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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® Biotrin Parvovirus B19 IgM Plus, LIAISON® Biotrin Control Parvovirus B19 IgM Plus
Generic NameASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
ApplicantDiaSorin, Inc.
1951 Northwestern Ave.
Stillwater, MN 55082
PMA NumberP250039
Supplement NumberS001
Date Received06/04/2026
Decision Date06/24/2026
Product Code MYM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
implement a manufacturing process scale up
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