FDA Registration
Active
🇺🇸 United States
VITROS Chemistry Products Calibrator Kit 25
Reg #: 1319809
·
FEI: 1000305840
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Registration Number
- 1319809
- FEI Number
- 1000305840
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 513 Technology Blvd.
- City
- ROCHESTER
- State
- NY
- ZIP
- 14626
- Country
- US
Regulatory Submissions
- 510(k) Number
- K042006
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 |
|---|---|---|---|---|---|
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2024-04-02 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2024-04-02 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2024-04-02 |
Proprietary Names
VITROS Chemistry Products Calibrator Kit 25
VITROS Chemistry Products Performance Verifiers
VITROS Chemistry Products dHDL Slides
Establishment Types
Manufacture Medical Device