BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

    PMA: P220034 · Supplement: S007 · Decision Oct 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    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
    Supplement Number
    S007
    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
    October 10, 2025
    Date Received
    July 16, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the use of an alternative polypropylene resin for production of the plastic vials hosting the LIAISON assays reagents

    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