FDA device listing
MarDx Borrelia burgdorferi Lyme EIA IgG Specific Kit
FDA device listing 1309408099 · TRINITY BIOTECH, PLC
Key facts
| Proprietary names | MarDx Borrelia burgdorferi Lyme EIA IgG Specific Kit |
|---|---|
| Owner/operator | TRINITY BIOTECH, PLC |
| Owner/operator number | 9025161 |
| Premarket submissions | K894224 |
| Product codes | LSR |
| Device names | LSR - Reagent, Borrelia Serological Reagent |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3830 |
| Review panels | Microbiology |
| Registered establishments | Trinity Biotech USA |
| Establishment registrations | 1318354 |
| FEI numbers | 1318354 |
| Establishment operations | Manufacturer |
| 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