BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

    PMA: P220034 · Decision Mar 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
    Trade Name
    LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus
    PMA Number
    P220034
    Device Class
    FDA Class 3
    Product Code
    MYL
    Generic Name
    ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 29, 2024
    Date Received
    December 27, 2022
    Expedited Review
    N
    Docket Number
    24M-1612

    Advisory Committee Statement

    Approval for LIAISON Biotrin Parvovirus B19 IgG Plus and LIAISON Biotrin Control Parvovirus B19 IgG Plus. The LIAISON Biotrin Parvovirus B19 IgG Plus, a chemiluminescent immunoassay (CLIA), is intended for the qualitative detection of IgG antibodies to B19 virus (B19V, previously known as human parvovirus B19) in human serum, lithium heparin, dipotassium EDTA (K2-EDTA), and sodium citrated plasma. The test may be used for testing women of childbearing age where there is a suspicion of exposure to human B19V. 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
    MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg