FDA Registration
Active
🇨🇳 China
At Work Drug Test (Model 9145 25C and 9177 25C)
Reg #: 3012073813
·
FEI: 3012073813
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Hangzhou AllTest Biotech Co.,Ltd
- Registration Number
- 3012073813
- FEI Number
- 3012073813
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 550, Yinhai Street, Hangzhou Economic & Technological Development Area
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K994093
Owner / Operator
- Firm Name
- Hangzhou AllTest Biotech Co.,Ltd
- Operator Number
- 10050156
- Address
- No. 550, Yinhai Street, Hangzhou Economic & Technological Development Area
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310018
- Country
- CN
- Correspondent
- Yanli Wu
US Agent
- Business Name
- ACESO LABORATORIES INC.
- Contact Name
- Joseph Fan
- Address
- 14020 Central Ave, Suite 520
- City
- Chino
- State
- CA
- ZIP
- 91710
- Country
- US
- [email protected]
- Phone
- 310 8060719
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2023-06-26 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2023-06-26 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2023-06-26 |
Proprietary Names
At Work Drug Test (Model 9145 25C and 9177 25C)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)