FDA device listing
Glutathione Reductase
FDA device listing 1145532870 · RANDOX LABORATORIES, LTD.
Key facts
| Proprietary names | Glutathione Reductase |
|---|---|
| Owner/operator | RANDOX LABORATORIES, LTD. |
| Owner/operator number | 8020890 |
| Product codes | JLO |
| Device names | JLO - Enzymatic (Glutathione Reductase), Glutathione |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1365 |
| Review panels | Clinical Chemistry |
| Registered establishments | RANDOX LABORATORIES LIMITED |
| Establishment registrations | 3004493545 |
| FEI numbers | 3004493545 |
| 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