BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    PMA: P140025 · Supplement: S017 · Decision Jul 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
    Trade Name
    VENTANA ALK (D5F3) CDx Assay
    PMA Number
    P140025
    Supplement Number
    S017
    Device Class
    FDA Class 3
    Product Code
    PKW
    Generic Name
    Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 21, 2022
    Date Received
    February 16, 2022
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II.

    Classifications

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

    Product Code Device Name
    PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase