BEUDAMED
    Product Code: DEA FDA class 2 21 CFR 866.5680

    Myoglobin, Fitc, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting myoglobin using FITC as a fluorescent conjugate, including antigen, antiserum, and control components for immunofluorescence-based measurement of this cardiac and skeletal muscle protein released upon muscle damage, used as an early cardiac injury biomarker. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DEA, regulated under 21 CFR 866.5680, within the Immunology specialty.

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

    Basic Information

    Product Code
    DEA
    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

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.