BEUDAMED
    Product Code: GPR FDA class 1 21 CFR 866.3500

    Antiserum, Cf, Q Fever

    Microbiology

    The Q Fever CF (Complement Fixation) Antiserum is a reference reagent used to validate complement fixation tests for the detection of Coxiella burnetii antibodies, supporting the serological diagnosis of Q fever, a zoonotic disease caused by this intracellular bacterium. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GPR, regulated under 21 CFR 866.3500 in the Microbiology specialty.

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    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    GPR
    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

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.