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.
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- Device
- Kit, Test, Pregnancy, Hcg, Over The Counter
- Product code
- LCX
- Country
- China
Makers of Kit, Test, Pregnancy, Hcg, Over The Counter in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Assure Tech. (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Complaint file establishment, Manufacturer, Specification developer | 4 | February 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 4 | February 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Exporter to the US, Manufacturer | 4 | September 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Equinox Biotech Co., Ltd. | Shantou Guangdong, China | Manufacturer | 3 | February 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 2 | August 7, 2015 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 2 | August 7, 2015 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 2 | July 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 2 | July 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 2 | July 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nantong Egens Biotechnology Co.,ltd. | NANTONG Jiangsu, China | Exporter to the US, Manufacturer | 2 | January 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| W.H.P.M. Bioresearch & Technology Co., Ltd. | Beijing, China | Manufacturer | 2 | May 20, 2004 | 0 | 0 | 0 | api.fda.gov |
| Andon Health Co., Ltd | Tianjin, China | Specification developer | 1 | December 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Anhui Deepblue Medical Technology Co., Ltd. | Hefei Anhui, China | Manufacturer | 1 | October 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Atlas Link Technology Co., Ltd. | Langfang Hebei, China | Manufacturer | 1 | August 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| Co-Innovation Biotech Co.,ltd. | Guangzhou Guangdong, China | Manufacturer | 1 | April 5, 2022 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Aichek Medical Technology Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 1 | April 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Clongene Biotech Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 1 | December 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd. | Qian'an Hebei, China | Manufacturer | 1 | November 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | Nantong Jiangsu, China | Manufacturer | 1 | October 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Qingdao Hightop Biotech Co., Ltd. | Qingdao Shandong, China | Manufacturer | 1 | September 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Safecare Biotech(hangzhou)co.,ltd | Huzhou Zhejiang, China | Manufacturer | 1 | August 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Sejoy Biomedical Co., Ltd. | Hangzhou City Zhejiang, China | Manufacturer | 1 | February 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Weihai Kangzhou Biotechnology Engineering Co., Ltd. | Weihai Shandong, China | Manufacturer | 1 | January 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer, Manufacturer | 1 | July 28, 2011 | 0 | 0 | 0 | api.fda.gov |
| Acon Biotech (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 | |
| Andon Medical co., LTD | Tianjin, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Technology Co., Ltd. | Changping District Beijing, China | Contract 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 | |
| Hynaut Health Technology Co., LTD. | Qingdao Shandong, China | Contract manufacturer, Exporter to the US, 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.