BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Delta Serological Reagents

    PMA: P850062 · Supplement: S002 · Decision Feb 26, 1997
    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
    PMA Number
    P850062
    Supplement Number
    S002
    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
    February 26, 1997
    Date Received
    January 21, 1997
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE SPECIFICATIONS FOR THE CONJUGATE CONCENTRATE FROM A NEGATIVE CONTROL SAMPLE WITH A STANDARD RATION OF 0.90- 1.10, TO A NEGATIVE CONTROL MEAN O.D. OF 1.17 - 1.43

    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