FDA Registration
Active
🇨🇳 China
Abbott Diagnostics (Shanghai) Co., Ltd.
Reg #: 3005128563
·
FEI: 3005128563
·
Expires 2026
Products
4
Proprietary Names
58
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Abbott Diagnostics (Shanghai) Co., Ltd.
- Registration Number
- 3005128563
- FEI Number
- 3005128563
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 151 LIBING ROAD, Pilot Free Trade Zone
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
US Agent
- Business Name
- Alere Inc.
- Contact Name
- Yingying Wang
- Address
- 150 S. Saunders Road, Landmark of Lake Forest
- City
- Lake Forest
- State
- IL
- ZIP
- 60045
- Country
- US
- [email protected]
- Phone
- 224 5320210
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2006-01-31 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2011-12-01 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2008-03-10 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2023-06-13 |
Proprietary Names
Clearblue Pregnancy Planning Kit
Clearblue Digital and Visual Pregnancy Kit
Clearblue Visual Preg Test
Kroger +/- Preg Test
Best Choice +/- Preg Test
Western Family +/- Preg Test
Shur Fine +/- Preg Test
Rite Aid Early Pregnancy Bilingual Test
Walgreens Early Pregnancy Bilingual Test
Walmart Equate Visual Early Preg Test
Hy-Vee Visual Early Preg Test
Topcare Visual Early Preg Test
HEB Bi-Ling Early Preg Test
Best Choice Early Preg Test
Walmart Equate +/- Preg Test
Western Family Visual Early Preg Test
Health Mart +/- Preg Test
Loblaws +/- Preg Test
Sunmark +/- Preg Test
Meijer +/- Preg Test
Target Visual Early Preg Test
London Drug +/- Preg Test
Pharmasave +/- Preg Test
Shopko Visual Early Preg Test
Rite Aid +/- Preg Test
SDM +/- Preg Test
CVS Visual Early Preg Test
Loblaws Visual Early Preg Test
Target +/- Preg Test
Shopko +/- Preg Test
Exchange Select +/- Preg Test
Fact Plus +/- Preg Test
Walgreens Visual Early Preg Test
Meijer Visual Early Preg test
Discount Drug +/- Preg Test
Generic +/- Preg Test
Equaline Visual Early Preg Test
Good Sense Visual Early Preg Test
Good Sense +/- Preg Test
Clearblue Fertility Monitor Sticks
Clearblue Fertility Monitor
Walmart Equate Early Ovulation
Clearblue Connected Ovulation Test System
Clearblue +/- Ovulation and Digital Pregnancy
Clearblue +/- Ovulation Test
Clearblue Preg Planning Kit
Clearblue Digital Pregnancy Test
Walgreens Digital Early Pregnancy Test
CVS Digital Early Pregnancy Test
Topcare Digital Pregnancy Test
Signature Care Digital Pregnancy Test
Rite Aid Digital Pregnancy Test
HEB Digital Pregnancy Test
Shoppers Drug Mart Digital Early and Visual Pregnancy Test
Target Digital Pregnancy Test
CVS Yes/No Digital Pregnancy Test
Equaline Digital Pregnancy Test
Clearblue Digital Preg and Visual Ovulation Test
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)