BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    Assay, Genotyping, Hepatitis C Virus

    PMA: P160016 · Supplement: S006 · Decision Aug 27, 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
    S006
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 27, 2020
    Date Received
    July 31, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Manufacturing process change to replace with new RNA QC samples.

    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