FDA device listing
15 mL Magnetic Tube Dock,2 mL Magnetic Tube Dock,50 mL Magnetic Tube Dock,5 mL Magnetic Tube Dock,EpiSep MSD5 (Five…
FDA device listing 1591271748 · WaveSense, Inc. dba nRichDX
Key facts
| Proprietary names | 15 mL Magnetic Tube Dock,2 mL Magnetic Tube Dock,50 mL Magnetic Tube Dock,5 mL Magnetic Tube Dock,EpiSep MSD5 (Five Position Magnetic Slide Dock),EpiSep NSD II (Neo-Magnetic Slide Dock),EpiSep NSD I (Neo-Magnetic Slide Dock),Revolution System |
|---|---|
| Owner/operator | WaveSense, Inc. dba nRichDX |
| Owner/operator number | 10034778 |
| Product codes | LXG |
| Device names | LXG - Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | WAVESENSE, INC. |
| Establishment registrations | 3005592623 |
| FEI numbers | 3005592623 |
| Establishment operations | Manufacturer |
| 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