FDA Registration
Active
🇨🇳 China
OralTox Oral Fluid Drug Test
Reg #: 3011522054
·
FEI: 3011522054
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Hangzhou Biotest Biotech Co.,Ltd.
- Registration Number
- 3011522054
- FEI Number
- 3011522054
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 17#,Futai Road,Zhongtai Street,Yuhang
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K171403
Owner / Operator
- Firm Name
- Hangzhou Biotest Biotech Co.,Ltd.
- Operator Number
- 10048622
- Address
- 17#,Futai Road,Zhongtai Street,Yuhang
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311121
- Country
- CN
- Correspondent
- WADE WU
US Agent
- Business Name
- Advin Biotech, Inc
- Contact Name
- Daniel Hsu
- Address
- 10237 Flanders Ct, San Diego, CA 92121
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
- [email protected]
- Phone
- 858 8668382
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2022-11-01 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2022-11-01 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2022-11-01 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2022-11-01 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2022-11-01 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2022-11-01 |
Proprietary Names
OralTox Oral Fluid Drug Test
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)