BEUDAMED
    Product Code: KJM FDA class 1 21 CFR 864.1850

    Bismarck Brown Y

    Hematology

    Bismarck Brown Y is a synthetic diazo dye used as a histological stain to stain mucins, cartilage, and certain other tissue components in tissue sections, applied in routine and special staining protocols to assist in the identification of these tissue structures under the microscope. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KJM, regulated under 21 CFR 864.1850, within the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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

    Research product code KJM 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
    KJM
    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.