Data / Medical devices / Radioimmunoassay, Tricyclic Antidepressant Drugs / China
FDA-registered makers of Radioimmunoassay, Tricyclic Antidepressant Drugs in China: 12 establishments
12 establishments in China are registered with the FDA to make Radioimmunoassay, Tricyclic Antidepressant Drugs (product code LFG). 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
- Radioimmunoassay, Tricyclic Antidepressant Drugs
- Product code
- LFG
- Country
- China
Makers of Radioimmunoassay, Tricyclic Antidepressant Drugs in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Prometheus Bio Inc. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 2 | September 20, 2007 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer, Manufacturer | 1 | August 18, 2015 | 0 | 0 | 0 | api.fda.gov |
| Abon Biopharm (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech. (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Co-Innovation Biotech Co.,ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | 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 | |
| W.H.P.M. Bioresearch & Technology Co., Ltd. | Beijing, China | 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.