FDA device listing
ABAXIS CHEMISTRY CONTROL LEVEL 1,ABAXIS CHEMISTRY CONTROL LEVEL 2,APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Beckman…
FDA device listing 1120537850 · RANDOX LABORATORIES, LTD.
Key facts
| Proprietary names | ABAXIS CHEMISTRY CONTROL LEVEL 1,ABAXIS CHEMISTRY CONTROL LEVEL 2,APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Apo LinVer - BC),APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Roche Systems) (ApoLV-R),APOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1),APOLIPOPROTEIN CONTROL - LEVEL 2 (APO CONTROL 2),APOLIPOPROTEIN CONTROL - LEVEL 3 (APO CONTROL 3),ASSAYED BOVINE MULTI… |
|---|---|
| Owner/operator | RANDOX LABORATORIES, LTD. |
| Owner/operator number | 8020890 |
| Product codes | JJY |
| Device names | JJY - Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | RANDOX LABORATORIES LIMITED |
| Establishment registrations | 3004493545, 3014607865 |
| FEI numbers | 3004493545, 3014607865 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler |
| 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