BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    PMA: P970027 · Supplement: S007 · Decision Jul 8, 2009
    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 ANTIBODY TO HCV (ANTI-HCV)
    PMA Number
    P970027
    Supplement Number
    S007
    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
    July 8, 2009
    Date Received
    November 13, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE ANTIMICROBIAL FORMULATION TO THE AXSYM ANTI-HCV REAGENT SDB2 (SPECIMEN DILUENT). IN ADDITION, DUE TO THE REFORMULATION OF THE SDB2, THE INSTRUCTION TO USE STERILE WATER FOR TUBING DECONTAMINATION IS NO LONGER A REQUIRED PROCEDURE AND CAN BE REMOVED FROM THE PACKAGE INSERT LABELING.

    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