BEUDAMED
    FDA Registration Active 🇺🇸 United States

    THC Urine HEIA Kit 500

    Reg #: 2020952 · FEI: 2020952 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    19
    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
    K151203

    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
    Drug Specific Control Materials LAS
    Calibrators, Drug Specific DLJ
    Enzyme Immunoassay, Cannabinoids LDJ

    Proprietary Names

    THC Urine HEIA Kit 500 cTHC Urine Control Set, 2 x 5 mL cTHC Urine Calibrator Level 4 200, 1 x 5 mL cTHC Urine Calibrator Level 3 100, 1 x 15mL cTHC Urine Calibrator Level 3 100, 1 x 5 mL cTHC Urine Calibrator Level 4 200, 1 x 25mL THC Urine HEIA Kit 100 cTHC Urine Calibrator Level 2 50, 1 x 25mL cTHC Urine Calibrator Level 1 20, 1 x 25mL cTHC Urine Calibrator Level 1 20, 1 x 15mL THC Urine HEIA Olympus Wedge Kit 60 THC Urine HEIA Kit 25 cTHC Urine Calibrator Level 3 100, 1 x 25mL cTHC Urine Control Set, 2 x 15mL cTHC Urine Calibrator Level 2 50, 1 x 5 mL cTHC Urine Calibrator Level 1 20, 1 x 5 mL cTHC Urine Calibrator Level 4 200, 1 x 15mL cTHC Urine Calibrator Level 2 50, 1 x 15mL cTHC Urine Control Set, 2 x 25mL

    Establishment Types

    Manufacture Medical Device