FDA Registration
Active
🇺🇸 United States
Galectin 3
Reg #: 1721937
·
FEI: 1000117401
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CORGENIX, INC.
- Registration Number
- 1721937
- FEI Number
- 1000117401
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11575 MAIN ST., SUITE 400
- City
- BROOMFIELD
- State
- CO
- ZIP
- 80020
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093758
Owner / Operator
- Firm Name
- CORGENIX, INC.
- Operator Number
- 9001900
- Address
- 11575 MAIN ST., SUITE 400
- City
- Broomfield
- State
- CO
- Postal Code
- 80020
- Country
- US
- Correspondent
- Souda Truong
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Galectin-3 In Vitro Diagnostic Assay | OSX | Class 2 | Clinical Chemistry | No | 2012-10-30 |
Proprietary Names
Galectin 3
Establishment Types
Manufacture Medical Device