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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Applicant SIEMENS HEALTHCARE DIAGNOSTICS productcode LOM Decision Date To 05/04/2024
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Atellica IM Anti-Hepatitis B core Total (HBcT) Ass... SIEMENS HEALTHCARE DIAGNOSTICS P040004 S017 04/03/2020
Atellica IM Hepatitis B e Antigen (HBeAg) Assay SIEMENS HEALTHCARE DIAGNOSTICS P090024 S008 04/03/2020
Atellica IM Anti-Hepatitis B surface Antigen 2 (aH... SIEMENS HEALTHCARE DIAGNOSTICS P100039 S009 04/03/2020
ADVIA Centaur and Atellica IM HBc IgM SIEMENS HEALTHCARE DIAGNOSTICS P030040 S016 03/19/2020
ADVIA Centaur HBsAg SIEMENS HEALTHCARE DIAGNOSTICS P030049 S014 03/19/2020
ADVIA Centaur and Atellica IM HBc Total SIEMENS HEALTHCARE DIAGNOSTICS P040004 S016 03/19/2020
ADVIA Centaur and Atellica IM HBeAg SIEMENS HEALTHCARE DIAGNOSTICS P090024 S007 03/19/2020
ADVIA Centaur and Atellica IM Anti-HBs2 (aHBs2) SIEMENS HEALTHCARE DIAGNOSTICS P100039 S008 03/19/2020
IMMULITE 2000 HBsAg & HBs Ag Confirmatory Siemens Healthcare Diagnostics P010050 S017 12/19/2019
IMMULITE 2000 Anti-HBc Siemens Healthcare Diagnostics P010051 S012 12/19/2019
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