FDA Registration
Active
🇺🇸 United States
HemosIL Liquid Anti-Xa (Part No. 0020302601)
Reg #: 3037000637
·
FEI: 3037000637
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INSTRUMENTATION LABORATORY CO. - Devens
- Registration Number
- 3037000637
- FEI Number
- 3037000637
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 11 Grant Road
- City
- Devens
- State
- MA
- ZIP
- 01434
- Country
- US
Owner / Operator
- Firm Name
- Instrumentation Laboratory Co.
- Operator Number
- 1217183
- Address
- 180 Hartwell Road, --
- City
- Bedford
- State
- MA
- Postal Code
- 01730
- Country
- US
- Correspondent
- Carol - Marble
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Assay, Oral Direct Thrombin Inhibitor | QBG | Class N | Unknown | No | 2018-03-13 |
Proprietary Names
HemosIL Liquid Anti-Xa (Part No. 0020302601)
HemosIL Direct Thrombin Inhibitor Assay (0020302800)
Establishment Types
Manufacture Device in the United States for Export Only