BEUDAMED
    Product Code: KKD FDA class 1 21 CFR 864.1850

    Nigrosin

    Hematology

    Nigrosin is a synthetic mixture of black aniline dyes used as a histological staining reagent in hematology, commonly applied as a background stain or negative stain to enhance contrast for certain microorganisms and cellular structures in microscopic examination. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KKD and it is regulated under 21 CFR 864.1850 within 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 KKD 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
    KKD
    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.