Data / Medical devices / Test, Luteinizing Hormone (Lh), Over The Counter / China

FDA-registered makers of Test, Luteinizing Hormone (Lh), Over The Counter in China: 40 establishments

Name: FDA-registered makers of Test, Luteinizing Hormone (Lh), Over The Counter in China
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

40 establishments in China are registered with the FDA to make Test, Luteinizing Hormone (Lh), Over The Counter (product code NGE). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device: Test, Luteinizing Hormone (Lh), Over The Counter
Product code: NGE
Country: China

Makers of Test, Luteinizing Hormone (Lh), Over The Counter in China

Maker	Location	Role	Recall events	Source
Acon Biotech (hangzhou) Co., Ltd.	HANGZHOU Zhejiang, China	Contract manufacturer	0	api.fda.gov
Anhui Deepblue Medical Technology Co., Ltd.	Hefei Anhui, China	Manufacturer	0	api.fda.gov
Assure Tech. (hangzhou) Co., Ltd.	Hangzhou Zhejiang, China	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Ave Science & Technology Co., Ltd	Changsha Hunan, China	Exporter to the US, Manufacturer	0	api.fda.gov
Abbott Diagnostics (Shanghai) Co., Ltd.	Shanghai, China	Contract manufacturer	0	api.fda.gov
Assure Tech. (Hangzhou) Co., Ltd.	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Atlas Link Technology Co., Ltd.	Langfang Hebei, China	Manufacturer	0	api.fda.gov
Baoding Abiores Chip Co., Ltd.	Baoding Hebei, China	Contract manufacturer	0	api.fda.gov
Changchun Merydi Bio-Tech Co., Ltd.	changchun Jilin, China	Manufacturer	0	api.fda.gov
Changchun Wancheng Bio-Electron Co., Ltd.	Changchun Jilin, China	Manufacturer	1	api.fda.gov
Core Technology Co., Ltd.	Changping District Beijing, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.	Shijiazhuang Hebei, China	Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler	0	api.fda.gov
Dongguan Bao Kang Dian Zi Ke Ji Limited	Dongguan City Guangdong, China	Contract manufacturer	0	api.fda.gov
Equinox Biotech Co., Ltd.	Shantou Guangdong, China	Manufacturer	0	api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.	Guangzhou Guangdong, China	Complaint file establishment, Manufacturer	0	api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.	Dongguan Guangdong, China	Manufacturer	0	api.fda.gov
Guangzhou Decheng Biotechnology Co., Ltd.	Guangzhou Guangdong, China	Complaint file establishment, Manufacturer	0	api.fda.gov
Hangzhou Aichek Medical Technology Co., Ltd.	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Hangzhou Clongene Biotech Co., Ltd.	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Hangzhou Laihe Biotech Co.,ltd.	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Hangzhou Lysun Biotechnology Co.ltd	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Hangzhou Tongzhou Biotechnology Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Hangzhou AllTest Biotech Co.,Ltd	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Hangzhou AllTest Biotech Co.,Ltd	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Hangzhou AllTest Biotech Co.,Ltd	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Hangzhou Biotest Biotech Co.,Ltd.	Hangzhou Zhejiang, China	Complaint file establishment, Contract manufacturer, Manufacturer	0	api.fda.gov
Hangzhou Careomedic Tech Co., Ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd.	Qian'an Hebei, China	Manufacturer	0	api.fda.gov
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.	Nantong Jiangsu, China	Manufacturer	0	api.fda.gov
Jilin Hongyi Bio-Tech Co., Ltd.	Changchun Jilin, China	Exporter to the US, Manufacturer	0	api.fda.gov
Nantong Egens Biotechnology Co.,ltd.	NANTONG Jiangsu, China	Manufacturer	0	api.fda.gov
Qingdao Hightop Biotech Co., Ltd.	Qingdao Shandong, China	Manufacturer	0	api.fda.gov
Safecare Biotech(hangzhou)co.,ltd	Huzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Sejoy Biomedical Co., Ltd.	Hangzhou City Zhejiang, China	Manufacturer	0	api.fda.gov
Trummed Medical (hangzhou) Co.,ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	0	api.fda.gov
W.H.P.M. Bioresearch & Technology Co., Ltd.	Beijing, China	Manufacturer	0	api.fda.gov
Weihai Kangzhou Biotechnology Engineering Co., Ltd.	Weihai Shandong, China	Manufacturer	0	api.fda.gov
Xiamen Boson Biotech Co., Ltd.	Xiamen Fujian, China	Manufacturer	0	api.fda.gov
Zhejiang Orient Gene Biotech	Huzhou Zhejiang, China	Contract manufacturer, Manufacturer	0	api.fda.gov
ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, China	Manufacturer	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.