BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    PMA: P200019 · Decision Apr 22, 2021
    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
    PMA Number
    P200019
    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
    Approved
    Decision Code
    APPR
    Decision Date
    April 22, 2021
    Date Received
    March 16, 2020
    Expedited Review
    N
    Docket Number
    21M-0416

    Advisory Committee Statement

    Approval for the Ventana MMR RxDx Pavel as a CDx for identifying patients with endometrial cancer with dMMR status who may benefit from treatment with Jemperli.

    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