FDA Registration
Active
🇺🇸 United States
ELISA CLIA Analyzer System
Reg #: 2020726
·
FEI: 2020726
·
Expires 2025
Products
1
Proprietary Names
9
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 |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2024-11-02 |
Proprietary Names
ELISA CLIA Analyzer System
NeoEldex® ELISA Analyzer Touch Screen (IN009)
NeoLumax® CLIA Analyzer Touch Screen (IN010)
AutoPlex® ELISA & CLIA Analyzer 2nd Generation- Single Plate (IN006-2)
AutoPlex® ELISA & CLIA Analyzer 3rd Generation- Two Plate (IN006-3)
PrisMatic® ELISA Analyzer (IN013)
LuMatic® CLIA Analyzer (IN008)
PlateWash - Immunoassay Washer (IN002)
AutoPlex® ELISA Analyzer - Single Plate (IN006)
Establishment Types
Manufacture Medical Device