BEUDAMED
    Product Code: DBN FDA class 1 21 CFR 866.5530

    Fc, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting the Fc fragment of immunoglobulins, the constant region that mediates immune effector functions, with antigen, antiserum, and control components for use in clinical immunology and research laboratory applications. It is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification or approval. The product code is DBN, regulated under 21 CFR 866.5530, within the Immunology specialty.

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

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    Basic Information

    Product Code
    DBN
    Device Class
    FDA class 1
    Regulation Number
    866.5530
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K894538 QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK

    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.