BEUDAMED
    Product Code: JGR FDA class 2 21 CFR 862.1635

    Refractometric, Total Protein

    Clinical Chemistry

    Refractometric Total Protein measurement is a clinical chemistry test system that uses refractive index measurements of biological fluids to estimate total protein concentration, commonly employed as a rapid, non-destructive method in clinical and veterinary laboratories. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and general and special controls compliance. The product code is JGR, regulated under 21 CFR 862.1635, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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

    Product Code
    JGR
    Device Class
    FDA class 2
    Regulation Number
    862.1635
    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.