BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SEFRIA Fentanyl Urine Kit 100 mL

    Reg #: 2020952 · FEI: 2020952 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Alere San Diego Inc.
    Registration Number
    2020952
    FEI Number
    2020952
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    829 Towne Center Drive
    City
    Pomona
    State
    CA
    ZIP
    91767
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161216

    Owner / Operator

    Firm Name
    Abbott
    Operator Number
    9006731
    Address
    100 Abbott Park Road, Dept. RX51/J55/MS 6134
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Calibrators, Drug Specific DLJ
    Enzyme Immunoassay, Opiates DJG

    Proprietary Names

    SEFRIA Fentanyl Urine Kit 100 mL Fentanyl Urine Calibrator 2 ng / mL Fentanyl Urine Calibrator 4 ng / mL Fentanyl Urine Calibrator 1 ng / mL SEFRIA Fentanyl Urine Kit 25 SEFRIA Fentanyl Urine Kit 500 mL SEFRIA Fentanyl Urine Kit 60 mL Wedge Fentanyl Urine Calibrator Level 1 - 1 ng/mL

    Establishment Types

    Manufacture Medical Device