BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P070006 · Supplement: S015 · Decision Aug 29, 2022
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    T-SPOT. TB Test
    PMA Number
    P070006
    Supplement Number
    S015
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 29, 2022
    Date Received
    November 2, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the T-Cell Select kit. The device is intended for use with the T-SPOT.TB test for the isolation of mononuclear immune cells from whole blood stored at room temperature (18 – 25 °C), using positive selection via a magnetic bead-based cell separation system.