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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.
 
DeviceLIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantDiaSorin Inc.
1951 Northwestern Avenue
Stillwater, MN 55082
PMA NumberP180039
Supplement NumberS015
Date Received10/12/2023
Decision Date11/08/2023
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
optimization of a packaging process
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