FDA Registration
Active
🇺🇸 United States
VITROS Chemistry Products Calibrator Kit 25
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
- 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
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility