BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DRI Opiates Assay

    Reg #: 3010939897 · FEI: 3010939897 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Microgenics Corporation
    Registration Number
    3010939897
    FEI Number
    3010939897
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    46500 Kato Road
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US

    Regulatory Submissions

    510(k) Number
    K011150

    Owner / Operator

    Firm Name
    Thermo Fisher Scientific
    Operator Number
    2517925
    Address
    168 Third Avenue, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    Products

    Device Name Product Code
    Enzyme Immunoassay, Opiates DJG

    Proprietary Names

    DRI Opiates Assay MULTIGENT Opiates Assay Alinity c Opiates Reagent Kit MULTIGENT OPIATES LOW CONTROL

    Establishment Types

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