BEUDAMED
    Product Code: GSG FDA class 1 21 CFR 866.3355

    Antisera, Fluorescent, All Types, Listeria Monocytogenes

    Microbiology

    The Antisera, Fluorescent, All Types, Listeria Monocytogenes is a fluorescent antiserum reagent used in immunofluorescence testing to detect and type all serotypes of Listeria monocytogenes, an important foodborne pathogen that causes listeriosis. It is an FDA Class 1 device subject to general controls only, with no premarket notification required. Regulated under 21 CFR 866.3355 with product code GSG in the Microbiology specialty. No special flags apply to this device.

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    Basic Information

    Product Code
    GSG
    Device Class
    FDA class 1
    Regulation Number
    866.3355
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting