FDA Registration
Active
🇺🇸 United States
VITROS Calibrator Kit 17
Reg #: 1319808
·
FEI: 1000305841
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Registration Number
- 1319808
- FEI Number
- 1000305841
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1000 LEE RD.
- City
- Rochester
- State
- NY
- ZIP
- 14606
- Country
- US
Regulatory Submissions
- 510(k) Number
- K041799
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 |
|---|---|---|---|---|---|
| Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | NQD | Class 2 | Immunology | No | 2022-12-19 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2022-12-19 |
Proprietary Names
VITROS Calibrator Kit 17
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device