FDA device listing
HCG Test Strip
FDA device listing 1129895379 · Hynaut Health Technology Co., LTD.
Key facts
| Proprietary names | HCG Test Strip |
|---|---|
| Owner/operator | Hynaut Health Technology Co., LTD. |
| Owner/operator number | 10040387 |
| Product codes | LCX |
| Device names | LCX - Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1155 |
| Review panels | Clinical Chemistry |
| Registered establishments | Hynaut Health Technology Co., LTD. |
| Establishment registrations | 3008808560 |
| FEI numbers | 3004601847 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, 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