BEUDAMED
    Product Code: CJZ FDA class 2 21 CFR 862.1035

    Acid, Hydroxyazobenzene-Benzoic, Albumin

    Clinical Chemistry

    The Hydroxyazobenzene-Benzoic Acid (HABA), Albumin test system (product code CJZ) is an in-vitro diagnostic device used in clinical chemistry to measure albumin concentrations in serum using the hydroxyazobenzene-benzoic acid dye-binding colorimetric method. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1035 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
    CJZ
    Device Class
    FDA class 2
    Regulation Number
    862.1035
    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