FDA Registration
Active
🇨🇳 China
U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold)
Reg #: 3010220539
·
FEI: 3010220539
·
Expires 2025
Products
12
Proprietary Names
1
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- CO-INNOVATION BIOTECH CO.,LTD.
- Registration Number
- 3010220539
- FEI Number
- 3010220539
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 9 Baihe 3 street, Economic and Technological Development East Zone,
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K182530
Owner / Operator
- Firm Name
- Co-Innovation Biotech Co.,Ltd.
- Operator Number
- 10042828
- Address
- No. 9 Baihe 3 street,Economic and, Technological Development East Zone,
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510530
- Country
- CN
- Correspondent
- Hong Feng
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2024-12-17 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2024-12-17 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2024-12-17 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2024-12-17 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2024-12-17 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2024-12-17 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2024-12-17 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2024-12-17 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2024-12-17 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2024-12-17 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2024-12-17 |
| Test, Morphine, Over The Counter | NGI | Class 2 | Clinical Toxicology | No | 2024-12-17 |
Proprietary Names
U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)