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

FDA-registered makers of Enzyme Immunoassay, Amphetamine in the United States: 37 establishments

37 establishments in the United States are registered with the FDA to make Enzyme Immunoassay, Amphetamine (product code DKZ). 29 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Enzyme Immunoassay, Amphetamine
Product code
DKZ
Country
United States

Makers of Enzyme Immunoassay, Amphetamine in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ucp Biosciences, Inc.Milpitas, CA, United StatesSpecification developer8August 21, 2015000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer7May 19, 2006000api.fda.gov
Alfa Scientific Designs, Inc.Poway, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler6February 23, 2018000api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesSpecification developer4November 13, 2006060api.fda.gov
Lin-Zhi International, Inc.Santa Clara, CA, United StatesManufacturer4February 4, 2014000api.fda.gov
Microgenics CorporationFremont, CA, United StatesContract manufacturer, Manufacturer4October 30, 2024000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer, Repackager or relabeler3February 23, 2018000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer3February 13, 2009000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer3February 13, 2009010api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer3January 7, 2005000api.fda.gov
ABOUND Diagnostics, IncSan Diego, CA, United StatesSpecification developer2December 13, 2023000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer2December 13, 2023000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesSpecification developer2November 13, 2006010api.fda.gov
Lumiquick Diagnostics, Inc.Santa Clara, CA, United StatesManufacturer, Repackager or relabeler2May 17, 2004000api.fda.gov
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer2April 13, 1995000api.fda.gov
Princeton BioMeditech Corp.Plainsboro, NJ, United StatesManufacturer2April 13, 1995000api.fda.gov
Princeton BioMeditech Corp.Skillman, NJ, United StatesManufacturer2April 13, 1995000api.fda.gov
Advin Biotech, Inc.San Diego, CA, United StatesContract manufacturer, Manufacturer1June 17, 2013000api.fda.gov
Alere San Diego, Inc.Pomona, CA, United StatesManufacturer, Manufacturer for export1February 6, 2015000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer1May 5, 2000000api.fda.gov
Calbiotech, Inc.El Cajon, CA, United StatesManufacturer for export, Repackager or relabeler1June 17, 2013000api.fda.gov
CorDx, Inc.Alpharetta, GA, United StatesManufacturer1April 15, 2016000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler1July 31, 2001000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer1September 9, 2015000api.fda.gov
Omega Laboratories, Inc.Mogadore, OH, United StatesManufacturer1July 28, 2015000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler1November 22, 2006000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1November 22, 2006000api.fda.gov
Premier Biotech, LLCMinneapolis, MN, United StatesComplaint file establishment, Manufacturer for export, Specification developer1June 17, 2013000api.fda.gov
Quidel Cardiovascular Inc.San Diego, CA, United StatesManufacturer, Manufacturer for export1June 19, 2019000api.fda.gov
Ark Diagnostics IncFremont, CA, United StatesManufacturer for export0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Chemtron Biotech, Inc.San Diego, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Medical Disposables CorpOrlando, FL, United StatesComplaint file establishment, Manufacturer for export, Repackager or relabeler0000api.fda.gov
Nano-Ditech CorporationCranbury, NJ, United StatesManufacturer for export0000api.fda.gov
Phamatech Inc.San Diego, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
W.H.P.M., Inc.Irwindale, CA, United StatesContract manufacturer0000api.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.