FDA Registration
Active
🇺🇸 United States
0 Calibrator Steroid & Thyroid (T3-T4) Matrix (Ref 625MM)
Reg #: 2020726
·
FEI: 2020726
·
Expires 2025
Products
1
Proprietary Names
5
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 |
|---|---|---|---|---|---|
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 2021-11-30 |
Proprietary Names
0 Calibrator Steroid & Thyroid (T3-T4) Matrix (Ref 625MM)
Sample Dilient (hCG-Free) (Ref 8525145MM)
0 Calibrator Multiligand Matrix (Ref 440MM)
0 Calibrator FSH-Ferritin-Folate & Vitamin B12 Matrix (Ref 731MM)
Serum Diluent 10X (Anti-H. Pylori, Anti-Tg & Anti-TPO) (Ref 144MM)
Establishment Types
Manufacture Device in the United States for Export Only