BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    PMA: P970027 · Supplement: S006 · Decision Feb 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
    Trade Name
    ABBOTT AXSYM ANTI-HCV
    PMA Number
    P970027
    Supplement Number
    S006
    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
    February 22, 2008
    Date Received
    February 11, 2008
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING MODIFICATIONS THAT CORRECT THE ERROR IN THE AXSYM ANTI-HCV PACKAGE INSERT (LIST NUMBER 5C36) UNDER REATENTS SECTION. THE MINIMUM CONCENTRATION OF ?% SOLIDS? FOR THE RECOMBINANT HCV ANTIGEN COATED MICROPARTICLES OF THE AXSYM ANTI-HCV REAGENT PACK IS BEING CHANGED FROM ?0.05%? TO ?0.04%? TO ALIGN WITH CURRENT MANUFACTURING PROCESS.

    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