BEUDAMED
    Product Code: GPO FDA class 1 21 CFR 866.3500

    Antigen, Cf, Typhus Fever Group

    Microbiology

    The Typhus Fever Group CF (Complement Fixation) Antigen is a serological reagent used in complement fixation tests to detect antibodies against the typhus group of Rickettsia organisms, which includes the causative agents of epidemic and murine typhus. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GPO, regulated under 21 CFR 866.3500 in the Microbiology specialty.

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

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    Basic Information

    Product Code
    GPO
    Device Class
    FDA class 1
    Regulation Number
    866.3500
    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
    K924395 NEOTHROMITIN(R)

    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.