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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 AUSAB / Alinity i Anti-HBs
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 NumberS051
Date Received05/08/2023
Decision Date10/11/2023
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 formulation change for the common accessories Pre-Trigger and Trigger, and storage condition changes for Pre-Trigger, used on ARCHITECT i2000SR, ARCHITECT i1000SR and Alinity i analyzer.
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