Abbott Diagnostics (Shanghai) Co., Ltd.
Registered establishment in Shanghai, China. 4 device types.
Abbott Diagnostics (Shanghai) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Radioimmunoassay, Luteinizing Hormone, Kit, Test, Pregnancy, Hcg, Over The Counter and 2 other device types. Its earliest product listing with the FDA dates from 2006.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3005128563 |
| FEI number | 3005128563 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 151 LIBING ROAD |
| Postal code | 201203 |
| Country | China |
Group
Abbott Diagnostics (Shanghai) Co., Ltd. is one of 2 plants registered under ABBOTT LABORATORIES.
| Plant | City | Device types |
|---|---|---|
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | 17 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | Shur Fine +/- Preg Test, Walmart Equate Visual Early Preg Test, Walgreens Early Pregnancy Bilingual Test, Rite Aid Early Pregnancy Bilingual Test, Western Family +/- Preg Test, Hy-Vee Visual Early Preg Test and 45 more | 2007 | 30 |
| Radioimmunoassay, Luteinizing Hormone | Class 1 | Clearblue Preg Planning Kit, Walmart Equate Early Ovulation, Clearblue Connected Ovulation Test System, Clearblue +/- Ovulation Test, Clearblue +/- Ovulation and Digital Pregnancy | 2006 | 16 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | 2023 | 30 | |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | Clearblue Fertility Monitor, Clearblue Fertility Monitor Sticks | 2008 | 38 |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Diagnostic tools, Health diagnostics |
|---|
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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