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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
 
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ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica ... Siemens Healthcare Diagnostics P210019 S002 04/28/2023
ADVIA Centaur® and Atellica IM Hepatitis B Core Ig... SIEMENS HEALTHCARE DIAGNOSTICS P030040 S022 02/06/2023
ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Cent... Siemens Healthcare Diagnostics P210019 S001 12/20/2022
IMMULITE® 2000 HBsAg and IMMULITE® 2000 HBsAg Conf... Siemens Healthcare Diagnostics P010050 S021 10/14/2022
IMMULITE® 2000 Anti-HBc Siemens Healthcare Diagnostics P010051 S017 10/14/2022
IMMULITE® 2000 Anti-HBs Siemens Healthcare Diagnostics P010052 S016 10/14/2022
IMMULITE® 2000 Anti-HBc IgM Siemens Healthcare Diagnostics P010053 S016 10/14/2022
ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica ... Siemens Healthcare Diagnostics P210019 07/27/2022
IMMULITE 2000 Anti-HBc Siemens Healthcare Diagnostics P010051 S015 03/29/2022
IMMULITE 2000 Anti-HBc IgM Siemens Healthcare Diagnostics P010053 S014 03/29/2022
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