2,678 results
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30ms
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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
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·cobas HPV for use on the cobas 6800/8800 Systems
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·IMMULITE, IMMULITE 1000 ANTI-HBC AND IMMULITE 2000 ANTI-HBC
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR HEPATITIS B E ANTIGEN ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBeAg
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·IMMULITE 2000 XPI HBSAG
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
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
·IMMULITE 2000 XPI ANTI-HBC IMG
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR HBSAG AND HBSAG CONFIRMATORY ASSAYS
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® HBV
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL MUREX HBc lgM assay and Control
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Anti-HBe2 (aHBe2)
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS TaqMan HBV Test, High Pure System Viral Nucleic Acid Kit
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM CORE-M 2.0 & AXSYM CORE-M 2.0 CONTROLS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR HBC TOTAL ASSAY