FDA Registration
Active
🇨🇳 China
Co-innovation
Reg #: 3010220539
·
FEI: 3010220539
·
Expires 2025
Products
13
Proprietary Names
2
Establishment Types
1
Classifications
13
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
- K153050
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 |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2016-05-03 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2016-05-03 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2016-05-03 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2016-05-03 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2016-05-03 |
| Thin Layer Chromatography, Morphine | DNK | Class 2 | Clinical Toxicology | No | 2016-05-03 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2016-05-03 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2016-05-03 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2016-05-03 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2016-05-03 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2016-05-03 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2016-05-03 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2016-05-03 |
Proprietary Names
Co-innovation
ACCU KNOW Urine Drug Test
Establishment Types
Manufacture Medical Device