BEUDAMED
    Product Code: CZL FDA class 2 21 CFR 866.5510

    Iga, Peroxidase, Antigen, Antiserum, Control

    Immunology

    The IgA, Peroxidase, Antigen, Antiserum, Control test system (product code CZL) is an in-vitro diagnostic device used in immunology to detect or quantify immunoglobulin A (IgA) using a horseradish peroxidase label in an enzyme-linked immunoassay format, with included 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.

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

    Basic Information

    Product Code
    CZL
    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

    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.