Data / Medical devices / Kit, Screening, Urine

Kit, Screening, Urine (JXA): 20 FDA-registered makers in 8 countries

Name: FDA-registered makers of Kit, Screening, Urine
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

20 establishments in 8 countries are registered with the FDA to make Kit, Screening, Urine (product code JXA, Class 1, 21 CFR 866.2660). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 44 510(k) clearances under this code, the latest on November 30, 2001, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: JXA
Device class: 1
Regulation: 866.2660
Medical specialty: Microbiology

Makers by country

Country	Makers
United States	7
China	7
Israel	1
France	1
Spain	1
United Kingdom	1
Singapore	1
Indonesia	1

Makers of Kit, Screening, Urine

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Source
Savyon Diagnostics Ltd.	ASHDOD Southern, Israel	Manufacturer	3	October 7, 1998	api.fda.gov
Tri-Tech Forensics, Inc.	Leland, NC, United States	Manufacturer	1	June 20, 1995	api.fda.gov
Andwin Scientific	Simi Valley, CA, United States	Manufacturer	0		api.fda.gov
Biomerieux France	CRAPONNE Rhone, France	Manufacturer	0		api.fda.gov
Biomerieux Spain	Tres Cantos Madrid(Province), Spain	Manufacturer	0		api.fda.gov
Biomedical Polymers, Inc.	Sterling, MA, United States	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	0		api.fda.gov
Changchun LYZ Technology Co.,LTD	Changchun City Jilin, China	Exporter to the US, Manufacturer	0		api.fda.gov
Dynamic Diagnostics Incorporated	Plymouth, MI, United States	Manufacturer	0		api.fda.gov
Jilin Hongyi Bio-Tech Co., Ltd.	Changchun Jilin, China	Exporter to the US, Manufacturer	0		api.fda.gov
Jilin Test Bio-Electron Co.,ltd	Changchun Jilin, China	Manufacturer	0		api.fda.gov
Mast Group Ltd.	BOOTLE, MERSEYSIDE Liverpool, United Kingdom	Manufacturer	0		api.fda.gov
Medical Chemical Corporation	Torrance, CA, United States	Manufacturer, Repackager or relabeler	0		api.fda.gov
NSP Tech Pte Ltd	Singapore Central Singapore, Singapore	Manufacturer	0		api.fda.gov
Onlycare Inc	Denver, CO, United States	Manufacturer	0		api.fda.gov
PT NSP Technology Batam	Batu Ampar Riau, Indonesia	Contract manufacturer	0		api.fda.gov
Teco Diagnostics	Anaheim, CA, United States	Manufacturer	0		api.fda.gov
Weihai Kangzhou Biotechnology Engineering Co., Ltd.	Weihai Shandong, China	Manufacturer	0		api.fda.gov
Weihai Kangzheng Medical Equipments Technology Co.,Ltd	weihai Shandong, China	Contract manufacturer, Manufacturer	0		api.fda.gov

Updated November 30, 2001. 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.