FDA device listing
Blood Lipid Analysis System(LPM-101, LPM- 102),Blood Lipid Test Strip (Dry Chemistry)(LPS-101),High Density Lipoprotein…
FDA device listing 1091129334 · HANGZHOU LYSUN BIOTECHNOLOGY CO.LTD
Key facts
| Proprietary names | Blood Lipid Analysis System(LPM-101, LPM- 102),Blood Lipid Test Strip (Dry Chemistry)(LPS-101),High Density Lipoprotein Cholesterol Test Strip (Dry Chemistry)(HLS-101) |
|---|---|
| Owner/operator | HANGZHOU LYSUN BIOTECHNOLOGY CO.LTD |
| Owner/operator number | 10089876 |
| Product codes | LBR |
| Device names | LBR - Ldl & Vldl Precipitation, Hdl |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1475 |
| Review panels | Clinical Chemistry |
| Registered establishments | HANGZHOU LYSUN BIOTECHNOLOGY CO.LTD |
| Establishment registrations | 3021010433 |
| FEI numbers | 3021010433 |
| 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