BEUDAMED
    Product Code: JMS FDA class 1 21 CFR 862.1500

    Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase

    Clinical Chemistry

    This device is an ultraviolet spectrophotometric clinical chemistry reagent system using oxalacetic acid and NADH oxidation to measure malic dehydrogenase activity in patient serum, an enzyme associated with myocardial and hepatic tissue damage when elevated in circulation. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls with no premarket notification. The product code is JMS, regulated under 21 CFR 862.1500, within the Clinical Chemistry medical specialty.

    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    JMS
    Device Class
    FDA class 1
    Regulation Number
    862.1500
    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 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.