BEUDAMED
    Product Code: JNN FDA class 1 21 CFR 862.1725

    P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin

    Clinical Chemistry

    The P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin test is a clinical chemistry diagnostic reagent used to measure trypsin activity in biological samples using the synthetic substrate TAME, which is hydrolyzed by trypsin and detected by ultraviolet spectrophotometry. Trypsin measurement is used in the investigation of pancreatic exocrine function and related disorders. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JNN and is regulated under 21 CFR 862.1725, within the Clinical Chemistry medical specialty.

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    510(k)s
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    JNN
    Device Class
    FDA class 1
    Regulation Number
    862.1725
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    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 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.