FDA Registration
Active
🇨🇳 China
SARS- CoV-2 lgM Assay Kits (Lateral Flow Immunoassay)
Reg #: 3012289707
·
FEI: 3012289707
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Shenzhen Lifotronic Technology Co.,Ltd.
- Registration Number
- 3012289707
- FEI Number
- 3012289707
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lifotronic Tower, No. 8, Qiuzhi East Road, Guancheng Community, Guanhu Street, Longhua
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen Lifotronic Technology Co., Ltd.
- Operator Number
- 10055994
- Address
- Lifotronic Tower, No. 8, Qiuzhi East Road, Guancheng Community, Guanhu Street, Longhua
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518110
- Country
- CN
- Correspondent
- Lei Xiang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-04-16 |
Proprietary Names
SARS- CoV-2 lgM Assay Kits (Lateral Flow Immunoassay)
SARS-CoV-2 IgM (Electrochemiluminescence Immunoassay)
SARS- CoV-2 lgG Assay Kits (Lateral Flow Immunoassay)
SARS-CoV-2 IgG (Electrochemiluminescence Immunoassay)
Establishment Types
Manufacture Medical Device