FDA Registration
Active
🇺🇸 United States
VITROS dTIBC Reagent
Reg #: 1319681
·
FEI: 1000136573
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Registration Number
- 1319681
- FEI Number
- 1000136573
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 100 Indigo Creek Dr
- City
- Rochester
- State
- NY
- ZIP
- 14626
- 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
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198