FDA Registration
Active
🇺🇸 United States
CorDx Tyfast Multi-Drug Rapid Test Card
Reg #: 3031823359
·
FEI: 3031823359
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- CorDx, Inc.
- Registration Number
- 3031823359
- FEI Number
- 3031823359
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5900 Windward Pkwy
- City
- Alpharetta
- State
- GA
- ZIP
- 30005
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190412
Owner / Operator
- Firm Name
- CorDx
- Operator Number
- 10050914
- Address
- 9540 Waples St Unit C
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Amber Wen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2024-08-04 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2024-08-04 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2024-08-04 |
Proprietary Names
CorDx Tyfast Multi-Drug Rapid Test Card
CorDx Tyfast Multi-Drug Rapid Test Cup
Establishment Types
Manufacture Medical Device