FDA Registration
Active
🇺🇸 United States
VITROS 4600 Chemistry System
Reg #: 2250051
·
FEI: 2250051
·
Expires 2025
Products
3
Proprietary Names
5
Establishment Types
1
Classifications
3
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
- K031924
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 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2023-02-27 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2023-02-27 |
Proprietary Names
VITROS 4600 Chemistry System
VITROS Calibrator Kit 19
VITROS 5,1 FS Chemistry System
VITROS 4600 Chemistry System Refurbished
VITROS 5,1 FS Chemistry System Refurbished
Establishment Types
Complaint File Establishment per 21 CFR 820.198