FDA Registration
Active
🇺🇸 United States
Synovasure Alpha Defensin Lateral Flow Test Kit
Reg #: 3011171357
·
FEI: 3011171357
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CD DIAGNOSTICS, INC
- Registration Number
- 3011171357
- FEI Number
- 3011171357
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 650 Naamans Road, Suite 100
- City
- Claymont
- State
- DE
- ZIP
- 19703
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN180032
Owner / Operator
- Firm Name
- CD Diagnostics, Inc
- Operator Number
- 10047552
- Address
- 650 Naamans Road (Suite 100)
- City
- Claymont
- State
- DE
- Postal Code
- 19703
- Country
- US
- Correspondent
- Leo Munar
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lateral Flow Immunochromatography Assay For Host Infection Biomarkers | QGN | Class 2 | Microbiology | No | 2019-05-31 |
Proprietary Names
Synovasure Alpha Defensin Lateral Flow Test Kit
Establishment Types
Manufacture Medical Device