FDA device listing
Microalbumin (μALB) Reagents,RANDOX TOTAL PROTEIN (UP),RANDOX URINARY PROTEIN
FDA device listing 1447798814 · RANDOX LABORATORIES, LTD.
Key facts
| Proprietary names | Microalbumin (μALB) Reagents,RANDOX TOTAL PROTEIN (UP),RANDOX URINARY PROTEIN |
|---|---|
| Owner/operator | RANDOX LABORATORIES, LTD. |
| Owner/operator number | 8020890 |
| Product codes | JIR |
| Device names | JIR - Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1645 |
| Review panels | Clinical Chemistry |
| Registered establishments | RANDOX LABORATORIES LIMITED |
| Establishment registrations | 3004493545 |
| FEI numbers | 3004493545 |
| Establishment operations | Contract Manufacturer, 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