BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P980041 · Supplement: S021 · Decision Feb 6, 2013
    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
    S021
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 6, 2013
    Date Received
    January 3, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE SPECIAL CLEAN MAINTENANCE PROCEDURE THAT MITIGATES VITAMIN B 12 CARRYOVER FROM A WASH BUFFER/ METHANOL COMBINATION TO A METHANOL/DI COMBINATION AND ALSO TO USE ETHANOL AND METHANOL INTERCHANGEABLY AS PART OF THE SPECIAL CLEAN MAINTENANCE PROCEDURE. THIS SPECIAL CLEAN PROCEDURE WOULD BE USED WITH THE ACCESS AFP, HYBRITECH FREE PSA,HYBRITECH PSA AND HYBRITECH P2PSA REAGENTS ON THE ACCESS, ACCESS 2, SYNCHRON LXI 725, AND UNICEL DXC 600I INTEGRATED CLINICAL SYSTEMS.

    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