FDA Registration
Active
🇺🇸 United States
VITROS dTIBC Reagent
Reg #: 2250051
·
FEI: 2250051
·
Expires 2025
Products
3
Proprietary Names
3
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
- K052867
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 |
|---|---|---|---|---|---|
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2022-12-19 |
Proprietary Names
VITROS dTIBC Reagent
VITROS Calibrator Kit 29
VITROS dTIBC Performance Verifiers
Establishment Types
Complaint File Establishment per 21 CFR 820.198