BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EDDP Specific Urine Calibrator Level 4 - 1000 ng/mL

    Reg #: 2020952 · FEI: 2020952 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    18
    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
    K151395

    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, Methadone DJR

    Proprietary Names

    EDDP Specific Urine Calibrator Level 4 - 1000 ng/mL EDDP Specific Urine Calibrator Level 3, 500ng/mL EDDP Specific Urine Calibrator Level 2 - 300 ng/mL EDDP Specific Urine, 25 mL Kit EDDP Specific Urine, 100 mL Kit EDDP Specific Urine Control Set 3, 2 x 5mL EDDP Specific Urine, 60 mL Wedge Kit EDDP Specific Urine Calibrator Level 2, 300ng/mL EDDP Specific Urine, 500 mL Kit EDDP Specific Urine Calibrator Level 1, 100ng/mL EDDP Specific Urine Calibrator Level 3 - 500 ng/mL EDDP Specific Urine HEIA 25 Kit EDDP Specific Urine Calibrator Level 1 - 100 ng/ml EDDP Specific Urine Control Set Level 1 EDDP Specific Urine Calibrator Level 4, 1000ng/mL EDDP Specific Urine Control Set 2, 2 x 5mL EDDP Specific Urine Control Set Level 2 EDDP Specific Urine Control Set 1, 2 x 5mL

    Establishment Types

    Manufacture Medical Device