BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Genotyping, Hepatitis C Virus

    PMA: P120012 · Supplement: S016 · Decision Sep 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Assay, Genotyping, Hepatitis C Virus
    Trade Name
    Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit
    PMA Number
    P120012
    Supplement Number
    S016
    Device Class
    FDA Class 2
    Product Code
    OBF
    Generic Name
    Assay, genotyping, hepatitis c virus
    Regulation Number
    866.3170
    Medical Specialty
    Microbiology
    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
    OBF Assay, Genotyping, Hepatitis C Virus