FDA Registration
Active
🇨🇳 China
U-Catch MAX Multi-Drug Test Cup Rx(Colloidal Gold)
Reg #: 3032147516
·
FEI: 3032147516
·
Expires 2025
Products
12
Proprietary Names
4
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- ETERBIO, INC.
- Registration Number
- 3032147516
- FEI Number
- 3032147516
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Office 420, No. 1316, Caixia Street, Hengqin, Zhuhai City, Guangdong Province, China
- City
- Zhuhai Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K230238
Owner / Operator
- Firm Name
- Eterbio, Inc.
- Operator Number
- 10091094
- Address
- Office 420, No. 1316, Caixia Street, Hengqin, Zhuhai City, Guangdong Province, China
- City
- zhuhai
- State
- Guangdong
- Postal Code
- 519000
- Country
- CN
- Correspondent
- XIAOXIN LIN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2024-07-29 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2024-07-29 |
Proprietary Names
U-Catch MAX Multi-Drug Test Cup Rx(Colloidal Gold)
S-Trust MAX Multi-Drug Test Cup(Colloidal Gold)
U-Catch MAX Multi-Drug Test Cup(Colloidal Gold)
S-Trust MAX Multi-Drug Test Cup Rx(Colloidal Gold)
Establishment Types
Manufacture Medical Device