BEUDAMED
    Product Code: DJK FDA class 1 21 CFR 862.3280

    Digitoxin Control Serum, Ria

    Clinical Toxicology

    The Digitoxin Control Serum for RIA is a reference material used in clinical toxicology laboratories to verify the accuracy of radioimmunoassay methods for measuring digitoxin, a cardiac glycoside drug, in patient specimens. It is classified as FDA Class 1, indicating low risk, and is subject only to general controls without premarket notification requirements. The device is regulated under 21 CFR 862.3280 within the Clinical Toxicology specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    DJK
    Device Class
    FDA class 1
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K780495 DIGITOXIN