FDA device listing
Kova KO-LEC-PAC,KOVA System Pac II,KOVA System Super Pac 1000,KOVA System Value Pac 500
FDA device listing 2057409905 · LGC Clinical Diagnostics
Key facts
| Proprietary names | Kova KO-LEC-PAC,KOVA System Pac II,KOVA System Super Pac 1000,KOVA System Value Pac 500 |
|---|---|
| Owner/operator | LGC Clinical Diagnostics |
| Owner/operator number | 10043604 |
| Product codes | NNW |
| Device names | NNW - Bag, Urine Collection, Leg, For External Use, Non-Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5250 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | KOVA INTERNATIONAL INC |
| Establishment registrations | 3010152370 |
| FEI numbers | 3010152370 |
| 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