FDA device listing
DIRUI H500 URINALYSIS SYSTEM
FDA device listing 2061798039 · Alius Scientific, LLC
Key facts
| Proprietary names | DIRUI H500 URINALYSIS SYSTEM |
|---|---|
| Owner/operator | Alius Scientific, LLC |
| Owner/operator number | 10072559 |
| Product codes | KQO |
| Device names | KQO - Automated Urinalysis System |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2900 |
| Review panels | Clinical Chemistry |
| Registered establishments | Alius Scientific,LLC |
| Establishment registrations | 3010324880 |
| FEI numbers | 3010324880 |
| 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