FDA device listing
Syphilis IgG, IgM ELISA
FDA device listing 1834438342 · ImmunoCentrix Corporation
Key facts
| Proprietary names | Syphilis IgG, IgM ELISA |
|---|---|
| Owner/operator | ImmunoCentrix Corporation |
| Owner/operator number | 10084773 |
| Product codes | LIP |
| Device names | LIP - Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3830 |
| Review panels | Microbiology |
| Registered establishments | IMMUNOCENTRIX CORPORATION |
| Establishment registrations | 3022178699 |
| FEI numbers | 3022178699 |
| 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