FDA Registration
Active
🇨🇳 China
Abbott Diagnostics (Shanghai) Co., Ltd.
Reg #: 3005128563
·
FEI: 3005128563
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Abbott Diagnostics (Shanghai) Co., Ltd.
- Registration Number
- 3005128563
- FEI Number
- 3005128563
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 151 LIBING ROAD, China (Shanghai) Pilot Free Trade Zone
- City
- SHANGHAI
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K210341
Owner / Operator
- Firm Name
- Abbott
- Operator Number
- 9006731
- Address
- 100 Abbott Park Road, Dept. RX51/J55/MS 6134
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2022-04-28 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)