BEUDAMED
    Product Code: HZQ FDA class 1 21 CFR 864.1850

    Red-Violet Lb

    Hematology

    Red-Violet LB is a histological dye used as a staining reagent in tissue preparation, providing coloration to specific cellular components in microscopic examination of biological specimens. It is regulated as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is HZQ, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.

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    Basic Information

    Product Code
    HZQ
    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