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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.
 
DeviceAlinity i Anti-HBs Reagent Kit (2x100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent K
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOTT LABORATORIES INC
100 ABBOTT PARK ROAD
DEPT 9VA- AP8-1
ABBOTT PARK, IL 60064
PMA NumberP050051
Supplement NumberS055
Date Received08/11/2023
Decision Date11/03/2023
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the release of Alinity i Anti-HBs, Alinity i Anti-HBc IgM, Alinity I Anti-HBc, Alinity i HBsAg Qualitative II, and Alinity i Qualitative II Confirmatory for use with Alinity ci-series
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