BEUDAMED
    Product Code: KFD FDA class 1 21 CFR 864.1850

    Aniline Blue

    Hematology

    Aniline Blue is a synthetic dye used as a histological stain, particularly in techniques such as Mallory trichrome, to stain collagen fibers and connective tissue components in tissue sections, facilitating the assessment of fibrosis and structural tissue architecture 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 KFD, 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
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    KFD
    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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K894045 MODIFIED POLYCHROME IV STAIN

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.