BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

    PMA: P970055 · Supplement: S017 · Decision Jun 13, 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 Enzyme Immunoassay (V619IMUS)
    PMA Number
    P970055
    Supplement Number
    S017
    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
    June 13, 2019
    Date Received
    August 8, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for relocating the manufacturing site to DiaSorin S.p.A., at Via Crescentino Snc, Saluggia, Italy.

    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