BEUDAMED
    Product Code: ICS FDA class 1 21 CFR 864.1850

    Azocarmine G

    Hematology

    Azocarmine G is a red fluorescent dye used in histology as a nuclear stain and component of Heidenhain's Azan trichrome method, where it stains nuclei and erythrocytes red before collagen and reticular fibers are colored blue with aniline blue. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is ICS, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.

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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
    ICS
    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 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.