BEUDAMED
    Product Code: IDF FDA class 1 21 CFR 864.1850

    Acid, Fuchsin

    Hematology

    Acid Fuchsin is a red anionic dye used in multiple histological staining procedures including Van Gieson's, Masson's trichrome, and PTAH methods, where it stains cytoplasm, muscle, and collagen in varying intensities depending on the procedure. 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 IDF, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.

    View on FDA
    510(k)s
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    IDF
    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
    K871545 NEW FUCHSIN SOLUTION

    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.