27 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
·ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE 2 HPV DNA TEST
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur® HBcT2 Quality Control (HBcT2 QC)
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADVISA SR MRI
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC)
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADVISA SR MRI