FDA Registration
Active
🇺🇸 United States
VITROS 250 Chemistry System
Reg #: 2250051
·
FEI: 2250051
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Registration Number
- 2250051
- FEI Number
- 2250051
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1001 US Highway 202
- City
- RARITAN
- State
- NJ
- ZIP
- 08869
- Country
- US
Regulatory Submissions
- 510(k) Number
- K922072
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 |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2023-02-27 |
Proprietary Names
VITROS 250 Chemistry System
VITROS 350 Chemistry System
VITROS 250 Chemistry System Refurbished
Establishment Types
Complaint File Establishment per 21 CFR 820.198