BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P080026 · Supplement: S021 · Decision Sep 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Hepatitis Viral B Dna Detection
    Trade Name
    Abbott Real Time HBV Amplification Reagent Kit / HBV Control Kit / HBV Calibrator Kit
    PMA Number
    P080026
    Supplement Number
    S021
    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
    September 1, 2017
    Date Received
    June 27, 2017
    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 changes to the polypropylene resin, cap colorant and inside diameter of the tubes and screw-caps used for storage and transport of the finished calibrators and controls, and for the master mix assembly.

    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