FDA device listing
EA001 Elisa Diluent Wash Buffer,EA022 Elisa Stop Solution,SC019 Microtitre Plates,SC020 Conjugate Solution,TMB005 One…
FDA device listing 1039129213 · RANDOX LABORATORIES, LTD.
Key facts
| Proprietary names | EA001 Elisa Diluent Wash Buffer,EA022 Elisa Stop Solution,SC019 Microtitre Plates,SC020 Conjugate Solution,TMB005 One Shot Substrate |
|---|---|
| Owner/operator | RANDOX LABORATORIES, LTD. |
| Owner/operator number | 8020890 |
| Product codes | MVU |
| Device names | MVU - Reagents, Specific, Analyte |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4020 |
| Review panels | Pathology |
| 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