BEUDAMED
    Product Code: DFL FDA class 2 21 CFR 866.5550

    Igm, Ferritin, Antigen, Antiserum, Control

    Immunology

    The IgM Ferritin Antigen, Antiserum, and Control is a ferritin-conjugated immunological reagent used for the detection and quantification of IgM immunoglobulins in laboratory assays. It is classified as FDA Class 2, a moderate-risk device requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5550 within the Immunology specialty. This device is eligible for third-party 510(k) review, streamlining the premarket review process through an FDA-accredited organization.

    View on FDA
    510(k)s
    3
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    3
    Years Active
    11

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    Basic Information

    Product Code
    DFL
    Device Class
    FDA class 2
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Review Panel
    IM
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K883493 TECHNICON DPA-1 IMMUNOGLOBULIN M
    K882822 FIAGEN FERRITIN
    K772079 RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M