1,259 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Pre Market Approval
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Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ETI-EBK PLUS
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM ASSAY
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBc
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE 2000 Anti HBc IgM
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Atellica® IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSCYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG, ELECSYS HBSAG CONFIRMATORY TEST
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc IgM
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBS IMMUNOASSAY
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ARCHITECT AUSAB / Alinity i Anti-HBs
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX HBsAg Qual assay and Control
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HBSAGII
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ARCHITECT CORE-M / Alinity i Anti-HBc IgM
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR, HBSAG CONFIRMATORY ASSAY
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA Pre-Market Approval
FDA Class 3
·Animas Vibe System
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Alinity i HBsAg Qualitative II Reagent Kit (2x100 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Alin
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·PRECICONTROL HBSAG