BEUDAMED
    Product Code: HZF FDA class 1 21 CFR 864.1850

    Nuclear Fast Red

    Hematology

    Nuclear Fast Red (also known as Kernechtrot) is a nuclear counterstain used in histology and immunohistochemistry to provide a red background color to cell nuclei following primary staining procedures. It is regulated as an FDA Class 1 device, representing the lowest risk category subject only to general controls without requiring premarket notification. The product code is HZF, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.

    View on FDA
    510(k)s
    0
    FEI Numbers
    17
    Registration Numbers
    17
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HZF
    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 17 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.