FDA Registration
Active
🇨🇳 China
SP10 Rapid Test Kit Midstream
Reg #: 3016902172
·
FEI: 3016902172
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NANJING SYNTHGENE MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3016902172
- FEI Number
- 3016902172
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building B6-2, No. 9, Weidi Road, Xianlin University Town, Xianlin Subdistrict, Qixia District, Nanjing City,
- City
- Nanjing Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Nanjing Synthgene Medical Technology Co., Ltd.
- Operator Number
- 10084444
- Address
- Building B6-2, No. 9, Weidi Road, Xianlin University Town, Xianlin Subdistrict, Qixia District, Nanjing City,
- City
- Nanjing
- State
- Jiangsu
- Postal Code
- 210000
- Country
- CN
- Correspondent
- ALVIN QIAN
US Agent
- Business Name
- Areterna LLC
- Contact Name
- Lin Li
- Address
- 15810 Gaither Drive, Suite 230, Gaithersburg, MD 20877
- City
- Gaithersburg
- State
- MD
- ZIP
- 20877
- Country
- US
- [email protected]
- Phone
- 240 4061859
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sperm, Antigen, Antiserum, Control | DFQ | Class 1 | Immunology | No | 2024-04-29 |
Proprietary Names
SP10 Rapid Test Kit Midstream
SP10 Rapid Test Kit Strip
SP10 Rapid Test Kit Cassette
Establishment Types
Manufacture Medical Device