BEUDAMED
    Product Code: CZM FDA class 2 21 CFR 866.5510

    Iga, Ferritin, Antigen, Antiserum, Control

    Immunology

    The IgA, Ferritin, Antigen, Antiserum, Control test system (product code CZM) is an in-vitro diagnostic device used in immunology to detect or quantify immunoglobulin A (IgA) using a ferritin label in an immunochemical assay, with associated antigen, antiserum, and control materials. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 866.5510 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
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    CZM
    Device Class
    FDA class 2
    Regulation Number
    866.5510
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K870930 TINA-QUANT(R) (A) C3