BEUDAMED
    Product Code: KKH FDA class 1 21 CFR 864.1850

    Tablet, Resazurin

    Hematology

    The Resazurin Tablet is a redox indicator reagent used in hematology and microbiology laboratory procedures, applied as a colorimetric indicator to assess cell viability and metabolic activity in biological samples. It is classified as FDA Class 1, indicating low risk subject to general controls without a requirement for premarket clearance or approval. The product code is KKH and the applicable regulation is 21 CFR 864.1850 under the Hematology specialty. This device is GMP exempt.

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

    Basic Information

    Product Code
    KKH
    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