BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cannabinoid Oral Fluid Calibrator Level 2

    Reg #: 2020952 · FEI: 2020952 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    1

    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

    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

    Proprietary Names

    Cannabinoid Oral Fluid Calibrator Level 2 Ethyl Glucuronide Urine Calibrator 1000 Tapentadol Urine Calibrator 1 - 100ng/mL Cannabinoid Oral Fluid Calibrator Level 1 Ethyl Glucuronide Urine Calibrator 500 Ecstasy Oral Fluid Calibrator Level 2 Cannabinoid Oral Fluid Calibrator Level 3 Tapentadol Urine Calibrator 4 - 1000ng/mL Carisoprodol Urine Calibrator - 50 ng/mL Cannabinoid Oral Fluid Calibrator Level 4 Carisoprodol Urine Calibrator - 200 ng/mL Ethyl Glucuronide Urine Calibrator - 250 ng/mL Ethyl Glucuronide Urine Calibrator - 2000 ng/mL Carisoprodol Urine Calibrator - 500 ng/mL Tapentadol Urine Calibrator 2 - 200ng/mL Carisoprodol Urine Calibrator - 100 ng/mL Tapentadol Urine Calibrator 3 - 300ng/mL Negative Oral Fluid Calibrator 2

    Establishment Types

    Manufacture Medical Device