BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Delta Serological Reagents

    PMA: P850062 · Supplement: S003 · Decision Sep 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Hepatitis Delta Serological Reagents
    Trade Name
    ABBOTT ANTI-DELTA (EIA) ASSAY
    PMA Number
    P850062
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    LQI
    Generic Name
    HEPATITIS DELTA SEROLOGICAL REAGENTS
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 5, 2002
    Date Received
    October 3, 2001
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE ABBOTT ANTI-DELTA (EIA) MASTER LOT TESTING.

    Classifications

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

    Product Code Device Name
    LQI Hepatitis Delta Serological Reagents