BEUDAMED
    Product Code: GMM FDA class 2 21 CFR 866.3780

    Antigens, Iha, Toxoplasma Gondii

    Microbiology

    The Toxoplasma Gondii IHA (Indirect Hemagglutination) Antigens are serological reagents used to detect antibodies against Toxoplasma gondii via indirect hemagglutination assay, supporting the diagnosis of toxoplasmosis in clinical settings. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GMM, regulated under 21 CFR 866.3780 in the Microbiology specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    8
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    7
    Years Active
    21

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    Basic Information

    Product Code
    GMM
    Device Class
    FDA class 2
    Regulation Number
    866.3780
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K981263 TOXOGEN
    K952818 ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
    K851977 HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT
    K851976 HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT
    K830870 POLYCHACO INDIRECT HEMAGGLUTINATION
    K802452 TOXOTEST-MT EIKEN KIT
    K790460 TXOCELL-IHA REAGENT SYSTEM
    K771560 TOXHA TEST