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Acro Biotech

États-UnisEntités : Acro Biotech Inc.

Marchés : France · Allemagne · Autriche · Chypre · Croatie · Danemark · Espagne · Finlande · Grèce · Hongrie · Irlande · Italie · Lettonie · Lituanie · Malte · Pologne · Roumanie · Tchéquie · États-Unis

Autorisations : UE – classe A · États-Unis (FDA) – 510(k) : 10 · classe II · dernière en 2018 · voir sur le site de la FDA

Mandataire UE : MedNet EC-REP GmbH (Allemagne)

info@acrobiotech.com

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93/42 Ancienne directive, pas encore certifié selon le règlement MDR
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Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
Bacteriology - RT & POC - other	W0105090199	Bacterial Diarrhea (Shigella/Cholerae/C.diff) Rapid Test98/79 Bacterial Diarrhea (Shigella/Salmonella/C.diff) Rapid Test98/79 Bordetella pertussis Antigen Rapid Test B-IBP-ACO502VN98/79 Brucella Abortus and Melitensis Antibody Combo Rapid Test98/79 Brucella Abortus Antibody Rapid Test98/79 80 autres Brucella Abortus Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Brucella Abortus IgG/IgM Rapid Test98/79 Campylobacter Rapid Test Cassette (Feces) ICAM-60298/79 Campylobacter Rapid Test Cassette acrCAM602R98/79 Campylobacter Rapid Test ICAM-ACO60798/79 Candida albicans and Trichomonas Vaginalis Combo Rapid Test ICT-ACO52598/79 Candida albicans Rapid Test Cassette (Vaginal Swab) ICA-R50298/79 CARBA-5 Rapid Test98/79 Cryptococcus Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma/ Cerebral Spinal Fluid (CSF)) ICRG-R40298/79 Febrile Antigens17 réf.98/79 Gardnerella Vaginalis Antigen Rapid Test98/79 Gonorrhea Rapid Test Cassette (Swab)98/79 H. pylori Antibody Rapid Test Cassette (Serum /Plasma) IHP-R30298/79 H. pylori Antibody Rapid Test Cassette IHP-R40298/79 H. pylori Antigen Rapid Test IHP-ACO60798/79 H. pylori Rapid Test IHP-ACO90198/79 H. pylori Rapid Test IHP-ACO90298/79 H. pylori Rapid Test IHP-ACO90498/79 H.pylori IgM Rapid Test IHPM-ACO40298/79 H.pylori/Transferrin Combo Rapid Test IHT-ACO62598/79 H.pylori Saliva (HPS) Rapid Test98/79 Legionella pneumophila Rapid Test Cassette98/79 Leptospira IgG/IgM Combo Rapid Test ILEP-ACO42598/79 Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) ILEP-R40298/79 Leptospira IgG/IgM Test Cassette ACO-LEP-40298/79 Leptospira IgM Rapid Test ILEPM-ACO40298/79 Leptospira IgM Semi-quantitative Rapid Test ILEM-ACO42598/79 Lyme IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) ILY-R40298/79 Lyme IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) ILY-40298/79 Melioidosis (Burkholderia pseudomallei) IgG/IgM Rapid Test98/79 Mycobacterium Tuberculosis Antigen Rapid Test98/79 Mycoplasma Genitalium (MG) IgG Rapid Test98/79 Mycoplasma pneumoniae Antigen Rapid Test Cassette (Throat Swab)98/79 Mycoplasma pneumoniae Antigen Test Cassette ACO-MP-50298/79 Rose Bengal Latex Reagents98/79 S. pneumoniae and L. pneumophila Combo Rapid Test Cassette (Urine)2 réf.98/79 S. pneumoniae Antigen Rapid Test Cassette ISP-R10298/79 Salmonella paratyphi Antigen Rapid Test98/79 Salmonella paratyphi Antigen Rapid Test Cassette (Feces)98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test Cassette (Feces)98/79 Salmonella typhi and paratyphi B Antigen Combo Rapid Test2 réf.98/79 Salmonella typhi and paratyphi B Antigen Combo Rapid Test (Feces)98/79 Salmonella Typhi Antigen Rapid Test98/79 Salmonella typhi and paratyphi B Antibody Combo Rapid Test98/79 Scrub Typhus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)2 réf.98/79 Scrub Typhus IgG/IgM Test Cassette98/79 Shigella Flexneri Antigen Rapid Test98/79 Shigella Flexneri Antigen Rapid Test Cassette98/79 Shigella Flexneri Antigen Rapid Test Cassette (Feces)98/79 Shigella Rapid Test Cassette (Feces) ISH-R62598/79 Shigella Rapid Test ISH-ACO62798/79 Shigella Sonnei Antigen Rapid Test98/79 Shigella Sonnei Antigen Rapid Test Cassette98/79 Shigella Sonnei Antigen Rapid Test Cassette (Feces)98/79 Tetanus Rapid Test Cassette (Whole Blood/Serum/Plasma) ITE-R40298/79 Tetanus Rapid Test Cassette ITE-R402SQ98/79 TGAb Test Cassette98/79 TPOAb Test Cassette98/79 Trichomonas Vaginalis Rapid Test Cassette acrTV502R98/79 Tuberculosis Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Tuberculosis IgG/IgM Rapid Test Cassette98/79 Tuberculosis Rapid Test Cassette2 réf.98/79 Tuberculosis Rapid Test Dipstick (Whole Blood/Serum/Plasma)98/79 Typhoid IgG Rapid Test Cassette98/79 Typhoid IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Typhoid IgM Rapid Test Cassette98/79 Typhoid IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Typhoid Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Typhoid Rapid Test Cassette (Serum/Plasma)98/79 Vibrio cholera O1 Inaba (VC O1 Inaba) Rapid Test Cassette (Feces)98/79 Vibrio Cholera O1 Ogawa (VC O1 Ogawa) Rapid Test Cassette (Feces)98/79 Vibrio cholerae O1/O139 Combo Rapid Test Cassette (Feces)2 réf.98/79 Vibrio cholerae O1 (VC O1) Rapid Test Cassette (Feces)2 réf.98/79 Vibrio Cholerae O1 Inaba (VC O1 Inaba) Rapid Test Cassette (Feces)98/79 Vibrio Cholerae O1 Ogawa (VC O1 Ogawa) Rapid Test Cassette (Feces)98/79 Vibrio cholerae O1/O139 Combo Rapid Test98/79 Vibrio cholerae O139 (VC O139) Rapid Test Cassette (Feces)2 réf.98/79 Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test (Feces)2 réf.98/79 Vibrio Cholerae O139,O1 Ogawa & Inaba Combo Rapid Test2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Controls infectious immunology - RT & POC	W0105094001	Adenovirus Control SCADE-D-L98/79 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/Influenza A+B Combo Control98/79 71 autres Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Control98/79 Adenovirus/RSV/Influenza A+B Control SCARI-S98/79 Astrovirus Control SCAS-D-L98/79 Bordetella pertussis Antigen Control98/79 Brucella Abortus Control2 réf.98/79 Campylobacter Control SCCAM-D-L98/79 Candida Albicans Control SCCA-D-L98/79 Chagas Control SCCHA-D98/79 Chikungunya control98/79 Chikungunya IgG/IgM Antibody Control SCCHI-D-L98/79 Chikungunya IgG/IgM Control98/79 Clostridium difficile GDH + Toxin A + Toxin B Control SCCD-D-L98/79 Clostridium difficile GDH Control SCCDG-D-L98/79 Clostridium difficile Toxin A +Toxin B Control SCCDT-D-L98/79 COVID-19 and Influenza A+B Antigen Combo Control98/79 COVID-19 Antigen Control2 réf.98/79 COVID-19 IgG Control98/79 Cryptococcus Antigen Control98/79 Cryptosporidium Antigen Control SCCRY-D-L98/79 Cryptosporidium Control SCCRY-L98/79 Dengue IgG/IgM Control SCDEGM-L98/79 Dengue NS1 Control3 réf.98/79 Entamoeba Histolytica Control SCEH-D-L98/79 Entamoeba/Giardia/Crypto Control2 réf.98/79 FIA Control50 réf.98/79 FIA Control CA125 Control98/79 FIA Control CA19-9 Control98/79 FIA Control SARS-CoV-2/Influenza A+B/RSV Antigen Control98/79 FIA Control Vibrio cholerae O1/O139 Control98/79 Giardia Lamblia Control SCGL-D-L98/79 H. pylori Antigen Control SCHPG-D-L98/79 H.pylori Ag Control SCHPG-S98/79 HPIV Control98/79 HPV Control SCHPV-S98/79 Human Metapneumovirus Antigen Control SCHMPV-D-L98/79 Influenza A Control SCFLA-S98/79 Influenza A/B+H1N1 Combo Control98/79 Legionella pneumophila Control2 réf.98/79 Leptospira IgG/IgM Antibody Control SCLEP-L98/79 Malaria P.f. Control SCMPF-D98/79 Malaria P.f./P.v. Control SCMPV-D98/79 Malaria P.f./P.v./Pan Control SCMPVF-D98/79 Monkeypox Virus Antibody control SCMXB-L98/79 Monkeypox Virus Antigen control SCMXG-D-L98/79 MONO Control SCMONO-L98/79 Multiplex Respiratory Antigen Control SCRTC-S98/79 Mycoplasma Pneumoniae Antigen Control SCMP-S98/79 Mycoplasma pneumoniae IgG/IgM Control SCMPGM-L98/79 Mycoplasma pneumoniae IgM Control SCMPM-L98/79 Norovirus Control SCNOR-D-L98/79 Norovirus/Astorvirus/Enterovirus Combo Control98/79 Norovirus/Rotavirus/Adenovirus Control SCNRA-D-L98/79 Rotavirus Control SCROT-D-L98/79 RSV Control SCRSV-S98/79 RSV/Influenza A+B Control SCRI-S98/79 S. pneumoniae/L. pneumophila Control2 réf.98/79 Salmonella paratyphi Control98/79 Salmonella typhi Antigen Control98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Control98/79 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/M.pneumoniae Control98/79 Scrub Typhus IgG/IgM Control2 réf.98/79 Streptococcus pneumoniae Control2 réf.98/79 Syphilis Control SCSYP-L98/79 Tetanus Control SCTET-D-L98/79 Trichomonas Vaginalis Control SCTV-D-L98/79 Tuberculosis Control98/79 Vibrio cholerae O1/O139 Control98/79 Zika IgG/IgM Control SCZIB-L98/79 Zika NS1 Control98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Virology - RT & POC - other	W0105099099	A Fluorescence Immunoassay for the qualitative detection of Rotavirus antigen and Adenovirus antigen in human feces, as an aid in the diagnosis of Rotavirus and/or Adenovirus infection.98/79 Adenovirus Antigen Rapid Test Cassette (Swab) IAD-R50298/79 Adenovirus pneumoniae and RSV Combo Test Cassette ACO-AR-50298/79 Adenovirus pneumoniae Antigen Test Cassette ACO-AD-50298/79 Adenovirus Rapid Test Cassette (Feces) IAD-R60298/79 61 autres Adenovirus Rapid Test IAD-ACO60798/79 Astrovirus Rapid Test Cassette (Feces) IAS-R60298/79 Astrovirus Rapid Test IAS-ACO60798/79 Astrovirus Test Cassette acrAS602F98/79 Chikungunya Antigen Rapid Test ICHIG-ACO40298/79 Chikungunya IgG/IgM Combo Rapid Test ICHI-425(SL)98/79 Chikungunya IgG/IgM Rapid Test Cassette (Serum/Plasma) ICHI-R30298/79 Chikungunya IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) ICHI-R40298/79 Chikungunya IgM Rapid Test Cassette ICKM-40298/79 COVID-19 and M. pneumoniae IgG Combo Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 and M. pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 Antigen Rapid Test98/79 Cryptosporidium and Giardia Lamblia Combo Rapid Test Cassette (Feces) ICGC-62598/79 Dengue Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IDEC-R42598/79 Dengue Combo Rapid Test IDEC-ACO43598/79 Dengue IgG, IgM and NS1 Combo Test Cassette98/79 Dengue IgG/IgM Combo Rapid Test IDEN-425(SL)98/79 Enterovirus 71 Test Cassette (Feces)98/79 Enterovirus Antigen Rapid Test IEV-ACO60298/79 H5N1 Antigen Rapid Test98/79 HAV IgG Rapid Test Cassette IHAG-40298/79 HAV IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IHAGM-R42598/79 HAV IgG/IgM Combo Rapid Test Cassette acrHAV425R98/79 HAV IgG/IgM Test Cassette acrHAV402F98/79 HAV IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IHA-R40298/79 HAV IgM Test Cassette acrHAVM402F98/79 HEV Antigen Rapid Test IHE-ACO10298/79 HEV IgG/IgM Rapid Test Cassette (Serum/Plasma) IHE-R30298/79 HEV IgM Rapid Test IHEM-ACO30298/79 HMPV Rapid Test98/79 HMPV Rapid Test (Nasopharyngeal Swab)98/79 HMPV Test Cassette98/79 HPIV 1/2/3 Rapid Test98/79 HPIV Rapid Test98/79 HPIV Rapid Test (Nasopharyngeal Swab)98/79 HPIV Test Cassette98/79 HPV 16/18 Antigen Rapid Test98/79 HPV Antigen Rapid Test Cassette (Cervical Swab) acrHPV502R98/79 HPV Antigen Rapid Test Cassette THPV-ACO50298/79 HPV Antigen Rapid Test THPV-ACO502B98/79 HSV 1 IgG/IgM Test Cassette98/79 HSV 2 IgG/IgM Test Cassette98/79 Influenza A/B + H5N1 Antigen Combo Rapid Test98/79 Influenza A/B+H1N1 Combo Rapid Test Cassette98/79 Influenza A/B+H1N1+H5N1 Antigen Combo Rapid Test98/79 Measles IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) IME-R40298/79 Measles IgG/IgM Rapid Test IME-ACO40298/79 Norovirus Rapid Test Cassette (Feces) INO-R60298/79 Norovirus Rapid Test INO-ACO60798/79 Norovirus Test Cassette ACO-NOV-60298/79 Rhinovirus Rapid Test (Nasopharyngeal Swab) acrRHV502R98/79 Rhinovirus Rapid Test IRHV-ACO50298/79 Rotavirus Rapid Test Cassette (Feces) IRO-R60298/79 Rotavirus Rapid Test IRO-ACO60798/79 Rotavirus Test Cassette ACO-ROT-60298/79 Tetanus IgG Test Cassette ACO-ROT-60298/79 West Nile Virus IgG/IgM Rapid Test IWNGM-ACO40298/79 Yellow Fever Virus IgG/IgM Rapid Test98/79 Zika IgG/IgM and NS1 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Zika IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IZIB-R40298/79 Zika NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Other multiple pathogens - RT & POC	W0105090699	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 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 56 autres 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 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 Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Chikungunya and Dengue Combo Rapid Test acrCKDE43598/79 Chikungunya/Zika Combo Rapid Test ICZ-ACO42598/79 Dengue NS1 and Zika NS1 Combo Rapid Test98/79 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 HAV IgG/IgM&Syphilis Combo Rapid Test IHAS-ACO43598/79 HAV IgM&Syphilis Combo Rapid Test IHAS-ACO42598/79 HSV 1/2 IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Multiplex Respiratory Antigen Rapid Test (Swab) acrRTC595R98/79 Mycoplasma pneumoniae/Adenovirus pneumoniae/ RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Cassette98/79 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/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 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/Adenovirus+Astrovirus Combo Rapid Test IRAA-ACO62598/79 RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Parasites - RT & POC - other	W0105090499	Chagas Rapid Test Cassette (Whole Blood/Serum/Plasma) ICHA-R40298/79 Chagas Rapid Test Cassette (Serum/Plasma) ICHA-R30298/79 Cryptosporidium and Giardia lamblia Combo Rapid Test Cassette (Feces) ICGC-R62598/79 Cryptosporidium Antigen Rapid Test Cassette (Feces) ICR-R60298/79 Cryptosporidium Antigens and Giardia Lamblia Combo Test Cassette (Feces) acrCG602F98/79 18 autres Cryptosporidium Rapid Test ICR-ACO60798/79 Entamoeba histolytica Rapid Test Cassette (Feces) IEH-R60298/79 Entamoeba histolytica Rapid Test IEH-ACO60798/79 Entamoeba+Giardia+Crypto Combo Rapid Test Cassette98/79 Entamoeba+Giardia+Crypto Combo Rapid Test (Feces)98/79 Entamoeba+Giardia+Crypto Combo Rapid Test98/79 Entamoeba+Giardia+Crypto Combo Rapid Test Cassette (Feces)98/79 Entamoeba/Giardia/Crypto Rapid Test Cassette98/79 Entamoeba/Giardia/Crypto Rapid Test Cassette (Feces)98/79 Entamoeba/Giardia/H.pylori Combo Rapid Test IEGH-ACO63598/79 Filariasis Antigen Rapid Test98/79 Filariasis IgG/IgM Rapid Test Cassette (Serum/Plasma)98/79 Filariasis IgG/IgM Rapid Test Cassette (Whole Blood /Serum/Plasma)2 réf.98/79 Filariasis IgG/IgM Test Cassette98/79 Giardia Lamblia Rapid Test Cassette (Feces) IGL-R60298/79 Giardia Lamblia Rapid Test IGL-ACO60798/79 Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) ILEI-R40298/79 Schistosoma Antibody Rapid Test ISC-ACO40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Syphilis - RT & POC	W0105090105	RPR Reagents5 réf.98/79 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 6 autres 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 Kit (CLIA)98/79 TPHA Reagents3 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	Clostridium difficile GDH Rapid Test Cassette ICDG-R60298/79 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 4 autres 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 Combo Test Cassette (Feces) ACO-CDT-62598/79	– 98/79	Fiche EUDAMED Signaler une erreur
Influenza a and /or b - RT & POC	W0105099004	H1N1 Antigen Rapid Test Cassette (Swab)98/79 Influenza A Rapid Test Cassette (Swab/Nasal Aspirate)2 réf.98/79 Influenza A Rapid Test Dipstick (Swab/Nasal Aspirate)98/79 Influenza A+B Rapid Test Cassette FLU2E98/79 Influenza A+B Rapid Test Cassette(Swab/Nasal Aspirate)98/79 3 autres Influenza A+B Rapid Test Dipstick (Swab/Nasal Aspirate)98/79 Influenza A+BRapid Test Cassette98/79 Influenza A/B +H1N1 Combo Rapid Test Cassette (Swab)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus antibodies - total	W0105041102	2019-nCoV IgG/IgM Rapid Test Cassette (Single use kit)98/79 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)2 réf.98/79 COVID-19 Antigen Rapid Test (Oral Fluid)98/79 COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma)2 réf.98/79 COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 2 autres COVID-19 IgG/IgM Rapid Test Dipstick (Whole Blood/Serum/Plasma)2 réf.98/79 COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mononucleosis (ebv) - RT & POC	W0105099003	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 MONO Rapid Test Cassette (Whole Blood/ Serum/ Plasma) IMO-R40298/79 2 autres Mononucleosis(MONO)Latex Reagents acrMONO001A98/79 MONORapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Plasmodium (malaria) - RT & POC	W0105090401	Malaria Antibody Rapid Test IMAB-ACO40298/79 Malaria P.f. /P.v. Rapid Test Cassette (Whole Blood) IMPV-R40298/79 Malaria P.f. Rapid Test Cassette (Whole Blood) IMA-R40298/79 Malaria P.f./P.v. /Pan Rapid Test Cassette MFVP2D98/79 Malaria P.f./P.v./Pan Rapid Test Cassette acrMPVF402R98/79 2 autres Malaria P.f./P.v./Pan Rapid Test Cassette IMPVF-40298/79 Malaria P.f./Pan Rapid Test Cassette (Whole Blood) IMPN-R40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus ag	W0105041101	COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)2 réf.98/79 COVID-19 Antigen Rapid Test Strip (Nasopharyngeal Swab)98/79 COVID-19 Antigen Test Cassette (Nasopharyngeal Swab)98/79 COVID-19 Antigen Test Cassette (Oral Fluid)98/79 SARS-CoV-2 Antigen Rapid Test (Nasal Swab)98/79 1 autre SARS-COV-2 RT-qPCR Assay98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus antibody (ab) - RT & POC	W0105090502	COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 Nab Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 S-RBD Ab Rapid Test (Whole Blood/Serum/Plasma)98/79 SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma)98/79 1 autre SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
H. pylori antibody assays	W0105010402	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 1 autre Helicobacter pylori (HP) IgG Test Kit (CLIA)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Monkeypox virus / mpox RT & POC	W0105099008	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 Rapid Test IMXG-ACO40298/79 Monkeypox Virus Antigen Rapid Test IMXG-ACOR40298/79 1 autre Monkeypox Virus Antigen Test Cassette ACO-MXG-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Multiple viruses - multiplex assays - other	W0105070399	Adenovirus and RSV Combo Rapid Test Cassette (Nasopharyngeal Swab) IARC-52598/79 Adenovirus,RSVand Influenza A+BCombo Rapid Test Cassette98/79 COVID-19 Antigen / Influenza A+B Combo Test Cassette (Nasopharyngeal Swab)98/79 RSV/ Influenza A+B Combo Rapid Test Cassette (Swab/ Nasal Aspirate)2 réf.98/79 SARS-Co V-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test98/79 1 autre SARS-Co V-2/Influenza A+B/RSVAntigen Combo Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Zika virus	W0105040630	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 Rapid Test Cassette (Whole Blood/Serum/Plasma) IZIB-40298/79 Zika IgM Test Cassette (Whole Blood/ Serum/ Plasma) ACO-ZIM-40298/79 1 autre Zika NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus / influenza - RT & POC	W0105090601	COVID-19 and Influenza A+B Antigen Combo Rapid Test2 réf.98/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 RSV and SARS-CoV-2 Antigen Combo Rapid Test98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test2 réf.98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
D-dimer	W0103020503	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	– 98/79	Fiche EUDAMED Signaler une erreur
H. pylori antigen detection	W0105010401	H. pylori Antigen Rapid Test Cassette HPG2F98/79 H. pylori Antigen Rapid Test Dipstick (Feces)98/79 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	– 98/79	Fiche EUDAMED Signaler une erreur
Multiple infectious - multiplex assays - other	W0105070599	Norovirus, Rotavirus and Adenovirus Combo Rapid Test Cassette (Feces) INRA-63598/79 Norovirus,Rotavirus,Adenovirusand Astrovirus Combo Rapid Test Cassette98/79 Norovirus/ Rotavirus/ Adenovirus Combo Rapid Test Cassette (Feces) INRA-R63598/79 Rotavirus and Adenovirus Combo Rapid Test Cassette (Feces) IRAC-R62598/79 Rotavirusand Adenovirus Combo Rapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Plasmodium (malaria)	W0105050209	Malaria P.f. Rapid Test Cassette (Whole Blood) IMA-40298/79 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. Rapid Test Cassette (Whole Blood) IMPV-40298/79 Malaria P.f./P.v./Pan Test Cassette (Whole Blood) ACO-MAL-43598/79	– 98/79	Fiche EUDAMED Signaler une erreur
Strep. a - RT & POC	W0105090103	Strep A Rapid Test Cassette (Throat Swab)2 réf.98/79 Strep A Rapid Test Cassette ISTB-R50298/79 Strep A Rapid Test Dipstick (Throat Swab)2 réf.98/79 Strep A Test Cassette (Throat Swab)98/79 Strep ARapid Test Cassette (Control Linein Red)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Adenovirus	W0105040601	Adenovirus Antigen Rapid Test Cassette (Swab) IAD-50298/79 Adenovirus antigen Test Cassette (Feces) ACO-AD-60298/79 Adenovirus Rapid Test Cassette (Feces) IAD-60298/79 Adenovirus Rapid Test Cassette ADE2F98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chikungunya virus	W0105040625	Chikungunya Ig G/Ig MRapid Test Cassette98/79 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	– 98/79	Fiche EUDAMED Signaler une erreur
Dengue virus	W0105040611	Dengue Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IDEC-42598/79 Dengue Combo Rapid Test Cassette DEC5D98/79 Dengue IgG/IgM Test Cassette (Whole Blood/ Serum/ Plasma) ACO-DEN-40298/79 Dengue NS1 Test Cassette (Whole Blood/ Serum/ Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv 1+2 antibodies - total	W0105040302	HSV 1/2 IgG/IgM Rapid Test Cassette (Serum/Plasma)98/79 HSV 1/2 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Serum/Plasma)98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Immunochemistry readers	W0201020201	Dry-type Fluorescent Immunoassay Analyzer Fluorescence Immunoassay Analyzer4 réf. Lateral Flow (LF) Portable Reader LF Reader Plus	A IVDR	Fiche EUDAMED Signaler une erreur
Salmonella antibody assays	W0105011002	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	– 98/79	Fiche EUDAMED Signaler une erreur
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	Blood Glucose/Ketone/Uric Acid/Cholesterol Monitoring Meter I ACA4022 réf. Blood Glucose/Ketone/Uric Acid/Cholesterol Monitoring Meter II ACA4032 réf. Cholesterol Meter ACA4012 réf. Uric Acid Meter ACA4062 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Automatic Chemiluminescence Immunoassay Analyzer,Brand:Asterlith Automatic Chemiluminescence Immunoassay Analyzer,Brand:Oupirou3 réf. LF Reader	A IVDR	Fiche EUDAMED Signaler une erreur
Chagas	W0105050202	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	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus igg	W0105041103	COVID-19 Nucleocapsid Protein IgG Antibody 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	– 98/79	Fiche EUDAMED Signaler une erreur
Influenza & para influenza	W0105040604	H1N1 Antigen Rapid Test Cassette (Swab)98/79 H1N1 Antigen Rapid Test Dipstick (Swab)98/79 Influenza A+B Test Cassette (Swab/ Nasal Aspirate)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Rsv - RT & POC	W0105099002	RSV Rapid Test Cassette (Nasopharyngeal swab/Nasal Aspirate)98/79 RSV Test Cassette (Nasopharyngeal Swab/Nasal Aspirate)98/79 RSVRapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Salmonella antigen detection	W0105011001	Salmonella paratyphi Antigen Rapid Test Cassette (Feces)98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test Cassette (Feces)98/79 Salmonella Typhi Antigen Rapid Test Cassette (Feces)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Strep. b - RT & POC	W0105090104	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	– 98/79	Fiche EUDAMED Signaler une erreur
C.difficile GDH detection	W0105011801	Clostridium difficile GDH Test Cassette (Feces) ACO-CDG-60298/79 Clostridiumdifficile GDHRapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus antigen (ag) - RT & POC	W0105090501	COVID-19 Antigen Rapid Test (Oral Fluid)98/79 SARS-CoV-2 (COVID-19) Antigen Rapid Test (Swab)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv 1+2 igg	W0105040303	HSV 1/2 IgG Rapid Test Cassette (Serum/Plasma)98/79 HSV 1/2 IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv 1+2 igm	W0105040304	HSV 1/2 IgM Rapid Test Cassette (Serum/Plasma)98/79 HSV 1/2 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Interleukin 6 (il-6)	W01030609	IL-6 Rapid Test (Whole Blood/Serum/Plasma)98/79 Interleukin-6 (IL-6) Test Kit (CLIA)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycoplasma antibody assays	W0105010802	Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IMP-42598/79 Mycoplasma Pneumoniae IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IMPM-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Rotavirus	W0105040606	Rotavirus Rapid Test Cassette (Feces) IRO-60298/79 Rotavirus Rapid Test Cassette ROT2F98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Strep. pneumoniae - RT & POC	W0105090109	Streptococcus pneumoniae Test Cassette (Urine)98/79 Streptococcuspneumoniae Antigen Rapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Urinalysis (ur) - laboratory analysers- instruments	W02010701	Cup Reader ACR-ACO100 Urine Analyzer ACA3043 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Astrovirus	W0105040629	Astrovirus Rapid Test Cassette IAS-60298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bacteriology controls - inf.imm.	W0105080801	Gonorrhea Control98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Brucella	W0105011701	Brucella Abortus Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
C.difficile GDH and toxin a/b combined detection	W0105011803	Clostridiumdifficile GDH+Toxin A+Toxin BCombo Rapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Candida albicans	W0105060302	Candida albicans Rapid Test Cassette (Vaginal Swab) ICA-50298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Cryptococcus	W0105060303	Cryptococcus Antigen Rapid Test Cassette (Whole Blood/ Serum/ Plasma/ Cerebral Spinal Fluid (CSF)) ICRG-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Cryptosporidium	W0105050207	Cryptosporidium Antigen Rapid Test Cassette (Feces) ICR-60298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Dengue - RT & POC	W0105099007	Dengue NS1 Rapid Test Cassette (Whole Blood/ Serum/ Plasma)2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Devices for samples transport - other	W050299	Viral Transport Medium(Inactivated Type)2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Ebv antibodies - other	W010504040199	EBV VCA and EBNA IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IECNG-42598/79	– 98/79	Fiche EUDAMED Signaler une erreur
Ebv ebna igg	W010504040106	EBNA IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) IENG-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Ebv vca igg	W010504040105	EBV VCA IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) IECG-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Entamoeba histolytica	W0105050201	Entamoebahistolytica Rapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Giardia lamblia	W0105050208	Giardia Lamblia Rapid Test Cassette (Feces) IGL-60298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Gonococcal antigen detection	W0105010201	Gonorrhea Rapid Test Cassette (Swab)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Haemoglobin (hb)	W0103010601	Hb Hemoglobin Test Strip (Whole Blood) OHBS-ACO41198/79	– 98/79	Fiche EUDAMED Signaler une erreur
Haemoglobin subtypes hba2, hbc, hbf, hbs, etc.(excl. hba1)	W0103010202	Sickle Cell Rapid Test OSCD-ACO40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hantavirus / bunyavirus	W0105040614	Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/ Serum/ Plasma) IHVGM-ACO40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hav antibody (total)	W0105020102	HAV IgG/IgM Combo Rapid Test Cassette HAV5D98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hav antibody igm	W0105020104	HAV IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IHA-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hev antibody (total)	W0105020503	HEV IgG/IgM Rapid Test Cassette (Serum/Plasma) IHE-30298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv 1 antibodies - total	W0105040305	HSV 1 IgG/IgM Rapid Test Cassette (Whole Blood/ Serum/ Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv 2 antibodies - total	W0105040308	HSV 2 IgG/IgM Rapid Test Cassette (Whole Blood/ Serum/ Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Legionella - RT & POC	W0105090108	Legionella Pneumophila Rapid Test Cassette (Urine)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Legionella antigen detection	W0105010501	Legionella pneumophila Test Cassette (Urine)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Leishmania	W0105050205	Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) ILEI-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Leptospira	W0105011704	Leptospira Ig G/Ig MRapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Measles virus igg	W0105040702	Measles IgG Antibody Rapid Test (Whole Blood/ Serum/ Plasma) IMEG-ACO40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycoplasma antigen detection	W0105010801	Mycoplasma pneumoniae Antigen Rapid Test Cassette (Throat Swab)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Norovirus	W0105040616	Norovirus Rapid Test Cassette (Feces) INO-60298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Parasitology controls - inf.imm.	W0105080805	Malaria P.f. /Pan Control SCMPN-D98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Rapid test hematology / histology / cytology instruments - other	W02020699	HB Hemoglobin Test Meter AHR-ACO1002 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Samples collection devices - other	W05019099	Virus Specimen Stabilizer	A IVDR	Fiche EUDAMED Signaler une erreur
Shigella	W0105011714	Shigella Rapid Test Cassette (Feces) ISH-ACO62598/79	– 98/79	Fiche EUDAMED Signaler une erreur
Syphilis antibody assays total	W0105010302	Syphilis Test Cassette (Whole Blood/ Serum/ Plasma) ACO-SYP-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Tetanus (clostridium t.)	W0105011709	Tetanus Rapid Test Cassette ITE-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Trichomonas	W0105050210	Trichomonas Vaginalis Rapid Test Cassette (Vaginal Swab) ITV-50298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Varicella zoster virus igm	W0105040903	Varicella Zoster Virus IgM Rapid Test Cassette IVZM-ACO40298/79	– 98/79	Fiche EUDAMED Signaler une erreur

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