Reagents

EMDN code W01

827 manufacturers, 24,186 models including 23,786 on the market, 46 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 827

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Bio SB FDA EU representative : QAdvis EAR AB (Sweden)	United States	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 others 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	Website ra@biosb.com EUDAMED record Report an error
Vitrosens	Türkiye	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 CFP3498/79 623 others 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 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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 refs ChainFor™ Gastroenteritis Bacterial ID-14 Genotyping qPCR Kit3 refs ChainFor™ Gastroenteritis v1.0 Genotyping qPCR Kit3 refs ChainFor™ Gastroenteritis ID-23 Genotyping qPCR Kit3 refs ChainFor™ H1N1 Detection qPCR Kit CFP6098/79 ChainFor™ HHV-6/HHV-7 Genotyping qPCR Kit2 refs ChainFor™ HHV-8 qPCR Kit3 refs ChainFor™ HPV 16/18 Genotyping qPCR Kit3 refs ChainFor™ HPV 16/18/45 Genotyping qPCR Kit3 refs ChainFor™ HPV ID-14 Genotyping qPCR Kit3 refs ChainFor™ HPV ID-14 Screening qPCR Kit3 refs ChainFor™ HPV ID-16 Genotyping qPCR Kit3 refs ChainFor™ HSV-1 qPCR Kit3 refs ChainFor™ HSV-1/HSV-2 Genotyping qPCR Kit2 refs ChainFor™ HSV-1/HSV-2/TP Genotyping qPCR Kit3 refs ChainFor™ HSV-1/HSV-2/VZV Genotyping qPCR Kit3 refs ChainFor™ HSV-2 qPCR Kit3 refs ChainFor™ Influenza A ID-4 Genotyping Detection qPCR Kit CFP6598/79 ChainFor™ LYO04WS243 refs ChainFor™ LYO185WS243 refs ChainFor™ LYO190WS243 refs ChainFor™ Parvovirus B19 qPCR Kit3 refs ChainFor™ Respiratory ID-28 Genotyping qPCR Kit2 refs ChainFor™ Respiratory v1.0 Genotyping qPCR Kit3 refs ChainFor™ Respiratory v2.0 Genotyping qPCR Kit3 refs ChainFor™ Respiratory v3.0 Genotyping qPCR Kit3 refs ChainFor™ Respiratory v5.0 Genotyping qPCR Kit3 refs ChainFor™ Respiratory ID-7 Genotyping qPCR Kit3 refs ChainFor™ SARS-CoV-2/FLU/RSV Genotyping qPCR Kit3 refs ChainFor™ Sepsis v1.0 Genotyping qPCR Kit3 refs ChainFor™ Sepsis v2.0 Genotyping qPCR Kit3 refs ChainFor™ STI ID-12 Genotyping qPCR Kit3 refs ChainFor™ UTI v1.0 Genotyping qPCR Kit3 refs ChainFor™ UTI ID-27 Genotyping qPCR Kit3 refs ChainFor™ Vaginosis v1.0 Genotyping qPCR Kit2 refs ChainFor™ Vaginosis ID-20 Genotyping qPCR Kit2 refs ChainFor™ Women’s Health v1.0 Genotyping qPCR Kit3 refs 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 refs 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 refs 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 refs PCPO07-01 PCPO27-01 PCPO28-01 PCPO29-01 PCPO30-01 PCPO31-01 PCPO32-01 PCPO33-01 PCPO34-01 PCPO35-01 PCPO44-01 RapidFor™82 refs 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 refs RapidFor™ E.coli O157:H7 Test Kit2 refs 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 refs RapidFor™ Influenza A H5 Test Kit2 refs 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 refs98/79 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 refs 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 refs RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + RhV + hMPV Test Kit3 refs RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV Test Kit5 refs RapidFor™ SARS-CoV-2 + FLU A/B + RSV + MP + HPIV Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + RSV + hMPV Test Kit2 refs RapidFor™ SARS-CoV-2 + FLU A/B + RSV Test Kit3 refs RapidFor™ SARS-CoV-2 + FLU A/B Test Kit6 refs RapidFor™ SARS-CoV-2 + RSV + ADV Test Kit3 refs RapidFor™ SARS-CoV-2 + RSV Test Kit2 refs RapidFor™ SARS-CoV-2 Test Kit2 refs 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	Website info@vitrosens.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	2019-CoV IgG/IgM Rapid Test Cassette2 refs98/79 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 Adenovirus Antigen Rapid Test Cassette IAD-50298/79 577 others 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 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 refs98/79 Bordetella pertussis Antigen Control SCBP-S98/79 Brucella Abortus Antigen Rapid Test Cassette2 refs98/79 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 refs 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 refs98/79 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 refs98/79 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 refs98/79 COVID-19 Antigen Test Cassette(Swab)2 refs98/79 COVID-19 IgG Control98/79 COVID-19 IgG Rapid Test3 refs98/79 COVID-19 IgG/IgM Rapid Test4 refs98/79 COVID-19 IgG/IgM Rapid Test Dipstick2 refs98/79 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 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 refs 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 refs Dengue IgG/IgM Test Cassette FI-DEN-40298/79 Dengue NS1 and Zika NS1 Combo Rapid Test98/79 Dengue NS1 Rapid Test3 refs Dengue NS1 Rapid Test Cassette2 refs98/79 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 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 refs98/79 EV71 IgM Rapid Test Cassette98/79 Family Health Self Test Helicobacter Pylori IHP-N602H-013 refs 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 Gesunder Magen2 refs98/79 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 refs98/79 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 refs 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 refs 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 refs98/79 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 refs98/79 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 refs98/79 HSV 1/2 IgG/IgM Combo Rapid Test98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette4 refs98/79 HSV 1/2 IgG/IgM Rapid Test Cassette3 refs98/79 HSV 1/2 IgM Rapid Test Cassette3 refs98/79 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 refs 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 refs98/79 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 Legionella pneumophila Control3 refs98/79 Legionella pneumophila Rapid Test3 refs 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 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 refs 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 refs 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 refs98/79 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 refs 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 refs98/79 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 refs98/79 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 refs 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 refs98/79 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 refs98/79 SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva)2 refs98/79 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 refs98/79 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 refs98/79 SARS-CoV-2 Antigen Rapid Test4 refs98/79 SARS-CoV-2 Antigen Rapid Test (Swab)98/79 SARS-CoV-2 Neutralization Antibody Rapid Test2 refs98/79 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 refs98/79 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 refs 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 refs98/79 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 refs Strep A Rapid Test ISTB-N501-253 refs 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 refs98/79 Streptococcus pneumoniae Antigen Rapid Test Cassette with LF READER ATR-001,10 T/kit98/79 Streptococcus Pneumoniae Antigen Test Cassette98/79 Streptococcus pneumoniae Control2 refs98/79 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 refs98/79 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 refs 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 refs98/79 Toxo IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 TPHA Reagents3 refs98/79 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 refs98/79 Typhoid Rapid Test Cassette (Serum/Plasma)2 refs98/79 Typhoid Rapid Test Dipstick98/79 Typhoid Test Cassette98/79 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 refs98/79 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 refs98/79 Zika NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 ZuhauseTEST Gesunder Magen2 refs98/79	B, C IVDR, 98/79	info@alltests.com.cn EUDAMED record Report an error
Cell Marque EU representative : Emergo Europe B.V. (Netherlands)	United States	<p>Somatostatin Receptor 2A (EP149) Rabbit Monoclonal Primary Antibody</p> 486R-1X series5 refs98/79 A-1-Antitrypsin Rabbit Polyclonal Antibody98/79 A-1-Antitrypsin Rabbit Polyclonal Antibody 223A-1X series5 refs98/79 ACTH Rabbit Polyclonal Antibody98/79 ACTH Rabbit Polyclonal Antibody 206A-7X series5 refs98/79 430 others Actin, Muscle Specific (HHF35) Mouse Monoclonal Antibody Actin, Muscle Specific (HHF35) Mouse Monoclonal Antibody 201M-9X series6 refs98/79 Actin, Smooth Muscle (1A4) Mouse Monoclonal Antibody Actin, Smooth Muscle (1A4) Mouse Monoclonal Antibody 202M-9X series3 refs Adenovirus (2/6 & 20/11) Mouse Monoclonal Primary Antibody98/79 Adenovirus (20/11 & 2/6) Mouse Monoclonal Antibody 212M-1X series5 refs98/79 Adipophilin Rabbit Polyclonal Antibody 393A-1X series3 refs ALK Protein (ALK-1) Mouse Monoclonal Antibody 204M-1X series5 refs98/79 Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary Antibody 203R-1X series5 refs98/79 Alpha-Fetoprotein Rabbit Polyclonal Antibody Androgen Receptor (SP107) Rabbit Monoclonal Antibody 200R-1X series3 refs Annexin A1 (MRQ-3) Mouse Monoclonal Antibody 221M-1X series5 refs98/79 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 refs ARID1A (EP303) Rabbit Monoclonal Primary Antibody 407R-1X series5 refs98/79 ATRX Rabbit Polyclonal Antibody ATRX Rabbit Polyclonal Antibody 485A-1X series3 refs BCA-225 (Cu-18) Mouse Monoclonal Antibody 225M-1X series5 refs98/79 BCL-6 (GI191E/A8) Mouse Monoclonal Antibody BCL2 (124) Mouse Monoclonal Antibody 226M-9X series3 refs BCL2 (E17) Rabbit Monoclonal Primary Antibody 226R-1X series3 refs BCL6 (GI191E/A8) Mouse Monoclonal Antibody 227M-9X series3 refs Beta-Catenin (14) Mouse Monoclonal Antibody Beta-Catenin (14) Mouse Monoclonal Antibody 224M-1X series3 refs BG8, Lewis<sup>Y</sup> (F3) Mouse Monoclonal Antibody 228M-1X series5 refs98/79 BOB.1 (SP92) Rabbit Monoclonal Antibody98/79 BOB.1 (SP92) Rabbit Monoclonal Antibody 294R-1X series5 refs98/79 c-Myc (EP121) Rabbit Monoclonal Primary Antibody 395R-1X series3 refs C3d Rabbit Polyclonal Antibody98/79 C3d Rabbit Polyclonal Antibody 403A-7X series5 refs98/79 C4d (SP91) Rabbit Monoclonal Antibody 404R-1X series3 refs CA-125 (OC125) Mouse Monoclonal Antibody CA-125 (OC125) Mouse Monoclonal Antibody 325M-1X series5 refs98/79 CA19-9 (121SLE) Mouse Monoclonal Antibody CA19-9 (121SLE) Mouse Monoclonal Antibody 399M-1X series3 refs Cadherin-17 (SP183) Rabbit Monoclonal Antibody 378R-1X series5 refs98/79 Calcitonin (SP17) Rabbit Monoclonal Antibody 229R-1X series5 refs98/79 Caldesmon (E89) Rabbit Monoclonal Antibody Caldesmon (E89) Rabbit Monoclonal Primary Antibody 230R-1X series3 refs Calponin (CALP) Mouse Monoclonal Antibody 231M-1X series5 refs98/79 Calponin-1 (EP798Y) Rabbit Monoclonal Antibody Calponin-1 (EP798Y) Rabbit Monoclonal Primary Antibody 231R-1X series3 refs Calretinin (SP13) Rabbit Monoclonal Antibody 232R-1X series3 refs Carbonic Anhydrase IX (CA IX) (EP161) Rabbit Monoclonal Primary Antibody 379R-1X series3 refs Carbonic Anhydrase IX (EP161) Rabbit Monoclonal Primary Antibody Cathepsin K (3F9) Mouse Monoclonal Antibody 402M-1X series5 refs98/79 CD10 (56C6) Mouse Monoclonal Antibody 110M-1X series3 refs CD103 (EP206) Rabbit Monoclonal Primary Antibody 437R-1X series5 refs98/79 CD117, c-kit (YR145) Rabbit Monoclonal Primary Antibody 117R-1X series3 refs CD11c (5D11) Mouse Monoclonal Antibody 111M-1X series5 refs98/79 CD123 (6H6) Mouse Monoclonal Antibody 198M-1X series5 refs98/79 CD13 (SP187) Rabbit Monoclonal Antibody 113R-1X series5 refs98/79 CD138 (EP201) Rabbit Monoclonal Primary Antibody 138R-2X series5 refs98/79 CD138/syndecan-1 (B-A38) Mouse Monoclonal Antibody CD138/syndecan-1 (B-A38) Mouse Monoclonal Antibody 138M-1X series3 refs CD14 (EPR3653) Rabbit Monoclonal Primary Antibody 114R-1X series3 refs CD15 (MMA) Mouse Monoclonal Antibody 115M-1X series5 refs98/79 CD16 (SP175) Rabbit Monoclonal Antibody 116R-1X series5 refs98/79 CD16 (SP175) Rabbit Monoclonal Primary Antibody CD163 (MRQ-26) Mouse Monoclonal Antibody CD163 (MRQ-26) Mouse Monoclonal Antibody 163M-1X series3 refs CD19 (MRQ-36) Mouse Monoclonal Antibody 119M-1X series5 refs98/79 CD1a (EP3622) Rabbit Monoclonal Antibody CD1a (EP3622) Rabbit Monoclonal Primary Antibody 101R-1X series3 refs CD2 (MRQ-11) Mouse Monoclonal Antibody CD2 (MRQ-11) Mouse Monoclonal Antibody 102M-1X series5 refs98/79 CD20 (L26) Mouse Monoclonal Antibody 120M-8X series6 refs98/79 CD21 (2G9) Mouse Monoclonal Antibody CD21 (2G9) Mouse Monoclonal Antibody 121M-1X series3 refs CD21 (EP3093) Rabbit Monoclonal Antibody CD21 (EP3093) Rabbit Monoclonal Primary Antibody 121R-1X series3 refs CD23 (1B12) Mouse Monoclonal Antibody 123M-1X series5 refs98/79 CD25 (4C9) Mouse Monoclonal Antibody98/79 CD25 (4C9) Mouse Monoclonal Antibody 125M-1X series5 refs98/79 CD3 (MRQ-39) Rabbit Monoclonal Antibody 103R-9X series5 refs98/79 CD30 (Ber-H2) Mouse Monoclonal Antibody 130M-9X series5 refs98/79 CD31 (JC70) Mouse Monoclonal Antibody CD31 (JC70) Mouse Monoclonal Antibody 131M-9X series3 refs CD33 (PWS44) Mouse Monoclonal Antibody 133M-1X series5 refs98/79 CD33 (SP266) Rabbit Monoclonal Primary Antibody98/79 CD34 (QBEnd/10) Mouse Monoclonal Antibody98/79 CD34 (QBEnd/10) Mouse Monoclonal Antibody 134M-1X series3 refs CD35 (EP197) Rabbit Monoclonal Primary Antibody 135R-1X series5 refs98/79 CD38 (SP149) Rabbit Monoclonal Antibody 118R-1X series3 refs CD4 (EP204) Rabbit Monoclonal Primary Antibody 104R-2X series5 refs98/79 CD4 (SP35) Rabbit Monoclonal Antibody 104R-1X series3 refs CD43 (MT1) Mouse Monoclonal Antibody 143M-1X series5 refs98/79 CD44 (MRQ-13) Mouse Monoclonal Antibody 144M-9X series5 refs98/79 CD45 (LCA) (2B11 & PD7/26) Mouse Monoclonal Antibody CD45 (LCA) (2B11 & PD7/26) Mouse Monoclonal Antibody 145M-9X series3 refs CD45RO (UCHL-1) Mouse Monoclonal Antibody 147M-9X series5 refs98/79 CD5 (4C7) Mouse Monoclonal Antibody 205M-1X series5 refs98/79 CD5 (SP19) Rabbit Monoclonal Antibody 205R-1X series5 refs98/79 CD56 (123C3.D5) Mouse Monoclonal Antibody 156M-8X series5 refs98/79 CD56 (MRQ-42) Rabbit Monoclonal Antibody CD56 (MRQ-42) Rabbit Monoclonal Antibody 156R-9X series3 refs CD57 (NK-1) Mouse Monoclonal Antibody98/79 CD57 (NK-1) Mouse Monoclonal Antibody 157M-9X series5 refs98/79 CD61 (2F2) Mouse Monoclonal Antibody CD61 (2f2) Mouse Monoclonal Antibody 161M-1X series3 refs CD63 (NKI/C3) Mouse Monoclonal Antibody 263M-1X series5 refs98/79 CD68 (Kp-1) Mouse Monoclonal Antibody 168M-9X series5 refs98/79 CD7 (MRQ-56) Mouse Monoclonal Antibody 107M-2X series5 refs98/79 CD71 (MRQ-48) Mouse Monoclonal Antibody CD71 (MRQ-48) Mouse Monoclonal Antibody 171M-9X series3 refs CD79a (JCB117) Mouse Monoclonal Antibody 179M-9X series5 refs98/79 CD8 (C8/144B) Mouse Monoclonal Antibody 108M-9X series5 refs98/79 CD99 (EPR3097Y) Rabbit Monoclonal Primary Antibody 199R-1X series5 refs98/79 CDK4 (DCS-31) Mouse Monoclonal Antibody 478M-9X series3 refs CDX-2 (EPR2764Y) Rabbit Monoclonal Antibody CDX-2 (EPR2764Y) Rabbit Monoclonal Primary Antibody 235R-1X series3 refs CEA (CEA31) Mouse Monoclonal Antibody CEA (CEA31) Mouse Monoclonal Antibody 236M-9X series3 refs CEA Rabbit Polyclonal Antibody 236A-1X series3 refs Chromogranin A (LK2H10) Mouse Monoclonal Antibody 238M-9X series3 refs CITED1 (5H6) Mouse Monoclonal Antibody 424M-1X series5 refs98/79 Claudin 1 Rabbit Polyclonal Antibody 359A-1X series5 refs98/79 Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody 468R-1X series3 refs CMV (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Antibody 213M-2X series3 refs CMV (DDG9/CCH2) Mouse Monoclonal Antibody 213M-1X series3 refs Collagen Type IV (CIV22) Mouse Monoclonal Antibody 239M-1X series5 refs98/79 COX-2 (SP21) Rabbit Monoclonal Antibody 240R-1X series5 refs98/79 Cyclin D1 (SP4) Rabbit Monoclonal Antibody 241R-1X series3 refs Cytokeratin (34betaE12) Mouse Monoclonal Antibody 334M-8X series6 refs98/79 Cytokeratin (35betaH11) Mouse Monoclonal Antibody98/79 Cytokeratin (35betaH11) Mouse Monoclonal Antibody 335M-9X series5 refs98/79 Cytokeratin (CAM 5.2) Mouse Monoclonal Antibody 452M-9X series3 refs Cytokeratin (OSCAR) Mouse Monoclonal Antibody Cytokeratin (OSCAR) Mouse Monoclonal Antibody 300M-1X series3 refs Cytokeratin 14 (LL002) Mouse Monoclonal Antibody 314M-1X series5 refs98/79 Cytokeratin 17 (EP98) Rabbit Monoclonal Primary Antibody 317R-1X series5 refs98/79 Cytokeratin 19 (A53-B/A2.26) Mouse Monoclonal Antibody Cytokeratin 19 (A53-B/A2.26) Mouse Monoclonal Antibody 319M-1X series3 refs Cytokeratin 19 (EP72) Rabbit Monoclonal Primary Antibody 319R-2X series5 refs98/79 Cytokeratin 20 (Ks20.8) Mouse Monoclonal Antibody 320M-1X series3 refs Cytokeratin 5 & 6 (D5 & 16B4) Mouse Monoclonal Antibody 356M-1X series3 refs Cytokeratin 5 & 6 (D5/16B4) + TTF-1 (8G7G3/1) Mouse Monoclonal Antibody 902H-0X series2 refs98/79 Cytokeratin 5 & 6 (EP24 & EP67) Rabbit Monoclonal Primary Antibody 356R-1X series5 refs98/79 Cytokeratin 5 (EP1601Y) + Cytokeratin 14 (LL002) Mouse/Rabbit Monoclonal Antibodies 905H-0X series2 refs98/79 Cytokeratin 5 (EP1601Y) Rabbit Monoclonal Primary Antibody 305R-1X series5 refs98/79 Cytokeratin 5 (SP27) Rabbit Monoclonal Primary Antibody Cytokeratin 7 (OV-TL 12/30) Mouse Monoclonal Antibody 307M-9X series3 refs Cytokeratin 8 & 18 (B22.1 & B23.1) Mouse Monoclonal Antibody Cytokeratin 8 & 18 (B22.1 & B23.1) Mouse Monoclonal Antibody 818M-9X series3 refs Cytokeratin Cocktail (AE1 & AE3) Mouse Monoclonal Antibody 313M-1X series3 refs Cytokeratin, HMW (AE3) Mouse Monoclonal Antibody 303M-1X series5 refs98/79 Cytokeratin, LMW (AE1) Mouse Monoclonal Antibody 301M-1X series5 refs98/79 DAB Substrate Kit 957D-X series3 refs Desmin (D33) Mouse Monoclonal Antibody 243M-1X series5 refs98/79 DOG1 (SP31) Rabbit Monoclonal Antibody 244R-1X series3 refs DOG1 (SP31) Rabbit Monoclonal Primary Antibody E-Cadherin (EP700Y) Rabbit Monoclonal Antibody E-cadherin (EP700Y) Rabbit Monoclonal Primary Antibody 246R-1X series3 refs EGFR (EP22) Rabbit Monoclonal Primary Antibody 414R-2X series5 refs98/79 EGFR (SP84) Rabbit Monoclonal Antibody 414R-1X series5 refs98/79 EMA (E29) Mouse Monoclonal Antibody 247M-9X series6 refs98/79 Ep-CAM/Epithelial Specific Antigen (BER-EP4) 248M-9X series3 refs Ep-CAM/Epithelial Specific Antigen (BER-EP4) Mouse Monoclonal Antibody Ep-CAM/Epithelial Specific Antigen (MOC-31) Mouse Monoclonal Antibody 248M-1X series3 refs Epstein Barr Virus (CS1-4) Mouse Monoclonal Antibody98/79 Epstein-Barr Virus (CS1-4) Mouse Monoclonal Antibody 245M-1X series5 refs98/79 ERG (EP111) Rabbit Monoclonal Primary Antibody 434R-1X series6 refs98/79 Estrogen Receptor (EP1) Rabbit Monoclonal Primary Antibody 249R-2X series6 refs98/79 Estrogen Receptor (SP1) Rabbit Monoclonal Antibody 249R-1X series5 refs98/79 EZH2 (11) Mouse Monoclonal Antibody 415M-1X series5 refs98/79 Factor VIII-R Ag. Rabbit Polyclonal Antibody98/79 Factor VIII-R Ag. Rabbit Polyclonal Antibody 250A-1X series5 refs98/79 Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody 251M-1X series3 refs Factor XIIIa (EP3372) Rabbit Monoclonal Antibody Factor XIIIa (EP3372) Rabbit Monoclonal Primary Antibody 251R-1X series3 refs FLI-1 (MRQ-1) Mouse Monoclonal Antibody 254M-1X series5 refs98/79 FOXA1 (2F83) Mouse Monoclonal Antibody 405M-1X series5 refs98/79 FoxP1 (SP133) Rabbit Monoclonal Antibody 350R-1X series5 refs98/79 FSH (EP257) Rabbit Monoclonal Primary Antibody 207R-1X series5 refs98/79 FSH Rabbit Polyclonal Antibody98/79 Galectin-3 (9C4) Mouse Monoclonal Antibody98/79 Galectin-3 (9C4) Mouse Monoclonal Antibody 255M-1X series5 refs98/79 Gastrin Rabbit Polyclonal Antibody Gastrin Rabbit Polyclonal Antibody 256A-1X series5 refs98/79 GATA3 (L50-823) Mouse Monoclonal Antibody 390M-1X series3 refs GATA3 (L50-823) Mouse Monoclonal Primary Antibody GCDFP-15 (23A3) + Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal Antibodies 906H-0X series2 refs98/79 GCDFP-15 (23A3) Mouse Monoclonal Antibody 257M-1X series6 refs98/79 GCDFP-15 (EP1582Y) Rabbit Monoclonal Antibody GH (EP267) Rabbit Monoclonal Primary Antibody 208R-1X series5 refs98/79 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 refs Glucagon (EP74) Rabbit Monoclonal Primary Antibody 259R-1X series5 refs98/79 GLUT1 Rabbit Polyclonal Antibody98/79 GLUT1 Rabbit Polyclonal Antibody 355A-1X series5 refs98/79 GLUT3 Rabbit Polyclonal Antibody 413A-1X series5 refs98/79 Glutamine Synthetase (GS-6) Mouse Monoclonal Antibody 389M-1X series3 refs 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 refs98/79 Glypican-3 (1G12) Mouse Monoclonal Antibody Glypican-3 (1G12) Mouse Monoclonal Antibody 261M-9X series3 refs Granzyme B (EP230) Rabbit Monoclonal Primary Antibody 262R-1X series5 refs98/79 Granzyme B Rabbit Polyclonal Antibody98/79 h-Caldesmon (hHCD) Mouse Monoclonal Antibody 451M-1X series5 refs98/79 HBME-1 (HBME-1) Mouse Monoclonal Antibody 283M-1X series3 refs hCG Rabbit Polyclonal Antibody98/79 hCG Rabbit Polyclonal Antibody 234A-1X series5 refs98/79 Heat Shock Protein 70 (EP377) Rabbit Monoclonal Primary Antibody 460R-1X series5 refs98/79 Helicobacter pylori Rabbit Polyclonal Antibody 215A-7X series3 refs Hemoglobin A (EPR3608) Rabbit Monoclonal Primary Antibody 360R-1X series5 refs98/79 Hemoglobin A (SP212) Rabbit Monoclonal Primary Antibody98/79 Hepatocyte Specific Antigen (Hep Par-1) (OCH1E5) Mouse Monoclonal Antibody 264M-9X series3 refs Hepatocyte Specific Antigen (OCH1E5) Mouse Monoclonal Antibody Her2/Neu (EP3) Rabbit Monoclonal Primary Antibody 237R-2X series6 refs98/79 Her2/Neu (SP3) Rabbit Monoclonal Antibody 237R-1X series5 refs98/79 Herpes Simplex Virus 1 (10A3) Mouse Monoclonal Primary Antibody Herpes Simplex Virus I (10A3) Mouse Monoclonal Antibody 361M-1X series3 refs Herpes Simplex Virus I Rabbit Polyclonal Antibody 361A-1X series3 refs Herpes Simplex Virus II (3C5.2) Mouse Monoclonal Antibody 362M-1X series3 refs HGAL (MRQ-49) Mouse Monoclonal Antibody 375M-9X series5 refs98/79 HHV-8 (13B10) Mouse Monoclonal Antibody HHV-8 (13B10) Mouse Monoclonal Antibody 265M-1X series3 refs HiDef Detection Alk Phos Polymer System 962D-X Series3 refs HiDef Detection HRP Polymer System 954D-X Series3 refs HMB-45 (HMB-45) Mouse Monoclonal Antibody 282M-9X series3 refs HMB-45 + MART-1 (Melan A) + Tyrosinase (HMB-45 + A103 + T311) Mouse Monoclonal Antibody 904H-0X series3 refs98/79 Human Placental Lactogen (hPL) Rabbit Polyclonal Antibody 266A-1X series5 refs98/79 IDH1 R132H (MRQ-67) Rabbit Monoclonal Antibody IDH1 R132H (MRQ-67) Rabbit Monoclonal Antibody 456R-3X series3 refs IgA (EP170) Rabbit Monoclonal Primary Antibody 267R-1X series5 refs98/79 IgD (EP173) Rabbit Monoclonal Primary Antibody 268R-1X series5 refs98/79 IgD Rabbit Polyclonal Antibody98/79 IgG Rabbit Polyclonal Antibody98/79 IgG Rabbit Polyclonal Antibody 269A-1X series5 refs98/79 IgG4 (MRQ-44) Mouse Monoclonal Antibody 367M-1X series3 refs IgM Rabbit Polyclonal Antibody98/79 IgM Rabbit Polyclonal Antibody 270A-1X series5 refs98/79 IMP3 (EP286) Rabbit Monoclonal Primary Antibody 433R-1X series5 refs98/79 Inhibin, alpha (MRQ-63) Rabbit Monoclonal Antibody 271R-2X series5 refs98/79 Inhibin, alpha (MRQ-63) Rabbit Monoclonal Primary Antibody INI-1 (MRQ-27) Mouse Monoclonal Antibody 272M-1X series3 refs INSM1 (MRQ-70) Rabbit Monoclonal Antibody 475R-9X series3 refs Islet-1 (EP283) Rabbit Monoclonal Primary Antibody 431R-1X series5 refs98/79 Kappa (L1C1) Mouse Monoclonal Antibody 274M-9X series6 refs98/79 KBA.62 (KBA.62) Mouse Monoclonal Antibody 366M-9X series5 refs98/79 Ki-67 (MRQ-64) Rabbit Monoclonal Antibody 275R-3X series6 refs98/79 Ki-67 (SP6) Rabbit Monoclonal Antibody 275R-1X series3 refs Lambda (Lamb14) Mouse Monoclonal Antibody 277M-9X series6 refs98/79 Langerin (12D6) Mouse Monoclonal Antibody 392M-1X series5 refs98/79 LEF1 (EP310) Rabbit Monoclonal Primary Antibody 442R-1X series3 refs LH Rabbit Polyclonal Antibody98/79 LH Rabbit Polyclonal Antibody 209A-1X series5 refs98/79 LMO2 (SP51) Rabbit Monoclonal Antibody 370R-1X series5 refs98/79 Lysozyme Rabbit Polyclonal Antibody98/79 Lysozyme Rabbit Polyclonal Antibody 278A-1X series5 refs98/79 MAGEC2 (EP405) Rabbit Monoclonal Primary Antibody 477R-1X series5 refs98/79 Mammaglobin (31A5) Rabbit Monoclonal Antibody Mammaglobin (31A5) Rabbit Monoclonal Antibody 280R-1X series3 refs Mammaglobin Cocktail (304-1A5 & 31A5) Mouse & Rabbit Cocktail Antibody 280C-1X series5 refs98/79 MART-1 (M2-7C10) + Tyrosinase (T311) Mouse Monoclonal Antibody 903H-0X series2 refs98/79 MART-1 (Melan A) (A103) Mouse Monoclonal Antibody 281M-8X series3 refs MART-1 (Melan A) (M2-7C10) Mouse Monoclonal Antibody 281M-9X series3 refs MDM2 (IF2) Mouse Monoclonal Antibody 479M-9X series3 refs Mesothelial Cell (HBME-1) Mouse Monoclonal Antibody Mesothelin (EP140) Rabbit Monoclonal Primary Antibody 439R-1X series5 refs98/79 Microphthalmia Transcription Factor (MiTF) (C5/D5) Mouse Monoclonal Antibody 284M-9X series3 refs MLH1 (G168-728) Mouse Monoclonal Antibody 285M-1X series6 refs98/79 MLH1 (M1) Mouse Monoclonal Antibody 285M-2X series6 refs98/79 MSH2 (G219-1129) Mouse Monoclonal Antibody 286M-1X series6 refs98/79 MSH6 (44) Mouse Monoclonal Antibody 287M-1X series6 refs98/79 MSH6 (SP93) Rabbit Monoclonal Antibody 287R-2X series5 refs98/79 MUC1 (MRQ-17) Mouse Monoclonal Antibody 290M-1X series5 refs98/79 MUC2 (MRQ-18) Mouse Monoclonal Antibody MUC2 (MRQ-18) Mouse Monoclonal Antibody 291M-1X series3 refs MUC4 (8G7) Mouse Monoclonal Antibody 406M-1X series3 refs MUC5AC (MRQ-19) Mouse Monoclonal Antibody98/79 MUC5AC (MRQ-19) Mouse Monoclonal Antibody 292M-9X series5 refs98/79 MUC6 (MRQ-20) Mouse Monoclonal Antibody MUC6 (MRQ-20) Mouse Monoclonal Antibody 293M-9X series5 refs98/79 MUM1 (EP190) Rabbit Monoclonal Primary Antibody MUM1 (EP190) Rabbit Monoclonal Primary Antibody 358R-1X series3 refs MUM1 (MRQ-8) Mouse Monoclonal Antibody 358M-1X series3 refs Myeloperoxidase (SP72) Rabbit Monoclonal Antibody 289R-1X series5 refs98/79 Myeloperoxidase Rabbit Polyclonal Antibody MyoD1 (EP212) Rabbit Monoclonal Primary Antibody MyoD1 (EP212) Rabbit Monoclonal Primary Antibody 386R-1X series3 refs Myogenin (F5D) Mouse Monoclonal Antibody Myogenin (F5D) Mouse Monoclonal Antibody 296M-1X series3 refs Myoglobin Rabbit Polyclonal Antibody 297A-7X series5 refs98/79 Myosin, Smooth Muscle (SMMS-1) Mouse Monoclonal Antibody Myosin, Smooth Muscle (SMMS-1) Mouse Monoclonal Antibody 298M-1X series3 refs Napsin A (MRQ-60) Mouse Monoclonal Antibody 352M-9X series3 refs Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody Napsin A Rabbit Polyclonal Antibody 352A-7X series3 refs Nerve Growth Factor Receptor (NGFR) (MRQ-21) Mouse Monoclonal Antibody 304M-1X series5 refs98/79 Nestin (10C2) Mouse Monoclonal Antibody 388M-1X series5 refs98/79 Neurofilament (2F11) Mouse Monoclonal Antibody98/79 Neurofilament (2F11) Mouse Monoclonal Antibody 302M-1X series5 refs98/79 NGFR (Nerve Growth Factor Receptor) (MRQ-21) Mouse Monoclonal Antibody NKX2.2 (EP336) Rabbit Monoclonal Primary Antibody 445R-1X series5 refs98/79 NKX3.1 (EP356) Rabbit Monoclonal Primary Antibody NKX3.1 (EP356) Rabbit Monoclonal Primary Antibody 441R-1X series3 refs NSE (MRQ-55) Mouse Monoclonal Antibody 306M-2X series5 refs98/79 Oct-2 (MRQ-2) Mouse Monoclonal Antibody Oct-2 (MRQ-2) Mouse Monoclonal Antibody 308M-1X series3 refs Oct-4 (MRQ-10) Mouse Monoclonal Antibody Oct-4 (MRQ-10) Mouse Monoclonal Antibody 309M-1X series3 refs Olig2 (211F1.1) Mouse Monoclonal Antibody 387M-1X series5 refs98/79 Olig2 (EP112) Rabbit Monoclonal Primary Antibody98/79 p120 Catenin (MRQ-5) Mouse Monoclonal Antibody 420M-1X series6 refs98/79 p16INK4A (JC2) Mouse Monoclonal Antibody 416M-1X series3 refs p21<sup>WAF1</sup> (DCS-60.2) Mouse Monoclonal Antibody 421M-1X series5 refs98/79 p27<sup>Kip1</sup> (SX53G8) Mouse Monoclonal Antibody 427M-9X series5 refs98/79 p40 (ZR8) Rabbit Monoclonal Antibody 483R-1X series6 refs98/79 P504s (13H4) Rabbit Monoclonal Antibody 504R-1X series3 refs p53 (DO7) Mouse Monoclonal Antibody 453M-9X series5 refs98/79 p57Kip2 (Kp10) Mouse Monoclonal Antibody 457M-9X series3 refs p63 (EP174) Rabbit Monoclonal Primary Antibody 482R-1X series6 refs98/79 Parathyroid Hormone (PTH) (MRQ-31) Mouse Monoclonal Antibody Parathyroid Hormone (PTH) (MRQ-31) Mouse Monoclonal Antibody 310M-2X series3 refs Parvovirus B19 (R92F6) Mouse Monoclonal Antibody 218M-1X series5 refs98/79 PAX-2 (EP235) Rabbit Monoclonal Primary Antibody 311R-1X series5 refs98/79 PAX-5 (24) Mouse Monoclonal Antibody 312M-1X series5 refs98/79 PAX-5 (SP34) Rabbit Monoclonal Antibody 312R-1X series5 refs98/79 PAX-7 (MRQ-69) Mouse Monoclonal Antibody 481M-9X series5 refs98/79 PAX-8 (EP331) Rabbit Monoclonal Primary Antibody PAX-8 (MRQ-50) Mouse Monoclonal Antibody 363M-1X series3 refs PAX-8 (SP348) Rabbit Monoclonal Antibody 363R-3X series3 refs PAX-8 Rabbit Polyclonal Antibody 363A-1X series3 refs PD-1 (NAT105) Mouse Monoclonal Antibody PD-1 (NAT105) Mouse Monoclonal Antibody 315M-9X series3 refs PD-L1 (28-8) Rabbit Monoclonal Primary Antibody 438R-1X series5 refs98/79 PD-L1 (ZR3) Rabbit Monoclonal Antibody 438R-2X series5 refs98/79 Perforin (MRQ-23) Mouse Monoclonal Antibody 316M-1X series5 refs98/79 Peripherin (8G2) Mouse Monoclonal Antibody 476M-1X series5 refs98/79 Permanent Red Chromogen Kit 960D-X series2 refs PGP 9.5 Rabbit Polyclonal Antibody PGP 9.5 Rabbit Polyclonal Antibody 318A-1X series3 refs Phosphohistone H3 (PHH3) Rabbit Polyclonal Antibody 369A-1X series3 refs Phosphohistone H3 Rabbit Polyclonal Antibody PHOX2B (EP312) Rabbit Monoclonal Primary Antibody 422R-1X series5 refs98/79 PLAP (NB10) Mouse Monoclonal Antibody PLAP (NB10) Mouse Monoclonal Antibody 321M-1X series5 refs98/79 PMS2 (EPR3947) Rabbit Monoclonal Primary Antibody 288R-1X series3 refs98/79 PMS2 (MRQ-28) Mouse Monoclonal Antibody 288M-1X series5 refs98/79 Pneumocystis jiroveci (carinii) (3F6) Mouse Monoclonal Antibody 219M-1X series5 refs98/79 PNL2 (PNL2) Mouse Monoclonal Antibody 365M-9X series5 refs98/79 Podoplanin (D2-40) Mouse Monoclonal Antibody Podoplanin (D2-40) Mouse Monoclonal Antibody 322M-1X series3 refs PRAME (EP461) Rabbit Monoclonal Primary Antibody 484R-1X series3 refs Progesterone Receptor (SP42) Rabbit Monoclonal Antibody 323R-3X series5 refs98/79 Progesterone Receptor (Y85) Rabbit Monoclonal Primary Antibody 323R-1X series6 refs98/79 Prolactin (EP193) Rabbit Monoclonal Primary Antibody 210R-1X series5 refs98/79 Prolactin Rabbit Polyclonal Antibody98/79 Prolactin Rabbit Polyclonal Antibody 210A-1X series5 refs98/79 Prostein (EP381) Rabbit Monoclonal Primary Antibody 450R-1X series5 refs98/79 PSAP (PASE/4LJ) Mouse Monoclonal Antibody98/79 PSAP (PASE/4LJ) Mouse Monoclonal Antibody 326M-1X series5 refs98/79 PSMA (EP192) Rabbit Monoclonal Primary Antibody98/79 PSMA (EP192) Rabbit Monoclonal Primary Antibody 327R-1X series5 refs98/79 PU.1 (EPR3158Y) Rabbit Monoclonal Primary Antibody 328R-1X series5 refs98/79 Renal Cell Carcinoma (PN-15) Mouse Monoclonal Antibody Renal Cell Carcinoma (PN-15) Mouse Monoclonal Antibody 329M-9X series3 refs ROS1 (MRQ-68) Rabbit Monoclonal Antibody 469R-9X series5 refs98/79 S-100 (4C4.9) Mouse Monoclonal Antibody 330M-1X series3 refs S100 beta (EP32) Rabbit Monoclonal Primary Antibody 449R-1X series5 refs98/79 S100A1 (EP184) Rabbit Monoclonal Primary Antibody 408R-1X series5 refs98/79 S100P (16/f5) Mouse Monoclonal Antibody 376M-9X series5 refs98/79 SALL4 (6E3) Mouse Monoclonal Antibody 385M-1X series3 refs SALL4 (6E3) Mouse Monoclonal Primary Antibody SATB2 (EP281) Rabbit Monoclonal Primary Antibody SATB2 (EP281) Rabbit Monoclonal Primary Antibody 384R-1X series3 refs SDHB (EP288) Rabbit Monoclonal Primary Antibody 466R-1X series5 refs98/79 SF-1 (EP434) Rabbit Monoclonal Primary Antibody SF-1 (EP434) Rabbit Monoclonal Primary Antibody 462R-1X series3 refs SMAD4 (MRQ-72) Rabbit Monoclonal Antibody 487R-9X series5 refs98/79 Smoothelin (R4A) Mouse Monoclonal Antibody 377M-1X series5 refs98/79 Somatostatin (EP130) Rabbit Monoclonal Primary Antibody 332R-1X series5 refs98/79 SOX-10 (EP268) Rabbit Monoclonal Primary Antibody 383R-1X series3 refs SOX-10 (SP267) Rabbit Monoclonal Primary Antibody SOX-11 (MRQ-58) Mouse Monoclonal Antibody 382M-1X series3 refs SOX-11 (MRQ-58) Mouse Monoclonal Primary Antibody SOX-2 (SP76) Rabbit Monoclonal Antibody 371R-1X series6 refs98/79 Spectrin (RBC2/3D5) Mouse Monoclonal Antibody 333M-1X series5 refs98/79 STAT6 (EP325) Rabbit Monoclonal Primary Antibody 426R-1X series3 refs Stathmin (SP49) Rabbit Monoclonal Antibody 394R-1X series5 refs98/79 SV40 (MRQ-4) Mouse Monoclonal Antibody SV40 (MRQ-4) Mouse Monoclonal Antibody 351M-1X series3 refs Synaptophysin (MRQ-40) Rabbit Monoclonal Antibody 336R-9X series3 refs Synaptophysin (MRQ-40) Rabbit MonoclonalAntibody T-bet (MRQ-46) Rabbit Monoclonal Antibody 368R-7X series5 refs98/79 TAG-72 (B72.3) Mouse Monoclonal Antibody98/79 TAG-72 (B72.3) Mouse Monoclonal Antibody 337M-8X series5 refs98/79 TCL1 (MRQ-7) Mouse Monoclonal Antibody 357M-1X series5 refs98/79 TdT Rabbit Polyclonal Antibody TdT Rabbit Polyclonal Antibody 338A-7X series3 refs TFE3 (MRQ-37) Rabbit Monoclonal Antibody 354R-1X series3 refs Thrombomodulin (1009) Mouse Monoclonal Antibody 339M-1X series5 refs98/79 Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody 340M-1X series5 refs98/79 TLE1 (1F5) Mouse Monoclonal Antibody 401M-1X series3 refs Treponema pallidum Rabbit Polyclonal Antibody 397A-1X series5 refs98/79 TROP2 (EP431) Rabbit Monoclonal Primary Antibody 465R-1X series5 refs98/79 Tryptase (G3) Mouse Monoclonal Antibody98/79 Tryptase (G3) Mouse Monoclonal Antibody 342M-1X series5 refs98/79 TSH (EP254) Rabbit Monoclonal Primary Antibody 211R-1X series5 refs98/79 TSH Rabbit Polyclonal Antibody98/79 TTF-1 (8G7G3/1) Mouse Monoclonal Antibody 343M-9X series3 refs Tyrosinase (T311) Mouse Monoclonal Antibody 344M-9X series5 refs98/79 Tyrosine Hydroxylase (LNC1) Mouse Monoclonal Antibody 490M-1X series5 refs98/79 Uroplakin III (AU-1) Mouse Monoclonal Antibody 345M-1X series5 refs98/79 Uroplakin III (SP73) Rabbit Monoclonal Antibody98/79 Varicella Zoster Virus (SG1-1, SG1-SG4, NCP-1 & IE-62) Mouse Monoclonal Antibody 364M-1X series3 refs Villin (CWWB1) Mouse Monoclonal Antibody98/79 Villin (CWWB1) Mouse Monoclonal Antibody 346M-1X series5 refs98/79 Vimentin (V9) Mouse Monoclonal Antibody 347M-1X series6 refs98/79 WT1 (6F-H2) Mouse Monoclonal Antibody WT1 (6F-H2) Mouse Monoclonal Antibody 348M-9X series3 refs	A, B, C IVDR, 98/79	Website EUDAMED record Report an 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Zytomed Systems	Germany	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 others 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	Website info@zytomed-systems.de EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	United States	2019-nCoV IgG/IgM Rapid Test Cassette (Single use kit)98/79 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)2 refs98/79 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-50298/79 316 others 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 Bordetella pertussis Antigen Control98/79 Brucella Abortus Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Brucella Abortus Control2 refs98/79 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 refs98/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 COVID-19 Antigen Control2 refs98/79 COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)2 refs98/79 COVID-19 Antigen Rapid Test (Oral Fluid)2 refs98/79 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 refs98/79 COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)2 refs98/79 COVID-19 IgG/IgM Rapid Test Dipstick (Whole Blood/Serum/Plasma)2 refs98/79 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 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 refs98/79 Dengue NS1 Rapid Test Cassette (Whole Blood/ Serum/ Plasma)2 refs98/79 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 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 refs98/79 Entamoebahistolytica Rapid Test Cassette98/79 FIA Control50 refs98/79 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 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 refs98/79 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 refs98/79 HSV 1/2 IgG Rapid Test Cassette (Serum/Plasma)98/79 HSV 1/2 IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)2 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 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 Legionella pneumophila Control2 refs98/79 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 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 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Control98/79 Scrub Typhus IgG/IgM Control2 refs98/79 Shigella Rapid Test Cassette (Feces) ISH-ACO62598/79 Sickle Cell Rapid Test OSCD-ACO40298/79 Strep A Rapid Test Cassette (Throat Swab)2 refs98/79 Strep A Rapid Test Cassette ISTB-R50298/79 Strep A Rapid Test Dipstick (Throat Swab)2 refs98/79 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 refs98/79 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 refs98/79 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 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	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Zeta FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	2026-10-02 00:00:00 ZM904 refs98/79 2026-10-02 00:00:00 ZR2274 refs98/79 ACTH ZM984 refs98/79 Actin, Muscle Specific (MSA) HHF354 refs98/79 Actin, Smooth Muscle (SMA) 1A44 refs98/79 314 others Adenovirus 20.11 & 2.64 refs98/79 AFP C34 refs98/79 ALDH1A1 ZM714 refs98/79 ALK ZR3054 refs98/79 AMACR 13H44 refs98/79 AMACR+p63 13H4+ZM704 refs98/79 AMACR+p63+HMW CK (Triple cocktail) 13H4+ZM70+34βE124 refs98/79 Androgen receptor (AR) ZR3344 refs98/79 Annexin A1 ZM2114 refs98/79 Arginase-1 ZR3684 refs98/79 ATRX ZR2444 refs98/79 BCA-22598/79 BCA-225 (Cu-18)3 refs98/79 BCL-2 1244 refs98/79 BCL-2 ZR1304 refs98/79 BCL-6 ZM224 refs98/79 BCL-6 ZR3804 refs98/79 BCOR C-104 refs98/79 Beta-catenin ZM134 refs98/79 BOB1 ZM744 refs98/79 BRCA-1 MS1104 refs98/79 BRG1/SMARCA4 ZR3904 refs98/79 Bruchyury ZR3914 refs98/79 c-myc ZR3554 refs98/79 C3d ZM3694 refs98/79 C4d ZM784 refs98/79 CA IX ZR3674 refs98/79 CA125 / MUC16 ZM534 refs98/79 CA19-9 121SLE4 refs98/79 Calcitonin ZM3014 refs98/79 Caldesmon ZM794 refs98/79 Calponin-1 ZM214 refs98/79 Calponin-1 ZR2974 refs98/79 Calretinin ZM854 refs98/79 CD10 ZR3294 refs98/79 CD117 ZM3214 refs98/79 CD11c ZM1034 refs98/79 CD123 ZM804 refs98/79 CD13 ZM2874 refs98/79 CD138 ZR2514 refs98/79 CD14 ZM1044 refs98/79 CD15 MMA4 refs98/79 CD163 ZM294 refs98/79 CD19 ZM1794 refs98/79 CD19 ZR2124 refs98/79 CD1a O104 refs98/79 CD2 ZR1004 refs98/79 CD20 L264 refs98/79 CD205 ZM3604 refs98/79 CD21 ZM754 refs98/79 CD22 ZM1834 refs98/79 CD23 ZM2094 refs98/79 CD23 ZR2254 refs98/79 CD3 ZM454 refs98/79 CD30 Ber-H24 refs98/79 CD30 ZR2484 refs98/79 CD31 JC70A4 refs98/79 CD31 ZR2744 refs98/79 CD34 QBEnd-104 refs98/79 CD35 ZR584 refs98/79 CD38 ZR3514 refs98/79 CD4 ZM1804 refs98/79 CD4 ZR1104 refs98/79 CD43 DF-T14 refs98/79 CD44 ZR1844 refs98/79 CD45 (LCA) ZR3614 refs98/79 CD45RA ZR1184 refs98/79 CD45RB (LCA) 2B11/PD7-264 refs98/79 CD45RO UCHL14 refs98/79 CD5 ZM614 refs98/79 CD5 ZR2284 refs98/79 CD56 123C3.D54 refs98/79 CD57 NK-14 refs98/79 CD61 ZM334 refs98/79 CD68 KP14 refs98/79 CD68 ZR3024 refs98/79 CD7 ZM2134 refs98/79 CD71 ZM1364 refs98/79 CD79a JCB1174 refs98/79 CD79a ZR2374 refs98/79 CD8 ZM544 refs98/79 CD8 ZR2864 refs98/79 CD99 ZM1394 refs98/79 CDK4 DCS-314 refs98/79 CDX2 ZR2154 refs98/79 CEA-M CEA314 refs98/79 CEA-P (Poly)4 refs98/79 CEACAM5 ZR3704 refs98/79 Chromogranin A ZM124 refs98/79 Collagen IV ZM1774 refs98/79 Collagen IV ZR1084 refs98/79 Cyclin D1 ZM1784 refs98/79 Cyclin D1 ZR1974 refs98/79 Cyclin-E ZM1214 refs98/79 Cytokeratin 14 LL0024 refs98/79 Cytokeratin 14 ZM3724 refs98/79 Cytokeratin 17 E34 refs98/79 Cytokeratin 18 DC-104 refs98/79 Cytokeratin 18 ZM2054 refs98/79 Cytokeratin 19 BA174 refs98/79 Cytokeratin 19 ZR1434 refs98/79 Cytokeratin 20 Ks20.84 refs98/79 Cytokeratin 20 ZM424 refs98/79 Cytokeratin 5 ZM1864 refs98/79 Cytokeratin 5 ZR2804 refs98/79 Cytokeratin 5/6 D5/16B44 refs98/79 Cytokeratin 7 OV-TL-12/304 refs98/79 Cytokeratin 8 ZM1234 refs98/79 Cytokeratin 8/18 B22.1 & B23.14 refs98/79 Cytokeratin 8/18 ZM1254 refs98/79 Cytokeratin CAM 5.2* CAM5.22 refs98/79 Cytokeratin, HMW 34βE124 refs98/79 Cytokeratin, Pan AE1/AE34 refs98/79 Cytokeratin, Pan OSCAR4 refs98/79 Desmin ZM344 refs98/79 Desmin ZR2404 refs98/79 Desmoglein-3 ZR1284 refs98/79 DOG-1 DOG1.14 refs98/79 DOG-1 ZR1464 refs98/79 DPC4 (SMAD4) B-84 refs98/79 DPC4 (SMAD4) ZR3924 refs98/79 E-cadherin ZM634 refs98/79 E-cadherin ZR3754 refs98/79 EGFR ZR164 refs98/79 EMA E294 refs98/79 EMA ZR1334 refs98/79 EP-CAM / ESA MOC-314 refs98/79 EP-CAM / ESA ZR3074 refs98/79 EP-CAM Ber-EP44 refs98/79 EP-CAM ZM1314 refs98/79 ER ZM3194 refs98/79 ER ZR1474 refs98/79 ERG ZR3314 refs98/79 Erythropoietin ZM1354 refs98/79 EZH2 ZR1504 refs98/79 Factor VIII-R Ag ZM644 refs98/79 Factor XIIIa ZM844 refs98/79 Fascin ZM1924 refs98/79 FoxP1 ZR3334 refs98/79 FSH ZR2464 refs98/79 Galectin-3 ZM1824 refs98/79 Gastrin ZM3594 refs98/79 GATA-3 L50-8234 refs98/79 GATA-3 ZR3584 refs98/79 GCDFP-15 ZM234 refs98/79 GFAP GA-54 refs98/79 GFAP ZR3564 refs98/79 Glucagon EP744 refs98/79 GLUT-1 ZM1374 refs98/79 GLUT-1 ZR3084 refs98/79 Glutamine Synthetase ZM3774 refs98/79 Glypican 3 1G124 refs98/79 Glypican 3 ZM1384 refs98/79 Granzyme B ZM664 refs98/79 Growth Hormone ZM1404 refs98/79 H. Pylori Poly4 refs98/79 HBME-14 refs98/79 HCG ZR3624 refs98/79 HepPar-1 OCH1E54 refs98/79 HHV-8 LN534 refs98/79 HHV-8 ZR1064 refs98/79 HSP70 ZR1524 refs98/79 HSV I 10A34 refs98/79 IDH1 ZR74 refs98/79 IgA ZR2914 refs98/79 IgD ZR1564 refs98/79 IgG ZR2474 refs98/79 IgG4 ZM564 refs98/79 IgG4 ZR2994 refs98/79 IgM ZR2494 refs98/79 IMP-3 EP2864 refs98/79 Inhibin-α R14 refs98/79 Inhibin-α ZM1134 refs98/79 INI-1 254 refs98/79 INI-1 ZR2824 refs98/79 INSM1 A84 refs98/79 Insulin ZM83a & ZM83b4 refs98/79 Kappa ZM814 refs98/79 Ki-67 MIB-14 refs98/79 Ki-67 ZM674 refs98/79 Lambda LcN-24 refs98/79 Langerin ZR1704 refs98/79 LEF1 ZR3364 refs98/79 LH ZR1734 refs98/79 LMO2 ZR874 refs98/79 Lysozyme ZM1204 refs98/79 Mammaglobin 304-1A54 refs98/79 Mammaglobin 31-A54 refs98/79 Mammaglobin Cocktail 304-1A5+31-A54 refs98/79 Mammaglobin ZR3634 refs98/79 MDM2 SMP144 refs98/79 Melan-A (MART-1) A1034 refs98/79 Melanosome (HMB-45)4 refs98/79 Mesothelin ZM254 refs98/79 MGMT ZM3144 refs98/79 MiTF C5/D54 refs98/79 MLH-1 G168-7284 refs98/79 MLH-1 ZR3474 refs98/79 MMP-2 CA-40014 refs98/79 MSH-2 G219-11294 refs98/79 MSH-2 ZR2604 refs98/79 MSH-6 ZM994 refs98/79 MSH-6 ZR3424 refs98/79 MUC-1 ZM324 refs98/79 MUC-2 Ccp584 refs98/79 MUC-2 ZR1754 refs98/79 MUC-4 ZR2014 refs98/79 MUC-5AC ZM1484 refs98/79 MUC-5AC ZR194 refs98/79 MUC-6 ZM894 refs98/79 Myelin basic protein (MBP) ZM2024 refs98/79 Myelin basic protein (MBP) ZR1094 refs98/79 Myeloperoxidase ZM3524 refs98/79 MyoD1 ZR2624 refs98/79 Myogenin F5D4 refs98/79 Myogenin ZM1494 refs98/79 Myoglobin ZR694 refs98/79 Myosin, SMHC SMMS-14 refs98/79 Napsin A ZR2064 refs98/79 Napsin-A ZM114 refs98/79 NeuN A604 refs98/79 NeuN ZR3864 refs98/79 Neurofilament 2F114 refs98/79 Neurofilament ZR2164 refs98/79 NGFR ZM554 refs98/79 NKX2.2 ZM144 refs98/79 NKX3.1 ZM954 refs98/79 NKX3.1 ZR2224 refs98/79 NSE ZM244 refs98/79 Nucleophosmin (NPM1) ZM824 refs98/79 OCT-4 C-104 refs98/79 OCT-4 ZR3644 refs98/79 Olig2 ZR3404 refs98/79 p120 ZR3164 refs98/79 p16INK4a G175-4054 refs98/79 p16INK4a JC24 refs98/79 p16INK4a MX0074 refs98/79 p21WAF1 ZR2884 refs98/79 p27Kip1 SX53G84 refs98/79 P40 ZR3034 refs98/79 p40 ZR84 refs98/79 p53 DO-74 refs98/79 p53 ZR1534 refs98/79 p57Kip2 KP104 refs98/79 p57Kip2 ZR2304 refs98/79 p63 ZM704 refs98/79 Parathyroid hormone (PTH) ZM2074 refs98/79 PAX-2 ZR2244 refs98/79 PAX-5 ZM264 refs98/79 PAX-5 ZR2684 refs98/79 PAX-8 ZM284 refs98/79 PAX-8 ZR14 refs98/79 PCNA ZR3784 refs98/79 PD-1 (PDCD1) ZM3574 refs98/79 PD-L1 ZR34 refs98/79 Perforin ZM1594 refs98/79 PGP9.5 ZM1604 refs98/79 PHH3 ZR2854 refs98/79 PHOX2B ZR2924 refs98/79 PIT1 ZM3854 refs98/79 PLAP ZM1614 refs98/79 PMS2 ZR3174 refs98/79 Podoplanin D2-404 refs98/79 Podoplanin ZM314 refs98/79 PR ZR2904 refs98/79 PR ZR44 refs98/79 Prolactin ZM2034 refs98/79 Prostein (P501S) ZR94 refs98/79 RCC 66.4.C24 refs98/79 Retinoblastoma (Rb) 1F84 refs98/79 RRM1 ZR1144 refs98/79 S-100 4C4.94 refs98/79 S-100P ZR1154 refs98/79 SALL4 ZR2764 refs98/79 SATB2 ZR1674 refs98/79 SDHB ZR3394 refs98/79 Smoothelin ZR1694 refs98/79 Somatostatin Receptor Type 2 ZR2334 refs98/79 SOX-10 ZM104 refs98/79 SOX-10 ZR2754 refs98/79 SOX-2 ZM574 refs98/79 SOX-9 ZM1714 refs98/79 STAT6 ZR2894 refs98/79 Stathmin ZR3984 refs98/79 Steroidogenic Factor-1 (SF-1) N16654 refs98/79 Surfactant ZM1244 refs98/79 Synaptophysin ZM2084 refs98/79 TCL1 ZM924 refs98/79 TdT ZM514 refs98/79 TFE3 ZR3654 refs98/79 Thrombomodulin / CD141 ZM1054 refs98/79 Thymidylate Synthase (TS) TS1064 refs98/79 Thymidylate Synthase (TS) ZR2454 refs98/79 Thyroglobulin 2H11+6E14 refs98/79 TIA-1 2G9A10F54 refs98/79 TIA-1 ZR2844 refs98/79 TLE1 ZM934 refs98/79 Toxoplasma gondii Poly4 refs98/79 TRAcP ZM1744 refs98/79 TRAcP ZR2344 refs98/79 Treponema pallidum Poly4 refs98/79 TROP2 ZR3884 refs98/79 TRPS1 ZR3824 refs98/79 Tryptase ZM964 refs98/79 TSH ZM2944 refs98/79 TTF-1 8G7G3/14 refs98/79 TTF-1/NKX2.1 ZR1764 refs98/79 Tyrosinase T3114 refs98/79 Ubiquitin ZM1914 refs98/79 Uroplakin ZM2044 refs98/79 VEGF ZR3894 refs98/79 Vimentin ZR3814 refs98/79 WT-1 6F-H24 refs98/79 ZAP-70 ZM974 refs98/79	– 98/79	Website EUDAMED record Report an error
Euroimmun FDA	Germany	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 G98/79 304 others 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 refs98/79 Anti-Borrelia afzelii-WESTERNBLOT (IgM) DY 2131 M2 refs98/79 Anti-Borrelia burgdorferi-WESTERNBLOT (IgM) DY 2132 M2 refs98/79 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 refs98/79 Anti-Borrelia EUROLINE-RN-AT (IgM) DN 2131 M3 refs98/79 Anti-Borrelia EUROLINE-RN-AT-11 (IgG) DN 2131-11 G2 refs98/79 Anti-Borrelia EUROLINE-RN-AT-11 (IgM) DN 2131-11 M2 refs98/79 Anti-Borrelia EUROLINE-RN-AT-adv (IgM) DN 2131-2 M3 refs98/79 Anti-Borrelia EUROLINE-WB (IgG) DY 2131-1 G4 refs98/79 Anti-Borrelia EUROLINE-WB (IgM) DY 2131-1 M4 refs98/79 Anti-Borrelia garinii-WESTERNBLOT (IgG) DY 2134 G2 refs98/79 Anti-Borrelia garinii-WESTERNBLOT (IgM) DY 2134 M2 refs98/79 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 refs98/79 Anti-Chikungunya virus IIFT (IgM) FI 293a M3 refs98/79 Anti-Chikungunya virus IIFT EUROPattern (IgG) FR 293a G2 refs98/79 Anti-Chikungunya virus IIFT EUROPattern (IgM) FR 293a M2 refs98/79 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 refs98/79 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 refs98/79 Anti-EBV-CA IIFT (IgM) FI 2791 M3 refs98/79 Anti-EBV-EA IIFT (IgG) FI 2795 G2 refs98/79 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 refs98/79 Anti-Helicobacter pylori EUROLINE-Westernblot (IgG) DY 2080-1 G2 refs98/79 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 refs98/79 Anti-HHV-6 IIFT (IgM) FI 2536 M4 refs98/79 Anti-HHV-6 IIFT EUROPattern (IgG) FR 2536 G4 refs98/79 Anti-HHV-6 IIFT EUROPattern (IgM) FR 2536 M4 refs98/79 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 refs98/79 Anti-Leishmania donovani IIFT (IgG) FI 2231 G2 refs98/79 Anti-Leishmania donovani IIFT (IgM) FI 2231 M2 refs98/79 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 refs98/79 Anti-Schistosoma mansoni IIFT (IgM) FI 2300 M98/79 Anti-TBE virus IIFT (IgG) FI 2661 G3 refs98/79 Anti-TBE virus IIFT (IgM) FI 2661 M2 refs98/79 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 refs98/79 Anti-Toxoplasma gondii IIFT (IgM) FI 2410 M2 refs98/79 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 refs98/79 Anti-Treponema pallidum IIFT (IgM) FI 2111 M3 refs98/79 Anti-Treponema pallidum Screen ELISA (IgGM) EI 2111 O98/79 Anti-Treponema pallidum WESTERNBLOT (IgG) DY 2111 G2 refs98/79 Anti-Treponema pallidum WESTERNBLOT (IgM) DY 2111 M2 refs98/79 Anti-Treponema pallidum WESTERNBLOT (IgM) DY 2112 M2 refs98/79 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 refs98/79 Anti-VZV IIFT (IgM) FI 2650 M3 refs98/79 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 refs98/79 Anti-West Nile virus IIFT (IgM) FI 2662 M3 refs98/79 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 refs98/79 Anti-Yersinia enterocolitica WESTERNBLOT (IgG) DY 2173 G2 refs98/79 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 refs98/79 Anti-Zika virus IIFT (IgM) FI 2668 M2 refs98/79 Anti-Zika virus IIFT EUROPattern (IgG) FR 2668 G2 refs98/79 Anti-Zika virus IIFT EUROPattern (IgM) FR 2668 M2 refs98/79 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 refs98/79 EUROArray Dermatomycosis MN 28504 refs98/79 EUROArray HPV MN 25404 refs98/79 EUROArray STI - 11 MN 28304 refs98/79 EUROLINE Anti-CMV (IgG) DN 2570-2 G3 refs EUROLINE Anti-CMV (IgM) DN 2570-2 M3 refs EUROLINE Anti-Treponema pallidum (IgG) DN 2111 G2 refs98/79 EUROLINE Anti-Treponema pallidum (IgM) DN 2111 M2 refs98/79 EUROLINE Anti-Yersinia enterocolitica (IgA) DN 2173 A2 refs98/79 EUROLINE Anti-Yersinia enterocolitica (IgG) DN 2173 G2 refs98/79 EUROLINE Bordetella pertussis (IgA) DN 2050 A2 refs98/79 EUROLINE Bordetella pertussis (IgG) DN 2050 G2 refs98/79 EUROLINE-WB Anti-Echinococcus (IgG) DY 2321-2 G2 refs EUROMicroblot Anti-Borrelia (IgG) KN 2131 G98/79 EUROMicroblot Anti-Borrelia (IgM) KN 2131 M98/79 EURORealTime Toxoplasma gondii MP 24102 refs IIFT Mosaic: Coxsackie virus A Types (IgG) FI 2730-2 G3 refs98/79 IIFT Mosaic: Coxsackie virus A Types (IgM) FI 2730-2 M3 refs98/79 IIFT Mosaic: L. monocytogenes 1/2a / L. monocytogenes 4b (IgG) FI 2141-1 G2 refs98/79 IIFT Mosaic: L. monocytogenes 1/2a / L. monocytogenes 4b (IgM) FI 2141-1 M2 refs98/79 IIFT Mosaic: Treponema pallidum / Treponema phagedenis (IgG) FI 2112 G2 refs98/79 IIFT Mosaic: Treponema pallidum / Treponema phagedenis (IgM) FI 2112 M2 refs98/79 IIFT: Borrelia afzelii / VlsE / Borrelia burgdorferi / OspC (IgG) FI 2136-1 G3 refs98/79 IIFT: Borrelia afzelii / VlsE / Borrelia burgdorferi / OspC (IgM) FI 2136-1 M2 refs98/79 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 refs98/79 IIFT: Hantavirus Mosaic 1 (IgM) FI 278h-1 M2 refs98/79 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 refs98/79 IIFT: Hantavirus Mosaic 2: Eurasia (IgM) FI 278h-2 M2 refs98/79 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 refs98/79 IIFT: Sandfly fever virus Mosaic 1 (IgG) FI 277a-1 G3 refs98/79 IIFT: Sandfly fever virus Mosaic 1 (IgM) FI 277a-1 M2 refs98/79 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 refs98/79 Mosaic: Coxsackie virus B Types FI 2730-3 G98/79 Mosaic: Coxsackie virus Type A7 / Type B1 (IgA) FI 2730-4 A2 refs98/79 Mosaic: Coxsackie virus Type A7 / Type B1 FI 2730-4 G2 refs98/79 Mosaic: Dengue virus types 1-4 IIFT (IgG) FI 266a-1 G3 refs98/79 Mosaic: Dengue virus types 1-4 IIFT (IgM) FI 266a-1 M3 refs98/79 Mosaic: Dengue virus types 1-4 IIFT EUROPattern (IgG) FR 266a-1 G2 refs98/79 Mosaic: Dengue virus types 1-4 IIFT EUROPattern (IgM) FR 266a-1 M2 refs98/79 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	B, C IVDR, 98/79	Website info@euroimmun.de EUDAMED record Report an error
TestLine Clinical Diagnostics s.r.o	Czechia	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 others 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	Website info@testlinecd.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	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 272 others 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 refs 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 refs 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 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 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 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 VESICULAR SCREENING KIT VIRAL DNA/RNA EXTRACTION KIT S WITH MAGNETIC BEAD VIS100230 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	Website info@visionbiotechnology.com EUDAMED record Report an error
Gold Standard Diagnostics FDA	Germany	Adenovirus IgA98/79 Adenovirus IgG98/79 Adenovirus IgM98/79 Aspergillus fumigatus IgG98/79 Aspergillus fumigatus IgM98/79 262 others Avidity Cytomegalovirus (CMV) IgG ELISA98/79 Avidity Rubella Virus IgG ELISA98/79 Avidity Toxoplasma gondii IgG98/79 Avidity Toxoplasma gondii IgG ELISA98/79 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 refs98/79 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 refs98/79 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 refs IgA Konjugat/Conjugate (anti-human) LINE3 refs 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 refs98/79 Leptospira IgG RE5893198/79 Leptospira IgM RE5894198/79 Malaria ELISA98/79 Malaria RE5890198/79 Measles Virus IgG98/79 Measles Virus IgG ELISA2 refs98/79 Measles Virus IgM98/79 Measles Virus IgM ELISA2 refs98/79 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 refs98/79 NovaLisa® Adenovirus IgA2 refs98/79 NovaLisa® Adenovirus IgG2 refs98/79 NovaLisa® Aspergillus fumigatus IgG2 refs98/79 NovaLisa® Aspergillus fumigatus IgM2 refs98/79 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 refs98/79 NovaLisa® Bordetella pertussis IgG2 refs98/79 NovaLisa® Bordetella pertussis IgM2 refs98/79 NovaLisa® Bordetella pertussis toxin (PT) IgA2 refs98/79 NovaLisa® Bordetella pertussis toxin (PT) IgG98/79 NovaLisa® Borrelia burgdorferi IgG2 refs98/79 NovaLisa® Borrelia burgdorferi IgM98/79 NovaLisa® Brucella IgG2 refs98/79 NovaLisa® Brucella IgM2 refs98/79 NovaLisa® Candida albicans IgA2 refs98/79 NovaLisa® Candida albicans IgG2 refs98/79 NovaLisa® Candida albicans IgM2 refs98/79 NovaLisa® Chagas (Trypanosoma cruzi) IgG2 refs98/79 NovaLisa® Chikungunya Virus IgG capture2 refs98/79 NovaLisa® Chikungunya Virus IgM μ-capture2 refs98/79 NovaLisa® Chlamydia pneumoniae IgA2 refs98/79 NovaLisa® Chlamydia pneumoniae IgG2 refs98/79 NovaLisa® Chlamydia pneumoniae IgM2 refs98/79 NovaLisa® Chlamydia trachomatis IgA2 refs98/79 NovaLisa® Chlamydia trachomatis IgG2 refs98/79 NovaLisa® Chlamydia trachomatis IgM2 refs98/79 NovaLisa® Clostridium tetani toxin 5S IgG2 refs98/79 NovaLisa® Clostridium tetani toxin 5S IgG plus2 refs98/79 NovaLisa® Clostridium tetani toxin IgG2 refs98/79 NovaLisa® Corynebacterium diphtheriae toxin 5S IgG2 refs98/79 NovaLisa® Corynebacterium diphtheriae toxin 5S IgG plus2 refs98/79 NovaLisa® Corynebacterium diphtheriae toxin IgG98/79 NovaLisa® Coxiella burnetii (Q-Fever) Phase 2 IgG2 refs98/79 NovaLisa® Coxiella burnetii (Q-Fever) Phase 1 IgG2 refs98/79 NovaLisa® Coxiella burnetii (Q-Fever) Phase 2 IgM2 refs98/79 NovaLisa® Cytomegalovirus (CMV) IgG2 refs98/79 NovaLisa® Cytomegalovirus (CMV) IgM2 refs98/79 NovaLisa® Dengue Virus IgG2 refs98/79 NovaLisa® Dengue Virus IgM2 refs98/79 NovaLisa® Dengue Virus IgM µ-capture2 refs98/79 NovaLisa® Dengue Virus NS1 Antigen98/79 NovaLisa® Echinococcus IgG2 refs98/79 NovaLisa® Entamoeba histolytica IgG2 refs98/79 NovaLisa® Epstein-Barr Virus (EA-D) IgG98/79 NovaLisa® Epstein-Barr Virus (EBNA) IgG2 refs98/79 NovaLisa® Epstein-Barr Virus (VCA) IgG2 refs98/79 NovaLisa® Epstein-Barr Virus (VCA) IgM2 refs98/79 NovaLisa® Hantavirus IgG98/79 NovaLisa® Hantavirus IgM98/79 NovaLisa® Helicobacter pylori IgG2 refs98/79 NovaLisa® Helicobacter pylori IgG plus2 refs98/79 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 refs98/79 NovaLisa® Herpes simplex Virus 1 (HSV 1) IgM2 refs98/79 NovaLisa® Herpes simplex Virus 1+2 (HSV) IgG2 refs98/79 NovaLisa® Herpes simplex Virus 1+2 (HSV) IgM2 refs98/79 NovaLisa® Herpes simplex Virus 2 (HSV 2) IgG2 refs98/79 NovaLisa® Herpes simplex Virus 2 (HSV 2) IgM2 refs98/79 NovaLisa® Influenza Virus A IgA2 refs98/79 NovaLisa® Influenza Virus A IgG2 refs98/79 NovaLisa® Influenza Virus A IgM2 refs98/79 NovaLisa® Influenza Virus B IgA2 refs98/79 NovaLisa® Influenza Virus B IgG2 refs98/79 NovaLisa® Influenza Virus B IgM2 refs98/79 NovaLisa® Legionella pneumophila IgG2 refs98/79 NovaLisa® Legionella pneumophila IgM2 refs98/79 NovaLisa® Leishmania infantum IgG2 refs98/79 NovaLisa® Leptospira IgG98/79 NovaLisa® Leptospira IgM2 refs98/79 NovaLisa® Malaria2 refs98/79 NovaLisa® Measles Virus IgG2 refs98/79 NovaLisa® Measles Virus IgM2 refs98/79 NovaLisa® Mumps Virus IgG2 refs98/79 NovaLisa® Mumps Virus IgM2 refs98/79 NovaLisa® Mycoplasma pneumoniae IgA98/79 NovaLisa® Mycoplasma pneumoniae IgG2 refs98/79 NovaLisa® Mycoplasma pneumoniae IgM2 refs98/79 NovaLisa® Parainfluenza Virus 1, 2, 3 IgA2 refs98/79 NovaLisa® Parainfluenza Virus 1, 2, 3 IgG2 refs98/79 NovaLisa® Parvovirus B19 IgG98/79 NovaLisa® Parvovirus B19 IgM2 refs98/79 NovaLisa® Respiratory Syncytial Virus IgA2 refs98/79 NovaLisa® Respiratory Syncytial Virus IgG2 refs98/79 NovaLisa® Respiratory Syncytial Virus IgM2 refs98/79 NovaLisa® Rubella Virus IgG98/79 NovaLisa® Rubella Virus IgM μ-capture2 refs98/79 NovaLisa® SARS-CoV-2 (COVID-19) IgA98/79 NovaLisa® SARS-CoV-2 (COVID-19) IgG98/79 NovaLisa® Schistosoma mansoni IgG2 refs98/79 NovaLisa® Schistosoma mansoni IgM98/79 NovaLisa® TBE / FSME IgM2 refs98/79 NovaLisa® TBE/FSME IgG2 refs98/79 NovaLisa® TBE/FSME IgG plus2 refs98/79 NovaLisa® Toxoplasma gondii IgG2 refs98/79 NovaLisa® Toxoplasma gondii IgM μ-capture2 refs98/79 NovaLisa® Varicella-Zoster Virus (VZV) IgG2 refs98/79 NovaLisa® Varicella-Zoster Virus (VZV) IgM2 refs98/79 NovaLisa® Yersinia enterocolitica IgA98/79 NovaLisa® Yersinia enterocolitica IgG98/79 NovaLisa® Zika Virus IgG capture2 refs98/79 NovaLisa® Zika Virus IgM μ-capture2 refs98/79 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 refs 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 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 refs98/79 Varicella-Zoster Virus (VZV) IgG RE5737198/79 Varicella-Zoster Virus (VZV) IgM98/79 Varicella-Zoster Virus (VZV) IgM ELISA2 refs98/79 Verd.-/Waschpuffer Dilution-/Washbuffer LINE Washing Buffer (20x concentrated)2 refs 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	Website info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	United States	"AHTV01-AHG48E， AHTV01-AHG96E"98/79 101A0227EY98/79 ABPTS02-AHG48E/ ABPTS02-AHG96E98/79 ACAB01-AHG48E; ACAB01-AHG96E98/79 ACAB04D-BHG48E98/79 244 others 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 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 EUDAMED record Report an error
Leicabiosystems FDA EU representative : AR Experts B.V. (Netherlands)	United Kingdom (ex Northern Ireland), United States	0.5% Acid Alcohol3 refs Alcoholic Eosin Y 5153 refs Alpha-Methylacyl-CoA Racemase EPMU1 7 mL PA021098/79 Anaplastic Lymphoma Kinase 5A4 7 mL PA083198/79 Bcl-2 bcl-2/100-D5 7 mL PA011798/79 238 others Bcl-6 LN22 7 mL PA020498/79 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 refs 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 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 refs 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 refs Herpesvirus (Type 8) 13B10 7 mL PA005098/79 HistoCore SPECTRA CV X1 Mounting Media3 refs 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 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 refs 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 refs Smooth Muscle Actin αsm-1 7 mL PA094398/79 ST Infinity 2.0 H&E Staining System2 refs 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	Website EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) and 1 other	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-FIARID2098/79 223 others 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 Brucella Abortus Antigen Rapid Test Device – WB/S/P98/79 Brucella Abortus Control2 refs98/79 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 refs98/79 COVID-19 IgG/IgM Test Device -Finger Prick WB, WB/S/P2 refs98/79 COVID-19 S-RBD IgG Antibody Test Device -WB/S/P2 refs98/79 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 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 refs98/79 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 refs98/79 Enterovirus 71 Ag Test Device-Feces2 refs98/79 FLU A+B Control98/79 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 refs98/79 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 refs98/79 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 refs98/79 Influenza A+B Test Device -Swab D-FIIABD2098/79 Influenza A/B+H1N1 Control98/79 Legionella pneumophila Control5 refs98/79 Legionella pneumophila Rapid Test Device – Urine98/79 Legionella pneumophila Test Device -Urine2 refs98/79 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 refs98/79 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 refs98/79 Multiplex 5 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Multiplex 6 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Multiplex 7 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Multiplex 8 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Multiplex 9 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 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 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 refs98/79 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 refs98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test-Nasopharyngeal Swab98/79 Scrub Typhus IgG/IgM Control2 refs98/79 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 refs98/79 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 refs98/79 Streptococcus pneumoniae Test Device -Urine2 refs98/79 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 refs98/79 Syphilis Rapid Test Strip – S/P D-TPSPS5098/79 Syphilis Rapid Test Strip – WB/S/P2 refs98/79 Syphilis Test Device -WB/S/P3 refs98/79 Syphilis Test Kit-human serum or plasma D-CITPK4098/79 Tetanus Control D-PL-CTET98/79 Tetanus Rapid Test Device – WB/S/P2 refs98/79 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 refs98/79 Typhoid Rapid Test Strip - WB/S/P98/79 Typhoid Rapid Test Strip – S/P98/79 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	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Dartmon FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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 DMRD055898/79 221 others 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 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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 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	Website EUDAMED record Report an error
Vircell	Spain	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 219 others 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 refs98/79 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 refs98/79 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 refs 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 refs 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 refs98/79 SARS-CoV-2/FluA/FluB/RSV REAL TIME PCR KIT RTPCR0212 refs 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 refs98/79 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 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 refs	A, B, C, D IVDR, 98/79	EUDAMED record Report an error
ZytoVision FDA	Germany	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 others FlexISH ALK/ROS1 DistinguISH Probe2 refs FlexISH BCL2/BCL6 DistinguISH Probe2 refs FlexISH ERBB2/CEN 17 Dual Color Probe2 refs FlexISH MYC/IGH TriCheck Probe FlexISH NTRK1/NTRK3 DistinguISH Probe2 refs98/79 FlexISH RET/KIF5B TriCheck Probe Rabbit anti-Helicobacter pylori [polyclonal]3 refs VisionArray HPV Chip 1.02 refs98/79 VisionArray HPV PreCise Master Mix98/79 VisionArray MYCO Chip 2.02 refs98/79 VisionArray MYCO PreCise Master Mix 2.098/79 ZytoDot 2C Glioma 1p/19q Probe Set2 refs ZytoDot 2C SPEC 19q13/19p13 Probe2 refs ZytoDot 2C SPEC 1p36/1q25 Probe2 refs ZytoDot 2C SPEC ALK Break Apart Probe2 refs 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 refs ZytoDot 2C SPEC ERBB2/CEN 17 Probe2 refs ZytoDot 2C SPEC ERBB2/CEN 17 Probe Kit2 refs 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 refs 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 refs 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 refs98/79 ZytoLight Bladder Cancer Quadruple Color Probe2 refs98/79 ZytoLight CEN 11 Probe98/79 ZytoLight CEN 12 Probe98/79 ZytoLight CEN 17/SPEC ERBB2 Dual Color Probe2 refs ZytoLight CEN 8 Probe2 refs ZytoLight CEN X/Y Dual Color Probe98/79 ZytoLight CEN X/Yq12 Dual Color Probe2 refs98/79 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 refs98/79 ZytoLight SPEC 18/CEN X/Y Triple Color Probe98/79 ZytoLight SPEC 19q13/19p13 Dual Color Probe2 refs ZytoLight SPEC 1p36/1q25 Dual Color Probe2 refs 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 refs ZytoLight SPEC ALK/2q11 Dual Color Probe ZytoLight SPEC ALK/EML4 TriCheck Probe2 refs 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 refs ZytoLight SPEC BCL2/IGH Dual Color Dual Fusion Probe2 refs ZytoLight SPEC BCL6 Dual Color Break Apart Probe2 refs ZytoLight SPEC BCOR Dual Color Break Apart Probe98/79 ZytoLight SPEC BCR/ABL1 Dual Color Dual Fusion Probe2 refs ZytoLight SPEC BIRC3/MALT1 Dual Color Dual Fusion Probe2 refs98/79 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 refs ZytoLight SPEC CCND1/CEN 11 Dual Color Probe2 refs ZytoLight SPEC CCND1/IGH Dual Color Dual Fusion Probe2 refs ZytoLight SPEC CD274,PDCD1LG2/CEN 9 Dual Color Probe2 refs ZytoLight SPEC CDK4/CEN 12 Dual Color Probe2 refs ZytoLight SPEC CDKN2A/CEN 3/7/17 Quadruple Color Probe2 refs ZytoLight SPEC CDKN2A/CEN 9 Dual Color Probe2 refs ZytoLight SPEC CIC Dual Color Break Apart Probe ZytoLight SPEC CKS1B/CDKN2C Dual Color Probe2 refs ZytoLight SPEC COL1A1 Dual Color Break Apart Probe ZytoLight SPEC COL1A1/PDGFB Dual Color Dual Fusion Probe2 refs 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 refs ZytoLight SPEC D13S319/13q34/CEN 12 Triple Color Probe2 refs ZytoLight SPEC DDIT3 Dual Color Break Apart Probe2 refs ZytoLight SPEC DiGeorge Triple Color Probe98/79 ZytoLight SPEC DiGeorge/Phelan McDermid Dual Color Probe98/79 ZytoLight SPEC EGFR/CEN 7 Dual Color Probe2 refs ZytoLight SPEC EGR1/D5S23,D5S721 Dual Color Probe ZytoLight SPEC ERBB2/CEN 17 Dual Color Probe2 refs ZytoLight SPEC ERBB2/CEN 17 Dual Color Probe Kit2 refs ZytoLight SPEC ERBB2/D17S122 Dual Color Probe2 refs ZytoLight SPEC ERBB2/TOP2A/CEN 17 Triple Color Probe2 refs 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 refs ZytoLight SPEC ETV6/RUNX1 Dual Color Dual Fusion Probe2 refs98/79 ZytoLight SPEC EWSR1 Dual Color Break Apart Probe2 refs ZytoLight SPEC EWSR1/FLI1 TriCheck Probe ZytoLight SPEC FGFR1 Dual Color Break Apart Probe2 refs ZytoLight SPEC FGFR1/CEN 8 Dual Color Probe2 refs ZytoLight SPEC FGFR2 Dual Color Break Apart Probe2 refs ZytoLight SPEC FGFR2/CEN 10 Dual Color Probe ZytoLight SPEC FGFR3 Dual Color Break Apart Probe2 refs 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 refs ZytoLight SPEC FOXO1/PAX3 Dual Color Single Fusion Probe2 refs ZytoLight SPEC FOXO1/PAX3 TriCheck Probe ZytoLight SPEC FOXO1/PAX7 Dual Color Single Fusion Probe2 refs 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 refs 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 refs ZytoLight SPEC JAK2 Dual Color Break Apart Probe ZytoLight SPEC JAZF1 Dual Color Break Apart Probe ZytoLight SPEC KMT2A Dual Color Break Apart Probe2 refs 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 refs ZytoLight SPEC MALT1/IGH Dual Color Dual Fusion Probe ZytoLight SPEC MAML2 Dual Color Break Apart Probe2 refs ZytoLight SPEC MCL1/1p12 Dual Color Probe ZytoLight SPEC MDM2/CEN 12 Dual Color Probe2 refs ZytoLight SPEC MDM4/1p12 Dual Color Probe ZytoLight SPEC MET/CEN 7 Dual Color Probe2 refs ZytoLight SPEC MYB Dual Color Break Apart Probe2 refs ZytoLight SPEC MYB/CEN 6 Dual Color Probe ZytoLight SPEC MYC Dual Color Break Apart Probe2 refs ZytoLight SPEC MYC/CEN 8 Dual Color Probe2 refs ZytoLight SPEC MYC/IGH Dual Color Dual Fusion Probe2 refs ZytoLight SPEC MYCN/2q11 Dual Color Probe2 refs ZytoLight SPEC NECTIN4/1p12 Dual Color Probe2 refs 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 refs ZytoLight SPEC NTRK2 Dual Color Break Apart Probe2 refs ZytoLight SPEC NTRK3 Dual Color Break Apart Probe2 refs 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 refs 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 refs98/79 ZytoLight SPEC Prader-Willi Dual Color Probe98/79 ZytoLight SPEC PTEN/CEN 10 Dual Color Probe2 refs ZytoLight SPEC PTPRT/20q11 Dual Color Probe ZytoLight SPEC RB1/13q34 Dual Color Probe2 refs98/79 ZytoLight SPEC RET Dual Color Break Apart Probe2 refs ZytoLight SPEC ROS1 Dual Color Break Apart Probe2 refs ZytoLight SPEC ROS1/CEN 6 Dual Color Probe2 refs ZytoLight SPEC RREB1/MYB/CEN 6 Triple Color Probe2 refs ZytoLight SPEC RUNX1/RUNX1T1 Dual Color Dual Fusion Probe2 refs98/79 ZytoLight SPEC SMARCB1/22q12 Dual Color Probe ZytoLight SPEC SS18 Dual Color Break Apart Probe2 refs 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 refs ZytoLight SPEC TFE3 Dual Color Break Apart Probe2 refs ZytoLight SPEC TP53/17q22 Dual Color Probe ZytoLight SPEC TP53/ATM Dual Color Probe2 refs ZytoLight SPEC TP53/CEN 17 Dual Color Probe2 refs ZytoLight SPEC TP63/TBL1XR1 TriCheck Probe98/79 ZytoLight SPEC USP6 Dual Color Break Apart Probe2 refs ZytoLight SPEC VHL/1p12/CEN 7/17 Quadruple Color Probe2 refs 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	Website info@zytovision.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	101A0227EY98/79 ABPTS02-AOG48E/ ABPTS02-AOG96E98/79 ACAB04D-BOG48E98/79 ACOV03-AOG48E; ACOV03-AOG96E; ACOV03D-AOG48E; ACOV03D-AOG96E98/79 Adenovirus Antigen Control Kit GCADE-PN298/79 207 others 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 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 refs 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® 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 refs 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 refs 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 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	B, C IVDR, 98/79	EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	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 I98/79 206 others 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 refs 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 refs98/79 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 refs98/79 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 refs98/79 High-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit2 refs98/79 High-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit（PCR-Fluorescence）2 refs98/79 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 refs98/79 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 refs98/79 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 refs Liferiver ® Auto AT96S A Extraction Kit2 refs Liferiver ® AutoAT96S C Extraction Kit2 refs Liferiver ® AutoEX16P A Extraction Kit2 refs Liferiver ® AutoEX36 C Extraction Kit2 refs Liferiver ® AutoEX36 D Extraction Kit2 refs Liferiver ® AutoEX36 E Extraction Kit2 refs Liferiver ® AutoEX36 F Extraction Kit2 refs Liferiver® AutoAT96P A Extraction Kit MVR102 refs Liferiver® AutoEX36 A Extraction Kit MVR012 refs Liferiver® AutoEX36 B Extraction Kit MVR092 refs Liferiver® Beads Column A Extraction Kit2 refs Liferiver® Preservation Medium MCS013 refs Liferiver® Preservation Solution ACS013 refs Listeria Monocytogenes Real Time PCR Kit98/79 LyoHarmonyHPV Test2 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 Respiratory AdenoVirus Real Time PCR Kit98/79 Respiratory Syncytial Virus (RSV) Typing A &B Real Time RT-PCR Kit2 refs98/79 Respiratory Syncytial Virus(RSV) Real Time RT-PCR Kit98/79 Rickettsia Real Time PCR Kit98/79 RNA Isolation Kit (Paramagnetic Beads Column)2 refs 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 refs98/79 Vancomycin-Resistant Staphylococcus Aureus (VRSA) Real Time PCR Kit98/79 Varicella Zoster Virus (VZV) Real Time PCR Kit98/79 VenusHPV Test2 refs98/79 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 refs Viral RNA Extraction Kit (for Auto-Extraction) MVR102 refs Viral RNA Extraction Kit (Preloaded for Auto-Extraction) MVR152 refs Viral RNA Extraction Kit MVR092 refs Viral RNA Isolation Kit (Preloaded for Auto-Extraction) MVR012 refs Viral Transport Medium RVR093 refs 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 refs98/79	A IVDR, 98/79	Website EUDAMED record Report an error
Dymind EU representative : Eunitor GmbH (Germany)	China	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×1098/79 200 others 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 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 Hematology Analyzer DH-61598/79 Cleanser CLE-P3 refs Cleanser CLR 500mL2 refs 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 refs98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) Specification 2 :R1 4.0 mL× 10, R2 30.0 mL× 52 refs98/79 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 refs Hematology Analyzer Diluent D-80DR(M)3 refs Hematology Analyzer Diluent DIL-A:20L2 refs Hematology Analyzer Diluent DIL-C:20L2 refs Hematology Analyzer Diluent DIL-E ,20L Hematology Analyzer Diluent DIL-K:20L3 refs Hematology Analyzer Diluent DIL-N:10L3 refs Hematology Analyzer Diluent DIL-R 10L2 refs Hematology Analyzer Dye D-80FD:12mL3 refs Hematology Analyzer Dye D-80FR(M)2 refs Hematology Analyzer Dye FDN-R:24mL3 refs 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 refs Hematology Analyzer Lyse L1：1L3 refs Hematology Analyzer Lyse LP3 refs Hematology Analyzer Lyse LYA-1：1L3 refs Hematology Analyzer Lyse LYC-1：1L3 refs Hematology Analyzer Lyse LYD-1：1L3 refs Hematology Analyzer Lyse LYE-1：1L Hematology Analyzer Lyse LYG-13 refs Hematology Analyzer Lyse LYK-13 refs Hematology Analyzer Lyse LYN-G:1L3 refs Hematology Analyzer Lyse LYR-1:1L3 refs Hematology Analyzer Reagent Kit (Diluent and Lyse) PTD-1 25 test/kit2 refs Hematology Analyzer Reagent Kit PTD-103 25 test/kit2 refs Hematology Calibrator DM-CAL 3mL × 13 refs Hematology Calibrator DM-CAL PLUS 3mL × 13 refs Hematology Calibrator DM-CAL-PF3 refs Hematology Control DM-3D High (H):3mL×14 refs Hematology Control DM-5D High (H):3mL×14 refs 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 refs 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 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 refs 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 EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany) and 3 others	Germany, Ireland, Japan, South Korea, United States	ABBOTT REALTIME HIV-15 refs Alere™ Malaria Ag P.f 05FK14098/79 Alere™ Malaria Ag P.f 05FK14198/79 Alere™ Malaria Ag P.f 05FK14398/79 Alinity27 refs 198 others Alinity 06S610198/79 Alinity 06S611098/79 Alinity 06S612098/79 ALINITY h-series CONTROL 29P4 refs Alinity HSV-1 IgG3 refs Alinity HSV-2 IgG3 refs Alinity m30 refs ALINITY M RESP-4-PLEX4 refs ALINITY M SAMPLE PREP 1 ALINITY M SAMPLE PREP 2 ALINITY M SARS-COV-22 refs Alinity SARS-CoV-2 IgG3 refs98/79 Alinity SARS-CoV-2 IgG II Quant3 refs Alinity SARS-CoV-2 IgM2 refs98/79 ARCHITECT28 refs ARCHITECT 06S600198/79 ARCHITECT 06S601098/79 ARCHITECT 06S602098/79 ARCHITECT HSV-1 IgG3 refs ARCHITECT HSV-2 IgG3 refs ARCHITECT SARS-CoV-2 IgG98/79 ARCHITECT SARS-CoV-2 IgG (Cal & Ctrl)2 refs98/79 ARCHITECT SARS-CoV-2 IgG II Quant3 refs ARCHITECT SARS-CoV-2 IgM3 refs98/79 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 refs98/79 Bioline™ Dengue Duo 11FK452 refs98/79 Bioline™ Dengue Duo 11FK462 refs98/79 Bioline™ Dengue IgG Capture ELISA 11EK1098/79 Bioline™ Dengue IgG/IgM 11FK1098/79 Bioline™ Dengue IgG/IgM WB 11FK202 refs98/79 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 refs98/79 Bioline™ HCV 02FK10CE98/79 Bioline™ HCV 02FK16CE98/79 Bioline™ HCV 02FK17CE98/79 Bioline™ HIV 1/2 3.0 03FK10CE2 refs98/79 Bioline™ HIV 1/2 3.0 03FK16CE2 refs98/79 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 refs98/79 Bioline™ Influenza Ultra 19FK133 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 Bioline™ Rota/Adeno98/79 Bioline™ Rota/Adeno 14FK203 refs98/79 Bioline™ Rotavirus98/79 Bioline™ Rotavirus 14FK1098/79 Bioline™ RSV 40FK122 refs98/79 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 refs98/79 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-DYN4 refs CELL-DYN Emerald 22 Diluent CELL-DYN Emerald 22 Lyse2 refs CheckNow™ 455340902398/79 CheckNow™ 456342902398/79 CheckNow™ 456381902398/79 Determine2 refs98/79 Determine HIV Early Detect98/79 Determine Syphilis TP 30T 7D244298/79 Determine™ TB LAM Ag (25T) 7D274198/79 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 refs 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™ 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 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 refs 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 refs98/79 SD BIOLINE Malaria Ag P.f 05FK5398/79 SD BIOLINE Malaria Ag P.f./Pan 05FK602 refs98/79 SD BIOLINE Malaria Ag P.f./Pan 05FK612 refs98/79 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 refs Panbio Dengue IgM Capture ELISA98/79 (no longer marketed) SD BIOLINE Zika IgM98/79 (no longer marketed)	A, B, C, D IVDR, 98/79	Website EUDAMED record Report an error
Idilbiotech	Türkiye	DirEXT Nucleic Acid Extraction Reagent3 refs98/79 DirEXT OneStep HPV DNA Extraction Reagent2 refs98/79 DirEXT OneStep Pathogen DNA/RNA Extraction Reagent2 refs98/79 RevoDx Viral DNA Purification Kit3 refs98/79 RevoDx Viral RNA Purification Kit3 refs98/79 195 others RevoDx Acinetobacter baumannii qPCR Kit2 refs98/79 RevoDx Adenovirus (F40/41) qPCR Kit2 refs98/79 RevoDx Adenovirus / CMV / EBV qPCR Kit2 refs98/79 RevoDx Adenovirus qPCR Kit2 refs98/79 RevoDx African Swine Fever Virus qPCR Kit2 refs98/79 RevoDx Aspergillus qPCR Kit2 refs98/79 RevoDx Astrovirus qPCR Kit2 refs98/79 RevoDx Atypical pneumonia Pathogen Detection Kit2 refs98/79 RevoDx Avian Influenza (H5N1) qPCR Kit2 refs98/79 RevoDx Bacterial Respiratory Pathogen Detection Kit2 refs98/79 RevoDx Bacterial/Fungal Meningitis-Encephalitis Pathogen Detection Kit3 refs98/79 RevoDx BK Virus qPCR Kit2 refs98/79 RevoDx BK Virus Quantitative qPCR Kit2 refs98/79 RevoDx Bocavirus 1/2/3/4 qPCR Kit2 refs98/79 RevoDx Bordetella pertussis qPCR Kit2 refs98/79 RevoDx Bordetella pertussis/parapertussis qPCR Kit2 refs98/79 RevoDx Campylobacter spp (C. jejuni, C. upsaliensis, C. coli) qPCR Kit2 refs98/79 RevoDx Campylobacter spp / Salmonella spp / Yersinia Enterocolitica qPCR Kit2 refs98/79 RevoDx Candida albicans qPCR Kit2 refs98/79 RevoDx Candida auris qPCR Kit2 refs98/79 RevoDx Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit3 refs98/79 RevoDx Cervical Specimens Transport Reagent3 refs98/79 RevoDx Chikungunya Virus qPCR Kit2 refs98/79 RevoDx Chlamydia Trachomatis qPCR Kit2 refs98/79 RevoDx Chlamydophila pneumoniae qPCR Kit2 refs98/79 RevoDx Clostridium difficile qPCR Kit3 refs98/79 RevoDx Colistin (mcr) resistance qPCR Kit2 refs98/79 RevoDx Coronavirus 229E/NL63/OC43/HKU1 qPCR Kit2 refs98/79 RevoDx Crimean-Congo Hemorrhagic Fever Virus qPCR Kit2 refs98/79 RevoDx Cryptococcus neoformans/gattii qPCR Kit2 refs98/79 RevoDx Cryptosporidium spp qPCR Kit2 refs98/79 RevoDx CT/NG plus Mycoplasma Hominis qPCR Kit3 refs98/79 RevoDx CT/NG qPCR Kit98/79 RevoDx Cyclospora cayetanensis qPCR Kit2 refs98/79 RevoDx Dengue / Zika / Chikungunya Virus qPCR Kit2 refs98/79 RevoDx Dengue Virus Screening qPCR Kit2 refs98/79 RevoDx Dengue Virus Typing qPCR Kit2 refs98/79 RevoDx Diarrheagenic Escherichia coli (DEC) Detection Kit2 refs98/79 RevoDx Diarrheagenic Escherichia coli (DEC) version 2.0 Detection Kit2 refs98/79 RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)3 refs98/79 RevoDx DNA Purification Kit from Bacteria3 refs98/79 RevoDx DNA Purification Kit from Blood2 refs98/79 RevoDx DNA Purification Kit from Blood Culture3 refs98/79 RevoDx DNA Purification Kit from Respiratory Samples3 refs98/79 RevoDx DNA Purification Kit from Tissue and Paraffin-Embedded Tissue3 refs98/79 RevoDx E. coli O157:H7 qPCR Kit2 refs98/79 RevoDx Eastern Equine Encephalitis Virus qPCR Kit2 refs98/79 RevoDx Entamoeba Histolytica qPCR Kit2 refs98/79 RevoDx Enterobacter cloacae qPCR Kit2 refs98/79 RevoDx Enterococcus faecalis qPCR Kit2 refs98/79 RevoDx Enterococcus faecium qPCR Kit2 refs98/79 RevoDx Enterovirus/Rhinovirus qPCR Kit2 refs98/79 RevoDx Epstein-Barr Virus / Adenovirus qPCR Kit2 refs98/79 RevoDx Epstein-Barr Virus qPCR Kit3 refs98/79 RevoDx Epstein-Barr Virus qPCR Kit (Quantitative) IP202216-25098/79 RevoDx Escherichia coli K1 qPCR Kit2 refs98/79 RevoDx Escherichia coli qPCR Kit2 refs98/79 RevoDx Extended Spectrum Beta-Lactamases (ESBL) Genes (CTX-M, TEM, SHV) qPCR Kit2 refs98/79 RevoDx Flu A / Flu B / RSV / SARS-CoV-2 qPCR Kit2 refs98/79 RevoDx Flu A&B / RSV / SARS-CoV-2 qPCR Kit2 refs98/79 RevoDx Flu A&B / SARS-CoV-2 qPCR Kit2 refs98/79 RevoDx Gardnerella Vaginalis qPCR Kit2 refs98/79 RevoDx Gastro Bacterial Pathogen Detection Kit3 refs98/79 RevoDx Gastro Parasitic Pathogen Detection Kit3 refs98/79 RevoDx Gastro Pathogen Detection Kit9 refs98/79 RevoDx Gastro Viral Pathogen Detection Kit3 refs98/79 RevoDx GEL/PCR Product Purification Kit3 refs98/79 RevoDx Genomic DNA Purification Kit from Blood98/79 RevoDx Genomic DNA Purification Kit from Yeast2 refs98/79 RevoDx Giardia Lamblia / Entamoeba Histolytica / Cryptosporidium spp qPCR Kit2 refs98/79 RevoDx Giardia Lamblia qPCR Kit2 refs98/79 RevoDx Haemophilus Ducreyi qPCR Kit2 refs98/79 RevoDx Haemophilus influenzae / Human Metapneumovirus / Mycoplasma pneumoniae qPCR Kit2 refs98/79 RevoDx Haemophilus influenzae / Neisseria Meningitidis / Streptococcus pneumoniae qPCR Kit2 refs98/79 RevoDx Haemophilus influenzae qPCR Kit2 refs98/79 RevoDx HBV qPCR Kit7 refs98/79 RevoDx HBV qPCR Kit (Qualitative)98/79 RevoDx HBV/HCV/HIV1&2 qPCR Kit2 refs98/79 RevoDx HCV Genotyping qPCR Kit v012 refs98/79 RevoDx HCV qPCR Kit8 refs98/79 RevoDx HDV qPCR Kit4 refs98/79 RevoDx Helicobacter pylori qPCR Kit2 refs98/79 RevoDx Hepatitis A Virus Qualitative qPCR Kit4 refs98/79 RevoDx Hepatitis A Virus Quantitative qPCR Kit4 refs98/79 RevoDx HIV-1 qPCR Kit6 refs98/79 RevoDx HIV-1/2 qPCR Kit2 refs98/79 RevoDx HIV-2 qPCR Kit4 refs98/79 RevoDx HPV 14 Genotyping Kit2 refs98/79 RevoDx HPV 26 Screening Kit2 refs98/79 RevoDx HPV 6/11 Genotyping Kit2 refs98/79 RevoDx HPV Screening plus 16/18 Kit2 refs98/79 RevoDx HSV-1 qPCR Kit2 refs98/79 RevoDx HSV-1/2 Screening qPCR Kit2 refs98/79 RevoDx HSV-2 qPCR Kit2 refs98/79 RevoDx Human herpes virus 6 (HHV-6) qPCR Kit2 refs98/79 RevoDx Human herpes virus 7 (HHV-7) qPCR Kit2 refs98/79 RevoDx Human Metapneumovirus qPCR Kit2 refs98/79 RevoDx Human parechovirus qPCR Kit2 refs98/79 RevoDx Influenza A H1N1 (pdm09) qPCR Kit2 refs98/79 RevoDx Influenza A&B qPCR Kit2 refs98/79 RevoDx Influenza A-H3 qPCR Kit2 refs98/79 RevoDx JC Virus qPCR Kit2 refs98/79 RevoDx JC Virus Quantitative qPCR Kit2 refs98/79 RevoDx Klebsiella pneumonia qPCR Kit3 refs98/79 RevoDx Legionella pneumophila qPCR Kit2 refs98/79 RevoDx Leptospira spp qPCR Kit2 refs98/79 RevoDx Listeria monocytogenes qPCR Kit2 refs98/79 RevoDx Magnetic Pathogen DNA/RNA Purification Kit3 refs98/79 RevoDx Magnetic Viral Nucleic Acid Purification Kit3 refs98/79 RevoDx Malaria qPCR Kit2 refs98/79 RevoDx Measles morbillivirus qPCR Kit2 refs98/79 RevoDx Meningitis/Encephalitis Pathogen PLUS Detection Kit9 refs98/79 RevoDx Methicillin resistance (mecA/mecC) qPCR Kit2 refs98/79 RevoDx Monkeypox qPCR Kit2 refs98/79 RevoDx Moraxella catarrhalis/ Haemophilus influenzae/ Streptococcus pyogenes qPCR Kit4 refs98/79 RevoDx MRSA qPCR Kit2 refs98/79 RevoDx MTBC qPCR Kit2 refs98/79 RevoDx Mumps virus qPCR Kit2 refs98/79 RevoDx Mycoplasma genitalium / Ureaplasma Parvum/Urealytıcum qPCR Kit3 refs98/79 RevoDx Mycoplasma Genitalium qPCR Kit2 refs98/79 RevoDx Mycoplasma Hominis qPCR Kit2 refs98/79 RevoDx Mycoplasma Hominis/Genitalium qPCR Kit3 refs98/79 RevoDx Mycoplasma pneumoniae qPCR Kit2 refs98/79 RevoDx Neisseria Gonorrhoeae qPCR Kit2 refs98/79 RevoDx Neisseria Meningitidis qPCR Kit2 refs98/79 RevoDx Norovirus genogroup I&II qPCR Kit2 refs98/79 RevoDx Parainfluenza virus 1 qPCR Kit2 refs98/79 RevoDx Parainfluenza virus 2 qPCR Kit2 refs98/79 RevoDx Parainfluenza virus 3 qPCR Kit2 refs98/79 RevoDx Parainfluenza virus 4 qPCR Kit2 refs98/79 RevoDx Parvovirus B19 Qualitative qPCR Kit2 refs98/79 RevoDx Parvovirus B19 Quantitative qPCR Kit2 refs98/79 RevoDx Pathogen DNA/RNA Purification Kit3 refs98/79 RevoDx Plasmid DNA Purification Kit3 refs98/79 RevoDx Plesiomonas shigelloides qPCR Kit2 refs98/79 RevoDx Pseudomonas aeruginosa qPCR Kit2 refs98/79 RevoDx Respiratory-11 Pathogen Detection Kit2 refs98/79 RevoDx Respiratory-24 Pathogen Detection Kit9 refs98/79 RevoDx Respiratory-24 Pathogen Detection Kit W010507050398/79 RevoDx Respiratory-24 v2.0 Pathogen Detection Kit9 refs98/79 RevoDx Respiratory-24 v3.0 Pathogen Detection Kit2 refs98/79 RevoDx Respiratory-27 Pathogen Detection Kit3 refs98/79 RevoDx Respiratory-34 Pathogen Detection Kit3 refs98/79 RevoDx Respiratory-5 Pathogen Detection Kit3 refs98/79 RevoDx Respiratory-5 version 2.0 Pathogen Detection Kit2 refs98/79 RevoDx Respiratory-5 version 3.0 Pathogen Detection Kit2 refs98/79 RevoDx Respiratory-5 version 4.0 Pathogen Detection Kit2 refs98/79 RevoDx Respiratory-6 Pathogen Detection Kit3 refs98/79 RevoDx Respiratory-6 version 3.0 Pathogen Detection Kit2 refs98/79 RevoDx Respiratory-7 Pathogen Detection Kit3 refs98/79 RevoDx Respiratory-9 Pathogen Detection Kit3 refs98/79 RevoDx Rotavirus A qPCR Kit2 refs98/79 RevoDx RSV qPCR Kit2 refs98/79 RevoDx Rubella Virus qPCR Kit2 refs98/79 RevoDx Salmonella qPCR Kit3 refs98/79 RevoDx Sapovirus (I, II, IV, V) qPCR Kit2 refs98/79 RevoDx SARS-CoV-2 qPCR Kit v2.22 refs98/79 RevoDx SARS-CoV-2 qPCR Kit v2.32 refs98/79 RevoDx Sepsis Pathogen Detection Kit9 refs98/79 RevoDx Sepsis Pathogen PLUS Detection Kit3 refs98/79 RevoDx Sexually Transmitted Infections (STIs) Pathogen Detection Kit9 refs98/79 RevoDx Sexually Transmitted Infections (STIs) Pathogen PLUS Detection Kit9 refs98/79 RevoDx Staphyloccocus aureus qPCR Kit2 refs98/79 RevoDx Staphyloccocus spp. qPCR Kit2 refs98/79 RevoDx Stenotrophomonas maltophilia qPCR Kit2 refs98/79 RevoDx STI-11 Pathogen Detection Kit9 refs98/79 RevoDx STI-18 Pathogen Detection Kit9 refs98/79 RevoDx STI-6 Pathogen Detection Kit3 refs98/79 RevoDx STI-8 Pathogen Detection Kit3 refs98/79 RevoDx Stool Pathogen DNA/RNA Purification Kit3 refs98/79 RevoDx Streptococcus agalactiae qPCR Kit2 refs98/79 RevoDx Streptococcus pneumoniae / pyogenes / agalactiae qPCR Kit2 refs98/79 RevoDx Streptococcus pneumoniae qPCR Kit2 refs98/79 RevoDx Streptococcus pyogenes qPCR Kit2 refs98/79 RevoDx TORCH qPCR Kit3 refs98/79 RevoDx Toxoplasma gondii qPCR Kit2 refs98/79 RevoDx Transplant Pathogen Detection Kit3 refs98/79 RevoDx Treponema pallidum qPCR Kit2 refs98/79 RevoDx Trichomonas Vaginalis qPCR Kit2 refs98/79 RevoDx Trypanosoma cruzi qPCR Kit98/79 RevoDx Ureaplasma Parvum qPCR Kit2 refs98/79 RevoDx Ureaplasma Parvum/Urealytıcum qPCR Kit3 refs98/79 RevoDx Ureaplasma Urealytıcum qPCR Kit2 refs98/79 RevoDx Urinary Tract Infections (UTIs) Pathogen Detection Kit3 refs98/79 RevoDx Vancomycin resistance (vanA/vanB) qPCR Kit2 refs98/79 RevoDx Vibrio cholerae qPCR Kit2 refs98/79 RevoDx Vibrio parahaemolyticus qPCR Kit2 refs98/79 RevoDx Vibrio vulnificus qPCR Kit2 refs98/79 RevoDx Viral Meningitis-Encephalitis Pathogen Detection Kit3 refs98/79 RevoDx Viral Nucleic Acid Purification Kit5 refs98/79 RevoDx Viral Transport Medium3 refs98/79 RevoDx VZV qPCR Kit2 refs98/79 RevoDx West Nile virus qPCR Kit2 refs98/79 RevoDx Yersinia Enterocolitica qPCR Kit2 refs98/79 RevoDx Zika Virus qPCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Sansure FDA EU representative : Lotus NL B.V. (Netherlands) and 3 others	China	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 refs98/79 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-4898/79 205 others 4 HFMD related Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 5 Diarrhea Escherichia coli Nucleic Acid Detection Kit (PCR-Fluorescence Probing)2 refs98/79 5 Encephalitis related Viruses Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 6 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 9 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 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 refs98/79 Adenovirus 41 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Adenovirus and Adenovirus 3/7 Subtypes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Adenovirus and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)3 refs98/79 Adenovirus Rapid Antigen Test (Colloidal Gold Method)3 refs98/79 Astrovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 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 refs98/79 Avian influenza virus H9 RNA Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 BK Virus DNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Bordetella Parapertussis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Bordetella Pertussis DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Brucella Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Campylobacter coli Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Campylobacter fetus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Campylobacter jejuni / Campylobacter coli / Campylobacter lari Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Campylobacter jejuni Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Candida Albicans, Acinetobacter Baumannii and Pneumocystis Jiroveci Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Candida Albicans, Cryptococcus Neoformans and Pneumocystis Jiroveci Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Chikungunya virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 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 refs98/79 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 refs98/79 Cryptosporidium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 D-Dimer Assay Kit (Chemiluminescent Immunoassay)2 refs98/79 D-Dimer Chemiluminescence Immunoassay Kit6 refs98/79 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 refs98/79 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 refs98/79 Drug Resistant Bordetella pertussis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Ebola Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Echovirus E11 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Echovirus E30 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Entamoeba Histolytica Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Enterococcus Faecalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Enterococcus Faecium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Enterococcus Faeciuma and Enterococcus Faecalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Enteropathogenic Escherichia Coli Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 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 refs98/79 Fibrin/fibrinogen Degradation Products Chemiluminescence Immunoassay Kit6 refs98/79 Forest encephalitis Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Giardia Lamblia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Group A Streptococcus (GAS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)3 refs Haemophilus influenzae (HI) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Helicobacter pylori typingl Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Helicobacter pylori universal Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 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 refs98/79 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 refs Human Parvovirus B19 DNA Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Human Rhinovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Human Rotavirus A and B Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Human Rotavirus A/B/C Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Influenza A (H5N1) Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing）2 refs98/79 Influenza A and BV/BY RNA Diagnositc Kit（PCR-Fluorescence Probing）2 refs98/79 Influenza A Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Influenza A/B Virus and Respiratory Syncytial Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Influenza A/B Virus Nucleic Acid Diagnostic Kit ( PCR-Fluorescence Probing)2 refs98/79 Influenza A/B Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Influenza BV/BY RNA Diagnostic Kit（PCR-Fluorescence Probing）2 refs98/79 Interleukin-10 Chemiluminescence Immunoassay Kit6 refs98/79 Interleukin-1β Chemiluminescence Immunoassay Kit6 refs98/79 Interleukin-2 Receptor Chemiluminescence Immunoassay Kit6 refs98/79 Interleukin-6 Assay Kit (Chemiluminescent Immunoassay)2 refs98/79 Interleukin-6 Chemiluminescence Immunoassay Kit6 refs98/79 Interleukin-8 Chemiluminescence Immunoassay Kit6 refs98/79 Japanese Encephalitis virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Japanese Encephalitis Virus/Tick-Borne Encephalitis Virus/West Nile Virus/Dengue Virus (JEV/TBEV/WNV/DFV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 JC Virus DNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Legionella pneumophila Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)3 refs98/79 Listeria Monocytogenes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Masern virus, Rubella virus, and Mumps virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Measles and Rubella virus (MeV/RV) RNA Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Methicillin-resistant Staphylococcus aureus mecA Gene Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Multi-type Sample DNA/RNA Extraction-Purification Kit (Magnetic beads method) S1006E3 refs Multiple Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Mycobacterium Multiplex Nucleic Acid Diagnostic Kit(Multiplex PCR-Fluorescence Probing)98/79 Mycobacterium tuberculosis (MTB) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)2 refs 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 refs98/79 Neisseria Meningitidis Serogroup A, B, and C nucleic acid Diagnostic Kit（PCR-Fluorescence Probing)2 refs98/79 Neisseria Meningitidis Serogroup W, X, and Y nucleic acid Diagnostic Kit（PCR-Fluorescence Probing)2 refs98/79 Norovirus GI/GII/Rotavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Norovirus GI/GII/Sapovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 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 refs Nucleic acid extraction (DNA/RNA) or purification kit(Magnetic beads method) S10013E3 refs Nucleic acid extraction (DNA) or purification kit(Magnetic beads method) S10012E3 refs Nucleic Acid Extraction-Purification Kit IV-IX3 refs Nucleic Acid Extraction-Purification Kit S10016E3 refs Nucleic Acid Extraction-Purification Kit S10018E3 refs Nucleic Acid Extraction-Purification Kit S50015E3 refs Nucleic Acid Extraction-Purification Kit S50016E3 refs Nucleic Acid Extraction-Purification Kit S5005E3 refs Nucleic Acid Extraction-Purification Kit V-VI3 refs Nucleic Acid Extraction-Purification Kit V-VII S5007E-483 refs Parainfluenza Virus type 1, 2 and 3 Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)3 refs98/79 Plasmodium DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Pneumocystis Jiroveci, Cryptococcus Neoformans and Aspergillus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 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 refs98/79 Respiratory Syncytial Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 S3102E-242 refs S3213E-48 S3401E98/79 Salmonella Paratyphi Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Salmonella Typhi and Salmonella Paratyphoid Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Salmonella Typhi Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Sample Diluent2 refs Sample Release and Storage Reagent X1009E-24D-2 Sample Release Reagent S1011E2 refs Sample Release Reagent S1012E3 refs Sample Release Reagent S1013E3 refs Sample Release Reagent S1014E3 refs Sample Release Reagent S1015E-243 refs Sample Storage Reagent X X1010E-48-13 refs Sample Storage Reagent X1001E2 refs Sample Storage Reagent X1002E3 refs Sample Storage Reagent X1003E3 refs Sample Storage Reagent X1004E3 refs Sample Storage Reagent X1006E3 refs Sample Storage Reagent XI X1011E-24A-33 refs SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)2 refs98/79 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 refs98/79 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 refs98/79 Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)2 refs Six Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs Staphylococcus Aureus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Streptococcus Pneumoniae Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Thrombin-Antithrombin III Complex Chemiluminescence Immunoassay Kit6 refs98/79 Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1 Complex Chemiluminescence Immunoassay Kit6 refs98/79 Toxigenic Clostridium difficile DNA Diagnostic Kit (PCR-Fluorescence Probing)3 refs98/79 Treponema Pallidum DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Tumor Necrosis Factor α Chemiluminescence Immunoassay Kit6 refs98/79 Varicella-zoster virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Vibrio Cholerae Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Vibrio Cholerae O1 and O139 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 West Nile Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Yersinia Enterocolitica Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Zika Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Adenovirus Group F Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Bocavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Dengue Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 (no longer marketed) High-risk Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 (no longer marketed) Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 (no longer marketed) Human Rotavirus A Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Human Rotavirus B Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Influenza B Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 (no longer marketed) MBGV/RVFV/CHIKV Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Mycoplasma Pneumoniae Rapid Antigen Test (Colloidal Gold Method)3 refs98/79 (no longer marketed) Norovirus GI and GII Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Norovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Nucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method) S10011E2 refs (no longer marketed) Plasmodium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 (no longer marketed) Plesiomonas Shigelloides Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Q Fever Rickettsia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) SARS Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 (no longer marketed) SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)4 refs98/79 (no longer marketed) Severe Fever with Thrombocytopenia Syndrome Bunyavirus（SFTSV） Nucleic Acid Detection Kit(PCR-Fluorescence Probing)2 refs98/79 (no longer marketed)	A, B, C IVDR, 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain)	China	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-AR02C598/79 179 others 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 Brucella Abortus Control2 refs98/79 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 refs98/79 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 refs98/79 EV71 IgM Rapid Test98/79 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 refs98/79 Hemoglobin Test strip C41-HBB498/79 HPIV Control98/79 HPV L51-HPV01S98/79 HSV 1/2 IgG Rapid Test2 refs98/79 HSV 1/2 IgG/IgM Rapid Test4 refs98/79 HSV 1/2 IgM Rapid Test2 refs98/79 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 refs98/79 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 refs98/79 One Step SARS-CoV-2 Antigen Test (Oral Fluid)98/79 One Step SARS-CoV-2 IgG Test2 refs98/79 One Step SARS-CoV-2 IgG/IgM Test2 refs98/79 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 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 refs98/79 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 refs98/79 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 refs98/79 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 Vibrio cholerae O1/O139 Control98/79 Zika IgG/IgM Control L51-ZIB01R98/79 Zika NS1 Control98/79	– 98/79	Website info@kylinew.com EUDAMED record Report an error
Biocyc	Germany	Albumin FITC4 refs98/79 ALK (QR017)3 refs AMACR (QR108)3 refs Androgen receptor (QR135)3 refs Arginase-1 (QR083)7 refs98/79 170 others BAP1 (QR119)3 refs Bcl2 (QR062)7 refs98/79 Bcl6 (QR047)7 refs98/79 Beta-Catenin (QR095)7 refs98/79 BOB.1 (QR072)7 refs98/79 c-Myc (QR061)3 refs C1q FITC4 refs98/79 C3c FITC4 refs98/79 C4c FITC4 refs98/79 C4d (QR053)7 refs98/79 Cadherin 17 (QR098)7 refs98/79 Caldesmon (QR063)7 refs98/79 Calponin 1 (QR139)3 refs Calretinin (QR059)7 refs98/79 Carbonic anhydrase 9 (QR114)3 refs CD10 (QR021)3 refs CD103 (QR081)7 refs98/79 CD117 (QR012)3 refs CD138 (QR102)7 refs98/79 CD15 (MMA)7 refs98/79 CD171/L1CAM (QR039)7 refs98/79 CD1a (QR123)3 refs CD20 (QR094)7 refs98/79 CD21 (QR076)7 refs98/79 CD23 (QR036)7 refs98/79 CD30 (QR109)7 refs98/79 CD31 (QR034)7 refs98/79 CD34 (QR093)7 refs98/79 CD3e (QR004)3 refs CD4 (QR032)7 refs98/79 CD45/LCA (QR106)7 refs98/79 CD5 (QR111)7 refs98/79 CD56 (QR044)7 refs98/79 CD68 (QR105)3 refs CD71 (QR073)7 refs98/79 CD79a (QR033)7 refs98/79 CD8 (QR068)7 refs98/79 CD99 (QR067)7 refs98/79 CDK4 (QR115)3 refs CDX2 (QR045)7 refs98/79 CEA (QR117)3 refs Chromogranin A (QR096)7 refs98/79 Claudin 4 (QR137)3 refs Cyclin D1 (QR022)7 refs98/79 Cytokeratin 14 (QR057)7 refs98/79 Cytokeratin 18 (QR147)3 refs Cytokeratin 19 (QR125)3 refs Cytokeratin 20 (Ks20.8)7 refs98/79 Cytokeratin 5 (QR027)7 refs98/79 Cytokeratin 5/14 (QR027 & QR057)7 refs98/79 Cytokeratin 5/6 (QR027 & QR028)7 refs98/79 Cytokeratin 6 (QR028)7 refs98/79 Cytokeratin 7 (QR049)7 refs98/79 Cytokeratin 8 (QR112)7 refs98/79 Cytokeratin HMW (34betaE12)7 refs98/79 Cytokeratin pan (MNF116)7 refs98/79 Cytokeratin pan (QR124)3 refs Desmin (QR026)7 refs98/79 DOG1 (QR070)7 refs98/79 E-Cadherin (QR035)7 refs98/79 EGFR (QR078)7 refs98/79 EMA (QR118)3 refs ERG (QR040)7 refs98/79 Estrogen Receptor (QR013)3 refs Factor XIIIa (QR086)7 refs98/79 Fibrinogen FITC4 refs98/79 GATA3 (QR018)3 refs GFAP (QR066)7 refs98/79 GLUT1 (QR082)7 refs98/79 Glutamine synthetase (QR090)7 refs98/79 Glypican 3 (QR103)7 refs98/79 Granzyme B (QR130)3 refs Helicobacter pylori (QR091)7 refs98/79 Hep Par-1 (QR122)3 refs Her2/Neu (QR003)7 refs98/79 Histone H3.3 G34W (QR133)3 refs HSP70 (QR087)7 refs98/79 IDH1 R132H (QM002)7 refs98/79 IgA (QR050)7 refs98/79 IgA FITC4 refs98/79 IgG FITC4 refs98/79 IgG4 (QR092)7 refs98/79 IgM FITC4 refs98/79 Inhibin alpha (QR088)7 refs98/79 INSM1 (QR128)3 refs IRTA1 (QM005)3 refs98/79 Kappa FITC4 refs98/79 Kappa light chain (QR051)7 refs98/79 Ki-67 (QR015) Ki67 (QR015)3 refs Lambda FITC4 refs98/79 Lambda light chain (QR052)7 refs98/79 Langerin (QR065)7 refs98/79 Mammaglobin (QR080)7 refs98/79 MDM2 (SMP14)6 refs98/79 Melan A (A103)7 refs98/79 Melan A (QR138)3 refs Melanoma (HMB-45)7 refs98/79 MLH1 (QM003)3 refs MPO (QR101)7 refs98/79 MSH2 (QR010)3 refs MSH6 (QR011)3 refs MTAP (QR131)3 refs MUM1 (QR075)7 refs98/79 MyoD1 (QR069)7 refs98/79 Myogenin (QR089)7 refs98/79 Myosin heavy chain 11 (QR064)7 refs98/79 Napsin A (QR058)6 refs98/79 Napsin A (QR058) C-N002-02598/79 NKX2.2 (QR077)7 refs98/79 NKX3.1 (QR055)3 refs NSE (QR104)6 refs98/79 NSE (QR105) NSE (QR104)98/79 NUT (QR043)7 refs98/79 Olig2 (QR071)7 refs98/79 p16 (QR019)3 refs p21 (QR085)7 refs98/79 p40 (QR020)7 refs98/79 p40 (QR152)3 refs p53 (QR025)7 refs98/79 p63 (QR007)3 refs pan-TRK (QR008)7 refs98/79 PAX2 (QR060)7 refs98/79 PAX5 (QR056)7 refs98/79 PAX8 (QR016)3 refs PD-1 (QR002)7 refs98/79 PD-L1 (QR001)7 refs98/79 PIN-Cocktail AMACR/p63 (QR108 & QM006)3 refs PLAP (QR084)7 refs98/79 PMS2 (QR009)3 refs Podoplanin (QR048)7 refs98/79 PolyQ Stain 1 step detection system goat anti-mouse AP3 refs PolyQ Stain 1 step detection system goat anti-mouse HRP3 refs PolyQ Stain 1 step detection system goat anti-mouse HRP, Peroxidase quench, DAB kit3 refs PolyQ Stain 1 step detection system goat anti-mouse/rabbit AP3 refs PolyQ Stain 1 step detection system goat anti-mouse/rabbit AP, Permanent Red kit3 refs PolyQ Stain 1 step detection system goat anti-mouse/rabbit HRP3 refs PolyQ Stain 1 step detection system goat anti-mouse/rabbit HRP, Peroxidase quench, DAB kit3 refs PolyQ Stain 1 step detection system goat anti-rabbit AP3 refs PolyQ Stain 1 step detection system goat anti-rabbit HRP3 refs PolyQ Stain 1 step detection system goat anti-rabbit HRP, Peroxidase quench, DAB kit3 refs PolyQ Stain 1 step double stain goat anti-mouse HRP, goat anti-rabbit AP3 refs PolyQ Stain 1 step double stain goat anti-rabbit HRP, goat anti-mouse AP3 refs PolyQ Stain 2 step detection system goat anti-mouse/rabbit AP3 refs PolyQ Stain 2 step detection system goat anti-mouse/rabbit AP, Permanent Red kit3 refs PolyQ Stain 2 step detection system goat anti-mouse/rabbit HRP3 refs PolyQ Stain 2 step detection system goat anti-mouse/rabbit HRP, Peroxidase quench, DAB kit3 refs PolyQ Stain DAB Substrate Buffer3 refs PolyQ Stain DAB, 2 components3 refs PolyQ Stain Permanent Red, 2 components3 refs PRAME (QR005)3 refs Progesterone Receptor (QR014) Progesteron Receptor (QR014)3 refs PSA (QR038)3 refs PSMA (QR079)7 refs98/79 PTEN (QR042)7 refs98/79 S100B (QR031)7 refs98/79 SALL4 (QR024)7 refs98/79 SATB2 (QR023)3 refs SMA (QR110)3 refs SMAD4 (QR029)7 refs98/79 SMARCA4 (QR132)3 refs SOX10 (QR006)3 refs SOX11 (QR074)7 refs98/79 STAT6 (QR041)3 refs Synaptophysin (QR054)7 refs98/79 TdT (QR037)7 refs98/79 TRPS1 (QR099)3 refs TTF1 (QR046)7 refs98/79 Tyrosinase (T311)7 refs98/79 Vimentin (QR097)7 refs98/79 WT1 (QR030)7 refs98/79	A, C IVDR, 98/79	Website info@biocyc.de EUDAMED record Report an error
Vitro FDA	Romania, Spain	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 refs master diagnóstica MAD-000125Q3 refs master diagnóstica MAD-000135Q15 refs98/79 167 others master diagnóstica MAD-000189Q15 refs98/79 master diagnóstica MAD-000198Q3 refs master diagnóstica MAD-000237QP-100/V2 refs master diagnóstica MAD-000305Q9 refs master diagnóstica MAD-000306Q3 refs master diagnóstica MAD-000308Q3 refs master diagnóstica MAD-000309Q3 refs master diagnóstica MAD-000310Q3 refs master diagnóstica MAD-000317Q3 refs master diagnóstica MAD-000319Q8 refs master diagnóstica MAD-000320Q3 refs master diagnóstica MAD-000333Q9 refs master diagnóstica MAD-000340Q3 refs master diagnóstica MAD-000375Q3 refs master diagnóstica MAD-000380Q9 refs master diagnóstica MAD-000402Q3 refs master diagnóstica MAD-000421Q15 refs98/79 master diagnóstica MAD-000425Q15 refs98/79 master diagnóstica MAD-000434Q3 refs master diagnóstica MAD-000435Q3 refs master diagnóstica MAD-000436Q3 refs master diagnóstica MAD-000440Q15 refs98/79 master diagnóstica MAD-000475Q3 refs master diagnóstica MAD-000487Q3 refs master diagnóstica MAD-000526Q15 refs98/79 master diagnóstica MAD-000533Q3 refs master diagnóstica MAD-000539Q3 refs master diagnóstica MAD-000578Q8 refs master diagnóstica MAD-000599Q8 refs master diagnóstica MAD-000600Q3 refs master diagnóstica MAD-000602Q3 refs master diagnóstica MAD-000603Q3 refs master diagnóstica MAD-000606Q3 refs master diagnóstica MAD-000607Q3 refs master diagnóstica MAD-000616Q3 refs master diagnóstica MAD-000619Q3 refs master diagnóstica MAD-000621Q16 refs98/79 master diagnóstica MAD-000630Q3 refs master diagnóstica MAD-000635Q3 refs master diagnóstica MAD-000636Q3 refs master diagnóstica MAD-000638Q9 refs master diagnóstica MAD-000644Q9 refs master diagnóstica MAD-000645Q3 refs master diagnóstica MAD-000646Q16 refs98/79 master diagnóstica MAD-000647Q16 refs98/79 master diagnóstica MAD-000648Q16 refs98/79 master diagnóstica MAD-000650Q3 refs master diagnóstica MAD-000651Q3 refs master diagnóstica MAD-000652Q9 refs master diagnóstica MAD-000654Q3 refs master diagnóstica MAD-000656Q3 refs master diagnóstica MAD-000658Q16 refs98/79 master diagnóstica MAD-000659Q3 refs master diagnóstica MAD-000667Q16 refs98/79 master diagnóstica MAD-000669Q9 refs master diagnóstica MAD-000670Q3 refs master diagnóstica MAD-000671Q3 refs master diagnóstica MAD-000672Q16 refs98/79 master diagnóstica MAD-000673Q9 refs master diagnóstica MAD-000674Q3 refs master diagnóstica MAD-000675Q9 refs master diagnóstica MAD-000676Q3 refs master diagnóstica MAD-000677Q3 refs master diagnóstica MAD-000681Q3 refs master diagnóstica MAD-000682Q3 refs master diagnóstica MAD-000686Q3 refs master diagnóstica MAD-000691Q3 refs master diagnóstica MAD-000692Q3 refs master diagnóstica MAD-000695Q3 refs master diagnóstica MAD-000696Q3 refs master diagnóstica MAD-000697Q8 refs master diagnóstica MAD-000698Q15 refs98/79 master diagnóstica MAD-000699Q15 refs98/79 master diagnóstica MAD-000701Q15 refs98/79 master diagnóstica MAD-000706Q3 refs master diagnóstica MAD-000710Q16 refs98/79 master diagnóstica MAD-000711Q9 refs master diagnóstica MAD-000712Q3 refs master diagnóstica MAD-000716Q3 refs master diagnóstica MAD-000718Q3 refs master diagnóstica MAD-000722Q3 refs master diagnóstica MAD-000726Q3 refs master diagnóstica MAD-000728Q3 refs master diagnóstica MAD-000733Q3 refs master diagnóstica MAD-000734Q3 refs master diagnóstica MAD-000735Q3 refs master diagnóstica MAD-000739Q3 refs master diagnóstica MAD-000742Q16 refs98/79 master diagnóstica MAD-000747Q3 refs master diagnóstica MAD-000749Q3 refs master diagnóstica MAD-000757Q16 refs98/79 master diagnóstica MAD-000761Q15 refs98/79 master diagnóstica MAD-000763Q3 refs master diagnóstica MAD-000765Q3 refs master diagnóstica MAD-000779Q11 refs98/79 master diagnóstica MAD-000793Q3 refs master diagnóstica MAD-000819Q3 refs master diagnóstica MAD-000916Q3 refs master diagnóstica MAD-001000Q3 refs master diagnóstica MAD-001004Q3 refs master diagnóstica MAD-001011Q3 refs master diagnóstica MAD-001100Q3 refs master diagnóstica MAD-001115Q16 refs98/79 master diagnóstica MAD-001122Q16 refs98/79 master diagnóstica MAD-001195Q3 refs master diagnóstica MAD-001200Q3 refs master diagnóstica MAD-001215Q16 refs98/79 master diagnóstica MAD-001221Q3 refs master diagnóstica MAD-001361Q3 refs master diagnóstica MAD-001380Q3 refs master diagnóstica MAD-001613Q8 refs master diagnóstica MAD-001619Q3 refs master diagnóstica MAD-001645Q3 refs master diagnóstica MAD-001701Q3 refs master diagnóstica MAD-001707Q3 refs master diagnóstica MAD-001709Q98/79 master diagnóstica MAD-001720Q16 refs98/79 master diagnóstica MAD-001904Q3 refs master diagnóstica MAD-001VS2 refs master diagnóstica MAD-002022Q9 refs master diagnóstica MAD-002037Q9 refs master diagnóstica MAD-002045Q9 refs master diagnóstica MAD-002048Q9 refs master diagnóstica MAD-002066Q3 refs master diagnóstica MAD-002084Q3 refs master diagnóstica MAD-002095Q3 refs master diagnóstica MAD-002097Q3 refs master diagnóstica MAD-002163Q3 refs master diagnóstica MAD-002VS master diagnóstica MAD-003930MU-HS12-243 refs master diagnóstica MAD-003938M-HS123 refs master diagnóstica MAD-003949M-W master diagnóstica MAD-003955M master diagnóstica MAD-003963M-W2 refs master diagnóstica MAD-003966M-L2 refs master diagnóstica MAD-003VS2 refs master diagnóstica MAD-004VS2 refs master diagnóstica MAD-005084Q9 refs master diagnóstica MAD-005103Q3 refs master diagnóstica MAD-005105Q3 refs master diagnóstica MAD-005138Q16 refs98/79 master diagnóstica MAD-005151Q16 refs98/79 master diagnóstica MAD-005671Q3 refs master diagnóstica MAD-005860Q9 refs master diagnóstica MAD-005VS2 refs master diagnóstica MAD-006VS2 refs master diagnóstica MAD-007VS2 refs master diagnóstica MAD-008VS2 refs master diagnóstica MAD-009059Q3 refs master diagnóstica MAD-009VS2 refs master diagnóstica MAD-010VS2 refs master diagnóstica MAD-011VS2 refs master diagnóstica MAD-013VS2 refs master diagnóstica MAD-014VS2 refs master diagnóstica MAD-015VS2 refs master diagnóstica MAD-016VS2 refs master diagnóstica MAD-017VS2 refs master diagnóstica MAD-018VS2 refs master diagnóstica MAD-019VS2 refs master diagnóstica MAD-024VS2 refs master diagnóstica MAD-025VS2 refs master diagnóstica MAD-103.020 master diagnóstica MAD-104.250M master diagnóstica MAD-HDH3-100VS2 refs 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	Website regulatory@vitro.bio EUDAMED record Report an error
Agilent FDA EU representative : Agilent Technologies Denmark ApS (Denmark)	Singapore, United States	Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A K589911-21 Artisan 50x Wash Solution AR102 Artisan Acid-Fast Bacillus (AFB) Stain Kit AR162 Artisan Alcian Blue pH 2.5 Stain Kit AR160 Artisan Alcian Blue/PAS Stain Kit AR169 187 others 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 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 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 DAB Away DAB Chromogen Removal System S1967 Dako DAB Enhancer S19612 refs 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 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 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 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 refs 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 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 Polyclonal Rabbit Anti-Human Lysozyme EC 3.2.1.17/FITC F037298/79 Protein Block Serum-Free Ready-to-Use X0909 Target Retrieval Solution pH 9 (50x) (Dako Omnis) GC309 Wash Buffer (20x) (Dako Omnis) GC80711-2 Monoclonal Mouse Anti-Human CD19/PerCP-Cy5.5, Clone HD37 PR7032 refs98/79 (no longer marketed) Monoclonal Mouse Anti-Human CD2/RPE, Clone MT910 R080798/79 (no longer marketed) Monoclonal Mouse Anti-Human CD20/RPE, Clone B-Ly1 R701398/79 (no longer marketed) Monoclonal Mouse Anti-Human CD22/PerCP-Cy5.5, Clone 4KB128 PR70798/79 (no longer marketed) Monoclonal Mouse Anti-Human CD3/RPE-Cy5, Clone UCHT1 C706798/79 (no longer marketed) Monoclonal Mouse Anti-Human CD38/RPE, Clone AT13/5 R714498/79 (no longer marketed) Monoclonal Mouse Anti-Human CD4/APC, Clone MT310 C722698/79 (no longer marketed) Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen/RPE-Cy5, Clone T29/33 C709998/79 (no longer marketed) Monoclonal Mouse Anti-Human CD45R0/RPE, Clone UCHL1 R084398/79 (no longer marketed) Monoclonal Mouse Anti-Human CD45RA/RPE, Clone 4KB5 R708698/79 (no longer marketed) Monoclonal Mouse Anti-Human CD7/FITC, Clone DK24 F078998/79 (no longer marketed) Monoclonal Mouse Anti-Human HLA-DR Antigen/FITC, Clone AB3 F726698/79 (no longer marketed) MultiMix Triple-Colour Reagent Anti-Human CD8/FITC, Anti-Human CD4/RPE, Anti-Human CD3/RPE-Cy5 TC64198/79 (no longer marketed) MultiMix™ Dual-Colour Reagent, Anti-Human CD10/FITC + Anti-Human CD19/RPE FR88398/79 (no longer marketed) MultiMix™ Dual-Colour Reagent, Anti-Human CD2/FITC + Anti-Human CD19/RPE FR89498/79 (no longer marketed) MultiMix™ Dual-Colour Reagent, Anti-Human CD3/FITC + Anti-Human CD19/RPE FR86698/79 (no longer marketed) MultiMix™ Dual-Colour Reagent, Anti-Human CD3/FITC + Anti-Human CD4/RPE FR87598/79 (no longer marketed) MultiMix™ Dual-Colour Reagent, Anti-Human CD3/FITC + Anti-Human CD8/RPE FR88198/79 (no longer marketed) MultiMix™ Dual-Colour Reagent, Anti-Human CD4/FITC + Anti-Human CD8/RPE FR86898/79 (no longer marketed) MultiMix™ Dual-Colour Reagent, Anti-Human CD45/FITC + Anti-Human CD20/RPE FR72998/79 (no longer marketed) MultiMix™ Dual-Colour Reagent, Anti-Human CD5/FITC + Anti-Human CD19/RPE FR88298/79 (no longer marketed) MultiMix™ Dual-Colour Reagent, Anti-Human HLA-DP, DQ, DR Antigen/FITC + Anti-Human CD3/RPE FR86798/79 (no longer marketed) MultiMix™ Dual-Colour Reagent, Anti-Human Kappa Light Chains/FITC + Anti-Human CD19/RPE FR04898/79 (no longer marketed) MultiMix™ Dual-Colour Reagent, Anti-Human Lambda Light Chains/FITC + Anti-Human CD19/RPE FR04498/79 (no longer marketed)	A, C IVDR, 98/79	Website info.dk@agilent.com EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other	China	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 others 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 refs98/79 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	EUDAMED record Report an error
SSI Diagnostica FDA	Denmark	Pneumococcus Factor 10b98/79 Pneumococcus Factor 10d98/79 Pneumococcus Factor 10f98/79 Pneumococcus Factor 11b98/79 Pneumococcus Factor 11c98/79 151 others 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 refs98/79 Pneumococcus Factor 6c98/79 Pneumococcus Factor 6c high titer2 refs98/79 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	– 98/79	Website info@ssidiagnostica.com EUDAMED record Report an error
Oacp	Ireland	Bladder Cancer cells chromosome and gene anomaly detection probe98/79 CL-004 fp-001 FP-00298/79 FP-00398/79 148 others FP-004 (FP-044)98/79 FP-00598/79 FP-00698/79 FP-00798/79 FP-0115 refs98/79 FP-011-698/79 FP-01298/79 FP-01398/79 FP-0143 refs98/79 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 TOP2A gene amplification probe detection kit98/79	A IVDR, 98/79	Website EUDAMED record Report an error
Technoclone	Austria	Abnormal Human Control Plasma3 refs AK-Calibrant98/79 AK-Verification2 refs APC Control Kit98/79 APC Resistance Kit2 refs98/79 135 others APIX CalSet APIX ControlSet98/79 CaCl2 25 mM3 refs CaCl2 50 mM2 refs Ceveron TGA CAL98/79 Citrate Buffer2 refs Coagulation CON N3 refs Coagulation Control A98/79 Coagulation Control AK98/79 Coagulation Control N98/79 Coagulation Reference2 refs DABI CalSet DABI ControlSet Dapttin3 refs DTI Chrom EDOX CalSet EDOX ControlSet98/79 Factor II immunads. Deficient Plasma98/79 Factor IX DP2 refs 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 refs Factor VIII immunads. Deficient Plasma2 refs98/79 Factor VIII INH CON Factor VIII INH Kit2 refs 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 refs Lupus Anticoagulant Test98/79 Lupus Inhibitor Plasma2 refs98/79 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 refs Siron LS3 refs 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 refs 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 refs98/79 Technoplastin HIS4 refs Technoplastin HIS Ceveron3 refs 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 refs Technoview Arixtra CAL Technoview Arixtra CON H98/79 Technoview Arixtra CON L98/79 Technoview Dabigatran CAL98/79 Technoview Dabigatran CON H2 refs Technoview Edoxaban CAL98/79 Technoview Edoxaban CON H3 refs Technoview LMWH CAL Technoview LMWH CON H2 refs Technoview LMWH CON M98/79 Technoview Orgaran CAL Technoview Orgaran CON H2 refs Technoview Rivaroxaban CAL98/79 Technoview Rivaroxaban CAL H98/79 Technoview Rivaroxaban CON H2 refs 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	Website regulatory@technoclone.com EUDAMED record Report an error
Stago FDA	France	ADP98/79 Arachidonic acid98/79 Asserachrom® HPIA98/79 Asserachrom® HPIA - IgG98/79 Asserachrom® D-Di98/79 135 others 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 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 Stachrom® Heparin98/79 Stachrom® PAI98/79 Staclot® LA98/79 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® - 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 refs 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 refs STA® - Liatest® VWF:Ag98/79 STA® - Liquid Anti-Xa 42 refs STA® - Liquid Fib STA® - Multi Hep Calibrator STA® - NeoPTimal 103 refs STA® - Néoplastine® CI Plus 102 refs 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 refs STA® - Staclot® Protein C 1 STA® - Staclot® Protein S98/79 STA® - System Control N+P98/79 STA® - Thrombin 102 refs STA® - Unicalibrator STA® - VWF:Ag Calibrator98/79 STA® - VWF:RCo98/79 STG® - Cal&Fluo98/79 sthemA CAL-CBC sthemO AT L sthemO CaCl2 M sthemO CK Prest sthemO Complete QC 1&2 sthemO Daily QC 1&2 sthemO DDi M sthemO dRVV confirm sthemO dRVV screen L2 refs 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 (no longer marketed)	A, B, C IVDR, 98/79	EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy)	Italy, United States	HerpeSelect® 1 and 2 Immunoblot IgG98/79 HerpeSelect® 2 ELISA IgG98/79 LIAISON ® EBV IgM LIAISON® Adenovirus98/79 LIAISON® Adenovirus Control Set98/79 127 others 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 refs 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® 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® Measles IgM LIAISON® Meridian H. pylori SA98/79 LIAISON® Meridian H. pylori SA Control Set98/79 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® 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 Control Toxo IgG Avidity LIAISON® XL Toxo IgG Avidity 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 refs98/79 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	Website ivdr_dsu@diasorin.com EUDAMED record Report an error
LGC Clinical Diagnostics FDA EU representative : MediMark Europe Sarl. (France)	United States	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 others 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 refs Optitrol Chagas-2, 1x pos, 1mL SR160352 refs Optitrol HEPA-1, 1x pos, 1mL SR120252 refs Optitrol HEPA-2, 1x pos, 1mL SR120352 refs Optitrol HEPR-1 SR120472 refs Optitrol HEPR-2, 1x pos, 1mL SR120572 refs Optitrol HIV 2, 1x pos, 1mL SR111133 refs Optitrol HIV p24, 1x pos,1mL SR111013 refs Optitrol HSV 2 SR130372 refs Optitrol Lyme/TBE G SR170183 refs Optitrol Lyme/TBE M SR170283 refs Optitrol Malaria SR160172 refs Optitrol Measles M SR150453 refs Optitrol Mumps M, 1x pos, 1mL SR150653 refs Optitrol NAT CMV, 10x 1.2 mL NT020212 refs Optitrol NAT CT/NG, 10x 1.2 mL NT020112 refs Optitrol NAT HAV, 10x 1.2 mL NT050112 refs Optitrol NAT HBV Screening, 10x 1,2 mL NT010112 refs Optitrol NAT HBV Viral Load, 10x 1.2 mL NT010132 refs Optitrol NAT HCV Screening, 10x 1,2 mL NT010212 refs Optitrol NAT HCV Viral Load, 10x 1.2 mL NT010232 refs Optitrol NAT HEV, 10x 1.2 mL NT011212 refs Optitrol NAT HIV Screening, 10x 1,2 mL NT010312 refs Optitrol NAT HIV Viral Load, 5x 1.2 mL NT01033 Optitrol NAT HIV-2, 10x 1,2 mL NT010352 refs Optitrol NAT HPV neg, 10x 1.2 mL NT060132 refs Optitrol NAT HPV, 10x 1.2 mL NT060112 refs Optitrol NAT NEG, 10x 1,2 mL NT010512 refs Optitrol NAT Parvo B19, 10x 1,2 mL NT050212 refs Optitrol NAT Triplex, 10x 1,2 mL NT010412 refs Optitrol Orange, 1x pos, 1mL SR110613 refs Optitrol Paediatric G negative, 2x neg, 2,5mL SR150253 refs Optitrol Paediatric G Pos SR150152 refs Optitrol Paediatric M Neg SR150032 refs Optitrol Parvo M SR150573 refs Optitrol Red, 1x pos, 1mL SR110513 refs Optitrol SeroNeg, 2x neg, 1mL SR110003 refs Optitrol Syphilis G SR111372 refs Optitrol ToRCH G Neg SR130193 refs Optitrol ToRCH M Neg SR130293 refs Optitrol VZV M SR150783 refs Optitrol Yellow 4x5 mL SR110213 refs 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	EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : Medunion S.L. (Spain) and 1 other	China	303034-0198/79 303034-0598/79 303034-4098/79 303057; 3030582 refs98/79 303059; 303060; 30306198/79 117 others 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 refs LYHER 303034701-01;303034701-05;303034701-20;303034701-25;303034701-403 refs LYHER 3030348013 refs LYHER 3030419013 refs LYHER 303045201-01;303045201-05;303045201-20;303045201-25;303045201-403 refs LYHER ICO-502-01; ICO-502-05; ICO-502-20; ICO-502-25; ICO-502-403 refs LYHER IDE-425-01; IDE-425-05; IDE-425-20; IDE-425-25; IDE-425-403 refs LYHER IDE-A402-01; IDE-A402-05; IDE-A402-20; IDE-A402-25; IDE-A402-403 refs LYHER IDE-B402-01; IDE-B402-05; IDE-B402-20; IDE-B402-25; IDE-B402-403 refs LYHER IFL-5022 refs LYHER IFL-A5022 refs LYHER IHP-4022 refs 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 refs 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 refs 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 refs LYHER ISY-402-01; ISY-402-05; ISY-402-20; ISY-402-25; ISY-402-403 refs Malaria Antigen Test Kit98/79 Respiratory Multiple Rapid Test98/79	B, C IVDR, 98/79	office@lyher.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	Adenovirus Quantification Kit (24)3 refs98/79 Adenovirus Quantification Kit (48)3 refs98/79 Adenovirus Quantification Kit (96)3 refs Aspergillus Identification and Monitoring Kit (24)3 refs98/79 Aspergillus Identification and Monitoring Kit (48)3 refs98/79 113 others Aspergillus Identification and Monitoring Kit (96)3 refs98/79 Aspergillus/Fusarium/Trichosporon Detection and Monitoring Kit (24)3 refs98/79 Bacterial Meningitis Detection and Monitoring Kit (24)3 refs98/79 Bacterial Meningitis Detection and Monitoring Kit (48)3 refs98/79 Bacterial Meningitis Detection and Monitoring Kit (96)3 refs98/79 Bacterial Sepsis Detection and Monitoring Kit (24)3 refs98/79 BKV Quantification Kit (24)3 refs98/79 BKV Quantification Kit (48)3 refs98/79 BKV Quantification Kit (96)3 refs98/79 Bordetella Detection and Monitoring Kit (24)3 refs98/79 Candida Auris Detection and Monitoring Kit (24)3 refs98/79 Candida Auris Detection and Monitoring Kit (48)3 refs98/79 Candida Auris Detection and Monitoring Kit (96)3 refs98/79 Candida Detection and Monitoring Kit (24)98/79 Clostridioides difficile Detection and Monitoring Kit (24)3 refs98/79 Clostridioides difficile Detection and Monitoring Kit (48)3 refs98/79 Covid Flu RSV Detection and Monitoring Kit (24)3 refs98/79 Covid Flu RSV Detection and Monitoring Kit (48)3 refs98/79 Covid Flu RSV Detection and Monitoring Kit (96)3 refs98/79 EBV Quantification Kit (24)3 refs98/79 EBV Quantification Kit (48)3 refs98/79 EBV Quantification Kit (96)3 refs98/79 Enteric Bacterial Detection and Monitoring Kit (24)3 refs98/79 Enteric Bacterial Detection and Monitoring Kit (48)3 refs98/79 Enteric Parasite Detection and Monitoring Kit (24)3 refs98/79 Enteric Parasite Detection and Monitoring Kit (48)3 refs98/79 Eye Infection Detection and Monitoring Kit (24)3 refs98/79 Gastrointestinal Detection and Monitoring Kit (24)3 refs98/79 Gastrointestinal Detection and Monitoring Kit (48)3 refs98/79 Gastrointestinal Detection and Monitoring Kit (96)3 refs98/79 HCV Genotyping Kit (24)3 refs98/79 HCV Genotyping Kit (48)3 refs98/79 HCV Genotyping Kit (96)3 refs98/79 Helicobacter pylori Detection and Monitoring Kit (24)2 refs98/79 Helicobacter pylori Detection and Monitoring Kit (24) Helicobacter pylori Detection and Monitoring Kit (48)98/79 Helicobacter pylori Detection and Monitoring Kit (48)3 refs98/79 HHV6 Quantification Kit (24)3 refs98/79 HHV6 Quantification Kit (48)3 refs98/79 HHV6 Quantification Kit (96)3 refs98/79 HPV Genotyping and Monitoring Kit (24)3 refs98/79 HPV Genotyping and Monitoring Kit (48)3 refs98/79 HPV Genotyping and Monitoring Kit (96)3 refs98/79 HPV Genotyping and Monitoring Plus Kit (24)3 refs98/79 HPV Genotyping and Monitoring Plus Kit (48)3 refs98/79 HPV Genotyping and Monitoring Plus Kit (96)3 refs98/79 HPV LR Genotyping and Monitoring Kit (24)3 refs98/79 HPV LR Genotyping and Monitoring Kit (48)3 refs98/79 HPV LR Genotyping and Monitoring Kit (96)3 refs98/79 HPV Screening and Monitoring Kit (24)3 refs98/79 HPV Screening and Monitoring Kit (48)3 refs98/79 HPV Screening and Monitoring Kit (96)3 refs98/79 HSV 1/2 Quantification Kit (24)3 refs98/79 HSV 1/2 Quantification Kit (48)3 refs98/79 HSV 1/2 Quantification Kit (96)3 refs98/79 Influenza-A Virus Detection and Monitoring Kit (24)3 refs98/79 Influenza-A Virus Detection and Monitoring Kit (48)3 refs98/79 Influenza-A Virus Detection and Monitoring Kit (96)3 refs98/79 JCV Quantification Kit (24)3 refs98/79 JCV Quantification Kit (48)3 refs98/79 JCV Quantification Kit (96)3 refs98/79 Joint Infection Detection and Monitoring Kit (24)3 refs98/79 Joint Infection Detection and Monitoring Kit (48)3 refs98/79 Joint Infection Detection and Monitoring Kit (96)3 refs98/79 Legionella pneumophila Detection and Monitoring Kit (24)3 refs98/79 Measles VirusDetection and Monitoring Kit (24)2 refs98/79 Measles VirusDetection and Monitoring Kit (24) Measles Virus Detection and Monitoring Kit (24)98/79 Meningitis Detection and Monitoring Kit (24)3 refs98/79 Meningitis Detection and Monitoring Kit (48)3 refs98/79 Meningitis Detection and Monitoring Kit (96)3 refs98/79 Monkeypox Virus Detection and Monitoring Kit (24)3 refs98/79 MTB Detection and Monitoring Kit (24)3 refs98/79 MTB Detection and Monitoring Kit (48)3 refs98/79 MTB Detection and Monitoring Kit (96)3 refs98/79 MTB/MDR Detection and Monitoring Kit (24)3 refs98/79 MTB/MDR Detection and Monitoring Kit (48)3 refs98/79 MTB/MDR Detection and Monitoring Kit (96)3 refs98/79 MTB/NTM Detection and Monitoring Kit (24)3 refs98/79 MTB/NTM Detection and Monitoring Kit (48)3 refs98/79 MTB/NTM Detection and Monitoring Kit (96)3 refs98/79 Mumps Virus Detection and Monitoring Kit (24)3 refs98/79 Parvovirus B19 Quantification Kit (24)3 refs98/79 Parvovirus B19 Quantification Kit (48)3 refs98/79 Parvovirus B19 Quantification Kit (96)3 refs98/79 Plasmodium Detection and Monitoring Kit (24)3 refs98/79 Respiratory Fast Screening and Monitoring Kit (24)3 refs98/79 Respiratory Fast Screening and Monitoring Kit (48)3 refs98/79 Respiratory Fast Screening and Monitoring Kit (96)3 refs98/79 Respiratory Pathogens Detection and Monitoring Kit (24)3 refs98/79 Respiratory Pathogens Detection and Monitoring Kit (48)3 refs98/79 Respiratory Pathogens Detection and Monitoring Kit (96)3 refs98/79 Salmonella spp Detection and Monitoring Kit (24)3 refs98/79 Sapovirus Detection and Monitoring Kit (24)3 refs98/79 Sapovirus Detection and Monitoring Kit (48)3 refs98/79 SARS-CoV-2 Detection and Monitoring Kit (24)3 refs98/79 SARS-CoV-2 Detection and Monitoring Kit (48)3 refs98/79 SARS-CoV-2 Detection and Monitoring Kit (96)3 refs98/79 Sepsis Detection and Monitoring Kit (24)3 refs98/79 STDs Detection and MonitoringKit (24)3 refs98/79 STDs Detection and MonitoringKit (48)3 refs98/79 STDs Detection and MonitoringKit (96)3 refs98/79 Streptococcus Pyogenes Detection and Monitoring Kit (24)3 refs98/79 TB-XDR Detection and Monitoring Kit (24)3 refs98/79 Tropical Fever Detection and Monitoring Kit (24)3 refs98/79 Urinary Tract Infection Detection and Monitoring Kit (24)3 refs98/79 Viral Meningitis Detection and Monitoring Kit (24)3 refs98/79 Viral Meningitis Detection and Monitoring Kit (48)3 refs98/79 Viral Meningitis Detection and Monitoring Kit (96)3 refs98/79 VZV Quantification Kit (24)3 refs98/79 VZV Quantification Kit (48)3 refs98/79 VZV Quantification Kit (96)3 refs98/79 West Nile Virus Detection and Monitoring Kit (24)3 refs98/79 West Nile Virus Detection and Monitoring Kit (48)3 refs98/79 West Nile Virus Detection and Monitoring Kit (96)3 refs98/79	C IVDR, 98/79	Website EUDAMED record Report an error
AusDiagnostics EU representative : Advena Limited (Malta) and 1 other	Australia	Demi DNA Reagent Cassette3 refs Extraction Control MT-Prep Blood DNA Extraction kit 1200 (48 samples)3 refs Respiratory Pathogens 12-well98/79 Respiratory Pathogens 12-well 80618P98/79 113 others 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 refs98/79 RIDA®Plex Urinogenital and Resistance 12 well Step 22 refs98/79 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 refs98/79 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	Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Mikrogen	Germany	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 others 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 refs 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 refs recomBead Yersinia IgA [IgM] 2.098/79 recomBead Yersinia IgG 2.098/79 recomBlot Rubella IgG recomBlot, recomLine Substrate TMB prec.3 refs 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 refs98/79 recomLine Borrelia IgM2 refs98/79 recomLine CMV IgG [Avidität]98/79 recomLine CMV IgM recomLine EBV IgM2 refs98/79 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 refs98/79 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 refs98/79 recomLine Treponema IgM2 refs98/79 recomLine Yersinia IgA [IgM] 2.02 refs98/79 recomLine Yersinia IgG 2.02 refs98/79 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	EUDAMED record Report an error
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş	Türkiye	Adenovirus Test IADV0198/79 Adenovirus Test RTADV0198/79 Adenovirus Test TADV0198/79 Adenovirus Test TIADV0198/79 Adenovirus Test TIADV0100198/79 112 others 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 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 Dengue NS1, IgG/IgM Test6 refs98/79 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 refs98/79 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	Website info@turklab.com.tr EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	Germany, United Kingdom (ex Northern Ireland)	ADVIA Centaur HBc Total 2 (HBcT2) IVDR_67_LLB_DUB-C_D_KIT_HBc Total 22 refs ADVIA Centaur HBc Total 2 (HBcT2) Quality Control IVDR_67_LLB_DUB-C_D_REAG_HBc Total 2 QC2 refs ADVIA Centaur Quantitative HBsAg (QHBs) IVDR_67_LLB_DUB-C_C_KIT_QHBs2 refs ADVIA Centaur Quantitative HBsAg (QHBs) Quality Control IVDR_67_LLB_DUB-C_C_REAG_QHBs QC2 refs Antiserum to Human Antithrombin III IVDR_27_MAR EB_C_REAG _AS_ATIII 103 others Antiserum to Human Fibrinogen IVDR_27_MAR EB_C_REAG_AS_FIB Antiserum to Human Plasminogen IVDR_27_MAR EB_B_REAG_AS_Plasm Batroxobin Reagent IVDR_27_MAR EB_C_REAG_Batrox2 refs BC Thrombin Reagent IVDR_27_MAR EB_C_KIT_BC_Thromb BC von Willebrand Reagent IVDR_27_MAR EB_C_REAG_BC_vW2 refs Berichrom a2-Antiplasmin IVDR_27_MAR EB_B_KIT_Ber_a2-Antipl3 refs Berichrom Antithrombin III (A) IVDR_27_MAR EB_C_PROF_KIT_Ber_ATIII3 refs Berichrom F XIII IVDR_27_MAR EB_C_KIT_Ber_FXIII2 refs Berichrom Plasminogen IVDR_27_MAR EB_B_KIT_Ber_Plasm3 refs Berichrom Protein C IVDR_27_MAR EB_C_KIT_Ber_Prot_C3 refs Calcium Chloride Solution IVDR_27_MAR EB_A_PROF_REAG_CaCl23 refs Coagulation Factor II Deficient Plasma IVDR_27_MAR EB_B_REAG_FII_Def_Pl3 refs Coagulation Factor IX Deficient Plasma IVDR_27_MAR EB_C_PROF_REAG_FIX_Def_Pl3 refs Coagulation Factor V Deficient Plasma IVDR_27_MAR EB_B_REAG_FV_Def_Pl3 refs Coagulation Factor VII Deficient Plasma IVDR_27_MAR EB_C_REAG_FVII_Def_Pl3 refs Coagulation Factor VIII Deficient Plasma IVDR_27_MAR EB_C_PROF_REAG_FVIII_Def_Pl2 refs Coagulation Factor X Deficient Plasma IVDR_27_MAR EB_C_REAG_FX_Def_Pl3 refs Coagulation Factor XI Deficient Plasma IVDR_27_MAR EB_B_PROF_REAG_FXI_Def_Pl3 refs Coagulation Factor XII Deficient Plasma IVDR_27_MAR EB_B_PROF_REAG_FXII_Def_Pl3 refs Control Plasma N IVDR_27_MAR EB_C_PROF_REAG_CPN3 refs Control Plasma P IVDR_27_MAR EB_C_PROF_REAG_CPP3 refs Dabigatran Standards IVDR_27_MAR EB_C_REAG_Dabi_Stand2 refs Dade Actin Activated Cephaloplastin Reagent IVDR_27_MAR EB_C_PROF_REAG_Actin3 refs Dade Actin FS Activated PTT Reagent IVDR_27_MAR EB_C_PROF_REAG_Actin_FS3 refs Dade Actin FSL Activated PTT Reagent IVDR_27_MAR EB_C_PROF_REAG_Actin_FSL3 refs Dade CA System Buffer IVDR_27_MAR EB_A_PROF_REAG_CA_Sys_Buff3 refs Dade Ci-Trol 1 IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 13 refs Dade Ci-Trol 2 IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 23 refs Dade Ci-Trol 3 IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 33 refs Dade Ci-Trol Heparin Control, High IVDR_27_MAR EB_C_REAG_Ci-Trol_Hep_Con3 refs Dade Data-Fi Abnormal Fibrinogen Control IVDR_27_MAR EB_C_REAG_Data-Fi_Abn_Fib_Con2 refs Dade Fibrinogen Determination Reagents IVDR_27_MAR EB_C_KIT_Fib_Determ_Reag3 refs Dade Innovin IVDR_27_MAR EB_C_PROF_REAG_Innovin3 refs Dade Owren's Veronal Buffer IVDR_27_MAR EB_A_REAG_OVB3 refs Dade PFA Collagen/ADP Test Cartridge IVDR_27_MAR EB_B_REAG_PFA_Coll_ADP_EPI2 refs Dade Thrombin Reagent IVDR_27_MAR EB_C_REAG_Thromb_Reag3 refs 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 refs Fibrinogen Calibrator Kit IVDR_27_MAR EB_C_KIT_Fib_Cal2 refs 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 refs 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 refs IMMULITE 2000 Syphilis Screen IVDR_67_LLB_DUB-C_C_KIT_Syphilis Screen2 refs 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 INNOVANCE Anti-Xa IVDR_27_MAR EB_C_KIT_INN_A-Xa2 refs INNOVANCE Antithrombin IVDR_27_MAR EB_C_PROF_KIT_INN_AT3 refs INNOVANCE Apixaban Standards IVDR_27_MAR EB_C_INN_Riva_Stand3 refs INNOVANCE D-Dimer 2.0 DILUENT IVDR_27_MAR EB_a_PROF_INN_D_Di_Sam_Dil_22 refs INNOVANCE D-Dimer 2.0 IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di_22 refs INNOVANCE D-Dimer IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di3 refs INNOVANCE D-Dimer Sample Diluent IVDR_27_MAR EB_A_PROF_REAG_NN_D-Di_Sam_Dil3 refs INNOVANCE Free PS Ag IVDR_27_MAR EB_B_REAG_INN_Free_PS_Ag2 refs INNOVANCE Heparin Calibrator IVDR_27_MAR EB_C_REAG_INN_Hep_Cal2 refs INNOVANCE Heparin IVDR_27_MAR EB_C_KIT_INN_Hep2 refs INNOVANCE PFA P2Y IVDR_27_MAR EB_B_REAG _INN_PFA_P2Y INNOVANCE VWF Ac IVDR_27_MAR EB_C_KIT_INN_VWF_Ac3 refs IVDR_27_MAR EB_B_KIT _vWF_Ag2 refs IVDR_27_MAR EB_C_KIT_ProC_Ac_R2 refs IVDR_27_MAR EB_C_REAG_Thromboclotin2 refs LA 1 Screening Reagent IVDR_27_MAR EB_B_REAG_LA1/23 refs LA Control High IVDR_27_MAR EB_B_REAG_LA_Con3 refs Multifibren U IVDR_27_MAR EB_C_REAG_Multifib_U3 refs 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 refs ProC Control Plasma IVDR_27_MAR EB_C_REAG_ProC_Con2 refs ProC Global IVDR_27_MAR EB_C_KIT_ProC_Glob2 refs Protein C Reagent IVDR_27_MAR EB_C_KIT _ProC_Reag2 refs Protein S Ac IVDR_27_MAR EB_C_KIT_Prot_S_Ac3 refs PT Multi-Calibrator IVDR_27_MAR EB_C_PROF_KIT_PT-Multi_Cal2 refs Standard Human Plasma IVDR_27_MAR EB_C_PROF_REAG_SHP3 refs Test Thrombin Reagent IVDR_27_MAR EB_C_KIT _Test_Thromb3 refs Thromborel S IVDR_27_MAR EB_C_PROF_REAG_Thr_S3 refs	A, B, C, D IVDR, 98/79	Website contact@siemens-healthineers.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) and 1 other	China	2019-nCoV Antigen Rapid Test Cassette28 refs98/79 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 refs98/79 100 others 6 Respiratory Pathogen Antigens Rapid Test Cassette (Colloidal Gold Method)116 refs98/79 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 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 refs98/79 Duplex Real-time PCR Detection Kit for Campylobacter Jejuni and Campylobacter coli2 refs98/79 Duplex Real-Time PCR Detection Kit for Influenza Virus A and Influenza Virus B3 refs98/79 Duplex Real-Time PCR Detection Kit for Mycoplasma Pneumoniae and Bordetella Pertussis2 refs98/79 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 refs98/79 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 refs98/79 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 Monkeypox virus (MPXV) Antigen Rapid Test Cassette9 refs98/79 Multiple Real-Time PCR Detection Kit for Norovirus GI/GII2 refs98/79 Multiple Real-Time PCR Kit for Detection of 2019-nCoV6 refs98/79 Multiplex PCR Detection Kit for 5 Diarrheagenic Escherichia coli2 refs98/79 Multiplex PCR Diagnostic Kit for Rapid Detection of Five Genera of Diarrheogenic E. coli (GB.V.)(Freeze-dried Type)2 refs98/79 Multiplex Real-Time PCR Detection Kit for 17 Species of Respiratory Pathogens3 refs98/79 Multiplex Real-Time PCR Detection Kit for 6 Respiratory Viruses98/79 Multiplex Real-time PCR Diagnostic Kit for Rapid Detection of Six Diarrheal Viruses2 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 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 Zika Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method)98/79	A IVDR, 98/79	EUDAMED record Report an error
Medcaptain FDA EU representative : R Sight B.V. (Netherlands)	China	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 MCC00316E98/79 100 others 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 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 refs98/79 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 refs FDP（CLIA）2 refs98/79 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 Functional Fibrinogen Assay MCT00601E98/79 Functional Fibrinogen Assay MCT00602E98/79 Functional Fibrinogen Assay MCT00603E98/79 Functional Fibrinogen Assay MCT01501E3 refs IL-6（CLIA）2 refs98/79 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 refs98/79 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 refs Prothrombin Time MCC00203E3 refs 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 refs98/79 Thromboelastographic Platelet Assay(AA/ADP)8 refs W010302050298/79 Washing Solution MCC01001E3 refs	A, C IVDR, 98/79	Website info@medcaptain.com EUDAMED record Report an error
Talentbiomedical EU representative : SUNGO Europe B.V. (Netherlands)	China	0.2ml98/79 100 Tests2 refs98/79 100ml98/79 10ml2 refs98/79 1100 Tests2 refs98/79 96 others 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 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 I\100 Tests98/79 I\50 Tests98/79 I\50 TestsEBER ISH Kit98/79 II\ 20 Tests98/79 II\100 Tests2 refs98/79 II\50 Tests2 refs98/79 Lmo2 Antibody (Immunohistochemistry) 0.2ml98/79 Lmo2 Antibody (Immunohistochemistry) 11ml98/79 Lmo2 Antibody (Immunohistochemistry) 1ml2 refs98/79 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 refs98/79 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 refs98/79 Renal Cell Carcinoma Marker Antibody (Immunohistochemistry) 3ml98/79 Renal Cell Carcinoma Marker Antibody (Immunohistochemistry) 6ml2 refs98/79 SALL4 Antibody (Immunohistochemistry) 0.2ml98/79 SALL4 Antibody (Immunohistochemistry) 11ml98/79 SALL4 Antibody (Immunohistochemistry) 1ml2 refs98/79 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 refs98/79 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 refs98/79 TLE1 Antibody (Immunohistochemistry) 3ml98/79 TLE1 Antibody (Immunohistochemistry) 6ml98/79	– 98/79	EUDAMED record Report an error
Biobase FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Quality control plasma(normal):1.0mL×1（521015）98/79 93 others 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 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 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 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 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 refs 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 refs 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 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 Nucleic Acid Extraction Kit II (Magnetic Beads Method) KY002 Nucleic Acid Extraction Kit (Magnetic Beads Method) 16 tests / box（121001）3 refs 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 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	A IVDR, 98/79	EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany) and 2 others	China	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 refs 89 others Borrelia Burgdorferi Real Time PCR Kit YJC60113NW-25T98/79 Borrelia Burgdorferi Real Time PCR Kit YJC60113NW-50T98/79 Brucella Real Time PCR Kit2 refs98/79 Cell Nucleic Acid Extraction Kit (Magnetic Bead Method) SDK80125-48T3 refs 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 refs Genetic-Specific Whole Blood DNA Extraction Kit (Magnetic Bead Method) SDK60128-48T(163)3 refs 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 refs Human Papillomavirus Genotyping Real Time PCR Kit2 refs98/79 Human Papillomavirus Real Time PCR Kit98/79 Influenza A and B Viruses Real Time PCR Kit2 refs98/79 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 refs 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 refs 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 refs 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 refs Nucleic Acid Extraction Rapid Kit 96T (Magnetic Bead Method) Pathogen DNA/RNA Extraction Kit (Magnetic Bead Method) SDK60120-48T(163)3 refs 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 refs98/79 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 refs Tissue DNA Isolation Kit (Magnetic Bead Method)3 refs Viral DNA/RNA Extraction Kit (Magnetic Bead Method) SDK60116-48T(163)3 refs Viral Nucleic Acid Extraction Kit (Magnetic Bead Method) SDK60104-32T(162)3 refs 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 refs 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	EUDAMED record Report an error
R&D Systems FDA EU representative : BIO-TECHNE SAS (France)	United States	3K Retic RETIC357 refs98/79 4K Retic RETIC37 refs98/79 ADVIA Retic Plus RETIC77 refs98/79 Body Fluid Control 0BF110VA298/79 Body Fluid Control 0BF220VA298/79 88 others 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 refs98/79 CBC-3D Plus CRP CBC-3D1C6 refs98/79 CBC-3D132 refs98/79 CBC-3K CBC-4K619 refs98/79 CBC-5D512 refs98/79 CBC-5DMR BC-5D314 refs98/79 CBC-7B21 refs98/79 CBC-CAL PLUS NCAL12 refs CBC-DH DH-5D16 refs98/79 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 refs CBC-ST Plus ST222 refs98/79 CBC-SYS SF323 refs98/79 CBC-Tech T815 refs98/79 CBC-X X00298/79 CBC-X X00398/79 CBC-X X003X98/79 CBC-XE19 refs98/79 CBC-XN14 refs98/79 CBC-XR20 refs98/79 HC WBC Control3 refs98/79 HC WBC Diff Control4 refs98/79 HCT Extended 0EH110TA398/79 HCT Extended 0EH220TA398/79 HCT Extended 0EH400TA398/79 HCT Extended HCT00498/79 HGB Extended CBC-7B11 refs98/79 LeukoReduced Combo Kit LRPLT, LRRBC22 refs98/79 LeukoReduced PLT2 refs98/79 LeukoReduced RBC LRRBC22 refs98/79 Platelet-Trol Extended9 refs98/79 PLT-LINE98/79 R&D Retic2 refs R&D Retic-I5 refs RET-LINE B RETLINE398/79 Retic-I DxH-800 RETIC72 refs98/79 SEDRite III ESR22 refs98/79 SEDRite Plus ESR222 refs98/79 Sickle QC Control 0SC110VA298/79 Sickle QC Control 0SC220VA298/79 Sickle QC Control SQC00198/79 Sickle QC Control SQC00298/79 StatusFlow WBFC210 refs98/79 StatusFlowLo WBFCD4Lo5 refs98/79 StatusFlowPro WBFC23410 refs98/79 SYSXR98/79 T898/79 Tech-Cal4 refs XE-nRBC12 refs98/79 XERet13 refs98/79	B IVDR, 98/79	regulatorydiagnosticsdivision@bio-techne.com EUDAMED record Report an error
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain)	United States	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 85 others 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 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 refs98/79 FLU A+B FIA Test98/79 Flu A+B Test2 refs98/79 Flu A+B Test (Swab/Nasal Aspirate)98/79 Flu A/B & H1N1 Combo Test98/79 H1N1 Ag Test98/79 HPV 16/18 qPCR Assay98/79 HSV 1/2 IgG Test2 refs98/79 HSV 1/2 IgG/IgM Test4 refs98/79 HSV 1/2 IgM Test2 refs98/79 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 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 refs98/79 SARS-CoV-2 & M.pneumoniae IgG Combo Test98/79 SARS-CoV-2 & M.pneumoniae IgG/IgM Combo Test98/79 SARS-CoV-2 Ag Test5 refs98/79 SARS-CoV-2 IgG/IgM Test3 refs98/79 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	– 98/79	info@acesolab.com EUDAMED record Report an error
Lifotronic FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other	China	32T/Kit 48T/Kit 64T/Kit 8T/Kit 96T/Kit 85 others 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 refs D-dimer Assay Kits (Lateral Flow Immunoassay)3 refs 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 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 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 refs Influenza A&B Test (GICA) 25T98/79 Interleukin-6 (Electrochemiluminescence Immunoassay)3 refs 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 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	Website EUDAMED record Report an error
Maccura EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others	China	APTT4 refs98/79 Automatic Hematology Analyzer CC-5 Cell Clean A 2 mL×6 Automatic Hematology Analyzer F-DC Diluent BL2200243: 1 L×1 BL2201243: 20 L×12 refs Automatic Hematology Analyzer GD-5 Diluent A 20 L×1 Automatic Hematology Analyzer LD-5 Lysing Reagent A 1 L×4; 1 L×1 83 others Automatic Hematology Analyzer LD-6 Lysing Reagent 500 mL×1 , 500 mL×2 ,1000 mL×1 ,1000 mL×23 refs 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 refs 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 refs98/79 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 refs EIM4410016 EIM4411016 EIM4414016 EIM44150163 refs Fibrinogen (Fib)4 refs98/79 Fibrinogen Degradation Product (FDP)7 refs98/79 Fibrinogen Degradation Product (FDP) Calibrator98/79 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 refs98/79 Hematology Analyzer Fluorescent Platelets Control13 refs98/79 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 refs98/79 HEV IgM Antibody Chemiluminescent Immunoassay Kit6 refs98/79 HSV-1/2 IgG2 refs98/79 HSV-1/2 IgM4 refs98/79 HSV-1/2 IgM Antibody Chemiluminescent Immunoassay Kit4 refs98/79 HSV-2 IgG3 refs98/79 IL-6 Chemiluminescent Immunoassay Kit4 refs98/79 IM4402017 IM4403017 IM4406017 IM4407017 EIM44920173 refs IM4405010 IM4401010 IM4406010 IM44070103 refs IM4410040 IM4411040 IM4414040 IM44150403 refs IM4410041 IM4411041 IM4414041 IM44150413 refs 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 refs98/79 SARS-CoV-2 Antigen (CLIA)98/79 Thrombin Time (TT)4 refs98/79 TOXO IgG Antibody Chemiluminescent Immunoassay Kit2 refs98/79 TOXO IgM Antibody Chemiluminescent Immunoassay Kit2 refs98/79 Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)3 refs98/79	A, B IVDR, 98/79	Website EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United States	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 83 others 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 refs ADVIA 120/2120/2120i® AUTOretic IVDR_67_TTN_DUB-C_A_REAG_autoRETIC2 refs 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 refs 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 360 Cleaner IVDR_67_TTN_DUB-C_A_REAG_360 Cleaner 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 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 Centaur aHAVT assay IVDR_67_TTN_DUB-C_B_KIT_aHAVT2 refs ADVIA Centaur Anti-HBe2 (aHBe2) IVDR_67_TTN_DUB-C_D_REAG_KIT_aHBe22 refs ADVIA Centaur Anti-HBe2 Quality Control (aHBe2 QC) IVDR_67_TTN_DUB-C_D_REAG_KIT_aHBe2 QC2 refs ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control IVDR_67_TTN_DUB-C_D_REAG_Anti-HBs2 QC2 refs ADVIA Centaur anti-HBs2 IVDR_67_TTN_DUB-C_D_KIT_Anti-HBs22 refs ADVIA Centaur CHIV IVDR_67_TTN_DUB-C_D_KIT_HIV Ag/Ab Combo2 refs ADVIA Centaur CMV IgM (CMV IgM) IVDR_67_TTN_DUB-C_C_REAG_KIT_CMV IgM2 refs ADVIA Centaur CMV IgM Quality Control (CMV IgM QC) IVDR_67_TTN_DUB-C_C_REAG_CMV IgM QC2 refs ADVIA Centaur HAV IgM (aHAVM) Quality Control IVDR_67_TTN_DUB-C_B_REAG_aHAVM_QC2 refs ADVIA Centaur HAV Total (aHAVT) Quality Control IVDR_67_TTN_DUB-C_B_REAG_aHAVT_QC2 refs ADVIA Centaur HBc IgM (aHBcM) Quality Control IVDR_67_TTN_DUB-C_D_REAG_aHBcM QC2 refs ADVIA Centaur HBeAg (HBe) Quality Control IVDR_67_TTN_DUB-C_D_REAG_Hepatitis B e Antigen QC2 refs ADVIA Centaur HBsAg Confirmatory (Conf) IVDR_67_TTN_DUB-C_D_REAG_HBsAg Confirmatory2 refs ADVIA Centaur HBsAg Quality Control Material IVDR_67_TTN_DUB-C_D_REAG_HBsAg Quality Control2 refs ADVIA Centaur HBsAgII IVDR_67_TTN_DUB-C_D_KIT_HBsAgII3 refs ADVIA Centaur HCV Quality Control IVDR_67_TTN_DUB-C_D_REAG_aHCV QC2 refs ADVIA Centaur Hepatitis B e Antigen IVDR_67_TTN_DUB-C_D_KIT_HBeAg2 refs ADVIA Centaur Herpes-1 IgG (HSV1) IVDR_67_TTN_DUB-C_C_KIT_HSV12 refs ADVIA Centaur Herpes-1 IgG (HSV1) Quality Control IVDR_67_TTN_DUB-C_C_REAG_HSV1 QC2 refs ADVIA Centaur Herpes-2 IgG (HSV2) IVDR_67_TTN_DUB-C_C_KIT_HSV22 refs ADVIA Centaur Herpes-2 IgG (HSV2) Quality Control IVDR_67_TTN_DUB-C_C_REAG_HSV2 QC2 refs ADVIA Centaur HIV Ag/Ab Combo Quality Control (CHIV QC) IVDR_67_TTN_DUB-C_D_REAG_ HIV Ag/Ab Combo QC2 refs 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 refs ADVIA Centaur Rub M quality control material IVDR_67_TTN_DUB-C_C_REAG_Rubella M Quality Control Material2 refs ADVIA Centaur Rubella G assay IVDR_67_TTN_DUB-C_C_REAG_Rub G assay2 refs ADVIA Centaur Rubella M IVDR_67_TTN_DUB-C_C_REAG_KIT_Rubella M2 refs 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 refs ADVIA Centaur Toxo M Quality Control Material IVDR_67_TTN_DUB-C_C_REAG_Toxo M QC2 refs ADVIA Centaur Toxoplasma G IVDR_67_TTN_DUB-C_C_KIT_Toxo G2 refs ADVIA Centaur Toxoplasma M IVDR_67_TTN_DUB-C_C_KIT_Toxo M2 refs ADVIA Centaur Zika Ab DX_LS_LEGACY_0063041424702198/79 ADVIA Centaur Zika IgM DX_LS_LEGACY_0063041424700798/79 ADVIA Centaur® HAV IgM IVDR_67_TTN_DUB-C_B_KIT_aHAVM2 refs ADVIA Centaur® HBc IgM IVDR_67_TTN_DUB-C_D_KIT_aHBcM2 refs ADVIA Centaur® HCV IVDR_67_TTN_DUB-C_D_KIT_aHCV2 refs 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 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 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 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	A, B, C, D IVDR, 98/79	Website contact@siemens-healthineers.com EUDAMED record Report an error
Tongzhoubio FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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 others 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 refs H1N1 Antigen Rapid Test2 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 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	EUDAMED record Report an error
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other	China	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 refs 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 81 others B-Z Cleanser3 refs 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 refs BF-LH Lyse 100mL， 200mL2 refs BF-SLS-I Lyse 500mL BF-SLS-II Lyse 2L BF-WFL Lyse 4L BF-WNL Lyse 4L Calibrator for Automatic Hematology Analyzer (5-part) 2.5 mL98/79 Coagulation Analysis Multi-Calibrator3 refs Coagulation Analysis Multi-Calibrator 10×1mL98/79 Coagulation Analysis Multi-Calibrator 1×1mL98/79 Coagulation Analysis Multi-Control3 refs 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 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)3 refs 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 1×100 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 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 refs98/79 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 refs Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay)3 refs 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 refs 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 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 Lyse 500mL2 refs Prothrombin Time Detection Kit (Coagulation Assay)6 refs 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 refs Thrombin Time Detection Kit (Coagulation Assay)3 refs 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 refs	A, C IVDR, 98/79	EUDAMED record Report an error
Bioxol	Hungary	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 others BioClean MN cleaning reagent 1L BioClean NK cleaning reagent 1L2 refs 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	Website EUDAMED record Report an error
Vidia	Czechia	ELISA-VIDITEST anti-Aspergillus fumigatus IgA2 refs98/79 ELISA-VIDITEST anti-Aspergillus fumigatus IgG2 refs98/79 ELISA-VIDITEST anti-Aspergillus fumigatus IgM2 refs98/79 ELISA-VIDITEST anti-BKV IgG2 refs98/79 ELISA-VIDITEST anti-Borelia recombinant IgG + VIsE (CSF)4 refs98/79 79 others ELISA-VIDITEST anti-Borelia recombinant IgM (CSF)4 refs98/79 ELISA-VIDITEST anti-Chlamydia pneumoniae IgA2 refs98/79 ELISA-VIDITEST anti-Chlamydia pneumoniae IgG2 refs98/79 ELISA-VIDITEST anti-Chlamydia pneumoniae IgM2 refs98/79 ELISA-VIDITEST anti-Chlamydia trachomatis IgA2 refs98/79 ELISA-VIDITEST anti-Chlamydia trachomatis IgG2 refs98/79 ELISA-VIDITEST anti-CMV IgG2 refs98/79 ELISA-VIDITEST anti-CMV IgG (CSF)5 refs98/79 ELISA-VIDITEST anti-CMV IgG a avidita IgG2 refs98/79 ELISA-VIDITEST anti-CMV IgG and IgG avidity98/79 ELISA-VIDITEST anti-CMV IgM2 refs98/79 ELISA-VIDITEST anti-EA (D) EBV IgG3 refs98/79 ELISA-VIDITEST anti-EA (D) EBV IgM2 refs98/79 ELISA-VIDITEST anti-EBNA-1 EBV IgG5 refs98/79 ELISA-VIDITEST anti-HHV-6 IgG3 refs98/79 ELISA-VIDITEST anti-HHV-6 IgG (CSF)3 refs98/79 ELISA-VIDITEST anti-HHV-6 IgM3 refs98/79 ELISA-VIDITEST anti-HSV 1+2 IgG2 refs98/79 ELISA-VIDITEST anti-HSV 1+2 IgG (CSF)2 refs98/79 ELISA-VIDITEST anti-HSV 1+2 IgM2 refs98/79 ELISA-VIDITEST anti-JCV IgG2 refs98/79 ELISA-VIDITEST anti-Mycoplasma pneumoniae IgA2 refs98/79 ELISA-VIDITEST anti-Mycoplasma pneumoniae IgG2 refs98/79 ELISA-VIDITEST anti-Mycoplasma pneumoniae IgM2 refs98/79 ELISA-VIDITEST anti-Pseudomonas aeruginosa IgG2 refs98/79 ELISA-VIDITEST anti-TBEV IgG (CSF)2 refs98/79 ELISA-VIDITEST anti-TBEV IgG and IgG avidity2 refs98/79 ELISA-VIDITEST anti-TBEV IgM2 refs98/79 ELISA-VIDITEST anti-Toxoplasma gondii IgG2 refs98/79 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 refs98/79 ELISA-VIDITEST anti-VCA EBV IgG3 refs98/79 ELISA-VIDITEST anti-VCA EBV IgG (CSF)5 refs98/79 ELISA-VIDITEST anti-VCA EBV IgG a avidita IgG2 refs98/79 ELISA-VIDITEST anti-VCA EBV IgG a IgG avidity98/79 ELISA-VIDITEST anti-VCA EBV IgM3 refs98/79 ELISA-VIDITEST anti-VZV IgG (CSF)4 refs98/79 ELISA-VIDITEST anti-VZV IgG (CSF) a avidita IgG2 refs98/79 ELISA-VIDITEST anti-VZV IgM2 refs98/79 ELISA-VIDITEST Interferon γ2 refs98/79 MONO -VIDITEST anti-Aspergillus fumigatus IgA2 refs98/79 MONO-VIDITEST anti-Aspergillus fumigatus IgG2 refs98/79 MONO-VIDITEST anti-Aspergillus fumigatus IgM2 refs98/79 MONO-VIDITEST anti-Borrelia sp. IgG + VIsE2 refs98/79 MONO-VIDITEST anti-Borrelia sp. IgM2 refs98/79 MONO-VIDITEST anti-Chlamydia pneumonieae IgA2 refs98/79 MONO-VIDITEST anti-Chlamydia pneumonieae IgG2 refs98/79 MONO-VIDITEST anti-Chlamydia pneumonieae IgM2 refs98/79 MONO-VIDITEST anti-Chlamydia trachomatis IgA2 refs98/79 MONO-VIDITEST anti-Chlamydia trachomatis IgG2 refs98/79 MONO-VIDITEST anti-CMV IgG2 refs98/79 MONO-VIDITEST anti-CMV IgG avidita98/79 MONO-VIDITEST anti-CMV IgG avidity98/79 MONO-VIDITEST anti-CMV IgM2 refs98/79 MONO-VIDITEST anti-EA (D) EBV IgG2 refs98/79 MONO-VIDITEST anti-EA (D) EBV IgM2 refs98/79 MONO-VIDITEST anti-EBNA-1 EBV IgG2 refs98/79 MONO-VIDITEST anti-HHV-6 IgG2 refs98/79 MONO-VIDITEST anti-HHV-6 IgM2 refs98/79 MONO-VIDITEST anti-HSV 1+2 IgG2 refs98/79 MONO-VIDITEST anti-HSV 1+2 IgM2 refs98/79 MONO-VIDITEST anti-Mycoplasma pneumoniae IgA2 refs98/79 MONO-VIDITEST anti-Mycoplasma pneumoniae IgG2 refs98/79 MONO-VIDITEST anti-Mycoplasma pneumoniae IgM2 refs98/79 MONO-VIDITEST anti-Pseudomonas aeruginosa IgG2 refs98/79 MONO-VIDITEST anti-TBEV IgG2 refs98/79 MONO-VIDITEST anti-TBEV IgG avidity2 refs98/79 MONO-VIDITEST anti-TBEV IgM2 refs98/79 MONO-VIDITEST anti-Toxoplasma gondii IgG2 refs98/79 MONO-VIDITEST anti-Toxoplasma gondii IgG avidita98/79 MONO-VIDITEST anti-Toxoplasma gondii IgG avidity98/79 MONO-VIDITEST anti-Toxoplasma gondii IgM2 refs98/79 MONO-VIDITEST anti-VCA EBV IgG2 refs98/79 MONO-VIDITEST anti-VCA EBV IgG avidita2 refs98/79 MONO-VIDITEST anti-VCA EBV IgM2 refs98/79 MONO-VIDITEST anti-VZV IgG2 refs98/79 MONO-VIDITEST anti-VZV IgG avidita2 refs98/79 MONO-VIDITEST anti-VZV IgM2 refs98/79	– 98/79	Website EUDAMED record Report an error
Instrumentation Laboratory FDA EU representative : Instrumentation Laboratory SpA (Italy)	United States	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 78 others 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	Website Regulatory@werfen.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others	China	Adenovirus Antigen Feces Rapid Test A49830125, A49830225 Adenovirus Antigen Nasal Rapid Test A46410120, A46410220 Adenovirus FIA ADV-F23F398/79 ADV FIA ADV-S23F398/79 Astrovirus FIA ASV-F23F398/79 77 others Astrovirus Test ASV-F2398/79 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 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 Shigella Rapid Test SGL-f2398/79 STA FIA STA-S23F398/79 Strep A Rapid Test Device Strip, Device A46310113 refs 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	Website contact@diareagent.com EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Activated Partial Thromboplastin Time (APTT) Assay Kit (Clotting Method) 105-023616-00、105-023617-00、105-023618-003 refs Anti-HAV Control 105-038862-00, 105-038863-00, 105-045982-00, 105-045981-00, 105-045980-00, 105-045979-003 refs 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 refs B30 Hematology Control BR60 Hematology Control，SC-CAL RET Hematology Calibrator3 refs 73 others 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 refs BC-5D Hematology Control Please see UDI-DI for details3 refs BC-RET Hematology Control Please see UDI-DI for details3 refs BR60 Hematology Contro 105-018565-00、105-018566-002 refs 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 Clean Solution 105-023651-00 Cleaning Solution B 105-056286-00 Coagulation Control 105-023642-00、105-023643-002 refs CRP Cleanser 105-004887-00、105-011300-002 refs Cytomegalovirus IgG (CLIA) 105-012536-00, 105-012537-00, 105-012539-00, 105-012540-003 refs Cytomegalovirus IgM (CLIA) 105-012542-00, 105-012543-00, 105-012545-00, 105-012546-003 refs D-Dimer (CLIA) 105-046778-00, 105-046779-003 refs 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 refs DCT DILUENT 105-020869-00/105-020868-00/105-020867-003 refs DS DILUENT Please see UDI-DIs for details.3 refs ESR Solution Reagent Please see UDI-DIs for details2 refs 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 refs Fibrinogen (FIB) Assay Kit (Clotting Method) 105-023622-00、105-023623-00、105-023624-00、105-023625-00、105-023626-00、105-023627-003 refs HAV IgM and HEV IgM Multi Control 105-043944-00, 105-043943-00, 105-043942-00, 105-043941-003 refs HBsAg121, HBsAg1223 refs HCY Control 105-009174-00、105-009175-00、105-009176-00、105-009194-003 refs Hepatitis A Virus IgM Antibody (CLIA) 105-038860-00, 105-038861-002 refs Hepatitis E Virus IgM Antibody (CLIA) 105-038866-00, 105-038867-002 refs Herpes Simplex Virus 1+2 IgG（CLIA） 105-012494-00、105-012495-00、105-012497-00、105-012498-003 refs Herpes Simplex Virus 1+2 IgM（CLIA） 105-012488-00、105-012489-00、105-012491-00、105-012492-003 refs Herpes Simplex Virus-1 IgG（CLIA） 105-012500-00、105-012501-00、105-012503-00、105-012504-003 refs Herpes Simplex Virus-2 IgG（CLIA） 105-012506-00 、105-012507-00、105-012509-00、105-012510-003 refs HEV IgG Control 105-038864-00, 105-038865-00, 105-045978-00, 105-045977-00, 105-045975-00, 105-045976-003 refs HLA-B27 Reagent 105-005727-0098/79 HLA-B27 Reagent 105-034921-00 LS LYSE 105-023579-00、105-023578-002 refs M-10CFL LYSE Please see UDI-DIs for details.3 refs M-18E E-Z CLEANSER Please see UDI-DIs for details.3 refs M-52D DILUENT Please see UDI-DIs for details3 refs M-6FM DYE Please see UDI-DI for details3 refs Prothrombin Time (PT) Assay Kit (Clotting Method) 105-023613-00、105-023614-00、105-023615-003 refs Rubella Virus IgG (CLIA) 105-012518-00, 105-012519-00, 105-012521-00, 105-012522-003 refs Rubella Virus IgM (CLIA) 105-012512-00, 105-012513-00, 105-012515-00, 105-012516-003 refs 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 Thrombin Time (TT) Assay Kit (Clotting Method) 105-023619-00、105-023620-00、105-023621-003 refs ToRCH IgG Positive Control 105-024832-00、105-024833-00、105-024834-00、105-024835-003 refs ToRCH IgG/IgM Negative Control 105-024824-00、105-024825-00、105-024826-00、105-024827-003 refs ToRCH IgM Positive Control 105-024840-00、105-024841-00、105-024842-00、105-024843-003 refs 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 refs Toxoplasma gondii IgG (CLIA) 105-012524-00, 105-012525-00, 105-012527-00, 105-012528-003 refs Toxoplasma gondii IgM (CLIA) 105-012530-00, 105-012531-00, 105-012533-00, 105-012534-003 refs	A, B, C, D IVDR, 98/79	Website EUDAMED record Report an error
Fortress Diagnostics	Northern Ireland	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 others 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	Website info@fortressdiagnostics.com EUDAMED record Report an error
Pro-Lab Diagnostics EU representative : Advena Limited (Malta)	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 others 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 refs98/79 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 refs98/79 Staph Xtra Latex Kit2 refs98/79 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	Website support@pro-lab.com EUDAMED record Report an error
Clonit	Italy	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 others 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 refs 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	Website info@clonit.it EUDAMED record Report an error
Sanymed	Italy	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 70 others 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 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 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 VDRL - VDRL Agglutinazione / VDRL Agglutination (Reagin Ab) Serology R1: 1x5ml + CTL+: 1x1ml + CTL-: 1x1ml - 250 Test98/79	– 98/79	Website info@sanymed.it EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	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 others 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 refs98/79 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	EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	(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 others 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	Website EUDAMED record Report an error
Diagnostic BioSystems FDA EU representative : MedEnvoy Global BV (Netherlands)	United States	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 refs 67 others Blue Hematoxylin Kit Histological Stains Calcium Stain Kit (Modified Von Kossa) IHC Stains CC/Mount Tissue Sealants2 refs Colloidal Iron Stain Kit IHC Stains Combined Eosinophil-Mast Cell Stain Kit IHC Stains Conjugated Enzyme Labels (ALP Labels) Detection Systems2 refs Conjugated Enzyme Labels (HRP Labels) Detection Systems2 refs Copper Stain Kit IHC Stains DAB Auto Chromogens3 refs DAPI Histological Stains2 refs Elastic Stain Kit IHC Stains Fite’s Stain Kit IHC Stains Fluoromount Tissue Sealants2 refs Fluoromount/Plus Tissue Sealants2 refs 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 refs Luxol Fast Blue Stain Kit IHC Stains Moh'S HRP-Green Kit Detection Systems2 refs Mono AEC/Plus Chromogens2 refs Montage DAB Gone kit General Purpose Reagents 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 refs Mouse/Rabbit UnoVue PlusTM AP/PermaRed Detection System3 refs Mouse/Rabbit UnoVueTM HRP/DAB Detection System3 refs 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 refs PermaBlack/HRP Chromogens2 refs PermaBlue Plus/AP Chromogens2 refs PermaBlue/HRP Chromogens4 refs PermaGreen Plus/AP Chromogens2 refs PermaRed/AP Chromogens2 refs PermaRed/AP-Auto Chromogens2 refs PermaRed/AP-AutoPlus Chromogens2 refs PermaYellow/HRP Chromogens2 refs 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 refs 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 refs UnoVue Mouse HRP Detection Reagent2 refs UnoVue Mouse/Rabbit AP Detection Reagent2 refs UnoVue Mouse/Rabbit HRP Detection Reagent2 refs UnoVue Rabbit AP Detection Reagent2 refs UnoVue Rabbit HRP Detection Reagent2 refs UnoVue'M Mouse AP Detection Reagent98/79 UnoVue™ Mouse AP Detection Reagent98/79 Warthin-Starry Stain Kit IHC Stains	A IVDR, 98/79	EUDAMED record Report an error
Microbiologics FDA EU representative : MediMark Europe Sarl. (France)	United States	8180 8181 8184 8187 8189 67 others 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	Website info@microbiologics.com EUDAMED record Report an error
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland)	Ireland, United States	Access anti-HAV C39444 Access anti-HAV Calibrator C39445 Access anti-HAV IgM C39447 Access anti-HAV IgM Calibrator C39448 Access anti-HAV IgM QC C39449 66 others 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 APC (675/633) Setup Kit98/79 AQUIOS Immuno-Trol Cells3 refs AQUIOS PLG Panel 400 Test3 refs AQUIOS Tetra-1 Panel2 refs CD8-ECD3 refs ClearLLab Bcell tube3 refs ClearLLab Compensation Beads ClearLLab Control Cells Abnormal ClerLLab Control Cells2 refs Coulter 5C Cell Control8 refs98/79 COULTER 628026 COULTER 6280274 refs COULTER 6C Plus Cell Control98/79 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 refs COULTER Retic-X Cell Control98/79 COULTER S-CAL Calibrator Kit2 refs98/79 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 refs 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 DxH 500 Series Calibrator B3688098/79 Flow Check Fluorospheres Flow Set Pro Fluorospheres Flow-Check Pro Fluorospheres Flow-Set Fluorospheres98/79 HAV Ab (Reagent pack)98/79 HbDIL DxC98/79 IMMUNO-BRITE Standards Kit98/79 IMMUNO-TROL Cells98/79 IMMUNO-TROL Low Cells98/79 Leuko-Trol Platelet Control Cells98/79 PC7 (770/488) SETUP KIT98/79 S-CAL Calibrator98/79 (no longer marketed)	A, B, C IVDR, 98/79	Website ra.clare@beckman.com EUDAMED record Report an error
Atlas Medical FDA	Germany	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 65 others 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	– 98/79	Website info@atlas-medical.com EUDAMED record Report an error
Bitrumed EU representative : VidaQuick Biotech S.L. (Spain)	China	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 others 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 refs98/79 Flu A+B Test2 refs98/79 Flu A/B & H1N1 Combo Test98/79 H1N1 Test98/79 HSV 1/2 IgG Test2 refs98/79 HSV 1/2 IgG/IgM Test4 refs98/79 HSV 1/2 IgM Test2 refs98/79 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 refs98/79 SARS-CoV-2 & M.pneumoniae IgG Combo Test98/79 SARS-CoV-2 & M.pneumoniae IgG/IgM Combo Test98/79 SARS-CoV-2 Ag Test3 refs98/79 SARS-CoV-2 Ag Test (Nasal Swab)98/79 SARS-CoV-2 Ag Test (Oral fluid)2 refs98/79 SARS-CoV-2 IgG Test2 refs98/79 SARS-CoV-2 IgG/IgM Test2 refs98/79 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 EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others	China	20 tests/kit11 refs98/79 40 tests/kit12 refs98/79 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 others 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 refs98/79 (no longer marketed) 24 tests/kit2 refs98/79 (no longer marketed) 25 tests/kit98/79 (no longer marketed) 48 tests/kit4 refs98/79 (no longer marketed) 50 tests/kit2 refs98/79 (no longer marketed) 5×4 mL98/79 (no longer marketed) 96 tests/kit3 refs98/79 (no longer marketed) Adeno/RSV Ag Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) Adeno/RSV Ag Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) Adenovirus(Adeno) Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) AP1: 96 tests/kit2 refs98/79 (no longer marketed) AP1:24 tests/kit2 refs98/79 (no longer marketed) AP1:48 tests/kit2 refs98/79 (no longer marketed) Brucellosis Rapid Test 20 tests/kit98/79 (no longer marketed) Brucellosis Rapid Test 40 tests/kit98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Nasal swab + throat swab)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Nasal swab + anterior nasal swab (short version))98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-10, 10Tests/kit (Positive control)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-10, 10Tests/kit(Positive and negative controls)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Anterior nasal swab (short version))98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Anterior nasal swab)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Nasal swab + anterior nasal swab (long version))98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Nasal swab + throat swab)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Nasal swab)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Positive control)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Throat swab)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit(Nasal swab + anterior nasal swab (short version))98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-5, 5Tests/kit (Nasal swab + throat swab)98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-C1098/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag02-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag02-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag02-C10,98/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag03-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag03-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag03-C1098/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag04-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag04-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag04-C1098/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag05-C1098/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag06-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag06-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag06-C1098/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag07-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag07-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag07-C1098/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag08-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag08-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-C0198/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-C0598/79 (no longer marketed) COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-C2098/79 (no longer marketed) COVID-19 Ag Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) COVID-19 Neutralizing Antibody( COVID-19 NAb) Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) COVID-19 Neutralizing Antibody( COVID-19 NAb) Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) COVID-19/Influenza Ag Combo Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) COVID-19/Influenza Ag Combo Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) Freeze-dried：100 tests/kit98/79 (no longer marketed) Freeze-dried：25 tests/kit98/79 (no longer marketed) Freeze-dried：50 tests/kit98/79 (no longer marketed) HPV （16+18）Rapid Test 20 tests/kit98/79 (no longer marketed) HPV （16+18）Rapid Test 40 tests/kit98/79 (no longer marketed) Influenza A+B/RSV Ag Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) Influenza A+B/RSV Ag Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) Influenza A/B Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) Influenza A/B Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) Mycoplasma Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) Mycoplasma Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) Norovirus(NORO) Test Kit (Immunofluorescence Method) 20 tests/kit2 refs98/79 (no longer marketed) QP1：100 tests/kit2 refs98/79 (no longer marketed) QP1：24 tests/kit98/79 (no longer marketed) QP1：25 tests/kit98/79 (no longer marketed) QP1：48 tests/kit98/79 (no longer marketed) QP1：50 tests/kit98/79 (no longer marketed) QP1：96 tests/kit98/79 (no longer marketed) Reagent 1: 5×5mL Reagent 2: 5×5mL98/79 (no longer marketed) Reagent 1：5×5 mL Reagent 2：5×5 mL Dilution：2×5 mL98/79 (no longer marketed) Reagent：5×5 mL Buffer：5×10 mL98/79 (no longer marketed) Respiratory Syncytial Virus Antigen(RSV Ag) Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) Respiratory Syncytial Virus Antigen(RSV Ag) Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) Rota/Adeno Combo Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) Rota/Adeno Combo Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) Rotavirus (ROTA) Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) Strep A Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) Strep A Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
R-Biopharm FDA	Germany	RIDASCREEN® Adenovirus3 refs RIDASCREEN® Astrovirus3 refs RIDASCREEN® Campylobacter3 refs RIDASCREEN® Clostridium difficile GDH3 refs RIDASCREEN® Clostridium difficile Toxin A/B3 refs 65 others RIDASCREEN® Control - RIDASCREEN® Cryptosporidium3 refs RIDASCREEN® Diluent 1 RIDASCREEN® Entamoeba3 refs RIDASCREEN® Giardia3 refs RIDASCREEN® Helicobacter3 refs RIDASCREEN® Legionella3 refs RIDASCREEN® Norovirus 3rd Generation3 refs RIDASCREEN® Rotavirus3 refs RIDASCREEN® Stop RIDASCREEN® Substrate RIDASCREEN® TDM Wash buffer 20x RIDASCREEN® Verotoxin3 refs RIDASCREEN® Wash buffer 10x 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 refs 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®Quick C. difficile GDH Toxin A/B Combi2 refs RIDA®QUICK Campylobacter2 refs RIDA®QUICK Clostridium difficile GDH2 refs RIDA®QUICK Clostridium difficile Toxin A/B2 refs RIDA®QUICK Cryptosporidium98/79 RIDA®QUICK Entamoeba98/79 RIDA®QUICK Giardia98/79 RIDA®QUICK Helicobacter2 refs RIDA®QUICK Norovirus2 refs RIDA®QUICK Parasite Combi Control98/79 RIDA®QUICK Rotavirus98/79 RIDA®QUICK Rotavirus/Adenovirus Combi Control98/79 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 (no longer marketed)	A, B, C IVDR, 98/79	Website EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other	China	Cassette IMAL-C5398/79 Cassette IRSVA-C8198/79 Ferrarihub98/79 RightSign8 refs Rightsign CDIM-C4198/79 64 others 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 EUDAMED record Report an error
Ecolidx	Czechia	ePure Bacterial DNA Extraction Kit ePure Blood DNA Extraction Kit 200 ePure CFC DNA Extraction Kit ePure FFPE DNA Extraction Kit ePure Forensic DNA Extraction Kit 63 others 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	Website EUDAMED record Report an error
Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇	Türkiye	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 others 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 refs98/79 IgG Kit 50mL98/79 IgG Turbidimetry Reagent Kit98/79 IgM Kit 100mL2 refs98/79 IgM Kit 50 mL98/79 IgM Kit 50mL98/79 IgM Turbidimetry Reagent Kit3 refs98/79 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 refs98/79 Immunoglobulin A Kit 50mL4 refs98/79 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 refs98/79 Immunoglobulin E Kit 60mL2 refs98/79 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 refs98/79 Immunoglobulin G Kit 50mL6 refs98/79 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 refs98/79 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 EUDAMED record Report an error
Safecare FDA EU representative : Medunion S.L. (Spain) and 4 others	China	"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 others 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	EUDAMED record Report an error
gerbion	Germany	alphaCube Babesia98/79 alphaCube Bordetella98/79 alphaCube Borrelia98/79 alphaCube BV-198/79 alphaCube C.difficile98/79 61 others 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 refs NukEx Pure RNA/DNA2 refs 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 EUDAMED record Report an error
Merck	Germany	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 refs 61 others Canada balsam for microscopy2 refs 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 refs Entellan™ rapid mounting medium for microscopy Eosin Y solution 1%, alcoholic for microscopy Eosin Y-solution 0.5% aqueous for microscopy2 refs Eosin Y-solution 0.5%, alcoholic for microscopy2 refs Formaldehyde solution 4%,buffered, pH 6.9 (approx. 10% Formalin solution) for histology3 refs Formaldehyde solution min. 37% free from acid stabilized with about 10% methanol and calcium carbonate for histology2 refs Giemsa’s azur eosin methylene blue for microscopy3 refs Giemsa’s azur eosin methylene blue solution for microscopy3 refs Glutardialdehyde solution 25% for electron microscopy, acc. to P.J. Anderson (purified and filled under nitrogen)2 refs 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 refs Hematoxylin cryst. (C.I.75290) for microscopy3 refs Hematoxylin monohydrate (C.I.75290) for microscopy Certistain®3 refs Hematoxylin solution modified acc. to Gill II for microscopy2 refs Hematoxylin solution modified acc. to Gill III for microscopy3 refs Histosec™ pastilles (without DMSO)solidification point 56-58°C embedding agent for histology3 refs Histosec™ pastilles solidification point 56-58 °C embedding agent for histology Histosec™ pastilles solidification point 56-58°C embedding agent for histology3 refs Kaiser’s glycerol gelatine,phenol-free for microscopy Leishman‘s eosin methylene blue solution modified for microscopy2 refs Leishman’s eosin methylene blue for microscopy2 refs M-FIX® spray fixative for cytodiagnosis2 refs 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 refs May-Grünwald’s eosine-methylene blue solution modified for microscopy3 refs Mayer’s hemalum solution for microscopy3 refs Methenamine silver plating kit acc. to Gomorifor the detection of argent-affine structuresin histological tissue Neo-Mount™ anhydrous mounting medium for microscopy2 refs 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 refs Papanicolaou’s solution 1a Harris hematoxylin solution for cytology Papanicolaou’s solution 1b Hematoxylin solution S for cytology2 refs Papanicolaou’s solution 2a Orange G solution (OG6) for cytology3 refs Papanicolaou’s solution 2b Orange II solution for cytology3 refs Papanicolaou’s solution 3a polychromatic solution EA 31 for cytology2 refs Papanicolaou’s solution 3a polychromatic solution EA 31 for cytology Papanicolaou’s solution 3b polychromatic solution EA 50 for cytology3 refs Papanicolaou’s solution 3c polychromatic solution EA 65 for cytology Papanicolaou’s solution 3d polychromatic solution EA 65 for cytology3 refs 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 refs 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 refs Wright’s eosin methylene blue solution for microscopy3 refs	A, B IVDR	Website service@merckgroup.com EUDAMED record Report an error
Poly Diagnostics	Luxembourg	Poly Diagnostics Adenovirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Astrovirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Atopobium vaginae, Lactobacillus crispatus sensu Lato, Mobiluncus mulieris, RNase P Real-Time PCR kit3 refs Poly Diagnostics B. parapertussis, B. pertussis, RNase P Real-Time PCR kit3 refs Poly Diagnostics Bacteroides fragilis, Megasphaera type I, BVAB2, RNase P Real-Time PCR kit3 refs 61 others Poly Diagnostics Blastocystis hominis, RNase P Real-Time PCR kit3 refs Poly Diagnostics Bocavirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics C. albicans, RNase P Real-Time PCR kit3 refs Poly Diagnostics C. difficile tcdA, tcdB Toxins Real-Time PCR kit3 refs Poly Diagnostics C. glabrata, RNase P Real-Time PCR kit3 refs Poly Diagnostics C. krusei, RNase P Real-Time PCR kit3 refs Poly Diagnostics C. parapsilosis, C. tropicalis, C. krusei, RNase P Real-Time PCR kit3 refs Poly Diagnostics C. parapsilosis, RNase P Real-Time PCR kit3 refs Poly Diagnostics C. tropicalis, RNase P Real-Time PCR kit3 refs Poly Diagnostics Campylobacter coli/jejuni, RNase P Real-Time PCR kit3 refs Poly Diagnostics Coronaviruses 229E, OC43, NL63, HKU1, RNase P Real-Time PCR kit3 refs Poly Diagnostics Coronaviruses 229E/HKU1, OC43, NL63, RNase P Real-Time PCR kit3 refs Poly Diagnostics Cryptosporidium spp., E. histolytica, G. lamblia, RNase P Real-Time PCR kit3 refs Poly Diagnostics Cryptosporidium spp., RNase P Real-Time PCR kit3 refs Poly Diagnostics D. fragilis, B. hominis, C. cayetanensis, RNase P Real-Time PCR kit3 refs Poly Diagnostics Dientamoeba fragilis, RNase P Real-Time PCR kit3 refs Poly Diagnostics E. coli Pathotyping Panel I Real-Time PCR kit3 refs Poly Diagnostics E. coli Pathotyping Panel II Real-Time PCR kit3 refs Poly Diagnostics E. coli Pathotyping Panel III Real-Time PCR kit3 refs Poly Diagnostics E.coli, RNase P Real-Time PCR kit3 refs Poly Diagnostics Entamoeba histolytica, RNase P Real-Time PCR kit3 refs Poly Diagnostics Enterovirus, Mumps, Parechovirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Gastrointestinal Disease Bacterial Panel III Real-Time PCR kit3 refs Poly Diagnostics Gastrointestinal Disease Panel I Real-Time PCR kit3 refs Poly Diagnostics Gastrointestinal Disease Parasite Panel IV Real-Time PCR kit3 refs Poly Diagnostics Gastrointestinal Disease Viral Panel II Real-Time PCR kit3 refs Poly Diagnostics Giardia lamblia, RNase P Real-Time PCR kit3 refs Poly Diagnostics Helicobacter pylori, RNase P Real-Time PCR kit3 refs Poly Diagnostics HMPV A/B, RNase P Real-Time PCR kit3 refs Poly Diagnostics HRSV a/b, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza A, Influenza B, Influenza C, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza A, Influenza B, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza A, Influenza B, SARS-CoV-2, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza A, Influenza B, SARS-CoV-2, RNase P, HRSV a/b Real-Time PCR kit3 refs Poly Diagnostics Influenza A, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza B, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza typing II Real-Time PCR kit3 refs Poly Diagnostics Influenza typing Real-Time PCR kit3 refs Poly Diagnostics K. pneumoniae, M. catarrhalis, P. aeruginosa, RNase P Real-Time PCR kit3 refs Poly Diagnostics Mumps virus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Norovirus GI, Norovirus GII+GIV, Astrovirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Norovirus GI, Norovirus GII+GIV, RNase P Real-Time PCR kit3 refs Poly Diagnostics Parainfluenza viruses 1, 2, 3, 4 Real-Time PCR kit3 refs Poly Diagnostics Parainfluenza viruses 1, 2, 3/4, RNase P Real-Time PCR kit3 refs Poly Diagnostics Parechovirus, HMPV A/B, Bocavirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Parechovirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Pseudomonas aeruginosa, RNase P Real-Time PCR kit3 refs Poly Diagnostics Respiratory Infection Viral Panel III Real-Time PCR kit3 refs Poly Diagnostics Respiratory Infection Viral Panel V Real-Time PCR kit3 refs Poly Diagnostics Rhinovirus/Enterovirus, Adenovirus, Bocavirus, HMPV A/B, RNase P Real-Time PCR kit3 refs Poly Diagnostics Rhinovirus/Enterovirus, Adenovirus, HRSV a/b, RNase P Real-Time PCR kit3 refs Poly Diagnostics Rhinovirus/Enterovirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Rotavirus A, RNase P Real-Time PCR kit3 refs Poly Diagnostics Salmonella spp., RNase P Real-Time PCR kit3 refs Poly Diagnostics Sapovirus GI, II, IV, V, Adenovirus, Rotavirus A, RNase P Real-Time PCR kit3 refs Poly Diagnostics SARS-CoV-2, RNase P Real-Time PCR kit3 refs Poly Diagnostics Shigella/EIEC, RNase P Real-Time PCR kit3 refs Poly Diagnostics Staphylococcus aureus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Streptococcus pyogenes, RNase P Real-Time PCR kit3 refs Poly Diagnostics Vibrio cholerae, RNase P Real-Time PCR kit3 refs Poly Diagnostics Yersinia enterocolitica, RNase P Real-Time PCR kit3 refs	B IVDR	Website info@polydiagnostics.com EUDAMED record Report an error
Vivachek FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	C. difficile Toxin A/B Rapid Test VICT98/79 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 59 others 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 refs98/79 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 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 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 Mononucleosis Rapid Test VIMO98/79 Mononucleosis Rapid Test VIMO-40198/79 Multiplex Respiratory Antigen Rapid Test VIRI3 refs98/79 Mycoplasma pneumoniae Ag Rapid Test VIMPg98/79 Mycoplasma pneumoniae IgM Rapid Test VIMPb98/79 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 refs98/79 Quick MASTER Strep A Test Kit (FIA) VID1072 refs98/79 Rotavirus Test Kit (FIA) VID12398/79 RSV Rapid Test VIRS2 refs98/79 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 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	– 98/79	info@vivachek.com EUDAMED record Report an error
altona Diagnostics FDA	Germany	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 others 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 refs 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	info@altona-diagnostics.com EUDAMED record Report an error
Geneproof	Czechia	croBEE 101A Whole Blood DNA Extraction Kit croBEE 2.0 Universal Nucleic Acid Extraction Kit croBEE 201A Nucleic Acid Extraction Kit GeneProof Adenovirus MC PCR Kit2 refs98/79 GeneProof Adenovirus PCR Kit2 refs98/79 58 others GeneProof Aspergillus MC PCR Kit2 refs98/79 GeneProof Aspergillus PCR Kit2 refs98/79 GeneProof BK Virus (BKV) MC PCR Kit2 refs98/79 GeneProof BK Virus (BKV) PCR Kit2 refs GeneProof Blood Pretreatment Sample Tube2 refs GeneProof Bordetella pertussis/parapertussis PCR Kit2 refs98/79 GeneProof Borrelia PCR Kit2 refs98/79 GeneProof Chlamydia pneumoniae PCR Kit3 refs GeneProof Chlamydia trachomatis MC PCR Kit2 refs GeneProof Chlamydia trachomatis PCR Kit3 refs GeneProof CT/NG/MG Multiplex PCR Kit3 refs GeneProof Cytomegalovirus (CMV) MC PCR Kit2 refs GeneProof Cytomegalovirus (CMV) PCR Kit3 refs GeneProof Enterovirus PCR Kit2 refs98/79 GeneProof Epstein-Barr Virus (EBV) MC PCR Kit2 refs98/79 GeneProof Epstein-Barr Virus (EBV) PCR Kit4 refs GeneProof Flu Multiplex PCR Kit2 refs98/79 GeneProof Hepatitis B Virus (HBV) PCR Kit2 refs98/79 GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit2 refs98/79 GeneProof Herpes Simplex Virus (HSV-1/2) MC PCR Kit2 refs98/79 GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit4 refs GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit2 refs98/79 GeneProof Human Herpesvirus 6/7 (HHV-6/7) MC PCR Kit2 refs98/79 GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit3 refs GeneProof Human Herpesvirus 8 (HHV-8) MC PCR Kit2 refs98/79 GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit3 refs GeneProof Human Papillomavirus (HPV) Screening PCR Kit2 refs98/79 GeneProof JC Virus (JCV) MC PCR Kit2 refs98/79 GeneProof JC Virus (JCV) PCR Kit2 refs GeneProof Legionella pneumophila PCR Kit2 refs98/79 GeneProof MH/UU/UP Multiplex PCR Kit3 refs GeneProof Mycobacterium tuberculosis PCR Kit2 refs98/79 GeneProof Mycoplasma genitalium MC PCR Kit2 refs98/79 GeneProof Mycoplasma genitalium/hominis PCR Kit4 refs GeneProof Mycoplasma hominis MC PCR Kit2 refs98/79 GeneProof Mycoplasma pneumoniae PCR Kit2 refs98/79 GeneProof Neisseria gonorrhoeae MC PCR Kit2 refs98/79 GeneProof Neisseria gonorrhoeae PCR Kit3 refs GeneProof Parvovirus B19 PCR Kit2 refs98/79 GeneProof PathogenFree DNA Isolation Kit GeneProof PathogenFree RNA Isolation Kit GeneProof SARS-CoV-2 Advanced PCR Kit2 refs98/79 GeneProof SARS-CoV-2 Screening MC PCR Kit2 refs98/79 GeneProof Treponema pallidum MC PCR Kit2 refs98/79 GeneProof Treponema pallidum PCR Kit2 refs98/79 GeneProof Trichomonas vaginalis MC PCR Kit2 refs98/79 GeneProof Trichomonas vaginalis PCR Kit2 refs GeneProof Universal Internal Control3 refs GeneProof Urine Pretreatment Sample Tube2 refs GeneProof Varicella-Zoster Virus (VZV) MC PCR Kit2 refs98/79 GeneProof Varicella-Zoster Virus (VZV) PCR Kit4 refs myCROBE Universal Control Set myCROBE Universal Internal Control98/79 myCROBE/croBEE 2.0 Universal Extraction Kit TaqPath™ Menu17 refs98/79 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	Website support@geneproof.com EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland)	Serbia	Adenovirus C1813ADN98/79 Adenovirus IgG N101V24IGG98/79 Adenovirus IgM N102V24IGM98/79 Astrovirus C1814AST98/79 Bordetella pertussis Toxin IgA N201T24IGA98/79 58 others 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 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	– 98/79	Website EUDAMED record Report an error
Certest	Spain	CerTest C. difficile GDH+Toxin A+B3 refs CerTest CLIA Clostridium difficile Toxin A/B Ag2 refs CerTest CLIA Rotavirus Ag2 refs CerTest Clostridium difficile antigen GDH3 refs CerTest Clostridium difficile Toxin A+B3 refs 57 others CerTest H. pylori3 refs CerTest Influenza A+B3 refs CerTest Legionella CerTest RSV3 refs CerTest S. pneumoniae CerTest SARS-CoV-23 refs CerTest SARS-CoV-2+ Flu A + Flu B3 refs CerTest SARS-CoV-2+ Flu A + Flu B + RSV3 refs VIASURE Adenovirus plus Real Time PCR Detection Kit3 refs VIASURE Adenovirus q Real Time PCR Detection Kit3 refs VIASURE Adenovirus, Metapneumovirus & Bocavirus Real Time PCR Detection Kit3 refs VIASURE Astrovirus Real Time PCR Detection Kit3 refs VIASURE BK virus q Real Time PCR Detection Kit3 refs VIASURE Blastocystis hominis + Dientamoeba fragilis Real Time PCR Detection Kit3 refs VIASURE Bordetella Real Time PCR Detection Kit3 refs VIASURE C. pneumoniae, M. pneumoniae & L. pneumophila Real Time PCR Detection Kit2 refs98/79 VIASURE Candida auris Real Time PCR Detection Kit3 refs VIASURE Chikungunya Virus Real Time PCR Detection Kit3 refs VIASURE Clostridium difficile Real Time PCR Detection Kit3 refs VIASURE Clostridium difficile toxB Real Time PCR Detection Kit3 refs VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit3 refs VIASURE Coronavirus 229E, NL63, OC43 & HKU1 Real Time PCR Detection Kit3 refs VIASURE Cryptosporidium, Giardia & E. histolytica Real Time PCR Detection Kit3 refs VIASURE Dientamoeba fragilis Real Time PCR Detection Kit3 refs VIASURE EBV q Real Time PCR Detection Kit3 refs VIASURE Entamoeba dispar Real Time PCR Detection Kit3 refs VIASURE Flu A + B Real Time PCR Detection Kit3 refs VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit3 refs VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit for BD MAX™ System VIASURE Flu Typing II Real Time PCR Detection Kit3 refs VIASURE Group A Streptococcus Real Time PCR Detection Kit3 refs VIASURE H. influenzae, N. meningitidis & S. pneumoniae Real Time PCR Detection Kit3 refs VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit3 refs VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit3 refs VIASURE Herpes virus 1, Herpes virus 2 & Varicella Zoster Virus Real Time PCR Detection Kit3 refs VIASURE HSV-1, HSV-2 & Treponema pallidum Assay for BD MAX™ System VIASURE Human Herpes Virus 6, 7 & 8 Real Time PCR Detection Kit3 refs VIASURE Macrolide resistance-associated mutations (23S rRNA) Real Time PCR Detection Kit3 refs 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 refs VIASURE Neisseria gonorrhoeae ciprofloxacin resistant Real Time PCR Detection Kit3 refs VIASURE Norovirus GI + GII Real Time PCR Detection Kit3 refs VIASURE Parainfluenza Real Time PCR Detection Kit3 refs VIASURE Respiratory Panel VII Real Time PCR Detection Kit3 refs VIASURE Respiratory Viral Panel I Real Time PCR Detection Kit3 refs VIASURE Respiratory Virus Extended Mix Real Time PCR Detection Kit for BD MAX™ System VIASURE Rhinovirus + Enterovirus Real Time PCR Detection Kit3 refs VIASURE Rotavirus Real Time PCR Detection Kit3 refs VIASURE RSV A + B Real Time PCR Detection Kit3 refs VIASURE Salmonella, Campylobacter & Shigella/EIEC Real Time PCR Detection Kit3 refs VIASURE Salmonella, Campylobacter & Y. enterocolitica Real Time PCR Detection Kit3 refs VIASURE SARS-CoV-2 Real Time PCR Detection Kit3 refs VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit3 refs VIASURE Toxoplasma gondii Real Time PCR Detection Kit3 refs VIASURE Tropical Panel Plus Real Time PCR Detection Kit3 refs VIASURE Trypanosoma cruzi Real Time PCR Detection Kit3 refs VIASURE Viral Meningitis Panel Real Time PCR Detection Kit3 refs	B, C IVDR, 98/79	Website quality@certest.es EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain)	China	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 56 others 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 refs98/79 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 refs98/79 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 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 refs98/79 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 refs98/79	– 98/79	info@actest.com.cn EUDAMED record Report an error
Immucor FDA EU representative : IMMUCOR Medizinische Diagnostik GmbH (Germany)	Germany, United States	Anti-A hel Anti-A1 Lectin2 refs Anti-IgG,-C3d (Murine Monoclonal); Polyspecific, Gamma-clone Anti-K (Kell) quick2 refs Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent 56 others 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 Freeze-Dried Papain GammaZyme-B GammaZyme-F immuClone (1) Anti-C Galileo IgM immuClone (1) Anti-C IgM3 refs immuClone (1) Anti-C Galileo IgM immuClone (1) Anti-C IgM and Galileo8 refs immuClone (1) Anti-E Galileo IgM immuClone (1) Anti-E IgM6 refs immuClone (1) Anti-E Galileo IgM immuClone (1) Anti-E IgM and Galileo6 refs immuClone (1) Anti-K Galileo IgM immuClone (1) Anti-K IgM and Galileo3 refs immuClone (2) Anti-c Galileo IgM immuClone (2) Anti-c IgM3 refs immuClone (2) Anti-c Galileo IgM immuClone (2) Anti-c IgM and Galileo8 refs immuClone (2) Anti-E Galileo IgM immuClone (2) Anti-E IgM and Galileo10 refs immuClone (2) Anti-K Automated IgM immuClone (2) Anti-K IgM and Automated2 refs immuClone Anti-CDE Galileo IgM + IgG3 refs immuClone Anti-Cw IgM2 refs immuClone Anti-D duo IgM+IgG2 refs immuClone Anti-H Galileo IgM2 refs immuClone Anti-M2 refs immuClone Anti-N Automated IgM2 refs immuClone Anti-P(1) IgM immuClone Anti-S IgM2 refs immuClone® Anti-A IgM2 refs immuClone® Anti-A,B IgM2 refs immuClone® Anti-B IgM2 refs immuClone® Anti-D fast IgM2 refs immuClone® Anti-D rapid Galileo IgM3 refs 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 refs PF4 IgG HAT13G2 refs Platelet Wash and Storage Solution Referencecells®-1 (Group A2) Referencells -2 (Group A1 and B)3 refs Specimen Diluent Specimen Diluent 403602 Streptavidin-PE 628511 W.A.R.M.(Warm Autoantibody Removal Medium)	A, C, D IVDR	Website regulatoryimmucor@werfen.com EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Luxus Lebenswelt GmbH (Germany) and 2 others	China	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 refs 55 others 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 refs98/79 Dengue NS1 Antigen Test Kit Cassette4 refs98/79 Dengue NS1 Antigen Test Kit Strip98/79 Group A Streptococcus Antigen Test Kit Cassette Strip2 refs98/79 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 refs 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 refs98/79 IL-6 Rapid Test Kit (Immunofluorescence Assay) Cassette98/79 Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) Cassette2 refs98/79 Influenza A+B Antigen Test Kit (Colloidal Gold) Cassette3 refs98/79 Malaria pf Test Kit Cassette98/79 Malaria pf/pan Test Kit Cassette98/79 Malaria pf/pv Test Kit Cassette4 refs98/79 Malaria pf/pv Test Kit Strip98/79 Mycoplasma Pneumoniae Antigen Test Kit (Colloidal Gold) Cassette3 refs98/79 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 refs98/79 Salmonella Typhi Antigen Rapid Test Kit Cassette98/79 Strep A Antigen Test Kit Cassette GAS1TST-13 refs TB Tuberculosis Antibody Test Kit Cassette98/79 TB Tuberculosis Antibody Test Kit Strip98/79 TOXO IgG/IgM Antibody Test Kit Cassette2 refs98/79 TOXO IgG/IgM Antibody Test Kit Strip98/79 TP Syphilis Antibody Test Kit Cassette Strip7 refs98/79 Zika IgG/IgM Antibody Test Kit (Colloidal Gold） Cassette98/79	C IVDR, 98/79	sales@dbluemedical.com EUDAMED record Report an error
bioMérieux FDA	France	ADENOVIRUS R-GENE® 69-010B AdV/hBoV R-GENE®98/79 BK Virus R-GENE® 69-013B Bordetella parapertussis R-GENE®98/79 BORDETELLA R-GENE® 69-011B98/79 55 others 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 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® Rhino&EV/Cc R-GENE® RSV/hMPV R-GENE®98/79 SARS-COV-2/FLUA/FLUB/RSV R-GENE® VIDAS® Anti-CHIKUNGUNYA IgG2 refs VIDAS® Anti-CHIKUNGUNYA IgM2 refs 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 refs 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® 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 refs VIDAS® vWF98/79 VZV R-GENE®	A, B, C IVDR, 98/79	EUDAMED record Report an error
Medotexbio EU representative : HUMISS TRADING S. L. (Spain) and 1 other	China	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 others 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 refs 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 refs 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	Website EUDAMED record Report an error
Dbbiotech	Slovakia	Anti-Alpha Smooth Muscle Actin DB 1473 refs Anti-Annexin A1 DB 2663 refs Anti-b-actin DB 0013 refs Anti-BRAF DB 1593 refs Anti-C3d complement DB 1063 refs 54 others Anti-C4d complement DB 1073 refs Anti-Cadherin1 (E-cadherin, CD324) DB 2653 refs Anti-CD117 DB 0623 refs Anti-CD15 DB 2113 refs Anti-CD163 DB 0453 refs Anti-CD1a DB 0713 refs Anti-CD21 DB 2133 refs Anti-CD23 DB 1353 refs Anti-CD3 DB 0823 refs Anti-CD34 DB 1513 refs Anti-CD45 DB 0423 refs Anti-CD7 DB 1143 refs Anti-CD8 DB 0853 refs Anti-Cerb-2 DB 0943 refs Anti-Chromogranin A DB 1583 refs Anti-Cytokeratin 14 DB 0993 refs Anti-Cytokeratin 16 DB 1003 refs Anti-Cytokeratin 17 DB 1013 refs Anti-Cytokeratin 18 DB 1023 refs Anti-Cytokeratin 19 DB 1033 refs Anti-Cytokeratin 20 DB 1193 refs Anti-Cytokeratin 5/6 DB 0973 refs Anti-Cytokeratin 7 DB 0513 refs Anti-Cytokeratin 8 DB 0983 refs Anti-Desmin DB 1483 refs Anti-EBV/LMP-1 DB 0603 refs Anti-EBV/LMP-1 DB 0613 refs Anti-EGFR DB 0923 refs Anti-EMA (CD227, Mucin-1) DB 0483 refs Anti-ER (Estrogen Receptor) DB 0533 refs Anti-Giardin α-1 DB 3193 refs Anti-Human IgG DB 1733 refs Anti-Human IgG DB 1743 refs Anti-Human Kappa Light Chain DB 0373 refs Anti-Human Kappa Light Chain DB 0383 refs Anti-Human Lambda Light Chain DB 0393 refs Anti-Human SOX10 DB 2603 refs Anti-iNOS DB 0033 refs Anti-Ki-67 DB 3183 refs Anti-Melan A DB 0503 refs Anti-Melanosome DB 0493 refs Anti-Napsin A DB 2623 refs Anti-p16 (mouse monoclonal) DB 2533 refs Anti-P504S (AMACR) DB 2083 refs Anti-p53 DB 0263 refs Anti-p60 DB 2033 refs Anti-p63 DB 1343 refs Anti-PLAP (Placental Alkaline Phosphatase) DB 0473 refs Anti-PR (Progesterone Receptor) DB 1093 refs Anti-PSA (Prostate-specific antigen) DB 2543 refs Anti-S-100 DB 0553 refs Anti-Synaptophysin DB 1563 refs Anti-Thyroglobulin DB 2593 refs Anti-TTF-1 DB 0893 refs	C IVDR	Website EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany) and 1 other	China	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 54 others 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 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 EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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 others 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 refs 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 EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Türkiye	Anatolia Geneworks51 refs Anatolia Geneworks Bosphore Aspergillus Detection Kit v13 refs98/79 Anatolia Geneworks Bosphore Bacterial DNA Extraction Spin Kit v2 Anatolia Geneworks Bosphore Bacterial Meningitis Panel Kit v23 refs98/79 Anatolia Geneworks Bosphore Bacterial Meningitis Panel Kit v33 refs98/79 53 others Anatolia Geneworks Bosphore Bacterial Vaginosis Screening Kit v13 refs98/79 Anatolia Geneworks Bosphore BKV Quantification Kit v13 refs98/79 Anatolia Geneworks Bosphore Candida auris Detection Kit v13 refs98/79 Anatolia Geneworks Bosphore CCHFV Quantification Kit v13 refs98/79 Anatolia Geneworks Bosphore CNS Mini Panel Kit v23 refs98/79 Anatolia Geneworks Bosphore CNS Screening Kit v2U3 refs98/79 Anatolia Geneworks Bosphore COVID-19 Sampling and Viral RNA Extraction Kit Anatolia Geneworks Bosphore CT/NG/MG Panel Kit v13 refs Anatolia Geneworks Bosphore EBV Quantification Kit v13 refs98/79 Anatolia Geneworks Bosphore Eye Infection Screening Kit v13 refs98/79 Anatolia Geneworks Bosphore Gastroenteritis Panel Kit v42 refs98/79 Anatolia Geneworks Bosphore Genomic DNA Extraction Spin Kit v2 Anatolia Geneworks Bosphore HCV Genotyping Kit v53 refs98/79 Anatolia Geneworks Bosphore HDV Quantification-Detection Kit v13 refs98/79 Anatolia Geneworks Bosphore HHV-6/7/8 Quantification Kit v13 refs98/79 Anatolia Geneworks Bosphore HIV-1 Quantification Kit3 refs98/79 Anatolia Geneworks Bosphore HPV Genotyping High Risk Kit v33 refs98/79 Anatolia Geneworks Bosphore HPV HR-LR Genotyping Kit v32 refs98/79 Anatolia Geneworks Bosphore HPV Screening Kit v13 refs98/79 Anatolia Geneworks Bosphore HPV Screening Kit v23 refs98/79 Anatolia Geneworks Bosphore hrHPV Screening Kit v13 refs98/79 Anatolia Geneworks Bosphore HSV 1-2 Quantification Kit v13 refs98/79 Anatolia Geneworks Bosphore Joint Infection Panel Kit v13 refs98/79 Anatolia Geneworks Bosphore Malaria Genotyping Kit v23 refs98/79 Anatolia Geneworks Bosphore Measles Detection Kit v13 refs98/79 Anatolia Geneworks Bosphore MTBC Detection Kit v23 refs98/79 Anatolia Geneworks Bosphore Neonatal Meningitis Panel Kit v13 refs98/79 Anatolia Geneworks Bosphore Parvovirus B19 Quantification Kit v13 refs98/79 Anatolia Geneworks Bosphore Respiratory Pathogens Panel Kit v122 refs98/79 Anatolia Geneworks Bosphore Respiratory Pathogens Panel Kit v53 refs98/79 Anatolia Geneworks Bosphore Respiratory Pathogens Panel Kit v73 refs98/79 Anatolia Geneworks Bosphore Respiratory Viral Basic Panel Kit v23 refs98/79 Anatolia Geneworks Bosphore Sepsis Screening Kit v33 refs98/79 Anatolia Geneworks Bosphore STD Basic Kit v13 refs98/79 Anatolia Geneworks Bosphore STDs Screening Kit v43 refs98/79 Anatolia Geneworks Bosphore STDs Screening Kit v63 refs98/79 Anatolia Geneworks Bosphore Tissue Genomic DNA Extraction Spin Kit v2 Anatolia Geneworks Bosphore Tropical Fever Panel Kit v13 refs98/79 Anatolia Geneworks Bosphore Tropical Fever Panel Kit v43 refs98/79 Anatolia Geneworks Bosphore UTI Panel Kit v42 refs98/79 Anatolia Geneworks Bosphore Viral Meningitis Panel Kit v23 refs98/79 Anatolia Geneworks Bosphore Viral Meningitis Panel Kit v33 refs98/79 Anatolia Geneworks Bosphore VZV (HHV-3) Quantification Kit v13 refs98/79 Anatolia Geneworks Bosphore Wound Panel Kit v13 refs98/79 Anatolia Geneworks Magnesia 2448 Bacterial DNA Extraction Kit Anatolia Geneworks Magnesia 2448 Viral DNA/RNA Extraction Kit Anatolia Geneworks Magnesia 2448 Viral DNA/RNA Extraction Kit EP2 refs Anatolia Geneworks Magnesia 2448 Whole Blood Genomic DNA Extraction Kit Anatolia Geneworks UNIO 96 Nucleic Acid Extraction Versatile Kit MG92 refs Anatolia Geneworks Unio 96 Nucleic Acid Extraction Versatile Kit Anatolia Geneworks Unio M32 Viral DNA/RNA Extraction Kit2 refs Anatolia Geneworks UNIO M32 Viral Nucleic Acid Extraction TB Anatolia Geneworks Unio Viral DNA/RNA Extraction Kit 600 µl2 refs	A, C, D IVDR, 98/79	Website info@anatoliagenetik.com EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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 refs Adenovirus FIA Kit 25 Tests/kit98/79 Adenovirus IgM Detection Kit(CLIA) 50 Tests/kit98/79 Coxsackie virus group A type 16 (CA16) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 52 others 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 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 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 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 α2-plasmininhibitor-Plasmin Complex(PIC) Detection Kit(CLIA) 50 Tests/kit98/79	A IVDR, 98/79	Website sales@szzijian.com EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	2019-nCoV Antigen Test (Lateral Flow Method)3 refs 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 Chikungunya Virus Antigen Test WL18P000198/79 52 others 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 refs98/79 Diagnostic Kit for Adenovirus Antigen (Immunochromatographic Assay)2 refs98/79 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 refs98/79 Diagnostic Kit for IgM Antibody to Hepatitis A Virus (Colloidal Gold)2 refs98/79 Diagnostic Kit for IgM Antibody to Hepatitis E Virus (Colloidal Gold)2 refs98/79 Diagnostic Kit for IgM Antibody to Human Enterovirus71 (Immunochromatographic Assay)2 refs98/79 Diagnostic Kit for Rotavirus Antigen (Colloidal Gold)2 refs98/79 Fibrinogen Reagent Kit (Clotting) W48298/79 Finecare5 refs98/79 One Step Chlamydia Swab / Urine Test98/79 One Step Dengue IgG/IgM Whole Blood/Serum/Plasma Test2 refs98/79 One Step Dengue NS1 Antigen Whole Blood/Serum/Plasma Test2 refs98/79 One Step Gonorrhea Swab Test2 refs98/79 One Step H. Pylori Feces Test4 refs98/79 One Step H.Pylori Serum/Plasma Test4 refs98/79 One Step Influenza A Test4 refs98/79 One Step Influenza A&B Test7 refs98/79 One Step Influenza B Test4 refs98/79 One Step Malaria HRP2 (P.f) Test4 refs98/79 One Step Malaria HRP2/pLDH (P.f/P.v) Test2 refs98/79 One Step Malaria HRP2/pLDH (P.f/Pan)Test3 refs98/79 One Step Strep A Swab Test7 refs98/79 One Step Syphilis Serum/Plasma Test2 refs98/79 One Step Syphilis Whole Blood/Serum/Plasma Test4 refs98/79 One Step Typhoid IgG/IgM Whole Blood/Serum/Plasma Test2 refs98/79 PA-Bluing Reagent PA-Immunochromogenic Reagent PA-Immunochromogenic Reagent (Dual staining)2 refs PA-Immunochromogenic Reagent (Red staining)2 refs 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 refs98/79 SmarLumi Herpes simplex virus-1 lgG (CLIA)4 refs98/79 SmarLumi Herpes simplex virus-1 lgM (CLIA)4 refs98/79 SmarLumi Herpes simplex virus-2 lgG (CLIA)4 refs98/79 SmarLumi Herpes simplex virus-2 lgM (CLIA)4 refs98/79 SmarLumi Interleukin-6 (CLIA)4 refs98/79 SmarLumi Plasmin-α2-Antiplasmin Complex (CLIA)4 refs98/79 SmarLumi Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)4 refs98/79 Thrombin Time Reagent Kit (Clotting) W48498/79 U-CardDxTM 20012 refs98/79 U-CardDx™ 200 6 Types of Diarrhea Pathogens Test3 refs98/79 U-Card™ 20012 refs98/79 Wondfo One Step HIV1/2 Whole Blood/Serum/Plasma Test2 refs	A, C, D IVDR, 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
Baso Diagnostics Zhuhai EU representative : Eunitor GmbH (Germany)	China	069523833010353 refs 1% hydrochloric acid ethanol solution2 refs Acetone fuchsin solution3 refs Acid Alcohol solution 1000ml2 refs Acid alcohol solution 4×1000mL2 refs 51 others Acid Fast Stain (Kinyoun)3 refs Acid Fast Stain (Phenol-free fuchsin staining method)2 refs Acid Fast Stain (Ziehl-Neelsen)3 refs Acid Fast Stain（None-phenol Auramine O staining method） Acid Phosphatase Stain(ACP)2 refs Acid α-Naphthyl Acetate Esterase Stain(ANAE)3 refs Alcian Blue and PAS Stain (AB-PAS)3 refs Alcoholic Eosin method3 refs Ammoniacal silver solution3 refs Aqueous 100mL Basophil Stain (Toluidine blue method)2 refs Brilliant green method2 refs Buffer(concentrated) 1000mL2 refs Carbolfuchsin solution2 refs Chromosome (solution A) 1000mL3 refs Congo Red Stain 3×100mL3 refs Cotton Blue Stain with Lactophenol Cryptococcus Neoformans Stain Crystal violet3 refs Diff Quick Cell Stain 4×100mL2 refs Diff-Quik Fix2 refs EA36 Solution3 refs Elastin stain3 refs Fix Solution3 refs Flagella Stain Fungal Fluorescence Stain (One-step method)3 refs Fungal immunofluorescence chromogenic reagent (Ⅰ)3 refs Gill3 refs Hemosiderin Stain2 refs Immunofluorescence Chromogenic Reagent3 refs Iron Stain 100 Tests3 refs Leukocyte Peroxidase Stain (POX) (Oxidation WG-KI method)3 refs Leukocyte Peroxidase Stain(POX)(Benzidine method)3 refs May-Grünwald’s Stain Methyl green method3 refs Mucicarmine Stain2 refs Naphthol AS-D Chloroacetate Esterase Stain(AS-DCE)3 refs Neutrophilic Leukocyte Alkaline Phosphatase Stain (NAP)3 refs Nuclear Fast Red solution3 refs Oil Red O Stain 2×20mL2 refs Pathology Hepatin Stain (PAS)3 refs Phosphate buffer (pH 6.8)3 refs Phosphate buffer（pH 6.8）（Solution B3 refs Reticulocyte Stain 2×100mL2 refs S method 3×20mL Sudan Black B Stain(SBB) Tissue marking reagent (black)3 refs Trypan blue Stain2 refs TypeⅠ3 refs α-Naphthyl Acetate Esterase Stain (α-NAE) (Fast blue method)3 refs α-Naphthyl Butyrate Esterase Stain(α-NBE)3 refs	A IVDR	EUDAMED record Report an error
Egyptian For Biotechnology-Spectrum Diagnostics EU representative : MDSS GmbH (Germany)	Egypt	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 others 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	Website info@spectrum-diagnostics.com EUDAMED record Report an error
Vitassay	Spain	Vitassay Microorganism-NA isolation kit Vitassay qPCR AMB98/79 Vitassay qPCR Aspergillosis98/79 Vitassay qPCR Astrovirus98/79 Vitassay qPCR BK98/79 51 others 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	Website info@vitassay.com EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Allplex™ 2019-nCoV Assay2 refs98/79 Allplex™ Bacterial Vaginosis plus Assay2 refs Allplex™ Candidiasis Assay3 refs Allplex™ CT/NG/MG/TV Assay3 refs Allplex™ Genital ulcer Assay3 refs 48 others Allplex™ GI-Bacteria(I) Assay3 refs98/79 Allplex™ GI-Bacteria(I) plus Assay2 refs Allplex™ GI-Bacteria(II) Assay3 refs98/79 Allplex™ GI-EB plus Screening Assay2 refs Allplex™ GI-EB Screening Assay3 refs98/79 Allplex™ GI-Helminth(I) Assay3 refs Allplex™ GI-Parasite Assay3 refs Allplex™ GI-Virus Assay3 refs Allplex™ GI-Virus plus Assay3 refs98/79 Allplex™ HPV HR Detection3 refs Allplex™ HPV28 Detection2 refs Allplex™ Meningitis-B Assay3 refs Allplex™ Meningitis-V1 Assay3 refs98/79 Allplex™ Meningitis-V2 Assay3 refs Allplex™ NG & DR Assay2 refs Allplex™ NTM Typing2 refs Allplex™ PneumoBacter Assay3 refs Allplex™ Respiratory Panel 1A3 refs98/79 Allplex™ Respiratory Panel 23 refs98/79 Allplex™ Respiratory Panel 33 refs98/79 Allplex™ Respiratory Panel 43 refs98/79 Allplex™ RP-Virus(I) Assay2 refs Allplex™ RP-Virus(II) Assay2 refs Allplex™ RP-Virus(III) Assay2 refs Allplex™ RV Master Assay2 refs Allplex™ SARS-CoV-2 Assay2 refs98/79 Allplex™ SARS-CoV-2 fast PCR Assay2 refs98/79 Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay2 refs98/79 Allplex™ STI Essential Assay3 refs Allplex™ STI Essential Assay Q(MH,UU)3 refs Allplex™ TS Strep ACG&AH2 refs Allplex™ Vaginitis screening Assay3 refs Anyplex™ II HPV28 Detection2 refs98/79 Anyplex™ II HPV HR Detection3 refs98/79 Anyplex™ II STI-7e Detection3 refs Anyplex™ MTB/NTMe Real-time Detection3 refs98/79 STARMag 96 ProPrep2 refs STARMag 96 ProPrep C2 refs STARMag 96 ProPrep plus2 refs 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 refs STARMag™ N/S Kit STARMag™ S96H Kit3 refs STARMag™ S96H N Kit2 refs STARMag™ SP32 Kit2 refs STARprep™ EZ Buffer2 refs	A, B, C IVDR, 98/79	Website info@seegene.com EUDAMED record Report an error
Bioeksen	Türkiye	Bio-Speedy® Bacteria/Fungi qPCR Kit98/79 Bio-Speedy® Bacterial Atypical Pneumonia Factors qPCR Kit98/79 Bio-Speedy® Bone & Joint qPCR Panel3 refs98/79 Bio-Speedy® Bordetella pertussis, B.parapertussis, B.bronchiseptica and B.holmesii Real-Time PCR Detection Kit2 refs98/79 Bio-Speedy® C. difficile Toxin A-B qPCR Kit2 refs98/79 47 others Bio-Speedy® CCHFV RT-qPCR Detection Kit2 refs98/79 Bio-Speedy® COVID-19/Flu RT-qPCR98/79 Bio-Speedy® GAS (Group A Streptococcus) qPCR Kit2 refs98/79 Bio-Speedy® Gastroenteritis qPCR MX-6L Parasitic Panel2 refs98/79 Bio-Speedy® Gastroenteritis qPCR MX-6T Parasitic Panel2 refs98/79 Bio-Speedy® Gastroenteritis RT-qPCR MX-24L Panel2 refs98/79 Bio-Speedy® Gastroenteritis RT-qPCR MX-24S Panel98/79 Bio-Speedy® Gastroenteritis RT-qPCR MX-24T Panel2 refs98/79 Bio-Speedy® Gastroenteritis RT-qPCR MX-5L Viral Panel2 refs98/79 Bio-Speedy® Gastroenteritis RT-qPCR MX-5T Viral Panel2 refs98/79 Bio-Speedy® GBS (Group B Streptococcus) qPCR Kit2 refs98/79 Bio-Speedy® H.pylori/Clarithromycin Resistance qPCR Kit98/79 Bio-Speedy® Human Papillomavirus 6-11-16-18-HR qPCR Kit2 refs98/79 Bio-Speedy® Human Papillomavirus Genotyping qPCR Panel5 refs98/79 Bio-Speedy® Human Papillomavirus High-Risk qPCR Panel5 refs98/79 Bio-Speedy® Human Papillomavirus Low-Medium Risk qPCR Panel5 refs98/79 Bio-Speedy® Human Papillomavirus qPCR Kit2 refs98/79 Bio-Speedy® Influenza A (H1-3-5-7) RT-qPCR Kit2 refs98/79 Bio-Speedy® Lower Respiratory Bacteria qPCR Panel5 refs98/79 Bio-Speedy® Measles Virus Real-Time PCR Detection Kit2 refs98/79 Bio-Speedy® Meningitis/Encephalitis RT-qPCR MX-17L Panel2 refs98/79 Bio-Speedy® Meningitis/Encephalitis RT-qPCR MX-17S Panel98/79 Bio-Speedy® Meningitis/Encephalitis RT-qPCR MX-17T Panel2 refs98/79 Bio-Speedy® MTB qPCR Kit4 refs98/79 Bio-Speedy® MTB/NTM qPCR Kit4 refs98/79 Bio-Speedy® Plasmodium qPCR Panel2 refs98/79 Bio-Speedy® Respiratory ID-1 Kit2 refs98/79 Bio-Speedy® Respiratory ID-1 Panel98/79 Bio-Speedy® Respiratory ID-2 Kit2 refs98/79 Bio-Speedy® Respiratory ID-2 Panel98/79 Bio-Speedy® Respiratory ID-3 Panel98/79 Bio-Speedy® Respiratory Tract 4T RT-qPCR Kit5 refs98/79 Bio-Speedy® Respiratory Tract RT-qPCR MX-19T Panel98/79 Bio-Speedy® Respiratory Tract RT-qPCR MX-24L Panel2 refs98/79 Bio-Speedy® Respiratory Tract RT-qPCR MX-24S Panel98/79 Bio-Speedy® Respiratory Tract RT-qPCR MX-24T Panel2 refs98/79 Bio-Speedy® Respiratory Tract Virus RT-qPCR Panel4 refs98/79 Bio-Speedy® SARS-CoV-2 N RT-qPCR Kit2 refs98/79 Bio-Speedy® SARS-CoV-2 Triple Gene RT-qPCR Kit4 refs98/79 Bio-Speedy® Sepsis qPCR MX-30L Panel2 refs98/79 Bio-Speedy® Sepsis qPCR MX-30S Panel98/79 Bio-Speedy® Sepsis qPCR MX-30T Panel2 refs98/79 Bio-Speedy® Sexually Transmitted Infections RT-qPCR Panel5 refs98/79 Bio-Speedy® Tropical Fever RT-qPCR Panel2 refs98/79 Bio-Speedy® Urinary Tract Infections qPCR Panel5 refs98/79 Bio-Speedy® West Nile Virus Real-Time PCR Detection Kit2 refs98/79 Bioeksen STL-B Sample Pre-treatment Buffer	A IVDR, 98/79	Website info@bioeksen.com.tr EUDAMED record Report an error
Bioer FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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 Biospin Omni Genomic DNA Extraction Kit BSC39S1, BSC39M12 refs Biospin Virus DNA/RNA Extraction Kit BSC77S1, BSC77M1, BSC77L13 refs Bocavirus, Human Metapneumovirus and Rhinovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ12L198/79 47 others Bocavirus, Human Metapneumovirus and Rhinovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ12M198/79 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 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 refs 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 refs 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 refs 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 refs 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 refs 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 refs MagaBio plus Virus DNA / RNA Purification Kit Ⅱ BSC71T1S, BSC71S1S, BSC71M1S,BSC71L1S, BSC71T1E,BSC71S1E, BSC71M1E, BSC71L1E, BSC71T1C, BSC71S1C, BSC71S1B, BSC71M1B, BSC71M1E-T, BSC71L1E-T3 refs 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 refs MagaBio plus Virus RNA Purification Kit Ⅱ BSC87T1S, BSC87S1S, BSC87M1S, BSC87N1E, BSC87T1E, BSC87S1E, BSC87M1E, BSC87L1E, BSC87S1B, BSC87M1B, BSC87M1E-T, BSC87L1E-T, BSC87T1P, BSC87S1P3 refs 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 refs 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 refs 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 refs Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR) BSJ09S1, BSJ09M1, BSJ09L13 refs Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluorescent PCR) BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A3 refs 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 Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluorescent RT- PCR) BSJ05S1, BSJ05M1, BSJ05L13 refs 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 refs 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	A, B, C IVDR, 98/79	Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Diapath FDA	Italy	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 refs 10% STABILIZED FORMALIN - 10 LT GENERAL FIXATIVE (FORMALDEHYDE 4%) RTU - 10% STABILIZED FORMALIN 5% NEUTRAL BUFFERED FORMALIN - 10 LT GENERAL FIXATIVE - 5% NEUTRAL BUFFERED FORMALIN A.F.O.G. (ACID FUCHSIN ORANGE G) KIT SPECIAL STAIN 47 others 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 refs DIAMOUNT - 500 ML DUBOSCQ-BRASIL PICROFORMALIN - 2 LT GENERAL FIXATIVE, SUITABLE FOR BIOPSIES, RTU - DUBOSCQ-BRASIL PICROFORMALIN EA50 - 1 LT STAINING SOLUTION - EA503 refs EOSIN G OR Y ALCOHOLIC 0,5 % - 1 LT STAINING SOLUTION - EOSIN G OR Y ALCOHOLIC 0,5 %3 refs 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 GIEMSA ACC. PAPPENHEIM - 1 LT STAINING SOLUTION - GIEMSA ACC. PAPPENHEIM 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 refs MICROMOUNT - 500 ML2 refs 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 refs 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 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 refs SILVER IMPREGNATION 100 TESTS KIT SPECIAL STAIN STAINTABS - EOSIN 10 TABS STAINTABS - HEMATOXYLIN 10 TABS	A IVDR	Website info@diapath.com EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	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 47 others 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 refs MagNXT Tissue & body fluids Nucleic acid extraction kit G2M2121213 refs 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 refs98/79 MTC-Q Real-Time PCR Kit G2M70732198/79 MTC-Q Real-Time PCR Kit G6100143 refs98/79 N. Gonorrhoeae-Q Real-Time PCR Kit G2M70642198/79 Para-Q Multiplex Real Time PCR kit G2M70612198/79 Para2-Q Real Time PCR Kit G2M80152198/79 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 refs SpiNXT FFPE DNA Extraction Kit G2M2321212 refs SpiNXT Tissue & body fluids Nucleic acid extraction kit G2M1314202 refs 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 refs98/79 TB-Q Comprehensive Real Time PCR Kit for Tuberculosis G2M80312198/79 TB-Q Comprehensive Real Time PCR Kit for Tuberculosis G6100343 refs98/79 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	Website EUDAMED record Report an error
Cybereagen EU representative : CMC Medical Devices & Drugs SL (Spain)	China	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 others 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 EUDAMED record Report an error
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany)	Singapore	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 46 others 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 refs 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 ViroKey Flu A/B & RSV RT-PCR Extension Kit 30107498/79 ViroKey HT Virus Total Nucleic Acid Kit (4x96) 300678, 3010892 refs ViroKey MP HPV 16, 18 PCR Test 301119, 301120, 30112198/79	A IVDR, 98/79	Website infoAPAC@veladx.com EUDAMED record Report an error
Alba Bioscience FDA EU representative : Emergo Europe B.V. (Netherlands)	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 others 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	Website regulatory.registrations@alivedx.com EUDAMED record Report an error
Ameritech Diagnostic Reagent (Jiaxing) EU representative : AR Experts B.V. (Netherlands) and 1 other	China	Exacto-85879598/79 PreventID Strep A R34-11298/79 PreventID Strep B R66-11298/79 R10-11098/79 R10-11698/79 45 others 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 refs98/79 R402-11298/79 R40S-11098/79 R40S-11298/79 R44-11298/79 R66-11098/79 R66-1122 refs98/79 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	EUDAMED record Report an error
ElitechGroup FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Italy, United States	Adenovirus - ELITe Positive Control3 refs AFB/TB Stain Control Slides Aerospray Stains3 refs ASPERGILLUS spp. - ELITe Positive Control98/79 ASPERGILLUS spp. ELITe MGB® Kit98/79 ASPERGILLUS spp. ELITe Standard98/79 45 others BKV - ELITe Positive Control3 refs Bordetella - ELITe Positive Control2 refs C. difficile - ELITe Positive Control98/79 C. difficile ELITe MGB® Kit98/79 Candida auris - ELITe Positive Control2 refs CMV - ELITe Positive Control3 refs CMV RNA - ELITe Positive Control3 refs CPE - Internal Control EBV - ELITe Positive Control3 refs ENTEROVIRUS - ELITe Positive Control3 refs GI Bacterial PLUS - ELITe Positive Control2 refs GI Norovirus PLUS - ELITe Positive Control2 refs GI Parasitic PLUS - ELITe Positive Control2 refs GI Viral PLUS - ELITe Positive Control2 refs 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 refs HHV8 - ELITe Positive Control HHV8 ELITe MGB® Kit3 refs HIV1 ELITe MGB® Kit HPV PLUS - ELITe Positive Control2 refs HSV1 - ELITe Positive Control HSV1 ELITe MGB® Kit3 refs HSV2 - ELITe Positive Control HSV2 ELITe MGB® Kit3 refs JCV - ELITe Positive Control3 refs Macrolide-R/MG - ELITe Positive Control2 refs Meningitis Bacterial - ELITe Positive Control98/79 Meningitis Bacterial ELITe MGB® Kit98/79 MTB EXTRA ELITe MGB® Kit98/79 Parvovirus B19 - ELITe Positive Control Parvovirus B19 ELITe MGB® Kit3 refs Pneumocystis - ELITe Positive Control3 refs Respiratory Bacterial PLUS - ELITe Positive Control2 refs 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 refs STI PLUS - ELITe Positive Control2 refs TOXOPLASMA g. ELITe MGB® Kit2 refs UroGen ELITe - Positive Control2 refs Viral Essential 1 - ELITe Positive Control Viral Essential 1 ELITe MGB® Kit2 refs Viral Essential 2 - ELITe Positive Control Viral Essential 2 ELITe MGB® Kit2 refs VZV - ELITe Positive Control3 refs WNV - ELITe Positive Control98/79 WNV ELITe MGB® Kit98/79 WNV ELITe Standard98/79	A, B, C, D IVDR, 98/79	Website info@elitechgroup.com EUDAMED record Report an error
Lorne Laboratories EU representative : Advena Limited (Malta)	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 others Anti-B Monoclonal ABO Monoclonal Antibody Reagents98/79 Anti-C Monoclonal Rhesus Monoclonal Antibody Reagents2 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 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	Website info@lornelabs.com EUDAMED record Report an error
nal von minden	Germany	dedicio® Strep A Test3 refs98/79 FUTURLAB® Strep A Test98/79 Hitado D-Dimer Test2 refs98/79 Hitado Mononucleosis Test98/79 Hitado strep a2 refs98/79 45 others Hitado strep a Test3 refs Lagaay Malaria Pf/Pan Ag 4 Species Test Malaria Pf/Pan Ag 4 SpeciesTest98/79 meditrol® D-Dimer Test5 refs98/79 meditrol® Strep A Test98/79 NADAL TPHA Microplate Haemagglutination Test98/79 NADAL® C. difficile GDH Ag Test2 refs98/79 NADAL® C. difficile Toxin A/B Test2 refs98/79 NADAL® C. difficile Toxin A/B+GDH Test2 refs98/79 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 refs98/79 NADAL® COVID-19 IgG/IgM Test98/79 NADAL® D-Dimer Test5 refs98/79 NADAL® Dengue NS1 Ag+IgG/IgM Test98/79 NADAL® H.pylori Ag Test2 refs98/79 NADAL® H.pylori Ab Test2 refs98/79 NADAL® Influenza A/B Scan Test98/79 NADAL® Influenza A/B Test2 refs98/79 NADAL® Legionella /S. pneumoniae Test98/79 NADAL® Legionella Test2 refs98/79 NADAL® Malaria Pf/Pan Ag 4 Species plus Test3 refs98/79 NADAL® Malaria Pf/Pan Ag 4 Species Test2 refs98/79 NADAL® Mononucleosis Test3 refs98/79 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 refs98/79 NADAL® Strep A Plus Test2 refs98/79 NADAL® Strep A Scan Test98/79 NADAL® Strep A Test8 refs NADAL® Strep B98/79 NADAL® Strep B Test98/79 NADAL® Syphilis Test2 refs98/79 NADAL® VDRL Test98/79 NEO CITOSTREP® Strep A Test98/79 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 refs98/79 StrepA PreMax® Test2 refs98/79	B IVDR, 98/79	Website info@nal-vonminden.com EUDAMED record Report an error
Tcoag FDA	Ireland	Ristocetin sthemA CL-15 sthemA CL-250 sthemA DL-2500 sthemA DL-9000 45 others 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 refs98/79 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	Website EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others	China	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 44 others 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 refs COVID-19/ Flu A&B Ag Rapid Test HWTS-RT200A3 refs 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 refs 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 refs 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 refs Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. HWTS-EV032A3 refs 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 refs 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 EUDAMED record Report an error
Biosynex EU representative : BIOSYNEX (France)	France, Switzerland	BIOSYNEX AMPLIFLASH MALARIA2 refs BIOSYNEX AMPLIQUICK Bordetella2 refs BIOSYNEX AMPLIQUICK Fecal Bacteriology3 refs BIOSYNEX AMPLIQUICK Fecal Virology3 refs BIOSYNEX AMPLIQUICK Helminths3 refs98/79 47 others BIOSYNEX AMPLIQUICK Leptospira BIOSYNEX AMPLIQUICK Malaria2 refs BIOSYNEX AMPLIQUICK Parasitology Lite3 refs BIOSYNEX AMPLIQUICK Protozoans3 refs98/79 BIOSYNEX AMPLIQUICK Respiratory Duplex2 refs98/79 BIOSYNEX AMPLIQUICK Respiratory Triplex98/79 BIOSYNEX AMPLIQUICK SARS-CoV-23 refs98/79 BIOSYNEX AMPLIQUICK STI Panel I3 refs BIOSYNEX C. difficile GDH BIOSYNEX COMBO ADENO/ROTA BSS98/79 BIOSYNEX COMBO COVID-FLU BSS98/79 BIOSYNEX COVID-19 Ag BSS98/79 BIOSYNEX CryptoPS2 refs 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 PYLORITOP Ab BSS98/79 PYLORITOP AG98/79 STREPTATEST2 refs98/79 TETANOTOP98/79 TETANOTOP BSX98/79 BIOSYNEX AMPLIFLASH GBS (no longer marketed) Ksmart D-DIMER98/79 (no longer marketed) Ksmart D-DIMER + Controls98/79 (no longer marketed) SYPHILITOP98/79 (no longer marketed)	B, C IVDR, 98/79	Website reglementaire@biosynex.com EUDAMED record Report an error
Human	Germany	CMV IgG98/79 Dengue IgG ELISA98/79 Dengue IgM ELISA98/79 H. pylori IgA ELISA98/79 H. pylori IgG ELISA98/79 44 others 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 refs98/79 HemoStat Calibrator98/79 HemoStat Control Plasma abnormal98/79 HemoStat Control Plasma normal98/79 HemoStat D-Dimer2 refs98/79 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 refs98/79 Herpes-Simplex (HSV) 1 IgG ELISA98/79 Herpes-Simplex (HSV) 2 IgG ELISA98/79 HSRate-Control98/79 HumaTex Febrile Antigens Control PC/NC98/79 IMTEC-Salmononella-Antibodies IgA (cut-off)98/79 IMTEC-Salmononella-Antibodies Screen (cut-off)98/79 Measles IgG ELISA98/79 Syphilis RPR Test3 refs98/79 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 (no longer marketed) IM Quick Test98/79 (no longer marketed)	A, B IVDR, 98/79	Website EUDAMED record Report an error
Ab Analitica	Italy	AMPLIQUALITY HCV TYPE PLUS3 refs AMPLIQUALITY HPV-TYPE EXPRESS v3.02 refs98/79 FERTILITY CUSTOM SERVICE 00-06R-5098/79 FERTILITY DECON TEST98/79 FERTILITY HISTON COLOR TEST98/79 42 others FERTILITY LIFE TEST98/79 FERTILITY ROUND CELL TEST 00-05R-5098/79 FERTILITY SWELLING TEST98/79 GENEQUALITY 2050 Extraction C GENEQUALITY 2050 Extraction P GENEQUALITY X120 PATHOGEN KIT IC 05-79-A2 refs REALQUALITY Aspergillus4 refs98/79 REALQUALITY InFLU-Typing2 refs98/79 REALQUALITY RQ-ADENO4 refs98/79 REALQUALITY RQ-ADENO STANDARD2 refs98/79 REALQUALITY RQ-BKV4 refs98/79 REALQUALITY RQ-BKV STANDARD2 refs98/79 REALQUALITY RQ-CMV4 refs98/79 REALQUALITY RQ-CMV STANDARD2 refs98/79 REALQUALITY RQ-EBV4 refs98/79 REALQUALITY RQ-EBV STANDARD2 refs98/79 REALQUALITY RQ-ENTERO8 refs98/79 REALQUALITY RQ-ENTERO STANDARD2 refs98/79 REALQUALITY RQ-HHV 6 STANDARD2 refs98/79 REALQUALITY RQ-HHV 74 refs98/79 REALQUALITY RQ-HHV 7 STANDARD2 refs98/79 REALQUALITY RQ-HHV 84 refs98/79 REALQUALITY RQ-HHV 8 STANDARD2 refs98/79 REALQUALITY RQ-HPV HR Multiplex4 refs98/79 REALQUALITY RQ-HPV HR/LR Multiplex6 refs98/79 REALQUALITY RQ-HPV Screen4 refs98/79 REALQUALITY RQ-HSV 1 STANDARD2 refs98/79 REALQUALITY RQ-HSV 2 STANDARD2 refs98/79 REALQUALITY RQ-JCV STANDARD2 refs98/79 REALQUALITY RQ-MBT COMPLEX4 refs98/79 REALQUALITY RQ-MBT COMPLEX STANDARD98/79 REALQUALITY RQ-Multi HPV Detection6 refs98/79 REALQUALITY RQ-PARVO B194 refs98/79 REALQUALITY RQ-PARVO B19 STANDARD2 refs98/79 REALQUALITY RQ-STI CT6 refs98/79 REALQUALITY RQ-TOXO4 refs98/79 REALQUALITY RQ-VZV STANDARD2 refs98/79 REALQUALITY RS-HHV 64 refs98/79 REALQUALITY RS-HSV 14 refs98/79 REALQUALITY RS-HSV 24 refs98/79 REALQUALITY RS-VZV4 refs98/79	A, C IVDR, 98/79	customersupport@abanalitica.it EUDAMED record Report an error
Bdbiosciences FDA EU representative : Becton Dickinson Ireland Limited (Ireland)	United States	BD FACSDiva CS&T IVD Beads (50 tests)2 refs BD LEUCOCOUNT4 refs BD MULTI-CHECK3 refs BD Multi-Check CD4 Low Controls3 refs BD MULTITEST 42 others 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 refs 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 refs FACS 7-C Setup Bead FC Beads 8-Color Kit for BD OneFlow™ Horizon CD138 Single Color Reagents3 refs Horizon CD27 Single Color Reagents3 refs Horizon CD279 Single Color Reagent Horizon CD3 Single Color Reagents3 refs Horizon CD45RA Single Color Reagents3 refs Horizon CD81 Single Color Reagent Not Applicable10 refs 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 refs Not Applicable BD® CD10 (HI10a)3 refs Not Applicable BD® CD193 refs Not Applicable BD® CD20 (L27)3 refs Not Applicable BD® CD22 (S-HCL-1)3 refs Not Applicable BD® CD23 (EBVCS-5)2 refs Not Applicable BD® CD45 (2D1)3 refs Not Applicable BD® CD79b (SN8)3 refs Not Applicable BD® FMC7 Not Applicable CD152 Single Color Reagent Not Applicable CD1a Single Color Reagent Not Applicable CD2 Single Color Reagents3 refs Not Applicable CD25 Single Color Reagents3 refs Not Applicable CD34 Single Color Reagents3 refs Not Applicable CD4 Single Color Reagents3 refs Not Applicable CD5 Single Color Reagents3 refs Not Applicable CD56 Single Color Reagents3 refs Not Applicable CD57 Single Color Reagent Not Applicable CD79a Single Color Reagents3 refs Not Applicable CD8 Single Color Reagents3 refs	A, B, C IVDR	Website EUDAMEDenquiries@bd.com EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium)	South Korea	AFIAS COVID-19 Ag98/79 AFIAS D-Dimer98/79 AFIAS D-Dimer Neo98/79 AFIAS Dengue IgG/IgM AFIAS Dengue NS1 Ag98/79 42 others 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 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 ExAmplex MTB/NTM kit98/79 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 hemochroma PLUS Calibrator hemochroma PLUS Control hemochroma PLUS Control Set 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™ IL-698/79 ichroma™ Influenza A+B98/79 ichroma™ Mycoplasma98/79 ichroma™ RSV98/79 ichroma™ Strep A98/79	B, C IVDR, 98/79	Website marketing@boditech.co.kr EUDAMED record Report an error
Denizbiyokimya	Türkiye	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 others 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	EUDAMED record Report an error
Diesse FDA	Italy	CHORUS BORRELIA IgG CHORUSBOG CHORUS CHIKUNGUNYA IgM CHORUS CHLAMYDOPHILA PNEUMONIAE IgA CHORUSCHA CHORUS CHLAMYDOPHILA PNEUMONIAE IgG CHORUSCHG CHORUS CHLAMYDOPHILA PNEUMONIAE IgM CHORUSCHM 42 others 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 refs CHORUS EPSTEIN-BARR VCA IgM II CHORUSEBMII 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 refs CHORUS INFLUENZA A IgG CHORUSIAG2 refs CHORUS INFLUENZA B IgA CHORUSIBA2 refs CHORUS INFLUENZA B IgG CHORUSIBG2 refs 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 refs CHORUS VARICELLA IgG CHORUSVZG CHORUS WEST NILE IgG CHORUSWNG CHORUS WEST NILE IgM CHORUSWNM 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 refs WF-DAT ADVANCED WFDAT	A, B, C IVDR	Website EUDAMED record Report an error
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 42 others 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 refs May-Grünwald solution for stainers 320830-2500 Mayer hemalum 320550-10002 refs MCDh 2 313570-25003 refs MCDh 3 313560-25003 refs MCDh 4 313600-25002 refs 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 refs R4 - Kit RAL StainBox BBM 313565-0250 R5 - Kit RAL StainBox BBM 313605-0250 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	Website info@ral-diagnostics.fr EUDAMED record Report an error
Richard-Allan Scientific EU representative : Epredia Netherlands B.V. (Netherlands)	United States	1% Acetic Acid Solution3 refs 10% Neutral Buffered Formalin Prefilled Container3 refs 10% Neutral Buffered Formalin Solvents3 refs 100% Dehydrant3 refs 37% Formaldehyde3 refs 42 others Acid Fast Bacillus Stain Kit - Blue Secondary Stain3 refs Acid Fast Bacillus Stain Kit - Green Secondary Stain2 refs Alcian Blue pH 2.5 Periodic Acid-Schiff Stain Kit3 refs Alcoholic Hematoxylin Solution3 refs Ammonium Hydroxide Solution (28-30%)3 refs Amyloid Stain Kit3 refs Aniline Blue Stain Solution3 refs Antibody Diluent OP Quanto Aqua Mount3 refs Bluing Reagent3 refs Cal-Rite™3 refs Cell-Fixx™3 refs Chromic Acid Solution (5%)3 refs Citrate Buffer for HIER3 refs Citrus Clearing Solvent3 refs ClearVue™ Mountant3 refs Cryochrome™ Blue3 refs Crystal Violet Solution3 refs Cyto-Stain™3 refs Cytocool™ II2 refs DAB Quanto2 refs Dewax and HIER Buffer H3 refs Eosin Y Alcoholic3 refs FITC Protein Blocking Agent (PBA)3 refs Giemsa Stain3 refs Gill 1 Hematoxylin3 refs Gomori’s Trichrome Stain - Green Collagen2 refs Gum Mastic Solution3 refs Hematoxylin 12 refs Histoplast IM3 refs Hydrochloric Acid Solution (20%)3 refs Kwik-Diff™ Solution 13 refs Mark-It™ Tissue Marking Dye Black3 refs Methyl Green-Pyronin Y Stain Solution Modified Grocott’s Methenamine Silver Stain Kit2 refs Modified Wright Stain Pack2 refs Mucicarmine Stain Kit2 refs PapSpin™ Collection Fluid3 refs Rapid-Chrome™ H&E Frozen Section Staining Kit2 refs Rapid-Chrome™ Papanicolaou Staining Kit Reticulocyte Stain UltraVision Quanto Detection System HRP DAB3 refs	A IVDR	EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Anti-TP Control98/79 Chlamydia pn. IgG Control Chlamydia pn. IgM Control CMV IgG Control CC843 CMV IgM Control CC844 42 others 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 HSV-1 IgG Control98/79 HSV-1 IgM Control98/79 HSV-2 IgG Control98/79 HSV-2 IgM Control98/79 iFlash-Anti-TP3 refs iFlash-Chlamydia pn. IgG3 refs iFlash-Chlamydia pn. IgM3 refs iFlash-CMV IgG3 refs iFlash-CMV IgM3 refs iFlash-D-dimer2 refs iFlash-EB EA IgG3 refs iFlash-EB EA IgM3 refs iFlash-EB NA IgG3 refs iFlash-EB VCA IgG3 refs iFlash-EB VCA IgM3 refs iFlash-FDP2 refs iFlash-HSV-1 IgG3 refs iFlash-HSV-1 IgM3 refs iFlash-HSV-2 IgG3 refs iFlash-HSV-2 IgM3 refs iFlash-IL-62 refs iFlash-Mycoplasma pn. IgG3 refs iFlash-Mycoplasma pn. IgM3 refs iFlash-PIC2 refs iFlash-Rubella IgG3 refs iFlash-Rubella IgM3 refs iFlash-TAT2 refs iFlash-Toxo IgG3 refs iFlash-Toxo IgM3 refs M. Pneumoniae IgG Control CC84798/79 M. Pneumoniae IgM Control CC84898/79 Procalcitonin Control CC82098/79 Rubella IgG Control CC845 Rubella IgM Control CC846 Toxo IgG Control Toxo IgM Control	C IVDR, 98/79	Website info@szyhlo.com EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	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 Helicobacter Pylori IgG assay (CLIA)98/79 41 others 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 refs 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 refs 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	C IVDR, 98/79	Website EUDAMED record Report an error
Immundiagnostik FDA	Germany	IDK® anti-SARS-CoV-2 IgG ELISA2 refs98/79 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 refs98/79 41 others IDK® Hemoglobin (human) ELISA2 refs98/79 IDK® Hemoglobin/Haptoglobin Complex (1-point-calibration) ELISA2 refs98/79 IDK® Hemoglobin/Haptoglobin Complex ELISA98/79 IDK® TNFα (Tumor Necrosis Factor alpha) ELISA98/79 IDK® TNFα ELISA Immunglobulin G ELISA2 refs98/79 MutaCLEAN Virus3 refs MutaPLEX C. difficile, PCR98/79 MutaPLEX® Bordetella pertussis/parapertussis, PCR2 refs98/79 MutaPLEX® Borrelia, PCR2 refs98/79 MutaPLEX® Coronavirus98/79 MutaPlex® Coronavirus 4G, PCR3 refs98/79 MutaPlex® Coronavirus, PCR2 refs98/79 MutaPlex® CoV-2 MUT 2, PCR98/79 MutaPlex® CoV-2 MUT 3, PCR2 refs98/79 MutaPlex® CoV-2 MUT, PCR98/79 MutaPLEX® Enterovirus, PCR2 refs98/79 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 refs98/79 MutaPLEX® GastroSys498/79 MutaPLEX® GastroSys4 MutaPLEX® GastroSys 498/79 MutaPLEX® GBS (Group B Streptococci), PCR2 refs98/79 MutaPLEX® Legionella pneumophila, PCR2 refs98/79 MutaPLEX® Legionella spp., PCR2 refs98/79 MutaPLEX® Norovirus, PCR2 refs98/79 MutaPlex® RespiraScreen 1, PCR2 refs98/79 MutaPlex® RespiraScreen 2 DIFF, PCR3 refs98/79 MutaPLEX® RespiraScreen 4 DIFF seqc., PCR3 refs98/79 MutaPLEX® RespiraSys 1, PCR2 refs98/79 MutaPLEX® Rickettsia, PCR2 refs98/79 MutaPlex® SC2 multi gene, PCR3 refs98/79 MutaPLEX® Tropica 1, PCR98/79 PreventID® C. diff Combo Tox A + B2 refs98/79 PreventID® CC3 refs98/79 PreventID® Entamoeba histolytica2 refs98/79 PreventID® H. pylori2 refs98/79 PreventID® H. pylori Antigen98/79 PreventID® Haemo/HaptOccult98/79 PreventID® Influenza A+B98/79 PreventID® SARS-CoV-2 Antigen98/79	A, B IVDR, 98/79	Website info@immundiagnostik.com EUDAMED record Report an error
Zybio FDA EU representative : Lotus NL B.V. (Netherlands) and 2 others	China	01.09.31.02.Z3.052 refs Activated Partial Thromboplastin Time Reagent Kit (Clotting Method)3 refs Anti-Xa Controls3 refs Anti-Xa Reagent Kit (Chromogenic Substrate Method)3 refs Antithrombin Ⅲ Reagent Kit (Chromogenic Substrate Method)3 refs 40 others CAL2 refs Cell-free DNA Extraction Kit (Magnetic Bead Method)3 refs CHECK-BFI3 refs CHECK-XN3 refs CHECK-XR3 refs Coagulation Controls2 refs D-Dimer (D-D) Kit(Latex Enhanced Immunoturbidimetric Method)2 refs98/79 D-Dimer Assay (CLIA)98/79 D-Dimer Controls2 refs D-Dimer Reagent Kit (Immunoturbidimetric Method)3 refs Diluent3 refs Fibrin/fibrinogen Degradation Products (FDP) Controls2 refs Fibrin/fibrinogen Degradation Products (FDP) Reagent Kit (Immunoturbidimetric Method)3 refs Fibrinogen (FIB) Kit (Immunoturbidimetric Method)98/79 Fibrinogen Reagent Kit (Clotting Method)3 refs H3 Check3 refs H5 Check3 refs H58 DN H58 DR2 refs H58 LD2 refs H58 LN2 refs H58 LS2 refs IL-6 Assay (CLIA)98/79 Interleukin-6 Assay (Immunofluorescence)98/79 Interleukin-6 Control2 refs LA3 refs Lyse2 refs Molaccu Mycoplasma pneumoniae and Chlamydia pneumoniae Nucleic Acid Detection Kit (Real-time PCR)3 refs Nucleic Acid Extraction Kit (Magnetic Bead Method) 01.09.20.00.B2.083 refs Nucleic Acid Extraction Kit (Magnetic Bead Method) 01.09.20.08.B2.083 refs Probe Cleanser Protein Cleaning Solution Prothrombin Time Reagent Kit (Clotting Method)3 refs TH-PClean3 refs TH-PDesorb2 refs TH-SP-Diluent2 refs Thrombin Time Reagent Kit (Clotting Method)3 refs Z5 DN Z5 LB3 refs Z5 LD	A, B, C IVDR, 98/79	PMS@zy-ivd.com EUDAMED record Report an error
Carloerbareagents	France	CARLO ERBA Reagents18 refs 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 refs CARLO ERBA Reagents Formaldehyde 4% w/v buffered at pH 6.914 refs 39 others 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	Website EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	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 refs98/79 D-Dimer Fast Test Kit (Immunofluorescence Assay)9 refs 39 others D-Dimer Reagent Kit (Immunoturbidimetric Method)98/79 Dengue IgG/IgM Antibody Fast Test Kit (Immunofluorescence Assay)7 refs98/79 Dengue NS1 Ag Fast Test Kit (Immunofluorescence Assay)7 refs98/79 H. pylori Antibody Fast Test Kit (Immunofluorescence Assay)7 refs98/79 H. pylori Antigen Fast Test Kit (Immunofluorescence Assay)7 refs 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 refs Influenza A/B Antigen Fast Test Kit (Immunofluorescence Assay)7 refs98/79 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 refs98/79 MAGICL HSV-I IgM (CLIA)2 refs98/79 MAGICL HSV-II IgG (CLIA)2 refs98/79 MAGICL HSV-II IgM (CLIA)2 refs98/79 MAGICL IL-10 (CLIA)2 refs98/79 MAGICL IL-1β (CLIA)2 refs98/79 MAGICL IL-2R (CLIA)2 refs98/79 MAGICL IL-6 (CLIA)2 refs MAGICL IL-8 (CLIA)2 refs98/79 MAGICL PIC (CLIA)2 refs98/79 MAGICL Syphilis (CLIA) MAGICL t-PAIC (CLIA)2 refs98/79 MAGICL TAT (CLIA)2 refs98/79 MAGICL TB-IGRA (CLIA) MAGICL TM (CLIA)2 refs98/79 MAGICL TNF-α (CLIA)2 refs98/79 Malaria P.f/P.v Antigen Fast Test Kit (Immunofluorescence Assay)3 refs98/79 RSV Fast Test Kit (Immunofluorescence Assay)98/79 SARS-CoV-2 Antigen Fast Test Kit (Immunofluorescence Assay)7 refs98/79 TNF-α Control (CLIA)98/79	B, C IVDR, 98/79	EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	100 Tests/Kit14 refs98/79 10mL×1098/79 200 Tests/Kit14 refs98/79 2mL×1098/79 30 Tests/Kit19 refs98/79 39 others 50 Tests/Kit28 refs98/79 5mL×1098/79 Cleanser RC-1, RC-23 refs Cleanser RC-863 refs Concentrated Cleanser RC-86C2 refs Concentrated Cleanser REC3 refs Diluent for Hematology Analyzer RD-502 refs Diluent for Hematology Analyzer RD-73 refs Diluent for Hematology Analyzer RD-862 refs Folate Lysis Reagent 200Tests/Kit3 refs Lyse for Hematology Analyzer RL-50D，RL-50H3 refs Lyse for Hematology Analyzer RL-73 refs Lyse for Hematology Analyzer RL-86D，RL-86H3 refs R1: 10 mL×10, R2: 120 mL×198/79 R1: 10mL×10, R2: 120mL×198/79 R1: 1mL×10, R2: 15mL×12 refs98/79 R1: 1mL×5, R2: 100mL×1, R3: 1mL×198/79 R1: 1mL×5, R2: 15mL×12 refs98/79 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 refs98/79 R1: 4ml x 9, R2: 4ml x 32 refs98/79 R1: 5ml x 9, R2: 5ml x 32 refs98/79 R1:10mL×10，R2:60mL×22 refs98/79 R1:2ml×10,R2:30ml×12 refs98/79 R1:2ml×5,R2:100ml×1,R3:1ml×12 refs98/79 R1:30mL×1 R2:10mL×12 refs98/79 R1:30mL×2 R2:10mL×22 refs98/79 R1:3mL×6 R2:3mL×22 refs98/79 R1:4mlx5,R2:100ml×1,R3:1ml×198/79 R1:4ml×10,R2:50ml×12 refs98/79 R1:4mL×5,R2:100mL×1,R3:1mL×198/79 R1:5mL×10，R2:60mL×12 refs98/79 R1:8mL×5,R2:100mL×2,R3:1mL×12 refs98/79 R1:9mL×3 R2:3mL×32 refs98/79 R1:9mL×6 R2:3mL×62 refs98/79 Sample Diluent RD-L1, RD-L23 refs Vitamin B12 Lysis Reagent 200Tests/Kit3 refs	A IVDR, 98/79	Website support@rayto.com EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	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 others 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 refs98/79 Card type, Card box type6 refs98/79 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	Website EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)2 refs Dengue Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)4 refs98/79 Dengue IgG/IgM Antibody Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)4 refs98/79 H.Pylori Antibody (H.p Ab) Diagnostic Kit (Immunochromatographic Assay)2 refs98/79 Helicobacter pylori Antigen (Hp-Ag) Diagnostic Kit (Immunochromatographic Assay)2 refs98/79 38 others Herpes Simplex Virus 1 IgG(HSV-1-IgG)Diagnostic Kit (Immunochromatographic Assay)2 refs98/79 Herpes Simplex Virus I IgM(HSV-I-IgM)Diagnostic Kit ( Immunochromatographic Assay)2 refs98/79 Herpes Simplex Virus II IgG(HSV-II-IgG)Diagnostic Kit ( Immunochromatographic Assay)2 refs98/79 Herpes Simplex Virus II IgM(HSV-II-IgM)Diagnostic Kit ( Immunochromatographic Assay)2 refs98/79 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 refs98/79 Malaria Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)4 refs98/79 Malaria Pf/ Pv Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 Malaria Pf/ Pv Antigen Test Kit (Immunochromatographic Assay)2 refs98/79 N. Gonorrhea Test kit(Colloidal Gold Chromatographic Immunoassay)2 refs98/79 Respiratory 13 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 Respiratory 9 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 Respiratory Bacteria & M.P 6 Antigen Combo Test Kit (Immunochromatographic Assay)2 refs98/79 Respiratory Virus, Bacteria & M.P 10 Antigen Combo Test Kit (Immunochromatographic Assay)2 refs98/79 Respiratory Virus, Bacteria & M.p 11 Antigen Combo Test Kit (Immunochromatographic Assay)2 refs98/79 Respiratory Virus, Bacteria & M.P 14 Antigen Combo Test Kit (Immunochromatographic Assay)2 refs98/79 S.p/L.p/S.aureus/Kpn/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 S.p/L.p/S.aureus/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 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 refs98/79 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 refs98/79 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 refs98/79 SARS-CoV-2/RhV/PIV/Influenza A/B / RSV/ADV/hMPV/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 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 refs98/79	C IVDR, 98/79	EUDAMED record Report an error
Biolytical FDA EU representative : Emergo Europe B.V. (Netherlands)	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 others 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	EUDAMED record Report an error
Biotical	Spain	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 others 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	Website EUDAMED record Report an error
HYPHEN BioMed FDA	France	BIOPHEN™ Abnormal Control Plasma3 refs BIOPHEN™ Apixaban Calibrator3 refs BIOPHEN™ Apixaban Control3 refs BIOPHEN™ Arixtra® Calibrator Fondaparinux Calibrator2 refs BIOPHEN™ Arixtra® Control Plasma Fondaparinux Control2 refs 37 others BIOPHEN™ AT anti-(h)-Xa LRT Antithrombin (AT) activity - AntiXa3 refs BIOPHEN™ DiXaI Direct Factor Xa inhibitors (DiXaIs) BIOPHEN™ Edoxaban Calibrator3 refs BIOPHEN™ Edoxaban Control3 refs BIOPHEN™ FIX Factor IX (FIX) chromogenic3 refs BIOPHEN™ FVIII Factor VIII (FVIII) chromogenic2 refs BIOPHEN™ FVIII variant Factor VIII (FVIII) bovine2 refs BIOPHEN™ Heparin Calibrator2 refs BIOPHEN™ Heparin LRT Factor Xa (FXa) inhibitors3 refs BIOPHEN™ LMWH Control C33 refs BIOPHEN™ Normal Control Plasma Control Normal Plasma3 refs BIOPHEN™ Orgaran® Calibrator Danaparoid Calibrator2 refs BIOPHEN™ Orgaran® Control Danaparoid Control2 refs BIOPHEN™ Protein C LRT Protein C chromogenic LRT BIOPHEN™ Protein C Protein C chromogenic BIOPHEN™ Rivaroxaban Calibrator Low3 refs BIOPHEN™ Rivaroxaban Control Low3 refs BIOPHEN™ UFH Calibrator BIOPHEN™ UFH Control C13 refs Calcium Chloride 0.025M3 refs CEPHEN™ aPTT2 refs CEPHEN™ LS aPTT Lupus Sensitive FIBRIPHEN™ LRT3 refs Hemostasis Hepes Buffer2 refs Imidazole buffer3 refs Isotonic Sample Diluent3 refs LIAPHEN™ vWF: Ag Von Willebrand Factor Antigen (vWF: Ag)2 refs Platelet Aggregation -ADP AG001K2 refs Platelet Aggregation -Arachidonic Acid2 refs Platelet Aggregation -Collagen AG005K2 refs Platelet Aggregation -Epinephrine2 refs Platelet Aggregation -Ristocetin AG004K2 refs Special Calcium Chloride Calcium chloride Heparin neutralizing Special Tris-BSA buffer Tris-NaCl-EDTA buffer, pH 7.85 ZYMUTEST™ HIA (Heparin Induced Antibodies) IgG2 refs ZYMUTEST™ HIA (Heparin Induced Antibodies) IgGAM2 refs	A, C IVDR	Website info@hyphen-biomed.com EUDAMED record Report an error
Medicamed	Romania	CLORURA DE SODIU 1000gr CLORURA FERICA 10% 2ml KIT COLORATIE GRAM 1000ml KIT COLORATIE GRAM 250ml REACTIV FENILALANINA 5g 37 others 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	Website office@medicamed.ro EUDAMED record Report an error
TIB MOLBIOL Syntheselabor	Germany	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 others 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	Website EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	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 36 others 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 refs98/79 MultNAT C.difficile Assay MultNAT EV Assay MultNAT Gastrointestinal Panel4 refs MultNAT GBS Assay MultNAT HPV Panel2 refs98/79 MultNAT Meningitis Encephalitis Panel98/79 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 refs98/79 MultNAT Respiratory Panel2 refs MultNAT Respiratory Panel 298/79 MultNAT SARS-CoV-2/Flu and RSV PCR Assay MultNAT Sexually Transmitted Infections Panel3 refs98/79 MultNAT STI Panel MultNAT Strep A Assay98/79 MultNAT Tropical Fever Panel3 refs PortNAT TB Assay	B, C IVDR, 98/79	Website service@bioustar.com EUDAMED record Report an error
Aesku FDA	Germany	AESKUBLOTS® Borrelia-G98/79 AESKUBLOTS® Borrelia-M98/79 AESKULISA® Cytomegalovirus IgG98/79 AESKULISA® Cytomegalovirus IgM98/79 AESKULISA® Toxoplasma gondii IgM98/79 35 others 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	Website EUDAMED record Report an error
Dialab	Austria	Abnormal Coagulation Control Plasma T95510198/79 Anti-Syphilis Ab Z0436698/79 Anti-Syphilis Ab Z0936898/79 Antithrombin III 5+16 refs98/79 Antithrombin III A0051098/79 35 others DIAQUICK Strep. A Cassette98/79 DLB3 Pack 125H DLB5 Pack 125H HBsAg Sensitive ELISA98/79 HCV Ab Sensitive2 refs98/79 HIV 1&2 Ab, cut-off2 refs98/79 HIV 1&2 Ag/Ab2 refs98/79 IM98/79 LISS Solution B0517898/79 MSPACK 125 HUM MS4 3 DIFF MSPACK HUM MS4 3 DIFF2 refs MSPACK 125 HUM MS4 5 DIFF MSPACK HUM MS4 5 DIFF2 refs MSPACK 250 HUM MS9 3 DIFF MSPACK 250 HUM MS9 5 DIFF 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 refs98/79 Syphilis RPR Carbon Reagent98/79 Syphilis RPR Negative Control98/79 Syphilis RPR Positive Control98/79 Syphilis TPHA3 refs98/79 Syphilis VDRL2 refs98/79	A IVDR, 98/79	Website office@dialab.at EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Lotus NL B.V. (Netherlands) and 2 others	China	2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)11 refs98/79 2019-Novel Coronavirus, Influenza A and B Virus Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)3 refs98/79 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 refs98/79 Candida auris and Antibiotic-Resistant Strain Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79 35 others 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 refs98/79 Clostridium difficile nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)3 refs98/79 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 refs98/79 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 refs98/79 Flu A/B + COVID-19 Antigen Combo Test Cassette Kit2 refs98/79 Gastrointestional Infections Multiplex Real Time PCR Detection Kit98/79 H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit3 refs98/79 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 refs98/79 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 refs98/79 Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)2 refs98/79 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 refs98/79 Multi-Antibiotic Resistant H.pylori Strain Real Time PCR Detection Kit2 refs98/79 Mycoplasma Pneumoniae and Macrolides-Resistant Strain Nucleic Acid Test Kit2 refs98/79 Nucleic Acid Extraction Kit (Boiling Method)3 refs Nucleic Acid Extraction Kit (Spin Column)3 refs Nucleic Acid Extraction Kit P01911P20643 refs Rubella And Measles Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79 SARS-CoV-2 Antigen Test Cassette2 refs98/79 SARS-CoV-2 Realtime PCR Test Kit (Lyophilized)4 refs98/79 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	EUDAMED record Report an error
Technogenetics FDA	Italy	IDS Borrelia Control Set IDS Borrelia IgG IDS Borrelia IgM IDS CMV Avidity Control Set IDS CMV Control Set 35 others 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	B, C IVDR	Website QA@TECHNOGENETICS.IT EUDAMED record Report an error
Viramed FDA	Germany	Bordetella pertussis ViraChip IgA Antigen Coated Wells Bordetella Antibodies2 refs Bordetella pertussis ViraChip IgA Deca Kit3 refs Bordetella pertussis ViraChip IgA Positive Control3 refs Borrelia All-In-One ViraChip AP-Anti-Human Conjugate Lyme Antibodies2 refs Borrelia All-In-One ViraChip Deca Kit2 refs 35 others Borrelia All-In-One ViraChip Negative Control2 refs Borrelia ViraChip IgG Antigen Coated Wells Lyme IgG Antibodies Borrelia ViraChip IgG Deca Kit2 refs Borrelia ViraChip IgG Positive Control2 refs Borrelia ViraChip IgM Antigen Coated Wells Lyme IgM Antibodies Borrelia ViraChip IgM Deca Kit2 refs Borrelia ViraChip IgM Positive Control CMV ViraChip IgG Antigen Coated Wells CMV IgG Antibodies2 refs CMV ViraChip IgG Deca Kit2 refs CMV ViraChip IgG Positive Control3 refs CMV ViraChip IgM Antigen Coated Wells CMV IgM Antibodies2 refs CMV ViraChip IgM Deca Kit2 refs CMV ViraChip IgM Positive Control2 refs EBV ViraChip IgG Antigen Coated Wells EBV IgG Antibodies EBV ViraChip IgG Deca Kit2 refs EBV ViraChip IgG Positive Control3 refs EBV ViraChip IgM Antigen Coated Wells EBV IgM Antibodies EBV ViraChip IgM Deca Kit2 refs EBV ViraChip IgM Positive Control2 refs Helicobacter ViraChip IgA Antigen Coated Wells Helicobacter Antibodies2 refs Helicobacter ViraChip IgA Deca Kit3 refs Helicobacter ViraChip IgA Positive Control3 refs Treponema + VDRL ViraChip IgG Antigen Coated Wells Syphilis IgG Antibodies2 refs Treponema + VDRL ViraChip IgG Deca Kit2 refs Treponema + VDRL ViraChip IgG Positive Control3 refs Treponema + VDRL ViraChip IgM Antigen Coated Wells Syphilis IgM Antibodies2 refs Treponema + VDRL ViraChip IgM Deca Kit2 refs Treponema + VDRL ViraChip IgM Positive Control2 refs ViraChip Chromogen / Substrate Solution2 refs ViraChip Sample Buffer3 refs ViraChip Wash Buffer Plus3 refs ViraChip® AP-Anti-Human IgA Conjugate3 refs Yersinia ViraChip IgA Deca Kit3 refs Yersinia ViraChip IgA Positive Control3 refs Yersinia ViraChip IgA,IgM Antigen Coated Wells Yersinia Antibodies2 refs	A, B, C IVDR	Website EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany)	China	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 others 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 EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands)	China	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 34 others 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	EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Andes virus (ANDV) Nucleic Acid Detection Kit (Fluorescence PCR Method)2 refs98/79 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 others EB Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)2 refs98/79 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 refs98/79 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 refs98/79 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	EUDAMED record Report an error
Diagnostics	Belgium	APTT (Act. Thromboplastine Time) HC0010098/79 Bacterial Antigen polyvalent control + 590198/79 Bacterial Antigen polyvalent control - 590298/79 Bacterial Antigens BA-SPEC98/79 Brucella abortus 509198/79 33 others 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 Diluent 20L CY006-R0198/79 Fibrinogen HC0030098/79 Giemsa HS003 - HS0042 refs H. Pylori 33398/79 Harris' Hematoxylin HS006 - HS007 - HS0093 refs 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	Website EUDAMED record Report an error
Hain Lifescience	Germany	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 33 others 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 refs GenoType MTBDRsl VER 2.02 refs98/79 GenoType Mycobacterium AS VER 1.098/79 GenoType Mycobacterium CM VER 2.02 refs98/79 GenoType NTM-DR VER 1.098/79 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 X2 Cartridge VER 1.0	A, C, D IVDR, 98/79	EUDAMED record Report an error
Orgentec	Germany	Anti-B. pertussis Toxin IgA ORG 916A98/79 Anti-B. pertussis Toxin IgG ORG 916G98/79 Anti-Borrelia IgG98/79 Anti-Borrelia IgG Liquor98/79 Anti-Borrelia IgM Abs.98/79 33 others 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	– 98/79	Website EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany)	China	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 32 others 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 refs Cwingene STI Multiplex Pro Detection Kit98/79 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	Website EUDAMED record Report an error
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	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 others 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 refs 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 refs 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 refs EuroGen Flu A+B Ag Rapid Test3 refs 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	Website info@gensurebio.com EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Hemolumi APTT (Clotting Assay)10 refs98/79 Hemolumi AT III (Chromogenic Substrate Assay)10 refs98/79 Hemolumi Coagulation Calibrators4 refs98/79 Hemolumi D-Dimer (Latex)8 refs98/79 Hemolumi D-Dimer Calibrators4 refs98/79 32 others Hemolumi FDP (Latex)8 refs98/79 Hemolumi FDP Calibrators4 refs98/79 Hemolumi Fibrinogen (Clotting Assay)10 refs98/79 Hemolumi PT (Clotting Assay)10 refs98/79 Hemolumi TT (Clotting Assay)10 refs98/79 MAGLUMI Adenovirus IgM (CLIA)3 refs 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 refs 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 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 refs MAGLUMI Influenza A Virus IgM (CLIA)3 refs MAGLUMI Influenza B Virus IgM (CLIA)3 refs MAGLUMI Legionella pneumophila IgM (CLIA)3 refs MAGLUMI Mycoplasma pneumoniae IgG (CLIA) Controls MAGLUMI Mycoplasma pneumoniae IgM (CLIA) Controls MAGLUMI Respiratory Syncytial Virus IgM (CLIA)3 refs MAGLUMI Toxo IgG (CLIA) Controls	B, C IVDR, 98/79	Website EUDAMED record Report an error
Antitoxin	Germany	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 others 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	Website EUDAMED record Report an error
Diagreat EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	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 31 others Acid Cleaning Solution 100mL×1 Alkaline Cleaning Solution 100mL×1 Chemiluminescent Substrate 100mL×12 refs Chemiluminescent Wash Solution 0 .5L×12 refs 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	Website info@diagreat.com EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany)	Egypt	"S.typhi-S.paratyphi "A Direct Antigen Detection98/79 APTT Reagent98/79 APTT Reagent (SP-UNICELIN)2 refs98/79 Brucella A/M5 refs98/79 Brucella Abortus98/79 31 others Brucella Combo2 refs98/79 Brucella Melitensis98/79 Brucella Rose Bengal98/79 CMV IgG/IgM Rapid Test-Cassette98/79 D-Dimer Turbi Latex7 refs98/79 FIBRINOGEN98/79 FIBRINOGEN Immuno - Turbidimetry98/79 FIBRINOGEN-LS Clauss Clotting Time Method2 refs98/79 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 refs98/79 Haemoglobin (Single Reagent)2 refs98/79 Haemoglobin Drabkin's Solution2 refs98/79 Hemoglobin (Ready-To-Use)Drabkin’s Solution2 refs98/79 Malaria Antigen Test Card2 refs98/79 Plasma control set For coagulation Assays98/79 PT Reagent (SP-Normoplastin)2 refs98/79 PT Reagent ISI 1.052 refs98/79 PT Reagent ISI 1.52 refs98/79 Recoplastin ISI 1.0 PT Reagent4 refs98/79 Rose Bengal Brucella Antigen4 refs98/79 RPR Syphilis Test4 refs98/79 S. Typhi/Para Typhi A Antigen2 refs98/79 Typhoid IgG/IgM Rapid Test-Cassette98/79 Typhoid Rapid Test Cassette (Serum/Plasma/Whole Blood)98/79 Widal Test (Salmonella Ab)13 refs98/79	– 98/79	Website EUDAMED record Report an error
Sysmex FDA EU representative : Sysmex Europe SE (Germany)	Japan	CELLCLEAN CELLCLEAN AUTO CELLPACK2 refs CELLPACK DCL3 refs CELLPACK DFL2 refs 34 others CELLPACK DST3 refs CyLyse LV EIGHTCHECK-3WP-H2 refs98/79 EIGHTCHECK-3WP-L2 refs98/79 EIGHTCHECK-3WP-N2 refs98/79 Fluorocell M Fluorocell PLT Fluorocell RET2 refs Fluorocell WDF3 refs Fluorocell WNR Fluorocell WPC HISCL HIT IgG Assay Kit HISCL HIT IgG Calibrator HISCL HIT IgG Control Lysercell M Lysercell WDF3 refs Lysercell WDF II2 refs Lysercell WNR3 refs Lysercell WPC Platelet CHECK2 refs98/79 pocH-pack 65 pocH-pack 65XL SCS-100098/79 STROMATOLYSER-WH SULFOLYSER3 refs XN CAL98/79 XN CAL PF98/79 XN CHECK6 refs98/79 XN CHECK BF2 refs98/79 XN-L CHECK3 refs98/79 RET-SEARCH(II) (no longer marketed) STROMATOLYSER-4DL2 refs (no longer marketed) STROMATOLYSER-4DS2 refs (no longer marketed) STROMATOLYSER-FB (no longer marketed)	A, C IVDR, 98/79	ra_archive@sysmex.co.jp EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	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 others 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 refs98/79 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	EUDAMED record Report an error
Chronolab	Spain	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 others 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	Website info@chronolab.com EUDAMED record Report an error
Erba	Czechia	ELite H CAL ELite H Clean ELite H5 CON3 refs ELite H580 Dil ELite H580 Lyse13 refs 30 others 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 refs Erba H360 Dil Erba H360 Lyse Erba H560 Dil Erba H560 Lyse12 refs Erba H7 CON3 refs Erba H7 ret CON3 refs Erba H7100 Clean 10x4 mL2 refs Erba H7100 Dil Erba H7100 Dil Ret (1 L)2 refs Erba H7100 Fluro Diff (22 mL)2 refs Erba H7100 Fluro Ret (12 mL)3 refs Erba H7100 Lyse 1 (1000 mL)3 refs 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	A, B IVDR, 98/79	Website EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	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 others 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 EUDAMED record Report an error
Horiba FDA	France	ABX Alphalyse 0.4L 09060043 refs ABX Basolyse 5L 0204050 ABX Basolyse II 1L 0906003 ABX Cleaner 0.5L 09030103 refs ABX Difftrol 20622073 refs 30 others ABX Diluent 10L 09010102 refs ABX Eosinofix 1L 0206010 ABX Fluocyte 0.5L 0904011 ABX Leucodiff 1L 0206013 ABX Lysebio 0.4L 09060122 refs ABX Minidil LMG 10L 08020102 refs ABX Minipack LMG 0602050 ABX Minocal 2032002 ABX Minotrol 16 20422023 refs ABX Minotrol Retic 2072201, 2072202, 1300136023, 1300136026, 13001360293 refs ESRtrol Minilysebio 0.4L 0906020 Nucediff 1L 1300027030 Whitediff 1L 1210906022 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 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	A, B, C IVDR, 98/79	EUDAMED record Report an error
Progenie molecular S.L.U	Spain	RealCycler ADNV-ABI3298/79 RealCycler ADNV-UX98/79 RealCycler ADVQ98/79 RealCycler AURI-ABI3298/79 RealCycler AURI-UX98/79 30 others 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	EUDAMED record Report an error
Sclavo	Italy	APTT-E K3000205098/79 D DIMER GREEN K3000408BK98/79 DETERGENT SOLUTION G523237403 refs FATTOE I PLASMA IMMUNODEPLETO K2910579098/79 FATTORE PLASMA IMMUNODEPLETO K2910579798/79 30 others 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 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 TT KIT K2900539298/79 SYSCLEAN G54350350	A IVDR, 98/79	qa@sclavo.it EUDAMED record Report an error
Titolchimica	Italy	BLU ALCIAN 8 GX2 refs BLU CRESIL BRILLANTE BOUIN fissativo CARAZZI EMALLUME CYTOBIOLOGIC FLUID (ROSSO)2 refs 30 others CYTOBIOLOGIC URINE (VERDE)2 refs EOSINA GIALLASTRA 0,5% ALCOLICA2 refs EOSINA GIALLASTRA 1% ACQUOSA FISSATIVO B5 FORMALINA 10% v/v (4% p/v)3 refs GIEMSA REAGENTE3 refs KIT ROSSO CONGO KIT ZIEHL NEELSEN LOEFFLER BLU METILENE SOLUZIONE MAY GRUNWALD REAGENTE3 refs MAYER EMALLUME3 refs MAYER EMALLUME modificato MONTANTE PTX UNIVERSALE 10% MONTANTE SINTETICO PER VETRINI2 refs MONTANTE SINTETICO PER VETRINI metodo con isoparaffina2 refs OLIO DI IMMERSIONE PAPANICOLAOU ARANCIO G (SOLUZIONE OG6)3 refs PAPANICOLAOU ARANCIO II SOLUZIONE3 refs PAPANICOLAOU EMATOSSILINA sec. GILL ( I )2 refs PAPANICOLAOU EMATOSSILINA sec. GILL ( II )2 refs PAPANICOLAOU EMATOSSILINA sec. GILL ( III ) PAPANICOLAOU EMATOSSILINA sec. HARRIS3 refs PAPANICOLAOU SOLUZIONE EA 503 refs Papanicolaou Soluzione EA653 refs PARAFFINA GOCCE PF 56-58 per uso istologico PERLS KIT SCHIFF REAGENTE PER ISTOLOGIA2 refs STERNHEIMER-MALBIN colorante per microscopia3 refs SUDAN soluzione alcolica satura ZIEHL-NEELSEN FUCSINA FENICATA2 refs	A IVDR	Website info@titolchimica.it EUDAMED record Report an error
3Bblackbio EU representative : Wellkang Ltd (Northern Ireland)	India	TRUPCR® Bacterial / Fungal DNA Extraction Kit2 refs TRUPCR® Bacterial DNA Extraction Kit2 refs TRUPCR® Blood DNA Extraction Kit2 refs TRUPCR® Blood RNA Extraction Kit TRUPCR® BS DNA Extraction Kit 29 others TRUPCR® CMV QT Kit3 refs TRUPCR® FFPE Tissue DNA Extraction Kit TRUPCR® Influenza A/B & RSV with SARS-CoV-2 RT qPCR Kit3 refs TRUPCR® Leptospira Detection Kit3 refs TRUPCR® Magbead Blood DNA Extraction Kit TRUPCR® Magbead FFPE Tissue DNA Extraction Kit2 refs TRUPCR® Magbead MTB/NTM DNA Extraction Kit2 refs TRUPCR® Magbead Tissue DNA Extraction Kit2 refs TRUPCR® Magbead Total Nucleic Acid Extraction Kit2 refs TRUPCR® Magbead Total Viral Nucleic Acid Extraction Kit2 refs TRUPCR® Magbead Viral RNA Extraction Kit2 refs TRUPCR® Meningitis Panel Kit3 refs TRUPCR® MTB/NTM DNA Extraction Kit TRUPCR® MTBC OneStep Nested Kit3 refs TRUPCR® Neuro Panel Kit3 refs TRUPCR® Panel Extraction Kit TRUPCR® Respiratory Pathogen Panel Kit3 refs TRUPCR® SARS-CoV-2 RT qPCR Kit TRUPCR® STD Panel Kit3 refs TRUPCR® Tissue DNA Extraction Kit TRUPCR® TORCH Panel Kit3 refs TRUPCR® Total Nucleic Acid Extraction Kit4 refs 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 refs TRUPCR® Toxoplasma Real-Time PCR Detection Kit3 refs TRUPCR® Tropical Fever Panel Kit3 refs TRUPCR® Viral RNA Extraction Kit2 refs TRUPCRÂ® Flu Panel with RSV detection Kit3 refs	A, B, C IVDR, 98/79	Website info@3bblackbio.com EUDAMED record Report an error
Aichek FDA EU representative : Medunion S.L. (Spain) and 1 other	China	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 COVID-19 Antigen Rapid Test98/79 COVID-19 IgG/IgM Rapid Test98/79 29 others 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	– 98/79	ra.rep@aichek.com EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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 others 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 EUDAMED record Report an error
Medikal Olusum Sanayi Ve Ticaret Sirketi	Türkiye	10% Neutral Buffered Formaldehyde 5L 37-40% Neutral Buffered Formaldehyde 5L EA 50 1000mL EA 50 250mL EA 50 500mL 29 others Elastic Van Giesson 100 Test Eosin Y 1% 1000mL Eosin Y 1% 250mL Eosin Y 1% 500mL Giemsa Solution 250mL Harris’ Hematoxylin 1000mL Harris’ Hematoxylin 250mL Harris’ Hematoxylin 500mL 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 Saffron Solution 1000mL Toluidine blue O 100 Test Toluidine blue O 1000mL Toluidine blue O 250mL Toluidine blue O 500mL Van Giesson 100 Test Verhoeff’s Elastic Stain Kit 100 Test	I, A IVDR, MDR	Website info@moslab.com EUDAMED record Report an error
Molbio Diagnostics EU representative : QbD RepS BV (Belgium)	India	STABILYSE Prep Free 90101PF05, 90101PF20, 90101PF25, 90101PF503 refs Truemix COVID-19 70143000898/79 Truemix COVID-19 70143002498/79 Truemix COVID-19 70143004898/79 Truemix COVID-19 70143009698/79 29 others 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 refs 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 refs Trueprep AUTO Universal Cartridge Based Sample Prep Kit 60203AR25, 60203AR502 refs Trueprep AUTO Universal Sample Pre-treatment Pack 60205AB05, 60205AB20, 60205AB25, 60205AB503 refs Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Kit 60207AR50	A, C IVDR, 98/79	Website customersupport@molbiodiagnostics.com EUDAMED record Report an error
Monobind FDA EU representative : AR Experts B.V. (Netherlands)	United States	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 29 others 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	– 98/79	Website info@monobind.com EUDAMED record Report an error
Oxoid FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	AMPLIFIED IDEIA HP STAR KIT CRYPTOCOCCUS ANTIGEN LATEX TEST KIT R30851501 DRYSPOT E. COLI O157 DRYSPOT LEGIONELLA PNEUMOPHILA 13 refs E. COLI O157 TEST KIT 29 others 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 refs98/79 IMAGEN Respiratory Syncytial Virus (RSV)98/79 Infectious Mononucleosis Test Kit DR0780M98/79 LEGIONELLA LATEX TEST DR0800M LEGIONELLA PNEUMO GROUP 13 refs OXOID SALMONELLA PATHODXTRA POSITIVE CONTROL PATHODXTRA STREP GROUP A LATEX3 refs 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 refs 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 refs	A, B, C IVDR, 98/79	Website EUDAMED record Report an error
Shenzhen Drawray Biotech EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	30 Tests/kit 5 Tests/kit 20 Tests/kit2 refs D-Dimer 20 tests/kit98/79 D-Dimer 5 tests/kit98/79 iStar-D-dimer 30 Tests98/79 29 others 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 refs98/79 Unicorn-IL-6 5 Tests/kit2 refs98/79	C IVDR, 98/79	Website info@szdrawray.com EUDAMED record Report an error
Sigma-Aldrich EU representative : MDSS GmbH (Germany)	United States	AMYLOID STAIN, CONGO RED HT60-1KT AUTOMATED WRIGHT STAIN SET WSHT-1SET CARBOL FUCHSIN SOLUTION HT70 and HT803 refs ELASTIC STAIN HT25A-1KT EOSIN Y SOLUTION ALCOHOLIC HT1103 refs 29 others FETAL HEMOGLOBIN Kit 285C-1KT and 285D-1KT2 refs FONTANA-MASSON KIT HT200-1KT GIEMSA STAIN, MODIFIED GS and MG3 refs GRAM STAIN KIT FOR FILMS HT90A-1KT and HT90T-1KT2 refs HARRIS HEMATOXYLIN SOLUTION, MODIFIED HHS3 refs HEMATOXYLIN SOLUTION, GILL NO 1 GHS3 refs IRON STAIN HT20-1KT LEUCOCYTE ALKALINE PHOSPHATASE KIT 86C-1KT and 86R-1KT2 refs 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 refs LEUKOCYTE NAPHTHOL AS-D CHLOROACETATE (SPECIFIC ESTERASE) KIT 90A1-1KT and 90C2-1KT2 refs LEUKOCYTE NAPHTHOL AS-D CHLOROACETATE (SPECIFIC ESTERASE) KIT 91A-1KT and 91C-1KT2 refs Leukocyte Peroxidase (Myeloperoxidase) Kit 390 390A-1KT Leukocyte Peroxidase (Myeloperoxidase) Kit 391 391A-1KT MAYERS HEMATOXYLIN SOLUTION MHS3 refs MUCICARMINE STOCK SOLUTION HT302 refs PAPANICOLAOU STAIN EA 50 HT403 refs 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 refs WEIGERTS IRON HEMATOXYLIN SET HT1079-1SET WRIGHT STAIN, MODIFIED WG / WS3 refs α-NAPHTHYL BUTYRATE ESTERASE, KIT, PART 1 181B-1KT	A IVDR	Website customer.caredesk@milliporesigma.com EUDAMED record Report an error
Trinitybiotech FDA EU representative : TrinityBiotech (Ireland)	United States	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 others 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	Website EUDAMED record Report an error
C-Luminary Biotechnology EU representative : Share info GmbH (Germany) and 1 other	China	Folate Releasing Agent 3.65 mL/Vial Sample Processing Solution 50mL/Vial2 refs Sharay (1-3)-β-D-Glucan (CLIA)98/79 Sharay (1-3)-β-D-Glucan (CLIA) R1+R398/79 Sharay Cytokine Profile (CLIA) Model 10: Sharay IFN-γ2 refs98/79 29 others Sharay Cytokine Profile (CLIA) Model 10: TNF-α2 refs98/79 Sharay Cytokine Profile (CLIA) Model 11: Sharay TNF-α98/79 Sharay Cytokine Profile (CLIA) Model 12: Sharay IFN-α2 refs98/79 Sharay Cytokine Profile (CLIA) Model 1: IL-1β2 refs98/79 Sharay Cytokine Profile (CLIA) Model 1: Sharay IL-1β98/79 Sharay Cytokine Profile (CLIA) Model 2: IL-22 refs98/79 Sharay Cytokine Profile (CLIA) Model 2: Sharay IL-298/79 Sharay Cytokine Profile (CLIA) Model 3: IL-42 refs98/79 Sharay Cytokine Profile (CLIA) Model 3: Sharay IL-498/79 Sharay Cytokine Profile (CLIA) Model 4: IL-52 refs98/79 Sharay Cytokine Profile (CLIA) Model 4: Sharay IL-598/79 Sharay Cytokine Profile (CLIA) Model 5: IL-62 refs98/79 Sharay Cytokine Profile (CLIA) Model 5: Sharay IL-698/79 Sharay Cytokine Profile (CLIA) Model 6: IL-82 refs98/79 Sharay Cytokine Profile (CLIA) Model 6: Sharay IL-898/79 Sharay Cytokine Profile (CLIA) Model 7: IL-102 refs98/79 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 refs98/79 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 refs98/79 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 (no longer marketed)	A IVDR, 98/79	EUDAMED record Report an error
BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain)	China	1 T/kit3 refs98/79 1 Test/Kit2 refs98/79 10 T/kit98/79 10 test /kit98/79 10 Tests/Kit98/79 28 others 100 test /kit98/79 100 Tests/Kit98/79 100T/kit6 refs98/79 15 T/kit3 refs98/79 15T/kit2 refs98/79 1T/kit3 refs98/79 20 test /kit98/79 20 Tests/Kit98/79 20T/kit98/79 25 test/kit98/79 40 T/kit4 refs98/79 40 test /kit98/79 40 Tests/Kit98/79 40T/kit2 refs98/79 5 T/kit2 refs98/79 5T/kit2 refs98/79 Cassette： 1T/kit2 refs98/79 Cassette：100T/kit2 refs98/79 Cassette：15T/kit2 refs98/79 Cassette：40T/kit2 refs98/79 Cassette：5T/kit2 refs98/79 Strip： 1000T/kit98/79 Strip：1 T/bag2 refs98/79 Strip：100 T/kit98/79 Strip：1000 T/kit98/79 Strip：100T/kit98/79 Strip：25T/canister2 refs98/79 Strip：50T/ kit2 refs98/79	– 98/79	EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain)	China	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 28 others 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 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	– 98/79	EUDAMED record Report an error
Chengdu Legend-Tec Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Anti-Human CD3 Antibody APC2 refs98/79 Anti-Human CD3 Antibody APC-Cy72 refs98/79 Anti-Human CD3 Antibody BV4212 refs98/79 Anti-Human CD3 Antibody BV5102 refs98/79 Anti-Human CD3 Antibody BV6052 refs98/79 28 others Anti-Human CD3 Antibody BV6502 refs98/79 Anti-Human CD3 Antibody BV7112 refs98/79 Anti-Human CD3 Antibody BV7502 refs98/79 Anti-Human CD3 Antibody FITC2 refs98/79 Anti-Human CD3 Antibody PE2 refs98/79 Anti-Human CD3 Antibody PE-Cy72 refs98/79 Anti-Human CD3 Antibody PerCP2 refs98/79 Anti-Human CD3 Antibody PerCP-Cy5.52 refs98/79 Anti-Human CD3 Antibody V4502 refs98/79 Anti-Human CD4 Antibody APC2 refs98/79 Anti-Human CD4 Antibody APC-AF7002 refs98/79 Anti-Human CD4 Antibody APC-Cy72 refs98/79 Anti-Human CD4 Antibody BV4212 refs98/79 Anti-Human CD4 Antibody BV5102 refs98/79 Anti-Human CD4 Antibody BV6052 refs98/79 Anti-Human CD4 Antibody BV6502 refs98/79 Anti-Human CD4 Antibody BV7112 refs98/79 Anti-Human CD4 Antibody BV7862 refs98/79 Anti-Human CD4 Antibody FITC2 refs98/79 Anti-Human CD4 Antibody Pacific Blue2 refs98/79 Anti-Human CD4 Antibody PE2 refs98/79 Anti-Human CD4 Antibody PE-Cy72 refs98/79 Anti-Human CD4 Antibody PerCP2 refs98/79 Anti-Human CD4 Antibody PerCP-Cy5.52 refs98/79 Anti-Human CD8 Antibody APC2 refs98/79 Anti-Human CD8 Antibody APC-Cy72 refs98/79 Anti-Human CD8 Antibody FITC2 refs98/79 Anti-Human CD8 Antibody PE4 refs98/79	– 98/79	Website EUDAMED record Report an error
Mpbio FDA EU representative : MP Biomedicals Germany GmbH (Germany)	Germany, Singapore	Dengue NS1 Antigen Rapid Test98/79 Diagnostic Kit for D-Dimer 07CTNL502598/79 MP Diagnostics ASSURE H. pylori Antigen Rapid Test98/79 MP Diagnostics ASSURE H. pylori Rapid Test98/79 MP Diagnostics HBsAg ELISA 4.1 23470-096 (96 wells)98/79 28 others 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 refs98/79 Rapid SARS-CoV-2 Antigen Test Card2 refs98/79 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 refs98/79	– 98/79	Website EUDAMED record Report an error
Nordic Biomarker	Sweden	Control Level 12 refs Control Level 22 refs D-Dimer Calibrator K50452 refs D-Dimer Control High SC109K D-Dimer Control Low SC108K 28 others D-Dimer Latex LRT3 refs D-Dimer PBS Diluent2 refs MRX Antithrombin98/79 MRX Antithrombin Calibrator98/79 MRX APTT2 refs MRX Blue D-dimer MRX Blue Free Protein S98/79 MRX Calcium Chloride3 refs 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 refs MRX PT Quick98/79 MRX PT Quick (INR) Calibrator Set98/79 MRX Red Free Protein S98/79 MRX Sample Diluent2 refs MRX Specialty Abnormal Control MRX Specialty Normal Control MRX Thrombin Time98/79 MRX vWF Antigen Calibrator98/79	A, C IVDR, 98/79	Website info@nordicbiomarker.com EUDAMED record Report an error
Spinreact	Spain	22% SEROLOGICAL ALBUMIN No98/79 30% SEROLOGICAL ALBUMIN No98/79 Anti-A Monoclonal Anti-A+B Monoclonal98/79 Anti-B Monoclonal98/79 28 others Anti-C monoclonal2 refs98/79 Anti-C+D+E monoclonal98/79 Anti-D IgG + IgM Monoclonal98/79 Anti-E monoclonal2 refs98/79 Anti-human globulin polyspecific No98/79 Anti-Kell Monoclonal98/79 APTT No98/79 ATHROM-III NO6 refs98/79 BACTERIAL ANTIGENS No45 refs98/79 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 refs98/79 HEMOGLOBIN No98/79 LYS-3 Lyse reagent Spincell 3 series2 refs LYS-5 Lyse reagent Spincell 5 series PT No5 refs98/79 ROSE BENGAL No98/79 RPR-CARBON -CONTROL + No98/79 RPR-CARBON No3 refs98/79 SHEA-5 Sheat reagent Spincell 5 series TPHA No98/79 VDRL No2 refs98/79	A, D IVDR, 98/79	Website EUDAMED record Report an error
Tellgencorp EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Aspergillus Galactomannan (GM) Assay Kit (CLIA)（)18 refs98/79 D-Dimer（CLIA)8 refs98/79 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 others EVU/CoxA16 and EV71 Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 FDP (CLIA)12 refs98/79 Fungus (1-3)-β-D-glucan Assay Kit (CLIA)12 refs98/79 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 refs98/79 Interleukin-1 β Assay Kit（CLIA）12 refs98/79 Interleukin-10 Assay Kit（CLIA）12 refs98/79 Interleukin-12p70 Assay Kit（CLIA）12 refs98/79 Interleukin-17A Assay Kit（CLIA）12 refs98/79 Interleukin-2 Assay Kit（CLIA）12 refs98/79 Interleukin-4 Assay Kit（CLIA）12 refs98/79 Interleukin-5 Assay Kit（CLIA）12 refs98/79 Interleukin-8 Assay Kit（CLIA）12 refs98/79 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 refs98/79 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 refs98/79 TellgenplexTM HPV27 genotyping Assay98/79 TM-7 (CLIA)12 refs98/79 Tumour Necrosis Factor-α Assay Kit（CLIA）11 refs98/79	– 98/79	Website sales@tellgen.com EUDAMED record Report an error
Vazyme EU representative : Obelis s.a. (Belgium) and 2 others	China	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 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2402CC98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2402CL98/79 28 others 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 refs 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 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 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	A, B IVDR, 98/79	EUDAMED record Report an error
InTec PRODUCTS EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	69361558COVID19-AG-BE**X5 ITP1601398/79 AQ+ COVID-19 Ag Rapid Test ITP160424 refs98/79 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 refs98/79 31 others 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 refs98/79 ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST ITP030042 refs98/79 One Step Dengue NS1 Ag Test ITP7100398/79 ONE STEP H. pylori Ag Test ITP100032 refs98/79 ONE STEP H. pylori Ag Test ITP1021398/79 ONE STEP Malaria(p.f.) Test ITP110022 refs98/79 ONE STEP Malaria(p.f/p.v) Tri-line Test ITP110032 refs98/79 Rapid Anti-H.Pylori Test ITP100022 refs98/79 Rapid Anti-H.Pylori Test ITP102122 refs98/79 Rapid Anti-HEV-IgM Test ITP0911012 refs98/79 Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test ITP710044 refs98/79 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 refs98/79 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 refs98/79 Rapid SARS-CoV-2 Antigen Test ITP1601398/79 W0105040601 ITP1400298/79 ITP01152-TC2598/79 (no longer marketed) ITP01153-TC4098/79 (no longer marketed) ITP02152-TC2598/79 (no longer marketed) ITP02152-TC4098/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Grifols FDA EU representative : Diagnostic Grifols, S.A. (Spain)	Spain, Switzerland	Anti-C3d Anti-Cw Mono-Type Dual Anti-Dia Dual Anti-H for DG Gel Anti-H Mono-Type 27 others 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 refs Bromelase 3098/79 Data-Cyte Extend 0.8% DG Gel Confirm D DG Gel DC Scan DG Gel DC Scan Plus DG-Papain98/79 Diego(a)-Cyte 0.8% Diego(a)-Cyte 3% Enlisst-II Mi(a)-Cyte 0.8% Serascan Diana Dia Specific Albumin 22% Specific Albumin 30%	A, C, D IVDR, 98/79	regulatoryaffairs_dxbu@grifols.com EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	101A0108EY98/79 101A0113EY98/79 101A0201EY,101A0201ED98/79 101A0202EY98/79 101A0204EY98/79 27 others 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 EUDAMED record Report an error
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Adenovirus Antigen Rapid Test Kit (QDs Immunofluorescence Method) ADV-QD2 refs98/79 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 others 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 refs98/79 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 refs98/79 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	Website EUDAMED record Report an error
Quimica Clinica Aplicada	Spain	AGS. FEB. SALMONELLA, CTRL+98/79 Alcian Blue (1 x 250 mL) Alcoholic Eosin 1% (1 x 1000 mL)3 refs ANTIGENOS FEBRILES: CONTROL POSITIVO PROTEUS98/79 ANTITROMBINA III98/79 27 others Antígenos Febriles: Control Positivo Brucella98/79 B5 FIXATIVE (1 x 1000mL)3 refs BRUCELLA ABORTUS98/79 BRUCELLA MELITENSIS98/79 CALIBRADOR DE COAGULACIÓN98/79 Carazzi’s Hematoxylin (1 x 1000 mL)3 refs CITRATO SODICO 3.2%3 refs CONTROLES DE COAGULACIÓN98/79 FIBRINÓGENO98/79 Giemsa (1 x 1000 mL)3 refs HEMOSCANN®2 refs98/79 LEISHMAN STAIN (1x125mL) Masson’s Trichrome stain (5 x 250mL)3 refs MAY-GRÜNWALD (1 x 1000 mL)3 refs Myeloperoxidase (330 mL) Nuclear Fast Red 0,1%2 refs Papanicolaou EA-36 (1 x 1000 mL)3 refs PARAFFIN DMSO PEARLS2 refs PAS (SOLUCIÓN AC. PERIODICO 0,5%) PERIODIC ACID SOLUTION 0.5% PLASMASCANN® LIQUIDO2 refs98/79 PROTEUS OX 1998/79 QUICK PANOPTIC CONCENTRATED 1:10 (3 x 100 mL)3 refs ROSA DE BENGALA98/79 Schiff's Reagent (1 x 500mL) Shorr’s stain (1 x 500 mL) Sudan Black kit (2 x 100mL) WRIGHT (1 x 1000 mL)2 refs	A IVDR, 98/79	Website EUDAMED record Report an error
Seramun	Germany	Seraline® Anti-Borrelia-8 IgG2 refs98/79 Seraline® Anti-Borrelia-8 IgM2 refs98/79 Seraline® Anti-Helicobacter-6 IgA98/79 Seraline® Anti-Helicobacter-6 IgG98/79 Seraline® Anti-Yersinia-6 IgA2 refs98/79 27 others Seraline® Anti-Yersinia-6 IgG2 refs98/79 SeraSpot® Anti-Borrelia IgG3 refs SeraSpot® Anti-Borrelia IgM3 refs SeraSpot® Anti-Borrelia-10 IgG3 refs98/79 SeraSpot® Anti-Borrelia-10 IgM3 refs98/79 SeraSpot® Anti-EBV-3 IgM2 refs98/79 SeraSpot® Anti-EBV-4 IgG2 refs98/79 SeraSpot® Anti-Helicobacter-6 IgA2 refs98/79 SeraSpot® Anti-Helicobacter-6 IgG2 refs98/79 SeraSpot® Anti-Parvovirus-5 IgM2 refs98/79 SeraSpot® Anti-Parvovirus-6 IgG2 refs98/79 SeraSpot® Anti-Treponema-4 IgG2 refs98/79 SeraSpot® Anti-Treponema-4 IgM2 refs98/79 SeraSpot® Anti-Yersinia-6 IgA2 refs98/79 SeraSpot® Anti-Yersinia-6 IgG2 refs98/79 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 EUDAMED record Report an error
Urit FDA EU representative : Medunion S.L. (Spain) and 1 other	China	BH-DR68 Diluent BH-DS68 Diluent BH-FP68 Fluorescent dye BH-FR68 Fluorescent dye BH-LD68 Lyse 26 others BH-LH68 Lyse BH-LN68 Lyse BH-LP68 Lyse 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 Interluekin-6 (IL-6) Assay Kit (Chemiluminescent Microparticle Immunoassay)98/79 Reticulocyte Calibrator URIT CA 3198/79 Staining Solution for Urine Analysis UFL-61 Staining Solution for Urine Analysis UFL-70、UFL-60 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	A, B IVDR, 98/79	Website service@uritest.com EUDAMED record Report an error
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 25 others Access HIV combo V2 QC C2843298/79 Access HIV combo V2 QC plus C4357698/79 CONCENTRATED WASHING SOLUTION (20X) Geenius HIV 1/2 Confirmatory Assay 7246098/79 Geenius HIV 1/2 Confirmatory Controls 7232998/79 Pastorex Meningitis3 refs Pastorex Staph-Plus2 refs Pastorex Strep3 refs 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 RPR2 refs Syphilis Total Ab 7253098/79 Syphilis Total Ab 7253198/79 TPHA 7250398/79 TPHA 7250498/79	A, B, C IVDR, 98/79	Website contact@bio-rad.com EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	ACON HIV 1/2/O Tri-line Rapid Test Cassette (Serum/Plasma/Whole blood)3 refs ACON SARS-CoV-2 IgG/IgM Rapid Test2 refs98/79 FIAflex5 refs98/79 FIAflex Dengue NS1 Ag FIA Test98/79 FIAflex IL-6 FIA Test98/79 24 others FIAflex SARS-CoV-2 & Influenza A/B Ag Combo FIA98/79 FIAflex SARS-CoV-2 Antigen FIA98/79 Flowflex25 refs98/79 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 refs98/79 Flowflex SARS-CoV-2 Antigen FIA98/79 Flowflex SARS-CoV-2 Antigen Rapid Test4 refs98/79 Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)2 refs98/79 Flowflex SARS-CoV-2 Antigen Rapid Test Slim2 refs98/79 Influenza A/B Rapid Test (Self-Testing) L031-1193598/79 Mission CCC-17198/79 Mission CCS-1712 refs98/79 Promotor Nucleic Acid (DNA) Extraction Kit3 refs Promotor Nucleic Acid (RNA) Extraction Kit3 refs Promotor Nucleic Acid Extraction Kit Promotor Viral DNA/RNA Isolation Kit2 refs Promotor Viral Nucleic Acid Isolation Kit Promotor Whole Blood Genomic DNA Extraction Kit2 refs Quik-Check7 refs98/79	A, D IVDR, 98/79	Website EUDAMED record Report an error
Qiagen FDA EU representative : QIAGEN GmbH (Germany)	Germany, United States	artus CMV QS-RGQ Kit98/79 artus CMV RG PCR Kit2 refs98/79 artus EBV QS-RGQ Kit98/79 artus EBV RG PCR Kit2 refs98/79 artus HBV QS-RGQ Kit2 refs98/79 24 others artus HBV RG PCR Kit2 refs98/79 artus HSV-1/2 QS-RGQ Kit98/79 artus HSV-1/2 RG PCR Kit2 refs98/79 EZ1 DSP DNA Blood Kit EZ1 DSP Virus Kit QFT-Plus 2 Plate Kit ELISA2 refs QIAamp DSP DNA Blood Mini Kit QIAamp DSP DNA FFPE Tissue Kit QIAamp DSP Virus Kit QIAamp DSP Virus Spin Kit QIAstat-Dx BCID GN Plus AMR Panel QIAstat-Dx BCID GPF Plus AMR Panel QIAstat-Dx Gastrointestinal Panel 22 refs QIAstat-Dx Meningitis/Encephalitis (ME) Panel2 refs QIAstat-Dx Respiratory SARS-CoV-2 Panel2 refs QIAsymphony DSP DNA Midi Kit2 refs QIAsymphony DSP DNA Virus/Pathogen Midi Kit2 refs QuantiFERON Monitor 2 Plate Kit ELISA98/79 QuantiFERON Monitor 2 Plate Kit ELISA QuantiFERON CMV 2 Plate kit ELISA98/79 QuantiFERON Monitor LyoSpheres98/79 RNeasy DSP FFPE Kit RNeasy DSP Midi Kit RNeasy DSP MinElute Cleanup Kit careHPV Test Kit98/79 (no longer marketed)	A, C IVDR, 98/79	Website info@qiagen.com EUDAMED record Report an error
Jiangsu Qitian Gene biotechnology EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other	China	Bacillus anthracis Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Brucella Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 COVID-19 Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）3 refs98/79 Ebola virus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 23 others Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Japanese Encephalitis Virus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Listeria Monocytogenes Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Mpox Virus Nucleic Acid Detection Kit（Fluorescent RAA)3 refs98/79 Plasmodium Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 RAA Nucleic Acid Amplication Kit2 refs RAA Nucleic Acid Amplication Kit(Fluorescent Method)2 refs RAA Nucleic Acid Amplication Kit(Test Strip Method)2 refs RT-RAA Nucleic Acid Amplication Kit2 refs RT-RAA Nucleic Acid Amplication Kit(Fluorescent Method)2 refs RT-RAA Nucleic Acid Amplication Kit(Test Strip Method)2 refs Salmonella Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 SARS-CoV-2 Nucleic Acid Detection Kit98/79 Schistosoma Haematobium Nucleic Acid Detection Kit（Fluorescent RAA)3 refs98/79 Schistosoma Mansoni Nucleic Acid Detection Kit（Fluorescent RAA)3 refs98/79 Staphylococcus Aureus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 V1-D/R-64JⅠ3 refs V2-D/R-64J3 refs Vibrio Cholerae Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Vibrio Parahemolyticus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Yellow Fever Virus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Yersinia Pestis Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Zika Virus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79	A IVDR, 98/79	Website EUDAMED record Report an error
Nexlab EU representative : MedNet EC-REP GmbH (Germany)	China	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 others 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	EUDAMED record Report an error
Xiamen Zeesan Biotech FDA EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other	China	DNA Extraction Kit (Lab-Aid 896)3 refs High Risk HPV Genotyping Assay (MMCA)98/79 High Risk HPV Genotyping Kit (Sanity 2.0)98/79 Low Risk HPV Genotyping Assay98/79 Low Risk HPV Genotyping Kit (Sanity 2.0)98/79 23 others 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 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 refs98/79	A IVDR, 98/79	info@zsandx.com EUDAMED record Report an error
Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium)	Belgium, Japan	AIA-PACK D-Dimer CONTROL SET98/79 AIA-PACK Homocysteine CONTROL SET98/79 CL AIA-PACK CMV IgG ADJUSTER SET98/79 CL AIA-PACK CMV IgG TEST CUP98/79 CL AIA-PACK CMV IgM ADJUSTER SET2 refs 27 others 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 refs CL AIA-PACK Toxo IgG ADJUSTER SET98/79 CL AIA-PACK Toxo IgG TEST CUP98/79 CL AIA-PACK Toxo IgM ADJUSTER SET2 refs GR F&A2 Calibrator Set GR01 β-Thalassemia Elution Buffer No. 13 refs 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 (no longer marketed) CL AIA-PACK SARS-CoV-2-Ag CONTROL SET98/79 (no longer marketed) CL AIA-PACK SARS-CoV-2-Ag SAMPLE TREATMENT SOLUTION98/79 (no longer marketed) CL AIA-PACK SARS-CoV-2-Ag TEST CUP98/79 (no longer marketed) Hemoglobin F&A2 Calibrator98/79 (no longer marketed)	A, B, C IVDR, 98/79	Website csc@tosoh.co.jp EUDAMED record Report an error
Biolabo	France	BE APTT K APTT Kaolin + CaCl23 refs BE APTT SL APTT Silica + CaCl23 refs BE Cal Ref Reference Plasma2 refs BE Cal Set Calibration Plasma PT Prothrombin Time Standard Set2 refs BE Clean SOLEA 1003 refs 22 others BE DDimer D-DIMER Turbidimetric Immunoassay3 refs BE DDTrol 1 DDimer Plasma low D-DIMER Controls3 refs BE Factor II Deficient Plasma FII2 refs BE Factor IX Deficient Plasma FIX2 refs BE Factor V Deficient Plasma FV2 refs BE Factor VII Deficient Plasma FVII2 refs BE Factor VIII Deficient Plasma FVIII2 refs BE Factor X Deficient Plasma FX2 refs BE Factor XI Deficient Plasma FXI2 refs BE Factor XII Deficient Plasma FXII2 refs BE FIB Thrombin Kaolin + Buffer Fibrinogen Reagents3 refs BE Owren Buffer2 refs BE PT HI Thromboplastin high ISI Prothrombin Time (High ISI)3 refs BE PT LI Thromboplastin low ISI Prothrombin Time (Low ISI)3 refs BE Trol 1 Plasma Level 1 CONTROL PLASMAS with coagulation factors3 refs BE TT Thrombin Time2 refs CALCIUM CHLORIDE 0.025M CHLORURE DE CALCIUM 0,025M Cleaning Solution for TIA3 refs CONTROL PLASMA Level 1 CONTROL PLASMAS without coagulation factors3 refs HAEMOGLOBIN Colorimetric Method (Cyanmethemoglobin) HbA1c Control Set HbA1c Standard Set	A, B, C IVDR	support@biolabo.fr EUDAMED record Report an error
Biologicals Quality Control	Netherlands	P0048 ViraQ Negative3 refs P0063 ViraQ HCV Check 1252 refs P0064 ViraQ HIV-1 Check 1252 refs P0065 ViraQ HBV Check 1252 refs P0067 ViraQ HCV Trend 252 refs 22 others P0068 ViraQ HIV-1 Trend 25 P0077 SeraQ TPHA Syphilis2 refs P0078 SeraQ ARCHITECT2 refs P0154 ViraQ HBV Trend 502 refs P0179 SeraQ Elecsys2 refs P0180 SeraQ LIAISON2 refs P0237 SeraQ LIAISON Syphilis2 refs P0247 ViraQ WNV Check 1253 refs P0259 SeraQ Murex2 refs P0260 SeraQ Murex Syphilis2 refs P0264 ViraQ HEV Check 1253 refs P0266 ViraQ Parvo B19/HAV Check3 refs P0267 SeraQ TPHA Syphilis V22 refs P0273 ViraQ Multi-Marker Check 752 refs P0309 SeraQ BIO-RAD2 refs P0312 SeraQ Elecsys Syphilis2 refs P0313 SeraQ BIO-RAD Syphilis2 refs P0317 SeraQ Alinity Syphilis2 refs P0318 ViraQ HIV-2 Check 1253 refs P0320 SeraQ Alinity V22 refs P0374 SeraQ Alinity V32 refs P0386 SeraQ Alinity V42 refs	B IVDR	Website info@bioqcontrol.com EUDAMED record Report an error
Cesna	Türkiye	BACTERIAL PATHOGEN DETECTION KIT GASTROENTERITIS SCREENING KIT GASTROINTESTINAL BACTERIAL PANEL V2 GASTROINTESTINAL PARASITE PANEL CSNP025 GASTROINTESTINAL VIRAL PANEL CSNP027 22 others GASTROİNTESTİNAL BAKTERİ PANELİ V1 GASTROINTESTINAL BACTERIAL PANEL V1 H.PYLORI AB HIZLI TESTİ H.PYLORI AG HIZLI TESTİ 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	B IVDR	Website info@cesna.com.tr EUDAMED record Report an error
Genegeo EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	12-DDL 12-DHL 12-DRF 12-DRS 12-DWL 22 others 8P-DFL Cleaning Solution DCC2 refs CS DCS Diluent for Hematology Analysis 10-DRS3 refs DXS2 refs Fluorescent Dye for Hematology Analysis 10-DDF3 refs Fluorescent Dye for Hematology Analysis 10-DPF3 refs Fluorescent Dye for Hematology Analysis 10-DRF3 refs Fluorescent Dye for Hematology Analysis 10-DTF3 refs Fluorescent Dye for Hematology Analysis 10-DWF3 refs Fluorescent Dye for Hematology Analysis 6-ODF3 refs Fluorescent Dye for Hematology Analysis 8-DFF3 refs GE-DXS Lysing Reagent for Hematology Analysis 10-DDL3 refs Lysing Reagent for Hematology Analysis 10-DHL3 refs Lysing Reagent for Hematology Analysis 10-DPL3 refs Lysing Reagent for Hematology Analysis 10-DWL3 refs Lysing Reagent for Hematology Analysis 6-ODL3 refs Lysing Reagent for Hematology Analysis 6-OHB3 refs Lysing Reagent for Hematology Analysis 8-DFL3 refs Lysing Reagent for Hematology Analysis 8-WHB2 refs	A IVDR	sales@genegeo.com EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium)	United States	Aptima Assay Fluids3 refs Aptima Chlamydia trachomatis Assay Aptima CMV Quant Assay3 refs Aptima Combo 2 Assay2 refs Aptima Controls Kit 22 others Aptima CV/TV Assay3 refs Aptima DBS Extraction Buffer3 refs Aptima HBV Quant Assay3 refs Aptima HCV Quant Dx Assay3 refs Aptima Herpes Simplex Viruses 1 & 2 Assay2 refs Aptima HIV-1 Quant Dx Assay3 refs Aptima HPV 16 18/45 Genotype Assay2 refs Aptima HPV Assay3 refs Aptima Mycoplasma genitalium Assay2 refs Aptima Neisseria gonorrhoeae Aptima SARS-CoV-2 Assay2 refs Aptima Trichomonas vaginalis Assay3 refs Panther Fusion AdV/hMPV/RV Assay2 refs Panther Fusion Flu A/B/RSV Assay2 refs Panther Fusion GBS Assay2 refs Panther Fusion GI Bacterial Assay2 refs Panther Fusion GI Expanded Bacterial Assay2 refs Panther Fusion Internal Control-B3 refs Panther Fusion MRSA Assay2 refs Panther Fusion Paraflu Assay2 refs Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay2 refs ThinPrep Stain Bluing II Solution3 refs	A, B, C, D IVDR	EUDAMED record Report an error
Hybribio EU representative : Emergo Europe B.V. (Netherlands) and 3 others	China	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 refs 16 Tests/ Kit, 48 Tests/ Kit 16 Tests/Kit2 refs98/79 16 Tests/Kit, 32 Tests/Kit, 48 Tests/Kit, 128Tests/Kit, 160 Tests/Kit, 192 Tests/Kit3 refs 22 others 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 refs 50 tests/kit 6 tests/kit6 refs98/79 6 Tests/Kit，30 Tests/Ki 60 Tests/Kit98/79 90 Tests/Kit98/79 96 Tests/Kit98/79 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 refs	A IVDR, 98/79	EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain)	South Korea	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 22 others 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 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	EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium)	South Korea	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 22 others 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 refs98/79 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 refs98/79 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 refs98/79 PowerChek™ STI Multiplex Real-time PCR Kit Ⅲ2 refs98/79 PowerChek™ STI Multiplex Real-time PCR KitⅡ2 refs98/79 PowerChek™ ZIKV / DENV / CHIKV Multiplex Real-time PCR Kit2 refs98/79 PowerPrep™ Pathogen NA Extraction Kit EXP2 refs PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0 PowerPrep™ Viral NA Extraction Kit EXP2 refs PowerPrep™ Whole blood NA Extraction Kit EXP2 refs	A IVDR, 98/79	Website info@kogene.co.kr EUDAMED record Report an error
Microgenics FDA EU representative : B·R·A·H·M·S GmbH (Germany)	United States	96005098/79 96005198/79 96049998/79 96050098/79 96050198/79 21 others 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	– 98/79	Website EUDAMED record Report an error
Operon FDA	Spain	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 others 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 refs 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 refs 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 refs Simple Flu A+B 9.080.XX.YYY.ZZZ3 refs SIMPLE GDH / STICK GDH 9.045.XXX.YY.ZZZ3 refs Simple GDH-Toxins 9.065.XXX.YY.ZZZ3 refs 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 refs Simple RSV-Flu A+B 9.081.XXX.YY.ZZZ3 refs 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 refs	B IVDR, 98/79	Website infoeudamed@operon.es EUDAMED record Report an error
Phasescientific FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Hong Kong SAR China	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 others 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	Website info@phasesci.com EUDAMED record Report an error
Qnostics EU representative : WMDE B.V. (Netherlands)	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 others 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 EUDAMED record Report an error
Realytech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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 others 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	Website info@realytech.com EUDAMED record Report an error
Aitbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	Singapore	30010798/79 30010898/79 30014298/79 30014398/79 30014498/79 20 others 30015598/79 30015698/79 30018598/79 30018698/79 30022198/79 30022298/79 30026798/79 30026898/79 30027598/79 30027698/79 302011 302012 302013 302014 800814 800827 800841 800941 800945 800971	A IVDR, 98/79	Website EUDAMED record Report an error
Nanjing Norman Biological Technology EU representative : Sungo Cert GmbH (Germany)	China	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 D-Dimer Test Kit (Immunoturbidimetry) 50tests/box98/79 20 others 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 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	– 98/79	EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany)	United States	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 20 others 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 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 RVP Control Set98/79 Savanna RVP Control Set (1-set)98/79 Savanna RVP Control Set (4-set)98/79 Savanna RVP4 Assay98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Wizbiotech EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	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 20 others 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	– 98/79	EUDAMED record Report an error
Arcdia	Finland	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 others 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 (no longer marketed) mariPOC® RTI combi test plate (no longer marketed)	A IVDR, 98/79	Website office@arcdia.com EUDAMED record Report an error
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 others 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	Website contact@ablsa.com EUDAMED record Report an error
Advanced Molecular Diagnostics EU representative : Advena Limited (Malta)	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 others 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	Website info@am-diagnostics.co.uk EUDAMED record Report an error
Bioneer FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	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 19 others 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 ExiStation™ FA DNA/RNA Kit (V2) ExiStation™ FA DNA/RNA Kit (V3) MagListo™ 5M Viral DNA/RNA Extraction Kit	A, D IVDR, 98/79	Website sales@bioneer.com EUDAMED record Report an error
Clongene FDA EU representative : HUMISS TRADING S. L. (Spain) and 1 other	China	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 others 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	Website marketing@clongene.com EUDAMED record Report an error
Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach	Poland	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 others 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 refs 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	Website EUDAMED record Report an error
Biocare Medical EU representative : Emergo Europe B.V. (Netherlands)	United States	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 others 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 (no longer marketed) MLH1 PM220H98/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Genobio Pharmaceutical FDA EU representative : Caretechion GmbH (Germany) and 1 other	China	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 17 others Aspergillus IgM Antibody Detection K-Set(CLIA)98/79 Aspergillus Molecular Detection Kit (Real-time PCR)2 refs98/79 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 refs98/79 Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay)2 refs98/79 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 Fungus (1-3)-β-D-Glucan Detection Kit (CLIA)98/79 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 refs98/79 Pneumocystis Molecular Detection Kit (Real-time PCR)2 refs98/79	– 98/79	Website marketing@era-bio.com EUDAMED record Report an error
Synthgene (Yixing) Health Technology EU representative : MedPath GmbH (Germany)	China	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 others 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 EUDAMED record Report an error
Giesse Diagnostics	Italy	Antitrombina III 670498/79 D-Dimero 673798/79 Fibrinogeno 780498/79 IgA 671198/79 IgG 671098/79 16 others 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	Website info@giessediagnostics.com EUDAMED record Report an error
Syscanbio EU representative : Obelis s.a. (Belgium)	China	Activated Partial Thromboplastin Time (APTT) Reagent(Ellagic Acid) Coagulation Analyzer2 refs98/79 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 others 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 refs98/79 Fibrin Degradation Product (FDP) Control Coagulation Analyzer2 refs98/79 Fibrinogen Reference Plasma Coagulation Analyzer STD-FIB-0198/79 Prothrombin Time (PT) Reagent Coagulation Analyzer2 refs98/79 Thrombin Reagent (for Fbg assay) Coagulation Analyzer3 refs98/79 Thrombin Time (TT) Reagent Coagulation Analyzer3 refs98/79	– 98/79	EUDAMED record Report an error
Taiwan Advanced Nanotech FDA EU representative : mdi Europa GmbH (Germany)	Taiwan	611 series3 refs 612 series3 refs 615 series3 refs 61C series3 refs 61E series3 refs 16 others 61F series3 refs 61G series3 refs 61H series3 refs 61P series3 refs 621 series3 refs 622 series3 refs 635 series3 refs 63F series3 refs 665 series3 refs 66P-MS series3 refs 685 series3 refs 6K2 series3 refs 6SC series3 refs 6ST series3 refs 6T2 series3 refs 6TF series3 refs	A IVDR	Website EUDAMED record Report an error
TECO Medical Instruments, Production + Trading	Germany	Blue D-Dimer LC98/79 Red D-Dimer D2010-01298/79 TECal DD98/79 TECal N98/79 TEChrom98/79 16 others 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 refs98/79 TEClot PT-B98/79 TEClot PT-S3 refs98/79 TEClot TT98/79 TEControl A98/79 TEControl A Plus98/79 TEControl N98/79	– 98/79	Website info@teco-medical.com EUDAMED record Report an error
Xenta Biomedical Science FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	COVID-19 Antigen Rapid Detection Kit (Nasal Swab)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (NP Swab)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (Saliva Lollipop)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (Saliva)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (Throat Swab)2 refs98/79 16 others D-Dimer Detection Kit (Fluorescent Immune Chromatography)2 refs98/79 D-Dimer Rapid Quantitative Test XRDL007A105OS98/79 D-Dimer Rapid Quantitative Test XRDL007A120OS98/79 Fibrin and Fibrinogen Degradation Products (FDP) Rapid Quantitative Test2 refs98/79 IFA & IFB & COVID-19 Antigen Joint Detection Kit (Immunochromatography Assay)2 refs98/79 IFA & IFB Antigen Joint Detection Kit (Immunochromatography Assay)2 refs98/79 IL-6 Detection Kit (Fluorescent Immune Chromatography)2 refs98/79 Interleukin-6 (IL-6) Rapid Quantitative Test2 refs98/79 Malaria Antigen P.f Detection Reagent (Colloidal Gold method)2 refs98/79 Malaria Antigen P.f/P.v Detection Reagent (Colloidal Gold method)2 refs98/79 Malaria Antigen P.f/Pan Detection Reagent (Colloidal Gold method)2 refs98/79 Plasmin-α2-Plasmin Inhibitor Complex (PIC) Rapid Quantitative Test2 refs98/79 Plasminogen (PLG) Rapid Quantitative Test2 refs98/79 TB Specific Cell Immune Response Detection Kit2 refs98/79 Thrombin-Antithrombin Ⅲ Complex (TAT) Rapid Quantitative Test2 refs98/79 Tissue-Type Plasminogen Activator Inhibitor-1 Complex (t-PAIC) Rapid Quantitative Test2 refs98/79	– 98/79	Website EUDAMED record Report an error
Orasure FDA EU representative : QbD RepS BV (Belgium)	United States	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 others 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 (no longer marketed) OraQuick HCV Rapid Antibody Test 1001-037198/79 (no longer marketed) OraQuick HIV Self-Test 1001-070698/79 (no longer marketed) OraQuick HIV Self-Test 1001-0706U98/79 (no longer marketed)	– 98/79	Website customercare@orasure.com EUDAMED record Report an error
DiaMex	Germany	Optitrol Blue3 refs Optitrol Green3 refs Optitrol HEPA-13 refs Optitrol HEPR-13 refs Optitrol HIV 23 refs 15 others Optitrol HIVp243 refs Optitrol NAT HBV Screening No2 refs Optitrol NAT HBV Viral Load2 refs Optitrol NAT HCV Screening Optitrol NAT HCV Viral Load2 refs Optitrol NAT HEV2 refs Optitrol NAT HIV Screening2 refs Optitrol NAT HIV Viral Load2 refs Optitrol NAT HIV-22 refs Optitrol NAT NEG2 refs Optitrol NAT Triplex2 refs Optitrol Orange3 refs Optitrol Red3 refs Optitrol SeroNeg3 refs Optitrol Yellow3 refs	B IVDR	Website EUDAMED record Report an error
Ingenetix	Austria	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 others 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	Website office@ingenetix.com EUDAMED record Report an error
Linear FDA	Spain	APTT98/79 Clonatest2 refs98/79 Cromatest16 refs98/79 Cromatest Plasma Control Level 12 refs98/79 Cromatest Plasma Control Level 22 refs98/79 15 others Cromatetst98/79 Fibrinogen98/79 PT-HS98/79 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	A IVDR, 98/79	Website info@linear.es EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium)	China	DD Nucleic Acid Dye Group B Streptococcus Nucleic Acid Detection Kit (Real-Time PCR)98/79 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 15 others Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot)2 refs98/79 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	A IVDR, 98/79	Website EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	India, South Korea	Q-NCOV-07G4 refs 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™ H. pylori Ag Control C-HPY-01 15 others STANDARD™ Legionella Ag Control C-LGN01G STANDARD™ M10 C. difficile BT M10-CBT-01 STANDARD™ M10 C. difficile M10-CDF-0198/79 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 refs STANDARD™ Q HCV Ab Test QHCV01B2 refs STANDARD Q Malaria P.f/P.v Ag RK025-40 (no longer marketed)	A, B, C, D IVDR, 98/79	Website EUDAMED record Report an error
Autobio Diagnostics FDA EU representative : QbD RepS BV (Belgium)	China	AutoLumo B19 IgG Calibrators AutoLumo analyzer3 refs AutoLumo B19 IgM Calibrators AutoLumo analyzer3 refs AutoLumo IL-6 Calibrators AutoLumo Analyzer3 refs CMV IgG CLIA Microparticles Autolumo analyzer3 refs CMV IgM CLIA Microparticles Autolumo analyzer3 refs 14 others EA IgG CLIA Microparticles2 refs98/79 HSV-1 IgG CLIA Microparticles Autolumo analyzer3 refs HSV-1 IgM CLIA Microparticles Autolumo analyzer3 refs HSV-2 IgG CLIA Microparticles Autolumo analyzer3 refs HSV-2 IgM CLIA Microparticles Autolumo analyzer3 refs NA IgG CLIA Microparticles2 refs98/79 Rubella IgG CLIA Microparticles Autolumo analyzer3 refs Rubella IgM CLIA Microparticles Autolumo analyzer3 refs ToRCH IgG Control AutoLumo analyzer3 refs ToRCH IgM Control AutoLumo analyzer3 refs Toxo IgG CLIA Microparticles Autolumo analyzer3 refs Toxo IgM CLIA Microparticles Autoluno analyzer3 refs VCA IgG CLIA Microparticles2 refs98/79 VCA IgM CLIA Microparticles2 refs98/79	C IVDR, 98/79	info@autobio-diagnostics.com EUDAMED record Report an error
Bio-Rad Medical Diagnostics	Germany	Anti-C3 Anti-C3d Anti-C4 Anti-Dia (DI1) Anti-IgG 14 others 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	Website contact@bio-rad.com EUDAMED record Report an error
Citest Diagnostics EU representative : VidaQuick Biotech S.L. (Spain)	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 H. pylori Antibody Rapid Test Cassette IHP-302(CT)98/79 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 14 others 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	– 98/79	ra02@citestdiagnostics.com EUDAMED record Report an error
Eurobio Scientific	France	Bleu Trypan 4,0%2 refs EBX GI Helminths3 refs98/79 EBX GI Protozoans3 refs98/79 EurobioPlex Bartonella3 refs98/79 EurobioPlex BK Virus3 refs98/79 14 others EurobioPlex BK virus / JC virus3 refs98/79 EurobioPlex Bordetella pertussis et parapertussis3 refs98/79 EurobioPlex Coxiella Burnetii3 refs98/79 EurobioPlex Dengue 12343 refs98/79 EurobioPlex FluCoSyn EBX-0425 refs98/79 EurobioPlex HHV6-HHV83 refs98/79 EurobioPlex JC Virus3 refs98/79 EurobioPlex Méningite bactérienne communautaire2 refs98/79 EurobioPlex Méningite bactérienne materno-foetale2 refs98/79 EurobioPlex Parvovirus B193 refs98/79 EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)3 refs98/79 EurobioPlex Zika Virus3 refs98/79 Lymphocyte separation medium CMSMSL01-013 refs MYCOKIT SERO98/79	A IVDR, 98/79	reglementaire@eurobio-scientific.com EUDAMED record Report an error
Genekam	Germany	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 others 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	Website office@genekam.de EUDAMED record Report an error
Gmt Sarl	France	CLE-P Cleanser 500.05 Cleaner 360.5, Cleaner 360.12 refs Concentrated Cleaner 360.02, Concentrated Cleaner 360.012 refs Detergent 20 RET DIL-A Diluent 580.20 14 others DIL-C Diluent 560.20 Diluent 20 RET Diluent 360.20, Diluent 360.52 refs LYA-1 Lyse 580.5, LYA-1 Lyse2 refs LYA-2 Lyse 580.51, LYA-2 Lyse2 refs LYA-3 Lyse 580.1, LYA-3 Lyse2 refs LYC-1 Lyse 560.2, LYC-1 Lyse 560.012 refs LYC-2 Lyse 560.5, LYC-2 Lyse 560.22 refs Lyse 1 RET Lyse 360.05, Lyse 360.032 refs Probe Cleaner 360.01, Probe Cleaner 360.0052 refs Probe Cleaner RET Sheath 20 RET Stain RET OR50T0020	A IVDR	Website EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland)	China	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 others 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	Website sales@limingbio.com EUDAMED record Report an error
MedicalSystem Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands)	China	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 refs 14 others Automated Hematology Analyzer Lyse LYC-1, LYC-22 refs 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	EUDAMED record Report an error
MTD Diagnostics	Italy	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 14 others Diluent M-SYS98/79 Homocysteine LS HP98/79 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	Website EUDAMED record Report an error
Norgen Biotek EU representative : Emergo Europe B.V. (Netherlands)	Canada	Blood Genomic DNA Isolation Mini Kit Dx Cryptosporidium TaqMan RT-PCR Kit Dx EBV TaqMan PCR Kit Dx FFPE DNA Purification Kit Dx FFPE RNA Purification Kit Dx 14 others 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 refs Plasma/Serum Circulating and Exosomal RNA Purification Kit Dx (Slurry Format) Plasma/Serum Circulating DNA Purification Mini Kit Dx (Slurry Format) Saliva DNA Isolation Kit Dx Saliva/Swab RNA Purification Kit Dx2 refs Stool DNA Isolation Kit Dx Stool Total RNA Purification Kit Dx Total RNA Purification Kit Dx3 refs Urine DNA Isolation Kit Dx Urine Total RNA Purification Maxi Kit Dx (Slurry Format)	A, B IVDR	Website regulatory@norgenbiotek.com EUDAMED record Report an error
Sejoy FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Adenovirus Rapid Test (Feces) Cassette98/79 Dengue IgG/IgM Rapid Test Device Cassette98/79 Dengue IgG／IgM／NS1 Combo Rapid Test Cassette98/79 Dengue NS1 Antigen Rapid Test Cassette98/79 H.pylori Antibody Rapid Test Cassette98/79 14 others 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 Strep A Rapid Test ISTA-811298/79 Syphilis Antibody Rapid Test Cassette,Strip98/79 Typhoid IgG/IgM Rapid Test Cassette98/79	– 98/79	Website EUDAMED record Report an error
ZeptoMetrix FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	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 others 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	Website EUDAMED record Report an error
Diatron FDA	Hungary	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 13 others 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 refs 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	Website EUDAMED record Report an error
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Cleaner HC310 Cleaner HC600 Diluent HD310 Diluent HD600 Diluent HD93R 13 others 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	EUDAMED record Report an error
Genrui Biotech FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	225 tests98/79 25 tests98/79 50T/Kit98/79 D-Dimer Detection Kit (Nephelometry)98/79 D-Dimer Detection Kit (Nephelometry) 225 tests98/79 13 others D-Dimer Detection Kit (Nephelometry) 25 tests98/79 D-Dimer test kit (Immunofluorescence) 25T/kit98/79 E-Z Cleanser 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 KT03 Diluent please see UDI-DI for details2 refs KT03 Lyse Solution Please see UDI-DIs for details.2 refs KT05 DIFF Lyse Please see UDI-DIs for details2 refs KT05/KT05A LD Lyse2 refs KT05A DIL Diluent KT05A LH Lyse Please see UDI-DIs for details3 refs Probe Cleanser4 refs	A IVDR, 98/79	Website service@genrui-bio.com EUDAMED record Report an error
Kalians EU representative : MDSS GmbH (Germany)	Egypt	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 others 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 refs98/79 Haemoglobin (Single Reagent) Drabkin’s Solution2 refs98/79 Haemoglobin Drabkin’s Solution2 refs98/79 Liquid PT Reagent ISI 1.03 refs98/79 Malaria Antigen Test (Whole Blood) For Plasmodium falciparum & vivax98/79 PT Reagent ISI 1.53 refs98/79 PTT Reagent98/79 Rose Bengal Brucella Antigen2 refs98/79 RPR Syphilis Test98/79 Typhoid IgG/IgM Rapid Test- Cassette98/79 Widal Test (Salmonella Ab)10 refs98/79	– 98/79	EUDAMED record Report an error
Nanjing Synthgene Medical Technology FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	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 others 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 refs 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	Website sales@syngenebio.com EUDAMED record Report an error
Wheisman Medical Technology EU representative : Umedwings Netherlands B.V. (Netherlands)	China	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 13 others 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 refs Hematology Reagent - Diluent W-31D：2L, 5L, 10L, 20L3 refs Hematology Reagent - Lyse W-31L：250mL、250mL×3、500mL、500mL×3、1L3 refs Hematology Reagent - Lyse W-61LD：250mL、250mL×3、500mL、500mL×3、1L3 refs Hematology Reagent - Lyse W-61LH：250mL、250mL×3、500mL、500mL×3、1L3 refs Hematology Reagent - Lyse W-62LD： 250mL, 500mL, 500mL×4, 1L 1L×43 refs Hematology Reagent - Lyse W-63LD1： 200mL, 500mL, 1L, 1L×43 refs Hematology Reagent - Lyse W-63LD2： 100mL, 250mL, 500mL, 500mL×43 refs Hematology Reagent - Probe Cleanser 50mL、50mL×22 refs	A IVDR, 98/79	EUDAMED record Report an error
AIDA	Germany	Annexin V-GM98/79 Borrelia IgG98/79 Borrelia IgM98/79 Choline-GM98/79 Ethanolamin-A98/79 12 others 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	EUDAMED record Report an error
Anhui Formaster Biosci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	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 others 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	Website EUDAMED record Report an error
Astra Biotech	Germany	Chlamydia trachomatis PCR kit (Form F)3 refs98/79 Chlamydia trachomatis PCR kit (Form S)3 refs98/79 Chlamydia trachomatis PCR kit (Form T)3 refs98/79 Magnetic DNA / RNA Auto Extraction kit Magnetic DNA/RNA Auto Extraction kit (Form P1) 12 others 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 refs98/79 Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form S)3 refs98/79 Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form T)3 refs98/79 Neisseria gonorrhoeae PCR kit3 refs98/79 Prime DNA/RNA Extraction kit Trichomonas vaginalis PCR kit3 refs98/79 Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form F)3 refs98/79 Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form S)2 refs98/79 Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form T)3 refs98/79	A IVDR, 98/79	Website info@astrabiotech.de EUDAMED record Report an error
CellSolutions FDA EU representative : CellSolutions GmbH (Germany)	United States	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 others 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	Website EUDAMED record Report an error
Dynamiker EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other	China	100 tests14 refs98/79 12 tests/kit98/79 20 tests9 refs98/79 20 tests (A)98/79 200 tests14 refs98/79 12 others 24 tests5 refs98/79 24 tests/kit10 refs98/79 40 tests98/79 40 tests/kit (A)98/79 48 tests9 refs98/79 48 tests/kit11 refs98/79 50 tests5 refs98/79 50 tests/kit3 refs98/79 50 tests/kit (A)98/79 96 tests3 refs98/79 96 tests/kit98/79 DNK-2103-198/79	– 98/79	Website marketing@dynamiker.com EUDAMED record Report an error
Shenzhen Superbio Technology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	CLIA FDP Control98/79 D-Dimer Assay Kit CLIA2 refs98/79 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 refs98/79 12 others HCY Assay kit CLIA2 refs98/79 IL-6 Assay Kit CLIA2 refs98/79 InFluA/InFluB Ag Rapid Test (Immunochromatography Assay)98/79 Monkeypox Virus (MPxV) Antigen Quality Control2 refs98/79 ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test (Colloidal Gold)2 refs98/79 ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)2 refs98/79 ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold)2 refs98/79 PIC Assay kit CLIA2 refs98/79 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 refs98/79 tPAIC Assay kit CLIA2 refs98/79	– 98/79	info@sup-bio.com EUDAMED record Report an error
Abon Biopharm(Hangzhou) EU representative : Medical Technology Promedt Consulting GmbH (Germany)	China	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 others 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	EUDAMED record Report an error
Goldsite EU representative : CMC Medical Devices & Drugs SL (Spain)	China	FIA Go D-Dimer Kit98/79 G-3DIL Diluent G-3LHB Lyse GPP-100 D-Dimer Kit98/79 HbA2 & HbF & HbA1c Calibrator98/79 11 others HbA2 & HbF & HbA1c Control2 refs98/79 Kemilo D-Dimer Kit98/79 Kemilo IL-6 Kit98/79 Monkeypox Virus Real-time PCR Kit3 refs98/79 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 refs98/79 SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing)4 refs98/79 SARS-CoV2 & Influenza A/B Antigen Kit (Colloidal Gold)3 refs98/79	A IVDR, 98/79	Website export@goldsite.com.cn EUDAMED record Report an error
Haemokinesis EU representative : Compliance Management Solutions Europe LTD (Bulgaria)	Australia	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 11 others 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 STARGEL10 STAR SOLUTION STATUS1 Solution	A IVDR, 98/79	EUDAMED record Report an error
Hartbio FDA EU representative : Amstermed UK Ltd (Northern Ireland)	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 others 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	EUDAMED record Report an error
Keyubio EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	KEYU Cryptosporidium Antigen Test Kit (Colloidal Gold Method) CRY-Ⅰ98/79 KEYU Entamoeba histolytica Antigen Test Kit (Colloidal Gold Method)98/79 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 11 others 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 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	– 98/79	Website export@keyubio.com EUDAMED record Report an error
LTA	Italy	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 others 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	Website office@ltaonline.it EUDAMED record Report an error
r2 Diagnostics FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	United States	Emicizumab Calibrator98/79 Emicizumab Controls98/79 FibroTek Fibrinogen kit98/79 LupoTek Correctin VL98/79 LupoTek Detectin VL98/79 11 others LupoTek KCT98/79 NoFact IX98/79 NoFact VIII98/79 Phospholin ES2 refs98/79 Phosphoplastin RL2 refs98/79 PlasmaCon L198/79 PlasmaCon L298/79 PlasmaCon LA98/79 PlasmaCon N98/79 T-Tek98/79 ThromboTek PSe98/79	– 98/79	Website qa@r2diagnostics.com EUDAMED record Report an error
Reagena	Finland	Eosin solution 100072 Etanolifiksatiivi 50 % V/V, sis. eosiinia (120 x 10 ml) 102354SC3 refs Formalin 10 % (1 L), phosphate buffered pH 7,2 incl. 4 % formaldehyde 1022563 refs Formalin 10 % in sample container (120 x 30 ml), phosphate buffered pH 7,2 incl. 4 % formaldehyde 102256SC3 refs GEWF solution 102448 11 others Giemsa solution 100119 May-Grünwald solution 1002112 refs Mayer's hematoxylin solution 100210 PEG-ethanol cytology fixative (120 x 10 ml) 105028SC2 refs 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	Website info@reagena.com EUDAMED record Report an error
Techlab FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	C. DIFF CHEK -602 refs98/79 C. DIFF QUIK CHEK98/79 C. DIFF QUIK CHEK COMPLETE2 refs C. DIFFICILE TOX A/B II2 refs98/79 C. DIFFICILE TOX-B TEST98/79 11 others 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	Website EUDAMED record Report an error
Dakewe FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	CK20 Antibody Reagent2 refs98/79 Cytokeratin Pan Antibody Reagent2 refs98/79 Eosin Staining Solution Alcohol-soluble; Water-soluble2 refs Giemsa Staining Solution2 refs Harris 10 others Hematoxylin-Eosin Staining Solution HD Immunochromogenic Reagent3 refs Immunochromogenic Reagent HI3 refs Ki-67 Antibody Reagent2 refs98/79 Mounting Medium NB-30, NB-1002 refs Mounting Medium QD-20 O.C.T. Compound p63 Antibody Reagent98/79 Papanicolaou Staining Solution EA50 SMA Antibody Reagent98/79	A IVDR, 98/79	Website EUDAMED record Report an error
Ddk Italia	Italy	Acetate buffered formalin3 refs Acid alcohol solution3 refs Acridine orange for plasmodium and DNA3 refs Afog stain solution3 refs AgNOR3 refs 10 others Albumine glicerinate3 refs Blocstore 9 container for 450 block3 refs Blue cresyl brilliant Ddclear (D-Limonene)3 refs Denatured ethyl alcohol 99A3 refs Eosin for sperm vitality3 refs Gentian violet phenic solution3 refs Giemsa L (stock solution)3 refs HC1 pH 8.0 buffer3 refs Tissue marking dyes black3 refs	A IVDR	info@ddkitalia.com EUDAMED record Report an error
Diapro	Italy	anti-HCV ELISA 5127498/79 Dengue virus NS1 Ag98/79 DIA.CHEMILUX HSV 2 IgM RAHSV2M.CE98/79 EBV DNA Quantitation (QT) EBVDNAQT.CE98/79 ENTEROVIRUS ONE-STEP ENTERONE.CE98/79 10 others 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 Parvovirus B19 IgM PARVOM.CE98/79 SYPH IgM SIM.CE98/79 Syphilis Screen ELISA 5100498/79 ZIKV IgM ZIKVM.CE98/79	– 98/79	Website info@diapro.it EUDAMED record Report an error
Iontek	Türkiye	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 others 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	Website EUDAMED record Report an error
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany)	China	Adenovirus & Rhinovirus & mycoplasma pneumoniae Nucleic Acid Detection Kit (Fluorescence PCR )5 refs98/79 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 Influenza A&B Nucleic Acid Detection Kit(RNA Amplification Lateral Flow)3 refs98/79 10 others Influenza A/B & RSV Nucleic Acid Multiplex Detection Kit(Fluorescence PCR)5 refs98/79 Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR)2 refs98/79 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 refs Ureaplasma urealyticum, Mycoplasma hominis, Mycoplasma genitalium Nucleic Acid Multiplex Detection Kit (Fluorescence PCR)98/79	A IVDR, 98/79	EUDAMED record Report an error
NORMA Instruments Zártkörűen Működő Részvénytársaság	Hungary	H3-Check Complete control blood set for 3-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials NormaCont3+ KIT K13 refs H3-Compact 100 Norma-iRP313 refs H3/5-CAL calibrator for Hemolyzer® hematology analyzers NormaCal3 calibrator2 refs H3/5-Hypoclean2 refs 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 refs 10 others H5-Compact 100 Norma-iRP513 refs H5-Compact 100-O Norma-iRP51 OP3 refs H5-Opticlean2 refs Norma-iClean5 Norma-iDil3 Norma-iDil5 Norma-iLyse3 Norma-iLyse5 Norma-iRP20 Norma-iRP212 refs Norma-iSol32 refs	A IVDR	EUDAMED record Report an error
Orphée EU representative : PZ CORMAY Spółka Akcyjna (Poland)	Switzerland	CLEANER FOR MYTHIC 22 DILUENT FOR MYTHIC 22 MYT-3CRP98/79 MYT-3CRP CAL98/79 MYT-3CRP N98/79 10 others Myt-3D3 refs98/79 Myt-5D2 refs98/79 Myt-CAL98/79 Mythic 18 Cyanide free Lytic solution2 refs Mythic 18 Diluent2 refs Mythic 18-22 Enzymatic Cleaning Solution MYTHIC 3CRP Cleaner MYTHIC 3CRP Diluent2 refs MYTHIC 3CRP Lysing Reagent2 refs OnlyOne	A IVDR, 98/79	ra@orphee-medical.com EUDAMED record Report an error
Shenzhen Chenghui Medical Technology EU representative : HUMISS TRADING S. L. (Spain)	China	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 others 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	EUDAMED record Report an error
Sichuan Orienter Biotechnology EU representative : Medunion S.L. (Spain)	China	Alpha Tumor Necrosis Factor (TNFα) Assay Kit (Chemiluminescent Immunoassay) 2×50 test/box Calibrator:0.5mL×298/79 D-Dimer (D-D) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 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 10 others 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 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	– 98/79	Website info@orienterglobal.com EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain)	China	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 10 others 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 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 refs Nucleic Acid Extraction Reagents(Magnetic Bead) TM-363 refs Nucleic Acid Releaser (For PCR) SR05050, SR10050, SR05080, SR10080,SR05100, SR10100, SR50001, SR100001, SR5L01, SR20L01	A IVDR, 98/79	sales@singuway.com EUDAMED record Report an error
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 refs 10 others 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 refs 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 refs 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 refs VERBIESE Formol tamponné pbs 4 % en solution3 refs	A IVDR	Website contact@verbiese.fr EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI Device (IHP-402)98/79 QINGLI Device(IAD-602)98/79 QINGLI Device:20 Test/Kit40 refs98/79 QINGLI Device:20 Test/Kit, Strip: 25Test/Kit QINGLI IHP-60298/79 10 others 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 refs98/79 Strep A Rapid Test Device IST-502s	C IVDR, 98/79	EUDAMED record Report an error
Wiener Laboratorios SAIC FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Argentina	APTT ellagic2 refs98/79 APTTest ellágico98/79 Chagatest ELISA lisado2 refs98/79 Chagatest ELISA recombinante v.4.02 refs98/79 Coagulation Calibrator2 refs98/79 26 others Control Plasma Normal98/79 Control Plasma Pathologic98/79 Fibrinogen98/79 Fibrinógeno98/79 Plasma Control Normal98/79 Prothrombin Time98/79 Prothrombin Time plus2 refs98/79 Soluplastin3 refs98/79 Thrombin Time98/79 Albúmina bovina 30% (no longer marketed) Anticoagulante TP (no longer marketed) APTTest98/79 (no longer marketed) Chrom ATIII98/79 (no longer marketed) Chrom Protein C98/79 (no longer marketed) Coagulation Control N98/79 (no longer marketed) Coagulation Control P98/79 (no longer marketed) Factor IX Deficient Plasma98/79 (no longer marketed) Factor VIII Deficient Plasma98/79 (no longer marketed) Imidazole buffer (no longer marketed) Plasma Control Patológico98/79 (no longer marketed) Tiempo de Trombina98/79 (no longer marketed) WL 19 E-Z Cleanser AA (no longer marketed) WL 19 Rinse AA2 refs (no longer marketed) WL Diluent2 refs (no longer marketed) WL Lyse2 refs (no longer marketed) WL Probe Cleanser (no longer marketed)	A IVDR, 98/79	Website marketing@wiener-lab.com EUDAMED record Report an error
Hangzhou Genesis Biodetection Biocontrol FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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 others 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 (no longer marketed) Dengue NS1 Rapid Test Device P23110498/79 (no longer marketed) Malaria Pf Antigen Rapid Test Device P23110798/79 (no longer marketed) Malaria Pf/Pan Antigen Rapid Test Device P23110998/79 (no longer marketed) Malaria Pf/Pv Antigen Rapid Test Device P23110898/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Beijing Wantai Biological Pharmacy Enterprise EU representative : QbD RepS BV (Belgium)	China	AiD HIV 1+2 Ag/Ab ELISA Plus2 refs98/79 AiDTM HBsAg ELISA2 refs98/79 AiD anti-HCV ELISA Plus2 refs98/79 AiD anti-HIV 1+2 ELISA2 refs98/79 Rapid Test for Antibody to Syphilis (Colloidal Gold Device)2 refs98/79 9 others Rapid Test for IgM Antibody to Hepatitis A Virus (Colloidal Gold Device)2 refs98/79 Rapid Test for IgM Antibody to Hepatitis E Virus (Colloidal Gold Device)98/79 Rotavirus Group A Diagnostic Kit (Colloidal Gold Device)2 refs98/79 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	EUDAMED record Report an error
Biomaxima	Poland	Clostridium difficile GDH kasetki 20 szt2 refs Clostridium difficile GDH+A+B kas. 20szt Denga Ab/Ag / Dengue Ab/Ag Dengue - kasetki 20 szt. Dengue NS1 kasetki 20 szt. 9 others 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 refs RSV + Adeno-resp. - kasetki 20 szt. RSV - kasetki 20 szt. Syfilis / Syphilis Syfilis kasetki 40 szt.2 refs	B, C IVDR, 98/79	Website info@biomaxima.com EUDAMED record Report an error
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH	Germany	PoET B19V98/79 PoET Extraction PoET HAV98/79 PoET HBV98/79 PoET HCV98/79 9 others PoET HEV98/79 PoET HEV Positive Control98/79 PoET HIV98/79 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	Website info@gfeblut.de EUDAMED record Report an error
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 others 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	Website contact@ibjb.fr EUDAMED record Report an error
Jiangsu Confidence Medical Technology EU representative : JOYSUN GROUP S.L.U (Spain)	China	25 tests/kit (including calibration)98/79 D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)6 refs98/79 Interleukin-10 (IL-10) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)11 refs98/79 Interleukin-12p70 (IL-12p70) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)12 refs98/79 Interleukin-17A (IL-17A) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)12 refs98/79 9 others Interleukin-17F (IL-17F) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)11 refs98/79 Interleukin-1β (IL-1β ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)11 refs98/79 Interleukin-2 (IL-2 ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)12 refs98/79 Interleukin-2R (IL-2R ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)10 refs98/79 Interleukin-4 (IL-4 ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)11 refs98/79 Interleukin-5 (IL-5 ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)12 refs98/79 Interleukin-6 (IL-6) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)6 refs98/79 Interleukin-6 (IL-6) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)11 refs98/79 Interleukin-8 (IL-8) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)12 refs98/79	– 98/79	EUDAMED record Report an error
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	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 9 others 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 Salmonella spp Detection KIT98/79 RADI Shigella spp Detection KIT98/79 RADI West nile virus Detection Kit98/79 RADIPREP3 refs	A IVDR, 98/79	Website info@khmedical.co.kr EUDAMED record Report an error
Meril Diagnostics FDA EU representative : Obelis s.a. (Belgium)	India	CLZCCR-04 HIVFIND HIVSST-013 refs HIVWBS-01 HIVWBS-02 HIVWBS-03 HIVWBS-043 refs HPBELI-0398/79 MBTREK-01 MBTREK-023 refs 9 others MEGRA Detergent DETCCR-04 DETCCR-052 refs MEGRA Diluent BDTCCR-023 refs MEGRA Lyse -FDT CLYCCR-033 refs Merilisa HPBELI-0698/79 Merilisa HPBELI-0798/79 MERISCREEN HCV RPDHCV-01 RPDHCV-032 refs MERISCREEN HVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 HVWRPD-08 HVWRPD-09 HVWRPD-10 HVWRPD-11 HVWRPD-123 refs MERISCREEN RPDHBV-01 RPDHBV-032 refs SAAEIW-03	A, D IVDR, 98/79	Website ram.kanoje@merillife.com EUDAMED record Report an error
Nihon Kohden FDA EU representative : NIHON KOHDEN EUROPE GmbH (Germany)	India, Japan	"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 refs 9 others CLEANAC MEK-5203 refs Diluent2 refs HEMATOLOGY CONTROL for reticulocyte MK-RE13 refs HEMATOLOGY CONTROL+CRP MK-3CH3 refs HEMOLYNAC 310- MK-310WH2 refs HEMOLYNAC 5-MEK-910H2 refs Hemolynac･310 MK-310W3 refs Hemolynac･510 MK-510W ISOTONAC･3 MEK-6403 refs	A, B, C IVDR	Website information@db.nkc.co.jp EUDAMED record Report an error
Remel Europe FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	PATHODX HERPES TYPING CONTROL SLIDES PATHODX HERPES TYPING KIT PATHODX STREP A GROUPING LATEX3 refs PATHODX STREP GROUPING KIT PATHODX STREP GROUPING UNIVERSAL KIT2 refs 9 others ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay98/79 STREPTEX2 refs STREPTEX LATEX A3 refs 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	Website EUDAMED record Report an error
Roche FDA	Germany	CoaguChek XS PT Test PST10 refs cobas lumira SARS-CoV-2 Ag Ultra4 refs cobas lumira SARS-CoV-2 Ag Ultra QC2 refs Elecsys Anti-HBs II2 refs Elecsys HTLV-I/II3 refs 9 others Elecsys IGRA TB PreciControl HTLV PreciControl HTLV-I/II VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody2 refs VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody2 refs VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody2 refs VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody2 refs VENTANA anti-PMS2 (SP487) Mouse Monoclonal Primary Antibody VENTANA PD-L1 (SP263) Assay	B, C, D IVDR	Website EUDAMED record Report an error
ZOVEC diagnostics	Germany	DETERGENT Z-RDE5RP98/79 DILUENT2 refs98/79 LYSE98/79 LYSE SOLUTION98/79 PROBE CLEANER98/79 9 others Reticulocyte Tube Z-RR5RP98/79 SHEATH Z-RS5RP98/79 Z-GEM 5 DILUENT2 refs98/79 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 CLEANSER98/79	– 98/79	Website EUDAMED record Report an error
Bio-Optica Milano FDA	Italy	10% neutral buffered formalin (ready to use)3 refs 10% neutral buffered formalin Fixatives for histology3 refs ACID PHOSPHATASE Stain 05-06002/L3 refs B-Mount ISO 250 ml Mezzi di montaggio per istologia e citologia3 refs Bio Mount HM3 refs 8 others Bouin 1 flacone da 1 litro Fissativi per istologia Eosin Y 1% aqueous solution3 refs Formalin concentrate - 10 l2 refs Giemsa Pappenheim3 refs Immersion oil for optical microscope2 refs MGG Quick Stain2 refs Mount Quick aqueous Reattivo di Schiff Feulgen 1 flacone da 250 ml Soluzioni coloranti per istologia	A IVDR	Website info@bio-optica.it EUDAMED record Report an error
CareDx FDA EU representative : QbD RepS BV (Belgium)	Australia, Sweden	AlloSeq Tx3 refs 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 others AlloSeq Tx 9(96) Set A98/79 AlloSeq Tx 9(96) Set B98/79 Oelrup SSP98/79 Olerup QTYPE 112 refs98/79 Olerup QTYPE LC480 II Cal Plate98/79 OLerup SSP167 refs98/79 QTYPE2 refs QTYPE Colour Compensation Plate	A, C IVDR, 98/79	Website regulatory-au@gendx.com EUDAMED record Report an error
Cellomics (Shenzhen) EU representative : Lotus NL B.V. (Netherlands)	China	Circulating epithelial cell detection kit IFCP0100 Circulating epithelial cell detection kit IFCP0101 Immuno-Chromogenic Reagent IFCP00013 refs Immuno-Chromogenic Reagent IFCP0005 Immuno-Chromogenic Reagent IFCP0006 8 others 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	EUDAMED record Report an error
Cormay	Poland	AURYX 90 D-dimer STAT Reagent Kit2 refs98/79 AURYX 90 IL-6 Reagent Kit2 refs98/79 CLEANER2 refs DILUENT5 refs ENZYMATIC CLEANER FORTE 8 others 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 LYSING REAGENT CN FREE3 refs LYSING REAGENT KX21 CN FREE	A IVDR, 98/79	regulatory_affairs@cormay.com EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	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 RSV External Control Set98/79 8 others 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 SARS-CoV-2/Flu/RSV Assay98/79 VitaSIRO solo SARS-CoV-2/Flu/RSV External Control Set98/79	– 98/79	service@credodxbiomed.com EUDAMED record Report an error
Diaglobal	Germany	Erythroctes Photometer98/79 Erythrocyten Diaglobal Photometer98/79 Erytrocten Eckküvetten98/79 Erytrocyten Kontrolle Diaglobal Photometer98/79 Haemoglobin HB 442A98/79 8 others Hämatokrit Diaglobal Photometer98/79 Hämglobin Diaglobal Photometer98/79 Hämoglobin 2500 ml Flasche98/79 Hämoglobin 500 mL Flasche98/79 Hämoglobin Diaglobal Photometer2 refs98/79 Hämoglobin Eck-Küvetten Photometer98/79 Hämoglobin Eckküvetten98/79 Hämoglobin Kontrolle Diaglobal Photometer98/79	– 98/79	Website info@diaglobal.de EUDAMED record Report an error
Guangzhou KOFA Biotechnology EU representative : Medunion S.L. (Spain)	China	D-Dimer CLIA8 refs98/79 D-Dimer Immunofluorescence Assay6 refs98/79 FDP CLIA8 refs98/79 IL-10 CLIA8 refs98/79 IL-1β CLIA8 refs98/79 8 others IL-2R CLIA8 refs98/79 IL-6 CLIA8 refs98/79 IL-6 Immunofluorescence Assay6 refs98/79 IL-8 CLIA8 refs98/79 PIC CLIA8 refs98/79 t-PAIC CLIA7 refs98/79 TAT CLIA8 refs98/79 TNF-α CLIA8 refs98/79	– 98/79	EUDAMED record Report an error
Hotgen FDA EU representative : MedNet EC-REP GmbH (Germany)	China	D-Dimer test (Chemiluminescence Immunoassay) Please see the IFU Dengue IgM/IgG Rapid test (Colloidal Gold) Please see the IFU2 refs 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 others 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 refs Tumor Necrosis Factor Alpha Chemiluminescence Immunoassay Kit (CLIA) Please see the IFU98/79	B, C IVDR, 98/79	service@hotgen.com.cn EUDAMED record Report an error
Hunan Ehome Health Technology EU representative : Medunion S.L. (Spain) and 1 other	China	Calibrator for Hematology Analyzer YH-CA50298/79 Cleaning Solution YH-HC301 D-Dimer Rapid Test Kit HU-RE-F07F04500198/79 D-Dimer Rapid Test Kit HU-RE-F07F04500298/79 Hematology Analyzers Control kit YH-QC50098/79 8 others Hematology Reagent Kit YH-HC300 IL-6 Rapid Quantitative Test2 refs98/79 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 YH-CA50098/79	A IVDR, 98/79	EUDAMED record Report an error
Ing. Petr Švec - PENTA s.r.o	Czechia	BOUIN ROZTOK DRABKIN ROZTOK DUSIČNAN STŘÍBRNÝ p.a. FORMALDEHYD 4% PUFROVANÝ pH 7,2-7,4 GIEMSA-ROMANOWSKI roztok 8 others HAEMATOXYLIN EHRLICH HAEMATOXYLIN HARRIS HAEMATOXYLIN MAYER MAY-GRÜNWALD roztok MUCIKARMÍN WEIGERT ROZTOK ZKOUMADLO EOSINOVÝ ROZTOK ČERVEŇ KONGO indikátor	A IVDR	Website info@pentachemicals.eu EUDAMED record Report an error
Labsystems Diagnostics FDA	Finland	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 8 others 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	– 98/79	Website EUDAMED record Report an error
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	LYSUN BHM-202 LYSUN CRP-W21-1(25PCS)98/79 LYSUN DEG-P21（25PCS）98/79 LYSUN DIM-W21（25PCS）98/79 LYSUN FLU-S21（25PCS）98/79 8 others 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	EUDAMED record Report an error
Meridian Bioscience FDA EU representative : Meridian Bioscience Europe S.r.l. (Italy)	United States	Alethia Chlamydia Alethia CMV Alethia CMV External Controls alethia® Gonorrhea alethia® Group B Streptococcus 8 others 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	A, C IVDR	Website EUDAMED record Report an error
Ortho-Clinical Diagnostics Summers Ridge San Diego EU representative : MDSS GmbH (Germany)	United States	QuickVue Dipstick Strep A 25-Test Kit2 refs98/79 QuickVue Dipstick Strep A 50-Test Kit2 refs98/79 QuickVue In-Line Strep A Test3 refs98/79 QuickVue Influenza A+B Test2 refs98/79 QuickVue RSV98/79 8 others Sofia 2 C. difficile FIA98/79 Sofia 2 Flu + SARS Antigen FIA98/79 Sofia Influenza A+B FIA2 refs98/79 Sofia Legionella FIA98/79 Sofia RSV 25T2 refs98/79 Sofia S. pneumoniae FIA98/79 Sofia SARS FIA98/79 Sofia Strep A+ FIA 25T2 refs98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Redcell	Türkiye	Bromelin Solution RCBS10 Cell ID 1198/79 Cell Reverse A1B98/79 Cell Screen 1-2-398/79 Comp / Cross98/79 8 others Forward / Reverse98/79 Forward / Reverse Donor98/79 Forward AB Plus98/79 Forward ABO Patient98/79 LISS Diluent2 refs Newborn98/79 Rh Phenotype98/79 Rh Phenotype Plus98/79	A IVDR, 98/79	Website info@redcell.com.tr EUDAMED record Report an error
Steellex EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	10010198/79 10×10ml98/79 10×2ml2 refs98/79 10×5ml2 refs98/79 L1 10×1ml98/79 8 others L2 101mL98/79 R1:510ml R2:330ml98/79 R1:510ml R2:510ml98/79 R1:52ml R2:330ml98/79 R1:52ml R2:52ml2 refs98/79 R1:54ml R2:54ml98/79 R1:55ml R2:330ml98/79 R1:55ml R2:5*5ml98/79	– 98/79	info@steellex.com EUDAMED record Report an error
Thermofisher FDA EU representative : Life Technologies Europe B.V. (Netherlands)	Finland, Lithuania, United States	D-Dimer D-Dimer Calibration Set D-Dimer Control D-Dimer Control High Dynabeads HLA Class I2 refs98/79 8 others Dynabeads HLA Class II2 refs98/79 HIV-1 Genotyping Kit A5440198/79 MagMax Dx Viral/Pathogen NA Isolation Kit (A52735, A52736)2 refs MagMax Viral/Pathogen II Nucleic Acid Isolation Kit A48383 TaqPath™ 1-Step Multiplex Master Mix (No ROX)2 refs98/79 TaqPath™ COVID-19 Control2 refs98/79 TaqPath™ COVID-19 Control Dilution Buffer98/79 TaqPath™ COVID-19 RT-PCR Kit2 refs98/79	A, C IVDR, 98/79	Website info.baltics@thermofisher.com EUDAMED record Report an error
Yvsolab	Belgium	5 L ALCOOL ISO-PROPYLIQUE PUR / UN RECIPIENT EN PLASTIQUE 5 L ISOPROPANOL3 refs 5 L FORMALDEHYDE 4 % / TAMPONNEE / PH NEUTRALE / RECIPIENT EN PLASTIQUE Formaldehyde 4% 5L3 refs 5 L METHANOL PUR / UN RECIPIENT EN PLASTIQUE3 refs 5 L TOLUENE PUR / UN RECIPIENT EN PLASTIQUE2 refs 5 L XYLEEN ZUIVER / UN RECIPIENT IN PLASTIEK2 refs 8 others 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	Website info@yvsolab.be EUDAMED record Report an error
Aidian FDA	Finland	Protein Calibrator Set98/79 Protein Control98/79 QuikRead CRP Control98/79 QuikRead go CRP Control98/79 QuikRead go CRP Control Low98/79 7 others 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 Strep A98/79 Urine Albumin Control98/79	– 98/79	Website eudamed@aidian.eu EUDAMED record Report an error
Anbio EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	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 Dengue IgM/IgG Rapid Test Kit A1000400198/79 7 others Dengue NS1 Rapid Test Kit98/79 Group A Streptococcus Test Kit A0216700298/79 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	– 98/79	info@anbio.com EUDAMED record Report an error
Artronlab FDA EU representative : MedNet EC-REP GmbH (Germany)	Canada	Acmex Hepatitis B Surface Antigen (HBsAg) Test Cassette2 refs Acmex Hepatitis C Virus (HCV) Antibody Test Cassette2 refs Acmex Human Immunodeficiency Virus 1/2 (HIV1/2) Antibody Test Cassette2 refs Acmex Treponema Pallidum (TP) Antibody Test Cassette2 refs Artron Dengue NS1 Antigen Test Cassette98/79 7 others 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 refs98/79 Artron One Step Treponema Pallidum (TP) Antibody Test Strip98/79	C, D IVDR, 98/79	Website info@artronlab.com EUDAMED record Report an error
CellPath FDA EU representative : Emergo Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	10% ACETIC ZINC FORMALIN 10% FORMAL SALINE - 120ml - CELLSTOR POT3 refs CELLSTOR - 10L - 10% NEUTRAL BUFFERED FORMALIN3 refs CELLSTOR – 20L – 100% NEUTRAL BUFFERED FORMALIN CONCENTRATE CELLWAX PLUS (P) - 4 x 2.5Kg3 refs 7 others DPX (PHTHALATE FREE) MOUNTING MEDIUM - 1L3 refs EOSIN Y STAIN 1% (ALCOHOLIC) - 1L3 refs HAEMATOXYLIN ‘Z’ STAIN – 1L3 refs PAPANICOLAOU EA50 STAIN (ORTHO) - 1L3 refs PAPANICOLAOU OG6 STAIN (ORTHO) - 1L3 refs XMARK FIX - 250ML3 refs XYLENE - 5L	A IVDR	Website info@cellpath.com EUDAMED record Report an error
Celnovte EU representative : Umedwings Netherlands B.V. (Netherlands)	China	AB-PAS stain kit Acid-fast stain kit Alcian Blue stain kit Congo red stain kit HS22092 refs Elastic fiber stain kit HS2210 7 others Helicobacter pylori stain kit HS2206 Iron stain kit HS2202 Methenamine sliver stain kit3 refs Mucicarmine stain kit Periodic acid Schiff-PAS stain kit Primary Antibody Diluent Trichrome-Masson stain kit2 refs	A IVDR	EUDAMED record Report an error
DNA-Technology, Research & Production EU representative : Obelis s.a. (Belgium)	Russia	PREP-CITO DBS DNA Extraction Kit, Package N PREP-GS DNA Extraction Kit3 refs PREP-MB DWP DNA/RNA Extraction Kit, Package A3 refs PREP-MB MAX DNA Extraction Kit, Package A2 refs PREP-MB-DBS DWP DNA Extraction Kit, package N3 refs 7 others PREP-MB-RAPID II DNA Extraction Kit, Package A3 refs PREP-NA DNA/RNA Extraction Kit3 refs PREP-NA-FET DNA Extraction Kit PREP-NA-S DNA/RNA Extraction Kit PREP-OPTIMA DNA Extraction Kit. Package N3 refs PREP-PK Kit for sample pretreatment while processing of nucleic acids isolation, Set № 12 refs PREP-RAPID DNA Extraction Kit2 refs	A IVDR	Website EUDAMED record Report an error
Eurotrol FDA	Netherlands	Hb 301 Control High98/79 Hb 301 Control Low98/79 Hb 301 Control Normal98/79 HemoTrol Duo High98/79 HemoTrol Duo Low98/79 7 others HemoTrol Duo Normal98/79 HemoTrol High (Level 3)2 refs98/79 HemoTrol Low (Level 1)2 refs98/79 HemoTrol Normal (Level 2)2 refs98/79 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	Website office@eurotrol.com EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other	China	1 test/kit35 refs98/79 25 tests/kit34 refs98/79 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 others 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 EUDAMED record Report an error
Illumaxbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	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 7 others 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	– 98/79	Website EUDAMED record Report an error
Irvine Scientific FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	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 others 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	EUDAMED record Report an error
Labnovation EU representative : MedNet EC-REP GmbH (Germany)	China	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 H. Pylori Antibody Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 H. Pylori Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 7 others 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 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	– 98/79	Website info@labnovation.com EUDAMED record Report an error
Microbio EU representative : Qualrep Services B.V. (Netherlands)	Australia	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 others 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	Website info@microbio.com.au EUDAMED record Report an error
Nano Diagnosis for Health Biotech (Guangzhou) EU representative : MedPath GmbH (Germany)	China	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 7 others 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 Syphilis Rapid Test SYP-01、SYP-0298/79 Tuberculosis (TB) Rapid Test98/79	– 98/79	EUDAMED record Report an error
NanoEntek FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	BioTracer™ Dengue Combo Rapid Card98/79 BioTracer™ Dengue IgG/IgM Rapid Card98/79 BioTracer™ Dengue NS1 Ag Rapid Card98/79 BioTracer™ Influenza A&B Rapid Card98/79 BioTracer™ Influenza A&B Test98/79 7 others 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 D-Dimer98/79 FREND FLU A&B98/79 Influenza A&B control swab FIC-FLSW98/79	– 98/79	Website eudamed@nanoentek.com EUDAMED record Report an error
One Lambda FDA EU representative : MDSS GmbH (Germany)	United States	AllType NGS Library Prep Kit3 refs AllType™ FASTplex™ NGS 11 Kit (Box 2 of 2) ALL-FAST11LF2 refs AllType™ FASTplex™ NGS 11 Loci Kit – 48 (Box 1 of 2) ALL-FAST11L C1qScreen Class I Positive Control C1qScreen™ C1q3 refs FlowPRA™ Class I Positive Control3 refs 7 others HybriType™ HLA Plus 18 Loci Flex Kit – 4 Enrichments HYB18LF3 refs LABScreen™ MICA Single Antigen - Group 13 refs LABScreen™ Multi LABType™ CWD Class I A Locus Typing Test - 20 tests3 refs LABType™ SSO Class I A Locus Typing Test3 refs LinkSēq HLA-ABC 384 Typing Kit3 refs SeCore GSSP3 refs	C IVDR	Website EUDAMED record Report an error
Ortho-Clinical Diagnostics Raritan EU representative : Ortho-Clinical Diagnostics France (France)	United States	VITROS Anti-A1 Lectin (Anti-ABO4)98/79 VITROS Anti-C (Anti- RH2) (Monoclonal) BioClone98/79 VITROS Anti-c (Anti-RH4) (Monoclonal) BioClone98/79 VITROS Anti-D (RH1) IgM + IgG BioClone98/79 VITROS Anti-E (Anti-RH3) (Monoclonal) BioClone98/79 7 others 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 refs98/79 VITROS ORTHO HCV 3.0 ELISA Test System with Enhanced SAVe (Sample Addition Verification)98/79 VITROS RESOLVE Panel B98/79 VITROS SELECTOGEN2 refs98/79 VITROS SURGISCREEN2 refs98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Pilotgene EU representative : Medunion S.L. (Spain)	China	Digital PCR Universal Kit dPCR EM98/79 FS98/79 HHV98/79 MP2198/79 7 others Nucleic Acid Extraction or Purification Reagent CF12 refs Nucleic Acid Extraction or Purification Reagent Easy-CF2 Nucleic Acid Extraction or Purification Reagent TF1 P1198/79 RP0198/79 SC98/79 TB0198/79	A IVDR, 98/79	EUDAMED record Report an error
Reagen EU representative : CMC Medical Devices & Drugs SL (Spain)	China	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 others 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	Website info@reagenus.com EUDAMED record Report an error
RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi	Türkiye	RTA CMV Real Time PCR Kit2 refs98/79 RTA CMV Real Time PCR Kit, v2.03 refs98/79 RTA HBV Real Time PCR Kit 25 tests/ kit98/79 RTA HBV Real Time PCR Kit v2.03 refs98/79 RTA HCV Real Time PCR Kit2 refs98/79 7 others RTA HCV Real Time PCR Kit, v2.03 refs98/79 RTA HIV-1 Real Time PCR Kit2 refs98/79 RTA HIV-1 Real Time PCR Kit v2.03 refs98/79 RTA MB VIRAL NUCLEIC ACID ISOLATION KIT (12 Tests) 12 Tests/ Kit, 24 Tests/ Kit, 48 Tests/ Kit3 refs RTA TOTAL NUCLEIC ACID EXTRACTION KIT 16 Tests/ Kit, 48 Tests/ Kit, 96 Tests/ Kit3 refs RTA VIRAL NUCLEIC ACID ISOLATION KIT (100 TESTS) 50 tests/ kit, 100 tests/ kit2 refs RTA VIRAL RNA ISOLATION KIT (100 TESTS) 50 Tests, 100 Tests2 refs	A IVDR, 98/79	Website EUDAMED record Report an error
Shanghai BioGerm Medical Technology EU representative : MedNet EC-REP GmbH (Germany) and 2 others	China	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 others 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 refs98/79 Nucleic acid extraction and purification kit 96 tests/ kit2 refs Respiratory Syncytial Virus/HumanParainfluenza Virus /Human Rhinovirus Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 tests/kit98/79	A IVDR, 98/79	EUDAMED record Report an error
Widufit	Germany	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 others 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 refs98/79 WiduMed Strep A Kassettentest98/79 WiduMed Strep A Streifentest98/79 WiduMed Strep B Kassettentest98/79	– 98/79	Website info@widufit.de EUDAMED record Report an error
Diagon	Hungary	Abacus Abaclean3 refs CELL CLENZ Cellaclean3 refs Dia-Blue Panoptic Dia-CaCl22 refs 6 others 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 refs	A IVDR, 98/79	Website EUDAMED record Report an error
IBL International	Germany	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 6 others Haemophilus influenzae B IgG ELISA98/79 Helicobacter pylori IgA ELISA98/79 Helicobacter pylori IgG ELISA98/79 Helicobacter pylori IgM ELISA98/79 sInterleukin-2-Receptor ELISA TBE virus (FSME) IgG ELISA98/79	B IVDR, 98/79	Website EUDAMED record Report an error
Labex Canada EU representative : Obelis s.a. (Belgium)	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 refs 6 others Labex Canada 1L Labex Canada 3mL Labex Canada 5mL, 100mL, 1L Labex Canada Concentrated 1.0mL116 refs98/79 Labex Canada Ready to use 6mL113 refs98/79 W01030709 Ready to use 6mL2 refs98/79	A IVDR, 98/79	Website info@labexcanada.com EUDAMED record Report an error
Ldbio Diagnostics	France	ASPERGILLUS ICT IgG-IgM2 refs98/79 ASPERGILLUS WB IgG3 refs98/79 CHAGAS WB IgG3 refs98/79 ECHINOCOCCUS WB IgG3 refs98/79 FASCIOLA ES WB IgG3 refs98/79 6 others LDBIO TOXO II IgG3 refs LDBIO TOXO II IgM3 refs LEISHMANIA WB IgG3 refs98/79 SCHISTO II WB IgG3 refs98/79 SCHISTOSOMA ICT IgG-IgM2 refs98/79 TOXOPLASMA ICT IgG-IgM2 refs98/79	C IVDR, 98/79	Website EUDAMED record Report an error
Nhs FDA EU representative : Quality First International OÜ (Estonia)	United Kingdom (ex Northern Ireland)	PR01298/79 PR01498/79 PR01598/79 PR02298/79 PR03398/79 6 others PR03498/79 PR03598/79 PR03698/79 PR04498/79 PR04598/79 PR04698/79	– 98/79	EUDAMED record Report an error
Pluslife EU representative : Kingsmead Service B.V. (Netherlands) and 2 others	China	Influenza A/Influenza B/RSV Nucleic Acid Test Card98/79 MiniDock MTB Test Mycobacterium Tuberculosis Nucleic Acid Assay Control2 refs Pluslife Mycoplasma Pneumoniae Card98/79 Pluslife RSV Card98/79 6 others 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	C IVDR, 98/79	Website ra@pluslife.com EUDAMED record Report an error
PRIMA Lab EU representative : QbD RepS BV (Belgium)	Switzerland	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 others 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 EUDAMED record Report an error
Sanquin Reagents FDA	Netherlands	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 others 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	Website info@essange-reagents.nl EUDAMED record Report an error
Vellap	Germany	Cleartest D-Dimer98/79 Cleartest Influenza A+B98/79 Cleartest Strep A2 refs98/79 IDEAL Influenza A+B98/79 IDEAL Strep A98/79 6 others TOP D-Dimer C3 0501-5-MTU98/79 TOP Strep A2 refs98/79 VELLAP D-Dimer3 refs VELLAP Influenza A/B98/79 VELLAP Legionella98/79 VELLAP Strep A98/79	C IVDR, 98/79	info@vellap.de EUDAMED record Report an error
Zetmedikal	Türkiye	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 others 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	Website info@zetmedikal.com EUDAMED record Report an error
Aaz Productions Le Materiel Biomedical	France	ALL IN QUADRIPLEX®98/79 autotest COVID-VIRO ALL IN®5 refs98/79 autotest COVID-VIRO®9 refs98/79 autotest VIH® 2nd GENERATION3 refs COV-GRIP98/79 5 others COVID-VIRO98/79 SYPHILIS ALL IN® TR-SYP-00198/79 TetaQuick98/79 TROD'ANGINE2 refs98/79 TROD'DENGUE98/79	D IVDR, 98/79	EUDAMED record Report an error
Abacus Diagnostica	Finland	GenomEra HSV 1/2, VZV + EV Assay Kit CDX-1702 refs98/79 GenomEra Norovirus Assay kit CDX-1002 refs98/79 GenomEra® C. difficile Assay Kit CDX-403 refs98/79 GenomEra® C. difficile Control Set CDX-20-56198/79 GenomEra® GBS Assay Kit CDX-602 refs98/79 5 others GenomEra® MRSA/SA AC Assay Kit CDX-30-052 refs98/79 GenomEra® MRSA/SA Multi Swab Assay Kit CDX-30-0298/79 GenomEra® S. pneumoniae Assay Kit CDX-702 refs98/79 GenomEra® SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit CDX-1602 refs98/79 GenomEra® SARS-CoV-2, Flu A/B + RSV Assay Kit CDX-1402 refs98/79	– 98/79	info@abacusdiagnostica.com EUDAMED record Report an error
Ailex EU representative : CMC Medical Devices & Drugs SL (Spain)	China	150Tests98/79 200Tests98/79 Calibrator 1～2：2×0.1mL98/79 Calibrator 1～2：2×0.2mL98/79 Control1～2：2×0.2mL98/79 5 others Control1～2：4×0.2mL98/79 Eluent1: 800mL×1bag98/79 Eluent2: 800mL×1bag98/79 Eluent3: 800mL×1bag98/79 Hemolysis & Wash Solution:2L×1bottle98/79	– 98/79	EUDAMED record Report an error
Bgi	Denmark	4800T98/79 BGI 10 tests/kit4 refs98/79 BGI 25 tests/kit4 refs98/79 BGI 32tests BGI 48 tests 5 others BGI 5 tests/kit4 refs98/79 BGI 50 tests/kit6 refs98/79 BGI 50 tests/package98/79 Nucleic Acid Extraction Kit 96 tests Seq-hpv-1, Seq-hpv-298/79	A IVDR, 98/79	Website EUDAMED record Report an error
Cube Dx	Austria	hybcell Bacteria DNA xB98/79 hybcell Fungi DNA xB98/79 hybcell Pathogens DNA xB98/79 IPC98/79 PCR-Box Bacteria98/79 5 others PCR-Box Bacteria 48rx-s98/79 PCR-Box Fungi98/79 PCR-Box Fungi 48rx-s98/79 PCR-Box IPC98/79 PCR-Box Resistance2 refs98/79	– 98/79	Website info@cubedx.com EUDAMED record Report an error
Daan Gene EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	20 tests/kit3 refs98/79 24 tests/kit7 refs98/79 48 tests/kit3 refs98/79 Large package, 10 tests/kit4 refs98/79 Large package, 20 tests/kit6 refs98/79 5 others Large package, 24 tests/kit3 refs98/79 Large package, 48 tests/kit14 refs98/79 Single tube, 10 tests/kit6 refs98/79 Single tube, 20 tests/kit11 refs98/79 Single tube, 48 tests/kit98/79	– 98/79	EUDAMED record Report an error
FlashDx Shenzhen EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Arbovirus Panel (ENA) ABVP8E-1098/79 CRE Test CRE-P5-1098/79 GBS Test GBS-P1-1098/79 MRSA/SA Test B-MARSA-10NU98/79 Respiratory Panel 1.0 RP1-P10-1098/79 5 others 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	– 98/79	info@flash-dx.com EUDAMED record Report an error
Genmark	Türkiye	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 others 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	Website info@genmark.com.tr EUDAMED record Report an error
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 others 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	Website EUDAMED record Report an error
Hangzhou Zhunxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	HA-00298/79 HA-00898/79 HA-01098/79 HA-01198/79 HA-01298/79 5 others HA-01698/79 HA-01798/79 HA-01998/79 HA-02298/79 HA-02398/79	– 98/79	EUDAMED record Report an error
Lituo EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Cell Preservative Solution Model I, Model II3 refs EA-503 refs EA50/OG6 Combo3 refs Gram Stain Kit Model Ⅰ, Model Ⅱ, Model Ⅲ, Model Ⅳ, Model Ⅴ3 refs HE Stain Kit 5 others Hematoxylin3 refs Iodine Solution（Lugol's Solution）3 refs Leucorrhoea Staining Solution3 refs OG-63 refs 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 refs	A IVDR	Website EUDAMED record Report an error
Medicon Hellas FDA	Greece	CUVETTE CLEANER D-DIMER3 refs G-6-PDH98/79 MEDI DETERGENT 3D3 refs MEDI DILUENT 5 others MEDI SHEATH MEDICLEAN3 refs MEDILYSE 3D2 refs MEDILYSE DIFF3 refs MEDITON DIFF	A, C IVDR, 98/79	Website EUDAMED record Report an error
Micropointbio EU representative : Obelis s.a. (Belgium)	China	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 others 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	Website EUDAMED record Report an error
Rrmechatronics FDA	Netherlands	Starrsed Cleaning Agent Starrsed Control Level A - Blister 6*QRR 0490022 refs Starrsed CR 10L Starrsed Diluent Starrsed Disinfectant 5 others Starrsed DL 10L Starrsed PC 500 ml Starrsed Rinse Solution 10L2 refs Starrsed Saline Starrsed X-Clean	A IVDR	Website support@rrmechatronics.com EUDAMED record Report an error
Sentinel FDA	Italy	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 5 others 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	Website EUDAMED record Report an error
Singclean EU representative : SUNGO Europe B.V. (Netherlands)	China	FASUAL COVID-19 Test kit (Colloidal Gold Method)98/79 Singclean Cassette：1 test/box2 refs98/79 Singclean Cassette：10 tests/box2 refs98/79 Singclean Cassette：20 tests/box2 refs98/79 Singclean Cassette：5 tests/box2 refs98/79 5 others Singclean® COVID-19 Antigen Test kit (Colloidal Gold Method)4 refs98/79 Singclean® COVID-19 IgG Test kit (Colloidal Gold Method)2 refs98/79 Singclean® COVID-19 IgM Test kit (Colloidal Gold Method)4 refs98/79 Singclean® COVID-19 Neutralizing Antibody Test Kit(Colloidal Gold)4 refs98/79 Singclean® COVID-19 Test kit (Colloidal Gold Method)6 refs98/79	– 98/79	Website EUDAMED record Report an error
Targetingone EU representative : Medunion S.L. (Spain) and 1 other	China	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 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 5 others 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	– 98/79	EUDAMED record Report an error
Tisenc EU representative : QbD RepS BV (Belgium) and 1 other	China	Tisenc D-Dimer (CLIA)4 refs98/79 Tisenc Dengue Virus IgG Antibody (CLIA)4 refs98/79 Tisenc Dengue Virus IgM Antibody (CLIA)4 refs98/79 Tisenc Dengue Virus NS1 Antigen (CLIA)4 refs98/79 Tisenc Interleukin-6 (CLIA)4 refs98/79 5 others Wondfo D-Dimer (CLIA)4 refs98/79 Wondfo Dengue Virus IgG Antibody (CLIA)4 refs98/79 Wondfo Dengue Virus IgM Antibody (CLIA)4 refs98/79 Wondfo Dengue Virus NS1 Antigen (CLIA)4 refs98/79 Wondfo Interleukin-6 (CLIA)4 refs98/79	– 98/79	Website EUDAMED record Report an error
VMRD FDA EU representative : MediMark Europe Sarl. (France)	United States	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 others 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	Website EUDAMED record Report an error
Daltonbio EU representative : MedPath GmbH (Germany) and 2 others	China	/98/79 DH3 High-Risk HPV DNA Test3 refs 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 others 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 (no longer marketed)	C IVDR, 98/79	Website EUDAMED record Report an error
3D Biomedicine Science & Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	100 Tests/kit3 refs98/79 50 tests/kit2 refs98/79 64 Tests/kit 64Test/Kit3 refs 64Tests/kit2 refs 4 others 96A Automated Viral DNA/RNA Isolation Kit2 refs 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	EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Medunion S.L. (Spain) and 2 others	China	(MP) Mycoplasma Pneumoniae Test Strip & Cassette98/79 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 Monkeypox Virus Fluorescence PCR Kit（Direct qPCR） Cassette98/79 4 others 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	EUDAMED record Report an error
ALS Life Sciences Portugal	Portugal	InviMag® Blood DNA Mini Kit/ IG InviMag® Universal Kit/ IG InviMag® Universal Kit/ KF962 refs InviSorb® Spin Blood Mini Kit (250)2 refs InviSorb® Spin Universal Kit (250)2 refs 4 others InviTrap® Spin Universal RNA Mini Kit (250)2 refs PSP® SalivaGene DNA Kit (250)2 refs PSP® Spin Stool DNA Basic Kit (250)2 refs RTP® Pathogen Kit (250)2 refs	A IVDR	Website EUDAMED record Report an error
Avioq Bio-tech EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	1 Test/Kit98/79 2 Tests/Kit98/79 20 Tests/Kit98/79 24 Tests/Kit98/79 25 Tests/Kit98/79 4 others 40 Tests/Kit98/79 48 Tests/Kit98/79 5 Tests/Kit98/79 96 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Biobase Diagnostic Technology (Shandong) EU representative : Luxus Lebenswelt GmbH (Germany)	China	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 Nucleic Acid Extraction Kit ZD001 4 others 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	EUDAMED record Report an error
Biosystems FDA	Spain	ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)3 refs98/79 ANTI-PHOSPHOLIPID IgG/IgM (APLA)98/79 D-DIMER2 refs98/79 D-DIMER CONTROLS I / II98/79 D-DIMER STANDARD98/79 4 others FIBRINOGEN3 refs98/79 FIBRINOGEN CONTROL PLASMA98/79 FIBRINOGEN STANDARD98/79 RPR-CARBON2 refs98/79	– 98/79	Website EUDAMED record Report an error
GenDx FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China, United States	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 others 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	Website orders@genbio.com EUDAMED record Report an error
Kingcreate EU representative : Kingsmead Service B.V. (Netherlands) and 1 other	China	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 others 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 refs	A, C IVDR, 98/79	EUDAMED record Report an error
Nanjing Leading Medical Technology EU representative : Medunion S.L. (Spain)	China	1 Test/Bag98/79 1 Test/Box98/79 101.6 mL98/79 25 Tests/Box98/79 50 Tests/Box98/79 4 others 50.8 mL98/79 level 12 refs98/79 level 1+level 22 refs98/79 level 22 refs98/79	– 98/79	EUDAMED record Report an error
Realmindbio EU representative : Lotus NL B.V. (Netherlands)	China	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 Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit11 refs98/79 4 others 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	– 98/79	EUDAMED record Report an error
Shenzhen YOUYI Bioscience EU representative : Medunion S.L. (Spain) and 1 other	China	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 4 others EUYI IP-10 Rapid Test for MTB R4898/79 EUYI MTB DNA Test R4898/79 EUYI p16/Ki-67 Dual Staining kit (immunocytochemical method) YY014 refs EUYI Pap Staining Kit2 refs	A IVDR, 98/79	EUDAMED record Report an error
Solveco	Sweden	Blåsfix Formaldehyd 35% Formaldehyd 4 % obuffrad Formaldehyd 4% med Fosfatbuffert Formaldehyd 7% i vatten 200L Returfat 4 others GEWF - Lösning SolvClear Urifix Xylen	A IVDR	Website EUDAMED record Report an error
Tigsun EU representative : CMC Medical Devices & Drugs SL (Spain)	China	1 test3 refs98/79 10 tests3 refs98/79 100 tests3 refs98/79 20 tests3 refs98/79 25 tests3 refs98/79 4 others 40 tests3 refs98/79 5 tests3 refs98/79 50 tests3 refs98/79 80 tests3 refs98/79	– 98/79	EUDAMED record Report an error
Wwhsbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	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 4 others 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	– 98/79	Website info@wwhsbio.com EUDAMED record Report an error
Anchor Diagnostics	Germany	Anchor C. difficile PCR Kit98/79 ANCHOR CMV PCR Kit2 refs Anchor EBV PCR Kit98/79 Anchor HSV 1/2 PCR Kit98/79 Anchor Influenza A/B PCR Kit98/79 3 others 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 EUDAMED record Report an error
Association Of Medicine Analytics EU representative : CMC Medical Devices & Drugs SL (Spain)	Russia	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 others 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	Website EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland)	United States	BD Respiratory Viral Panel-SCV2 for BD MAX™ System BD SurePath™ Collection Vial Kit 500 CYTORICH3 refs MAX5 refs MGIT 3 others Not Applicable2 refs Onclarity4 refs SurePath	A, B, C IVDR	Website EUDAMED record Report an error
BioChain (Beijing) Science & Technology EU representative : Medunion S.L. (Spain)	China	1 test/kit98/79 10 tests/kit2 refs98/79 100 tests/kit98/79 20 servings / box2 refs98/79 20 tests/kit2 refs98/79 3 others 24 Tests/Kit2 refs98/79 5 tests/kit2 refs98/79 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
BioFire Diagnostics FDA EU representative : bioMérieux SA (France)	United States	BIOFIRE FILMARRAY GI1.1 Panel2 refs BioFire® Blood Culture Identification 2 (BCID2) Panel2 refs BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel BioFire® Joint Infection (JI) Panel2 refs BioFire® Respiratory Panel 2.1 plus (RP2.1 plus) 3 others BIOFIRE® FILMARRAY® Pneumonia Panel plus2 refs FilmArray® Gastrointestinal (GI) Panel2 refs FilmArray® Meningitis/Encephalitis (ME) Panel2 refs	B, C, D IVDR	EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruCell98/79 TruDerma98/79 TruHemo7 refs98/79 TruVue24 refs98/79 TruVue COVID-19 Antigen Rapid Test (LFA)98/79 3 others 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	– 98/79	EUDAMED record Report an error
BioGnost	Croatia	A.F.O.G. kit, 6x100 mL3 refs Acridine Orange boja u prahu, C.I. 46005, 25 g3 refs Bio-Diff 1 RTU reagens, 100 mL3 refs BioMount Aqua, 100 mL3 refs BioWax 52/54, 1 kg3 refs 3 others BM Fixative One, 1 L3 refs DAB Chromogen kit, for 1250 tests3 refs LeukoGnost ACP, za 50 testiranja3 refs	A IVDR	Website EUDAMED record Report an error
Bordier FDA EU representative : Leman Diagnostics SARL (France)	Switzerland	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 others Fasciola hepatica IgG ELISA Leishmania infantum IgG ELISA98/79 Schistosoma mansoni IgG ELISA	B IVDR, 98/79	Website EUDAMED record Report an error
DiagCor Life Science EU representative : Medunion S.L. (Spain) and 1 other	Hong Kong SAR China	24 tests98/79 48 tests3 refs98/79 9200798/79 9200898/79 9202998/79 3 others 92031 92033 GenoQuest HPV 24 Genotyping qPCR Assay 48 tests98/79	A IVDR, 98/79	QARA@diagcorlifescience.com EUDAMED record Report an error
Diagnostic Systems	Germany	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 others 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	Website info@ab-ds.de EUDAMED record Report an error
Dutch Diagnostics	Netherlands	Chagas Test98/79 Chikungunya IgG/IgM Test98/79 Dengue IgG/IgM Test98/79 H.Pylori Ab Test2 refs98/79 H.Pylori Ag Test98/79 3 others Influenza A+B Test3 refs98/79 Strep A Test3 refs98/79 TMS Strep A2 refs98/79	– 98/79	Website info@dutch-diagnostics.com EUDAMED record Report an error
Dyonmed	Greece	DyonCDA98/79 DyonDimer (D-Dimer)98/79 DyonHpAb triple98/79 DyonHpsA98/79 DyonMono98/79 3 others DyonStrepA-strip98/79 Pylori test (1 test/box)98/79 Pylori test (10 tests/box)98/79	– 98/79	Website customerservice@dyonmedical.com EUDAMED record Report an error
FRIZ Biochem	Germany	COVID-19 direct RT-PCR GastroVir1 direct RT-PCR GastroVir2 direct RT-PCR res2plex direct PCR res3plex direct PCR res1plex direct PCR 3 others res4plex direct RT-PCR Ax, Bx, Cx3 refs res5plex direct RT-PCR res6plex direct RT-PCR	B IVDR	Website info@frizbiochem.de EUDAMED record Report an error
Genetree EU representative : Obelis s.a. (Belgium)	South Korea	NamuPlex™ GNT-2013-1 NamuPlex™ Q005A NamuPlex™ Q006A98/79 NamuPlex™ Q016A98/79 NamuPlex™ Q021A 3 others NamuPlex™ Q022A NamuPlex™ Q023A NamuPlex™ Q024A	B, C IVDR, 98/79	Website ra@genetree.co.kr EUDAMED record Report an error
Hunan Kangxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	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 others 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	EUDAMED record Report an error
inno-train Diagnostik	Germany	Lymphodex 500 ml2 refs 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 others Rabbit Complement 5 × 2 ml98/79 Rabbit Complement 5 × 3 ml98/79 Rabbit Complement, frozen 5 × 1 ml98/79	A IVDR, 98/79	Website info@inno-train.de EUDAMED record Report an error
Laboveritas	Latvia	Express Genetics DNA 0018 ExtraMag 1000 0020 Laboveritas 475104263LVE00156T VeriLab Express DNA 0014 VeriLab ExtraMag 500 0019 3 others Verilab GMag 0012 VeriLab UMag Verilab USorb 0011	A IVDR	Website EUDAMED record Report an error
Ortho-Clinical Diagnostics FDA EU representative : 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 refs 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 refs Anti-Human Globulin Anti-lgG, -C3d; polyspecific (Rabbit and Murine Monoclonal) (Green) Neutral Solution Ortho BioVue System (Poly/Neutral Cassette) VITROS2 refs Bovine Albumin 22% VITROS2 refs 3 others Neutral Ortho BioVue System (Neutral Cassette) VITROS2 refs ORTHO BROMELIN MT6 VITROS VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Extraction Buffer	A, C IVDR	Website PRRC@quidelortho.com EUDAMED record Report an error
Pentapharm FDA EU representative : Emergo Europe B.V. (Netherlands)	Switzerland	APCr APCr Controls Batroxobin Time Pefaclot® UFH Controls98/79 Pefaclot® UFH98/79 3 others Pefakit® APC-R Factor V Leiden Controls98/79 Pefakit® APC-R Faktor V Leiden98/79 Pefakit® Reptilase® Time98/79	B IVDR, 98/79	Website RA@pentapharm.com EUDAMED record Report an error
Shenzhen Kang Sheng Bao Bio-Technology EU representative : QbD RepS BV (Belgium)	China	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 others H.pylori Ag Rapid Test98/79 RSV Rapid Test98/79 Strep A Rapid Test98/79	– 98/79	Website info@ksbbiotech.com EUDAMED record Report an error
SpeeDx FDA EU representative : MedEnvoy Global BV (Netherlands)	Australia	PlexPCR Colour Compensation 1.0 PlexPCR Flu/RSV/SARS-CoV-2 1.0 PlexPCR RespiVirus (610) 1.03 refs PLexPCR VHS (LC480) 1.03 refs Positive Control Flu/RSV/SARS 1.0 3 others Positive Control HSV/VZV/TP 1.0 ResistancePlus GC (550) 1.03 refs ResistancePlus MG 1.03 refs	A, B, C IVDR	Website regulatory@speedx.com.au EUDAMED record Report an error
General Biologicals EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Taiwan	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 refs98/79 3 others NANBASE C-96 V4.02 refs98/79 SURASE B-96 (TMB)2 refs98/79 ANTISURGEN B98/79 (no longer marketed)	– 98/79	sales.group@gbc.com.tw EUDAMED record Report an error
Innodx EU representative : QbD RepS BV (Belgium)	China	HAV Ab CLIA2 refs98/79 HAV IgM CLIA2 refs98/79 HEV IgG CLIA2 refs98/79 HEV IgM CLIA2 refs98/79 IL-6 CLIA2 refs98/79 3 others TB-IGRA CLIA2 refs TP Ab CLIA2 refs98/79 INNODX TB-IGRA CMIA2 refs98/79 (no longer marketed)	C IVDR, 98/79	Website EUDAMED record Report an error
Avantor Performance Materials Poland FDA	Poland	Cervix Spray Fixative 12 X 125 ML HDPE CyMet 22 CN Free3 refs Diluid™ 100 Plus3 refs Formaldehyde 3,8 - 4,2%,3 refs Hypochlorite NR3 refs 2 others Phosphate Buffered Saline2 refs UltraKitt3 refs	A IVDR	Website regulatory.pl@avantorsciences.com EUDAMED record Report an error
AVE Science & Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	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. 50mL4, 100mL4, 250mL4. 5mL/bottle, 10mL/bottle, 25mL/bottle, 40mL/bottle, 50mL/bottle, 100mL/bottle, 150mL/bottle, 200mL/bottle, 250mL/bottle. AVE-FA01. 2 others 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	EUDAMED record Report an error
Beaverbio EU representative : Kingsmead Service B.V. (Netherlands)	China	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 2 others BeaverBeads™ Viral DNA RNA Kit 70406 BEAVER™ Cell Free DNA Tubes 43803	A IVDR	sales@beaverbio.com EUDAMED record Report an error
Biokit FDA	Spain	D-Dimer 01R10013 refs HemosIL AcuStar VWF:CB 0009802044 HemosIL FDP3 refs HemosIL HIT- Ab(PF4-H) Controls2 refs HemosIL VWF:RCo 0020300900 2 others monogen kit 150 tests2 refs Quantia D-Dimer3 refs	B, C IVDR	EUDAMED record Report an error
Capitalbiotech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	12 tests/kit98/79 20 tests /kit98/79 24 tests/kit98/79 32 tests/kit98/79 32tests/kit98/79 2 others 48 tests/kit98/79 96 tests/kit98/79	– 98/79	EUDAMED record Report an error
Chemtronbio EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others	China	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 others Influenza A+B Antigen Combo Rapid Test 8062C01 Influenza A+B Antigen Combo Rapid Test Cassette 8010C98/79	B, C IVDR, 98/79	Website EUDAMED record Report an error
CorDx FDA EU representative : Medunion S.L. (Spain)	United States	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 others CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID) Cassette CorDx Respiratory Antigen Combo Rapid Test (PIV/HMPV) Cassette	C IVDR	EUDAMED record Report an error
Diasia FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	1 Test/kit98/79 10 Tests/kit98/79 100 Tests/kit5 refs98/79 25 Tests/kit5 refs98/79 5 Tests/kit98/79 2 others 50 Tests/kit6 refs98/79 WBC Colour Agent	A IVDR, 98/79	Website EUDAMED record Report an error
Eurospital FDA	Italy	EasyCal Helori98/79 Eu-Mag DNA/RNA extraction Helori FAST98/79 Helori Turbo98/79 Helori Urease 2 others Myp-test IgA98/79 Myp-test IgM98/79	A, B IVDR, 98/79	regulatory@eurospital.it EUDAMED record Report an error
Hecin EU representative : Share info GmbH (Germany)	China	AccuProbe Influenza A Virus PCR Kit3 refs AccuProbe Influenza A/B Virus PCR Kit3 refs AccuProbe Influenza B Virus PCR Kit3 refs AccuProbe RSV PCR Kit3 refs COVID-19/Flu A&B Rapid Antigen Test3 refs 2 others HCPlex RSV PCR Kit3 refs Influenza A&B Rapid Antigen Test RJ05-13 refs	B IVDR	EUDAMED record Report an error
Inbios FDA EU representative : AR Experts B.V. (Netherlands)	United States	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 others DENV Detect™ NS1 ELISA98/79 West Nile Detect™ IgM Capture ELISA98/79	– 98/79	Website EUDAMED record Report an error
Kamiya Biomedical FDA EU representative : Advena Limited (Malta)	United States	Coagulation Control K204C-10M3 refs 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 others K-ASSAY H. pylori Control K242C-2M98/79 K-ASSAY H. pylori KAI-24098/79	B IVDR, 98/79	Website info@k-assay.com EUDAMED record Report an error
Lumatas FDA EU representative : QNET B.V. (Netherlands)	United States	DAB Away Kit Hematoxylin Solution Titan AP Fast Red 30mL Kit Titan AP Fast Red 30 mL Kit Titan Double Stain Kit Titan HRP DAB 30 mL Kit 2 others Titan Prime Universal AP Polymer Detection Kit with Fast Red Titan Prime Universal HRP Polymer Detection Kit with DAB	A IVDR	EUDAMED record Report an error
PaxGenBio EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	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 others PaxView TB/NTM MPCR-ULFA Kit V040198/79 PaxView® SARS-CoV-2 real-time RT-PCR Kit R050298/79	A IVDR, 98/79	Website EUDAMED record Report an error
Reetoo EU representative : Umedwings Netherlands B.V. (Netherlands)	China	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 2 others RC-CAL，RC-CAL RET98/79 RQ-6D，RQ-NRBC，RQ-RET，RQ-BF98/79	– 98/79	Website service@reetoo.com.cn EUDAMED record Report an error
Scytek FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Acetate Buffer Solution, pH 8.0 1000 mL3 refs Actin, Alpha-Smooth Muscle; Clone 1A4 (Concentrate) 1 mL3 refs Aqueous Mount (Low Viscosity) 1000 mL3 refs BCIP/INT Solution3 refs Bouin's Fluid 1 Gal.3 refs 2 others Giemsa Stain Kit (May-Grunwald) 1 kit(s)3 refs PolyTek Anti-Mouse Polymerized Alk-Phos 1000 mL3 refs	A, C IVDR	Website EUDAMED record Report an error
Seekxbio EU representative : GRZAN GROUP SL (Spain)	China	Activated Clotting Time Cartridge(ACT) CK20133 refs98/79 Coagulation Panel Cartridge CK20013 refs98/79 Coagulation Panel Cartridge CK20023 refs98/79 Coagulation Panel Cartridge CK20033 refs98/79 Coagulation Panel Cartridge CK20043 refs98/79 2 others NeoCoag Coagulation Test Strip Neo1013 refs98/79 NeoCoag Coagulation Test Strip Neo1023 refs98/79	– 98/79	EUDAMED record Report an error
Seleo	Italy	AFSC Haemoglobin control98/79 Hemoglobin A2 elevated control98/79 Hemoglobin A2 normal control98/79 Hemoglobin electrophoresis kit 100 tests 4 samples98/79 Hemoglobin electrophoresis kit 200 tests98/79 2 others Hemoglobin electrophoresis kit 200 tests 4 samples98/79 Hemoglobin electrophoresis kit 80 tests98/79	– 98/79	Website EUDAMED record Report an error
XEMA EU representative : Polmed.de Beata Rozwadowska (Germany)	Russia	Aspergillus IgG EIA98/79 GalMAg EIA98/79 Giardia lamblia Total Ab EIA98/79 H. pylori IgG EIA98/79 H. pylori IgM EIA98/79 2 others Mycoplasma IgG EIA98/79 Ureaplasma IgG EIA98/79	– 98/79	Website EUDAMED record Report an error
Xi'An Huawei Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	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 refs 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 refs 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 refs 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 refs 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 refs 2 others Magnetic Bead DNA/RNA Purification Kit 64T/Box (Pre-filled), 16T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips2 refs 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 refs	A IVDR	EUDAMED record Report an error
Yzymedical EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	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 others 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	EUDAMED record Report an error
Genetic Signatures FDA EU representative : mdi Europa GmbH (Germany)	Australia	EasyScreen8 refs98/79 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 refs98/79 3 others EasyScreen™ Sample Processing Kit3 refs EasyScreen Respiratory Pathogen Detection Kit (RP007)98/79 (no longer marketed) EasyScreen® SARS CoV-2 Detection Kit98/79 (no longer marketed)	A IVDR, 98/79	Website RAQA@geneticsignatures.com EUDAMED record Report an error
Atomo Diagnostics EU representative : QbD RepS BV (Belgium)	Australia	ARST001-0298/79 ARST001-0498/79 ARST001-0598/79 Newfoundland HIV Self Test NFLD001-0198/79 NFLD001-0298/79 2 others NFLD001-0398/79 Simplitude ByMe Galileo Platform2 refs98/79 (no longer marketed)	– 98/79	Website info@atomodiagnostics.com EUDAMED record Report an error
Biyosistem	Türkiye	BASEMOULD 10X10X53 refs Biopsy Foam, Blue2 refs Bluing Reagent Solution, 1000 ml2 refs HistoCool Freezer Spray, 200 ml OCT Plus3 refs HMD Tissue Marking Dye, 3 Color Set, 30 ml3 refs 1 other Paraffin Wax 56-58 °C, 1 Kg HistoPlus3 refs	A IVDR	Website info@biyosistem.com.tr EUDAMED record Report an error
Cepheid FDA EU representative : Cepheid AB (Sweden)	Sweden, United States	Xpert®25 refs Xpert® HIV-1 Qual XC98/79 Xpert® HIV-1 Viral Load XC98/79 Xpert® Xpress CoV-2 plus98/79 Xpert® Xpress CoV-2/Flu/RSV plus98/79 1 other Xpert® Xpress SARS-CoV-298/79	A, B, C IVDR, 98/79	Website EUDAMED record Report an error
CTK Biotech FDA EU representative : MDSS GmbH (Germany)	United States	Aria H. pylori Ab Combo Rapid Test R0191C3 refs Aria Influenza A/B Ag Rapid Test R0187C2 refs Aria RSV Ag Rapid Test R0186C2 refs Aria® Dengue Ag Rapid Test R0063C3 refs Aria® H. pylori Ag Rapid Test R0192C3 refs 1 other Aria® Syphilis Ab Combo Rapid Test R0031C3 refs	B, C IVDR	Website info@ctkbiotech.com EUDAMED record Report an error
E-LAB Biological Science & Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Hematology Analyzer Diluent E5-D 20L×1,10L×1,5.5L×2,5.5L×13 refs Hematology Analyzer Diluent 20L×1，10L×1，5.5L×2，5.5L×13 refs Hematology Analyzer Lyse E5-LH 200mL×4,200mL×1,100mL×4,100mL×13 refs Hematology Analyzer Lyse 200ml×4，100ml×4，500ml×1，250ml×1 ，100ml×13 refs Hematology Analyzer Lyse E5-DIFF 500mL×4，500mL×2，500mL×13 refs 1 other Probe Cleanser 50mLx1,17mL×122 refs	A IVDR	EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	1 test/kit9 refs98/79 20 tests/kit98/79 25 tests/kit22 refs98/79 50 tests/kit98/79 Cassette(25 tests/kit)98/79 1 other ICP-32598/79	– 98/79	info@fanttest.com EUDAMED record Report an error
Iline Microsystems FDA	Spain	microINR Chips CHB0025AA98/79 microINR Chips CHB0025AB98/79 microINR Chips CHB0025AB-1098/79 microINR Chips CHB0025AC98/79 microINR Chips CHB0025AU98/79 1 other microINR EasyControl EKA0005UU98/79	– 98/79	eudamed@ilinemicrosystems.com EUDAMED record Report an error
Jiangxi Medicalsystem Biological Technology EU representative : Medunion S.L. (Spain)	China	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 other Tumor Necrosis Factor-α Kit（CLIA） 50T98/79	– 98/79	EUDAMED record Report an error
Konsung FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	D-Dimer Test Kit (Immunofluorescence Method)98/79 HBC-3A3 refs98/79 Helicobacter pylori Antibody (IgG) Test Kit (Colloidal Gold)98/79 Helicobacter pylori Antigen Test kit (Colloidal Gold)2 refs98/79 Influenza A&B Rapid Test Kit (Colloidal Gold)2 refs98/79 1 other Konsung C1013 refs	A IVDR, 98/79	info@konsung.com EUDAMED record Report an error
Maine Molecular Quality Controls FDA EU representative : QbD RepS BV (Belgium)	United States	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 other FilmArray® Pneumonia/Pneumoniaplus Control M34098/79	B IVDR, 98/79	Website info@mmqci.com EUDAMED record Report an error
Micras	Italy	Antibody diluent 500 ml Staining solutions and reagents not dangerous3 refs Blood Quick stain 500 ml Reagent and staining solutions for histology and cytology3 refs Bouin 500 ml Fixatives3 refs Cover Mount 8 x 500 ml Mounting media for microscopy3 refs Eosin Nigrosin 100 ml3 refs 1 other Gill 1 Hematoxylin 20 l3 refs	A IVDR	info@micras.it EUDAMED record Report an error
Milenia Biotec	Germany	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 other STic Expert HIT Control98/79	– 98/79	Website info@milenia-biotec.de EUDAMED record Report an error
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 other R&D DIAGNOSTICS SQMMR75098/79	– 98/79	Website info@ndimopoulos.gr EUDAMED record Report an error
PathoNostics	Netherlands	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 other PathoNostics Extraction kit PN-502	A, B IVDR, 98/79	Website info@pathonostics.com EUDAMED record Report an error
Roboscreen	Germany	INSTANT Virus RNA/DNA Kit2 refs INSTANT Virus RNA/DNA Kit - FX3 refs Rapid INSTANT Virus RNA/DNA Kit – FX RoboGene HBV DNA Quantification Kit 3.03 refs98/79 RoboGene HCV RNA Quantification Kit 3.03 refs98/79 1 other RoboGene HDV RNA Quantification Kit 2.04 refs98/79	A IVDR, 98/79	Website info@roboscreen.com EUDAMED record Report an error
Seamaty EU representative : MedNet EC-REP GmbH (Germany)	China	Cleaner SMT-5C(50ml/200mL)2 refs Diluent SMT-3D（5L、10L、20L）3 refs Diluent SMT-5D(5L、10L、20L)3 refs Lyse SMT-3L（50ml、100mL、 200ml、250ml 、500mL、1L）3 refs Lyse SMT-5L-D（50ml、100mL、 200ml、250ml 、500mL、1L）3 refs 1 other Lyse SMT-5L-H（50ml、100mL、 200ml、250ml 、500mL、1L）3 refs	A IVDR	EUDAMED record Report an error
Serosep FDA	Ireland	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 1 other EntericBio® Viral Panel 3 EBVP398/79	– 98/79	Website info@serosep.com EUDAMED record Report an error
Tauns EU representative : Emergo Europe B.V. (Netherlands)	Japan	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 other Positive Control Flu98/79	A IVDR, 98/79	Website EUDAMED record Report an error
Triplex International Biosciences (China) EU representative : Lotus NL B.V. (Netherlands)	China	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 other Mycobacterium Tuberculosis Nucleic Acid Detection Kit (Fluorescent PCR)98/79	– 98/79	Website info@tibchina.com EUDAMED record Report an error
Vacure EU representative : CMC Medical Devices & Drugs SL (Spain)	China	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 other Rifampicin-resistant Mycobacterium Tuberculosis Kit (Fluorescent PCR)98/79	– 98/79	EUDAMED record Report an error
Vwr FDA	France	Coverquick 1000 Q Path3 refs Easyfix Q Path3 refs Eosin Y alcoholic 0,2% Q Path3 refs Formaldehyde 4% Pink Q Path / FORMALINE 10% (PINK)3 refs PARAFFIN NORMAL Q PATH3 refs 1 other Q Path Fixative Ethanol	A IVDR	Website EUDAMED record Report an error
Wells Bio EU representative : MDSS GmbH (Germany)	South Korea	BGS-E0258298/79 BHP-E0258298/79 BSG-E0258298/79 BSH-E0258298/79 MST-N0508298/79 1 other MST-N1008298/79	– 98/79	Website info@wellsbio.net EUDAMED record Report an error
Adaltis	Italy	EIAgen Detect HIV Combo Kit ++M52108131C98/79 EIAgen HBsAg Kit98/79 EIAgen HCV Ab (v.4) Kit ++M52107106LG98/79 EIAgen Syphilis Ab Kit98/79 MOLgen Universal Extraction Kit98/79	– 98/79	Website info@adaltis.net EUDAMED record Report an error
Ademtech	France	60307 60318 60405 60406 60407	B IVDR	Website EUDAMED record Report an error
Ant Medi̇kal İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	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	Website info@antmedical.com EUDAMED record Report an error
Atom Scientific EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Acetic Acid 0.5% Solution Biological Stain3 refs Acetic Acid 10% Solution Stains (Histolab)3 refs Acetic Acid 5% Solution Fixatives (Histolab)3 refs AFB Stain Kit (Light Green Counterstain)3 refs Alcoholic Formalin 10% Cytology Fixative Solution3 refs	A IVDR	Website EUDAMED record Report an error
Azubio Diagnostics EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Pen A46060H11 Pen A47660H11 Pen A48410H11 Pen A49560H11 Pen A4D660H11	C IVDR	EUDAMED record Report an error
Beijing Biosynthesis Biotechnology EU representative : Medunion S.L. (Spain)	China	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	EUDAMED record Report an error
Cytecs	Germany	CD4 count kit98/79 CD4 count kit - dry98/79 CD4% Kit98/79 CD4% kit - dry98/79 Rapid Fluorescent Malaria Test - UV98/79	– 98/79	Website info@cytecs.com EUDAMED record Report an error
Cytogen FDA	Germany	Amnioquick98/79 CytogenAmnio2 refs98/79 CytogenLympho2 refs98/79 CytogenMarrow2 refs98/79 CytogenPrena98/79	– 98/79	info@cytogen.net EUDAMED record Report an error
Eiken FDA EU representative : Human Gesellschaft für Biochemica und Diagnostica mbH (Germany)	Japan	Loopamp(TM) PURE DNA Extraction Kit Loopamp™ Malaria Pan Detection Kit2 refs Loopamp™ Malaria Pf Detection Kit Loopamp™ Malaria Pv Detection Kit Loopamp™ MTBC Detection Kit	A, C IVDR	regulatoryaffairs@eiken.co.jp EUDAMED record Report an error
Eurolyser	Austria	D-Dimer control kit ST150098/79 D-Dimer test kit (16 tests)98/79 D-Dimer test kit (6 tests)98/79 PT (INR) control kit98/79 PT (INR) test kit (32 tests)98/79	– 98/79	Website EUDAMED record Report an error
Exbio FDA	Czechia	CD34 QuantiFlowEx Kit DryFlowEx TBNK 6-color KOMBITEST B/NK Cell 4-color KOMBITEST T Cell 4-color KOMBITEST TBNK 6-color	C IVDR	Website info@exbio.cz EUDAMED record Report an error
Guangzhou Biotron Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Human Papillomavirus (HPV) 15 Genotype Detection Kit (Fluorescent PCR-Melting Curve Method)2 refs98/79 Human Papillomavirus (HPV) 31 Genotype Detection Kit (Fluorescent PCR-Melting Curve Method)2 refs98/79 Human Papillomavirus (HPV) E6/E7 mRNA Genotyping Detection Kit (Fluorescent PCR Melting Curve Method)2 refs98/79 Respiratory 12-Pathogen Nucleic Acid Detection Kit (Fluorescent PCR Melting Curve Method)2 refs98/79 Respiratory 15-Pathogen Nucleic Acid Detection Kit (Fluorescent PCR Melting Curve Method)2 refs98/79	– 98/79	EUDAMED record Report an error
Guangzhou LBP Medicine Science & Technology EU representative : Kingsmead Service B.V. (Netherlands)	China	100 tests/kit 100 tests/kit 200 tests/kit2 refs 300 tests/kit 300 tests/kit 600 tests/kit 900 tests/kit3 refs 60 tests/kit 150 tests/kit 600 tests/kit3 refs	A IVDR	EUDAMED record Report an error
Innovacon EU representative : MDSS GmbH (Germany)	United States	456482900098/79 456483900198/79 456484900198/79 456485900098/79 456487900198/79	– 98/79	EUDAMED record Report an error
Katsura EU representative : Kingsmead Service B.V. (Netherlands)	Taiwan	Katsura Biological Coporation 310111 Katsura Biological Coporation 310211 Katsura Biological Coporation 310311 Katsura Biological Coporation 320211 Katsura Biological Coporation 320311	A IVDR	Website EUDAMED record Report an error
Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Sti	Türkiye	CERTAIN7 refs98/79 CERTIN98/79 LABOQUICK9 refs98/79 Laboquick LHAB.01 SURELAB6 refs98/79	B IVDR, 98/79	Website info@koroglugroup.com EUDAMED record Report an error
Lansionbio EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other	China	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	EUDAMED record Report an error
Microbix FDA EU representative : Obelis s.a. (Belgium)	Canada	REDx HPV 16 Positive Control RED-62-163 refs REDx Mycoplasma genitalium Positive Control RED-63-01 REDx SARS-CoV-2 Negative Control RED-19-013 refs REDx STI Negative RED-99-M1 REDxFLOQ Respiratory Swab Negative Control RED-S-99-012 refs	B IVDR	Website customer.service@microbix.com EUDAMED record Report an error
Ningbo BESTest Bio-technology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	1 test/kit2 refs98/79 25 tests/kit2 refs98/79 5 tests/kit2 refs98/79 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	EUDAMED record Report an error
Panreac Química, S.L.U	Spain	PanReac AppliChem 2510863 refs PanReac AppliChem 2529313 refs PanReac AppliChem 253211 PanReac AppliChem 2564623 refs PanReac AppliChem 256993	A IVDR	EUDAMED record Report an error
Precision Biosensor FDA EU representative : mdi Europa GmbH (Germany)	South Korea	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	Website info@precision-bio.com EUDAMED record Report an error
Pro-med (Beijing) Technology EU representative : Sungo Cert GmbH (Germany)	China	1 test/kit98/79 10 tests/kit98/79 25 tests/kit98/79 5 tests/kit98/79 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Ravo	Germany	Helicobacter pylori p120 (CagA) ELISA98/79 Hemkit Aspergillus IHA98/79 Hemkit Candida IHA98/79 Hemkit Lyme IHA98/79 Leptospiren IHA98/79	– 98/79	Website info@ravo.de EUDAMED record Report an error
Remel FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)	United States	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	Website EUDAMED record Report an error
Shenzhen CoooSeee Biomedical EU representative : MedNet EC-REP GmbH (Germany)	China	Hematology Analyzer Diluent DIL, 6DR, DS3 refs Hematology Analyzer Dye DIFF、RET、WNB、PLT、WPC3 refs Hematology Analyzer LYSE 3LHD, 5LDA, 5LDB, 5LH, 5LDS, 5LHS, 6LD, 6LH, 6LN3 refs Probe Cleanser3 refs Sample Diluent CP A3 refs	A IVDR	service@comenbio.com EUDAMED record Report an error
Shenzhen Dake Medical Technology EU representative : HyperCert Limited B.V. (Netherlands)	China	D-Dimer Assay kit Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs Interleukin-6 Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs Thrombin-antithrombin Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs 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 refs	B, C IVDR	EUDAMED record Report an error
Shenzhen Huian Biosci Technology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	1T/Kit16 refs98/79 20T/Kit17 refs98/79 5T/Kit9 refs98/79 REF206-00198/79 REF206-02098/79	– 98/79	info@huiantech.com EUDAMED record Report an error
Shenzhen Sciarray Biotech EU representative : SUNGO Europe B.V. (Netherlands)	China	1 test/ kit98/79 10 tests/ kit98/79 20 tests/ kit98/79 3 tests/ kit98/79 5 tests/ kit98/79	– 98/79	EUDAMED record Report an error
Streck FDA EU representative : MediMark Europe Sarl. (France)	United States	Para 12 Plus3 refs Streck 2124313 refs Streck 2187503 refs Streck 2254803 refs Streck Cell Preservative3 refs	A, B IVDR	Website EUDAMED record Report an error
TECOmedical EU representative : EUROBIO SCIENTIFIC (France)	Switzerland	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	Website info@tecomedical.com EUDAMED record Report an error
Ventana Medical Systems FDA EU representative : Roche Diagnostics GmbH (Germany)	United States	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	EUDAMED record Report an error
Viuick EU representative : SUNGO Europe B.V. (Netherlands)	China	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	EUDAMED record Report an error
Zhejiang Wantaifu Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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	Website EUDAMED record Report an error
Etablissement Francais Du Sang	France	NatQal B19-L NatQal 23 refs NatQal HBV NatQal 13 refs SeroQal ALINI 63 refs Trousse NG-Mix Multiloci98/79 SeroQal MALARIA 10198/79 (no longer marketed)	B IVDR, 98/79	EUDAMED record Report an error
PathoFinder	Netherlands	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 (no longer marketed)	B IVDR, 98/79	Website info@pathofinder.com EUDAMED record Report an error
Actim FDA	Finland	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	Website support@actimtest.com EUDAMED record Report an error
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 refs Open lyophilized One-Step qPCR Kit IVD	A IVDR, 98/79	Website EUDAMED record Report an error
Appolon Bioteck	France	ABility Smart Extract2 refs ABility STIplex Resist+ RespiGUARD4plex SARS-CoV-2 RT-qPCR DETECTION KIT98/79	A, B, C IVDR, 98/79	Website contact@appolonbioteck.com EUDAMED record Report an error
Archem	Türkiye	DS DILUENT DS DILUENT Please see UDI-DIs for details. G6PDH REAGENT98/79 PROBE CLEANSER Please see UDI-DIs for details.2 refs	A IVDR, 98/79	Website EUDAMED record Report an error
Arkray FDA EU representative : Arazy Group GmbH (Germany)	India	Crystal Crystal 58IC104-25, 58IC104-50 Crystal Dengue NS1 PARAHIT-F VER. 1.0 Rapid Test for P. falciparum Malaria Device	B, C IVDR	Website EUDAMED record Report an error
B&E Bio-Technology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	CellCleaner (Detergent Rinse) CellLyse HbA1c Level 1: 0.1ml×1; Level 2: 0.1ml×198/79 Sheath-Sys,Sheath-Ruby,Sheath-XN3 refs	A IVDR, 98/79	EUDAMED record Report an error
Beijing OriginPoly Bio-Tec EU representative : SUNGO Europe B.V. (Netherlands)	China	(12 tests), (24 tests), (48 tests)3 refs CISVECO®98/79 CISVECO® 24 tests/kit98/79 CISVECO® 48 tests/kit98/79	A IVDR, 98/79	EUDAMED record Report an error
Biohit FDA	Finland	BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 Control98/79 BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 UFT3004 refs98/79 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 IgG98/79 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 quick test98/79	– 98/79	Website info@biohit.fi EUDAMED record Report an error
Calth EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	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	Website info@thecalth.com EUDAMED record Report an error
Cellabs EU representative : WMDE B.V. (Netherlands)	Australia	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	Website enquiries@cellabs.com.au EUDAMED record Report an error
Coyotebio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	FlashDetect17 refs98/79 FlashDetectTM SARS-CoV-2&Flu A&Flu B&RSV External Quality Control98/79 FlashDetect™ LyocartE Enterovirus 71 Assay98/79 FlashDetect™ LyocartE HSV-1&HSV-2 Assay2 refs98/79	– 98/79	sales@coyotebio.com EUDAMED record Report an error
Elisabeth	Czechia	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	Website info@elisabeth.cz EUDAMED record Report an error
Fisher Diagnostics A division of Fisher Scientific EU representative : B·R·A·H·M·S GmbH (Germany)	United States	100356, J10035698/79 100402, J10040298/79 100403, J10040398/79 100607, J10060798/79	– 98/79	Website EUDAMED record Report an error
GaDia EU representative : ER Egészségügyi, Kereskedelmi és Szolgáltató Kft. (Hungary)	Switzerland	CandiDia-Antibody98/79 FungaDia-Aspergillus ELISA98/79 FungaDia-Aspergillus Rapid Test98/79 SchistoDia Antibody SCH-02598/79	– 98/79	Website info@gadia.net EUDAMED record Report an error
GC Medical Science EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	GENEDIA Multi Influenza Ag Rapid Test Kit98/79 GENEDIA W COVID-19 Ag3 refs98/79 GENEDIA W COVID-19 Ag External Control Swab98/79 Greencare Flu 2 Influenza A&B Ag98/79	– 98/79	EUDAMED record Report an error
Gc Medis EU representative : Obelis s.a. (Belgium)	South Korea	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™ Hb Plus Hemoglobin Control Solution H 40098/79 CERA-CHEK™ Hb Plus Hemoglobin Test Strip H 40098/79	– 98/79	Website EUDAMED record Report an error
General Life Biotechnology FDA EU representative : MDSS GmbH (Germany)	Taiwan	BeneCheck Hb Hemoglobin Control Solution BK-CSH3098/79 BeneCheck Hb Hemoglobin Control Solution BK-CSH3198/79 BeneCheck Hb Hemoglobin Control Solution BK-CSH3298/79 BeneCheck Hb Hemoglobin Test Strip BK-H298/79	– 98/79	Website service@glbiotech.com.tw EUDAMED record Report an error
Genfine EU representative : MedPath GmbH (Germany)	China	DNA/RNA Extraction Kit(Column) D102：200preps/box3 refs DNA/RNA Extraction Kit(Magnetic Beads) 101-B: 25preps/box3 refs Virus DNA/RNA Kit(Column) D501:200preps/box3 refs Virus DNA/RNA Kit(Magnetic Beads) 502-B: 480preps/box3 refs	A IVDR	EUDAMED record Report an error
Guangdong Hao Jiang Laboratories EU representative : SUNGO Europe B.V. (Netherlands)	China	"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	EUDAMED record Report an error
Huzhou Jierunxin Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	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	EUDAMED record Report an error
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	Website info@id-solutions.fr EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	12 reaction/kit98/79 12 reactions/kit18 refs Galaxy CT/NG/UU Assay 12 reactions/kit Influenza A Virus / Influenza B Virus/Respiratory Syncytial Virus Diagnostic Kit (PCR-Fluorescence)98/79	C IVDR, 98/79	support@igenesisbio.com EUDAMED record Report an error
Immunotech FDA	France	AQUIOS STEM CD34 Control Cells AQUIOS STEM kit Stem-Kit™ Reagents Stem-Trol Control Cells	C IVDR	EUDAMED record Report an error
Jiangsu CoWin Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	C. difficile GDH and toxin A/B detection kit CWX315M98/79 CWX101S/CWX101M2 refs CWX102S/CWX103S/CWX103S-BR/CWX103S-ZY/CWX103S-SLD/CWX104S/CWX104S-BR/CWX104S-ZY/CWX104S-M3 refs CWX112S	A IVDR, 98/79	EUDAMED record Report an error
Kaltek	Italy	CYTOKIT 3 CON SOLUZIONE ALCOLICA3 refs DIF STAIN KIT 3 X 250 ml3 refs FORMALDEIDE 4% per Tissue Filling pH 7,2-7,4 FORMALDEIDE AL 4% XILMOUNT MONTANTE PER VETRINI 100 ml3 refs	A IVDR	info@kaltek.it EUDAMED record Report an error
Kangmei Tianhong Biotech (Beijing) EU representative : Lotus NL B.V. (Netherlands)	China	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	Website info@kindmay.com EUDAMED record Report an error
Kolasa Spółka Jawna	Poland	Barwnik Giemsy (roztwór) 100ml3 refs EA-36 100ml3 refs Formaldehyd 10% buforowany (Utrwalacz do badań histologicznych) 1kg3 refs GRADISOL G Odczynnik do izolowania limfocytów i granulocytów 400ml3 refs	A IVDR	EUDAMED record Report an error
LaCAR MDx Technologies FDA	Belgium	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	Website EUDAMED record Report an error
Life Technologies Grand Island EU representative : Life Technologies Europe B.V. (Netherlands)	United States	AmnioMAX C-100 Basal Medium 11269-0163 refs KaryoMAX Colcemid Solution in HBSS2 refs MarrowMAX Bone Marrow Medium2 refs PB-MAX Karyotyping Medium 12557-0132 refs	A IVDR	EUDAMED record Report an error
Lordsmark EU representative : Obelis s.a. (Belgium)	India	LordsMed Diluent LM008 LordsMed Lyse LM010 LordsMed Probe Cleaner LM011 LordsMed Rinse LM009	A IVDR	Website EUDAMED record Report an error
Macrunbio EU representative : SUNGO Europe B.V. (Netherlands)	China	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	EUDAMED record Report an error
MagBio Genomics FDA EU representative : CEpartner4U (Netherlands)	United States	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	Website info@magbiogenomics.com EUDAMED record Report an error
Newmarket Biomedical FDA EU representative : MDSS GmbH (Germany)	United Kingdom (ex Northern Ireland)	NewBio Syphilis EIA TA - 96 Test Kit98/79 Newbio TPHA 1003 refs NewBio TPHA plus 100 test kit3 refs PK7400 TP HA Reagent98/79	C IVDR, 98/79	Website regulatory@new-bio.com EUDAMED record Report an error
Nihon Kohden Firenze	Italy	Cleanac Detergent3 refs Hemolynac-310 Lysing reagent for RBC2 refs Hemolynac-5 Lysing reagent for WBC2 refs Isotonac-3 Diluent2 refs	A IVDR	Website info@nkf.it EUDAMED record Report an error
NovaGray	France	NovaGray RILA Breast98/79 NovaGray RILA Legacy Breast98/79 NovaGray RILA Legacy Prostate98/79 NovaGray RILA Prostate98/79	– 98/79	contact@nova-gray.com EUDAMED record Report an error
Nuclear Laser Medicine	Italy	CHLAMYDIA TRACHOMATIS REAL TIME 2.0 Estrazione rapida di DNA genomico umano GEN-C 3.0 GEN-C Real Time	A, C IVDR	Website quality@nlm.it EUDAMED record Report an error
Pushkang EU representative : MedPath GmbH (Germany) and 1 other	China	150tests98/79 1ml*102 refs98/79 60 tests98/79 CBC Assay Kit HE5010198/79	– 98/79	EUDAMED record Report an error
Randox FDA	Northern Ireland	HAEMATOLOGY CONTROL - LEVEL 1,2,3 (HAEM CNTL - LEVEL 1,2,3) SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL POSITIVE)3 refs SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)2 refs SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +)3 refs	B IVDR	Website EUDAMED record Report an error
Shanghai Rendu Biotechnology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	AmpSure® Chlamydia Trachomatis (CT) RNA Assay AmpSure® HPV 16/18 Genotype Assay AmpSure® HPV Assay RNA033 refs	A, C IVDR	EUDAMED record Report an error
Shenzhen AmTech Bioengineering EU representative : SUNGO Europe B.V. (Netherlands)	China	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	– 98/79	EUDAMED record Report an error
Shenzhen Cinnaray Life Technology EU representative : HUMISS TRADING S. L. (Spain)	China	Cleaning A038500mL3 refs DiLuent3 refs Lyse3 refs 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 refs	A IVDR	EUDAMED record Report an error
Shenzhen Lvshiyuan Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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	Website EUDAMED record Report an error
Tianjin Bai Lixin Bio-tech EU representative : Kingsmead Service B.V. (Netherlands)	China	Eosin Stain Hematoxylin and Eosin (H&E) stain Papanicolaou Stain A Hematoxylin Solution Papanicolaou Stain D EA/OG	A IVDR	Website EUDAMED record Report an error
Zentech FDA	Belgium	J-LS-480PartA98/79 J-LS-480PartB98/79 J-LS-96PartA98/79 J-LS-96PartB98/79	– 98/79	EUDAMED record Report an error
Zymo Research FDA EU representative : DAVID Catherine Elisabeth Marie (France)	United States	EZ DNA Methylation-Lightning Kit (200 rxns) D5030-E3 refs Quick-DNA-RNA™ HT - Dx (1000 preps) R2140-E3 refs ZymoBIOMICS 96 MagBead DNA Kit (Lysis Rack) D4302-E3 refs EZ-96 DNA Methylation-Lightning Kit (Deep-Well) - 2 x 96 Rxns D5033-E (no longer marketed) EZ-96 DNA Methylation-Lightning Kit (Shallow-Well) -2 x 96 Rxns D5032-E (no longer marketed)	A IVDR	info@zymoresearch.com EUDAMED record Report an error
Sinocare FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	D-Dimer Reagent Kit 2N00198/79 Hematology Reagent Kit Prothrombin Time Reagent Kit 1S00198/79 Sinocare98/79 (no longer marketed)	A IVDR, 98/79	RA@sinocare.com EUDAMED record Report an error
AmplexDiagnostics	Germany	eazyplex® Candida auris eazyplex® Pneumocystis jirovecii eazySNP C. auris FKS1 S639	C IVDR	info@amplexdiagnostics.de EUDAMED record Report an error
Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)	China	COX-1 Platelet Aggregation Test Reagent Card (Turbidimetry) 10 tests/kit98/79 P2Y12 Receptor Platelet Aggregation Test Reagent Card (Turbidimetry) 10 tests/kit98/79 SARS-COV-2 Antigen Rapid Tests for Self-Testing CG361098/79	– 98/79	EUDAMED record Report an error
Bio-Gram Diagnostics FDA	Germany	FixOstar - Hema Giemsa JetDye-AF3 refs JaClean	A IVDR	Website contact@bio-gram.de EUDAMED record Report an error
Bio-Novum	Poland	BN SARS CoV 2 Ag Rapid Test98/79 BN SARS CoV 2 IgG/IgM Rapid Test98/79 BN Syphilis Rapid Test98/79	– 98/79	Website EUDAMED record Report an error
Biohermes FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	BF C063 refs98/79 BF S065 refs98/79 BF S215 refs98/79	– 98/79	EUDAMED record Report an error
BioLegend FDA EU representative : MedEnvoy Global BV (Netherlands)	United States	Keratin 14 Polyclonal Antibody, Purified98/79 Keratin 5 Polyclonal Antibody, Purified98/79 Keratin 5 Polyclonal Chicken Antibody, Purified98/79	– 98/79	EUDAMED record Report an error
Biomed FDA	Germany	Hemafix® Blau2 refs Hemafix® Fixierlösung2 refs Hemafix® Rot2 refs	A IVDR	Website info@biomed.de EUDAMED record Report an error
Biopanda	Northern Ireland	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	Website info@biopanda.co.uk EUDAMED record Report an error
Bonraybio FDA EU representative : MDSS GmbH (Germany)	Taiwan	LensHooke® Prestained Morphology Slide CR0 LensHooke® Sperm DNA Fragmentation Rapid Test Kit (SCD Assay) R102 refs LensHooke® Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay) R11 Plus2 refs	A IVDR	service@bonraybio.com EUDAMED record Report an error
Bosurebio EU representative : Lotus NL B.V. (Netherlands)	China	HC-20198/79 Hemoglobin Control Solution HC-10198/79 Hemoglobin Test Strips BS-10198/79	– 98/79	Website info@bosurebio.com.cn EUDAMED record Report an error
B·R·A·H·M·S FDA	Germany	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	C IVDR	EUDAMED record Report an error
Cariad EU representative : PureCE B.V. (Netherlands)	China	10 Tests/Kit, 20 Tests/Kit4 refs 10 Tests/Kit, 20 Tests/Kit, 50 Tests/Kit3 refs 3mL×3, 5mL×3, 10mL×3, 50mL×3, 100mL×3, 500mL×3.3 refs	A IVDR	Website support@cariad.com.cn EUDAMED record Report an error
CLARO-PROM društvo s ograničenom odgovornošću za proizvodnju, trgovinu i usluge	Croatia	10%-tna puferirana otopina formaldehida, 10L 4%-tna puferirana otopina formaldehida3 refs 37%-tna otopina formaldehida, 1L (plastika)3 refs Claroplast, 10 kg2 refs	A IVDR	EUDAMED record Report an error
CleanNA	Netherlands	Clean cell free DNA kit CCF-D0384 Clean Quick Viral2 refs CleanNGS Dx2 refs	A IVDR	Website info@cleanna.com EUDAMED record Report an error
CoaguSense FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Coag-Sense Control Test Strip Kit - 10 Count 03P69-1098/79 Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit 10021898/79 Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit 20020998/79	– 98/79	Website EUDAMED record Report an error
Coei Biotech EU representative : Medunion S.L. (Spain)	China	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	EUDAMED record Report an error
Diagast FDA	France	BROMELINE3 refs LISS2 refs PALERM Papain	A IVDR	Website contact@diagast.com EUDAMED record Report an error
Diagenode FDA	Belgium	Panther Fusion Bordetella Assay2 refs Panther Fusion BKV Quant Assay - BKV Reagent Cartridge2 refs Panther Fusion EBV Quant Assay3 refs	B, C IVDR	info@diagenode.com EUDAMED record Report an error
DiaMed FDA EU representative : Bio-Rad (France)	Switzerland	05761_ID-Diluent 2 51051_DiaClon ABD-Confirmation for Donors98/79 52160_DiaClon Antigen Profile II	A, D IVDR, 98/79	Website contact@bio-rad.com EUDAMED record Report an error
Dianabiotech	Czechia	DBdirect™ COVID-19 Multiplex RT-PCR Kit2 refs98/79 DBdirect™ Respiratory panel 1: SARS-CoV-2/Flu/RSV2 refs98/79 RT-PCR Respiratory panel 1: SARS-CoV-2/Flu/RSV2 refs98/79	– 98/79	Website info@dianabiotech.com EUDAMED record Report an error
Diazyme FDA EU representative : MDSS GmbH (Germany)	United States	Diazyme D-Dimer Assay2 refs98/79 Diazyme D-Dimer Calibrator Set98/79 Diazyme D-Dimer Control Set98/79	– 98/79	Website EUDAMED record Report an error
EKF-diagnostic FDA	Germany	DiaSpect Control Pack HBT13 refs Hb-con Set 23 refs Hemo Control Hemoglobin Microcuvette3 refs	B IVDR	info@ekf-diagnostic.de EUDAMED record Report an error
FertiPro FDA	Belgium	LeucoScreen Plus LEUCO_PLUS3 refs Spermac Stain - 4x250ml SPS050 / SPS2503 refs VitalScreen3 refs	A, B IVDR	Website info@fertipro.com EUDAMED record Report an error
Fujirebio FDA	Belgium	INNO-LiPA HBV Genotyping <20T,CE> 80691 INNO-LiPA HCV 2.0 Amp <20T,CE> 815473 refs INNO-LiPA HPV Genotyping Extra II <20T,CE> 815342 refs	C IVDR	Website EUDAMED record Report an error
GeneFirst EU representative : Advena Limited (Malta)	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	Website EUDAMED record Report an error
GeneMatrix EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	NeoPlex™ GI-Virus 6 Detection Kit NG0198/79 NeoPlex™ RV-Panel B Detection Kit NR042 refs98/79 NeoPlex™ TBNTM-5 Detection Kit NR1598/79	– 98/79	Website support@genematrix.net EUDAMED record Report an error
HemoCue FDA	Sweden	HemoCue Plasma/Low Hb Microcuvettes3 refs98/79 HemoCue WBC DIFF Microcuvettes4 refs98/79 HemoCue WBC Microcuvettes3 refs98/79	– 98/79	Website info@hemocue.se EUDAMED record Report an error
Hemonart	Türkiye	BlacT ACT Test Tube98/79 PlacT ACT Test Tube98/79 Whole Blood Quality Controls98/79	– 98/79	Website info@hemonart.com EUDAMED record Report an error
Hospitex	Italy	CYTOfast Kit Urine - Eco StandAlone - 3x20 ml3 refs Ematossilina di Harris 500 ml Soluzione CYTOfast - 1 lt3 refs	A IVDR	Website info@hospitex.com EUDAMED record Report an error
Hunan AccuBio Biotech EU representative : SUNGO Europe B.V. (Netherlands) and 1 other	China	100T6 refs98/79 1L，10L 50T6 refs98/79	A IVDR, 98/79	info@hn-accubio.com EUDAMED record Report an error
Jiangsu Medomics Medical Technology FDA EU representative : R Sight B.V. (Netherlands) and 1 other	China	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 refs Group A streptococcus Rapid test Kit98/79	C IVDR, 98/79	Website info@medomics-dx.com EUDAMED record Report an error
Jiangsu Rongsheng Jiamei Biological Reagent EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	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	EUDAMED record Report an error
Junocare EU representative : Humiss International B.V. (Netherlands)	China	EA/Orange-G Combo Stain2 refs HEMATOXYLIN Stain2 refs SUPERPap 480ml2 refs	A IVDR	Website EUDAMED record Report an error
Kreatech Biotechnology	Netherlands	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	Website QA.Amsterdam@leicabiosystems.com EUDAMED record Report an error
Ldn	Germany	IL-1β-ELISA IL E-300098/79 IL-6-ELISA IL E-320098/79 TNF-α-ELISA IL E-310098/79	– 98/79	Website regulatory@ldn.de EUDAMED record Report an error
Medical & Biological Laboratories EU representative : QbD RepS BV (Belgium)	Japan	HEXAMATE Factor XIII HEXAMATE Factor XIII - Calibrator HEXAMATE Factor XIII – Control I/II	B IVDR	EUDAMED record Report an error
Neo-nostics (Suzhou) Bioengineering EU representative : Medunion S.L. (Spain) and 1 other	China	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	EUDAMED record Report an error
Poclight EU representative : HUMISS TRADING S. L. (Spain)	China	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 EUDAMED record Report an error
Precision BioLogic FDA EU representative : Emergo Europe B.V. (Netherlands)	Canada	CRYOcheck26 refs CRYOcheck Abnormal 1 Reference Control2 refs CRYOcheck Abnormal 2 Reference Control	C IVDR	EUDAMED record Report an error
Premier Medical EU representative : Obelis s.a. (Belgium)	India	First Response HBsAg Card Test PI10FRC4 refs98/79 First Response HCV Card Test PI03FRC4 refs98/79 First Response HIV 1-2.O Card Test (Version 2.0 PI05FRC4 refs98/79	– 98/79	Website info@premiermedcorp.com EUDAMED record Report an error
Proekosrl	Italy	DECOLORANTE DI GRAM 250 ml3 refs DIFF STAIN QUICK FISSATIVO 250 ml3 refs DIFF STAIN QUICK KIT IC4002 refs	A IVDR	Website info@proekosrl.com EUDAMED record Report an error
Reagens Fejlesztő Gyártó És Kereskedelmi Kft	Hungary	AGGI-LISS Aktív liofilizált papain Bromelin 1000 ml3 refs	A IVDR	Website EUDAMED record Report an error
Rocgene FDA EU representative : Medunion S.L. (Spain) and 1 other	China	10 tests/kit17 refs98/79 10200602G 50 tests/kit17 refs98/79	A IVDR, 98/79	sale@rocgene.com EUDAMED record Report an error
Sakura	Netherlands	Tissue-Tek® Glas™ Mounting Medium3 refs Tissue-Tek® O.C.T. Compound Tissue-Tek® Paraffin Wax TEK III3 refs	A IVDR	Website quality@sakura.eu EUDAMED record Report an error
Sekisui Diagnostics FDA EU representative : MDSS GmbH (Germany)	United States	OSOM® Mono Test 14598/79 OSOM® RSV/Adeno Control Kit 198E98/79 OSOM® RSV/Adeno Test 197E98/79	– 98/79	Website EUDAMED record Report an error
Shanghai Kehua Bio-engineering EU representative : QbD RepS BV (Belgium)	China	Interleukin-6 Quantitative Detection KIT (Chemiluminescent Immunoassay)98/79 Nucleic Acid Extraction Kit 32 Nucleic Acid Extraction Kit 962 refs Nucleic Acid Extraction Kit KH-G-M-565-48-CE	A IVDR, 98/79	EUDAMED record Report an error
Tianjin Jianbo Biological EU representative : CMC Medical Devices & Drugs SL (Spain)	China	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	EUDAMED record Report an error
Tianjin Mingao Biotechnology EU representative : SUNGO Europe B.V. (Netherlands)	China	Cassette98/79 Midstream98/79 Strip98/79	– 98/79	EUDAMED record Report an error
Toda Pharma	France	Toda Dengdiag combo 198/79 Toda Dengdiag combo 1098/79 Toda Dengdiag combo 2098/79	– 98/79	Website qualite@todapharma.com EUDAMED record Report an error
Transgen EU representative : Kingsmead Service B.V. (Netherlands)	China	EasyPure® Viral DNA/ RNA Kit ER201 MagicPure® 96 Viral DNA/RNA Kit EC301-96 MagicPure® 32 Viral DNA/RNA Kit EC301-32	A IVDR	EUDAMED record Report an error
Ukinbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Hematology Testing Pack HT 300 / HT5002 refs 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	A IVDR, 98/79	sales@ukinbio.com EUDAMED record Report an error
Wuhan MGI Tech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	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 refs Sample Collection and Release Reagent SCR-100	A IVDR	EUDAMED record Report an error
X-ZELL Biotech Pte EU representative : X-ZELL Biotech GmbH (Germany)	Singapore	Cryophore™ Ascitic Fluid Cryophore™ Pleural Fluid 1 Cryophore™ Pleural Fluid 3	A IVDR	Website support@x-zell.com EUDAMED record Report an error
Yhlo Biotech (Nanjing) EU representative : Medunion S.L. (Spain)	China	Fibrinogen (FIB) Assay Kit (Immunoturbidimetric Method)2 refs98/79 Helicobacter Pylori Antibody (HP) Assay Kit (Latex-enhanced Immunoturbidimetric Method)2 refs98/79 Homocysteine (HCY) Assay Kit (Enzymatic Cycling Method)2 refs98/79	– 98/79	EUDAMED record Report an error
Zhongshan Bio-Tech EU representative : Lotus NL B.V. (Netherlands)	China	20 tests/kit98/79 25 tests/kit5 refs98/79 96 tests/kit4 refs98/79	– 98/79	EUDAMED record Report an error
Suzhou Sym-Bio Lifescience EU representative : Emergo Europe B.V. (Netherlands)	China	48 tests 50 tests Level 1: 0.75mL×4, Level 2: 0.75mL×498/79 (no longer marketed) SuperFlex Interleukin-6 Kit98/79 (no longer marketed)	A, C IVDR, 98/79	quality.taicang@revvity.com EUDAMED record Report an error
Ortho-Clinical Diagnostics Rochester EU representative : Ortho-Clinical Diagnostics France (France)	United States	ORTHO BLISS (4 x 50 ml bottles) VITROS2 refs VITROS Chemistry Products HCY 2 Reagent98/79 ORTHO Antibody Enhancement Solution VITROS (no longer marketed)	A IVDR, 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
-Diagnostics EU representative : mdi Europa GmbH (Germany)	United States	Logix Smart ABC (Influenza A/B, SARS-Cov-2) ABC-K-00198/79 Logix Smart MTB Test Kit MTB-K-00798/79	– 98/79	Website EUDAMED record Report an error
1drop EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	1copy™ COVID-19 qPCR 4plex Kit M2498/79 1copy™ COVID-19/FluA/FluB/RSV qPCR Kit M2598/79	– 98/79	Website sales@1drop.co.kr EUDAMED record Report an error
Advanced Cell Diagnostics FDA EU representative : QbD RepS BV (Belgium)	United States	RNAscope™ ISH Probe High Risk HPV98/79 RNAscope™ ISH Probe UBC (Positive Control)98/79	– 98/79	EUDAMED record Report an error
Aehealth EU representative : MedNet EC-REP GmbH (Germany)	China	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	– 98/79	sales@aehealth.com.cn EUDAMED record Report an error
AO Vector-Best EU representative : BIORON GmbH (Germany)	Russia	RealBest DNA-express RealBest UniMag Universal NA Extraction Kit2 refs	A IVDR	Website EUDAMED record Report an error
Apiro	Hungary	QC1 2011EU QC2 2021EU	C IVDR	Website info@apiro.eu EUDAMED record Report an error
Avecon Healthcare EU representative : Amstermed B.V. (Netherlands)	India	MAXCOUNT6 refs MAXLYTE	A IVDR	Website EUDAMED record Report an error
Beckman EU representative : Beckman Coulter Ireland Inc. (Ireland)	India	ClearLLab Compensation Kit ClearLLab LS Lymphoid Screen Reagent	C IVDR	Website EUDAMED record Report an error
Beijing Healthgene Laboratory EU representative : Lotus NL B.V. (Netherlands)	China	20 Tests/Kit98/79 COVID-19 Nucleic Acid Detection Kit(Fluorescence PCR)2 refs98/79	– 98/79	EUDAMED record Report an error
Beijing North Institute of Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	BNIBT RI003C98/79 BNIBT RI003C-2098/79	– 98/79	info@eugenebio.com EUDAMED record Report an error
Bioclarma	Italy	SensiQuant Direct CELL Buffer98/79 SMART SNP Sample Diluent98/79	– 98/79	Website EUDAMED record Report an error
Biodetect EU representative : Lotus NL B.V. (Netherlands)	China	2019-nCoV Molecular Diagnostic Kit(Fluorescent PCR Test)98/79 Monkeypox Virus Molecular Diagnostic Kit (Fluorescent PCR Test) (Lyophilized)98/79	– 98/79	Website EUDAMED record Report an error
Biomerica FDA EU representative : MDSS GmbH (Germany)	United States	GAP IgM Helicobacter pylori ELISA 700698/79 Hp Detect™ Stool Antigen ELISA 708398/79	– 98/79	Website info@biomerica.com EUDAMED record Report an error
Biotecnica	Italy	ANTITHROMBIN III TURB 61098/79 HOMOCYSTEINE 55398/79	– 98/79	EUDAMED record Report an error
Boule FDA	Sweden	Medonic M-serie Diluent 20L3 refs Swelab Alfa ComboPack 2003 refs	A IVDR	Website info@boule.com EUDAMED record Report an error
Bruker FDA	Germany	Micro-Dx2 refs98/79 SepsiTest-UMD2 refs98/79	– 98/79	Website info.md@bruker.com EUDAMED record Report an error
C.P.M. Compagnia Per La Medicina	Italy	D-DIMER I02276/398/79 Fibrinogen‐ONE I021798/79	– 98/79	Website EUDAMED record Report an error
Campmedica	Romania	See Now6 refs See Now Dengue NS1 antigen98/79	B IVDR, 98/79	Website EUDAMED record Report an error
Canterbury Scientific FDA EU representative : Emergo Europe B.V. (Netherlands)	New Zealand	extendSURETM Haemoglobin F and A2 Calibrators HB110SCALAr98/79 extendSURE™ Haemoglobin F and A2 Controls HB110SSBAr98/79	– 98/79	Website cseymour@canterburyscientific.com EUDAMED record Report an error
Chengdu Find Medical Devices EU representative : MedPath GmbH (Germany)	China	Cell-Free Fetal DNA Library Prepare Kit Nucleic acid extraction or purification reagent N001	A IVDR	EUDAMED record Report an error
Citotest FDA EU representative : Obelis s.a. (Belgium) and 1 other	China	CITOTEST CITOTEST white particles3 refs	A IVDR	Website info@citotest.com EUDAMED record Report an error
Cupidlimited FDA EU representative : Amstermed B.V. (Netherlands)	India	CupiKIT2 refs CupiKIT HIV 1 & 2 Antibody Test Kit	C, D IVDR	Website qa@cupidlimited.com EUDAMED record Report an error
Cytochipinc FDA EU representative : Medunion S.L. (Spain)	United States	CitoCBC Cartridge 121098/79 CitoCBC Control 131098/79	– 98/79	quality@cytochipinc.com EUDAMED record Report an error
Darui Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	100 tests/kit98/79 96 tests/kit98/79	– 98/79	EUDAMED record Report an error
Diagnostics For Real World FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	United States	SAMBA III SCoV-2/Flu/RSV Test SAMBA III STI Ulcer Panel Test 7000-12	B, C IVDR	Website ra@drw-ltd.com EUDAMED record Report an error
Diagre EU representative : SUNGO Europe B.V. (Netherlands)	China	48 tests/box98/79 DR-ZTQ001-50 DR-ZTQ001-1002 refs	A IVDR, 98/79	EUDAMED record Report an error
Di̇a Pro Tibbi̇ Ürünler San. Ve Ti̇c. A.Ş	Türkiye	Across Gel5 refs ACROSS GEL ACROSS RBC A1/B2 refs	A, D IVDR	EUDAMED record Report an error
Elektromed	Poland	PATHOSOLUTIONS - ClearFix, 1L3 refs Pathosolutions - Parafina Histopatologiczna Premium 1 kg3 refs	A IVDR	Website EUDAMED record Report an error
Elitech Microbio	France	E.L.I.H.A TOXO 666102 refs ELI.H.A Echinococcus 666042 refs	B, C IVDR	Website EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Wako Chemicals Europe GmbH (Germany)	Japan	LAL Control 993-04201, 997-04101, 995-044013 refs β-Glucan Sample Diluent 999-04301	A, C IVDR	EUDAMED record Report an error
Gangdong Group FDA EU representative : MDSS GmbH (Germany)	South Korea	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	Website EUDAMED record Report an error
Genesystem FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Media:DirectTM Extraction Buffer Swab:DirectTM Extraction Kit, Swab:DirectTM Extraction Kit (2mL) / Trans:DirectTM Extraction Kit2 refs	A IVDR	Website ra@genesystem.co.kr EUDAMED record Report an error
Gold Probe Diagnostic Biotechnology Mf EU representative : Lotus NL B.V. (Netherlands)	China	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	EUDAMED record Report an error
Guangzhou Deaou Gene Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	4 tests/kit5 refs98/79 8 tests/kit5 refs98/79	– 98/79	EUDAMED record Report an error
Guangzhou Decheng Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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	Website service@dochekbio.com EUDAMED record Report an error
Hailife EU representative : Medunion S.L. (Spain)	China	20 tests/kit, 50 tests/kit2 refs 20 tests/kit, 50tests/kit2 refs	A IVDR	EUDAMED record Report an error
Hangzhou Aokai Biotech EU representative : VidaQuick Biotech S.L. (Spain)	China	AllDx CS10598/79 AllDx S10598/79	– 98/79	info@aokais.com.cn EUDAMED record Report an error
Hangzhou New Horizon Health Technology EU representative : MedPath GmbH (Germany) and 1 other	China	48 tests/ kit98/79 UU Tube 1 test/ kit	C IVDR, 98/79	Website compliance@nhbio.com.cn EUDAMED record Report an error
Hebei Sanxin Pharmaceutical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	D-Dimer Fluorescent Immunochromatographic Assay (FIA) Kit 25 tests per box98/79 IL-6 Fluorescent Immunochromatographic Assay (FIA) Kit 25 tests per box98/79	– 98/79	EUDAMED record Report an error
Helena Biosciences Europe FDA EU representative : Advena Limited (Malta) and 1 other	United Kingdom (ex Northern Ireland)	Thromboplastin L 5265HL3 refs V8 Haemoglobin UltraScreen Kit 80110098/79	C IVDR, 98/79	Website EUDAMED record Report an error
Hisztopatológia Kft	Hungary	HISTOLS-DAB HISTOLS-Rezisztens AEC2 refs	A IVDR	Website info@histopat.hu EUDAMED record Report an error
Hoyotek EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	D-Dimer Rapid Test Kit (Fluorescence Immunochromatographic Assay) Please see the IFU.2 refs98/79 lnterleukin-6 Rapid Test Kit (Fluorescence Immunochromatographic Assay) Please see the IFU.2 refs98/79	– 98/79	Website inquiry@hoyotek.cn EUDAMED record Report an error
Hunan Hehao Medical Technology EU representative : Lotus NL B.V. (Netherlands)	China	Fecal Occult Blood (FOB) Test Kit (LIA)2 refs98/79 Fecal Occult Blood (FOB) Test Kit (LIA) Hitachi 7020, 7180, Beckman AU680,OC-Sensor IO2 refs	B IVDR, 98/79	EUDAMED record Report an error
Hyris	Italy	NL SOLUTION (Prefilled) HK043X020 NL SOLUTION HK038X0502 refs	A IVDR	Website support@hyris.net EUDAMED record Report an error
Invitrosco EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	AdvanSure™ i3 TB-IGRA98/79 AdvanSure™ TB-IGRA ELISA98/79	– 98/79	Website EUDAMED record Report an error
IQ Products FDA	Netherlands	Fetal Cell Count™ kit98/79 FMH QuikQuant98/79	– 98/79	Website orders@iqproducts.nl EUDAMED record Report an error
Luminex Molecular Diagnostics FDA EU representative : DiaSorin Italia S.p.A. (Italy)	Canada	NxTAG® Gastrointestinal Pathogen Panel98/79 NxTAG® Respiratory Pathogen Panel v2	B IVDR, 98/79	Website regulatoryaffairs@luminexcorp.com EUDAMED record Report an error
Luminexcorp FDA EU representative : DiaSorin Italia S.p.A. (Italy)	United States	LIAISON PLEX® Gastrointestinal Flex Assay LIAISON PLEX® Respiratory Flex Assay	C IVDR	Website regulatoryaffairs@luminexcorp.com EUDAMED record Report an error
Lybe Scientific	Norway	NAxtra®3 refs NAxtra® 2.0 nucleic acid extraction kit3 refs	A IVDR	Website contact@lybescientific.com EUDAMED record Report an error
Marfour	Poland	BioClear NEW3 refs Pojemnik na wycinki chirurgiczne napełniony 10% formaliną w ilości 1800 ml3 refs	A IVDR	Website info@marfour.com.pl EUDAMED record Report an error
Mascia Brunelli	Italy	HEMOFAST2 refs STROMATOL2 refs	A IVDR	Website EUDAMED record Report an error
Medconn FDA EU representative : Kingsmead Service B.V. (Netherlands)	China	D-Dimer Reagent Kit 100 Tests/kit98/79 D-Dimer Reagent Kit 50 Tests/kit98/79	– 98/79	EUDAMED record Report an error
Medical Electronic Systems Europe FDA	Belgium	QwikCheck DFI Kit98/79 QwikCheck Vitality	A IVDR, 98/79	EUDAMED record Report an error
MES Medical Electronic Systems EU representative : Arazy Group GmbH (Germany)	Israel	QwikCheck DFI Kit98/79 QwikCheck Vitality Kit	A IVDR, 98/79	EUDAMED record Report an error
Milestone FDA	Italy	FineFIX2 refs FORMALIN2 refs	A IVDR	Website marketing@milestonemedsrl.com EUDAMED record Report an error
Moelab	Germany	möLab® D-Dimer Test98/79 möLab® Gonorrhoe Test98/79	– 98/79	Website info@moelab.de EUDAMED record Report an error
Monlab	Spain	H. pylori Ag MonlabTest MO-804001 25 tests98/79 Norovirus MO-804018 20 Tests98/79	– 98/79	Website EUDAMED record Report an error
Mpw	Poland	CYTO base and insert3 refs CYTO set	A IVDR	Website EUDAMED record Report an error
Nichirei Biosciences EU representative : MedEnvoy Global BV (Netherlands)	Japan	N-Histofine DAB-3S KIT3 refs N-Histofine Simple Stain MAX PO (M)3 refs	A IVDR	Website EUDAMED record Report an error
Ningbo HEALTH Gene Technologies EU representative : Lotus NL B.V. (Netherlands)	China	HPV Genotyping Kit (PCR capillary analysis) (F650)98/79 HPV Genotyping Kit (PCR-Capillary Electrophoresis Fragment Analysis) (F488)98/79	– 98/79	EUDAMED record Report an error
Noul FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	miLab™ Cartridge MAL CMAA98/79 SafeFix CSFA	A IVDR, 98/79	Website cs@noul.com EUDAMED record Report an error
PentaBase	Denmark	CoviFLU98/79 RespiDetect98/79	– 98/79	Website info@pentabase.com EUDAMED record Report an error
PreAnalytiX FDA EU representative : QIAGEN GmbH (Germany)	Switzerland	PAXgene Blood RNA Kit QIAsymphony PAXgene Blood ccfDNA Kit	A IVDR	Website EUDAMED record Report an error
Precision System Science FDA EU representative : Emergo Europe B.V. (Netherlands)	Japan	MagDEA Dx MV Ⅱ MagDEA Dx SV	A IVDR	service@pss.co.jp EUDAMED record Report an error
Pro-Lab Diagnostics UK EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Field's Stain A PL.71233 refs Rabbit Coagulase Plasma4 refs98/79	A IVDR, 98/79	Website EUDAMED record Report an error
Promega FDA EU representative : Abbott GmbH (Germany)	United States	Abbott mSample Preparation System 04J70-24 Abbott mSample Preparation SystemDNA 06K12-24	A IVDR	EUDAMED record Report an error
Rastin EU representative : Source of Commerce GmbH (Germany)	Iran	Rastin HI25 Rastin HI50G	C IVDR	Website EUDAMED record Report an error
ReLIA Biotechnologies (Jiangsu) EU representative : Luxus Lebenswelt GmbH (Germany)	China	ReLIA6 refs98/79 ReLIA Interleukin-6 Test (Fluorescence Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
Sakura Finetek Japan EU representative : Sakura Finetek Europe B.V. (Netherlands)	Japan	Tissue-Tek® Eosin For Prisma (Plus) standard solution reservoir Tissue-Tek® Hematoxylin 3G For Prisma (Plus) standard solution reservoir	A IVDR	Website EUDAMED record Report an error
Sanqi Biomedical Shandong EU representative : Lotus NL B.V. (Netherlands)	China	Interleukin-6 (IL-6) test kit (fluorescence immunochromatography) 3Q-FA1000 Novel Coronavirus Antigen Test Kit(Latex beads) 3Q-FA1000	A IVDR	EUDAMED record Report an error
Sarstedt FDA	Germany	Formalin Set 25 ml2 refs Formalin System 450 ml2 refs	A IVDR	Website EUDAMED record Report an error
Self-screen	Netherlands	HPV-Risk assay QHR1317298/79 QIAscreen HPV PCR test98/79	– 98/79	Website EUDAMED record Report an error
Shandong Bohong Gene Technology EU representative : Luxus Lebenswelt GmbH (Germany)	China	Disposable Virus Sampling Tube2 refs Nucleic Acid Extraction Kit BH002	A IVDR	EUDAMED record Report an error
Shenzhen Channel Biotechnology EU representative : Luxus Lebenswelt GmbH (Germany)	China	D-Dimer (D-D) Determination Kit (Chemiluminescence Immunoassay) 10 Tests/Kit or 20 Tests/Kit98/79 Interleukin-6 (IL-6) Determination Kit (Chemiluminescence Immunoassay) 10 Tests/Kit or 20 Tests/Kit98/79	– 98/79	Website service.channel@szchenna.com EUDAMED record Report an error
Shenzhen Uni-medica Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Uni-medica 64T, 96T, 384T, 100T, 300T, 1000T, 4800T2 refs Uni-medica TypeB 100 tests/kit	A IVDR	Website marketing@uni-medica.com EUDAMED record Report an error
Suny (Xiamen) Biotechnology EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	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	EUDAMED record Report an error
Sussex Biologicals EU representative : Eurolink Europe Compliance Limited (Ireland)	United Kingdom (ex Northern Ireland)	Phosphate Buffered Saline 10 Litres2 refs Phosphate Buffered Saline Concentrate 1 x 250ml bottle	A IVDR	Website info@sussexbiologicals.co.uk EUDAMED record Report an error
Suzhou Hokapi Biomedical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	HOKAPI™ D-DIMER3 refs HOKAPI™ IL-63 refs	C IVDR	EUDAMED record Report an error
Tem Innovations FDA	Germany	ROTROL N 503-2498/79 ROTROL P 503-2598/79	– 98/79	EUDAMED record Report an error
Tianjin Bioscience Diagnostic Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	100 TEST/KIT4 refs98/79 500 TEST/KIT98/79	– 98/79	EUDAMED record Report an error
WellMed FDA	Netherlands	CryoCompound7 refs Imsolmount2 refs	A IVDR	Website info@wellmed.nl EUDAMED record Report an error
Wesailbio EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Test Kit (Immunofluorescence) 20 tests/kit98/79 Interleukin-6 Test Kit (Immunofluorescence) 20 tests/kit98/79	– 98/79	EUDAMED record Report an error
Whpm FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Cassette WH-AT-OFLU98/79 One-Step Immunological Fecal Occult Blood Test Strip; Cassette98/79	– 98/79	customerservice@whpm.com.cn EUDAMED record Report an error
Xiamen Sciendox Biological Technology EU representative : MedPath GmbH (Germany)	China	Sciendox ® Extraction Kit for Faecal Nucleic Acid (DNA) Sciendox ® Nucleic acid conversion and purification reagent	A IVDR	EUDAMED record Report an error
ZEUS Scientific FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	FTA-ABS DS Test System FA7001DS98/79 FTA-ABS Test System FA700198/79	– 98/79	Website regulatory@zeusscientific.com EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Mycoplasma IgM Rapid Test2 refs98/79 Adenovirus Ag Rapid Test98/79 (no longer marketed) Brucellosis Antibody（Brucella Ab）Rapid Test98/79 (no longer marketed) Candida Albicans/Gardnerella Vaginalis /Trichomonas Vaginalis Combo Rapid Test（Swab）98/79 (no longer marketed) Chlamydia Rapid Test Device (Swab)98/79 (no longer marketed) 41 others Clostridium Difficile Toxin A+B Rapid Test98/79 (no longer marketed) Clostridium Difficile Toxin AB+GDH Rapid Test98/79 (no longer marketed) CMV(Cytomegalovirus) IGG IGM Rapid Test98/79 (no longer marketed) COVID-19 /Flu A&B /RSV /ADENO Ag Combo Rapid Test Cassette (Swab)98/79 (no longer marketed) COVID-19 /Flu A&B /RSV /ADENO/M.P Ag Combo Rapid Test Cassette (Swab)98/79 (no longer marketed) COVID-19 /Flu A&B /RSV Ag Combo Rapid Test Cassette (Swab)98/79 (no longer marketed) COVID-19 AG & INFLUENZA A/B COMBO RAPID TEST98/79 (no longer marketed) COVID-19 Antigen Rapid Test98/79 (no longer marketed) COVID-19 IgG IgM Rapid Test Kit98/79 (no longer marketed) D-dimer Rapid Test98/79 (no longer marketed) Dengue IgM/IgG Rapid Test98/79 (no longer marketed) Dengue NS1 Antigen & IgG/IgM Rapid Test（Whole Blood/Serum/Plasma）98/79 (no longer marketed) Dengue NS1 Rapid Test98/79 (no longer marketed) Giardia antigen Rapid Test98/79 (no longer marketed) Gonorrhea Antigen Rapid Test98/79 (no longer marketed) H. pylori Antibody Rapid Test98/79 (no longer marketed) H.pylori Antigen Rapid Test98/79 (no longer marketed) HAV IGG IGM Rapid Test98/79 (no longer marketed) HPV 16/18 Antigen Rapid Test98/79 (no longer marketed) HSV IgG/IgM Rapid Test98/79 (no longer marketed) Influenza A/B Ag Rapid Test98/79 (no longer marketed) Leishmania IgG IgM Rapid Test98/79 (no longer marketed) Leptospira IgG IgM Rapid Test98/79 (no longer marketed) Lyme Ab Rapid Test98/79 (no longer marketed) Malaria pf/pan One Step Rapid Test98/79 (no longer marketed) Malaria pf/pv One Step Rapid Test98/79 (no longer marketed) Monkeypox Antibody Rapid Test (Whole blood/Serum/Plasma)98/79 (no longer marketed) Monkeypox Antigen Rapid Test98/79 (no longer marketed) Mycoplasma Antigen Rapid Test98/79 (no longer marketed) Norovirus Antigen Rapid Test98/79 (no longer marketed) Parvovirus antigen（CPV Ag/FPV Ag） Rapid Test98/79 (no longer marketed) Rotavirus Rapid Test98/79 (no longer marketed) RSV Antigen Rapid Test（Swab）98/79 (no longer marketed) Strep A Rapid Test98/79 (no longer marketed) Streptococcus pneumoniae antigen rapid test98/79 (no longer marketed) TORCH Rapid Test98/79 (no longer marketed) Treponema Pallidum Antibody Rapid Test98/79 (no longer marketed) Typhoid IgG/IgM Rapid Test98/79 (no longer marketed) Typhoid Para Ag Test Device98/79 (no longer marketed) Typhus IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 (no longer marketed) Zika Rapid Test98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Responsebio FDA EU representative : Emergo Europe B.V. (Netherlands)	Canada	RAMP D-dimer (C1106)98/79 RAMP Total b-hCG Controls - Level 1 (C4003-1)98/79 (no longer marketed) RAMP Total b-hCG Controls - Level 2 (C4003-2)98/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Lionex	Germany	LIOFeron® TB/LTBI3 refs LIODetect® D-Dimer Rapid Test98/79 (no longer marketed)	C IVDR, 98/79	Website info@lionex.de EUDAMED record Report an error
"Bio-Ksel"	Poland	Bio-Ksel PT plus98/79	– 98/79	Website EUDAMED record Report an error
Abviris	Germany	Prevo-Check98/79	– 98/79	Website info@abviris.de EUDAMED record Report an error
Acmexbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Acmex Cassette14 refs98/79	– 98/79	info@acmexbio.com EUDAMED record Report an error
Addaxbio FDA	Italy	GAF® Fixative 1 l3 refs	A IVDR	Website administration@addaxbio.com EUDAMED record Report an error
Aikang Diagnostics EU representative : MedNet EC-REP GmbH (Germany)	China	Interleukin 6(IL-6) in vitro diagnostic kit (Chemiluminescent Immunoassay)98/79	– 98/79	marketing@aikang-medical.com EUDAMED record Report an error
Akmedical	Italy	FISSATORE CITOLOGICO	A IVDR	commerciale@akmedical.it EUDAMED record Report an error
Alifax FDA	Italy	M-SMASHER KIT2 refs	A IVDR	Website regulatory@alifax.com EUDAMED record Report an error
Allsheng FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Nucleic acid Extraction and Purification Kit	A IVDR	EUDAMED record Report an error
Arghavan Teb Kavian EU representative : Medisol Technologies S.L. (Spain)	Iran	ATK HPV	C IVDR	Website info@atkdiagnostic.com EUDAMED record Report an error
Arrow Diagnostics	Italy	AD4SEQ HIV-1 SOLUTION V2	C IVDR	Website info@arrowdiagnostics.it EUDAMED record Report an error
Atlas Link Technology FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	China	Respiratory Antigen Multiple Test Kit C21343 refs	C IVDR	Website EUDAMED record Report an error
B.P.C. Biosed –	Italy	EXTRA CLEANING CO40152 refs	A IVDR	Website info@bpcbiosed.it EUDAMED record Report an error
Beijing Kewei Clinical Diagnostic Reagent EU representative : Lotus NL B.V. (Netherlands)	China	Helicobacter Pylori Antigen Rapid Test Kit (FIA)98/79	– 98/79	Website EUDAMED record Report an error
Beijing Microfuture Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	ULSEN ®SARS-CoV-2 Whole Genome Capture Kit Instruction98/79	– 98/79	EUDAMED record Report an error
Beijing Zhongjian Antai Diagnostic Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Mycoplasma Pneumoniae Antigen Combo Test Cassette: 1 Test/Kit	B IVDR	EUDAMED record Report an error
Bensrl	Italy	CALCIUM CHLORIDE VLR01022 refs	A IVDR	Website EUDAMED record Report an error
Beyotime EU representative : SUNGO Europe B.V. (Netherlands)	China	>200T	A IVDR	EUDAMED record Report an error
Bio-Rad Laboratories FDA EU representative : Bio-Rad (France)	United States	BioPlex 2200 MMRV IgG Control Set BioPlex 2200 MMRV IgG Assay2 refs	C IVDR	Website contact@bio-rad.com EUDAMED record Report an error
Biodatacorp EU representative : mdi Europa GmbH (Germany)	United States	Lupus Anticoagulant Confirmation Reagent (LACR)	A IVDR	Website customer.service@biodatacorp.com EUDAMED record Report an error
Bioeuropegmbh	Germany	Fortel Ulcer (H. pylori) Screening Test 1005-198/79	– 98/79	Website info@bioeuropegmbh.com EUDAMED record Report an error
BioGX FDA	Netherlands	BioGX Syphilis - OSR for BD MAX98/79	– 98/79	Website EUDAMED record Report an error
BiopSafe FDA	Denmark	BiopSafe®3 refs	A IVDR	Website info@biopsafe.com EUDAMED record Report an error
Biosense EU representative : MD&D Alliance GmbH (Germany)	India	HbChek	A IVDR	regulatory.affairs@biosense.in EUDAMED record Report an error
biosurfit	Portugal	spinit®2 refs98/79	– 98/79	info@biosurfit.com EUDAMED record Report an error
Bioteke FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	ZK1000-1, ZK1500-1, ZK1000-5, ZK1500-2, ZK1500-3, ZK1500-4, ZK1500-53 refs	A IVDR	Website info@bioteke.cn EUDAMED record Report an error
Bioyuan EU representative : Obelis s.a. (Belgium)	China	Coagulation Control refer to IFU14 refs98/79	– 98/79	ra@bioyuan.cn EUDAMED record Report an error
Bredlifesci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Kit for Determination of the DNA Fragmentation level in Spermatozoa (SCD method)2 refs	A IVDR	info@bredlifesci.com EUDAMED record Report an error
Candore EU representative : CMC Medical Devices & Drugs SL (Spain)	India	CANfrag CA-0012 refs	A IVDR	Website EUDAMED record Report an error
Cerca Biotech	Germany	RNXtract Kit	A IVDR	EUDAMED record Report an error
Cespu	Portugal	CESPU Diagnóstico CYTO2 refs	A IVDR	EUDAMED record Report an error
Challenbio EU representative : MedPath GmbH (Germany)	China	IsFlower QC Beads2 refs	A IVDR	sale@challenbio.com EUDAMED record Report an error
Changsha Han Biotechnology EU representative : Medunion S.L. (Spain)	China	Blood Cell Test Reagent JY-05：50 tests/kit	A IVDR	EUDAMED record Report an error
Chengdu One-Chip Biotechnology EU representative : Share info GmbH (Germany)	China	eTrust® 1 test/kit98/79	– 98/79	EUDAMED record Report an error
Chengdu Polytech Biological Technology EU representative : MedNet EC-REP GmbH (Germany)	China	tHb Kit(Colorimetry)98/79	– 98/79	EUDAMED record Report an error
Core Technology FDA EU representative : Medunion S.L. (Spain)	China	HAV IgM Test Strip & Cassette B01-1198/79	– 98/79	EUDAMED record Report an error
Credence Genomics EU representative : Obelis s.a. (Belgium)	Sri Lanka	Bactfast CGNBF001	A IVDR	Website EUDAMED record Report an error
Cyanagen	Italy	STAR BEADS PATHOGEN DNA/RNA EXTRACTION KIT	A IVDR	Website EUDAMED record Report an error
Cytocell FDA EU representative : Sysmex Europe SE (Germany)	United Kingdom (ex Northern Ireland)	DAPI Antifade ES2 refs	A IVDR	Website contact@ogt.com EUDAMED record Report an error
Dagatron FDA EU representative : BZT-TCP Certification GmbH (Germany)	South Korea	AFB(Fluorescence) Stain Reagent Kit3 refs	A IVDR	Website EUDAMED record Report an error
Delbio EU representative : Emergo Europe B.V. (Netherlands)	Taiwan	DELBIO GS1 Nucleic Acid Extraction Kit3 refs	A IVDR	Website EUDAMED record Report an error
Demeditec FDA	Germany	Epstein-Barr Virus (VCA) IgG ELISA98/79	– 98/79	Website info@demeditec.de EUDAMED record Report an error
Desitec	Italy	10xBRJ60 BIOREJAR3 refs	A IVDR	Website info@desitec.it EUDAMED record Report an error
Diatech Pharmacogenetics	Italy	EasyPGX ready HPV	C IVDR	Website info@diatechpharmacogenetics.com EUDAMED record Report an error
Dynodx EU representative : HUMISS TRADING S. L. (Spain)	China	CBCR type, CBC type98/79	– 98/79	EUDAMED record Report an error
Edna	Türkiye	CarciScan HPV PCR Assay for Cervical Cancer Screening Genotyping for HPV16, HPV18 and HPV 45 (CS3), 100 tests98/79	– 98/79	Website EUDAMED record Report an error
Eifelfango	Germany	Natriumcitrat Lösung 3,13% 10 x 1 ml Natriumcitrat Lösung 3,13% 10x1ml	A IVDR	Website EUDAMED record Report an error
Eschweiler	Germany	ESCHWEILER Sensor tHb98/79	– 98/79	Website info@eschweiler-kiel.de EUDAMED record Report an error
Esteriplas	Portugal	150ml ANAPAT Prefilled, contentores pré-cheios com Formol a 10% tamponado2 refs	A IVDR	Website EUDAMED record Report an error
FAR	Italy	HEMOGLOBIN A298/79	– 98/79	order@fardiag.com EUDAMED record Report an error
Farmasino EU representative : Humiss International B.V. (Netherlands)	China	Dengue Rapid Test Kit (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Feinchemie	Germany	Lugols-Lösung	A IVDR	Website info@feinchemie.de EUDAMED record Report an error
Filling	Germany	EUKITT3 refs	A IVDR	info@orsatec.de EUDAMED record Report an error
GenBody FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	HMCT001	B IVDR	EUDAMED record Report an error
Geneall EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	AllEx™ Mini Viral DNA/RNA Kit 972-048	A IVDR	Website sales@geneall.com EUDAMED record Report an error
Genemind EU representative : Medunion S.L. (Spain)	China	GeneMind 96 tests/kit2 refs98/79	– 98/79	regulatoryaffairs@genemind.com EUDAMED record Report an error
Genhawk (Wuhan) Biotech EU representative : SUNGO Europe B.V. (Netherlands)	China	Neisseria meningitidis antisera21 refs98/79	– 98/79	EUDAMED record Report an error
GenMark Diagnostics FDA EU representative : Roche Diagnostics GmbH (Germany)	United States	cobas® eplex respiratory pathogen panel 3 (RP3)	B IVDR	regulatory.rmd_international@roche.com EUDAMED record Report an error
Geratherm	Germany	Geratherm® chlamydia check98/79	– 98/79	Website info@geratherm.com EUDAMED record Report an error
Guangzhou Hearty Expression Medical Technology EU representative : Everbiz GmbH (Germany)	China	Immunol Fluorescence Staining Kit	A IVDR	EUDAMED record Report an error
Guangzhou Huayue Keju Biotech EU representative : SUNGO Europe B.V. (Netherlands)	China	HuayueKeju BS-450;BS-5002 refs	A IVDR	EUDAMED record Report an error
Hangzhou Beiwo Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	Pathogen DNA/RNA Purification Kit (Beads) BW-MGD2411-A00 BW-MGD2411-A32 BW-MGD2411-A32-32 BW-MGD2411-A96	A IVDR	EUDAMED record Report an error
Hangzhou DIAN Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	GENEDIAN2 refs98/79	– 98/79	EUDAMED record Report an error
Hangzhou HealthSky Biotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Healthsky FPA01-AT FPA02-ET FPA02-FT FPA01-ET FPA02-GT FPA01-BT FPA02-MT3 refs	A IVDR	EUDAMED record Report an error
Hangzhou Higene Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	FLU A+B Antigen combo Rapid Test98/79	– 98/79	EUDAMED record Report an error
Hangzhou MiYin Biotechnology EU representative : SUNGO Europe B.V. (Netherlands)	China	TQ-XJ-D-032 ；TQ-XQ-R-0323 refs	A IVDR	EUDAMED record Report an error
Hangzhou Testsea Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Influenza Ag A/B Test RB00798/79	– 98/79	EUDAMED record Report an error
Helixgen (GUANGZHOU) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	PT/INR test strip98/79	– 98/79	EUDAMED record Report an error
Hosmed Grup Medi̇kal Sağlik Hi̇zmetleri̇ Şi̇rketi̇	Türkiye	HOSMED PATHGYNE FIX 1022 refs	A IVDR	EUDAMED record Report an error
Huachenyang (Shenzhen) Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	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 refs	A IVDR	EUDAMED record Report an error
Humadx EU representative : Human Gesellschaft für Biochemica und Diagnostica mbH (Germany)	China	25T2 refs98/79	– 98/79	service@humadx.com.cn EUDAMED record Report an error
Imedikers EU representative : Veritas Eston OÜ (Estonia)	South Korea	I-PREP LBC Solution GYN	A IVDR	info@veritaseston.eu EUDAMED record Report an error
ImmuChrom	Germany	HPLC testkit Homocysteine98/79	– 98/79	info@immuchrom.de EUDAMED record Report an error
Jiangxi CellGene Biotechnology EU representative : Medunion S.L. (Spain)	China	TBNK Kit with Absolute Counting (Lyophilized Pellets) 50tests/kit98/79	– 98/79	marketing@cell-genebio.com EUDAMED record Report an error
Jiezibio EU representative : SUNGO Europe B.V. (Netherlands)	China	10tests/kit98/79	– 98/79	EUDAMED record Report an error
Kurabo EU representative : MedNet EC-REP GmbH (Germany)	Japan	QuickGene-AutoS DNA Blood Kit	A IVDR	Website qa@kurabo-grp.com EUDAMED record Report an error
Lab Diagnostic Systems (SMC) EU representative : SUNGO Europe B.V. (Netherlands)	Pakistan	R-test Cryptococcus Capsular Polysaccharide Rapid Test 50 Tests98/79	– 98/79	info@ldspak.com EUDAMED record Report an error
Labpathexperts	Poland	Paraffin 54-57 deg C, Blue3 refs	A IVDR	Website office@labpathexperts.com EUDAMED record Report an error
Laurypath	France	10% NEUTRAL BUFFERED FORMALIN 10L3 refs	A IVDR	Website contact@laurypath.fr EUDAMED record Report an error
Leadmanbio EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Treponema Pallidum Antibody（Anti-TP）Assay Kit 100 Tests98/79	– 98/79	EUDAMED record Report an error
Lgm International FDA EU representative : Wellkang Ltd (Northern Ireland)	United States	Liqui-PREP® Collection Vials - 200 60-010	A IVDR	Website customerservice@lpalp.com EUDAMED record Report an error
Livzondiagnostics FDA EU representative : QbD RepS BV (Belgium)	China	100 tests/kit (20×5)；220 tests/kit (55 × 4)2 refs	C IVDR	Website ra@livzondiagnostics.com EUDAMED record Report an error
LM4med	Germany	Formaldehyde solution 4% buffered3 refs	A IVDR	Website EUDAMED record Report an error
Macherey-Nagel FDA	Germany	NucleoMag® Dx Pathogen	A IVDR	Website sales@mn-net.com EUDAMED record Report an error
magtivio	Netherlands	MagSi-DX Pathogen Plus3 refs	A IVDR	info@magtivio.com EUDAMED record Report an error
Mdlsrl FDA	Italy	BIOREJAR	A IVDR	Website info@mdlsrl.com EUDAMED record Report an error
Medilab	Czechia	Paraffin Wax - 1 kg3 refs	A IVDR	Website EUDAMED record Report an error
MEDx (Suzhou) Translational Medicine EU representative : Kingsmead Service B.V. (Netherlands)	China	30 tests /kit2 refs98/79	– 98/79	ra@medxtmc.com EUDAMED record Report an error
Menarinidiagnostics	Italy	PRIME MDx DNA/RNA Extraction kit 2 x48 rxn2 refs	A IVDR	Website EUDAMED record Report an error
Molzym	Germany	MolYsis-SNplus™ IVD U-300-0122 refs	A IVDR	info@molzym.com EUDAMED record Report an error
Mondial	Italy	DT18 - ALDEIDE FORMICA PER ISTOLOGIA3 refs	A IVDR	Website info@mondialprod.it EUDAMED record Report an error
Newscen EU representative : Wellkang Ltd (Northern Ireland)	China	HIV3-292040170003 refs	D IVDR	Website EUDAMED record Report an error
OSANG Healthcare FDA EU representative : Obelis s.a. (Belgium)	South Korea	GeneFinder STDI( CT/NG/UU) Multiplex Real-time PCR kit IFMR-0398/79	– 98/79	Website EUDAMED record Report an error
Oxford Immunotec FDA EU representative : Wallac Oy (Finland)	United Kingdom (ex Northern Ireland)	T-SPOT.TB TB.300	C IVDR	regulatory.oxford@revvity.com EUDAMED record Report an error
Pharmaline	Türkiye	UniPatogen CerviPan HPV qPCR Screening Kit3 refs	C IVDR	info@pharmaline.com.tr EUDAMED record Report an error
PHC FDA EU representative : PHC Europe B.V. (Netherlands)	Japan	PATHFAST D-Dimer	C IVDR	EUDAMED record Report an error
PlexBio FDA EU representative : MDSS GmbH (Germany)	Taiwan	IntelliPrep Blood GenomicDNA Extraction Kit 830153 refs	A IVDR	EUDAMED record Report an error
Poth Hille & FDA EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Histology Wax3 refs	A IVDR	Website EUDAMED record Report an error
Preox	Germany	preOx - HUT Helicobacter Urease Test7 refs98/79	– 98/79	Website sales@preox.de EUDAMED record Report an error
PreTect FDA	Norway	PreTect X2 refs	A IVDR	Website EUDAMED record Report an error
Probe & go Labordiagnostica	Germany	Glucose Lösung	A IVDR	Website info@probe-go.de EUDAMED record Report an error
Proteome EU representative : Propath bv (Belgium)	United Kingdom (ex Northern Ireland)	Formalin3 refs	A IVDR	Website EUDAMED record Report an error
Qingdao Huaren Medical Product EU representative : Lotus NL B.V. (Netherlands)	China	Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)5 refs98/79	– 98/79	EUDAMED record Report an error
Quidel Cardiovascular FDA EU representative : MDSS GmbH (Germany)	United States	Triage D-Dimer2 refs98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
RBCBioscience EU representative : Obelis s.a. (Belgium)	Taiwan	MagCore® Circulating DNA large volume kit3 refs	A IVDR	Website EUDAMED record Report an error
Reme-D For Laboratory Equipment Chemicals EU representative : Qualitech International B.V. (Netherlands)	Egypt	COL-NA Universal DE-01-U	A IVDR	Website EUDAMED record Report an error
Runpubio EU representative : R Sight B.V. (Netherlands)	China	BT Liss	A IVDR	Website EUDAMED record Report an error
RWD Life Science FDA EU representative : WISELINK MEDICAL, S.L.U. (Spain)	China	Frozen Section Embedding Compound FS-EM	A IVDR	Website EUDAMED record Report an error
Sacace	Italy	DNA-Sorb-A3 refs	A IVDR	Website info@sacace.com EUDAMED record Report an error
Sakura Finetek USA EU representative : Sakura Finetek Europe B.V. (Netherlands)	United States	Tissue-Tek Xpress® Molecular Fixative Solution Pre-Processing Solution3 refs	A IVDR	PRRC@sakuraus.com EUDAMED record Report an error
Salofa FDA	Finland	Strep A test kit 75-75STREPA-xx98/79	– 98/79	Website info@salofa.com EUDAMED record Report an error
Samantree FDA EU representative : SamanTree Medical France SASU (France)	Switzerland	Histolog®️ Dip 005	A IVDR	Website info@samantree.com EUDAMED record Report an error
Sanway Gene Tech EU representative : Obelis s.a. (Belgium)	China	Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)98/79	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Screen Italia	Italy	Screen Test FLU A/B SC-0623-2098/79	– 98/79	Website info@screenitalia.it EUDAMED record Report an error
Shandon Diagnostics FDA EU representative : Epredia Netherlands B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	Histoplast 10kg2 refs	A IVDR	EUDAMED record Report an error
Shanghai Zymetas Medtech EU representative : SUNGO Europe B.V. (Netherlands)	China	24T98/79	– 98/79	EUDAMED record Report an error
Shenzhen Freecom Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	GP100098/79	– 98/79	EUDAMED record Report an error
Shenzhen Huisong Technology Development EU representative : Lotus NL B.V. (Netherlands)	China	Product Name Nucleic Acid Extraction Kit HH-6160	A IVDR	EUDAMED record Report an error
Shenzhen Huiyan Sci-Tech Biotechnology EU representative : Medunion S.L. (Spain)	China	Interleukin 6 (IL-6) Test Kit (Immunofluorescence)98/79	– 98/79	sales@szhykc.com EUDAMED record Report an error
Shenzhen Nucleus Biotechnology EU representative : Kingsmead Service B.V. (Netherlands)	China	Nucleic Acid Extraction Kit NBE01-C	A IVDR	EUDAMED record Report an error
Shenzhen Wellgrow Biotech EU representative : SUNGO Europe B.V. (Netherlands)	China	CD3 FITC 50T/Kit98/79	– 98/79	Website EUDAMED record Report an error
Sichuan Xincheng Biological EU representative : CMC Medical Devices & Drugs SL (Spain)	China	25 Tests98/79	– 98/79	EUDAMED record Report an error
Sinseng EU representative : Sungo Cert GmbH (Germany)	China	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 refs	A IVDR	service@sinseng.com.cn EUDAMED record Report an error
Sunbiote EU representative : Lotus NL B.V. (Netherlands)	China	Imidazole Buffer Solution2 refs	A IVDR	Website EUDAMED record Report an error
Sykehusapotekene	Norway	Etanol SA 50 % til cytologi	A IVDR	Website EUDAMED record Report an error
Taho Future ( Tianjin ) Biotechnology EU representative : MedPath GmbH (Germany)	China	Cleaning Solution MC-Coulter	A IVDR	info@tahobiology.com EUDAMED record Report an error
tascom EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	SimplexTAS 101 Hb Reagent Cartridge98/79	– 98/79	EUDAMED record Report an error
Techno-path Manufacturing FDA	Ireland	Multichem ID-Chagas	C IVDR	Website EUDAMED record Report an error
Tecnobilife	Italy	SAFE BIOPSY BOX 20 ML - CONTENITORE CON FORMALINA E SISTEMA DI SICUREZZA 000223 refs	A IVDR	EUDAMED record Report an error
Tharmac	Germany	GynoPrep Verdünnungsflüssigkeit 30 ml3 refs	A IVDR	Website info@tharmac.de EUDAMED record Report an error
Tianjin Readybio Medical Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Cleaning Solution MC-Coulter	A IVDR	EUDAMED record Report an error
Todylaboratories	Romania	ADENOVIRUS RAPID TEST CASSETTE (FECES) C61RT10052 refs	A IVDR	Website contact@todylaboratories.com EUDAMED record Report an error
Vector Surgical FDA EU representative : MDSS GmbH (Germany)	United States	Vividex Suite	A IVDR	Website regulatory@vectorsurgical.com EUDAMED record Report an error
Veracyte FDA EU representative : Veracyte Global BV (Netherlands)	France, United States	Veracyte FFPE RNA Extraction Kit	A IVDR	Website EUDAMED record Report an error
Vitapaw Tech Hk EU representative : Maybon Noxa OÜ (Estonia)	Hong Kong SAR China	D3IN1	A IVDR	EUDAMED record Report an error
Vitromed FDA	Germany	V-SPERM MOPRHO SLIDE	A IVDR	Website info@vitromed.com EUDAMED record Report an error
Wallac	Finland	RESOLVE Hb FASC Control Kit98/79	– 98/79	Website regulatoryaffairs.turku@revvity.com EUDAMED record Report an error
Wizbiosolution EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	W73052-100	A IVDR	EUDAMED record Report an error
Xprecia Testing Pty EU representative : MediMark Europe Sarl. (France)	Australia	Xprecia Stride PT/INR Test Strips98/79	– 98/79	Website EUDAMED record Report an error
YD Diagnostics FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	EASYPREP Preservative solution(GYN), EASYPREP Preservative solution(NON-GYN)2 refs	A IVDR	Website admin@yd-diagnostics.com EUDAMED record Report an error
Zafena	Sweden	Simple Simon PT98/79	– 98/79	Website info@zafena.se EUDAMED record Report an error
Zhejiang Gewuzhizhi Biotechnology EU representative : Medunion S.L. (Spain)	China	Interleukin-8 (IL-8) Test Kit (CLIA) 100Test/Kit98/79	– 98/79	Website EUDAMED record Report an error
Zhongshan Chuangyi Biochemical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	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.	A IVDR	EUDAMED record Report an error
Zhuhai Shineway Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	SW-RCA-0198/79	– 98/79	Website EUDAMED record Report an error
Vitro Scient EU representative : MDSS GmbH (Germany) No model still on the market	Egypt	Antihuman globulin (Polyspecific) 10 x 10 ml - 2060198/79 (no longer marketed) Bovine serum Albumin 22% 10 x 10 ml - 2050198/79 (no longer marketed) Bovine serum Albumin 30% 10 x 10 ml - 2070198/79 (no longer marketed) Brucella Abortus 100 tests - 5100198/79 (no longer marketed) Brucella Melitensis 100 tests - 5110198/79 (no longer marketed) 44 others D-Dimer Turbilatex 50 Tests - 7050198/79 (no longer marketed) FDP 15 Tests - 3050198/79 (no longer marketed) Febrile Antigen 2 x 100 tests - 5170198/79 (no longer marketed) Febrile Antigen 4 x 100 tests98/79 (no longer marketed) Febrile Antigen 6 x 100 tests - 5130198/79 (no longer marketed) Febrile Antigen 8 x 100 tests98/79 (no longer marketed) Febrile Antigen Salmonella Paratyphi AH98/79 (no longer marketed) Febrile Antigen Salmonella Paratyphi BH 100 tests - 5040198/79 (no longer marketed) Febrile Antigen Salmonella Paratyphi BO 100 tests - 5070198/79 (no longer marketed) Febrile Antigen Salmonella Paratyphi CH 100 tests - 5050198/79 (no longer marketed) Febrile Antigen Salmonella Typhi AO 100 tests - 5060198/79 (no longer marketed) Febrile Antigen Salmonella Typhi CO 100 tests - 5080198/79 (no longer marketed) Febrile Antigen Salmonella Typhi H 100 tests - 5020198/79 (no longer marketed) Febrile Antigen Salmonella Typhi O 100 tests - 5010198/79 (no longer marketed) Fibrinogen 20 Tests - 3040198/79 (no longer marketed) Hemoglobin ( 1 + 9 ) 4 x 100 ml - 1240198/79 (no longer marketed) Hemoglobin ( 1 + 99 ) 1 x 25 ml - 1280198/79 (no longer marketed) Hemoglobin ( 1 + 99 ) 10 x 25 ml - 1280498/79 (no longer marketed) Hemoglobin ( 1 + 99 ) 2 x 25 ml - 1280298/79 (no longer marketed) Hemoglobin ( 1 + 99 ) 5 x 25 ml - 1280398/79 (no longer marketed) Hemoglobin (Ready for use) 1 x 500 ml - 1270198/79 (no longer marketed) Hemoglobin (Ready for use) 2 x 500 ml - 1270298/79 (no longer marketed) Partial Thromboplastin Time 1 X 4 ml - 3030198/79 (no longer marketed) Partial Thromboplastin Time 10 X 4 ml - 3030698/79 (no longer marketed) Partial Thromboplastin Time 4 X 5 ml - 3030498/79 (no longer marketed) Partial Thromboplastin Time 5 X 3 ml - 3030398/79 (no longer marketed) Partial Thromboplastin Time 5 X 4 ml - 3030598/79 (no longer marketed) Partial Thromboplastin Time 8 X 2 ml - 3030298/79 (no longer marketed) Plasma Control L-1 1 ml - 3060198/79 (no longer marketed) Plasma Control L-2 3070198/79 (no longer marketed) Prothrombin time (ISI 1.00) 1 X 8 ml - 3020298/79 (no longer marketed) Prothrombin time (ISI 1.00) 10 X 8 ml - 3020598/79 (no longer marketed) Prothrombin time (ISI 1.00) 2 X 8 ml - 3020398/79 (no longer marketed) Prothrombin time (ISI 1.00) 4 X 5 ml - 3020698/79 (no longer marketed) Prothrombin time (ISI 1.00) 6 X 8 ml - 3020498/79 (no longer marketed) Prothrombin time (ISI 1.00) 8 X 2 ml - 3020198/79 (no longer marketed) Prothrombin time (ISI 1.5) 1 X 8 ml - 3010298/79 (no longer marketed) Prothrombin time (ISI 1.5) 10 X 8 ml - 3010598/79 (no longer marketed) Prothrombin time (ISI 1.5) 2 X 8 ml - 3010398/79 (no longer marketed) Prothrombin time (ISI 1.5) 4 X 5 ml - 3010698/79 (no longer marketed) Prothrombin time (ISI 1.5) 6 X 8 ml - 3010498/79 (no longer marketed) Prothrombin time (ISI 1.5) 8 X 2 ml - 3010198/79 (no longer marketed) Rose Bengal 100 Tests - 5160298/79 (no longer marketed) Rose Bengal 50 Tests - 5160198/79 (no longer marketed)	– 98/79	Website info@vitroscient.com EUDAMED record Report an error
Biotime EU representative : Lotus NL B.V. (Netherlands) and 1 other No model still on the market	China	BIOTIME10 refs98/79 (no longer marketed) BIOTIME Dengue NS1 Antigen Rapid Test98/79 (no longer marketed) D-Dimer Rapid Quantitative Test BT210598/79 (no longer marketed) Dengue Ag &Ab Combo Rapid Test BT010180198/79 (no longer marketed) Dengue IgG/IgM Rapid Test BT010170198/79 (no longer marketed) 11 others IL-6 Rapid Quantitative Test (Fluorescence Immunoassay)98/79 (no longer marketed) Malaria P.f Antigen Rapid Test BT010190198/79 (no longer marketed) Malaria P.f/P.v Antigen Rapid Test BT010210198/79 (no longer marketed) Malaria P.f/Pan Antigen Rapid Test BT010220198/79 (no longer marketed) Malaria P.v Antigen Rapid Test BT010200198/79 (no longer marketed) MPV Quantitative Test (Realtime PCR)98/79 (no longer marketed) MPV Rapid Quantitative Test (eRDA)2 refs98/79 (no longer marketed) Mycoplasma Pneumoniae Antigen Rapid Qualitative Test BT010260198/79 (no longer marketed) Mycoplasmal Pneumonia IgM Rapid Qualitative Test98/79 (no longer marketed) SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）4 refs98/79 (no longer marketed) Treponema pallidum Antibody Rapid Qualitative Test BT010270198/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Mobidiag No model still on the market	Finland	Amplidiag Bacterial GE Kit98/79 (no longer marketed) Amplidiag C. difficile+027 Kit98/79 (no longer marketed) Amplidiag COVID-19 Kit98/79 (no longer marketed) Amplidiag Easy Extraction Kit I (no longer marketed) Amplidiag H. pylori+ClariR Kit98/79 (no longer marketed) 8 others Amplidiag RESP-4 Kit98/79 (no longer marketed) Amplidiag Stool Parasites Kit98/79 (no longer marketed) Amplidiag Viral GE Kit98/79 (no longer marketed) Novodiag Bacterial GE+98/79 (no longer marketed) Novodiag C. difficile98/79 (no longer marketed) Novodiag COVID-1998/79 (no longer marketed) Novodiag RESP-498/79 (no longer marketed) Novodiag Stool Parasites98/79 (no longer marketed)	A IVDR, 98/79	Website sales.mob@hologic.com EUDAMED record Report an error
Nantong EgensBiotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) and 1 other No model still on the market	China	Dengue IgM/IgG test cassette Dengue-IgM/IgG 25210298/79 (no longer marketed) Dengue NS1 antigen test cassette Dengue-NS1 25210298/79 (no longer marketed) Dengue NS1/IgM/IgG test cassette Dengue-NS1/IgM/IgG 25210298/79 (no longer marketed) Diagnostic kit for anti-HAV IgM( Colloidal Gold) HAV-IgM strip cassette98/79 (no longer marketed) Diagnostic kit for Antibody to Treponema Pallidum (Colloidal Gold) TP strip cassette98/79 (no longer marketed) 7 others Diagnostic Kit for Helicobacter pylori antigen (Colloidal Gold) HP-Ag strip cassette98/79 (no longer marketed) Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold) MA-Pf/Pv strip cassette98/79 (no longer marketed) Diagnostic Kit for P.falciparum Antigen （Colloidal Gold) MA-Pf strip cassette98/79 (no longer marketed) Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold) MA-Pan/Pf strip cassette98/79 (no longer marketed) H.Pylori Antibody (HP) Test HP strip cassette98/79 (no longer marketed) Influenza A/Influenza B (FluA+B) Antigens Rapid Test Kit Flu Cassette98/79 (no longer marketed) Typhoid IgG/IgM test cassette98/79 (no longer marketed)	– 98/79	qa@egens-bio.cn EUDAMED record Report an error
Princeton BioMeditech FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) No model still on the market	United States	Accusay Mono98/79 (no longer marketed) BioSign Flu A&B98/79 (no longer marketed) BioSign H. pylori98/79 (no longer marketed) BioSign Mono98/79 (no longer marketed) BioStrep A98/79 (no longer marketed) 7 others Immunocard STAT Flu A&B98/79 (no longer marketed) Immunocard STAT Flu A&B Nasopharyngeal Wash/Aspirate accessory kit98/79 (no longer marketed) Status COVID-19/Flu98/79 (no longer marketed) Status Flu A+B98/79 (no longer marketed) Status H. pylori98/79 (no longer marketed) Status Mono98/79 (no longer marketed) Status Strep A98/79 (no longer marketed)	– 98/79	Website info@pbmc.com EUDAMED record Report an error
Chemclin EU representative : MedNet EC-REP GmbH (Germany) No model still on the market	China	Interleukin 6 (Light-initiated Chemiluminescence Immunoassay, LiCA) 2 × 100 Tests98/79 (no longer marketed) Interleukin 6 (Light-initiated Chemiluminescence Immunoassay, LiCA) 2 × 200 Tests98/79 (no longer marketed) Interleukin 6 (Light-initiated Chemiluminescence Immunoassay, LiCA) 4 × 100 Tests98/79 (no longer marketed) Interleukin 6 (Light-initiated Chemiluminescence Immunoassay, LiCA) 4 × 200 Tests98/79 (no longer marketed) LiCA D-Dimer 2 × 100 Tests98/79 (no longer marketed) 4 others LiCA D-Dimer 2 × 50 Tests98/79 (no longer marketed) LiCA D-Dimer 4 × 100 Tests98/79 (no longer marketed) LiCA D-Dimer 4 × 50 Tests98/79 (no longer marketed) LiCA Toxo lgG 2 × 50 Tests; 2 × 50 Tests; 2 × 100 Tests; 4 × 100 Tests3 refs (no longer marketed)	C IVDR, 98/79	Website EUDAMED record Report an error
Uniogen No model still on the market	Finland	GenomEra C. difficile Assay Kit CDX-403 refs98/79 (no longer marketed) GenomEra GBS Assay Kit CDX-602 refs98/79 (no longer marketed) GenomEra HSV 1/2, VZV + EV Assay Kit CDX-1702 refs98/79 (no longer marketed) GenomEra MRSA/SA AC Assay Kit CDX-30-052 refs98/79 (no longer marketed) GenomEra MRSA/SA Multi Swab Assay Kit CDX-30-0298/79 (no longer marketed) 4 others GenomEra Norovirus Assay kit CDX-1002 refs98/79 (no longer marketed) GenomEra S. pneumoniae Assay Kit CDX-702 refs98/79 (no longer marketed) GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit CDX-1602 refs98/79 (no longer marketed) GenomEra SARS-CoV-2, Flu A/B + RSV Assay Kit CDX-1403 refs98/79 (no longer marketed)	– 98/79	info@uniogen.com EUDAMED record Report an error
Chemelex No model still on the market	Spain	Antígenos Bacterianos11 refs98/79 (no longer marketed) Antígenos Bacterianos Control Negativo98/79 (no longer marketed) Antígenos Bacterianos Control Positivo98/79 (no longer marketed) Antígenos Bacterianos PROTEUS OX1998/79 (no longer marketed) Antígenos Bacterianos PROTEUS OX298/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Hangzhou ShengTing Medical Technology EU representative : Medunion S.L. (Spain) No model still on the market	China	Mycobacterium nucleic acid and M. tuberculosis drug resistance gene detection kit V2.198/79 (no longer marketed) Mycobacterium nucleic acid and M. tuberculosis drug resistance gene detection kit V2.298/79 (no longer marketed) Mycobacterium nucleic acid and M. tuberculosis drug resistance gene detection kit V3.198/79 (no longer marketed) Smartseq-DNA&RNA detection kit V3.198/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Labquality No model still on the market	Finland	B-Trol ESR Control L12 refs98/79 (no longer marketed) B-Trol ESR Control L22 refs98/79 (no longer marketed) B-Trol Plus Control Abnormal Level98/79 (no longer marketed) B-Trol Plus Control Normal Level98/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Ns Biotec EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	Egypt	Brucella Brob-Ma-10098/79 (no longer marketed) D-dimer Ddm-Cal-05098/79 (no longer marketed) Fibrinogen Fib-M-050198/79 (no longer marketed) PTT98/79 (no longer marketed)	– 98/79	Website info@nsbiotec.com EUDAMED record Report an error
Anouve EU representative : Obelis s.a. (Belgium) No model still on the market	China	Anouve 32 tests/box (no longer marketed) Anouve 48 tests/box (no longer marketed) Anouve 50 tests/box (no longer marketed)	A IVDR	Website EUDAMED record Report an error
Deben Diagnostics EU representative : EU-UK Authorised Representative Ltd (Northern Ireland) No model still on the market	United Kingdom (ex Northern Ireland)	Haemagglutination Assay (TPHA) Kit3 refs98/79 (no longer marketed) Rapid Plasma Reagin (RPR) Kit2 refs98/79 (no longer marketed) VDRL Carbon Antigen98/79 (no longer marketed)	– 98/79	Website info@debendiagnostics.co.uk EUDAMED record Report an error
IDL Biotech No model still on the market	Sweden	TUBEX TF 10-20198/79 (no longer marketed) TUBEX TF Wash 10-50198/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Raingene EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	FluA/FluB/RSV Virus Nucleic Acid Detection Kit 10tests/kit, 20tests/kit98/79 (no longer marketed) Multiply Respiratory Pathogen Virus Nucleic Acid Detection Kit 10tests/kit，20tests/kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Xpenarray EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	China	XN 3000\XN 3100\XN 3200\XN 33002 refs98/79 (no longer marketed) XN 6000\XN 6100\XN 6200\XN 6300\XN 6500\XN 6600\XN 67003 refs98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
AccuBio EU representative : Advena Limited (Malta) No model still on the market	United Kingdom (ex Northern Ireland)	VISITECT AB37698/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Innobiochips No model still on the market	France	SirYus Covidiag2 refs98/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Rossix FDA No model still on the market	Sweden	Rox Factor IX98/79 (no longer marketed)	– 98/79	Website info@rossix.com EUDAMED record Report an error
S.D. Sight Diagnostics FDA EU representative : CEpartner4U (Netherlands) No model still on the market	Israel	Sight OLO CBC Test Kit TK198/79 (no longer marketed)	– 98/79	Website info@sightdx.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 613

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Epitomics Inc.	–	Rabbit Monoclonal Anti-Human ER Alpha Antibody, EP1 Rabbit Monoclonal Anti-Human MSH6 Antibody, EP49 Rabbit Monoclonal Anti-Human HER2 / ErbB2 Antibody, EP3 Rabbit Monoclonal Anti-Human Estrogen Receptor Antibody, EP220 Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody, EP2 Rabbit Monoclonal Anti-Human c-Kit/CD117 Antibody, EP10	registered
BIOGENEX LABORATORIES	United States	ANTI-C-ERBB-2 (HER-2/NEU) ANTI-HER2/ERBB2 ANTI-EGFR ANTI-ESTROGEN RECEPTOR-ALPHA ANTI-P16(INK4) ANTI-PMS2	registered
Lonza Verviers	–	ProCHO5 w/Pluronic w/o L-Gln or HT, 1L PowerCHO-2 CD - 50L bag X-Vivo 20 w/o Genta, PR w/ U1,Optiferrin LONZA MEDIUM BASE 1 - 100 g ProCHO5 w/Pluronic w/o L-Gln or HT, 200L BPMSS L1_5M NaCl- 500 L bag	registered
Fuzhou Maixin Biotech Co., Ltd.	China	Mouse Monoclonal Anti-Human Desmin(MX046) Antibody Mouse Monoclonal Anti-Human TdT(MX010) Antibody Mouse Monoclonal Anti-Human Calretinin(MX027) Antibody Rabbit Monoclonal Anti-Human pan-TRK(MXR032) Antibody Mouse Monoclonal Anti-Human Galectin-3(MX060) Antibody Rabbit Monoclonal Anti-Human CD4(MXR036) Antibody	registered
MetaSystems Probes GmbH	Germany	MetaSystems Probes	registered
Life Technologies Corporation	United States	Ion Torrent Ion Torrent™ Dx Total NA Isolation Kit (-20 C) Ion Torrent™ Dx cDNA Synthesis Kit This is to test the length of the brand field and what it looks like in the GUDI Ion Torrent™ Dx RNA Quantification Kit Ion Torrent™ Dx DNA Quantification Kit	K241806 (2025)
Slmp, LLC	–	IHC	registered
Lonza Walkersville, Inc.	United States	GLS CHO Feed F CHO Feed Base L TheraPRO® CHO Feed UltraCulture Lonza Medium Base 1 CHO Feed Base F	registered
Phadia AB Present in Europe in other categories	Sweden	EliA Stool Extraction Buffer plus ImmunoCAP Allergen Rk208, Allergen component nGal d 4 Lysozyme, Egg ImmunoCAP Rare Allergen Rf333, Linseed ImmunoCAP Allergen Rf343, Raspberry ImmunoCAP Allergen Rf308, Sardine (Pilchard) ImmunoCAP Allergen Rt37, Bald cypress	registered
NOVODIAX, INC. Present in Europe in other categories	United States	QSX-Enh-P ER (ASR) QSX-Enh-P PR (ASR) QSX-Enh-P HER2 (ASR) DAB Kit ihcDirect® AE1/AE3 Abs ihc DAB 1:1 Kit	registered
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.	–	Research and Diagnostic Systems R&D CBC-XR Hematology Control	registered
Genbio	United States	ImmunoFLOW Negative Control Mycoplasma IgM IMMUNOFLOW™ Mycoplasma pneumoniae IgM Test ImmunoFLOW Mycoplasma IgM Positive Control ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST GenDx-LongMix	K963054 (1997)
IMMUNALYSIS CORP	–	Immunalysis Immunalysis Corporation	registered
CLARK LABORATORIES, INC.	United States	Trinity Biotech MarDx Bartels Phoenix Biotech BIO-RAD Bio-Stat	K980596 (1998)
Alpha-TEC Systems, Inc.	United States	Alpha-Tec Systems PVA (Zn) Fix/10% Formalin 25 sets	K890861 (1989)
MARDX DIAGNOSTICS, INC.	United States	Trinity Biotech	K951709 (1996)
Elitechgroup Mdx LLC	–	MGB Alert® EBV Probe Mix ASR - 480 Reactions MGB Alert® BKV ASR v3.0 Probe Mix MGB Alert HSV Ensemble Probe Mix ASR - 480 rxn MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reaction DSQ Alert® HT Pneumocystis jirovecii Probe Mix DSQ Alert HT Norovirus GII Primer Mix ASR	registered
George King Bio-Medical, Inc.	United States	George King Factor VIII Deficient Plasma with Inhibitor George King Factor XIII Deficient Plasma George King Positive Lupus Anticoagulant George King von Willebrand Plasma, Type 2A George King von Willebrand Plasma Type 3 George King von Willebrand Plasma Type 1	K161316 (2017)
Fort Worth Diagnostics, LLC	United States	Fort Worth Diagnostics	registered
DIAGNOSTIC HYBRIDS, INC.	United States	D3 Ultra D3 Fastpoint D3 D3 Duet Quidel Molecular Lyra	K092882 (2009)
Miltenyi Biotec B.V. & Co. KG Present in Europe in other categories	–	Anti-TCRg/d-PE-Vio770 CD2-VioBlue CD11b-APC CD45-APC CD117-APC CD66c-PE	registered
Nova Biomedical Corp.	United States	STAT PROFILE NOVA STATSTRIP STATSENSOR Nova Max NOVA/STAT PROFILE	K041016 (2004)
PRO-LAB, INCORPORATED Present in Europe in other categories	Canada	Prolex E. coli Non-O157 Identification Kit Prolex E. coli O157 Latex Test Reagent Kit (50 tests) Prolex E. coli O157 Latex Test Reagent Kit (100 tests) Prolex E. coli O26 Latex Reagent Prolex E. coli O111 Latex Reagent Prolex E. coli O91 Latex Reagent	K934383 (1995)
Fisher Scientific Co., LLC	United States	Sure-Vue Fisherbrand	K850636 (1985)
HARDY DIAGNOSTICS	United States	StaphTEX™ StrepPRO™ HardyDisk™ OxiSticks™ OxiStrips™ BlueMount™	K961191 (1996)
THE BINDING SITE GROUP LIMITED Present in Europe in other categories	United States	Human Antithrombin III BINDARID™ Radial Immunodiffusion Kit Optilite® Hevylite® IgM Lambda Control Pack Freelite® Human Kappa Free Control Pack For use on the Roche Cobas™ c Systems Freelite® Human Lambda Free Control Pack for use on the Siemens BN™II IgD AMR Fluid Optilite® Alpha-1-Antitrypsin Control Pack	K981914 (1999)
EXACT DIAGNOSTICS, LLC	–	Exact Diagnostics	registered
Helena Laboratories	United States	APTT-SA (Soluble Activator) Reagent Kit 0.25 M Calcium Chloride AB-TROL 2 Coagulation Control Coagulation S.A.C.-2 (Specialty Assay Control) AB-Trol 3 Coagulation Control Coagulation S.A.R.P (Specialty Assayed Reference Plasma)	K192931 (2022)
Roche Molecular Systems, Inc.	United States	cobas® cfDNA Sample Preparation Kit COBAS® AmpliPrep Instrument cobas® 4800 CT/NG Test v2.0 cobas® 4800 System Control Diluent Kit cobas&#x00AE PCR Media Uni Swab Sample Kit cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems	K260021 (2026)
Scientific Device Laboratory, Inc.	United States	–	K884069 (1988)
Fisher Diagnostics	United States	Thermo Scientific Pacific Hemostasis® Thermo Scientific Nerl® Thermo Scientific Protocol™ Parasitology System	K010750 (2001)
DRUCKER DIAGNOSTICS Present in Europe in other categories	United States	QBC Diagnostics	registered
Immunodiagnostic Systems , Ltd. Present in Europe in other categories	United Kingdom	IDS-iSYS 25 VitDS Control Set IDS ACTH II Calibrator Set IDS-iSYS Intact PTH Calibration Verifiers IDS-iSYS Ostase® BAP Calibration Verifiers IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers IDS-iSYS Intact PTH Control Set	K161082 (2016)
GENOLUTION. INC. Present in Europe in other categories	South Korea	NX Universal DNA Kit B NUE962 NX-Duo Universal DNA Kit A DUE961 NX Stool NA Kit A CSN231 NX Genomic DNA Kit A NGD041 NX-Duo Genomic DNA Kit A DGD961 NX-Duo cfDNA Kit A DCF242	registered
FUJIFILM IRVINE SCIENTIFIC, INC.	–	Chang Medium C Chang Medium in SITU Chang Amnio Chang Medium MF with Gentamicin Chang Medium BMC with Gentamicin Chang Medium D	registered
Quest Intl., Inc.	United States	ReQuest SeraQuest	K162276 (2016)
Quidel Corp.	United States	QuickVue Sofia QuickVue In-Line QuickVue+ InflammaDry Lyra	K230349 (2023)
Inova Diagnostics, Inc. Present in Europe in other categories	United States	NOVA Lite® IFA Hu (ANNA-1) Positive Control QUANTA Flash® β2GPI IgA Controls QUANTA Flash® DGP Screen Controls QUANTA Flash® LKM-1 Controls QUANTA Flash® Ro60 Controls QUANTA Flash RF IgM Controls	K024334 (2003)
Alere Scarborough, Inc.	United States	BinaxNOW RSV BinaxNOW Nasopharyngeal Swab Accessory Kit BinaxNOW RSV Control Swab Kit BinaxNOW Strep A Card BinaxNOW Strep A Control Swab Pack BinaxNOW Streptococcus pneumoniae Antigen Card	K173932 (2018)
DREW SCIENTIFIC, INC.	United Kingdom	Drew Scientific JAS Diagnostics Drew	K071562 (2007)
INVIVOSCRIBE, INC.	United States	Invivoscribe	registered
SARTORIUS STEDIM LAB LIMITED	–	Vivafree 500 Vivafree 2 Vivapore 5 Vivaspin 6 Vivapore 10/20 Vivaspin Turbo 4	registered
Sarstedt Aktiengesellschaft & Co.KG	–	Sediplus® S 200, 12 V DC Sediplus® S 2000 NX Micro tube 1.3ml K3E Micro tube 1.3ml LH Micro tube 1.3ml Z Micro tube 1ml 9NC	registered
ACCRIVA DIAGNOSTICS HOLDINGS, INC. Present in Europe in other categories	United States	Hemochron Whole Blood Microcoagulation System Hemochron Whole Blood Coagulation System directCHECK Whole Blood Controls HepCheck Whole Blood Control directCHECK ACT-LR Whole Blood Control, Level 2 directCHECK ACT+ Whole Blood Control Level 1	registered
OMNIS HEALTH, LLC	–	Embrace Gestational Diabetes Package - LARGE (9 vials) Embrace 50ct Test Strip Embrace Value Kit (50ct Included) Embrace Gestational Diabetes Package - SMALL (5 vials) Embrace Gestational Diabetes - Strips Refill Bundle (4 vials) Embrace Pro Meter	registered
CAROLINA LIQUID CHEMISTRIES CORPORATION	United States	CLC FAST DETERGENT 1 ALKALINE WASHING SOLUTION 100263 CAROLINA LIQUID CHEMISTRIES CORP.® WASH CONCENTRATE ST160 CAROLINA LIQUID CHEMISTRIES CORP.® WASH CONCENTRATE KIT 88805 CAROLINA LIQUID CHEMISTRIES CORP.® WASH SOLUTION AU-160 CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE WASH SOLUTION DT160 CAROLINA LIQUID CHEMISTRIES CORP.® WASH SOLUTION AU-2000	registered
INTERMOUNTAIN LIFE SCIENCES, LLC	–	Water for Injection, USP Sterile Grade Water for Irrigation, USP Sterile Grade Purified Water, USP Sterile Grade Water for Injection, EP/USP Sterile Grade Purified Water, USP Non-Sterile Grade Tryptic Soy Broth, Non-Animal Solution	registered
Cardinal Health 200, LLC Present in Europe in other categories	United States	CARDINAL HEALTH SP	registered
Incell Corporation, LLC	United States	ZAPR™ EZ-CPZ-ND™ EZ-CPZ™ M3:BaseF™ ZTM:A2™ M3:BaseA™	registered
Chromsystems Instruments + Chemicals GmbH	Germany	Plasma Control Plasma Control Bi-Level Serum Control Urine Control Whole Blood Control Bi-Level Serum Control Bi-Level	registered
HORIBA INSTRUMENTS INCORPORATED	United States	Pointe Lipoprotein (a) Control Set Pointe Scientific, Inc. Toxoplasma IgG Pointe Scientific, Inc. Toxoplasma IgM DIFFTROL MINOTROL 16 Pointe Scientific, Inc.	registered
TRIVIDIA HEALTH, INC.	United States	TRUE METRIX TRUEtrack TRUE FOCUS TRUEcontrol TRUENESS	registered
Diagnostic Automation, Inc.	–	AccuDiag ™ QMedix™	registered
Biomedica ADI Inc.	–	ACTISCREEN XL-FDP XL-FDP agglutination reagent DIMERTEST Latex assay LAtrol ABNORMAL CONTROL PLASMA ACTICLOT Protein C Resistance control plasmas LAtrol NORMAL CONTROL PLASMA	registered
Diamedix Corp.	United States	Diamedix	K093101 (2011)
MCKESSON MEDICAL-SURGICAL INC.	–	McKesson	registered
ENTOPSIS, LLC	–	PCRopsis	registered
MERCK MILLIPORE LIMITED Present in Europe in other categories	–	Amicon Ultra – 4 Amicon Ultra – 15 Centriprep-30K Centriprep-10K Minicon B15 Centrifree	registered
Mmqci	–	Birlinn™ CoV2-Flu-RSV Control Panel M509 BioFire RP2.1/RP2.1plus Control Panel M441 FilmArray GI Control Panel M238 SPOTFIRE RSP Negative Control FilmArray Warrior Control Panel M290 SPOTFIRE RSP Pos & Neg Controls	registered
DRG Instruments Gesellschaft mit beschränkter Haftung	–	Influenza Virus B IgG ELISA Influenza Virus A IgG ELISA Bordetella pertussis IgG ELISA Histamine ELISA Crosslaps Serum ELISA Borrelia burgdorferi IgG (Lyme) ELISA	registered
DRG International Inc	United States	Influenza Virus B IgG ELISA Influenza Virus A IgG ELISA Bordetella pertussis IgG ELISA Histamine ELISA Crosslaps Serum ELISA B. burgdorferi IgG/IgM ELISA	registered
Immuno-Mycologics, Inc.	United States	IMMY	registered
Primus Corp.	United States	Trinity Biotech	K955283 (1996)
BIOCYTECH CORPORATION SDN. BHD. Present in Europe in other categories	Malaysia	PathTezt®	registered
CYTOGNOS SL Present in Europe in other categories	Spain	CD45-APC-C750™ CD38-multi-epitope-FITC Kappa-APC MPO-FITC Lambda-APC-C750™ CD38-FITC	registered
Phoenix Diagnostics, Inc.	United States	PHOENIX DIAGNOSTICS, INC. Phoenix Diagnostics	registered
Advanced Instruments, Inc. Present in Europe in other categories	United States	Advanced Instruments GloCyte® Count Template Cartridge Advanced Instruments RBC Reagent Filtration Kit Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume Advanced Instruments GloCyte® Instrument Assembly Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays Advanced Instruments GloCyte® Automated Cell Counter System	K152776 (2016)
Mechatronics USA LLC	–	Starrsed	registered
BIOTEST MEDICAL CORPORATION	–	Oracle Perfect 3 Smartest PersonaII B T M	registered
FORA CARE INC. Present in Europe in other categories	Taiwan	FORA	registered
SCIMEDX CORPORATION	–	L. pneu 1-6C/Specimen Slide L.pneu 1-6 IFA Poly(HT)60 Test L. pneu 1-6/bdglmj DFA Screen L.pneu Gr.1(Mono)(HT) 18 Well L.pneu 1-6/bdglmj/C Specimen Slide L.pneuGR1-6&Mic.Screen(HT)18W	registered
ACON Laboratories, Inc.	United States	Flowflex Plus Strep A Rapid Test Cassette Flowflex Plus Strep A Rapid Test Strip Mission Plus Hemoglobin (Hb) Control Solution Kit On Call Plus Glucose Control Solution Kit On Call Express Voice Blood Glucose Monitoring System On Call Plus Blood Glucose Monitoring System	K251697 (2025)
GENIAL HELIX LTD	United Kingdom	Product of Conception Growth Supplement Chromosome Resolution Additive Cytoclear Cytoplasm Remover Optimal Hypotonic Solution Solid Tumor Growth Supplement Metaphase Arresting Solution	registered
PHARMIGENE, Inc.	Taiwan	–	registered
Sebia Present in Europe in other categories	United States	CAPILLARYS HEMOGLOBIN CAPILLARYS 3 DBS MINICAP HEMOGLOBIN CAPI 3 NEONAT Hb CAPILLARYS 3 DBS MICROPLATES CAPI 3 NEONAT HEMOLYSING SOLUTION	K232027 (2024)
Visby Medical, Inc.	United States	Visby Medical Power Adapter, Right Angle Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack Visby Medical Sexual Health Test Visby Medical Power Adapter Visby Medical Men’s Sexual Health Test Visby Medical Respiratory Health	K251501 (2025)
BIOCHEMICAL DIAGNOSTICS INC Present in Europe in other categories	United States	Pregnancy-Skreen CENMED Adulter-Skreen iScreen	registered
GERMAINE LABORATORIES, INC	United States	AIMSTRIP HEMOGLOBIN CONTROL SET STREPAIM AimStrip Tandem Lipid Profile and glucose measuring system KETONE SERUM CONTROLS AimStrip Tandem Total Cholesterol Control Solution AimStrip Tandem Total Triglycerides Control Solution	registered
HMD BIOMEDICAL INC. Present in Europe in other categories	–	PRECICHEK AutoCode foil packed test strip PRECICHEK AutoCode vial packed test strip PRECICHEK AC300 GL GoodLife AC11-Strip(foil) GL GoodLife AC-302 Blood Glucose Monitoring System(CORP.)	registered
ARLINGTON SCIENTIFIC, INC.	United States	ASI Rubella IgG EIA Test ASI Rubella IgM EIA Test ASI Toxoplasma IgG EIA Test ASI Toxoplasma IgM EIA Test ASI Measles IgG EIA Test ASI Mumps IgG EIA Test	registered
Biofire Defense, LLC	United States	BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel BioFire® Global Fever Special Pathogens Panel BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane BioFire Warrior Panel Control Kit BioFire® COVID-19 Test 2	K261475 (2026)
IMMCO DIAGNOSTICS, INC.	United States	Immco Diagnostics, Inc.	registered
Immudex ApS	Denmark	Dextramer CMV Kit CMV Dextramer MHC Dextramer	K153538 (2017)
AnalytiChem USA, Inc.	United States	Redipor	registered
Augurex Life Sciences Corp	Canada	Augurex Auguerx	registered
CELLAY, INC.	United States	DiskFISH OligoFISH	registered
MAST GROUP LIMITED Present in Europe in other categories	United Kingdom	Mast Assure Antisera Mast Assure Escherichia coli O26 antiserum Mast Assure Mast Assure Escherichia coli O111 Antiserum	registered
BTNX Inc	–	Rapid Response	registered
Biobase Biodustry(Shandong)Co., Ltd.	China	BIOBASE	registered
Biomedica Diagnostics Inc	Canada	QuikCoag APTT-EA QuikCoag Calcium Choride 0.02M QuikCoag Calcium Chloride 0.02M QuikCoag Control Level 3 High Abnormal QuikCoag Control Level 1 Normal QuikCoag Control Level 2 Low Abnormal	registered
M DIALYSIS INC. Present in Europe in other categories	Sweden	Glutamate reagent Reagent Set A Reagent Kit Reagent Set C L-P-G Reagent kit Glucose reagent	registered
MESA BIOTECH, INC.	United States	Silaris RSV Supplemental Pack Accula Programming Cassette Accula Dock Silaris Influenza A&B Control Kit SilarisTM Influenza A&B Starter Pack Sialris Influenza A&B Supplemental Pack	K181443 (2018)
Quantimetrix Corp.	United States	Ammonia Alcohol Control Level 3 Set 3x5mL Dropper Spinal Fluid Control Level 2 Set 3x3mL Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL Ammonia Alcohol Control Level 1 Set 3x5mL Dropper Spinal Fluid Control Level 1&2 Set 2x3mL Ammonia Alcohol Control Level 2 Set 3x5mL	K152117 (2016)
HOME AIDE DIAGNOSTICS, INC.	–	Easy Trak Control Solution - HIGH Easy Talk Control Solution - HIGH Easy Step Control Solution - HIGH Easy Plus II Control Solution - LOW Easy Plus II Control Solution - HIGH Easy Step Control Solution - LOW	registered
Instrumentation Laboratory CO Present in Europe in other categories	United States	HemosIL AcuStar Anti-Cardiolipin IgM Controls HemosIL Homocysteine Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls HemosIL AcuStar Anti-B2GPI Domain 1 Controls HemosIL AcuStar Anti-Cardiolipin IgG Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls	K170854 (2017)
JEOL LTD.	Japan	ISE Buffer (IS) Cuvette Wash Solution 7 Lamp Coolant C Reagent Probe Wash K Reagent Probe Wash S Reagent Probe Wash 1	registered
PHILOSYS Co., Ltd	United States	GlucoTrack Solution Level 2 GlucoTrack Solution Level 1 Gmate® Control Solution Level 2 Gmate® Control Solution Level 3 Pip Control Solution Low GlucoTrack Solution Level 3	registered
WAL-MART STORES, INC.	–	ReliOn Ultima ReliOn™ Premier Control Solution Level 1 ReliOn™ Premier Control Solution Level 2 ReliOn™ Premier Voice Basic Meter ReliOn™ Premier Classic Meter ReliOn™ Confirm/Micro Control	registered
BIONIME CORPORATION Present in Europe in other categories	United States	GE Rightest RIGHTEST GT333 Control Solution	K133003 (2013)
CORGENIX MEDICAL CORPORATION	–	REAADS Coagulation Control 2 REAADS Coagulation Control 1 REAADS von Willebrand Factor Antigen Test Kit REAADS von Willebrand Factor Activity Test Kit REAADS Protein S Antigen Test kit REAADS Monoclonal Free Protein S Antigen	registered

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