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Data / Medical devices / Enzyme Immunoassay, Opiates / United States

FDA-registered makers of Enzyme Immunoassay, Opiates in the United States: 40 establishments

40 establishments in the United States are registered with the FDA to make Enzyme Immunoassay, Opiates (product code DJG). 30 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, Opiates
Product code
DJG
Country
United States

Makers of Enzyme Immunoassay, Opiates in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Lin-Zhi International, Inc.Santa Clara, CA, United StatesManufacturer13June 18, 2025010api.fda.gov
Microgenics CorporationFremont, CA, United StatesContract manufacturer, Manufacturer8September 27, 2023000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer8July 25, 2023000api.fda.gov
Alere San Diego, Inc.Pomona, CA, United StatesManufacturer, Manufacturer for export7May 9, 2022000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer, Manufacturer for export7January 29, 2026000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer, Manufacturer for export7January 29, 2026000api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesSpecification developer4April 21, 2006000api.fda.gov
Chemtron Biotech, Inc.San Diego, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer4December 20, 2023000api.fda.gov
Ark Diagnostics IncFremont, CA, United StatesManufacturer, Manufacturer for export3November 9, 2023000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesSpecification developer3April 21, 2006000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer3July 31, 2023000api.fda.gov
Lumiquick Diagnostics, Inc.Santa Clara, CA, United StatesManufacturer, Repackager or relabeler3April 26, 2016000api.fda.gov
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer, Manufacturer for export3February 26, 2014000api.fda.gov
Princeton BioMeditech Corp.Plainsboro, NJ, United StatesManufacturer3February 26, 2014000api.fda.gov
Princeton BioMeditech Corp.Skillman, NJ, United StatesManufacturer3February 26, 2014000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer3October 18, 2017010api.fda.gov
Advin Biotech, Inc.San Diego, CA, United StatesContract manufacturer, Manufacturer2September 17, 2020000api.fda.gov
Alfa Scientific Designs, Inc.Poway, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler2May 7, 2007000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer2January 29, 1999010api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer2January 27, 2015000api.fda.gov
Omega Laboratories, Inc.Mogadore, OH, United StatesManufacturer2January 8, 2015000api.fda.gov
Phamatech Inc.San Diego, CA, United StatesManufacturer, Repackager or relabeler2February 7, 2005000api.fda.gov
ABOUND Diagnostics, IncSan Diego, CA, United StatesSpecification developer1July 31, 2023000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer1July 31, 2023000api.fda.gov
Boston Easy Biotech IncBelmont, MA, United StatesSpecification developer1March 31, 2023000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler1May 3, 2004000api.fda.gov
Healgen Life Science LLCHouston, TX, United StatesComplaint file establishment, Specification developer1August 15, 2025000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler1December 15, 2006000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1December 15, 2006010api.fda.gov
Ucp Biosciences, Inc.Milpitas, CA, United StatesSpecification developer1February 24, 2010000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Calbiotech, Inc.El Cajon, CA, United StatesManufacturer for export, Repackager or relabeler0000api.fda.gov
CorDx, Inc.Alpharetta, GA, United StatesManufacturer0000api.fda.gov
Keva Inc.Blaine, WA, United StatesManufacturer for export0000api.fda.gov
Medical Disposables CorpOrlando, FL, United StatesComplaint file establishment, Manufacturer for export, Repackager or relabeler0000api.fda.gov
Medinova Group Co.Laguna Beach, CA, United StatesManufacturer for export0000api.fda.gov
Nano-Ditech CorporationCranbury, NJ, United StatesManufacturer0000api.fda.gov
Premier Biotech, LLCMinneapolis, MN, United StatesComplaint file establishment, Manufacturer for export, Specification developer0000api.fda.gov
Quidel Cardiovascular Inc.San Diego, CA, United StatesManufacturer, Manufacturer for export0000api.fda.gov
W.H.P.M., Inc.Irwindale, CA, United StatesContract manufacturer0000api.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.