Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005641941

FEI Number

3005641941

Entity Name

ABON BIOPHARM (HANGZHOU) CO., LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

#198 12th Street East, HANGZHOU ECONOMIC &, TECHNOLOGICAL DEVELOPMENT AREA, Hangzhou Zhejiang 310018, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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) iScreen Urine Test Drug Screen Dip Card iCassette Urine Test Drug Screen Cassette SureStep Urine Drug Test Cassette CERTUM mAMP One Step Methamphetamine Test Strip SureStep Urine Test Drug Screen Strip, Methamphetamine (MET 500) iScreen Urine Test Drug Screen Dip Card 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) SureStep Urine Test Drug Screen Strip Bio-Rad TOX/See Drug Screen Test-PCP in Urine SureStep Urine Test Drug Screen Strip, Phencyclidine (PCP 25) iScreen Urine Test Drug Screen Dip Card 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 Drug Test Cassette 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) iScreen Urine Test Drug Screen Dip Card SureStep Urine Test Drug Screen Strip SureStep Urine Test Drug Screen Strip, Cocaine (COC 300) CERTUM COC One Step Cocaine Test Strip COC One Step Cocaine Single Drug Test (Urine) iCassette Urine Test Drug Screen Cassette MTD One Step Methadone Single Drug Test (Urine) Bio-Rad TOX/See Drug Screen Tests -MTD iScreen Urine Test Drug Screen Dip Card SureStep Urine Test Drug Screen Strip 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) iScreen Urine Test Drug Screen Dip Card SureStep Urine Test Drug Screen Strip, Opiate (MOP 300) SureStep Urine Test Drug Screen Strip 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 iScreen Urine Test Drug Screen Dip Card SureStep Urine Test Drug Screen Strip, Barbiturates (BAR 300) SureStep Urine Test Drug Screen Strip SureStep Urine Drug Test Cassette 1 Step Detects DTX THC One Step Marijuana Single Drug Test (Urine) THC One Step Marijuana Test Device SureStep Urine Test Drug Screen Strip iCassette Urine Test Drug Screen Cassette 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) iScreen Urine Test Drug Screen Dip Card 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 iCassette Urine Test Drug Screen Cassette SureStep Urine Test Drug Screen Strip, Opiate (OPI 2000) SureStep Urine Drug Test Cassette OPI One Step Opiate Single Drug Test (Urine) iScreen Urine Test Drug Screen Dip Card 1 Step Detects DTX OPI One Step Opiate Single Drug Test (Urine) SureStep Urine Test Drug Screen Strip Bio-Rad TOX/See Drug Screen Test-TCA TCA One Step Tricyclic Antidepressants Single Drug Test (Urine) SureStep Urine Test Drug Screen Strip iScreen Urine Test Drug Screen Dip Card 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 iScreen Urine Test Drug Screen Dip Card iCassette Urine Test Drug Screen Cassette 1 Step Detects DTX OXY One Step Oxycodone Single Drug Test (Urine) SureStep Urine Test Drug Screen Strip mAMP One Step Methamphetamine Test Device Bio-Rad TOX/See Drug Screen Test-MET iScreenTM Urine Test Drug Screen Dip Card SureStep Urine Test Drug Screen Strip CERTUM mAMP One Step Methamphetamine Test Strip 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 iCassette Urine Test Drug Screen Cassette iScreen Urine Test Drug Screen Dip Card CERTUM AMP One Step Amphetamine Test Strip SureStep Urine Test Drug Screen Strip 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2008-11-20
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2008-11-20
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2008-11-20
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2008-11-20
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2008-11-20
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2008-11-20
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2008-11-20
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2008-11-20
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2008-11-20
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2008-11-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-11-20
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2008-11-20
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2008-11-20
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2006-04-19
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2008-11-20
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2006-04-19
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2012-03-05
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2013-06-18
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2008-11-20
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2006-04-19
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2006-04-19
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2008-12-03
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2008-11-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-11-20
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2008-11-20
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2008-11-20
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2008-11-20
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2008-11-20
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2008-11-20
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2008-11-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-11-20
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2006-04-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2006-04-19
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	1999-02-12
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2006-04-19
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2006-04-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-11-20
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2006-04-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2006-04-19
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2007-07-09

Official Correspondent

No official correspondent registered.

US Agent Details

Irene Yasuda Business: Ameditech, Inc. Email: irene.yasuda@abbott.com Phone: (619) 3726179

Related Public Records

Same Entity

ABBOTT LABORATORIES

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K896937	Hycor Biomedical, Inc.	HYCOR ACCUPINCH COCAINE TEST	1990-03-06
K915371	Diagnostic Reagents, Inc.	COCAINE METABOLITE EIA TEST	1991-12-18
K131754	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)	2013-07-31
K121166	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL	2012-05-08
K112071	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P	2011-09-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0010-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005641941. Last updated year: 2026. Please use registration number 3005641941 when referencing this establishment in official correspondence.