BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Folr1

    PMA: P220006 · Supplement: S001 · Decision Aug 23, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Folr1
    Trade Name
    VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
    PMA Number
    P220006
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    QUL
    Generic Name
    Immunohistochemistry Assay, Antibody, FOLR1
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Medical Genetics
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 23, 2023
    Date Received
    March 1, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to modify the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay to remove the Stain Intensity Reference (SIR) slide from the assay configuration.

    Classifications

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

    Product Code Device Name
    QUL Immunohistochemistry Assay, Antibody, Folr1