BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P980041 · Supplement: S013 · Decision Jul 1, 2011
    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
    ACCESS IMMUNOASSAY SYSTEMS
    PMA Number
    P980041
    Supplement Number
    S013
    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
    July 1, 2011
    Date Received
    September 27, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING MODIFICATIONS MADE TO THE ACCESS, SYNCHRON AND UNICEL FAMILIES OF INSTRUMENTATION PLATFORMS: 1) MODIFICATION OF THE OCCLUSION BRACKET ON THE ACCESS AND UNICEL INSTRUMENTS, B) REVISION OF THE UNICEL SYSTEM SOFTWARE, AND C) REDESIGN OF THE SAMPLE PROBE TUBE ASSEMBLY, AND D) NEW INFORMATION REGARDING POTENTIAL INTERFERENTS OF AFP MEASUREMENT DUE TO THE PRESENCE OF IMMUNOSUPPRESSANT DRUGS PRESCRIBED TO PREGNANT WOMEN.

    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