BEUDAMED
    Product Code: KJO FDA class 1 21 CFR 864.1850

    Brilliant Green

    Hematology

    Brilliant Green is a synthetic triarylmethane dye used in microbiology and histology as a selective bacteriostatic agent and stain, incorporated into selective culture media to inhibit gram-positive organisms, and used in tissue staining protocols to differentiate cellular and structural components of tissue specimens. 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 KJO, regulated under 21 CFR 864.1850, within the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KJO
    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 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.