BEUDAMED
    Product Code: KKI FDA class 1 21 CFR 864.1850

    Rose Bengal

    Hematology

    Rose Bengal is a fluorescent synthetic dye used as a histological staining reagent in hematology and diagnostic laboratories, applied to stain dead or degenerated cells and certain microorganisms in tissue preparations. It is classified as FDA Class 1, indicating low risk subject only to general controls with no premarket submission required. The product code is KKI 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
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KKI
    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

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.