BEUDAMED
    Product Code: HYT FDA class 1 21 CFR 864.1850

    Luxol Fast Blue

    Hematology

    Luxol fast blue is a solvent-based dye used in histology to selectively stain myelin sheaths in the central and peripheral nervous system, commonly combined with cresyl violet or periodic acid-Schiff (PAS) stains for neuropathological diagnosis of demyelinating diseases. It is classified as an FDA Class 1 device under 21 CFR 864.1850, indicating minimal risk and general controls. Product code HYT falls under the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    HYT
    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 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.