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

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    PMA: P200019 · Supplement: S005 · Decision Jul 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
    Trade Name
    VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)
    PMA Number
    P200019
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    QNH
    Generic Name
    Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 29, 2022
    Date Received
    July 12, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of alternative suppliers for component parts.

    Classifications

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

    Product Code Device Name
    QNH Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay