FDA Registration
Active
🇨🇳 China
Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card
Reg #: 3008987086
·
FEI: 3008987086
·
Expires 2025
Products
10
Proprietary Names
2
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.
- Registration Number
- 3008987086
- FEI Number
- 3008987086
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, Jilin
- City
- Changchun Jilin
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K232228
Owner / Operator
- Firm Name
- Changchun Wancheng Bio-Electron Co., Ltd.
- Operator Number
- 10049606
- Address
- No. 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, Jilin
- City
- Changchun
- State
- Jilin
- Postal Code
- 130000
- Country
- CN
- Correspondent
- Yanru Zhang
US Agent
- Business Name
- ABMED MEDICAL TECHNOLOGY INC
- Contact Name
- hui hong
- Address
- 800 East Wishkah Street, 1021 Aberdeen,
- City
- Aberdeen
- State
- WA
- ZIP
- 98520
- Country
- US
- [email protected]
- Phone
- 303 8000162
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2024-12-30 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2024-12-30 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2024-12-30 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2024-12-30 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2024-12-30 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2024-12-30 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2024-12-30 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2024-12-30 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2024-12-30 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2024-12-30 |
Proprietary Names
Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card
Multi-drug Urine Test Cup;Multi-drug Urine Test Dip Card;
Establishment Types
Repack or Relabel Medical Device