BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

    PMA: P230016 · Supplement: S001 · Decision Feb 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4
    Trade Name
    MAGE-A4 IHC 1F9 pharmDx
    PMA Number
    P230016
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    SBL
    Generic Name
    Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 28, 2025
    Date Received
    January 31, 2025
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for additional quality control tests to raw materials and intermediates that to enhance safety of the finished devices without impacting effectiveness.

    Classifications

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

    Product Code Device Name
    SBL Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4