BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Assay, Genotyping, Hepatitis C Virus

    PMA: P160016 · Decision Mar 14, 2017
    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
    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 (Reclassification)
    Decision Code
    APRL
    Decision Date
    March 14, 2017
    Date Received
    June 6, 2016
    Expedited Review
    N
    Docket Number
    17M-1713

    Advisory Committee Statement

    Approval for the VERSANT HCV Genotype 2.0 Assay (LiPA) is a line probe assay, which identifies Hepatitis C virus (HCV) genotypes 1 to 6 and subtypes 1a and 1b in human serum or plasma (K2EDTA, ACD-A CPD, and CPDA) samples. The VERSANT HCV Genotype 2.0 Assay (LiPA) is intended to be used as an aid in the management of patients with chronic HCV infection to guide the selection of antiviral treatment.

    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