BEUDAMED
    Product Code: CGH FDA class 1 21 CFR 862.1330

    Electrophoretic, Globulin

    Clinical Chemistry

    The Electrophoretic, Globulin test system (product code CGH) is an in-vitro diagnostic device used in clinical chemistry to measure globulin protein fractions in serum by electrophoretic separation. It is classified as FDA Class 1, representing the lowest risk, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1330 in the Clinical Chemistry medical specialty.

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

    Product Code
    CGH
    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
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    Summary Malfunction Reporting