2,057 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Aptima HBV Quant Assay
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE 2 HPV DNA TEST
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·cobas HPV Test
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
FDA Pre-Market Approval
FDA Class 3
·T-SPOT®.TB Test
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR AHBS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur Anti-HBe2 (AHBe2) Assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-MAK-2 PLUS ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBS EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
FDA Pre-Market Approval
FDA Class 3
·T-SPOT TB TEST
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·MONOLISA ANTI-HBC IGM EIA
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·LIAISON QuantiFERON - TB Gold Plus and LIAISON Control QuantiFERON - TB Gold Plus
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·-LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·MONOLISA ANTI-HBS EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anti-HBs Immunoassay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-CORE-IGMK PLUS ASSAY
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
·ETI-AB-EBK PLUS ASSAY