Data / Medical devices / Single (Specified) Analyte Controls (Assayed And Unassayed) / China
FDA-registered makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in China: 11 establishments
11 establishments in China are registered with the FDA to make Single (Specified) Analyte Controls (Assayed And Unassayed) (product code JJX). 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
- Single (Specified) Analyte Controls (Assayed And Unassayed)
- Product code
- JJX
- Country
- China
Makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Acon Biotech (hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BD Rapid Diagnostics (Suzhou) Co. Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Genesee Biotech, Inc. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Sinocare Inc. | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dirui Industrial Co., Ltd. | CHANGCHUN Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Human Metabolomics Institute, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sejoy Biomedical Co., Ltd. | Hangzhou City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vivachek Biotech (hangzhou) Co., Ltd | Hangzhou, Zhuji Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yasee Biomedical Inc | QINGDAO Shandong, 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.