BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Genotyping, Hepatitis C Virus

    PMA: P120012 · Supplement: S010 · Decision Mar 7, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Assay, Genotyping, Hepatitis C Virus
    Trade Name
    ABBOTT REALTIME HCV GENOTYPE II
    PMA Number
    P120012
    Supplement Number
    S010
    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
    March 7, 2016
    Date Received
    December 16, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for revisions to the application specification file for changes to the liquid level sense and pipette aspiration/dispense volumes during the sample preparation extraction process.

    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