Data / Medical devices / Multi-Analyte Respiratory Virus Antigen Detection Test / China
FDA-registered makers of Multi-Analyte Respiratory Virus Antigen Detection Test in China: 6 establishments
6 establishments in China are registered with the FDA to make Multi-Analyte Respiratory Virus Antigen Detection Test (product code SCA). 2 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
- Multi-Analyte Respiratory Virus Antigen Detection Test
- Product code
- SCA
- Country
- China
Makers of Multi-Analyte Respiratory Virus Antigen Detection Test in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Andon Medical co., LTD | Tianjin, China | Manufacturer | 2 | December 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 2 | August 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Biohit Healthcare (hefei) Co., Ltd. | Hefei Anhui, China | Contract 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 | |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, 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.