FDA device listing
HELICOBACTER PYLORI ANTIBODY TEST,HELICOBACTER PYLORI ANTIGEN TEST
FDA device listing 2040600832 · Keva Inc.
Key facts
| Proprietary names | HELICOBACTER PYLORI ANTIBODY TEST,HELICOBACTER PYLORI ANTIGEN TEST |
|---|---|
| Owner/operator | Keva Inc. |
| Owner/operator number | 10094570 |
| Product codes | LYR |
| Device names | LYR - Helicobacter Pylori |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3110 |
| Review panels | Microbiology |
| Registered establishments | KEVA INC. |
| Establishment registrations | 3043196750 |
| FEI numbers | 3043196750 |
| 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