BEUDAMED
    Product Code: PCZ FDA not classified

    Investigational Use Only - Immunology

    Unknown

    The Investigational Use Only - Immunology product code is assigned to immunology diagnostic devices that are for investigational use only and for products imported into the United States only; these devices have not completed the FDA's standard device classification process. The device is currently not classified (Class N) and has no assigned regulation number or medical specialty description. This code facilitates the importation of uncleared investigational immunology devices for research use. It is not an implant and is not life-sustaining.

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

    Basic Information

    Product Code
    PCZ
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    HE
    Submission Type
    7

    Device Characteristics

    ✓
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Investigational use only and for products imported into the US only.

    Unclassified Reason

    6