Data / Medical devices / Reagent, Occult Blood / China
FDA-registered makers of Reagent, Occult Blood in China: 6 establishments
6 establishments in China are registered with the FDA to make Reagent, Occult Blood (product code KHE). 5 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
- Reagent, Occult Blood
- Product code
- KHE
- Country
- China
Makers of Reagent, Occult Blood in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist., Chongqing, China | Manufacturer | 1 | July 14, 2006 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 1 | May 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 1 | May 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| W.H.P.M. Bioresearch & Technology Co., Ltd. | Beijing, China | Manufacturer | 1 | August 12, 2004 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer, Manufacturer | 1 | September 14, 2011 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | Hangzhou 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.