BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P930036 · Supplement: S003 · Decision Oct 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
    Trade Name
    ACS 180/ADVIA CENTAUR AFP IMMUNOASSAY
    PMA Number
    P930036
    Supplement Number
    S003
    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
    October 7, 2005
    Date Received
    July 22, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ACS:180 AND THE CENTAUR AFP ASSAYS ON THE ADVIA CENTAUR CP SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR CP AFP AND IS INDICATED FOR IN VITRO DIAGNOSTIC USE IN THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN 1) HUMAN SERUM AND IN AMNIOTIC FLUID FROM SPECIMENS OBTAINED AT 15 AND 20 WEEKS GESTATION, AS AN AID IN DETECTING OPEN NEURAL TUBE DEFECTS (NTDS) WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY AND AMNIOGRAPHY TESTING 2) HUMAN SERUM, AS AN AID IN MANAGING NON-SEMINOMATOUS TESTICULAR CANCER WHEN USED IN CONJUNCTION WITH PHYSICAL EXAMINATION, HISTOLOGY/PATHOLOGY, AND OTHER CLINICAL EVALUATION PROCEDURES, USING THE (BAYER) SYSTEM.

    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