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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 HBsAg Qual, LIAISON XL MUREX HBsAg Confirmatory Test
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantDiaSorin Inc
1951 Northwestern Avenue
Stillwater, MN 55082
PMA NumberP190017
Supplement NumberS009
Date Received10/18/2022
Decision Date04/13/2023
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for removal of repeat testing for samples greater than or equal to 140 s/co by the LIAISON XL MUREX HBsAg Qual assay and removal of testing these samples with LIAISON XL MUREX HBsAg Confirmatory Test.
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