BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SureStep™ Urine Drug Test Cassette

    Reg #: 2027969 · FEI: 1000125596 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Alere San Diego, Inc.
    Registration Number
    2027969
    FEI Number
    1000125596
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    9942 Mesa Rim Road
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K011353

    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
    Enzyme Immunoassay, Opiates DJG

    Proprietary Names

    SureStep™ Urine Drug Test Cassette SureStep™ Urine Test Drug Screen Strip CERTUM OPI One Step Opiate Test Strip Alere iScreen Drugs of Abuse Test Card including SVT Tests iScreen™ Urine Test Drug Screen Dip Card iCassette™ Urine Test Drug Screen Cassette 1 Step Detects DTX OPI One Step Opiate Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Opiate (OPI 2000) OPI One Step Opiate Single Drug Test (Urine)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility