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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSiemens Healthcare Diagnostics, Inc.
511 Benedict Avenue
Tarrytown, NY 10591
PMA NumberP210019
Supplement NumberS002
Date Received10/31/2022
Decision Date04/28/2023
Product Code LOM 
Docket Number 23M-1698
Notice Date 05/01/2023
Advisory Committee Microbiology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approve inclusion of pediatric subjects in the intended use population for the ADVIA Centaur XP/XPT, ADVIA Centaur CP, and Atellica IM Analyzers
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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