BEUDAMED
    Product Code: KKM FDA class 1 21 CFR 864.1850

    Methylene Blue Thiocyanate

    Hematology

    Methylene Blue Thiocyanate is a synthetic dye compound used as a histological staining reagent in hematology and microbiology laboratories, applied to stain nucleic acids, bacteria, and various tissue components for microscopic visualization. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KKM and the applicable regulation is 21 CFR 864.1850 under the Hematology specialty. This device is GMP exempt.

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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
    KKM
    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 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.