BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    PMA: P050042 · Supplement: S002 · Decision Mar 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
    Trade Name
    ARCHITECT ANTI-HCV
    PMA Number
    P050042
    Supplement Number
    S002
    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
    March 5, 2007
    Date Received
    January 11, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO EXTEND THE EXPIRATION DATING OF REAGENTS, CALIBRATORS, AND CONTROLS TO 14 MONTHS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARCHITECT ANTI-HCV AND IS INDICATED FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN).

    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