BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P980041 · Supplement: S018 · Decision Nov 19, 2012
    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 AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
    PMA Number
    P980041
    Supplement Number
    S018
    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 19, 2012
    Date Received
    October 25, 2012
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF INFORMATION TO THE MANUFACTURING PROCEDURES OF THE INSTRUMENT (SPECIFICALLY, THE INSTRUCTIONS FOR APPLICATION OF THE ADHESIVE TO THE MIXER PULLEY ASSEMBLY AND THE IMPLEMENTATION OF A VERIFICATION TEST TO ENSURE THE MIXER PULLEY ASSEMBLIES PASS THE TORQUE SPECIFICATION.)

    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