Data / Medical devices / Enzyme Immunoassay, Cocaine And Cocaine Metabolites / United States

FDA-registered makers of Enzyme Immunoassay, Cocaine And Cocaine Metabolites in the United States: 36 establishments

Name: FDA-registered makers of Enzyme Immunoassay, Cocaine And Cocaine Metabolites in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

36 establishments in the United States are registered with the FDA to make Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO). 20 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.

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Device: Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Product code: DIO
Country: United States

Makers of Enzyme Immunoassay, Cocaine And Cocaine Metabolites in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Siemens Healthcare Diagnostics Inc.	Newark, DE, United States	Manufacturer, Specification developer	8	October 25, 2017	0	api.fda.gov
Princeton Biomeditech Corp.	Monmouth Jct, NJ, United States	Manufacturer	7	June 10, 2002	0	api.fda.gov
Princeton BioMeditech Corp.	Plainsboro, NJ, United States	Manufacturer	7	June 10, 2002	0	api.fda.gov
Princeton BioMeditech Corp.	Skillman, NJ, United States	Manufacturer	7	June 10, 2002	0	api.fda.gov
Microgenics Corporation	Fremont, CA, United States	Contract manufacturer, Manufacturer	5	September 24, 2021	1	api.fda.gov
Teco Diagnostics	Anaheim, CA, United States	Manufacturer, Repackager or relabeler	4	February 1, 2012	0	api.fda.gov
Alfa Scientific Designs, Inc.	Poway, CA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	2	August 14, 2000	0	api.fda.gov
Alere San Diego, Inc.	San Diego, CA, United States	Specification developer	2	February 17, 2004	0	api.fda.gov
Lin-Zhi International, Inc.	Santa Clara, CA, United States	Manufacturer	2	November 22, 2011	0	api.fda.gov
Omega Laboratories, Inc.	Mogadore, OH, United States	Manufacturer	2	November 13, 2013	0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, United States	Complaint file establishment, Specification developer	2	July 23, 2003	0	api.fda.gov
Alere San Diego, Inc.	Pomona, CA, United States	Manufacturer, Manufacturer for export	1	June 29, 2015	0	api.fda.gov
Beckman Coulter, Inc.	Brea, CA, United States	Specification developer	1	November 30, 1994	0	api.fda.gov
Bio-Rad Laboratories, Inc.	Hercules, CA, United States	Specification developer	1	July 9, 2001	1	api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.	Woodland Hills, CA, United States	Manufacturer, Manufacturer for export	1	June 2, 2017	0	api.fda.gov
Germaine Laboratories, Inc.	San Antonio, TX, United States	Manufacturer, Repackager or relabeler	1	July 9, 2001	0	api.fda.gov
Healgen Scientific LLC	Houston, TX, United States	Complaint file establishment, Specification developer	1	July 17, 2014	0	api.fda.gov
Lumiquick Diagnostics, Inc.	Santa Clara, CA, United States	Manufacturer, Repackager or relabeler	1	June 2, 2017	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Manufacturer, Repackager or relabeler	1	November 16, 2006	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Complaint file establishment, Specification developer	1	November 16, 2006	1	api.fda.gov
ABOUND Diagnostics, Inc	San Diego, CA, United States	Specification developer	0		0	api.fda.gov
Aceso Laboratories Inc.	Chino, CA, United States	Manufacturer	0		0	api.fda.gov
Advin Biotech, Inc.	San Diego, CA, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Beckman Coulter, Inc.	Carlsbad, CA, United States	Contract manufacturer	0		0	api.fda.gov
Calbiotech, Inc.	El Cajon, CA, United States	Manufacturer for export, Repackager or relabeler	0		0	api.fda.gov
Chemtron Biotech, Inc.	San Diego, CA, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	api.fda.gov
CorDx, Inc.	Alpharetta, GA, United States	Manufacturer	0		0	api.fda.gov
Medical Disposables Corp	Orlando, FL, United States	Complaint file establishment, Manufacturer for export, Repackager or relabeler	0		0	api.fda.gov
Medtox Diagnostics, Inc.	Burlington, NC, United States	Manufacturer	0		0	api.fda.gov
Medtox Diagnostics, Inc.	Burlington, NC, United States	Manufacturer	0		1	api.fda.gov
Nano-Ditech Corporation	Cranbury, NJ, United States	Manufacturer	0		0	api.fda.gov
Phamatech Inc.	San Diego, CA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Premier Biotech, LLC	Minneapolis, MN, United States	Complaint file establishment, Manufacturer for export, Specification developer	0		0	api.fda.gov
Scientific Supplies & Technology, Inc.	Doral, FL, United States	Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Ucp Biosciences, Inc.	Milpitas, CA, United States	Specification developer	0		0	api.fda.gov
W.H.P.M., Inc.	Irwindale, CA, United States	Contract manufacturer	0		0	api.fda.gov

Updated November 3, 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.