BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Genotyping, Hepatitis C Virus

    PMA: P160016 · Supplement: S005 · Decision Sep 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Assay, Genotyping, Hepatitis C Virus
    Trade Name
    VERSANT HCV Genotype 2.0 Assay (LiPA)
    PMA Number
    P160016
    Supplement Number
    S005
    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 23, 2020
    Date Received
    June 8, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to replace the Triton X-705 detergent, a component of the 5X Rinse Solution and Conjugate Diluent used in the VERSANT HCV Genotyping 2.0 Assay, with the detergent Tergitol 15-S-40.

    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