FDA Registration
Active
🇨🇳 China
Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
Reg #: 3016754982
·
FEI: 3016754982
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Jiangsu CoWin Biotech Co. Ltd
- Registration Number
- 3016754982
- FEI Number
- 3016754982
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No 58 G52 Building, East of Lujia Road, West Side of Tai Road, Pharmaceutical City of China
- City
- Taizhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- CoWin Biosciences, Inc
- Operator Number
- 10074981
- Address
- 625 Mount Auburn Street, Suite 105
- City
- Cambridge
- State
- MA
- Postal Code
- 02138
- Country
- US
- Correspondent
- chunxing Yang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-07-27 |
Proprietary Names
Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
Establishment Types
Manufacture Medical Device