BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Opiates Urine Calibrator 2000 Level 3 - 1000 ng/mL (15 mL)

    Reg #: 2020952 · FEI: 2020952 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    3

    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
    K143502

    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
    Drug Mixture Control Materials DIF
    Enzyme Immunoassay, Opiates DJG

    Proprietary Names

    Opiates Urine Calibrator 2000 Level 3 - 1000 ng/mL (15 mL) Opiates Urine HEIA Kit 100 Opiates Urine Calibrator 2000 Level 4 - 1000 ng/mL (15 mL) Opiates Urine Calibrator 2000 Level 2 - 1000 ng/mL (5 mL) Opiates Urine HEIA Kit 500 Opiates Urine Calibrator 2000 Level 1 - 1000 ng/mL (15 mL) Opiates Urine Calibrator 2000 Level 3 - 1000 ng/mL (5 mL) Opiates Urine Calibrator 2000 Level 2 - 1000 ng/mL (15 mL) Opiates Urine HEIA Kit 25 Opiates Urine HEIA Olympus Wedge Kit 60 Opiates Urine Calibrator 2000 Level 4 - 1000 ng/mL (5 mL) Opiates Urine Calibrator 2000 Level 1 - 1000 ng/mL (5 mL)

    Establishment Types

    Manufacture Medical Device