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Hangzhou Alltest Biotech

ChineEntités : Hangzhou Alltest Biotech.Co.,Ltd.

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Autorisations : UE – classe A, B, C · États-Unis (FDA) – 510(k) : 14 · classe I, II · dernière en 2026 · voir sur le site de la FDA

Mandataire UE : MedNet EC-REP GmbH (Allemagne)

info@alltests.com.cn

122 catégories, 894 modèles dont 894 en vente, 1 pays

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Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
Other multiple pathogens - RT & POC	W0105090699	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 Cassette98/79 130 autres 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 Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 CARBA-5 Rapid Test98/79 Chikungumya lgG&lgM/Dengue lgG&lgM/Dengue NS1 Combo Rapid Test98/79 Chikungunya/Zika Combo Rapid Test ICZ-42598/79 Dengue NS1 and Zika NS1 Combo Rapid Test98/79 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 HAV IgG/IgM&Syphilis Combo Rapid Test IHAS-43598/79 HAV IgM&Syphilis Combo Rapid Test IHAS-42598/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette98/79 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+H1N1+H5N1 Antigen Combo Rapid Test98/79 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 Norovirus+Rotavirus+Adenovirus+Astrovirus Combo Rapid Test IMVD-R64598/79 Norovirus+Rotavirus/Adenovirus+Astrovirus+Enterovirus Combo Rapid Test IMVD-65598/79 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 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 Rotavirus Group A and Norovirus GI/GII RT-qPCR Kit2 réf.98/79 Rotavirus/Adenovirus+Astrovirus Combo Rapid Test IRAA-62598/79 RSV &Influenza A+B Combo Rapid Test Cassette IRIC-R52598/79 RSV and SARS-CoV-2 Antigen Combo Rapid Test98/79 RSV&Influenza A+B Combo Rapid Test Cassette IRIC-52598/79 RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 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/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 Trichomonas vaginalis/Gardnerella vaginalis/Candida albicans Combo Rapid Test98/79 TropiDetect Triple Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bacteriology - RT & POC - other	W0105090199	ASO Test Cassette98/79 Bacterial Diarrhea (Salmonella/C.diff)Rapid Test98/79 Bacterial Diarrhea (Shigella/Cholerae/C.diff) Rapid Test98/79 Bacterial Diarrhea (Shigella/Salmonella) Rapid Test98/79 Bacterial Diarrhea (Shigella/Salmonella/C.diff) Rapid Test98/79 74 autres Bordetella pertussis Antigen Rapid Test IBP-50298/79 Bordetella pertussis IgM Rapid Test IBPM-40298/79 Brucella Abortus and Melitensis Antibody Combo Rapid Test98/79 Brucella Abortus Antibody Rapid Test98/79 Brucella Abortus Antigen Rapid Test Cassette98/79 Brucella Abortus IgG/IgM Rapid Test98/79 Campylobacter Prueba Rápida de Casete98/79 Campylobacter Rapid Test Cassette (Feces) ICAM-60298/79 Campylobacter Rapid Test Cassette ICAM-R60298/79 Campylobacter Rapid Test ICAM-60798/79 Candida albicans and Trichomonas Vaginalis Combo Rapid Test ICT-52598/79 CARBA-5 Rapid Test98/79 Clostridium difficile GDH+Toxin A+Toxin B Combo Rapid Test ICD-63798/79 Febrile Antigens10 réf.98/79 Gardnerella Vaginalis Antigen Rapid Test98/79 Gonorrhea Rapid Test4 réf. Gonorrhea Rapid Test Cassette98/79 Gonorrhea Rapid Test W010509019998/79 H. pylori Antibody Rapid Test Cassette IHP-R40298/79 H. pylori Antigen Rapid Test Cassette MH-HP-602H98/79 H.pylori IgM Rapid Test IHPM-40298/79 H.pylori Rapid Test IHP-90498/79 H.pylori Saliva (HPS) Rapid Test98/79 H.pylori/Transferrin Combo Rapid Test IHT-62598/79 Helicobacter Pylori (HP) IgA Test Kit (CLIA)98/79 Leptospira IgG/IgM Combo Rapid Test ILEP-42598/79 Leptospira IgG/IgM Test Cassette FI-LEP-40298/79 Leptospira IgM Rapid Test ILEPM-40298/79 Leptospira IgM Semi-quantitative Rapid Test ILEM-42598/79 Lyme IgG/IgM Rapid Test Cassette 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 Test Cassette FI-MP-50298/79 Mycoplasma Pneumoniae IgG Rapid Test IMPG-40298/79 Mycoplasma pneumoniae IgG/IgM ComboRapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Mycoplasma pneumoniae IgG/IgM Rapid Test IMP-40298/79 Mycoplasma pneumoniae IgM Test Cassette FI-MPM-40298/79 Rose Bengal Latex Reagents98/79 S. pneumoniae and L. pneumophila Combo Rapid Test Cassette98/79 S. pneumoniae and L. pneumophila Combo Rapid Test Cassette (Urine)98/79 Salmonella paratyphiAntigen Rapid Test98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test98/79 Salmonella typhi and paratyphi B Antibody Combo Rapid Test98/79 Salmonella typhi and paratyphi B Antigen Combo Rapid Test2 réf.98/79 Salmonella typhi Antigen Rapid Test4 réf. Salmonella typhi AntigenRapid Test Cassette(Feces)98/79 Scrub Typhus IgG/IgM Rapid Test Cassette2 réf.98/79 Scrub Typhus IgG/IgM Test Cassette98/79 Shigella Flexneri Antigen Rapid Test98/79 Shigella Flexneri Antigen Rapid Test Cassette98/79 Shigella Sonnei Antigen Rapid Test98/79 Shigella Sonnei Antigen Rapid Test Cassette98/79 ShigellaRapid Test98/79 Streptococcus pneumoniae and Legionella pneumophila Combo Rapid Test Cassette2 réf.98/79 Syphilis Rapid Test ISY-10298/79 Tetanus Rapid Test Cassette ITE-40298/79 Tuberculosis IgG/IgM Rapid Test Cassette98/79 Tuberculosis Rapid Test Cassette2 réf.98/79 Tuberculosis Rapid Test Dipstick98/79 Typhoid IgG Rapid Test Cassette98/79 Typhoid IgM Rapid Test Cassette98/79 Typhoid Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Vibrio cholerae O1 (VC O1) Rapid Test Cassette2 réf.98/79 Vibrio cholerae O1 (VC O1) Rapid Test Cassette (Feces)98/79 Vibrio Cholerae O1 Inaba (VC O1 Inaba) Rapid Test Cassette2 réf.98/79 Vibrio Cholerae O1 Ogawa (VC O1 Ogawa) Rapid Test Cassette2 réf.98/79 Vibrio cholerae O1/O139 Combo Rapid Test98/79 Vibrio cholerae O1/O139 Combo Rapid Test Cassette2 réf.98/79 Vibrio cholerae O1/O139 Combo Rapid Test Cassette (Feces)98/79 Vibrio cholerae O139 (VC O139) Rapid Test98/79 Vibrio cholerae O139 (VC O139) Rapid Test Cassette98/79 Vibrio cholerae O139 (VC O139) Rapid Test Cassette (Feces)98/79 Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test4 réf.98/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Virology - RT & POC - other	W0105099099	Adenovirus Antigen Rapid Test Cassette (Swab) IAD-50298/79 Adenovirus pneumoniae Antigen Test Cassette FI-AD-50298/79 Adenovirus Rapid Test Cassette(Feces) IAD-60298/79 Adenovirus Rapid Test IAD-60798/79 Adenovirus Rapid Test IAD-N602-203 réf. 71 autres Astrovirus Rapid Test Cassette (Feces) IAS-60298/79 Astrovirus Rapid Test IAS-60798/79 Astrovirus Test Cassette FI-AS-60298/79 ChikuFast IgG/IgM Rapid Test2 réf.98/79 Chikungunya Antigen Rapid Test ICHIG-40298/79 Chikungunya IgG/IgM Combo Rapid Test ICHI-425(SSW)98/79 Chikungunya IgG/IgM Rapid Test Cassette ICHI-40298/79 Chikungunya IgM Rapid Test Cassette ICKM-40298/79 COVID-19 and M. pneumoniae IgG Combo Rapid Test98/79 COVID-19 and M. pneumoniae IgG/IgM Combo Rapid Test98/79 COVID-19 Antigen Rapid Test2 réf.98/79 Cryptosporidium and Giardia lamblia Combo Rapid Test Cassette ICGC-62598/79 Cryptosporidium and Giardia lamblia Combo Rapid Test Cassette ICGC-R62598/79 Dengue Combo Rapid Test IDEC-43598/79 Dengue IgG/IgM & NS1 Combo Test98/79 Dengue IgG/IgM Combo Rapid Test IDEN-425(SSW)98/79 Dengue IgG/IgM Rapid Test DEN-RTC-1298/79 Dengue lgG&lgM/Chikungunya lgG&lgM/Zika lgG&lgM Combo Rapid Test98/79 Dengue lgG&lgM/Zika lgG&lgM/Chikungunya lgG/chikungunya lgM Combo Rapid Test98/79 Dengue/Chikungunya/Zika Combo Rapid Test Cassette IDCZ-R43598/79 Dengue/Zika/Chikungunya Combo Rapid Test Cassette IDZC-R44598/79 Dispositivo de Prueba Rápida para Chikungunya IgG/IgM98/79 Enterovirus 71 Test Cassette98/79 Enterovirus Antigen Rapid Test IEV-60298/79 H5N1 Antigen Rapid Test98/79 HAV IgG/IgM Combo Rapid Test Cassette IHAGM-R42598/79 HAV IgG/IgM Test Cassette FI-HAV-40298/79 HAV IgM Test Cassette FI-HAVM-40298/79 HEV Antigen Rapid Test IHE-10298/79 HEV IgM Rapid Test IHEM-30298/79 HMPV Rapid Test98/79 HMPV Test Cassette98/79 HPIV 1/2/3 Rapid Test98/79 HPIV Rapid Test98/79 HPIV Test Cassette98/79 HPV 16/18 Antigen Rapid Test98/79 HPV Antigen Rapid Test THPV-502B98/79 HPV Test THPV-10198/79 HSV 1 IgG/IgM Test Cassette98/79 HSV 1/2 IgG/IgM Rapid Test Cassette98/79 HSV 1/2 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HSV 2 IgG/IgM Test Cassette98/79 Human Bocavirus Antigen Rapid Test IBOV-50298/79 Influenza A+B Test(Nasal Swab) MH-IN-502H98/79 Measles IgG/IgM Rapid Test IME-40298/79 Mononucleosis(MONO) Latex Reagents IMONO-S50T98/79 Norovirus Rapid Test Cassette (Feces) INO-60298/79 Norovirus Rapid Test INO-60798/79 Norovirus Rapid Test INO-R60298/79 Norovirus Test Cassette FI-NOV-60298/79 Norovirus,Rotavirus and Adenovirus Combo Rapid test Cassette INRA-R63598/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test INRA-63598/79 Rhinovirus Rapid Test IRHV-50298/79 Rotavirus and Adenovirus Combo Test Cassette FI-RAC-60298/79 Rotavirus and Adenovirus Test Cassette-98/79 Rotavirus Rapid Test Cassette(Feces) IRO-60298/79 Rotavirus Rapid Test IRO-60798/79 Rotavirus Rapid Test IRO-N602-203 réf. Rotavirus Test Cassette FI-ROT-60298/79 Rotavirus Test Cassette(Feces)98/79 SARS-CoV-2 Antigen Rapid Test2 réf.98/79 SARS-CoV-2(COVID-19) Antigen Rapid Test98/79 Test rapide COVID-19 COVI'LAB98/79 Viral diarrhea (Norovirus+Rotavirus+Adenovirus+Astrovirus) Combo Rapid Test3 réf. Viral diarrhea (Rotavirus + Adenovirus) Combo Rapid Test3 réf. West Nile Virus IgG/IgM Rapid Test IWNGM-40298/79 West Nile Virus IgG/IgM Rapid Test(Whole Blood/Serum/Plasma) IWNGM-40298/79 Yellow Fever Virus IgG/IgM Rapid Test98/79 Zika IgG/IgM &NS1 Combo Test98/79 Zika IgG/IgM Test ZIB-RTC-1098/79 Zika NS1 Test98/79	B, C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Controls infectious immunology - RT & POC	W0105094001	Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Control98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Control98/79 Bacterial Diarrhea (Shigella/Salmonella/C.diff) Control98/79 Bordetella pertussis Antigen Control SCBP-S98/79 Brucella Abortus Control98/79 56 autres Chagas Control SCCHA-D98/79 Chikungunya IgG/IgM Antibody Control SCCHI-D-L98/79 Clostridium difficile GDH + Toxin A + Toxin B Control SCCD-D-L98/79 Clostridium difficile GDH Control SCCDG-D-L98/79 COVID-19 and Influenza A+B Antigen Combo Control98/79 COVID-19 IgG Control98/79 Cryptococcus Antigen Control SCCRG-D-L98/79 Cryptosporidium Antigen Control SCCRY-D-L98/79 Cryptosporidium Control SCCRY-L98/79 Dengue IgG/IgM Control SCDEGM-L98/79 Entamoeba/Giardia/Crypto Control2 réf.98/79 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 Giardia Lamblia Control SCGL-D-L98/79 HPIV Control98/79 HPV Antigen Control SCHPV-S98/79 Human Metapneumovirus Antigen Control SCHMPV-D-L98/79 Influenza A/B+H1N1 Control98/79 Legionella pneumophila Control3 réf.98/79 Leptospira IgG/IgM Antibody Control SCLEP-L98/79 Monkeypox Virus Antibody Control SCMXB-L98/79 Monkeypox Virus Antigen Control SCMXG-D-L98/79 Multiplex Respiratory Antigen Control SCRTC-S98/79 Mycoplasma pneumoniae IgG/IgM Control SCMPGM-L98/79 Mycoplasma pneumoniae IgM Control SCMPM-L98/79 Norovirus/Astorvirus/Enterovirus Combo Control98/79 Rhinovirus Control SCRHV-S98/79 S. pneumoniae and L. pneumophila Control98/79 S. pneumoniae/ L. pneumophila Control98/79 Salmonella paratyphi Antigen Control98/79 Salmonella typhi and paratyphi Antigen Control98/79 Salmonella typhi Antigen Control98/79 SARS-CoV-2 Antigen Control2 réf.98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Control98/79 Scrub Typhus IgG/IgM Control98/79 Shigella Flexneri Control98/79 Shigella Sonnei Control98/79 Streptococcus pneumoniae Control2 réf.98/79 Tetanus Control SCTET-D-L98/79 Trichomonas Vaginalis Control SCTV-D-L98/79 Vibrio cholerae O1/O139 Control98/79 ZIKA IgG Control SCZIBG-D98/79 Zika IgG/IgM Control SCZIB-L98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Multiple infectious - multiplex assays - other	W0105070599	Adenovirus and RSV Combo Rapid Test Cassette IARC-R52598/79 Clostridium difficile GDH + Toxin A + Toxin B + Lactoferrin Combo Rapid Test ICDL-64598/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test98/79 Dengue, Zika and Chikungunya Virus RT-qPCR Kit98/79 Giardia/Rotavirus/Cryptosporidium Combo Rapid Test IGRC-63598/79 22 autres Influenza A+B/COVID-19 Combo Test Cassette98/79 Norovirus and Rotavirus Combo Rapid Test INRC-62598/79 Norovirus+Rotavirus+Adenovirus+Astrovirus Combo Rapid Test Cassette (Feces) IMVD-64598/79 Norovirus+Rotavirus+Adenovirus+H.pylori+ Clostridium difficile GDH+Toxin A+Toxin B Combo Rapid Test IMGP-67598/79 Norovirus+Rotavirus+Adenovirus+H.pylori+Clotridium difficile GDH+Toxin A+Toxin B Combo Rapid Test98/79 Norovirus,Rotavirus,Adenovirus and Astrovirus Combo Rapid Test Cassette (Feces) IMVD-64598/79 Norovirus,Rotavirus,Adenovirus,Astrovirus Combo Rapid Test IMVD-64798/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test Cassette INRA-63598/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test Cassette INRA-R63598/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test INRA-R63798/79 Prueba Rápida de Combinación deNorovirus+Rotavirus+Adenovirus+ Astrovirus en Casete98/79 Rotavirus and Adenovirus Combo Rapid Test Cassette (Feces) IRAC-62598/79 Rotavirus and Adenovirus Combo Rapid Test Cassette IRAC-R62598/79 Rotavirus and Adenovirus Combo Rapid Test IRAC-62798/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test2 réf.98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test cassette98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test(Nasal Swab)98/79 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 ToRCH IgM Combo Rapid Test98/79 ToRCH IgM Combo Rapid Test Cassette98/79 Vaginal pH/Candida albicans/Trichomonas Vaginalis Combo Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
H. pylori - RT & POC	W0105090102	Family Health Self Test Helicobacter Pylori IHP-N602H-013 réf. Gesunder Magen2 réf.98/79 H. pylori Antibody Rapid Test Cassette (Serum /Plasma) IHP-30298/79 H. pylori Antibody Rapid Test Cassette IHP-40298/79 H. pylori Antibody Rapid Test Cassette IHP-R40298/79 20 autres H. pylori Antibody Rapid Test IHP-N4023 réf. H. pylori Antigen Rapid Test (Feces) IHP-60798/79 H. pylori Antigen Rapid Test Cassette (Feces) IHP-60298/79 H. pylori Antigen Rapid Test Cassette IHP-602H98/79 H. pylori Antigen Rapid Test Cassette(Feces) IHP-602H98/79 H. pylori Antigen Rapid Test IHP-602H98/79 H. pylori Antigen Rapid Test IHP-N601-253 réf. H.pylori 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 IHP-60198/79 H.pylori Antigen Rapid Test IHP-60298/79 Magsår H. Pylori98/79 Mivolis H. pylori Antigen Rapid Test Cassette98/79 Mivolis Schnelltest Gesunder Magen2 réf.98/79 Prueba Rápida de antígeno de H. Pylori en casete98/79 Schnelltest Gesunder Magen98/79 Szybki test kasetkowy do wykrywania Helicobacter pylori w kale98/79 ZuhauseTEST Gesunder Magen2 réf.98/79	B, C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Multiple viruses - multiplex assays - other	W0105070399	Adenovinus/RSV /influenza A+B Combo Rapid Test Cassette98/79 Adenovirus / RSV / Influenza A+B Combo Rapid Test Cassette IARI-R53598/79 Adenovirus and RSV Combo Rapid Test Cassette IARC-52598/79 Adenovirus, RSV and lnfluenza А+В Combo Rapid Test Cassette98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 15 autres Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 COVID-19 Ag/Influenza A+B Combo Test Cassette(NP Swab)98/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test98/79 COVID-19 Antigen/Influenza A+B Combo Test Cassette98/79 Multi-Respiratory Antigen Test (Nasopharyngeal Swab) IRTC-595(DSW)98/79 Multiplex Respiratory Antigen Rapid Test (Nasopharyngeal Swab) IRTC-565(DSW)98/79 Multiplex Respiratory Antigen Rapid Test (Nasopharyngeal Swab) IRTC-575(DSW)98/79 RSV/Influenza A+B Combo Rapid Test Cassette IRIC-52598/79 RSV/Influenza A+B Combo Rapid Test Cassette IRIC-R52598/79 RSV/Influenza A+B Test Cassette FI-RIV-50298/79 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 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/InfluenzaA+B/RSV/Adenovirus/M. pneumoniae Antigen Combo Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Strep. a - RT & POC	W0105090103	berkeleyhealth Easy Check Strep A rapid test (Professional)98/79 Berkeleyhealth Easy Check Strep A rapid test cassette98/79 Cassette Test Rapide Strep A98/79 SCREEN® Strep A Test3 réf. Strep A Rapid Test Cassette (Control Line in Blue)(Throat Swab)98/79 14 autres Strep A Rapid Test Cassette (Control Line in Red) IST-50298/79 Strep A Rapid Test Cassette (Throat Swab)2 réf.98/79 Strep A Rapid Test Cassette IST-50298/79 Strep A Rapid Test Cassette IST-N50298/79 Strep A Rapid Test Cassette IST-R50298/79 Strep A Rapid Test Cassette ISTB-50298/79 Strep A Rapid Test Cassette ISTB-R50298/79 Strep A Rapid Test Dipstick98/79 Strep A Rapid Test Dipstick (Throat Swab)98/79 Strep A Rapid Test IST-50198/79 Strep A Rapid Test IST-N5013 réf. Strep A Rapid Test ISTB-N501-253 réf. Strep A Test Cassette FI-STA-50298/79 Strep A Test Cassette(Swab)98/79	B, C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Plasmodium (malaria) - RT & POC	W0105090401	Malaria Antibody Rapid Test IMAB-40298/79 Malaria P.f. /P.v. Rapid Test Cassette (Whole Blood) IMPV-40298/79 Malaria P.f. /P.v. Rapid Test Cassette IMPV-R40298/79 Malaria P.f. /P.v. Rapid Test IMPV-N402-203 réf. Malaria P.f. /Pan Rapid Test Cassette (Whole Blood) IMPN-40298/79 13 autres Malaria P.f. /Pan Rapid Test IMPN-N402-203 réf. Malaria P.f. Rapid Test Cassette98/79 Malaria P.f. Rapid Test Cassette (Whole Blood) IMA-40298/79 Malaria P.f./P.v. /Pan Rapid Test Cassette IMPVF-40298/79 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-R40298/79 Malaria P.f./Pan Rapid Test Dipstick98/79 Malaria P.f./Pan Rapid Test IMPN-40198/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Parasites - RT & POC - other	W0105090499	Chagas Rapid Test Cassette (Whole Blood/Serum/Plasma) ICHA-40298/79 Cryptosporidium Antigens and Giardia Lamblia Combo Test Cassette FI-CG-60298/79 Cryptosporidium Rapid Test ICR-60798/79 Entamoeba histolytica Rapid Test Cassette (Feces) IEH-60298/79 Entamoeba histolytica Rapid Test IEH-60798/79 12 autres Entamoeba+Giardia+Crypto Combo Rapid Test3 réf.98/79 Entamoeba+Giardia+Crypto Combo Rapid Test Cassette2 réf.98/79 Entamoeba/Giardia/Crypto Rapid Test Cassette2 réf.98/79 Entamoeba/Giardia/H.pylori Combo Rapid Test IEGH-63598/79 Filariasis Antigen Rapid Test98/79 Filariasis IgG/IgM Rapid Test98/79 Filariasis IgG/IgM Rapid Test Cassette3 réf.98/79 Filariasis IgG/IgM Test Cassette98/79 Giardia Lamblia Rapid Test Cassette (Feces) IGL-60298/79 Giardia Lamblia Rapid Test IGL-60798/79 Schistosoma Antibody Rapid Test ISC-40298/79 Toxo IgG/IgM Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Dengue - RT & POC	W0105099007	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-R42598/79 Dengue Combo Rapid Test IDEC-N425-103 réf. 10 autres 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 Rapid Test Cassette98/79 Dengue IgG/IgM Rapid Test Cassette IDEN-R40298/79 Dengue IgG/IgM Rapid Test IDEN-N402-103 réf. Dengue NS1 Rapid Test3 réf. Dengue NS1 Rapid Test Cassette2 réf.98/79 Dengue NS1 Rapid Test Cassette with LF READER PLUS98/79 Dengue NS1 Test Cassette (Whole Blood/Serum/Plasma)98/79 Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) IDEN-40298/79	B, C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	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+ 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 with LF READER PLUS98/79 9 autres Clostridium difficile GDH+Toxin A/B Test Cassette FI-CD-60298/79 Clostridium difficile GDH/Toxin A/Toxin B Test Cassette FI-CD-602B98/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-62598/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-625B98/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-R625B98/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette ICDT-R625B98/79 Clostridium difficile Toxin A/ toxin B Combo Test Cassette FI-CDT-62598/79 Clostridium difficileToxin A+Toxin B Combo Rapid Test Cassette2 réf.98/79 Combo Prueba Rápida Clostridium difficile GDH+Toxina A+Toxina B en Casete98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus antigen (ag) - RT & POC	W0105090501	AUTOTESTE COVID-19 Ag(SALIVA)98/79 COVID-19 Antigen Rapid Test6 réf.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 8 autres COVID-19 Antigen Rapid Test-ITA98/79 COVID-19 Antigen Test Cassette(Swab)98/79 SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva)2 réf.98/79 SARS-CoV-2 Antigen Rapid Test2 réf.98/79 SARS-CoV-2 Antigen Rapid Test (Swab)98/79 SARS-COV-2(COVID-19) Antigen Rapid Test2 réf.98/79 SARS-CoV-2-Antigen-Schnelltest (Nasenabstrich)98/79 Test Rapide de l’antigène SARS-CoV-2 (écouvillon nasal)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Influenza a and /or b - RT & POC	W0105099004	FLU A+B Test Cassette98/79 H1N1 Antigen Rapid 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 8 autres Influenza A Rapid Test Dipstick98/79 Influenza A+B Rapid Test3 réf. Influenza A+B Rapid Test Cassette IIN-50298/79 Influenza A+B Rapid Test Cassette IIN-R50298/79 Influenza A+B Rapid Test Cassette(Swab / Nasal Aspirate)98/79 Influenza A+B Rapid Test Dipstick98/79 Influenza A+B Rapid Test IIN-R50298/79 Influenza A/B+H1N1 Combo Rapid Test Cassette2 réf.98/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Syphilis - RT & POC	W0105090105	RPR Reagents5 réf.98/79 SYP Test Cassette98/79 Syphilis Rapid Test (Oral Fluid) ISY-80398/79 Syphilis Rapid Test Cassette ISY-30298/79 Syphilis Rapid Test Cassette ISY-40298/79 8 autres Syphilis Rapid Test Cassette ISY-R30298/79 Syphilis Rapid Test Dipstick2 réf.98/79 Syphilis Rapid Test Dipstick (Whole Blood /Serum/Plasma)98/79 Syphilis Rapid Test ISY-40298/79 Syphilis Rapid Test ISY-80398/79 Syphilis Rapid Test ISY-N4013 réf. Syphilis Test Kit (CLIA)98/79 TPHA Reagents3 réf.98/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Immunochemistry readers	W0201020201	16-Channel Fluorescence Immunoassay Analyzer2 réf. AUR-600 Semi-Quantitative Urine Analyzer98/79 Dry-type Fluorescent Immunoassay Analyzer (Single channel)2 réf. Fluorescence Immunoassay Analyzer98/79 Fluorescence Immunoassay Analyzer Instrument7 réf. 7 autres Fuorescence lmmunoassay Analyzer98/79 Lateral Flow (LF) Portable Reader Plus Instrument2 réf. Lateral Flow (LF) Reader98/79 Lateral Flow (LF) Reader Instrument Lateral Flow (LF) Reader Plus98/79 Lateral Flow (LF) Reader Plus Instrument LF Reader98/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Viral antigen/antibody detection - other	W0105040699	"Prueba Rápida Combinada de Rotavirus y Adenovirus en Casete "98/79 Chikungunya lgM Rapid Test98/79 Monkeypox Virus Antigen Rapid Test IMXG-40298/79 Mycoplasma pneumoniae/Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Cassette98/79 Nipah Virus IgG/IgM Rapid Test98/79 6 autres Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test IMVD-64798/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test IMVD-647H98/79 Rotavirus and Adenovirus Combo Rapid Test IRAC-62598/79 Rotavirus and Adenovirus Combo Rapid Test IRAC-N6252 réf. Rotavirus and Adenovirus Combo Rapid Test IRAC-N625J98/79 Rotavirus and Adenovirus Rapid Test (Feces) IRAC-62798/79	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus ag	W0105041101	COVID-19 Antigen Rapid Test3 réf.98/79 COVID-19 Antigen Rapid Test (Corona Lollipop Rapid Test)98/79 COVID-19 Antigen Test Cassette2 réf.98/79 COVID-19 Antigen Test Cassette(Swab)2 réf.98/79 One Step SARS-CoV-2 (COVID-19) Antigen Rapid Test98/79 5 autres SARS-CoV-2 (COVID-19) Antigen Rapid Test2 réf.98/79 SARS-CoV-2 and Variant Delta Virus RT-qPCR Kit98/79 SARS-CoV-2 Antigen Rapid Test2 réf.98/79 SARS-COV-2 RT-qPCR Assay98/79 SARS-CoV-2 Variant Omicron Virus RT-qPCR Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Strep. pneumoniae - RT & POC	W0105090109	Prueba Rápida de S. pneumoniae Antígeno en Casete98/79 S. pneumoniae Antigen Rapid Test Cassette ISP-10298/79 S. pneumoniae Antigen Rapid Test Cassette ISP-R10298/79 S. pneumoniae Antigen Rapid Test ISP-N102-103 réf. S.pneumoniae Antigen Rapid Test Cassette (Urine) ISP-10298/79 5 autres Streptococcus pneumoniae Antigen Rapid Test Cassette2 réf.98/79 Streptococcus pneumoniae Antigen Rapid Test Cassette with LF READER ATR-001,10 T/kit98/79 Streptococcus Pneumoniae Antigen Test Cassette98/79 Streptococcus pneumoniae Test Cassette98/79 Streptococcus pneumoniae Test Cassette (Urine)98/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Virology - NA reagents - other	W0105040599	Influenza A and B Virus RT-qPCR Kit98/79 Influenza A/B and Respiratory Syncytial Virus RT-qPCR Kit98/79 Monkeypox Virus Detection qPCR Kit98/79 Monkeypox Virus qPCR Kit98/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test INRA-63598/79 4 autres Respiratory Syncytial Virus RT-qPCR Kit98/79 SARS-CoV-2 and Influenza A/B Virus RT-qPCR Kit98/79 SARS-CoV-2 Nucleic Acid Detection Kit (CRISPR Lateral Flow Assay)98/79 SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus RT-qPCR Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Zika virus	W0105040630	Zika antigen Test Cassette FI-ZI-40298/79 Zika IgG/IgM and NS1 Combo Rapid Test Cassette2 réf.98/79 Zika IgG/IgM and NS1 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Zika IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IZIB-40298/79 Zika IgG/IgM Rapid Test Cassette IZIB-40298/79 4 autres Zika IgG/IgM Rapid Test Cassette IZIB-R40298/79 Zika IgM Test Cassette FI-ZIM-40298/79 Zika NS1 Rapid Test Cassette2 réf.98/79 Zika NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Salmonella antigen detection	W0105011001	Casete de prueba rápida de antígenos de Salmonella typhi y paratyphi98/79 Salmonella paratyphi Antigen Rapid Test98/79 Salmonella paratyphi Antigen Rapid Test Cassette98/79 Salmonella paratyphi Antigen Rapid Test Cassette (Feces)98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test Cassette2 réf.98/79 3 autres Salmonella typhi and paratyphi B Antigen Combo Rapid Test98/79 Salmonella typhi Antigen Rapid Test98/79 Salmonella typhi Antigen Rapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Salmonella antibody assays	W0105011002	Typhoid IgG/IgM Rapid Test Cassette98/79 Typhoid IgG Rapid Test Cassette98/79 Typhoid IgM Rapid Test Cassette98/79 Typhoid Rapid Test Cassette3 réf.98/79 Typhoid Rapid Test Cassette (Serum/Plasma)2 réf.98/79 2 autres Typhoid Rapid Test Dipstick98/79 Typhoid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Adenovirus	W0105040601	Adenovirus Antigen Rapid Test Cassette (Swab) IAD-50298/79 Adenovirus Antigen Rapid Test Cassette IAD-50298/79 Adenovirus Antigen Rapid Test Cassette IAD-R50298/79 Adenovirus antigen Test Cassette IAD-60298/79 Adenovirus Rapid Test Cassette IAD-60298/79 1 autre Adenovirus Rapid Test Cassette IAD-R60298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Combined abo typing + rhesus d	W0103030901	ABO and RhD Blood Grouping Rapid Test Cassette98/79 ABO and RhD Blood Grouping Rapid Test Cassette (Whole Blood)98/79 Schnelltest Vitamin D98/79 Vitamin D Rapid Test OVD-402H98/79 Vitamin D Rapid Test Cassette OVD-40298/79 1 autre Vitamin D Rapid Test Cassette OVD-402H98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus igg	W0105041103	COVID-19 IgG Rapid Test3 réf.98/79 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 SARS-CoV-2 Neutralization Antibody Rapid Test98/79 1 autre SARS-CoV-2 S-RBD IgG Antibody Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
D-dimer	W0103020503	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 FI-DDM-40298/79 D-Dimer Test Cassette(WB/P)98/79 1 autre D-Dimer Test Kit (CLIA)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
H. pylori antibody assays	W0105010402	H. pylori Antibody Rapid Test Cassette IHP-30298/79 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 Rapid Test IHP-90298/79 1 autre Helicobacter pylori(HP) IgG Test Kit(CLIA)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
H. pylori antigen detection	W0105010401	H pylori Antigen Rapid Test Dipstick98/79 H.pylori Antigen Rapid Test Cassette IHP-60298/79 H.pylori Antigen Rapid Test Cassette IHP-R60298/79 H.pylori Antigen Rapid Test IHP-60798/79 H.pylori Antigen Test Cassette FI-HP-60298/79 1 autre H.pylori Antigen Test Cassette(Feces)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
HIV 1 / 2 - RT & POC	W0105090302	Hexagon HbsAg98/79 Hexagon HIV98/79 HIV 1.2 Rapid Test Cassette2 réf.98/79 HIV 1.2 Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HIV 1.2.O Rapid Test Cassette(WB/S/P)98/79 1 autre Teste rápido em cassete de HIV 1.2(Sangue Total/Soro/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Monkeypox virus / mpox RT & POC	W0105099008	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 Rapid Test IMXG-40298/79 Monkeypox Virus Antigen Rapid Test IMXG-R40298/79 1 autre Monkeypox Virus Antigen Test Cassette FI-MXG-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mononucleosis (ebv) - RT & POC	W0105099003	EBV VCA and EBNA IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IECNG-42598/79 MONO Rapid Test Cassette IMO-40298/79 MONO Rapid Test Cassette IMO-R40298/79 MONO Rapid Test IMO-40298/79 MONO Rapid Test IMO-N402-253 réf. 1 autre Prueba Rápida de Mononucleosis en Casete98/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Parasitology - other	W0105050299	Cryptosporidium and Giardia lamblia Combo Rapid Test Cassette (Feces) ICGC-62598/79 Entamoeba+Giardia+Crypto Combo Rapid Test Cassette (Feces)98/79 Entamoeba/Giardia/Crypto Prueba Rápida de Casete98/79 Entamoeba/Giardia/Crypto Rapid Test Cassette (Feces)98/79 Filariasis IgG/IgM Rapid Test Cassette (Serum/Plasma)98/79 1 autre Filariasis IgG/IgM Rapid Test Cassette (Whole Blood /Serum/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chikungunya virus	W0105040625	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	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus / influenza - RT & POC	W0105090601	COVID-19 and Influenza A+B Antigen Combo Rapid Test98/79 SARS-CoV-2 a chřipka A+B Antigen Combo Rychly test (Vytěr z nosu)98/79 SARS-COV-2 and Influenza A+B Antigen Combo Rapid Test3 réf.98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab)98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Influenza & para influenza	W0105040604	FLU A+B Test Cassette(Swab)98/79 H1N1 Antigen Rapid Test Cassette2 réf.98/79 H1N1 Antigen Rapid Test Dipstick98/79 HPIV Rapid Test98/79 Influenza A+B Test Cassette FI-FLU-50298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Legionella - RT & POC	W0105090108	Casete de Prueba Rápida de Legionella pneumophila98/79 Legionella pneumophila Rapid Test3 réf. Legionella pneumophila Rapid Test Cassette98/79 Legionella pneumophila Rapid Test Cassette (Urine)98/79 Legionella pneumophila Test Cassette (Urine)98/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Plasmodium (malaria)	W0105050209	Malaria P.f. Rapid Test Cassette IMA-40298/79 Malaria P.f. Rapid Test Dipstick98/79 Malaria P.f./P.v. /Pan Test Cassette FI-MAL-43598/79 Malaria P.f./P.v. Rapid Test Cassette IMPV-40298/79 Malaria P.f./Pan Rapid Test Cassette IMPN-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Rsv - RT & POC	W0105099002	RSV Rapid Test Cassette IRS-50298/79 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	– 98/79	Fiche EUDAMED Signaler une erreur
Urinalysis (ur) - laboratory analysers- instruments	W02010701	Cup Reader ACR-100 Urine Analyzer AUR-1003 réf. Urine Analyzer AUR-20098/79 Urine Analyzer AUR-30098/79 Urine Analyzer AUR-4013 réf.	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system I3 réf. Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system II3 réf. Cup Reader ACR-10098/79 Fluorescence Immunoassay Analyzer98/79 Uric Acid Meter AUAR-1003 réf.	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
C.difficile GDH detection	W0105011801	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	– 98/79	Fiche EUDAMED Signaler une erreur
Candida albicans	W0105060302	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	– 98/79	Fiche EUDAMED Signaler une erreur
Chagas	W0105050202	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	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus antibodies - total	W0105041102	2019-CoV IgG/IgM Rapid Test Cassette2 réf.98/79 COVID-19 IgG/IgM Rapid Test2 réf.98/79 COVID-19 IgG/IgM Rapid Test Dipstick2 réf.98/79 COVID-19 IgG/IgM Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus antibody (ab) - RT & POC	W0105090502	COVID-19 IgG/IgM Rapid Test2 réf.98/79 SARS-CoV-2 Neutralization Antibody Rapid Test98/79 SARS-CoV-2 S-RBD Antibody Rapid Test98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Dengue virus	W0105040611	Dengue Combo Rapid Test Cassette IDEC-42598/79 Dengue IgG, IgM and NS1 Combo Test Cassette98/79 Dengue IgG/IgM Test Cassette FI-DEN-40298/79 Dengue NS1 Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hepatitis viruses - RT & POC - other	W0105090299	HAV IgG/IgM Combo Rapid Test Cassette IHAGM-42598/79 HAV IgG/IgM Rapid Test Cassette(WB/S/P)98/79 HAV IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IHA-40298/79 HAV IgM Rapid Test Cassette IHA-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Shigella	W0105011714	Shigella Flexneri Antigen Rapid Test Cassette98/79 Shigella Rapid Test Cassette ISH-62598/79 Shigella Rapid Test Cassette ISH-R62598/79 Shigella Sonnei Antigen Rapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Strep. b - RT & POC	W0105090104	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	– 98/79	Fiche EUDAMED Signaler une erreur
Tetanus (clostridium t.)	W0105011709	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	– 98/79	Fiche EUDAMED Signaler une erreur
Trichomonas	W0105050210	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	– 98/79	Fiche EUDAMED Signaler une erreur
Virology reagents - other	W01050499	Adenovirus / RSV / Influenza A+B Combo Rapid Test IARI-53598/79 Adenovirus and RSV Combo Rapid Test Cassette(Nasopharyngeal Swab) IARC-52598/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test Cassette IARI-53598/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test Cassette with LF READER PLUS98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bacteriology controls - inf.imm.	W0105080801	Gonorrhea Control98/79 Malaria P.f./P.v. Control SCMPV-D98/79 Syphilis Control98/79	– 98/79	Fiche EUDAMED Signaler une erreur
C.difficile GDH and toxin a/b combined detection	W0105011803	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 Test Cassette FI-CD-602B98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chlamydia ag - RT & POC	W0105090101	Chlamydia Rapid Test Cassette ICH-50298/79 Chlamydia Rapid Test ICH-50298/79 Chlamydia Rapid Test ICH-N502FH-013 réf.	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Cryptococcus	W0105060303	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	– 98/79	Fiche EUDAMED Signaler une erreur
Cryptosporidium	W0105050207	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	– 98/79	Fiche EUDAMED Signaler une erreur
D-dimer - RT & POC	W0103020803	D-dimer Rapid Test Cassette (WB / P)98/79 D-dimer Rapid Test Cassette CDM-40298/79 D-Dimer Test Cassette (Whole Blood/Plasma) FI-DDM-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Ebv antibodies - other	W010504040199	EBV VCA and EBNA IgG Combo Rapid Test Cassette IECNG-42598/79 EBV VCA and EBNA IgG Combo Rapid Test Cassette IECNG-R42598/79 EBV VCA IgA Rapid Test Cassette IECA-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hbsag - RT & POC	W0105090201	HBsAg Rapid Test Cassette (Whole Blood/Serum/Plasma) IHBSG-40298/79 HBsAg Rapid Test Cassette IHBSG-40298/79 Prueba Rápida de HBsAg en Casete98/79	– 98/79	Fiche EUDAMED Signaler une erreur
HCV antibody (total)	W0105020303	HCV Rapid Test Cassette IHC-40298/79 HCV Rapid Test IHC-40298/79 Hexagon HCV98/79	– 98/79	Fiche EUDAMED Signaler une erreur
HPV antigen / antibodies	W0105041001	HPV 16/18 qPCR Kit98/79 HPV Antigen Rapid Test Cassette THPV-50298/79 HPV Antigen Rapid Test Cassette THPV-R50298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv 1+2 antibodies - total	W0105040302	HSV 1/2 IgG/IgM Combo Rapid Test98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette3 réf.98/79 HSV 1/2 IgG/IgM Rapid Test Cassette3 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv 1+2 igm	W0105040304	Casete de Test Rápido de VHS 1/2 IgM98/79 HSV 1/2 IgM Rapid Test Cassette3 réf.98/79 HSV 1/2 IgM Rapid Test Cassette(Serum/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Interleukin 6 (il-6)	W01030609	IL-6 Rapid Test98/79 IL-6 Test Cassette98/79 Interleukin-6 (IL-6) Test Kit (CLIA)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Leishmania	W0105050205	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	– 98/79	Fiche EUDAMED Signaler une erreur
Leptospira	W0105011704	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	– 98/79	Fiche EUDAMED Signaler une erreur
Mycobacterial antibody assays	W0105010702	Tuberculosis (TB) Rapid Test Cassette98/79 Tuberculosis (TB) Rapid Test Cassette(WB/S/P)98/79 Tuberculosis Rapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycoplasma antibody assays	W0105010802	Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Cassette IMP-42598/79 Mycoplasma pneumoniae IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IMPM-40298/79 Mycoplasma Pneumoniae IgM Rapid Test Cassette IMPM-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycoplasma antigen detection	W0105010801	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	– 98/79	Fiche EUDAMED Signaler une erreur
Syphilis antibody assays total	W0105010302	Syphilis Rapid Test Cassette ISY-402H98/79 Syphilis Rapid Test Cassette ISY-R40298/79 Syphilis Test Cassette FI-SYP-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Astrovirus	W0105040629	Astrovirus Rapid Test Cassette IAS-60298/79 Astrovirus Rapid Test Cassette IAS-R60298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chlamydia trachomatis antigen detection	W0105010107	Chlamydia Rapid Test Cassette ICH-50298/79 Chlamydia Rapid Test ICH-50298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Cmv igm	W0105040204	CMV IgM Rapid Test Cassette (Serum/Plasma) ICM-30298/79 CMV IgM Rapid Test Cassette ICM-30298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Ebv ebna igg	W010504040106	EBNA IgG Rapid Test Cassette IENG-40298/79 EBNA IgG Rapid Test Cassette IENG-R40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Ebv vca igg	W010504040105	EBV VCA IgG Rapid Test Cassette IECG-40298/79 EBV VCA IgG Rapid Test Cassette IECG-R40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Entamoeba histolytica	W0105050201	Entamoeba histolytica Rapid Test Cassette IEH-60298/79 Entamoeba histolytica Rapid Test Cassette IEH-R60298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Giardia lamblia	W0105050208	Giardia Lamblia Rapid Test Cassette IGL-60298/79 Giardia Lamblia Rapid Test Cassette IGL-R60298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hav antibody igm	W0105020104	HAV IgM Rapid Test Cassette IHA-40298/79 HAV IgM Rapid Test Cassette IHA-R40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
HCV antibody -RT & POC	W0105090202	HCV Rapid Test Cassette IHC-40298/79 HCV Rapid Test IHC-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hev antibody (total)	W0105020503	HEV IgG/IgM Rapid Test Cassette IHE-30298/79 HEV IgG/IgM Rapid Test Cassette IHE-R30298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hev reagents - other	W0105020599	HEV IgG/IgM Rapid Test Cassette (Serum/Plasma) IHE-30298/79 HEV IgG/IgM Rapid Test Cassette IHE-30298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv 2 antibodies - total	W0105040308	HSV 2 IgG/IgM Rapid Test Cassette98/79 HSV 2 IgG/IgM Rapid Test Cassette(WB/S/P)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv reagents - other	W0105040399	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
Norovirus	W0105040616	Norovirus Rapid Test Cassette (Feces) INO-60298/79 Norovirus Rapid Test Cassette INO-R60298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Respiratory tract infections - multiplex NA reagents	W0105070503	Influenza A/B and RSV RT-qPCR Kit98/79 SARS-CoV-2, Influenza A/B and RSV RT-qPCR Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Rotavirus	W0105040606	Rotavirus Rapid Test Cassette IRO-60298/79 Rotavirus Rapid Test Cassette IRO-R60298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Rubella virus igm	W0105040103	Rubella IgM Rapid Test Cassette (Serum/Plasma) IRM-30298/79 Rubella IgM Rapid Test Cassette IRM-30298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Toxoplasma reagents - other	W0105050199	Toxo IgG/IgM Rapid Test98/79 Toxo IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Automatic Chemiluminescence Immunoassay Analyzer2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Brucella	W0105011701	Brucella Abortus Antigen Rapid Test Cassette2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
E. coli direct antigen detection	W0105011501	E.coli O157: H7 Antigen Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Enterovirus	W0105040602	EV71 IgM Rapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Gonococcal antigen detection	W0105010201	Gonorrhea Rapid Test Cassette2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Haemoglobin (hb)	W0103010601	Hb Hemoglobin Test Strip OHBS-41198/79	– 98/79	Fiche EUDAMED Signaler une erreur
Haemoglobin determinations (total hb)	W0103010201	Hb Hemoglobin Test Strip OHBS-41198/79	– 98/79	Fiche EUDAMED Signaler une erreur
Haemoglobin subtypes hba2, hbc, hbf, hbs, etc.(excl. hba1)	W0103010202	Sickle cell Rapid Test OSCD-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hantavirus / bunyavirus	W0105040614	Hantavirus lgG/lgM Rapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hav antibody (total)	W0105020102	HAV IgG/IgM Combo Rapid Test Cassette IHA-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hev antibody igm	W0105020505	HEV IgM Rapid Test IHEM-30298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv 1 antibodies - total	W0105040305	HSV 1 IgG/IgM Rapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv 1+2 igg	W0105040303	HSV 1/2 IgG Rapid Test Cassette3 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv antigen	W0105040301	HSV 1/2 IgG/IgM Combo Rapid Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Human metapneumovirus	W0105040617	HMPV Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Human metapneumovirus - NA reagents	W0105040517	Methicillin-resistant Staphylococcus Aureus qPCR Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Legionella antigen detection	W0105010501	Legionella pneumophila Test Cassette98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Lyme antibody total	W0105010602	Lyme IgG/IgM Rapid Test Cassette ILY-R40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Lyme borreliosis reagents - other	W0105010699	Lyme IgG/IgM Rapid Test Cassette ILY-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Measles virus antibodies - total	W0105040701	Measles IgG/IgM Rapid Test IME-R40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Measles virus igg	W0105040702	Measles IgG Antibody Rapid Test Cassette IMEG-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Monkeypox virus / mpox - NA reagent	W0105040532	Monkeypox Virus Detection qPCR Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Norovirus - NA reagents	W0105040516	Norovirus Rapid Test Cassette (Feces) INO-60298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Other antigen typing reagents	W0103030501	Blood Grouping Reagents-Lectin Anti-N2 réf.98/79	– 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-1002 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Respiratory syncytial virus (rsv)	W0105040605	RSV Rapid Test Cassette IRS-R50298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Rhinovirus	W0105040620	Rhinovirus Rapid Test IRHV-R50298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Strep. b detection by NA reagents	W0105011104	Strep B Rapid Test Cassette (Swab) ISB-50298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Toxoplasma antibody (total)	W0105050101	Toxo IgG/IgM Rapid Test Cassette2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Toxoplasma antibody igm	W0105050103	Toxo IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Varicella zoster virus igm	W0105040903	Varicella Zoster Virus IgM Rapid Test Cassette IVZM-40298/79	– 98/79	Fiche EUDAMED Signaler une erreur

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