BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    P2psa

    PMA: P090026 · Supplement: S031 · Decision Dec 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    P2psa
    Trade Name
    Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
    PMA Number
    P090026
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    OYA
    Generic Name
    P2psa
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 16, 2022
    Date Received
    April 19, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a modification to the UniCel DxI Immunoassay system’s sample probe and reagent probe wash nozzle design using injection molding to reduce production cost.

    Classifications

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

    Product Code Device Name
    OYA P2psa