2,708 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, Elecsys HBsAg II Auto Confirm
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL MUREX Anti-HBe, LIAISON® XL MUREX Control Anti-HBe
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus Urea Breath Test System
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBsAg Next Qualitative / Next Confirmatory
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
·DiaSorin ETI-AB-AUK PLUS assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB (LN 1L82)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·COBAS HPV TEST
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anti-HBc Immunoassay
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
·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
·ARCHITECT HBSAG QUALITATIVE CONFIRMATORY , LN 4P54
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M (LN 6L23)
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·ABBOTT REALTIME HBV
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, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC