BEUDAMED
    Product Code: CHR FDA class 2 21 CFR 862.1160

    Titrimetric Phenol Red, Carbon-Dioxide

    Clinical Chemistry

    The Titrimetric Phenol Red, Carbon Dioxide test system (product code CHR) is an in-vitro diagnostic device used in clinical chemistry to measure carbon dioxide (CO2) concentrations in serum or plasma using a titrimetric method with a phenol red indicator, supporting assessment of electrolyte and acid-base balance. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1160 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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

    Product Code
    CHR
    Device Class
    FDA class 2
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
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    Summary Malfunction Reporting