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Data / Medical devices / Enzyme Immunoassay, Opiates / China

FDA-registered makers of Enzyme Immunoassay, Opiates in China: 20 establishments

20 establishments in China are registered with the FDA to make Enzyme Immunoassay, Opiates (product code DJG). 15 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.

Get makers of this device in ChinaWatch these makers
Device
Enzyme Immunoassay, Opiates
Product code
DJG
Country
China

Makers of Enzyme Immunoassay, Opiates in China

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Co-Innovation Biotech Co.,ltd.Guangzhou Guangdong, ChinaManufacturer2March 8, 2024000api.fda.gov
Guangzhou Decheng Biotechnology Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer2May 10, 2024000api.fda.gov
Assure Tech. (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer1August 12, 2021000api.fda.gov
Assure Tech. (Hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer1August 12, 2021000api.fda.gov
Eterbio, Inc.Zhuhai Guangdong, ChinaManufacturer1March 31, 2023000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer1April 9, 2013000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Dongguan Guangdong, ChinaManufacturer1April 9, 2013000api.fda.gov
Hangzhou Laihe Biotech Co.,ltd.Hangzhou Zhejiang, ChinaManufacturer1January 9, 2024000api.fda.gov
Hongkong Conlight Medical Group LimitedTai Kok Tsui Hong Kong, ChinaManufacturer, Specification developer1February 23, 2024000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaContract manufacturer, Manufacturer1July 31, 2023000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaContract manufacturer, Manufacturer1July 31, 2023000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaContract manufacturer, Manufacturer1July 31, 2023000api.fda.gov
Prometheus Bio Inc.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer1February 24, 2010000api.fda.gov
Vivachek Biotech (hangzhou) Co., LtdHangzhou, Zhuji Zhejiang, ChinaManufacturer1June 14, 2024000api.fda.gov
W.H.P.M. Bioresearch & Technology Co., Ltd.Beijing, ChinaManufacturer1November 9, 2015000api.fda.gov
Abon Biopharm (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Core Technology Co., Ltd.Changping District Beijing, ChinaContract manufacturer0000api.fda.gov
Hangzhou Clongene Biotech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou Biotest Biotech Co.,Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer, 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.