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

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P120008 · Supplement: S008 · Decision Jul 13, 2015
    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
    ARCHITECT AFP ASSAY (LN 3P36)
    PMA Number
    P120008
    Supplement Number
    S008
    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
    July 13, 2015
    Date Received
    June 15, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE SUPPLIER OF BOVINE SERUM ALBUMIN (BSA) FOR USE INTHE MANUFACTURE OF PRECURSOR COMPONENTS FOR THE ARCHITECT HBSAG QUALITATIVE (LN 4P53),ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54), AND ARCHITECT AFP (LN 3P36) ASSAYS.

    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