Data / Medical devices / Over-The-Counter Covid-19 Antigen Test / China
FDA-registered makers of Over-The-Counter Covid-19 Antigen Test in China: 8 establishments
8 establishments in China are registered with the FDA to make Over-The-Counter Covid-19 Antigen Test (product code QYT). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Over-The-Counter Covid-19 Antigen Test
- Product code
- QYT
- Country
- China
Makers of Over-The-Counter Covid-19 Antigen Test in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Assure Tech. (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Complaint file establishment, Manufacturer | 1 | June 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| Andon Medical co., LTD | Tianjin, China | Manufacturer | 1 | May 31, 2024 | 0 | 0 | 0 | api.fda.gov |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 1 | June 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 1 | September 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 1 | September 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Acon Biotech (hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.