BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P080026 · Supplement: S002 · Decision Nov 30, 2011
    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 ASSAY
    PMA Number
    P080026
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    MKT
    Generic Name
    Hepatitis Viral B DNA Detection
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 30, 2011
    Date Received
    July 1, 2011
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A RAW MATERIAL CHANGE FOR TWO OF THE MICROVIALS USED TO MANUFACTURE THE REAGENT COMPONENTS IN THE ABBOTT REALTIME HBV AMPLIFICATION KIT WITHIN THE ABBOTT REALTIME HBV ASSAY.

    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