BEUDAMED
    Product Code: JLY FDA class 1 21 CFR 862.1255

    Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid

    Clinical Chemistry

    This device is a colorimetric clinical chemistry reagent system using phosphoglycerate mutase to measure 2,3-diphosphoglyceric acid (2,3-DPG) in red blood cells, an important regulator of hemoglobin oxygen affinity relevant to the management of stored blood products and red blood cell metabolism disorders. It is classified as FDA Class 1, subject only to general controls with no premarket submission required. The product code is JLY, regulated under 21 CFR 862.1255, within the Clinical Chemistry medical specialty.

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    FEI Numbers
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    Years Active
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    Basic Information

    Product Code
    JLY
    Device Class
    FDA class 1
    Regulation Number
    862.1255
    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