2,057 results · 21ms · Sources: EU EUDAMED, US FDA

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