Data / Medical devices / Enzyme Immunoassay, Amphetamine / China

FDA-registered makers of Enzyme Immunoassay, Amphetamine in China: 19 establishments

Name: FDA-registered makers of Enzyme Immunoassay, Amphetamine in China
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

19 establishments in China are registered with the FDA to make Enzyme Immunoassay, Amphetamine (product code DKZ). 11 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: Enzyme Immunoassay, Amphetamine
Product code: DKZ
Country: China

Makers of Enzyme Immunoassay, Amphetamine in China

Maker	Location	Role	510(k) clearances	Latest clearance	Source
Prometheus Bio Inc.	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	8	August 21, 2015	api.fda.gov
Hangzhou AllTest Biotech Co.,Ltd	Hangzhou Zhejiang, China	Manufacturer	2	December 13, 2023	api.fda.gov
Hangzhou AllTest Biotech Co.,Ltd	Hangzhou Zhejiang, China	Manufacturer	2	December 13, 2023	api.fda.gov
Hangzhou AllTest Biotech Co.,Ltd	Hangzhou Zhejiang, China	Manufacturer	2	December 13, 2023	api.fda.gov
Assure Tech. (hangzhou) Co., Ltd.	Hangzhou Zhejiang, China	Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer	1	March 31, 2016	api.fda.gov
Assure Tech. (Hangzhou) Co., Ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	1	March 31, 2016	api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.	Guangzhou Guangdong, China	Complaint file establishment, Manufacturer	1	February 25, 2014	api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.	Dongguan Guangdong, China	Manufacturer	1	February 25, 2014	api.fda.gov
Hangzhou Clongene Biotech Co., Ltd.	Hangzhou Zhejiang, China	Manufacturer	1	August 30, 2016	api.fda.gov
W.H.P.M. Bioresearch & Technology Co., Ltd.	Beijing, China	Manufacturer	1	May 19, 2004	api.fda.gov
Zhejiang Orient Gene Biotech	Huzhou Zhejiang, China	Contract manufacturer, Manufacturer	1	September 9, 2015	api.fda.gov
Abon Biopharm (hangzhou) Co., Ltd.	Hangzhou Zhejiang, China	Contract manufacturer	0		api.fda.gov
Co-Innovation Biotech Co.,ltd.	Guangzhou Guangdong, China	Manufacturer	0		api.fda.gov
Core Technology Co., Ltd.	Changping District Beijing, China	Contract manufacturer	0		api.fda.gov
Guangzhou Decheng Biotechnology Co., Ltd.	Guangzhou Guangdong, China	Complaint file establishment, Manufacturer	0		api.fda.gov
Hangzhou Laihe Biotech Co.,ltd.	Hangzhou Zhejiang, China	Manufacturer	0		api.fda.gov
Hongkong Conlight Medical Group Limited	Tai Kok Tsui Hong Kong, China	Manufacturer, Specification developer	0		api.fda.gov
Hangzhou Biotest Biotech Co.,Ltd.	Hangzhou Zhejiang, China	Contract manufacturer	0		api.fda.gov
Safecare Biotech(hangzhou)co.,ltd	Huzhou Zhejiang, 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.