BEUDAMED
    Product Code: DLY FDA class 1 21 CFR 862.2270

    Plate, Alumina, Tlc

    Clinical Chemistry

    The Plate, Alumina, for Thin Layer Chromatography is a laboratory consumable consisting of an aluminum oxide layer on a rigid support, used as the stationary phase in thin layer chromatography for the separation of drug compounds. It is a Class 1 device subject only to general controls and does not require premarket notification. The product code is DLY, regulated under 21 CFR 862.2270, within the Clinical Chemistry specialty. No special regulatory flags apply.

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    Basic Information

    Product Code
    DLY
    Device Class
    FDA class 1
    Regulation Number
    862.2270
    Medical Specialty
    Clinical Chemistry
    Review Panel
    TX
    Submission Type
    4

    Device Characteristics

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