BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P010007 · Decision Nov 9, 2001
    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
    IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP
    PMA Number
    P010007
    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
    November 9, 2001
    Date Received
    February 13, 2001
    Expedited Review
    N
    Docket Number
    01M-0537

    Advisory Committee Statement

    APPROVAL FOR IMMULITE AFP FOR USE WITH THE IMMULITE ANALYZER AND IMMULITE 2000 AFP FOR USE WITH THE IMMULITE 2000 ANALYZER. THESE DEVICES ARE INDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE QUANTITATIVE MEASUREMENT OF ALPHA-FETOPROTEIN (AFP) IN EITHER OF TWO CONTEXTS: A) SERIAL MEASUREMENTS IN HUMAN SERUM TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER: OR B) MEASUREMENT IN MATERNAL SERUM AND AMNIOTIC FLUID DURING GESTATIONAL WEEKS 15 THROUGH 20 - USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY - TO AID IN DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS.

    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