BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P930036 · Supplement: S026 · Decision May 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
    Trade Name
    ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP)
    PMA Number
    P930036
    Supplement Number
    S026
    Device Class
    FDA Class 3
    Product Code
    LOK
    Generic Name
    KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 11, 2026
    Date Received
    January 21, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    a change that will implement control system (medical decision pools and tiered standards) and a traceability (update to 22/216, 2nd WHO International Standard) change.

    Classifications

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

    Product Code Device Name
    LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects