FDA Registration
Active
🇺🇸 United States
VITROS XT 7600 Integrated System Certified
Reg #: 2250051
·
FEI: 2250051
·
Expires 2025
Products
4
Proprietary Names
6
Establishment Types
1
Classifications
4
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
- K182063
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 |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Carbamazepine | KLT | Class 2 | Clinical Toxicology | No | 2022-12-21 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2022-12-21 |
Proprietary Names
VITROS XT 7600 Integrated System Certified
VITROS XT 7600 Integrated System
VITROS TBIL Slides
VITROS XT 3400 Chemistry System
VITROS CREA Slides
VITROS CRBM Slides
Establishment Types
Complaint File Establishment per 21 CFR 820.198