BEUDAMED
    Product Code: DJO FDA class 1 21 CFR 862.2270

    Indicator, Cellulose Fluorescent, Tlc

    Clinical Chemistry

    The Cellulose Fluorescent Indicator for TLC is a thin layer chromatography accessory material impregnated with a fluorescent indicator to enable visualization of separated compounds under UV light in clinical chemistry and toxicology laboratory analyses. It is classified as FDA Class 1, indicating low risk, and is subject only to general controls without premarket notification requirements. The device is regulated under 21 CFR 862.2270 within the Clinical Chemistry 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
    DJO
    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