BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hydrocodone Oral Fluid 4

    Reg #: 2020952 · FEI: 2020952 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    26
    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 Mixture DKB

    Proprietary Names

    Hydrocodone Oral Fluid 4 Multi-Drug Calibrator Level 1 (15mL) AMP/6-AM Oral Fluid Calibrator Level 4 AMP/6-AM Oral Fluid Calibrator Level 2 Negative Urine Calibrator Multi-Drug Calibrator Level 2 (15 mL) Immunalysis Multi-Drug OF Calibrator Level 4 Hydrocodone Oral Fluid 1 Multi-Drug Calibrator Level 3 (25 mL) Immunalysis Synthetic Negative Oral Fluid 100 mL Immunalysis Multi-Drug OF Calibrator Level 2 AMP/6-AM Oral Fluid Calibrator Level 3 Immunalysis Multi-Drug OF Calibrator Level 3 Negative Reference Calibrator Multi-Drug Calibrator Level 4 (15 mL) Multi-Drug Calibrator Level 2 (25 mL) Immunalysis Multi-Drug OF Calibrator Level 1 Negative Reference Calibrator 10 mL Kit Drug Free Negative Urine Calibrator Multi-Drug Calibrator Level 1 (25mL) Multi-Drug Calibrator Level 4 (25 mL) Multi-Drug Calibrator Level 3 (15 mL) Immunalysis Synthetic Negative Oral Fluid 500 mL AMP/6-AM Oral Fluid Calibrator Level 1 Hydrocodone Oral Fluid 2 Hydrocodone Oral Fluid 3

    Establishment Types

    Manufacture Medical Device