BEUDAMED
    Product Code: GTH FDA class 2 21 CFR 866.3390

    Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae

    Microbiology

    The Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae is a fluorescent antiserum used in direct immunofluorescence testing to detect Neisseria gonorrhoeae, the causative agent of gonorrhea, across all antigenic groups in clinical specimens. It is an FDA Class 2 device, reflecting moderate risk and requiring 510(k) premarket clearance. Regulated under 21 CFR 866.3390 with product code GTH in the Microbiology specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    3
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    3
    Years Active
    10

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    Basic Information

    Product Code
    GTH
    Device Class
    FDA class 2
    Regulation Number
    866.3390
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K900546 BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT
    K861835 MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST
    K800328 NEISSERIA GONORRHOEAE FLUORO-KIT