BEUDAMED
    Product Code: KKE FDA class 1 21 CFR 864.1850

    Orange Ii

    Hematology

    Orange II is a synthetic monoazo dye used as a histological staining reagent in hematology laboratories for the staining and differentiation of tissue components and eosinophilic structures in microscopic preparations. It is classified as FDA Class 1, indicating low risk subject to general controls only, with no requirement for premarket clearance. The product code is KKE 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
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KKE
    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
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    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.