BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

    PMA: P250039 · Decision May 7, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
    Trade Name
    LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus
    PMA Number
    P250039
    Device Class
    FDA Class 3
    Product Code
    MYM
    Generic Name
    ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 7, 2026
    Date Received
    September 29, 2025
    Expedited Review
    N
    Docket Number
    FDA-5215

    Advisory Committee 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.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MYM Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm