BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    PMA: P970027 · Supplement: S015 · Decision Oct 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
    Trade Name
    AXSYM ANTI-HCV
    PMA Number
    P970027
    Supplement Number
    S015
    Device Class
    FDA Class 2
    Product Code
    MZO
    Generic Name
    Assay, enzyme linked immunosorbent, hepatitis c virus
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 7, 2011
    Date Received
    September 7, 2011
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL FOR THE AXSYM ANTI-HCV, ARCHITECT CORE-M AND AXSYM CORE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus