BEUDAMED
    Product Code: GPD FDA class 1 21 CFR 866.3200

    Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus

    Microbiology

    The Echinococcus Granulosus Indirect Fluorescent Antibody Test Antigen is a parasitology reagent used in indirect fluorescent antibody (IFA) tests to detect antibodies against Echinococcus granulosus, the tapeworm responsible for cystic echinococcosis (hydatid disease), a potentially serious condition affecting the liver and lungs. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GPD, regulated under 21 CFR 866.3200 in the Microbiology specialty.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    GPD
    Device Class
    FDA class 1
    Regulation Number
    866.3200
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.