FDA device listing
Rapid Response H. pylori Rapid Test Device (Serum/Plasma),Rapid Response H. pylori Rapid Test Device (Whole Blood)
FDA device listing 1027255122 · BTNX Inc.
Key facts
| Proprietary names | Rapid Response H. pylori Rapid Test Device (Serum/Plasma),Rapid Response H. pylori Rapid Test Device (Whole Blood) |
|---|---|
| Owner/operator | BTNX Inc. |
| Owner/operator number | 9058575 |
| Premarket submissions | K024350 |
| Product codes | LYR |
| Device names | LYR - Helicobacter Pylori |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3110 |
| Review panels | Microbiology |
| Registered establishments | BTNX Inc. |
| Establishment registrations | 3003917514 |
| FEI numbers | 3003917514 |
| Establishment operations | Foreign Private Label Distributor, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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