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

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    PMA: P150025 · Supplement: S015 · Decision Jul 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
    Trade Name
    PD-L1 IHC 28-8 pharmDx
    PMA Number
    P150025
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    PLS
    Generic Name
    Immunohistochemistry assay, antibody, programmed death-ligand 1
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 22, 2022
    Date Received
    June 17, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Update of manufacturing documents relating to Post-QC testing.

    Classifications

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

    Product Code Device Name
    PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1