FDA Registration
Active
🇺🇸 United States
Alere Determine TB LAM Ag
Reg #: 1221359
·
FEI: 1221359
·
Expires 2025
Products
1
Proprietary Names
5
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 |
|---|---|---|---|---|---|
| Device, General Purpose, Microbiology, Diagnostic | LIB | Class 1 | Microbiology | No | 2008-12-03 |
Proprietary Names
Alere Determine TB LAM Ag
BinaxNOW Filariasis
Determine TB LAM Ag
Alere Filariasis Test Strip
Bioline Filariasis Test Strip
Establishment Types
Manufacture Device in the United States for Export Only