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

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    PMA: P200019 · Supplement: S013 · Decision Jan 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
    Trade Name
    VENTANA anti-MSH6 (SP93) Antibody
    PMA Number
    P200019
    Supplement Number
    S013
    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
    January 6, 2026
    Date Received
    December 11, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval of manufacturing process changes

    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