BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

    PMA: P970055 · Supplement: S019 · Decision Apr 17, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
    Trade Name
    Parvovirus B19 IgM Immunoassy (V619IMUS)
    PMA Number
    P970055
    Supplement Number
    S019
    Device Class
    FDA Class 3
    Product Code
    MYM
    Generic Name
    ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 17, 2019
    Date Received
    March 22, 2019
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Add a process for a manual setting of a lot specific constant value for specific kit lots.

    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