BEUDAMED
    FDA Registration Active 🇨🇳 China

    ABON BIOPHARM (HANGZHOU) CO., LTD.

    Reg #: 3005641941 · FEI: 3005641941 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    155
    Establishment Types
    1
    Classifications
    17

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    Registration Details

    Registration Name
    ABON BIOPHARM (HANGZHOU) CO., LTD.
    Registration Number
    3005641941
    FEI Number
    3005641941
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #198 12th Street East, HANGZHOU ECONOMIC &, TECHNOLOGICAL DEVELOPMENT AREA
    City
    Hangzhou Zhejiang
    Country
    CN

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    US Agent

    Business Name
    Ameditech, Inc.
    Contact Name
    Irene Yasuda
    Address
    9940 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, Cocaine And Cocaine Metabolites DIO
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Barbiturate DIS
    Gas Chromatography, Methamphetamine LAF
    Enzyme Immunoassay, Propoxyphene JXN
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Opiates DJG
    Visual, Pregnancy Hcg, Prescription Use JHI
    Test System, Nicotine, Cotinine, Metabolites MRS
    Enzyme Immunoassay, Methadone DJR
    Test, Opiates, Over The Counter NGL
    Radioimmunoassay, Luteinizing Hormone CEP
    Antigens, All Groups, Streptococcus Spp. GTY
    Thin Layer Chromatography, Methamphetamine DJC

    Proprietary Names

    SureStep™ Urine Test Drug Screen Strip, Cocaine (COC 150) iScreen™ Urine Test Drug Screen Dip Card CERTUM COC One Step Cocaine Test Strip SureStep™ Urine Test Drug Screen Cassette, Cocaine (COC 150) SureStep™ Urine Drug Test Cassette Signify™ ER Urine Test Drug Screen Cassette - CLIA iCassette™ Urine Test Drug Screen Cassette - CLIA CLIA Waived multi-CLIN™ Drug Screen Test Device JANT Pharmacal Accutest MultiDrug ER II Drug Screen Test Device SureStep™ Urine Test Drug Screen Strip, Methylenedioxymethamphetamine (MDMA 500) Bio-Rad TOX/See Drug Screen Test-MDMA MDMA One Step Ecstasy Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip SureStep™ Urine Test Drug Screen Cassette, Methylenedioxymethamphetamine (MDMA 500) iCassette™ Urine Test Drug Screen Cassette CERTUM mAMP One Step Methamphetamine Test Strip SureStep™ Urine Test Drug Screen Strip, Methamphetamine (MET 500) PPX One Step Propoxyphene Single Drug Test (Urine) Bio-Rad TOX/See Drug Screen Test-PPX for Urine ICON 25 hCG Immunochemical Test for hCG in Urine (CLIA Waived) and Serum Sure-Vue Serum/Urine hCG Beckman Coulter Inc's ICON 25 hCG Henry Schein One Step+ hCG Combo test in Serum or Urine Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum Pro Advantage by NDC Urine/Serum Pregnancy Cassette Device PCP One Step Phencyclidine Single Drug Test (Urine) Bio-Rad TOX/See Drug Screen Test-PCP in Urine SureStep™ Urine Test Drug Screen Strip, Phencyclidine (PCP 25) iScreenTM Oral Fluid Test Drug Screen Pad JANT Pharmacal Accutest COT One Step Cotinine Test Device in Urine COT One Step Cotinine Urine Test Device in Urine SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200) iCassetteTM Urine Test Drug Screen Cassette Stanbio True 20 Pulse 1-Step Pregnancy Test Stanbio True 20 Plus Stanbio QuPid Plus Stanbio QuPid Stanbio QuPid Plus ER SureStep™ Urine Test Drug Screen Cassette, Amphetamine (AMP 300) SureStep™ Urine Test Drug Screen Strip, Amphetamine (AMP 300) CERTUM AMP One Step Amphetamine Test Strip AMP 300 One Step Amphetamine Single Drug Test (Urine) Bio-Rad TOX/See Drug Screen Test-COC COC One Step Cocaine Test Device 1 Step Detects DTX COC One Step Cocaine Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Cocaine (COC 300) COC One Step Cocaine Single Drug Test (Urine) MTD One Step Methadone Single Drug Test (Urine) Bio-Rad TOX/See Drug Screen Tests -MTD SureStep™ Urine Test Drug Screen Strip, Methadone (MTD 300) McKesson CONSULT Diagnostics hCG Combo Tests Cassette Cardinal Health hCG Combo Rapid Test Alere hCG Cassette (20 mIU/mL) in Urine McKesson CONSULT Diagnostics hCG Urine Tests Cassette Sure-Vue Serum/Urine hCG-STAT Medline hCG Combo+ Pregnancy Test Cassette Alere hCG Combo Cassette (20/10 mIU/mL) for Urine or Serum Express Results™ Integrated Multi-Drug Screen Cup Noble Medical Split-Specimen Cup JANT Pharmacal Accutest Integrated E-Z Split Key Cup II Integrated E-Z Split Key Cup II Henry Schein One Step+ hCG Urine Strip Test Sure-Vue Urine hCG Strip McKesson CONSULT hCG Urine Test Dipstick CLIA Waived Pro Advantage by NDC Urine Pregnancy Test Strip Medline hCG Pregnancy Test Strip Alere hCG Dipstick (25mIU/mL) in Urine Cardinal Health hCG Dipstick Rapid Test CLIA Waived MOP One Step Opiate Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Opiate (MOP 300) SureStep™ Urine Test Drug Screen Cassette, Opiate (MOP 300) SureStep™ Urine Test Drug Screen Cassette, Barbiturates (BAR 300) BAR One Step Barbiturates Single Drug Test (Urine) CERTUM BAR One Step Barbiturates Test Strip SureStep™ Urine Test Drug Screen Strip, Barbiturates (BAR 300) 1 Step Detects DTX THC One Step Marijuana Single Drug Test (Urine) THC One Step Marijuana Test Device THC One Step Marijuana Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Marijuana (THC 50) SureStep™ Urine Test Drug Screen Cassette, Marijuana (THC 50) Bio-Rad TOX/See Drug Screen Test-THC for Urine CERTUM THC One Step Marijuana Test Strip ARCHITECT LH Reagent Kit (LN 2P40-25, 2P40-35) Alinity i LH Reagent Kit (LN 07P9120, 07P9130) Walgreens Ovulation Predictor Test CVS Ovulation Predictor Test Rite Aid Ovulation Predictor Test CERTUM OPI One Step Opiate Test Strip SureStep™ Urine Test Drug Screen Strip, Opiate (OPI 2000) OPI One Step Opiate Single Drug Test (Urine) 1 Step Detects DTX OPI One Step Opiate Single Drug Test (Urine) Bio-Rad TOX/See Drug Screen Test-TCA TCA One Step Tricyclic Antidepressants Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000) SureStep™ Urine Test Drug Screen Strip, Oxycodone (OXY 100) Oxycodone One Step Oxycodone Test Device OXY One Step Oxycodone Single Drug Test (Urine) Bio-Rad TOX/See Drug Screen Test-OXY for Urine 1 Step Detects DTX OXY One Step Oxycodone Single Drug Test (Urine) mAMP One Step Methamphetamine Test Device Bio-Rad TOX/See Drug Screen Test-MET iScreenTM Urine Test Drug Screen Dip Card 1 Step Detects DTX mAMP One Step Methamphetamine Single Drug Test (Urine) SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 1000) mAMP One Step Methamphetamine Single Drug Test (Urine) BIO-RAD TOX/See Drug Screen Test-AMP SureStep™ Urine Test Drug Screen Cassette, Amphetamine (AMP 1000) AMP One Step Amphetamine Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Amphetamine (AMP 1000) Henry Schein, Inc. One Step + Urine Cassette Test Alere hCG Cassette (25mIU/mL) in Urine Cardinal Health hCG Cassette Rapid test CLIA Waived Sure-Vue Urine hCG Medline HCG Pregnancy Test Cassette Pro Advantage By NDC Urine Pregnancy Cassette Device Bio-Rad TOX/See Drug Screen Test-BUP 1 Step Detects DTX BUP One Step Buprenorpine Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Buprenorphine (BUP10) BUP One Step Buprenorphine Test Device BUP One Step Buprenorphine Single Drug test (Urine) JANT Pharmacal Accutest One Step Multi-Drug Multi-Line Screen Test Device One Step Multi-Drug Multi-Line Screen Test Device - CLIA Waived 1 Step Detects DTX One Step Multi-Drug Multi-Line Screen Test Device SureStep™ Urine Test Drug Screen Cassette, Benzodiazepines (BZO 300) BZO One Step Benzodiazepines Test Device CERTUM BZO One Step Benzodiazepines Test Strip 1 Step Detects DTX BZO One Step Benzodiazepimes Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Benzodiazepines (BZO 300) BZO One Step Benzodiazepines Single Drug Test (Urine) HENRY SCHEIN One Step+ Strep A Dipstick Test Alere Acceava Strep A Fisher Scientific Sure-Vue Strep A Test Clearview Strep A Exact II Dipstick Pro Advantage by NDC Strep A Test- Throat Swab Immunostics Inc. Detector Strep A McKesson CONSULT Strep A Tests Dipstick Cardinal Health Strep A Dipstick Rapid Test Medline Strep A Dipstick Stanbio QuStick Strep A Rapid Test Strip Procedure No. 6000 CLIA Waived SureStepTM Urine Test Drug Screen Dip Card SureStepTM Urine Drug Test Dipcard iScreenTM Urine Test E-Z Split KeyTM Drug Screen Cup Jant Pharmacal Accutest One Step Drug Screen Test Card for Multi-Drugs Bio-Rad TOX/See Drug Screen Test for Multiple Drugs One Step Drug Screen Test Card SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup CERTUM One Step Multi-Line Drug Screen EZ Split mCupTM Urine Test Drug Screen Cup CERTUM One Step Multi-Drug Screen Panel Express Results™ Multi-Drug Screen Card iCupTM Urine Test Drug Screen Cup One Step Multi-Drug Multi-Line Screen Test Device Jant Pharmacal Accutest Integrated E-Z Split Key Cup II for Multi-Drugs Integrated E-Z Split Key Cup II for Multi-Drugs

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)