BEUDAMED
    Product Code: KKW FDA class 1 21 CFR 864.1850

    Basic Fuchsin

    Hematology

    Basic Fuchsin is a synthetic triphenylmethane dye used as a histological staining reagent in hematology and pathology laboratories, applied to stain bacteria, nuclei, and certain tissue components, and as a component of Schiff reagent in PAS and Feulgen staining procedures. It is classified as FDA Class 1, indicating low risk subject to general controls only with no premarket submission required. The product code is KKW and the applicable regulation is 21 CFR 864.1850 in the Hematology specialty. This device is GMP exempt.

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    510(k)s
    0
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KKW
    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 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.