Data / Medical devices / Coronavirus Antigen Detection Test System. / China
FDA-registered makers of Coronavirus Antigen Detection Test System. in China: 12 establishments
12 establishments in China are registered with the FDA to make Coronavirus Antigen Detection Test System. (product code QKP). 0 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
- Coronavirus Antigen Detection Test System.
- Product code
- QKP
- Country
- China
Makers of Coronavirus Antigen Detection Test System. in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Andon Medical co., LTD | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Hotgen Biotech Co., Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biohit Healthcare (hefei) Co., Ltd. | Hefei Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioteke Corporation (wuxi) Co., Ltd | Wuxi City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Technology Co., Ltd. | Changping District Beijing, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Laihe Biotech Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Biotest Biotech Co.,Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Watmind Medical Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Yang Biotech Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Boson Biotech Co., Ltd. | Xiamen Fujian, China | 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.