BEUDAMED
    Product Code: DFM FDA class 2 21 CFR 866.5510

    Ige, Ferritin, Antigen, Antiserum, Control

    Immunology

    The IgE Ferritin Antigen, Antiserum, and Control is a ferritin-conjugated diagnostic reagent used to detect and quantify IgE immunoglobulins, which play a key role in allergic and hypersensitivity responses. It is designated FDA Class 2, indicating moderate risk with a requirement for 510(k) premarket notification, and is regulated under 21 CFR 866.5510 within the Immunology specialty. This device qualifies for third-party 510(k) review, allowing an accredited body to conduct the premarket review.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    DFM
    Device Class
    FDA class 2
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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