FDA Registration
Active
🇺🇸 United States
BinaxNOW Malaria Positive Control
Reg #: 1221359
·
FEI: 1221359
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Registration Number
- 1221359
- FEI Number
- 1221359
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10 Southgate Rd
- City
- Scarborough
- State
- ME
- ZIP
- 04074
- Country
- US
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 |
|---|---|---|---|---|---|
| Cell Enzymes (Erythrocytic And Leukocytic) | JBE | Class 2 | Hematology | No | 2012-02-03 |
Proprietary Names
BinaxNOW Malaria Positive Control
Establishment Types
Manufacture Device in the United States for Export Only