FDA device listing
M-30CFL LYSE,M-53LH LYSE,M-5LEO(II) LYSE,M-5LEO(I) LYSE
FDA device listing 1073850143 · Mindray DS USA, Inc.
Key facts
| Proprietary names | M-30CFL LYSE,M-53LH LYSE,M-5LEO(II) LYSE,M-5LEO(I) LYSE |
|---|---|
| Owner/operator | Mindray DS USA, Inc. |
| Owner/operator number | 10025908 |
| Product codes | GGK |
| Device names | GGK - Products, Red-Cell Lysing Products |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.8540 |
| Review panels | Hematology |
| Registered establishments | MINDRAY DS USA, Inc. |
| Establishment registrations | 2221819 |
| FEI numbers | 2221819 |
| Establishment operations | Complaint File Establishment |
| 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