BEUDAMED
    Product Code: NFZ FDA class 2 21 CFR 862.1225

    Test, Creatinine, Over The Counter

    Clinical Chemistry

    The Test, Creatinine, Over The Counter (product code NFZ) is an in vitro diagnostic test for consumer use that measures creatinine concentration in urine, often used alongside other tests to assess kidney function or verify specimen adequacy for drug testing. It is classified as an FDA Class 2 device within the Clinical Chemistry specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

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

    Basic Information

    Product Code
    NFZ
    Device Class
    FDA class 2
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Review Panel
    TX
    Submission Type
    1

    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.