BEUDAMED
    Product Code: KJS FDA class 1 21 CFR 864.1850

    Ethyl Eosin

    Hematology

    Ethyl Eosin is a synthetic eosin derivative used as a histological staining agent in hematology and pathology laboratories to stain cytoplasmic structures and tissue components for microscopic analysis. It is classified as FDA Class 1, indicating low risk subject to general controls without a premarket submission requirement. The product code is KJS and it is regulated under 21 CFR 864.1850, within the Hematology specialty. This device is GMP exempt.

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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
    KJS
    Device Class
    FDA class 1
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Review Panel
    PA
    Submission Type
    4

    Device Characteristics

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