BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Folr1

    PMA: P220006 · Supplement: S005 · Decision Jan 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Folr1
    Trade Name
    VENTANA FOLR1 (FOLR-2.1) RxDx Assay
    PMA Number
    P220006
    Supplement Number
    S005
    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
    January 26, 2024
    Date Received
    October 30, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208).

    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