BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Ki-67

    PMA: P210026 · Supplement: S002 · Decision Feb 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Ki-67
    Trade Name
    Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
    PMA Number
    P210026
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    QQT
    Generic Name
    Immunohistochemistry assay, antibody, Ki-67
    Medical Specialty
    Unknown
    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
    QQT Immunohistochemistry Assay, Antibody, Ki-67