BEUDAMED
    Product Code: CZQ FDA class 2 21 CFR 866.5150

    Bence-Jones Protein, Antigen, Antiserum, Control

    Immunology

    The Bence-Jones Protein, Antigen, Antiserum, Control test system (product code CZQ) is an in-vitro diagnostic device used in immunology to detect and characterize Bence-Jones proteins (free immunoglobulin light chains) in urine using immunochemical antigen-antiserum methods, supporting the diagnosis and monitoring of multiple myeloma and other plasma cell dyscrasias. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 866.5150 in the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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

    Basic Information

    Product Code
    CZQ
    Device Class
    FDA class 2
    Regulation Number
    866.5150
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K812327 KAPPA & LAMBDA BENCE JONES CONTROLS
    K802284 ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.