119 results
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30ms
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Sources: EU EUDAMED, US FDA
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL
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
·ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, Atellica IM Anti-Hepatitis B
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA Centaur and Atellica IM Anti-HBs2 (aHBs2)
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
·ADVIA CENTAUR ANTI-HBS2 ASSAY
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA Centaur aHBs2 Readypack Reagents and Quality Control Materials
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR ANTI-HBS2 MASTER CURVE MATERIALS
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR ANTI-HBS2 (AL-BS2) ASSAY
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
·Atellica IM Anti-Hepatitis B Surface Antigen 2 (aHBs2)
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR ANTI HBS2 ASSAY
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), Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (
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
·Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2); Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA Centaur aHBs2 Assay
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA Centaur anti-HBs2 (aHBs2), Atellica IM aHBs2
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)
ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LOM·November 14, 2025
ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOM·January 5, 2026