BEUDAMED
    Product Code: GSI FDA class 1 21 CFR 866.3355

    Antigens, Slide And Tube, All Types, Listeria Monocytogenes

    Microbiology

    The Antigens, Slide and Tube, All Types, Listeria Monocytogenes is a set of slide and tube agglutination antigens covering all serotypes of Listeria monocytogenes, used in clinical laboratory serotyping of isolates. As an FDA Class 1 device, it is subject only to general controls and requires no premarket clearance. Regulated under 21 CFR 866.3355 with product code GSI in the Microbiology specialty. No special flags apply to this device.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GSI
    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
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K840503 SDL LISTERIA MONOCYTOGENES CONTROL