BEUDAMED
    Product Code: KKL FDA class 1 21 CFR 864.1850

    Thionin

    Hematology

    Thionin is a thiazine dye used as a histological staining reagent in hematology and neuropathology laboratories, applied for nuclear staining and to demonstrate Nissl substance in neurons and other cellular components in tissue sections. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket clearance required. The product code is KKL 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
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KKL
    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 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.