FDA device listing
Hipro® Lipoprotein(a) Test Kit (Rate Scattering Turbidimetric Method)
FDA device listing 2023430457 · Shijiazhuang Hipro Biotechnology Co.,Ltd
Key facts
| Proprietary names | Hipro® Lipoprotein(a) Test Kit (Rate Scattering Turbidimetric Method) |
|---|---|
| Owner/operator | Shijiazhuang Hipro Biotechnology Co.,Ltd |
| Owner/operator number | 10072388 |
| Product codes | MSM |
| Device names | MSM - System, Test, Lipoprotein(A) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1475 |
| Review panels | Clinical Chemistry |
| Registered establishments | SHIJIAZHUANG HIPRO BIOTECHNOLOGY CO.,LTD |
| Establishment registrations | 3017379203 |
| FEI numbers | 3017379203 |
| 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