FDA device listing
URC Test Reagent for 5-Hydroxyindole Acetic Acid
FDA device listing 1144104152 · Wuhan Chenkang Science Technology Co., LTD
Key facts
| Proprietary names | URC Test Reagent for 5-Hydroxyindole Acetic Acid |
|---|---|
| Owner/operator | Wuhan Chenkang Science Technology Co., LTD |
| Owner/operator number | 10039309 |
| Product codes | CDA |
| Device names | CDA - Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1390 |
| Review panels | Clinical Chemistry |
| Registered establishments | WUHAN CHENKANG SCIENCE TECHNOLOGY CO., LTD |
| Establishment registrations | 3009514517 |
| FEI numbers | 3009514517 |
| Establishment operations | Contract Manufacturer, 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