BEUDAMED
    Product Code: GOX FDA class 1 21 CFR 866.3065

    Antigen, B. Pertussis

    Microbiology

    The Bordetella Pertussis Antigen is a microbiology reagent used in serological and agglutination tests to detect and identify Bordetella pertussis, the primary causative agent of whooping cough (pertussis), a highly contagious respiratory disease. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GOX, regulated under 21 CFR 866.3065 in the Microbiology specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    1
    Years Active
    —

    Research product code GOX in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    GOX
    Device Class
    FDA class 1
    Regulation Number
    866.3065
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K791454 AGGLUTINOTEST-PERTUSSIS

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.