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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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PMA
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ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica ... Siemens Healthcare Diagnostics P210019 S002 04/28/2023
ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Cent... Siemens Healthcare Diagnostics P210019 S001 12/20/2022
ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica ... Siemens Healthcare Diagnostics P210019 07/27/2022
Atellica® IM Anti-HBe2 Assay Siemens Healthcare Diagnostics P200017 S002 03/29/2022
ADVIA Centaur Anti-HBe2 (AHBe2) Assay Siemens Healthcare Diagnostics P200017 S001 01/06/2022
ADVIA Centaur Anti-HBe2 (aHBe2) assay Siemens Healthcare Diagnostics P200017 07/14/2021
Atellica® IM Anti-Hepatitis B surface Antigen 2 (a... SIEMENS HEALTHCARE DIAGNOSTICS P100039 S015 03/29/2022
ADVIA Centaur anti-HBs2 (aHBs2), Atellica IM aHBs2 SIEMENS HEALTHCARE DIAGNOSTICS P100039 S014 02/16/2022
Atellica IM Anti-Hepatitis B surface Antigen 2 (aH... SIEMENS HEALTHCARE DIAGNOSTICS P100039 S013 04/27/2021
ADVIA Centaur aHBs2 Assay SIEMENS HEALTHCARE DIAGNOSTICS P100039 S012 04/13/2021
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