BEUDAMED
    Product Code: LTS FDA class 1 21 CFR 866.2660

    Test Reagents, Neisseria Gonorrhoeae Biochemical

    Microbiology

    The Neisseria Gonorrhoeae Biochemical Test Reagents (product code LTS) are diagnostic microbiology reagents used to identify Neisseria gonorrhoeae, the bacterium responsible for gonorrhea, through biochemical testing methods. Regulated under 21 CFR 866.2660 and classified as a Class 1 device, these reagents are subject only to general controls and are not exempt from Good Manufacturing Practice requirements. They fall within the Microbiology medical specialty. The device is not flagged as an implant or life-sustaining device.

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

    Basic Information

    Product Code
    LTS
    Device Class
    FDA class 1
    Regulation Number
    866.2660
    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
    K954784 DRYSIDE NEISSERIA

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.