FDA Registration
Active
🇨🇳 China
CLIAwaived,Inc. Complete Drug Test Cup CDTC
Reg #: 3027519599
·
FEI: 3027519599
·
Expires 2025
Products
11
Proprietary Names
15
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- Hangzhou AllTest Biotech Co.,Ltd
- Registration Number
- 3027519599
- FEI Number
- 3027519599
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #383, Qiaoxin Road, Xiasha Street, Qiantang District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K250727
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
- 909 5415085
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2025-04-16 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2025-04-16 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2025-04-16 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2025-04-16 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2025-04-16 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2025-04-16 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2025-04-16 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2025-04-16 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2025-04-16 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2025-04-16 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2025-04-16 |
Proprietary Names
CLIAwaived,Inc. Complete Drug Test Cup CDTC
Citest Multi-Drug Urine Cup
AllTest Multi-Drug Rapid Urine Test Cup
DrugTect Multi-Drug Urine Test Cup
Atida Multiplex Drug of Abuse Urine Cup Test
CHOSEN Multi-Drug Rapid Urine Test Cup
CHOSEN Multi-Drug Urine Test Cup
Atida Multiplex Drug of Abuse Rapid Urine Cup Test
Identify Health Multi-Drug Urine Test Cup
DrugTect Multi-Drug Rapid Urine Test Cup
Labb Multi Drug Rapid Urine Test Cup
AllTest Multi-Drug Urine Test Cup
Identify Diagnostics Multi-Drug Urine Test Cup
Citest Multi-Drug Urine Test Cup
Labb Multi Drug Urine Test Cup
Establishment Types
Manufacture Medical Device