FDA device listing
ORTHO Bovine Albumin Solution Polymerized,ORTHO Bovine Serum Albumin, 22% Protein Concentration
FDA device listing 1358301377 · QuidelOrtho Corporation
Key facts
| Proprietary names | ORTHO Bovine Albumin Solution Polymerized,ORTHO Bovine Serum Albumin, 22% Protein Concentration |
|---|---|
| Owner/operator | QuidelOrtho Corporation |
| Owner/operator number | 2024674 |
| Product codes | DCF |
| Device names | DCF - Albumin, Antigen, Antiserum, Control |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5040 |
| Review panels | Immunology |
| Registered establishments | Ortho-Clinical Diagnostics European Support Center, ORTHO-CLINICAL DIAGNOSTICS, INC., Ortho Clinical Diagnostics, K.K., Ortho-Clinical Diagnostics Singapore Pte Ltd |
| Establishment registrations | 1319681, 2250051, 3000308930, 3002642396, 3012963943 |
| FEI numbers | 2250051, 1000136573, 3000308930, 3002642396, 3012963943 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database