FDA device listing
2San™ COVID-19 Rapid Self-Test,Hough™ COVID-19 Antigen Home Test,INDICAID® COVID-19 Antigen Home Test,WELLlife™ COVD-19…
FDA device listing 1234840154 · GUANGZHOU WONDFO BIOTECH CO., LTD.
Key facts
| Proprietary names | 2San™ COVID-19 Rapid Self-Test,Hough™ COVID-19 Antigen Home Test,INDICAID® COVID-19 Antigen Home Test,WELLlife™ COVD-19 Antigen Test,WELLlife™ COVID-19 Antigen Home Test |
|---|---|
| Owner/operator | GUANGZHOU WONDFO BIOTECH CO., LTD. |
| Owner/operator number | 9064561 |
| Premarket submissions | K241317 |
| Product codes | QYT |
| Device names | QYT - Over-The-Counter Covid-19 Antigen Test |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3984 |
| Review panels | Microbiology |
| Registered establishments | GUANGZHOU WONDFO BIOTECH CO., LTD. |
| Establishment registrations | 3004635103, 3023322455 |
| FEI numbers | 3004635103, 3023322455 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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