FDA Registration
Active
🇺🇸 United States
SCoV-2 Ag Detect Rapid Self-Test
Reg #: 3022137053
·
FEI: 3022137053
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CorDx Inc.
- Registration Number
- 3022137053
- FEI Number
- 3022137053
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3719 North Peachtree Road, Suite 200
- City
- Chamblee
- State
- GA
- ZIP
- 30341
- Country
- US
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 |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2022-01-18 |
Proprietary Names
SCoV-2 Ag Detect Rapid Self-Test
CorDx COVID-19 Ag Test
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device