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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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
Date Received09/29/2025
Decision Date05/07/2026
Product Code MYM 
Docket Number FDA-5215
Notice Date 05/12/2026
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for LIAISON Biotrin Parvovirus B19 IgM Plus and LIAISON Biotrin Control Parvovirus B19 IgM Plus. The LIAISON Biotrin Parvovirus B19 IgM Plus, a chemiluminescent immunoassay (CLIA), is intended for the qualitative detection of IgM antibodies to human parvovirus B19 in human serum, lithium heparin, K2-EDTA and sodium citrated plasma. This test, in conjunction with the LIAISON Biotrin Parvovirus B19 IgG Plus (chemiluminescent immunoassay), may be used for testing women of childbearing age to determine their serological status where there is a suspicion of exposure to human parvovirus B19. The results of these assays may be used to make a serological determination of past, recent, or current infection with parvovirus B19. The test may also be used for all patients as an aid in the diagnosis of fifth disease (erythema infectiosum). The test must be performed on the LIAISON XL Analyzer.
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