BEUDAMED
    Product Code: KJQ FDA class 1 21 CFR 864.1850

    Chlorazol Black E

    Hematology

    Chlorazol Black E is an azo dye used as a histological staining agent in hematology laboratories, typically applied to differentiate and visualize tissue components in microscopic preparations. It is classified as FDA Class 1, indicating low risk subject to general controls only, with no premarket submission required. The product code is KJQ and the applicable regulation is 21 CFR 864.1850, under the Hematology specialty. This device is GMP exempt.

    View on FDA
    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

    Research product code KJQ in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    KJQ
    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
    —
    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.