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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 assay, Control and Verifiers
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantDiaSorin, Inc.
1951 Northwestern Ave.
Stillwater, MN 55082
PMA NumberP180039
Supplement NumberS011
Date Received04/05/2022
Decision Date06/23/2022
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the alternate supplier, Balda Medical GmbH (Bad Oeynhausen, Germany), to produce vial and frame plastics components of the Reagent Integral.
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