BEUDAMED
    Product Code: DEP FDA class 2 21 CFR 866.5550

    Lambda, Peroxidase, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting the lambda light chain of immunoglobulins using peroxidase as an enzymatic conjugate, including antigen, antiserum, and control components for enzyme-linked immunoassay analysis. Lambda light chain detection supports diagnosis and monitoring of plasma cell disorders and B-cell malignancies. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DEP, regulated under 21 CFR 866.5550, within the Immunology specialty.

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

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    Basic Information

    Product Code
    DEP
    Device Class
    FDA class 2
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Review Panel
    PA
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K801662 J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.