FDA Registration
Active
🇺🇸 United States
VITROS Total bhCG II Calibrator
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
- K063720
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 |
|---|---|---|---|---|---|
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2022-12-21 |
Proprietary Names
VITROS Total bhCG II Calibrator
VITROS Total bhCG II Range Verifier
VITROS Total bhCG II Reagent Pack
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility