BEUDAMED
    Product Code: OTU FDA not classified

    Research Use Only/Pathology

    Unknown

    The Research Use Only/Pathology category (product code OTU) covers pathology devices and reagents intended for research use only and for products imported into the US only, excluding clinical diagnostic applications. These products are exempt from premarket notification requirements. This product code is classified as FDA Not Classified, is GMP exempt, and has no associated regulation number or medical specialty. It is reviewed by the Pathology panel. The devices are not implants and are not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

    Research product code OTU in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    OTU
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    PA
    Submission Type
    7

    Device Characteristics

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

    Definition

    For research use only and for products imported into the US only.

    Unclassified Reason

    6

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.