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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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBsAg II
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·IMMULITE® 2000 Anti-HBc IgM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)
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
·LIAISON XL MUREX HBc IgM and LIAISON XL MUREX Control HBc IgM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·BD Onclarity HPV Assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Alinity i Anti-HBc IgM Reagent Kit, Alinity i Anti-HBc IgM Calibrators, Alinity i Anti-HBc IgM Controls
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·PARVOVIRUS B19 IGG ENZYME 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
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·BIOTRON PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·DIASORIN ETI-MAK-2PLUS
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE 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 HBEAG REAGENT PACK AND CALIBRATOR
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·BD Onclarity HPV Assay, BD Viper LT System
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST,V2.0
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus® UBT System
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0