BEUDAMED
    FDA Registration Active 🇨🇳 China

    iScreenTM Urine Test Drug Screen Dip Card

    Reg #: 3005641941 · FEI: 3005641941 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    11

    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
    K061718

    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, Methadone DJR
    Enzyme Immunoassay, Amphetamine DKZ
    Thin Layer Chromatography, Methamphetamine DJC
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Propoxyphene JXN
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Benzodiazepine JXM

    Proprietary Names

    iScreenTM Urine Test Drug Screen Dip Card mCupTM Urine Test Drug Screen Cup One Step Multi-Drug Screen Test with Integrated iCUP/iCUP A.D. Bio-Rad TOX/See Drug Screen Test for Multiple Drugs Noble Medical Split-Specimen Cup SureStepTM Urine Drug Test Dipcard iCassetteTM Urine Test Drug Screen Cassette iScreenTM Urine Test E-Z Split KeyTM Drug Screen Cup Express Results™ Integrated Multi-Drug Screen Cup 1 Step Detects DTX One Step Multi-Drug Multi-Line Screen Test Device Jant Pharmacal Accutest One Step Drug Screen Test Card for Multi-Drugs Jant Pharmacal Accutest Integrated E-Z Split Key Cup II for Multi-Drugs eScreen mCUP Integrated E-Z Split Key Cup II for Multi-Drugs Integrated E-Z Split Key Cup II for Multi-Drugs iCupTM Urine Test Drug Screen Cup SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup SureStepTM Urine Test Drug Screen Dip Card CERTUM One Step Multi-Line Drug Screen EZ Split Express Results™ Multi-Drug Screen Card One Step Multi-Drug Multi-Line Screen Test Device One Step Drug Screen Test Card Alere iScreen Drugs of Abuse Test Card including SVT Tests CERTUM One Step Multi-Drug Screen Panel mCup™ Urine Test Drug Screen Cup - CLIA

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)