BEUDAMED
    Product Code: DDO FDA class 2 21 CFR 866.5680

    Myoglobin, Rhodamine, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting myoglobin, the oxygen-binding heme protein found in cardiac and skeletal muscle, using rhodamine as a fluorescent conjugate, including antigen, antiserum, and control components for immunofluorescence analysis. Myoglobin is released into the bloodstream during muscle injury and is used as an early biomarker of myocardial infarction. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DDO, regulated under 21 CFR 866.5680, within the Immunology specialty.

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

    Basic Information

    Product Code
    DDO
    Device Class
    FDA class 2
    Regulation Number
    866.5680
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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