BEUDAMED
    Product Code: JMQ FDA class 1 21 CFR 862.1490

    M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)

    Clinical Chemistry

    This device is a spectrophotometric clinical chemistry reagent system using Micrococcus lysodeikticus cells as substrate to measure lysozyme (muramidase) activity in patient specimens, used in the assessment of monocyte and macrophage activity and as a marker in certain leukemias and inflammatory conditions. It is classified as FDA Class 1, the lowest risk category, requiring only general controls with no premarket notification. The product code is JMQ, regulated under 21 CFR 862.1490, within the Clinical Chemistry medical specialty.

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    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    JMQ
    Device Class
    FDA class 1
    Regulation Number
    862.1490
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    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 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.