BEUDAMED
    Product Code: GPI FDA class 1 21 CFR 866.3850

    Antigen, Bentonite Flocculation, Trichinella Spiralis

    Microbiology

    The Trichinella Spiralis Bentonite Flocculation Antigen is a diagnostic reagent used in bentonite flocculation tests to detect antibodies against Trichinella spiralis, a parasitic nematode responsible for trichinellosis contracted from contaminated undercooked meat products. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GPI, regulated under 21 CFR 866.3850 in the Microbiology specialty.

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

    Basic Information

    Product Code
    GPI
    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