; EA169203' EA169204; EA169205; EA169206; EA169207	I MDR	info@bizemed.com Fiche EUDAMED Signaler une erreur
Shanghai Lu Xiangyi Centrifuge Instrument FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	TD2；TD3；TD4；TD5；TD5.5； TD6； TD4A；TD4G；TD4K；TD4N；TD4T；TD4X；TD4Y;TD5A；TD5B;TD5G； TD5M；TD5P；TD5T； TD5X； TD5Z； TD6B； TD6K； D5B；D5M；D5T；etc	A IVDR	Fiche EUDAMED Signaler une erreur
Shanghai Nokayun Medical Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Lymacyte（V-B-Y-R）、Lymacyte（V-B-Y）、Lymacyte（B-Y-R）、Lymacyte（V-B-R）、Lymacyte（V-B）、Lymacyte（B-Y）、Lymacyte（B-R）、Lymacyte（B）3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Shanghai Zymetas Medtech Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	24T98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Shenyang Bokan Biotechnology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	"Red blood collection glass tube（no needle） BKG720Z.BKG730Z.BKG740Z.BKG1020Z.BKG1030Z.BKG1040Z. BKG1050Z.BKG1060Z. BKG1070Z. BKG1080Z.BKG1090Z.BKG10100Z,or customized" etc	A IVDR	Fiche EUDAMED Signaler une erreur
Shenzhen Freecom Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	GP100098/79	– 98/79	Fiche EUDAMED Signaler une erreur
Shenzhen Huiyan Sci-Tech Biotechnology Mandataire UE : Medunion S.L. (Espagne)	Chine	Interleukin 6 (IL-6) Test Kit (Immunofluorescence)98/79	– 98/79	sales@szhykc.com Fiche EUDAMED Signaler une erreur
Shenzhen Medsoon Medical Laboratory Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	No additives/ Plain、Clot Activator、Gel/ Clot Activator、Lithium Heparin Sodium,etc	A IVDR	Fiche EUDAMED Signaler une erreur
Shenzhen MGI Biological Electronic Technology Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Genetic Sequencer DNBSEQ-T1+	A IVDR	Fiche EUDAMED Signaler une erreur
Shenzhen Nucleus Biotechnology Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	Nucleic Acid Extraction Kit NBE01-C	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Shenzhen Wellgrow Biotech Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	CD3 FITC 50T/Kit98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Shenzhen Tiantong Diagnostic Technology Mandataire UE : GRZAN GmbH (Allemagne)	Chine	Fluorescence Microscopy Imaging System HDS24-01，HDS24-022 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
ShijiYiKang (Tianjin) Medical Technology Development Mandataire UE : HUMISS TRADING S. L. (Espagne)	Chine	century clot YKCA-2, YKCA-1, YKCA-2V, YKCA-1V, YKCA-2F, YKCA-1F	A IVDR	Fiche EUDAMED Signaler une erreur
Shinkwang Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	Inde	Capillary Tube 20µl	A IVDR	Site web quality@shinkwang.co.in Fiche EUDAMED Signaler une erreur
Shinva FDA Mandataire UE : Eunitor GmbH (Allemagne)	Chine	Glycohemoglobin Analyzer SGH-200、SGH-400、SGH-3103 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Shinwha Medi Mandataire UE : Advena Limited (Malte)	Corée du Sud	easy M30	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Sichuan Xincheng Biological Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	25 Tests98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Sinobiocan Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Integrated Hand-held heat Sealer CL60-1S	I MDR	Fiche EUDAMED Signaler une erreur
Sinymedical Mandataire UE : REP Europe GmbH (Allemagne)	Chine	Petri Dish 697843434104MZ	I MDR	Site web sales@sinymedical.com Fiche EUDAMED Signaler une erreur
Skgmed Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Plain, EDTA K3, EDTA K2, Clot Activator, Gel+Clot Activator, 3.8% Sodium Citrate, 3.2% Sodium Citrate, Heparin Sodium, Heparin Lithium, ACD Solution A, ACD Solution B，EDTA K2+Gel， EDTA K3+ Gel, Cell-free DNA, Potassium Oxalate +Sodium Fluoride, etc	A IVDR	Fiche EUDAMED Signaler une erreur
Sterile Safequip Chemicals FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Inde	ZBT-ESR DT10	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Stratipath	Suède	Stratipath Breast98/79	– 98/79	Site web info@stratipath.com Fiche EUDAMED Signaler une erreur
Suesse	Allemagne	SuesseMicroscopeSlides3 réf.	A IVDR	info@suesse.de Fiche EUDAMED Signaler une erreur
Surgnova FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Electroporation Fixator support N30003 réf.	IIb MDR	Présent sur le marché en France qara@surgnova.com Fiche EUDAMED Signaler une erreur
Suzhou Astrabio Technology Mandataire UE : MedPath GmbH (Allemagne)	Chine	Automatic single molecular immunity Detection (SMID) analyzer AST-Dx90	A IVDR	marketing@astra-biotech.com Fiche EUDAMED Signaler une erreur
Suzhou Changhe Biotech Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	HTM-8T	A IVDR	Fiche EUDAMED Signaler une erreur
Suzhou Helmen Precision Insturments Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Automatic Dry Fluorescent Immunoassay Analyzer FIC-H1W、FIC-H1N、FIC-Q100、FIC-Q100N、FIC-H2、FIC-S100、FIC-A1600、FIC-M6、FIC-M6G、FIC-H0、FIC-H0mini、FIC-M2、FIC-M2NT3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
suzhou lingyan medical technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Lingyan "Plain tube(without additives);anticoagulant tubes(EDTA-K2,EDTA-K3,sod ium citrate 1:4,sodium citrate 1:9,heparin sodium,heparin lithium,Glucose tube Florude); coagulant tube(Clot activator);separation gel tube(Gel&activator)"3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Suzhou Sniper Medical Technologies FDA Mandataire UE : MedPath GmbH (Allemagne)	Chine	All-in-one Digital PCR Device DQ24-Dx	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Suzhou Sunmed FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	DEPAN3 réf.	I MDR	Site web Fiche EUDAMED Signaler une erreur
Swissmeca Mandataire UE : Axon Lab AG (Autriche)	Suisse	SpinAx – Homogenizer	A IVDR	Site web Info@swissmeca.ch Fiche EUDAMED Signaler une erreur
Sykehusapotekene	Norvège	Etanol SA 50 % til cytologi	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Taizhou Huangyan Fangye Technology Development Mandataire UE : Sungo Cert GmbH (Allemagne)	Chine	10ml	A IVDR	Fiche EUDAMED Signaler une erreur
Taizhou Jiaojiang Rongteng Glasses Factory Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	READING GLASSES 0005	I MDR	Fiche EUDAMED Signaler une erreur
Taizhou Yongfang Hygiene Supplies Factory Mandataire UE : MedPath GmbH (Allemagne)	Chine	Pasteur Pipette XG600013 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
tanit evolution	France	AIR'Protec	I MDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Tecan FDA	Autriche	INFINITE F50 PLUS	A IVDR	Présent sur le marché en France Site web regulatory.affairs.at@tecan.com Fiche EUDAMED Signaler une erreur
Techno-path Manufacturing FDA	Irlande	Multichem ID-Chagas	C IVDR	Site web Fiche EUDAMED Signaler une erreur
Tecnobilife	Italie	SAFE BIOPSY BOX 20 ML - CONTENITORE CON FORMALINA E SISTEMA DI SICUREZZA 000223 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Tecom Science Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	TECOM TC6090L, TC6030L, TC220, TC200	A IVDR	Fiche EUDAMED Signaler une erreur
Teletest	Espagne	KTT.12276	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Theradial	France	Théraflux98/79	– 98/79	Présent sur le marché en France Site web reglementaire@theradial.com Fiche EUDAMED Signaler une erreur
Thermogenesis FDA Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	XP	IIa MDR	Site web regulatoryaffairs@thermogenesis.com Fiche EUDAMED Signaler une erreur
Tianjin Readybio Medical Technology Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Cleaning Solution MC-Coulter	A IVDR	Fiche EUDAMED Signaler une erreur
TimeTeller	Allemagne	TimeTeller® – Your Circadian Rhythm	A IVDR	Fiche EUDAMED Signaler une erreur
Toby's	Pays-Bas	DA	A IVDR	Site web info@tobys.nl Fiche EUDAMED Signaler une erreur
Toroivd Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	TOROUNIT-P	A IVDR	Fiche EUDAMED Signaler une erreur
Tribo	Pologne	Szafa chłodnicza do przechowywania leków i wyrobów medycznych SK556002 réf.	I MDR	Site web Fiche EUDAMED Signaler une erreur
Trime	Tchéquie	Vitamin D Level	IIa MDR	Fiche EUDAMED Signaler une erreur
True Dose	Suède	TD-ABEMA TD KIT3 réf.	A IVDR	Site web info@truedose.se Fiche EUDAMED Signaler une erreur
Unicoproducts FDA Mandataire UE : Everbiz GmbH (Allemagne)	Chine	SPECIMEN CONTAINER HEA1992 réf.	I MDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Utsat	Turquie	CFΔ Collection System UCF2011	A IVDR	Site web info@utsat.com.tr Fiche EUDAMED Signaler une erreur
Vacutest Kima FDA	Italie	VACUTEST PLAST VACUTEST TEST TUBE499 réf.98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Vector Surgical FDA Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	Vividex Suite	A IVDR	Site web regulatory@vectorsurgical.com Fiche EUDAMED Signaler une erreur
Veracyte FDA Mandataire UE : Veracyte Global BV (Pays-Bas)	France, États-Unis	Veracyte FFPE RNA Extraction Kit	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Vigilant Biosciences FDA Mandataire UE : Vigilant Biosciences GmbH (Allemagne)	États-Unis	BeVigilant™ Reader2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Vignyburke Trading FDA Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Reading Glasses	I MDR	Fiche EUDAMED Signaler une erreur
Virtue Diagnostics (Suzhou) Mandataire UE : Kingsmead Service B.V. (Pays-Bas)	Chine	Automatic Chemiluminescence Immunoassay Analyzer VERCENTRA CS-1500, VERCENTRA CS-30002 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Vitapaw Tech Hk Mandataire UE : Maybon Noxa OÜ (Estonie)	Hong Kong	D3IN1	A IVDR	Fiche EUDAMED Signaler une erreur
Vodenmedical	Italie	Vchemys VCS-00P	A IVDR	Site web Fiche EUDAMED Signaler une erreur
VWR International FDA	Pays-Bas	MICROSCOPE KP CYTOLOGY SLIDES3 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Waters FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas)	États-Unis	ACQUITY UPLC CH-A IVD3 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Weihai Weigao Blood Collection Supplies Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	/14 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Wholecare Biomedical FDA Mandataire UE : MDSS GmbH (Allemagne)	Taïwan	Microlife GlucoTeq Blood Glucose Monitoring System BGMS 2002 réf.98/79	– 98/79	info.wholecare@microlife.com.tw Fiche EUDAMED Signaler une erreur
Wuhan Ammunition Life-tech Mandataire UE : Medunion S.L. (Espagne)	Chine	1 test/box	A IVDR	Fiche EUDAMED Signaler une erreur
Wuhan Heer Medical Technology Development Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	PathSCAN-4A	A IVDR	Fiche EUDAMED Signaler une erreur
WuHan LanYuan Protective Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	LY-NA-BST BLUE/WHITE/GREEN	A IVDR	Fiche EUDAMED Signaler une erreur
Wuxi Yanzhong Biotechnology Mandataire UE : AION CIRCUITS, LDA (Portugal)	Chine	ARK-01	A IVDR	Fiche EUDAMED Signaler une erreur
Wuzhou Aokace Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Electronic Vaginal Microscope AGC-HDC-1、AGC-HDC-22 réf.	I MDR	Fiche EUDAMED Signaler une erreur
Xiamen Zhixuan Biotech Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	VanGenes Cell free DNA preservative tubes3 réf.	A IVDR	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Xprecia Testing Pty Mandataire UE : MediMark Europe Sarl. (France)	Australie	Xprecia Stride PT/INR Test Strips98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Yancheng Huida Medical Instruments FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Plain tube; Clot activator tube; Sodium Citrate tube;ESR tube;Lithium Heparin tube; Sodium Heparin tube;Gel&Clot activator tube; Glucose tube; EDTA Tube(EDTA-K2/EDTA-K3/EDTA-Na2); PRP tube(ACD/ACD+ Gel etc.	A IVDR	Fiche EUDAMED Signaler une erreur
Yercon Diagnostic Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	YE-100P, YE-100F, YE-100H, YE-100S, YE-120B, YE-120F, YE-120H, YE-120S, YE-300A, YE-300F, YE-300H, YE-300S3 réf.	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Yiwu City Ange Medical Instrument Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Disposable Vacuum Blood Collection 1ml, 2ml, 3ml, 5ml, 10ml, 15ml	A IVDR	Fiche EUDAMED Signaler une erreur
Yiwu Xuanbao Trading Mandataire UE : HUMISS TRADING S. L. (Espagne)	Chine	reading glasses 5086,6008,8808,8508,8507,3003,1938	I MDR	Fiche EUDAMED Signaler une erreur
Yongkang Jinkang Health Equipment Factory FDA Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	JK-CXB3 réf.	I MDR	sales02@chinajinkang.com Fiche EUDAMED Signaler une erreur
YOUspan	Allemagne	YSPTK	IIa MDR	Fiche EUDAMED Signaler une erreur
Zacros FDA Mandataire UE : MDSS GmbH (Allemagne)	Japon	BAPA tube98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Zafena	Suède	Simple Simon PT98/79	– 98/79	Site web info@zafena.se Fiche EUDAMED Signaler une erreur
Zhejiang RonMai Medical Technology Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	Plain tube (No additive) Clot activator tube SST tube(Gel&Clot activator tube) Gel&Heparin Lithium Tube Gel&Heparin Sodium Tube etc	A IVDR	Fiche EUDAMED Signaler une erreur
Zhongke Meiling Cryogenics FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	Centrifuge CT-G165R, CT-G185R, CT-Q175R, CT-D60, CL-G210R	A IVDR	Fiche EUDAMED Signaler une erreur
Zhucheng Binfei Medi-Tek Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	BINFEI3 réf.	I MDR	Présent sur le marché en France admin@binfei-medtek.com Fiche EUDAMED Signaler une erreur
Zinexts Mandataire UE : Obelis s.a. (Belgique)	Taïwan	NeXgen 16HP	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Vitro Scient Mandataire UE : MDSS GmbH (Allemagne) Aucun modèle encore en vente	Égypte	Antihuman globulin (Polyspecific) 10 x 10 ml - 2060198/79 (plus commercialisé) Bovine serum Albumin 22% 10 x 10 ml - 2050198/79 (plus commercialisé) Bovine serum Albumin 30% 10 x 10 ml - 2070198/79 (plus commercialisé) Brucella Abortus 100 tests - 5100198/79 (plus commercialisé) Brucella Melitensis 100 tests - 5110198/79 (plus commercialisé) 44 autres D-Dimer Turbilatex 50 Tests - 7050198/79 (plus commercialisé) FDP 15 Tests - 3050198/79 (plus commercialisé) Febrile Antigen 2 x 100 tests - 5170198/79 (plus commercialisé) Febrile Antigen 4 x 100 tests98/79 (plus commercialisé) Febrile Antigen 6 x 100 tests - 5130198/79 (plus commercialisé) Febrile Antigen 8 x 100 tests98/79 (plus commercialisé) Febrile Antigen Salmonella Paratyphi AH98/79 (plus commercialisé) Febrile Antigen Salmonella Paratyphi BH 100 tests - 5040198/79 (plus commercialisé) Febrile Antigen Salmonella Paratyphi BO 100 tests - 5070198/79 (plus commercialisé) Febrile Antigen Salmonella Paratyphi CH 100 tests - 5050198/79 (plus commercialisé) Febrile Antigen Salmonella Typhi AO 100 tests - 5060198/79 (plus commercialisé) Febrile Antigen Salmonella Typhi CO 100 tests - 5080198/79 (plus commercialisé) Febrile Antigen Salmonella Typhi H 100 tests - 5020198/79 (plus commercialisé) Febrile Antigen Salmonella Typhi O 100 tests - 5010198/79 (plus commercialisé) Fibrinogen 20 Tests - 3040198/79 (plus commercialisé) Hemoglobin ( 1 + 9 ) 4 x 100 ml - 1240198/79 (plus commercialisé) Hemoglobin ( 1 + 99 ) 1 x 25 ml - 1280198/79 (plus commercialisé) Hemoglobin ( 1 + 99 ) 10 x 25 ml - 1280498/79 (plus commercialisé) Hemoglobin ( 1 + 99 ) 2 x 25 ml - 1280298/79 (plus commercialisé) Hemoglobin ( 1 + 99 ) 5 x 25 ml - 1280398/79 (plus commercialisé) Hemoglobin (Ready for use) 1 x 500 ml - 1270198/79 (plus commercialisé) Hemoglobin (Ready for use) 2 x 500 ml - 1270298/79 (plus commercialisé) Partial Thromboplastin Time 1 X 4 ml - 3030198/79 (plus commercialisé) Partial Thromboplastin Time 10 X 4 ml - 3030698/79 (plus commercialisé) Partial Thromboplastin Time 4 X 5 ml - 3030498/79 (plus commercialisé) Partial Thromboplastin Time 5 X 3 ml - 3030398/79 (plus commercialisé) Partial Thromboplastin Time 5 X 4 ml - 3030598/79 (plus commercialisé) Partial Thromboplastin Time 8 X 2 ml - 3030298/79 (plus commercialisé) Plasma Control L-1 1 ml - 3060198/79 (plus commercialisé) Plasma Control L-2 3070198/79 (plus commercialisé) Prothrombin time (ISI 1.00) 1 X 8 ml - 3020298/79 (plus commercialisé) Prothrombin time (ISI 1.00) 10 X 8 ml - 3020598/79 (plus commercialisé) Prothrombin time (ISI 1.00) 2 X 8 ml - 3020398/79 (plus commercialisé) Prothrombin time (ISI 1.00) 4 X 5 ml - 3020698/79 (plus commercialisé) Prothrombin time (ISI 1.00) 6 X 8 ml - 3020498/79 (plus commercialisé) Prothrombin time (ISI 1.00) 8 X 2 ml - 3020198/79 (plus commercialisé) Prothrombin time (ISI 1.5) 1 X 8 ml - 3010298/79 (plus commercialisé) Prothrombin time (ISI 1.5) 10 X 8 ml - 3010598/79 (plus commercialisé) Prothrombin time (ISI 1.5) 2 X 8 ml - 3010398/79 (plus commercialisé) Prothrombin time (ISI 1.5) 4 X 5 ml - 3010698/79 (plus commercialisé) Prothrombin time (ISI 1.5) 6 X 8 ml - 3010498/79 (plus commercialisé) Prothrombin time (ISI 1.5) 8 X 2 ml - 3010198/79 (plus commercialisé) Rose Bengal 100 Tests - 5160298/79 (plus commercialisé) Rose Bengal 50 Tests - 5160198/79 (plus commercialisé)	– 98/79	Site web info@vitroscient.com Fiche EUDAMED Signaler une erreur
Biotime Mandataire UE : Lotus NL B.V. (Pays-Bas) et 2 autres Aucun modèle encore en vente	Chine	BIOTIME10 réf.98/79 (plus commercialisé) BIOTIME Dengue NS1 Antigen Rapid Test98/79 (plus commercialisé) D-Dimer Rapid Quantitative Test BT210598/79 (plus commercialisé) Dengue Ag &Ab Combo Rapid Test BT010180198/79 (plus commercialisé) Dengue IgG/IgM Rapid Test BT010170198/79 (plus commercialisé) 12 autres HLC-100 Automatic Glycosylated Hemoglobin Analyzer (plus commercialisé) IL-6 Rapid Quantitative Test (Fluorescence Immunoassay)98/79 (plus commercialisé) Malaria P.f Antigen Rapid Test BT010190198/79 (plus commercialisé) Malaria P.f/P.v Antigen Rapid Test BT010210198/79 (plus commercialisé) Malaria P.f/Pan Antigen Rapid Test BT010220198/79 (plus commercialisé) Malaria P.v Antigen Rapid Test BT010200198/79 (plus commercialisé) MPV Quantitative Test (Realtime PCR)98/79 (plus commercialisé) MPV Rapid Quantitative Test (eRDA)2 réf.98/79 (plus commercialisé) Mycoplasma Pneumoniae Antigen Rapid Qualitative Test BT010260198/79 (plus commercialisé) Mycoplasmal Pneumonia IgM Rapid Qualitative Test98/79 (plus commercialisé) SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）4 réf.98/79 (plus commercialisé) Treponema pallidum Antibody Rapid Qualitative Test BT010270198/79 (plus commercialisé)	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Mobidiag Aucun modèle encore en vente	Finlande	Amplidiag Bacterial GE Kit98/79 (plus commercialisé) Amplidiag C. difficile+027 Kit98/79 (plus commercialisé) Amplidiag COVID-19 Kit98/79 (plus commercialisé) Amplidiag Easy Extraction Kit I (plus commercialisé) Amplidiag H. pylori+ClariR Kit98/79 (plus commercialisé) 9 autres Amplidiag RESP-4 Kit98/79 (plus commercialisé) Amplidiag Stool Parasites Kit98/79 (plus commercialisé) Amplidiag Viral GE Kit98/79 (plus commercialisé) Novodiag Bacterial GE+98/79 (plus commercialisé) Novodiag C. difficile98/79 (plus commercialisé) Novodiag COVID-1998/79 (plus commercialisé) Novodiag Instrument3 réf. (plus commercialisé) Novodiag RESP-498/79 (plus commercialisé) Novodiag Stool Parasites98/79 (plus commercialisé)	A IVDR, 98/79	Site web sales.mob@hologic.com Fiche EUDAMED Signaler une erreur
Nantong EgensBiotechnology FDA Mandataire UE : SUNGO Europe B.V. (Pays-Bas) et 1 autre Aucun modèle encore en vente	Chine	Dengue IgM/IgG test cassette Dengue-IgM/IgG 25210298/79 (plus commercialisé) Dengue NS1 antigen test cassette Dengue-NS1 25210298/79 (plus commercialisé) Dengue NS1/IgM/IgG test cassette Dengue-NS1/IgM/IgG 25210298/79 (plus commercialisé) Diagnostic kit for anti-HAV IgM( Colloidal Gold) HAV-IgM strip cassette98/79 (plus commercialisé) Diagnostic kit for Antibody to Treponema Pallidum (Colloidal Gold) TP strip cassette98/79 (plus commercialisé) 7 autres Diagnostic Kit for Helicobacter pylori antigen (Colloidal Gold) HP-Ag strip cassette98/79 (plus commercialisé) Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold) MA-Pf/Pv strip cassette98/79 (plus commercialisé) Diagnostic Kit for P.falciparum Antigen （Colloidal Gold) MA-Pf strip cassette98/79 (plus commercialisé) Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold) MA-Pan/Pf strip cassette98/79 (plus commercialisé) H.Pylori Antibody (HP) Test HP strip cassette98/79 (plus commercialisé) Influenza A/Influenza B (FluA+B) Antigens Rapid Test Kit Flu Cassette98/79 (plus commercialisé) Typhoid IgG/IgM test cassette98/79 (plus commercialisé)	– 98/79	qa@egens-bio.cn Fiche EUDAMED Signaler une erreur
Ns Biotec Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) Aucun modèle encore en vente	Égypte	Biosafety Cabinet98/79 (plus commercialisé) Brucella Brob-Ma-10098/79 (plus commercialisé) D-dimer Ddm-Cal-05098/79 (plus commercialisé) Fibrinogen Fib-M-050198/79 (plus commercialisé) NS Biotec blood cell counter Hema 2198/79 (plus commercialisé) 7 autres NS Biotec blood cell counter Hema 2598/79 (plus commercialisé) NS BIOTEC Chemistry Analyzer98/79 (plus commercialisé) NS Biotec electrolyte analyzer EA-20598/79 (plus commercialisé) NS BIOTEC Orbital shaker OS-25098/79 (plus commercialisé) NS Biotec Vertical Laminar Air Flow98/79 (plus commercialisé) NS BIOTEC WaterBath98/79 (plus commercialisé) PTT98/79 (plus commercialisé)	– 98/79	Site web info@nsbiotec.com Fiche EUDAMED Signaler une erreur
Princeton BioMeditech FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne) Aucun modèle encore en vente	États-Unis	Accusay Mono98/79 (plus commercialisé) BioSign Flu A&B98/79 (plus commercialisé) BioSign H. pylori98/79 (plus commercialisé) BioSign Mono98/79 (plus commercialisé) BioStrep A98/79 (plus commercialisé) 7 autres Immunocard STAT Flu A&B98/79 (plus commercialisé) Immunocard STAT Flu A&B Nasopharyngeal Wash/Aspirate accessory kit98/79 (plus commercialisé) Status COVID-19/Flu98/79 (plus commercialisé) Status Flu A+B98/79 (plus commercialisé) Status H. pylori98/79 (plus commercialisé) Status Mono98/79 (plus commercialisé) Status Strep A98/79 (plus commercialisé)	– 98/79	Site web info@pbmc.com Fiche EUDAMED Signaler une erreur
Chemclin Mandataire UE : MedNet EC-REP GmbH (Allemagne) Aucun modèle encore en vente	Chine	Interleukin 6 (Light-initiated Chemiluminescence Immunoassay, LiCA) 2 × 100 Tests98/79 (plus commercialisé) Interleukin 6 (Light-initiated Chemiluminescence Immunoassay, LiCA) 2 × 200 Tests98/79 (plus commercialisé) Interleukin 6 (Light-initiated Chemiluminescence Immunoassay, LiCA) 4 × 100 Tests98/79 (plus commercialisé) Interleukin 6 (Light-initiated Chemiluminescence Immunoassay, LiCA) 4 × 200 Tests98/79 (plus commercialisé) LiCA D-Dimer 2 × 100 Tests98/79 (plus commercialisé) 6 autres LiCA D-Dimer 2 × 50 Tests98/79 (plus commercialisé) LiCA D-Dimer 4 × 100 Tests98/79 (plus commercialisé) LiCA D-Dimer 4 × 50 Tests98/79 (plus commercialisé) LiCA PT 1000 (plus commercialisé) LiCA Smart (plus commercialisé) LiCA Toxo lgG 2 × 50 Tests; 2 × 50 Tests; 2 × 100 Tests; 4 × 100 Tests3 réf. (plus commercialisé)	A, C IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Uniogen Aucun modèle encore en vente	Finlande	GenomEra C. difficile Assay Kit CDX-403 réf.98/79 (plus commercialisé) GenomEra CDX Software CDX-102 réf. (plus commercialisé) GenomEra GBS Assay Kit CDX-602 réf.98/79 (plus commercialisé) GenomEra HSV 1/2, VZV + EV Assay Kit CDX-1702 réf.98/79 (plus commercialisé) GenomEra MRSA/SA AC Assay Kit CDX-30-052 réf.98/79 (plus commercialisé) 5 autres GenomEra MRSA/SA Multi Swab Assay Kit CDX-30-0298/79 (plus commercialisé) GenomEra Norovirus Assay kit CDX-1002 réf.98/79 (plus commercialisé) GenomEra S. pneumoniae Assay Kit CDX-702 réf.98/79 (plus commercialisé) GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit CDX-1602 réf.98/79 (plus commercialisé) GenomEra SARS-CoV-2, Flu A/B + RSV Assay Kit CDX-1403 réf.98/79 (plus commercialisé)	A IVDR, 98/79	info@uniogen.com Fiche EUDAMED Signaler une erreur
Xpenarray Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) Aucun modèle encore en vente	Chine	Automatic 5-Part Hematology Analyzer98/79 (plus commercialisé) Automatic Hematology Analyzer IA2005298/79 (plus commercialisé) Automatic Hematology Analyzer IA2005398/79 (plus commercialisé) XN 300098/79 (plus commercialisé) XN 3000\XN 3100\XN 3200\XN 33002 réf.98/79 (plus commercialisé) 5 autres XN 600098/79 (plus commercialisé) XN 6000\XN 6100\XN 6200\XN 6300\XN 6500\XN 6600\XN 67003 réf.98/79 (plus commercialisé) XN 610098/79 (plus commercialisé) XN 620098/79 (plus commercialisé) XN 650098/79 (plus commercialisé)	– 98/79	Fiche EUDAMED Signaler une erreur
Anouve Mandataire UE : Obelis s.a. (Belgique) Aucun modèle encore en vente	Chine	Anouve 10 mL tube, 50 tubes/box (plus commercialisé) Anouve 32 tests/box (plus commercialisé) Anouve 48 tests/box (plus commercialisé) Anouve 5 mL tube, 50 tubes/box (plus commercialisé) Anouve 50 tests/box (plus commercialisé)	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Chemelex Aucun modèle encore en vente	Espagne	Antígenos Bacterianos11 réf.98/79 (plus commercialisé) Antígenos Bacterianos Control Negativo98/79 (plus commercialisé) Antígenos Bacterianos Control Positivo98/79 (plus commercialisé) Antígenos Bacterianos PROTEUS OX1998/79 (plus commercialisé) Antígenos Bacterianos PROTEUS OX298/79 (plus commercialisé)	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Hangzhou ShengTing Medical Technology Mandataire UE : Medunion S.L. (Espagne) Aucun modèle encore en vente	Chine	Mycobacterium nucleic acid and M. tuberculosis drug resistance gene detection kit V2.198/79 (plus commercialisé) Mycobacterium nucleic acid and M. tuberculosis drug resistance gene detection kit V2.298/79 (plus commercialisé) Mycobacterium nucleic acid and M. tuberculosis drug resistance gene detection kit V3.198/79 (plus commercialisé) Smartseq-DNA&RNA detection kit V3.198/79 (plus commercialisé)	– 98/79	Fiche EUDAMED Signaler une erreur
Labquality Aucun modèle encore en vente	Finlande	B-Trol ESR Control L12 réf.98/79 (plus commercialisé) B-Trol ESR Control L22 réf.98/79 (plus commercialisé) B-Trol Plus Control Abnormal Level98/79 (plus commercialisé) B-Trol Plus Control Normal Level98/79 (plus commercialisé)	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Deben Diagnostics Mandataire UE : EU-UK Authorised Representative Ltd (Irlande du Nord) Aucun modèle encore en vente	United Kingdom (ex Northern Ireland)	Haemagglutination Assay (TPHA) Kit3 réf.98/79 (plus commercialisé) Rapid Plasma Reagin (RPR) Kit2 réf.98/79 (plus commercialisé) VDRL Carbon Antigen98/79 (plus commercialisé)	– 98/79	Site web info@debendiagnostics.co.uk Fiche EUDAMED Signaler une erreur
IDL Biotech Aucun modèle encore en vente	Suède	TUBEX TF 10-20198/79 (plus commercialisé) TUBEX TF Wash 10-50198/79 (plus commercialisé)	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Raingene Mandataire UE : Lotus NL B.V. (Pays-Bas) Aucun modèle encore en vente	Chine	FluA/FluB/RSV Virus Nucleic Acid Detection Kit 10tests/kit, 20tests/kit98/79 (plus commercialisé) Multiply Respiratory Pathogen Virus Nucleic Acid Detection Kit 10tests/kit，20tests/kit98/79 (plus commercialisé)	– 98/79	Fiche EUDAMED Signaler une erreur
S.D. Sight Diagnostics FDA Mandataire UE : CEpartner4U (Pays-Bas) Aucun modèle encore en vente	Israël	Sight OLO CBC Test Kit TK198/79 (plus commercialisé) Sight OLO OLO-E198/79 (plus commercialisé)	– 98/79	Site web info@sightdx.com Fiche EUDAMED Signaler une erreur
AccuBio Mandataire UE : Advena Limited (Malte) Aucun modèle encore en vente	United Kingdom (ex Northern Ireland)	VISITECT AB37698/79 (plus commercialisé)	– 98/79	Fiche EUDAMED Signaler une erreur
Beijingyicheng Mandataire UE : Caretechion GmbH (Allemagne) Aucun modèle encore en vente	Chine	Model 5D-1、 Model 5D-2、Model 5D-3、Model 5D-6、 Model 5D-7、 Model 5D-8B2 réf.98/79 (plus commercialisé)	– 98/79	Site web mail@beijingyicheng.com.cn Fiche EUDAMED Signaler une erreur
Biosci Healthcare Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) Aucun modèle encore en vente	Inde	Biovac3 réf. (plus commercialisé)	A IVDR	Site web info@bioscihealthcare.com Fiche EUDAMED Signaler une erreur
Chongqing Aolun Technology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) Aucun modèle encore en vente	Chine	Aolun Clini-Lab100Pro Clini-Lab80Pro，Clini-Lab100Pro，3 Clini-Lab500Pro3 réf. (plus commercialisé)	A IVDR	Fiche EUDAMED Signaler une erreur
Exact Sciences FDA Mandataire UE : Emergo Europe B.V. (Pays-Bas) Aucun modèle encore en vente	États-Unis	LBgard Blood Tubes version 1.298/79 (plus commercialisé)	– 98/79	regulatoryaffairs@exactsciences.com Fiche EUDAMED Signaler une erreur
Innobiochips Aucun modèle encore en vente	France	SirYus Covidiag2 réf.98/79 (plus commercialisé)	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
MolGen Aucun modèle encore en vente	Pays-Bas	MolGen Saliva Collector 08720299830509 (plus commercialisé)	A IVDR	Site web info@molgen.com Fiche EUDAMED Signaler une erreur
Omega Diagnostics Mandataire UE : Advena Limited (Malte) Aucun modèle encore en vente	United Kingdom (ex Northern Ireland)	SCP12 (plus commercialisé)	A IVDR	Site web Fiche EUDAMED Signaler une erreur
Primadiag Aucun modèle encore en vente	France	ACSIA PCR Edition (plus commercialisé)	A IVDR	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
QuantaMatrix Mandataire UE : KTR Europe GmbH (Allemagne) Aucun modèle encore en vente	Corée du Sud	QMIA QMAR0498/79 (plus commercialisé)	– 98/79	Fiche EUDAMED Signaler une erreur
Rossix FDA Aucun modèle encore en vente	Suède	Rox Factor IX98/79 (plus commercialisé)	– 98/79	Site web info@rossix.com Fiche EUDAMED Signaler une erreur

Un modèle enregistré dans EUDAMED n'est pas forcément commercialisé dans votre pays. Vérifiez la disponibilité et le marquage CE auprès du fabricant.

Autres fabricants connus aux États-Unis (FDA) 1 680

Fabricants qui vendent ce type de dispositif aux États-Unis d’après la FDA, absents d’EUDAMED pour cette catégorie à ce jour. Certains vendent pourtant en Europe : l’enregistrement des dispositifs déjà commercialisés est obligatoire jusqu’au 28 novembre 2026, et certains sont enregistrés sous le nom de leur maison mère. Le rangement dans la catégorie est déduit automatiquement de la classification américaine : il peut inclure des produits voisins.

Fabricant	Pays	Marques	Autorisation FDA
Nova Biomedical Corp. Présent sur le marché en France	États-Unis	STAT PROFILE NOVA NOVA/STAT PROFILE StatSensor/StatStrip STATSTRIP Nova Max	K221326 (2024)
Fisher Scientific Co., LLC Présent sur le marché en France	États-Unis	Fisherbrand Sure-Vue	K860919 (1986)
MEDLINE INDUSTRIES, INC. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Medline MEDLINE INDUSTRIES Medline Industries, Inc. Centurion Medical Products Corp	enregistré
Cardinal Health 200, LLC Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	CARDINAL HEALTH Dover Precision Kendall Monoject OEM CUSTOMER SPECIFIC	enregistré
ICU MEDICAL, INC. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Portex Jelco	K881201 (1988)
Thermo Electron LED GmbH Présent sur le marché en France	–	Thermo Scientific Fisher Scientific Cardinal Fisherbrand	enregistré
HENRY SCHEIN, INC. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Henry Schein CardioChek	enregistré
Chromsystems Instruments + Chemicals GmbH Présent sur le marché en France	Allemagne	Plasma Calibrator Set Plasma Calibration Standard Serum Calibrator Set Serum Calibration Standard Urine Calibration Standard Whole Blood Calibration Standard	enregistré
Cardinal Health, Inc. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Precision Dover Monoject Corvac Covidien	enregistré
Miltenyi Biotec B.V. & Co. KG Présent en Europe dans d’autres catégories Présent sur le marché en France	–	Anti-TCRg/d-PE-Vio770 CD2-VioBlue CD11b-APC CD45-APC CD117-APC CD66c-PE	enregistré
PLASMABIOTICS Présent en Europe dans d’autres catégories Présent sur le marché en France	–	Silicone connection set for colonoscopes, gastroscopes and duodenoscopes FUJIFIL Silicone connection set for colonoscopes, gastroscopes and duodenoscopes OLYMPUS Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX Autoclavable version of Fg5W C-G-D Autoclavable version of OP B-Bp Autoclavable version of OW C-G-D	enregistré
AnalytiChem USA, Inc. Présent sur le marché en France	États-Unis	Redipor Cell Pro	enregistré
Quidel Corp. Présent sur le marché en France	États-Unis	QuickVue Sofia QuickVue In-Line QuickVue+ InflammaDry Solana	K230349 (2023)
OWEN MUMFORD USA INCORPORATED Présent en Europe dans d’autres catégories Présent sur le marché en France	Royaume-Uni	Unistik VacuFlip Unistik ShieldLock Unistik	K223854 (2023)
CliniSys, Inc Présent sur le marché en France	États-Unis	Clinisys Atlas Clinisys Laboratory Solution Clinisys SQ Lab Sunquest Atlas Clinisys Laboratory Solutions Clinisys SQ Blood Bank	enregistré
Medtronic, Inc. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	DLP® CLOTtrac™ RACT CLOTtrac® HEPtrac® HEPline®	K103314 (2010)
CRYO BIO SYSTEM Présent sur le marché en France	États-Unis	STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND WHITE FLEXIBLE ROD / BLISTER 5X15 STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND GREEN FLEXIBLE ROD / BLISTER 5X15 CBS STERILE HIGH SECURITY TUBE BY 50 UNITS STERILE CBS 0.5 ML STRAW FOR SPERM WITH YELLOW COTTON PLUG / 5 X 20 STERILE CBS 0.5 ML STRAW FOR SPERM WITH COTTON PLUG / 5 x 20 STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND RED FLEXIBLE ROD / BLISTER 5X15	K002595 (2000)
JEOL LTD. Présent sur le marché en France	Japon	Potassium Electrode Sodium Electrode Chloride Electrode ISE Serum Standard Set NA Internal Standard ISE Urine Standard Set	enregistré
AngioDynamics, Inc. Présent sur le marché en France	États-Unis	NanoKnife	K253198 (2026)
ITL ASIA PACIFIC SDN. BHD. Présent en Europe dans d’autres catégories Présent sur le marché en France	–	Cell Culture Sampler Wide Cap 2mL SampLok® System with Hinged Lid SampLok® Adapter Cap Kit SampLok® SampLok® System with No Lid SampLok® Adapter Cap 3	enregistré
SB-KAWASUMI LABORATORIES, INC. Présent en Europe dans d’autres catégories Présent sur le marché en France	Japon	K-SHIELD Zen Winged Blood Collection Set K-SHIELD Zen Winged Blood Collection Set with Pre-attached Holder K-SHIELD Zen Winged Blood Collection Set with Multiple Sample Luer Adapter Rapid Access Kawasumi Multiple Sample Adapter with Pre-Attached Holder Rapid Transfer Kawasumi Multiple Sample Adapter with Pre-Attached Holder	K230408 (2023)
Vitrolife Sweden AB Présent en Europe dans d’autres catégories Présent sur le marché en France	Suède	Sperm Collection Container Culture Dish 60 mm 5 Well Culture Dish ICSI Dish Sample Tube 5 mL Culture Dish 40 mm	enregistré
Fresenius Kabi AG Présent en Europe dans d’autres catégories Présent sur le marché en France	Allemagne	Alyx Cart Sampling Site Coupler Fenwal Slide Clamp CompoMat G5 Hematype Segment Device CompoMat G5 Plus	enregistré
Welch Allyn, Inc. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Welch Allyn, Inc.	enregistré
ELITECH GROUP INC. Présent sur le marché en France	–	MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-25 MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-100 MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-100 MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 100 MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-25 MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-100	enregistré
Medtronic Minimed Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Enlite™ Serter CGMS® iPro™ GUARDIAN® MiniLink® REAL-Time Enlite® Serter Medtronic Guardian™ Link	enregistré
Vitrolife A/S Présent en Europe dans d’autres catégories Présent sur le marché en France	Danemark	MicroCell EmbryoViewer EmbryoScope+ ES server EmbryoScope time-lapse incubator	K173264 (2018)
ARTHREX, INC. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Arthrex®	enregistré
Chrono-Log Corp. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Chrono-log	K945414 (1995)
MACO PHARMA Présent en Europe dans d’autres catégories Présent sur le marché en France	France	9MPSBI485:MacoPress Smart and DMS RS485 Module-with breaker for main press 9MPSBIWIFI:MacoPress Smart and DMS WiFi Module-with breaker for main press 9MPSBR485: MacoPress Smart and DMS RS485 Module-no breaker 9MPSBRWIFI-MacoPress Smart and DMS WiFi Module-no breaker 9MPSBRLAN:MacoPress Smart and DMS Ethernet Module-no breaker 9MPSBILAN:MacoPress Smart and DMS Ethernet Module-w/breaker for main press	enregistré
STRYKER CORPORATION Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	SURGICOUNT TRITON SpinePlex VertaPlex VertaPlex HV	enregistré
Gpi Usa, Inc. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Donor Doc 3.x.x e-Delphyn LIS Donor ElDorado Donor 3.x.x e-Delphyn Donor Surround 5.x	enregistré
STERIS Corporation Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	VERIFY	enregistré
Bühlmann Laboratories AG Présent sur le marché en France	Suisse	CAST® Lysing Reagent Basophil CAST® Stimulation Buffer Basophil CAST® Stimulation Control Basophil CAST® Staining Reagent Basophil	enregistré
MEDTRONIC XOMED, INC. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	–	enregistré
Merit Medical Systems, Inc. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Cultura™	K201674 (2021)
Terumo BCT, INC. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Vista ® TOMEs TERUMO OPERATIONAL MEDICAL EQUIPMENT SOFTWARE Vista®	enregistré
ADVANCE MEDICAL DESIGNS, INC. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Angiographic Waste Bag Waste Bag	enregistré
Ambu A/S Présent en Europe dans d’autres catégories Présent sur le marché en France	Danemark	aScope BronchoSampler™ 60 SC	enregistré
Amico Diagnostic Incorporated Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Amico Diagnostic Illuminator	enregistré
BIOMEDICAL DATA SOLUTIONS LIMITED Présent en Europe dans d’autres catégories Présent sur le marché en France	Royaume-Uni	ORTHO CONNECT	enregistré
NANOSTRING TECHNOLOGIES, INC. Présent sur le marché en France	–	nCounter Prep Station 5s nCounter Digital Analyzer 5s	enregistré
Nidek, Inc. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	IOL-Station	enregistré
Stemcell Technologies Canada Inc Présent en Europe dans d’autres catégories Présent sur le marché en France	Canada	EasySep™ Red Blood Cell Lysis Buffer, 10X Concentrate EasySep™ Buffer	enregistré
Verathon Medical (Canada) ULC Présent en Europe dans d’autres catégories Présent sur le marché en France	Canada	BFlex™	enregistré
ASSOCIATES OF CAPE COD, INC. Présent sur le marché en France	États-Unis	BG Analytics Software	enregistré
BAXTER INTERNATIONAL INC. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Fibrinotherm	enregistré
Ge Medical Systems Information Technologies Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	MAC	enregistré
Hamamatsu Photonics K.K. Présent sur le marché en France	Japon	NanoZoomer S360MD Slide scanner system	K260964 (2026)
Med Auxil analysis aids e.K. Présent en Europe dans d’autres catégories Présent sur le marché en France	Allemagne	Stool Collection Aid	enregistré
Micro-tech Usa Présent sur le marché en France	États-Unis	ESD Specimen Tray	enregistré
Millipore Corp. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	ORTHO Daily QC Simulated Whole Blood Quality Control Kit	enregistré
Pall International Sàrl Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Pall® Oxygenator Gas Line Filter	enregistré
Pfizer, Inc. Présent sur le marché en France	États-Unis	wtATTR-CM AcceleraTTR™	enregistré
SPINEVISION Présent sur le marché en France	États-Unis	Hexanium® TLIF	enregistré
Smith & Nephew, Inc. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Intramedullary Nail System	enregistré
Takeda Pharmaceuticals U.S.A., Inc. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	Recombinant Factor VIII Substrate, Porcine Sequence	enregistré
ANHUI MEDFAITH MEDICAL DEVICES CO., LTD. Présent en Europe dans d’autres catégories Présent sur le marché en France	Chine	–	enregistré
Abbott Rapid Diagnostics Présent sur le marché en France	États-Unis	–	K171650 (2017)
Appasamy Associates Private Limited (MN Kuppam) Présent en Europe dans d’autres catégories Présent sur le marché en France	Inde	–	enregistré
Appasamy Associates Private Limited (Thiruvandar Koil) Présent en Europe dans d’autres catégories Présent sur le marché en France	Inde	–	enregistré
Arrow International LLC (subsidiary of Teleflex Incorporated Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	–	enregistré
Avanos Medical, Inc. Présent sur le marché en France	États-Unis	–	enregistré
B.Braun Medical, Inc. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	–	enregistré
BMmedical Présent sur le marché en France	Pays-Bas	–	enregistré
Baxter Healthcare Corp Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	–	enregistré
Biocare Corp. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	–	enregistré
Canon, Inc. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	–	enregistré
Carl Zeiss, Inc. Présent sur le marché en France	États-Unis	–	enregistré
Cook, Inc. Présent sur le marché en France	États-Unis	–	enregistré
Corza Medical, Inc. Présent sur le marché en France	États-Unis	–	enregistré
DIAsource ImmunoAssays, SA Présent sur le marché en France	Belgique	–	enregistré
Diagnostic Consulting Network, LLC. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	–	enregistré
Echosens Présent en Europe dans d’autres catégories Présent sur le marché en France	France	–	enregistré
Eurofins Genomics LLC Présent sur le marché en France	États-Unis	–	enregistré
Guangdong Transtek Medical Electronics Co., Ltd. Présent en Europe dans d’autres catégories Présent sur le marché en France	Chine	–	enregistré
HEFEI MT MEDICAL CO.,LTD. Présent en Europe dans d’autres catégories Présent sur le marché en France	Chine	–	enregistré
Hangzhou Ruidi Biotechnology , Ltd. Présent en Europe dans d’autres catégories Présent sur le marché en France	Chine	–	K253846 (2026)
IDEXX LABORATORIES INC. Présent sur le marché en France	États-Unis	–	enregistré
IGEA S.p.A. Présent en Europe dans d’autres catégories Présent sur le marché en France	Italie	–	enregistré
IMMY, Inc. (Immunomycologics, Inc.) Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	–	enregistré
Ids, Ltd. Présent en Europe dans d’autres catégories Présent sur le marché en France	Corée du Sud	–	enregistré
MEDI.PLAN GmbH & Co. KG Présent sur le marché en France	Allemagne	–	enregistré
MEDIMAGING INTEGRATED SOLUTION INC. Présent en Europe dans d’autres catégories Présent sur le marché en France	Chine	–	enregistré
Medi Soft SA Présent sur le marché en France	Belgique	–	enregistré
Mgc Diagnostics Corporation Présent sur le marché en France	États-Unis	–	K251674 (2025)
Motion Dental Equipment Corp. Présent en Europe dans d’autres catégories Présent sur le marché en France	Taïwan	–	enregistré
NIPRO CORPORATION Présent en Europe dans d’autres catégories Présent sur le marché en France	Japon	–	enregistré
NORTH COAST MEDICAL, INC. Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	–	enregistré
Ningbo Risenmed Technology Co.,Ltd. Présent en Europe dans d’autres catégories Présent sur le marché en France	Chine	–	enregistré
Nissha Medical Technologies Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	–	enregistré
O&M HALYARD, INC. Présent sur le marché en France	États-Unis	–	enregistré
Opia Technologies SAS Présent en Europe dans d’autres catégories Présent sur le marché en France	France	–	enregistré
PURPLE SURGICAL INTERNATIONAL LIMITED Présent en Europe dans d’autres catégories Présent sur le marché en France	Royaume-Uni	–	enregistré
RegenLab Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	–	enregistré
Richard Wolf GmbH Présent en Europe dans d’autres catégories Présent sur le marché en France	Allemagne	–	enregistré
Sectra AB Présent en Europe dans d’autres catégories Présent sur le marché en France	États-Unis	–	K232208 (2024)
Shanghai Chuangshi Medical Technology (Group) Co., Ltd. Présent en Europe dans d’autres catégories Présent sur le marché en France	Chine	–	enregistré
Siemens Corp. Présent sur le marché en France	États-Unis	–	P110041 (2025)
Siemens Healthcare Diagnostic Products GmbH Présent en Europe dans d’autres catégories Présent sur le marché en France	Allemagne	–	K253985 (2026)

Les 100 fabricants les plus actifs sont affichés, sur 1 680.

Vous n'avez pas trouvé ?

Décrivez ce que vous cherchez. Les demandes nous indiquent quelles catégories ajouter en priorité.