Data / Medical devices / Urinalysis Controls (Assayed And Unassayed) / United States

FDA-registered makers of Urinalysis Controls (Assayed And Unassayed) in the United States: 19 establishments

Name: FDA-registered makers of Urinalysis Controls (Assayed And Unassayed) in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

19 establishments in the United States are registered with the FDA to make Urinalysis Controls (Assayed And Unassayed) (product code JJW). 12 have a 510(k) clearance or PMA approval on file and 3 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 the United States Watch these makers

Device: Urinalysis Controls (Assayed And Unassayed)
Product code: JJW
Country: United States

Makers of Urinalysis Controls (Assayed And Unassayed) in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Bio-Rad Laboratories Inc.	Irvine, CA, United States	Manufacturer	4	April 25, 2007	0	api.fda.gov
Bio-Rad Laboratories Inc.	Irvine, CA, United States	Manufacturer	4	April 25, 2007	0	api.fda.gov
Kova International Inc	Garden Grove, CA, United States	Manufacturer	4	October 4, 1994	0	api.fda.gov
Quantimetrix Corp.	Redondo Beach, CA, United States	Contract manufacturer, Manufacturer, Manufacturer for export	3	April 10, 2015	2	api.fda.gov
Beckman Coulter, Inc.	Miami, FL, United States	Specification developer	2	December 21, 2007	3	api.fda.gov
Siemens Healthcare Diagnostics Inc	East Walpole, MA, United States	Complaint file establishment, Specification developer	2	October 31, 1994	1	api.fda.gov
Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, United States	Complaint file establishment, Specification developer	2	October 3, 2005	0	api.fda.gov
Siemens Healthcare Diagnostics, Inc.	Mishawaka, IN, United States	Manufacturer	2	October 31, 1994	0	api.fda.gov
Acon Laboratories, Inc.	San Diego, CA, United States	Manufacturer, Specification developer	1	February 2, 2011	0	api.fda.gov
Cliniqa Corporation	San Marcos, CA, United States	Contract manufacturer, Manufacturer	1	January 16, 2009	0	api.fda.gov
Germaine Laboratories, Inc.	San Antonio, TX, United States	Manufacturer, Repackager or relabeler	1	February 2, 2011	0	api.fda.gov
Kenlor Industries, Inc.	Santa Ana, CA, United States	Contract manufacturer, Manufacturer	1	March 9, 1989	0	api.fda.gov
Beckman Coulter, Inc.	Carlsbad, CA, United States	Contract manufacturer	0		0	api.fda.gov
Biosys Laboratories, Inc.	S Pasadena, CA, United States	Specification developer	0		0	api.fda.gov
LGC Clinical Diagnostics, Inc.	Milford, MA, United States	Manufacturer	0		0	api.fda.gov
LGC Clinical Diagnostics, Inc.	Gaithersburg, MD, United States	Manufacturer	0		0	api.fda.gov
LGC Clinical Diagnostics, Inc.	Cumberland Foreside, ME, United States	Manufacturer	0		0	api.fda.gov
Microgenics Corporation	Fremont, CA, United States	Manufacturer	0		0	api.fda.gov
Nova Biomedical Corporation	Waltham, MA, United States	Complaint file establishment, Manufacturer	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.