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Data / Medical devices / Kit, Test, Pregnancy, Hcg, Over The Counter / China

FDA-registered makers of Kit, Test, Pregnancy, Hcg, Over The Counter in China: 30 establishments

30 establishments in China are registered with the FDA to make Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX). 24 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Device
Kit, Test, Pregnancy, Hcg, Over The Counter
Product code
LCX
Country
China

Makers of Kit, Test, Pregnancy, Hcg, Over The Counter in China

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Assure Tech. (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaComplaint file establishment, Manufacturer, Specification developer4February 13, 2025000api.fda.gov
Assure Tech. (Hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer4February 13, 2025000api.fda.gov
Guangzhou Decheng Biotechnology Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Exporter to the US, Manufacturer4September 9, 2025000api.fda.gov
Equinox Biotech Co., Ltd.Shantou Guangdong, ChinaManufacturer3February 22, 2019000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer2August 7, 2015000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Dongguan Guangdong, ChinaManufacturer2August 7, 2015000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaContract manufacturer, Manufacturer2July 15, 2025000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaContract manufacturer, Manufacturer2July 15, 2025000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaContract manufacturer, Manufacturer2July 15, 2025000api.fda.gov
Nantong Egens Biotechnology Co.,ltd.NANTONG Jiangsu, ChinaExporter to the US, Manufacturer2January 26, 2024000api.fda.gov
W.H.P.M. Bioresearch & Technology Co., Ltd.Beijing, ChinaManufacturer2May 20, 2004000api.fda.gov
Andon Health Co., LtdTianjin, ChinaSpecification developer1December 20, 2024000api.fda.gov
Anhui Deepblue Medical Technology Co., Ltd.Hefei Anhui, ChinaManufacturer1October 11, 2024000api.fda.gov
Atlas Link Technology Co., Ltd.Langfang Hebei, ChinaManufacturer1August 4, 2021000api.fda.gov
Co-Innovation Biotech Co.,ltd.Guangzhou Guangdong, ChinaManufacturer1April 5, 2022000api.fda.gov
Hangzhou Aichek Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer1April 12, 2024000api.fda.gov
Hangzhou Clongene Biotech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer1December 11, 2019000api.fda.gov
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd.Qian'an Hebei, ChinaManufacturer1November 22, 2019000api.fda.gov
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.Nantong Jiangsu, ChinaManufacturer1October 13, 2023000api.fda.gov
Qingdao Hightop Biotech Co., Ltd.Qingdao Shandong, ChinaManufacturer1September 5, 2019000api.fda.gov
Safecare Biotech(hangzhou)co.,ltdHuzhou Zhejiang, ChinaManufacturer1August 13, 2020000api.fda.gov
Sejoy Biomedical Co., Ltd.Hangzhou City Zhejiang, ChinaManufacturer1February 18, 2022000api.fda.gov
Weihai Kangzhou Biotechnology Engineering Co., Ltd.Weihai Shandong, ChinaManufacturer1January 10, 2019000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer, Manufacturer1July 28, 2011000api.fda.gov
Acon Biotech (hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer0000api.fda.gov
Abbott Diagnostics (Shanghai) Co., Ltd.Shanghai, ChinaContract manufacturer0000api.fda.gov
Andon Medical co., LTDTianjin, ChinaContract manufacturer0000api.fda.gov
Core Technology Co., Ltd.Changping District Beijing, ChinaContract manufacturer0000api.fda.gov
Hangzhou Biotest Biotech Co.,Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Hynaut Health Technology Co., LTD.Qingdao Shandong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.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.