FDA Registration
Active
🇺🇸 United States
NeoLumax® CLIA Analyzer (IN010)
Reg #: 2020726
·
FEI: 2020726
·
Expires 2025
Products
1
Proprietary Names
13
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 |
|---|---|---|---|---|---|
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2012-04-12 |
Proprietary Names
NeoLumax® CLIA Analyzer (IN010)
TITIN® ELISA & CLIA Analyzer (IN015-EC)
Immunoassay Plate Washer (IN002)
Autoplex® 2nd Generation ELISA & CLIA Analyzer (IN006-2)
Impulse3® CLIA Analyzer (IN007)
PrisMatic® ELISA Analyzer (IN013)
NeoEldex® ELISA Analyzer (IN009)
TITIN-s® ELISA Analyzer (IN016-E)
LuMatic® CLIA Analyzer (IN008)
Autoplex® 3rd Generation ELISA & CLIA Analyzer (IN006-3)
TITIN® ELISA Analyzer (IN016-E)
Autoplex® ELISA Analyzer & CLIA Processor (IN006)
TITIN-s® ELISA & CLIA Analyzer (IN016-EC)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility