BEUDAMED
    FDA PMA FDA Class 1 Approved 🇺🇸 United States

    Kit, Identification, Neisseria Gonorrhoeae

    PMA: N17985 · Supplement: S002 · Decision Jan 4, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Kit, Identification, Neisseria Gonorrhoeae
    Trade Name
    GONOSTICON DRI-DOT TEST
    PMA Number
    N17985
    Supplement Number
    S002
    Device Class
    FDA Class 1
    Product Code
    JSX
    Generic Name
    KIT, IDENTIFICATION, NEISSERIA GONORRHOEAE
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 4, 1983
    Date Received
    November 29, 1982
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    JSX Kit, Identification, Neisseria Gonorrhoeae