BEUDAMED
    Product Code: OTQ FDA not classified

    Research Use Only/Hematology Devices

    Unknown

    The Research Use Only/Hematology Devices category (product code OTQ) encompasses hematology devices and reagents that are intended for research use only and for products imported into the US only, not for clinical diagnostic use. These products are not subject to premarket notification requirements, as they are not intended for use in clinical diagnosis. 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 Hematology panel. The devices are not implants and are not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    OTQ
    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

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

    Unclassified Reason

    6

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.