FDA device listing
Asserachrom HPIA - IgG
FDA device listing 1406958700 · Diagnostica Stago, Inc.
Key facts
| Proprietary names | Asserachrom HPIA - IgG |
|---|---|
| Owner/operator | Diagnostica Stago, Inc. |
| Owner/operator number | 9003476 |
| Product codes | DBL |
| Device names | DBL - Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5660 |
| Review panels | Immunology |
| Registered establishments | DIAGNOSTICA STAGO, INC. |
| Establishment registrations | 2245451 |
| FEI numbers | 2245451 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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