BEUDAMED
    Product Code: LGA FDA class 3 21 CFR 866.2420

    Device, Oxidase Test For Gonorrhea

    Microbiology

    An oxidase test device for gonorrhea is a microbiological diagnostic test used to detect the oxidase enzyme produced by Neisseria gonorrhoeae as part of the laboratory identification of gonorrhea infection. The device is FDA Class 3, the highest risk category, meaning it requires a Pre-Market Approval (PMA) application demonstrating safety and effectiveness before it may be marketed. It carries product code LGA and is regulated under 21 CFR 866.2420 within the Microbiology specialty. No special flags apply to this device.

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

    Product Code
    LGA
    Device Class
    FDA class 3
    Regulation Number
    866.2420
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    2

    Device Characteristics

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

    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.