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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 (REF 318250), LIAISON® Control XL Murex HBsAg (REF 318251) and LIAISON® XL Murex HBsAg Confirmat
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 NumberS018
Date Received10/25/2023
Decision Date04/16/2025
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the migration of the LIAISON Murex HBsAg, LIAISON Murex Control HBsAg, and LIAISON Murex HBsAg Confirmatory to the LIAISON XS Analyzer.
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