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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.
 
DeviceARCHITECT HBsAg Next Qualitative and ARCHITECT HBsAg Next Confirmatory Assay
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantAbbott Laboratories
100 Abbott Park Road
DEPT: 09AA BLDG: AP8-1
Abbott Park, IL 60064
PMA NumberP210003
Supplement NumberS004
Date Received11/14/2022
Decision Date05/08/2023
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Migration of the Abbott ARCHITECT HBsAg Next Qualitative and ARCHITECT HBsAg Next Confirmatory assay to the ARCHITECT i1000SR System.
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