BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    OMNIgene ORAL (OM-501, OMR-110, OMR-120)

    Reg #: 3003742580 · FEI: 3003742580 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DNA GENOTEK, INC.
    Registration Number
    3003742580
    FEI Number
    3003742580
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3000 - 500 Palladium Drive
    City
    Ottawa Ontario
    Country
    CA

    Owner / Operator

    Firm Name
    DNA GENOTEK, INC.
    Operator Number
    9054962
    Address
    3000 - 500 Palladium Drive
    City
    Ottawa
    State
    Ontario
    Postal Code
    K2V 1C2
    Country
    CA

    US Agent

    Business Name
    ORASURE TECHNOLOGIES INC.
    Contact Name
    Tiffany Miller
    Address
    OraSure Technologies, Inc., 220 East First Street
    City
    Bethlehem
    State
    PA
    ZIP
    18015
    Country
    US
    Email
    [email protected]
    Phone
    610 8821820 ext. 3014

    Products

    Device Name Product Code
    Research Use Only/Microbiology OTT

    Proprietary Names

    OMNIgene ORAL (OM-501, OMR-110, OMR-120) OMNIgene GUT (OMR-200) OMNIgene VAGINAL (OMR-130) OMNImet GUT (OME-200) OMNIgene SKIN (OMR-140) OMNIgene GUT DNA & RNA (OMR-205) N00345_RUO Colli-Pee UAS FV-5010-RUO N00339_PROTO Colli-Pee UAS FV-5020-PROTO N00327_RUO Colli-Pee UCM FV-5010-RUO N00260_RUO Colli-Pee UCM FV-5004-RUO N00342_RUO Colli-Pee UAS FV-5040-RUO N00176_RUO Colli-Pee UCM FV-5020-RUO N00269_RUO Colli-Pee Large Volumes RUO N00290_RUO Colli-Pee 4 mL RUO

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device