FDA Registration
Active
🇺🇸 United States
Logix Smart HCV
Reg #: 3014214006
·
FEI: 3014214006
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CODIAGNOSTICS
- Registration Number
- 3014214006
- FEI Number
- 3014214006
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2401 S Foothill Dr Ste D
- City
- Salt Lake City
- State
- UT
- ZIP
- 84109
- Country
- US
Owner / Operator
- Firm Name
- Co-Diagnostics, Inc.
- Operator Number
- 10052747
- Address
- 2401 Foothill Dr. Ste D
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84109
- Country
- US
- Correspondent
- Marisa Frost
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Investigational Use Only - Microbiology | PCY | Class N | Unknown | No | 2018-11-15 |
Proprietary Names
Logix Smart HCV
Logix Smart HBV
Logix Smart MAL
Logix Smart ZDC (ZIKV, DENV, CHIKV)
Logix Smart DENV
Logix Smart HIV
Logix Smart HPV
Establishment Types
Manufacture Device in the United States for Export Only