FDA Registration
Active
🇺🇸 United States
Free T4 AccuLite® CLIA Test System (1275-300A,1275-300B, 1275-300D, 1275-300E)
Reg #: 2020726
·
FEI: 2020726
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MONOBIND, INC.
- Registration Number
- 2020726
- FEI Number
- 2020726
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 100 N. POINTE DR.
- City
- Lake Forest
- State
- CA
- ZIP
- 92630
- Country
- US
Owner / Operator
- Firm Name
- MONOBIND, INC.
- Operator Number
- 2020726
- Address
- 100 N. POINTE DR., --
- City
- Lake Forest
- State
- CA
- Postal Code
- 92630
- Country
- US
- Correspondent
- Alicia Jerome
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2021-11-03 |
Proprietary Names
Free T4 AccuLite® CLIA Test System (1275-300A,1275-300B, 1275-300D, 1275-300E)
FT3 FT4 TSH AccuLite® VAST CLIA (7075-300B, 7075-300D, 7075-300E)
FT3 FT4 TSH AccuBind® VAST ELISA (7025-300B, 7025-300D, 7025-300E)
Establishment Types
Manufacture Device in the United States for Export Only