Data / Medical devices / Reagent, Coronavirus Serological / China
FDA-registered makers of Reagent, Coronavirus Serological in China: 13 establishments
13 establishments in China are registered with the FDA to make Reagent, Coronavirus Serological (product code QKO). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Reagent, Coronavirus Serological
- Product code
- QKO
- Country
- China
Makers of Reagent, Coronavirus Serological 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 | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atlas Link Technology Co., Ltd. | Langfang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biohit Healthcare (hefei) Co., Ltd. | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Laihe Biotech Co.,ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Biotest Biotech Co.,Ltd. | Hangzhou Zhejiang, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd. | Qian'an Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Hipro Biotechnology Co.,ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Lifotronic Technology Co.,Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Watmind Medical Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gene Science Co., Ltd | shaoxing Zhejiang, 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.