BEUDAMED
    Product Code: LCW FDA class 2 21 CFR 862.3300

    Radioimmunoassay, Digitoxin (125-I)

    Clinical Toxicology

    Radioimmunoassay for digitoxin using iodine-125 tracer is a laboratory test system used to measure serum levels of digitoxin, a cardiac glycoside used for heart failure and arrhythmias, where therapeutic drug monitoring is critical due to the drug's narrow therapeutic index. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is LCW, regulated under 21 CFR 862.3300, in the Clinical Toxicology specialty. Third-party review is available.

    View on FDA
    510(k)s
    3
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    3
    Years Active
    6

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    Basic Information

    Product Code
    LCW
    Device Class
    FDA class 2
    Regulation Number
    862.3300
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K834080 MATCHED COMPONENT SET FOR DIGITOXIN
    K802461 ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT
    K780766 (125 I) DIGITOXIN RIA KIT