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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 Assay
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantDiaSorin, Inc.
1951 Northwestern Ave.
Stillwater, MN 55082
PMA NumberP190017
Supplement NumberS012
Date Received05/10/2023
Decision Date06/07/2023
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approved for correction of typographical errors in the package insert of the LIAISON XL MUREX HBsAg Qual Assay.
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