BEUDAMED
    Product Code: JIB FDA class 1 21 CFR 862.1310

    U.V. Method, Galactose

    Clinical Chemistry

    UV Method for Galactose is a clinical chemistry test system that uses ultraviolet spectrophotometric measurement to quantify galactose in biological specimens, supporting diagnosis and management of galactosemia and other galactose metabolism disorders. It is classified as FDA Class 1 (lowest risk), governed by general controls only. The product code is JIB, regulated under 21 CFR 862.1310, within the Clinical Chemistry medical specialty. This device is eligible for third-party review where applicable.

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    510(k)s
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    FEI Numbers
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    Years Active
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    Basic Information

    Product Code
    JIB
    Device Class
    FDA class 1
    Regulation Number
    862.1310
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

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