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

FDA-registered makers of Enzyme Immunoassay, Barbiturate in the United States: 33 establishments

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

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Device
Enzyme Immunoassay, Barbiturate
Product code
DIS
Country
United States

Makers of Enzyme Immunoassay, Barbiturate in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesContract manufacturer, Manufacturer, Specification developer5April 20, 2001000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer3April 13, 2001000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer3April 13, 2001000api.fda.gov
Microgenics CorporationFremont, CA, United StatesContract manufacturer, Manufacturer3May 6, 1996000api.fda.gov
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer3April 15, 1999000api.fda.gov
Princeton BioMeditech Corp.Plainsboro, NJ, United StatesManufacturer3April 15, 1999000api.fda.gov
Princeton BioMeditech Corp.Skillman, NJ, United StatesManufacturer3April 15, 1999000api.fda.gov
Alfa Scientific Designs, Inc.Poway, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler2May 29, 2001000api.fda.gov
Phamatech Inc.San Diego, CA, United StatesManufacturer, Repackager or relabeler2December 7, 2007000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer2April 20, 2001000api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesSpecification developer1November 9, 2001010api.fda.gov
Alere San Diego, Inc.Pomona, CA, United StatesManufacturer, Manufacturer for export1October 14, 2016000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer1December 29, 1994010api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesSpecification developer1November 9, 2001000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler1November 9, 2001000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer1April 24, 2015000api.fda.gov
Lin-Zhi International, Inc.Santa Clara, CA, United StatesManufacturer1November 3, 2003010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler1January 5, 2007000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1January 5, 2007000api.fda.gov
Ucp Biosciences, Inc.Milpitas, CA, United StatesSpecification developer1April 20, 2011000api.fda.gov
ABOUND Diagnostics, IncSan Diego, CA, United StatesSpecification developer0000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer0000api.fda.gov
Advin Biotech, Inc.San Diego, CA, United StatesManufacturer0000api.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
Chemtron Biotech, Inc.San Diego, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer, Remanufacturer0000api.fda.gov
Lumiquick Diagnostics, Inc.Santa Clara, CA, United StatesManufacturer, Repackager or relabeler0000api.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
Quidel Cardiovascular Inc.San Diego, CA, United StatesManufacturer, Manufacturer for export0000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer0000api.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.