FDA device listing
Immunoassay, Pregnanediol Glucuronide, Over The Counter
FDA device listing 1706800286 · Hangzhou Careomedic Tech Co.,Ltd
Key facts
| Owner/operator | Hangzhou Careomedic Tech Co.,Ltd |
|---|---|
| Owner/operator number | 10053819 |
| Product codes | QKE |
| Device names | QKE - Immunoassay, Pregnanediol Glucuronide, Over The Counter |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1620 |
| Review panels | Clinical Chemistry |
| Registered establishments | Hangzhou Careomedic Tech Co., Ltd. |
| Establishment registrations | 3013587414 |
| FEI numbers | 3013587414 |
| 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