BEUDAMED
    Product Code: GPG FDA class 1 21 CFR 866.3850

    Antigen, Latex Agglutination, Trichinella Spiralis

    Microbiology

    The Trichinella Spiralis Latex Agglutination Antigen is a parasitology reagent used in latex agglutination tests to detect antibodies against Trichinella spiralis, a roundworm parasite that causes trichinellosis following ingestion of raw or undercooked meat. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GPG, regulated under 21 CFR 866.3850 in the Microbiology specialty.

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    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    3

    Basic Information

    Product Code
    GPG
    Device Class
    FDA class 1
    Regulation Number
    866.3850
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K904613 TRICHINELLA SEROLOGY MICROTITER ELISA
    K882149 MINIFUGE, MODEL 70