BEUDAMED
    Product Code: DNJ FDA class 2 21 CFR 862.3320

    Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.

    Clinical Toxicology

    The Radioimmunoassay for Digoxin using iodine-125 with goat antibody and second antibody separation is a laboratory test system that measures digoxin, a cardiac glycoside drug, in patient serum using a double-antibody radioimmunoassay format. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DNJ, regulated under 21 CFR 862.3320, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    0

    Basic Information

    Product Code
    DNJ
    Device Class
    FDA class 2
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K771877 DIGOXIN RIA KIT
    K771533 DIGOXIN RIA KIT