370 results
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17ms
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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 IGM REAGENT PACK AND CALIBRATOR
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 and Calibrator
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M Reagent Kit, 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
·ARCHITECT CORE-M Reagent Kit, 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
·ABBOTT ARCHITECT CORE ASSAY
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Evia HF /HF-T; Entovis HF/ HF-T ; Edora 8 HF-T; Entira 8 HF-1; Etrinsa 8 HF-T; Epyra 8 HF-T; Eluna 8 HF-T; Edora 8HF-T Q
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI