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

    Immunohistochemistry Assay, Antibody, Claudin 18

    PMA: P230018 · Supplement: S001 · Decision Jun 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Claudin 18
    Trade Name
    VENTANA CLDN18 (43-14A) RxDx Assay
    PMA Number
    P230018
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    QZJ
    Generic Name
    Immunohistochemistry assay, antibody, claudin 18
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 20, 2025
    Date Received
    May 21, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    qualification of an alternate supplier for assay kit component

    Classifications

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

    Product Code Device Name
    QZJ Immunohistochemistry Assay, Antibody, Claudin 18