BEUDAMED
    Product Code: OTT FDA not classified

    Research Use Only/Microbiology

    Unknown

    The Research Use Only/Microbiology category (product code OTT) covers microbiology devices and reagents intended solely for research use and for products imported into the US only, not for clinical diagnostic application. These products do not require premarket clearance as they are not used in patient 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 Microbiology panel. The devices are not implants and are not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    OTT
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    MI
    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 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.