BEUDAMED
    Product Code: KJP FDA class 1 21 CFR 864.1850

    Carmine

    Hematology

    Carmine is a biological dye derived from the cochineal insect, used as a histological staining reagent in hematology laboratory procedures to differentiate tissue components under microscopy. It is classified as FDA Class 1, meaning it presents low risk and is subject only to general controls, with no requirement for premarket notification or approval. The product code is KJP and it is regulated under 21 CFR 864.1850, within 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
    KJP
    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.