BEUDAMED
    Product Code: GNE FDA class 1 21 CFR 866.3870

    Antigen, Latex Agglutination, T. Cruzi

    Microbiology

    The Trypanosoma Cruzi Latex Agglutination Antigen is a microbiology diagnostic reagent used to detect antibodies against Trypanosoma cruzi, the causative agent of Chagas disease, through latex agglutination methodology. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GNE, regulated under 21 CFR 866.3870 in the Microbiology specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GNE
    Device Class
    FDA class 1
    Regulation Number
    866.3870
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    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
    K834328 DAT TEST FOR CHAGAS' DISEASE