FDA device listing
Cardiochek Bioscanner plus
FDA device listing 1597403045 · East West
Key facts
| Proprietary names | Cardiochek Bioscanner plus |
|---|---|
| Owner/operator | East West |
| Owner/operator number | 10058019 |
| Product codes | CHH, JGY, LBR |
| Device names | CHH - Enzymatic Esterase--Oxidase, Cholesterol, JGY - Colorimetric Method, Triglycerides, LBR - Ldl & Vldl Precipitation, Hdl |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1175, 862.1475, 862.1705 |
| Review panels | Clinical Chemistry |
| Registered establishments | East West Wisconsin |
| Establishment registrations | 3002736372 |
| FEI numbers | 3004631140 |
| Establishment operations | Contract 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