FDA Registration
Active
🇺🇸 United States
Mycobacterium Tuberculosis Drug Resistance Panel Kit
Reg #: 3014214006
·
FEI: 3014214006
·
Expires 2025
Products
1
Proprietary Names
1
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 |
|---|---|---|---|---|---|
| System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen | PEU | Class 2 | Microbiology | No | 2016-09-26 |
Proprietary Names
Mycobacterium Tuberculosis Drug Resistance Panel Kit
Establishment Types
Manufacture Device in the United States for Export Only