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Data / Medical devices / Diazo Colorimetry, Bilirubin / United States

FDA-registered makers of Diazo Colorimetry, Bilirubin in the United States: 25 establishments

25 establishments in the United States are registered with the FDA to make Diazo Colorimetry, Bilirubin (product code CIG). 18 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.

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Device
Diazo Colorimetry, Bilirubin
Product code
CIG
Country
United States

Makers of Diazo Colorimetry, Bilirubin in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer6February 27, 2026020api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer3April 2, 2015000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesManufacturer3June 2, 2004030api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer2April 26, 1994000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer2July 27, 1993000api.fda.gov
Carolina Liquid ChemistriesBrea, CA, United StatesManufacturer2August 27, 2001000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer2September 25, 1997000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer2March 1, 2013000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer2April 26, 2019020api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer2April 26, 2019020api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer2February 27, 2026020api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer2June 7, 1988000api.fda.gov
Advanced Instruments, LLCNorwood, MA, United StatesManufacturer1June 15, 1979000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesManufacturer1June 7, 1984000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesManufacturer1July 18, 1983000api.fda.gov
Instrumentation Laboratory Co.Bedford, MA, United StatesManufacturer1June 18, 2010000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesContract manufacturer, Manufacturer1November 1, 2006000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer1February 2, 1981000api.fda.gov
Abaxis, Inc.Union City, CA, United StatesManufacturer0000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0010api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer0000api.fda.gov
Hemagen Diagnostics, Inc.Baltimore, MD, United StatesManufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer0000api.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.