Abon Biopharm (Hangzhou) Co., Ltd.
Registered establishment in Hangzhou, Zhejiang, China. 17 device types.
Abon Biopharm (Hangzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Methadone and 15 other device types. Its earliest product listing with the FDA dates from 1999.
Registration
| Registered name | ABON BIOPHARM (HANGZHOU) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005641941 |
| FEI number | 3005641941 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 艾博生物医药（杭州）有限公司 |
|---|---|
| Unified social credit code | 91330100747181663M |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | #198 12th Street East |
| Postal code | 310018 |
| Country | China |
Group
Abon Biopharm (Hangzhou) Co., Ltd. is one of 2 plants registered under ABBOTT LABORATORIES.
| Plant | City | Device types |
|---|---|---|
| Abbott Diagnostics (Shanghai) Co., Ltd. | Shanghai | 4 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Antigens, All Groups, Streptococcus Spp. | Class 1 | Stanbio QuStick Strep A Rapid Test Strip Procedure No. 6000 CLIA Waived, Medline Strep A Dipstick, Immunostics Inc. Detector Strep A, Clearview Strep A Exact II Dipstick, Fisher Scientific Sure-Vue Strep A Test, Alere Acceava Strep A and 4 more | 2007 | 6 |
| Enzyme Immunoassay, Amphetamine | Class 2 | iCassette™ Urine Test Drug Screen Cassette – CLIA, 1 Step Detects DTX One Step Multi-Drug Multi-Line Screen Test Device, One Step Multi-Drug Multi-Line Screen Test Device – CLIA Waived, JANT Pharmacal Accutest One Step Multi-Drug Multi-Line Screen Test Device, Signify™ ER Urine Test Drug Screen Cassette – CLIA, CLIA Waived multi-CLIN™ Drug Screen Test Device and 34 more | 2006 | 16 |
| Enzyme Immunoassay, Barbiturate | Class 2 | iCassette™ Urine Test Drug Screen Cassette – CLIA, Signify™ ER Urine Test Drug Screen Cassette – CLIA, CLIA Waived multi-CLIN™ Drug Screen Test Device, JANT Pharmacal Accutest MultiDrug ER II Drug Screen Test Device, CERTUM BAR One Step Barbiturates Test Strip, BAR One Step Barbiturates Single Drug Test (Urine) and 24 more | 2006 | 12 |
| Enzyme Immunoassay, Benzodiazepine | Class 2 | iCassette™ Urine Test Drug Screen Cassette – CLIA, Signify™ ER Urine Test Drug Screen Cassette – CLIA, CLIA Waived multi-CLIN™ Drug Screen Test Device, JANT Pharmacal Accutest MultiDrug ER II Drug Screen Test Device, BZO One Step Benzodiazepines Test Device, 1 Step Detects DTX BZO One Step Benzodiazepimes Single Drug Test (Urine) and 27 more | 2006 | 13 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | Bio-Rad TOX/See Drug Screen Test-THC for Urine, CERTUM THC One Step Marijuana Test Strip, SureStep™ Urine Test Drug Screen Cassette, Marijuana (THC 50), 1 Step Detects DTX THC One Step Marijuana Single Drug Test (Urine), SureStep™ Urine Test Drug Screen Strip, Marijuana (THC 50), THC One Step Marijuana Test Device and 33 more | 2006 | 18 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class 2 | iCassette™ Urine Test Drug Screen Cassette – CLIA, 1 Step Detects DTX One Step Multi-Drug Multi-Line Screen Test Device, One Step Multi-Drug Multi-Line Screen Test Device – CLIA Waived, JANT Pharmacal Accutest One Step Multi-Drug Multi-Line Screen Test Device, Signify™ ER Urine Test Drug Screen Cassette – CLIA, CLIA Waived multi-CLIN™ Drug Screen Test Device and 34 more | 2006 | 16 |
| Enzyme Immunoassay, Methadone | Class 2 | MTD One Step Methadone Single Drug Test (Urine), SureStep™ Urine Test Drug Screen Strip, Methadone (MTD 300), iScreen™ Urine Test Drug Screen Dip Card, Bio-Rad TOX/See Drug Screen Tests -MTD, SureStep™ Urine Test Drug Screen Strip, Jant Pharmacal Accutest One Step Drug Screen Test Card for Multi-Drugs and 19 more | 2006 | 11 |
| Enzyme Immunoassay, Opiates | Class 2 | SureStep™ Urine Test Drug Screen Strip, Opiate (OPI 2000), iScreen™ Urine Test Drug Screen Dip Card, OPI One Step Opiate Single Drug Test (Urine), CERTUM OPI One Step Opiate Test Strip, SureStep™ Urine Drug Test Cassette, SureStep™ Urine Test Drug Screen Strip and 43 more | 2006 | 17 |
| Enzyme Immunoassay, Phencyclidine | Class U | iCassette™ Urine Test Drug Screen Cassette – CLIA, 1 Step Detects DTX One Step Multi-Drug Multi-Line Screen Test Device, One Step Multi-Drug Multi-Line Screen Test Device – CLIA Waived, JANT Pharmacal Accutest One Step Multi-Drug Multi-Line Screen Test Device, Signify™ ER Urine Test Drug Screen Cassette – CLIA, CLIA Waived multi-CLIN™ Drug Screen Test Device and 27 more | 2006 | 16 |
| Enzyme Immunoassay, Propoxyphene | Class 2 | iCassette™ Urine Test Drug Screen Cassette – CLIA, Signify™ ER Urine Test Drug Screen Cassette – CLIA, CLIA Waived multi-CLIN™ Drug Screen Test Device, JANT Pharmacal Accutest MultiDrug ER II Drug Screen Test Device, PPX One Step Propoxyphene Single Drug Test (Urine), Bio-Rad TOX/See Drug Screen Test-PPX for Urine and 20 more | 2006 | 10 |
| Gas Chromatography, Methamphetamine | Class 2 | CERTUM mAMP One Step Methamphetamine Test Strip, iScreenTM Urine Test Drug Screen Dip Card, mAMP One Step Methamphetamine Test Device, SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 1000), Bio-Rad TOX/See Drug Screen Test-MET, 1 Step Detects DTX mAMP One Step Methamphetamine Single Drug Test (Urine) and 21 more | 2006 | 10 |
| Radioimmunoassay, Luteinizing Hormone | Class 1 | Rite Aid Ovulation Predictor Test, CVS Ovulation Predictor Test, ARCHITECT LH Reagent Kit (LN 2P40-25, 2P40-35), Alinity i LH Reagent Kit (LN 07P9120, 07P9130), Walgreens Ovulation Predictor Test | 1999 | 16 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | Class 2 | iCassette™ Urine Test Drug Screen Cassette – CLIA, Signify™ ER Urine Test Drug Screen Cassette – CLIA, CLIA Waived multi-CLIN™ Drug Screen Test Device, JANT Pharmacal Accutest MultiDrug ER II Drug Screen Test Device, iScreen™ Urine Test Drug Screen Dip Card, SureStep™ Urine Test Drug Screen Strip and 23 more | 2006 | 9 |
| Test System, Nicotine, Cotinine, Metabolites | Class 1 | iCassetteTM Urine Test Drug Screen Cassette, iScreenTM Oral Fluid Test Drug Screen Pad, SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200), COT One Step Cotinine Urine Test Device in Urine, JANT Pharmacal Accutest COT One Step Cotinine Test Device in Urine | 2012 | 11 |
| Test, Opiates, Over The Counter | Class 2 | iScreen™ Urine Test Drug Screen Dip Card, MOP One Step Opiate Single Drug Test (Urine), SureStep™ Urine Test Drug Screen Cassette, Opiate (MOP 300), SureStep™ Urine Test Drug Screen Strip, Opiate (MOP 300), SureStep™ Urine Test Drug Screen Strip | 2008 | 18 |
| Thin Layer Chromatography, Methamphetamine | Class 2 | Jant Pharmacal Accutest One Step Drug Screen Test Card for Multi-Drugs, Integrated E-Z Split Key Cup II for Multi-Drugs, 1 Step Detects DTX One Step Multi-Drug Multi-Line Screen Test Device, iScreenTM Urine Test E-Z Split KeyTM Drug Screen Cup, One Step Multi-Drug Multi-Line Screen Test Device, One Step Drug Screen Test Card and 14 more | 2008 | 12 |
| Visual, Pregnancy Hcg, Prescription Use | Class 2 | Medline HCG Pregnancy Test Cassette, Sure-Vue Urine hCG, Cardinal Health hCG Cassette Rapid test CLIA Waived, Pro Advantage By NDC Urine Pregnancy Cassette Device, Alere hCG Cassette (25mIU/mL) in Urine, Henry Schein, Inc. One Step + Urine Cassette Test and 26 more | 2007 | 16 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Main products | In vitro diagnostic devices, Rapid diagnostic tests, Syphilis test devices, mRNA vaccines, Therapeutic vaccines |
| Certifications | FDA, CE |
| Export markets | Over 100 countries and regions |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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