Data / Medical devices / Radioimmunoassay, Luteinizing Hormone / China
FDA-registered makers of Radioimmunoassay, Luteinizing Hormone in China: 14 establishments
14 establishments in China are registered with the FDA to make Radioimmunoassay, Luteinizing Hormone (product code CEP). 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
- Radioimmunoassay, Luteinizing Hormone
- Product code
- CEP
- Country
- China
Makers of Radioimmunoassay, Luteinizing Hormone in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abon Biopharm (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Diagnostics (Shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Hotgen Biotech Co., Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioteke Corporation (wuxi) Co., Ltd | Wuxi City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Co-Innovation Biotech Co.,ltd. | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Computime Ltd. | LONGGANG REGION, SHENZHAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dirui Industrial Co., Ltd. | CHANGCHUN Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Polygreen Technology Co., Ltd. | DONGGUAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Getein Biotech, Inc. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen H&T Intelligent Control Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen Guangdong, 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 | |
| Weihai Kangzhou Biotechnology Engineering Co., Ltd. | Weihai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Kangzheng Medical Equipments Technology Co.,Ltd | weihai Shandong, China | Contract manufacturer, 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.