BEUDAMED
    Product Code: JGE FDA class 1 21 CFR 862.1330

    Turbidimetric Method, Globulin

    Clinical Chemistry

    Turbidimetric Method for Globulin is a clinical chemistry test system that measures globulin protein concentrations in serum by quantifying light scattering caused by protein-precipitate complexes, used in evaluating immune and hepatic disorders. It is classified as FDA Class 1 (lowest risk), governed solely by general controls. The product code is JGE, regulated under 21 CFR 862.1330, within the Clinical Chemistry medical specialty. No special flags apply to this device.

    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
    JGE
    Device Class
    FDA class 1
    Regulation Number
    862.1330
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K980055 CARESIDE GLOBULIN