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

    Hepatitis Viral B Dna Detection

    PMA: P080026 · Supplement: S005 · Decision Feb 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Hepatitis Viral B Dna Detection
    Trade Name
    ABBOTT REALTIME HBV
    PMA Number
    P080026
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    MKT
    Generic Name
    Hepatitis Viral B DNA Detection
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 7, 2013
    Date Received
    December 26, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE EXISTING LABEL PRINT AND INSPECTION EQUIPMENT WITH 2 NEW LABEL PRINTERS, NEW LABEL PRINTING SOFTWARE, AND A NEW LABEL INSPECTION SYSTEM THAT IS USED TO PRINT AND INSPECT LABELS FOR ALL MANUFACTURED PARTS AT ABBOTT MOLECULAR INC. IN DES PLAINES, ILLINOIS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MKT Hepatitis Viral B Dna Detection