BEUDAMED
    Product Code: DCE FDA class 1 21 CFR 866.5520

    Fab, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting the Fab fragment of immunoglobulins, the antigen-binding portion of antibody molecules, using antigen, antiserum, and control components for standard immunoassay applications in clinical and research laboratories. It is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. The product code is DCE, regulated under 21 CFR 866.5520, within the Immunology specialty.

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    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    1

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    Basic Information

    Product Code
    DCE
    Device Class
    FDA class 1
    Regulation Number
    866.5520
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    4

    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K781951 ANTISERA, RHODAMINE CONJUGATED FRAGMENT
    K772128 FLUORESCEIN CONJUGATED