BEUDAMED
    Product Code: GOY FDA class 1 21 CFR 866.3065

    Antisera, Agglutinating, B. Pertussis, All

    Microbiology

    The Bordetella Pertussis Agglutinating Antisera (All Types) are reference reagents used in agglutination tests to identify and type Bordetella pertussis isolates responsible for whooping cough, a severe respiratory disease particularly dangerous in infants. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GOY, regulated under 21 CFR 866.3065 in the Microbiology specialty.

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    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GOY
    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

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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
    K781727 CHANGE IN STERILIZATION PROCEDURE

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.