BEUDAMED
    Product Code: DNL FDA class 2 21 CFR 862.3320

    Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.

    Clinical Toxicology

    The Radioimmunoassay for Digoxin using iodine-125 with rabbit antibody and second antibody separation is a clinical laboratory test system that quantifies digoxin in patient serum using a double-antibody radioimmunoassay format, important for monitoring therapeutic levels and preventing cardiac glycoside toxicity. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DNL, 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
    8
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    8
    Years Active
    8

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    Basic Information

    Product Code
    DNL
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K852343 DIG RADIOIMMUNOASSAY TEST SYSTEM
    K852291 TIPSEP DIGOXIN RIA
    K811212 DIGOXIN (RIA) KIT
    K810966 DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT
    K802841 DIGOXIN RADIOIMMUNOASSAY KIT
    K781834 TEST SET, 125 I-DIGOXIN
    K781495 RIANEN ASSAY SYSTEM, 125I KIT
    K772110 IN VITRO DIGOXIN RIA TEST