2,708 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS® AmpliPrep® / COBAS® TaqMan® HBV Test, v2.0
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anti-HBs II
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·cobas HBV
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
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Atellica Im Anti-Hepatitis B core Total (HBcT) Assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Alinity i Anti-HBc (List Number 07P84)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Alinity i Anti-HBs Reagent Kit
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 & CALIBRATOR & CONFIRMATORY KIT
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV 16 18/45 Genotype Assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB / Alinity i Anti-HBs
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
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBsAg Qualitative/Confirmatory / Alinity i HBsAg Qualitative II/Confirmatory
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB ASSAY
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV ASSAY
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 AND COBAS TAQMAN HBV TEST
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-EBK PLUS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170