BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P980041 · Supplement: S024 · Decision Aug 20, 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
    S024
    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
    August 20, 2013
    Date Received
    April 12, 2013
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR UPDATING THE LABELING OF UNICEL DX1 INSTRUCTIONS FOR USE, OPERATOR'S GUIDE, REFERENCE MANUAL AND ONBOARD SYSTEM HELP. REQUESTED CHANGES TO THE LABELING INCLUDE CHANGING CURRENT CAUTION STATEMENTS TO WARNING STATEMENTS (TO ENHANCE THESAFETY OF THE OPERATOR, AND REMOVING REDUNDANT CAUTION STATEMENTS), ADDING NEW CAUTION STATEMENTS (NOTES FOR PROCEDURE CLARIFICATION), ADDING NEW WARNING STATEMENTS, CHANGING WARNINGTO CAUTION AND RELOCATING EXISTING WARNING/CAUTION STATEMENTS IN ORDER TO ENHANCE THE SAFETY IN THE USE OF THE REAGENTS ON THE UNICEL DXL 800/600 IMMUNOASSAY SYSTEMS AND UNICEL DXC 880I/860I/680I/ 660I SYNCHRON ACCESS 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