FDA Registration
Active
🇺🇸 United States
Hs-CRP AccuBind® ELISA Test System (Ref 3125-300A and 3125-300B)
Reg #: 2020726
·
FEI: 2020726
·
Expires 2025
Products
1
Proprietary Names
2
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 |
|---|---|---|---|---|---|
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2010-09-21 |
Proprietary Names
Hs-CRP AccuBind® ELISA Test System (Ref 3125-300A and 3125-300B)
Hs-CRP AccuLite® CLIA Test System (Ref 3175-300A and 3175-300B)
Establishment Types
Manufacture Device in the United States for Export Only