FDA Registration
Active
🇺🇸 United States
Savanna RVP4 Assay
Reg #: 1528450
·
FEI: 1000122536
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Ortho-Clinical Diagnostics, Inc.
- Registration Number
- 1528450
- FEI Number
- 1000122536
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2005 East State Street, Suite 100
- City
- ATHENS
- State
- OH
- ZIP
- 45701
- Country
- US
Owner / Operator
- Firm Name
- QuidelOrtho Corp.
- Operator Number
- 2024674
- Address
- 9975 Summers Ridge Road, --
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices | QLT | Class N | Unknown | No | 2022-05-09 |
Proprietary Names
Savanna RVP4 Assay
Establishment Types
Manufacture Device in the United States for Export Only