BEUDAMED
    FDA Registration Active 🇨🇳 China

    SureStep™ Urine Drug Test Cassette

    Reg #: 3005641941 · FEI: 3005641941 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ABON BIOPHARM (HANGZHOU) CO., LTD.
    Registration Number
    3005641941
    FEI Number
    3005641941
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #198 12th Street East, HANGZHOU ECONOMIC &, TECHNOLOGICAL DEVELOPMENT AREA
    City
    Hangzhou Zhejiang
    Country
    CN

    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

    US Agent

    Business Name
    Abbott Rapid Diagnostics
    Contact Name
    Irene Yasuda
    Address
    9942 Mesa Rim Rd.
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    619 3726179

    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

    Manufacture Medical Device for Another Party (Contract Manufacturer)