2,081 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control anti-HBc
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS HBV
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·QUANTIFERON -TB GOLD
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·DIASORIN ETI-CORE-IGMK PLUS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-AB-AUK PLUS Assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·DIASORIN ETI-AB-EBK PLUS ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBeAg and PreciControl HBeAg
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV Assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anit-HBc IgM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBS TEST SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM HBsAgII (HBsII)/Atellica IM HBsAg Confirmatory
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anti-HBc IgM Immunoassays
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·cobas HBV
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Alinity m HBV
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBS IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBS
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK CALIBRATOR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ABBOTT AXSYM AUSAB