FDA Registration
Active
🇺🇸 United States
VITROS C3 Reagent
Reg #: 1319681
·
FEI: 1000136573
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
2
Classifications
4
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
- K042494
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 |
|---|---|---|---|---|---|
| Complement C4, Antigen, Antiserum, Control | DBI | Class 2 | Immunology | No | 2022-12-19 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Complement C3, Antigen, Antiserum, Control | CZW | Class 2 | Immunology | No | 2022-12-19 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2022-12-19 |
Proprietary Names
VITROS C3 Reagent
VITROS C4 Reagent
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility