FDA Registration
Active
🇨🇳 China
iCassette Urine Test Drug Screen Cassette - CLIA
Reg #: 3005641941
·
FEI: 3005641941
·
Expires 2025
Products
10
Proprietary Names
4
Establishment Types
1
Classifications
10
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
- K041685
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 protected]
- Phone
- 619 3726179
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2008-11-20 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2008-11-20 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2008-11-20 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2008-11-20 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2008-11-20 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2008-11-20 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2008-11-20 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2008-11-20 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2008-11-20 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2008-11-20 |
Proprietary Names
iCassette Urine Test Drug Screen Cassette - CLIA
CLIA Waived multi-CLIN Drug Screen Test Device
Signify ER Urine Test Drug Screen Cassette - CLIA
JANT Pharmacal Accutest MultiDrug ER II Drug Screen Test Device
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)