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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 and LIAISON® XL MUREX Control HBsAg Qual
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 NumberS026
Date Received07/16/2025
Decision Date10/10/2025
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the use of an alternative polypropylene resin for production of the plastic vials hosting the LIAISON assays reagents
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