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Data / Medical devices / Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) / United States

FDA-registered makers of Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (product code JJB). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers of this device in the United StatesWatch these makers
Device
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Product code
JJB
Country
United States

Makers of Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer1April 24, 1995000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer1April 24, 1995000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer0000api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Miami, FL, United StatesSpecification developer0000api.fda.gov
Biorex Labs LLCBroadview Heights, OH, United StatesManufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesManufacturer, Remanufacturer0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer, Remanufacturer0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesSpecification developer0000api.fda.gov
Siemens Healthcare Diagnostics, Inc.Mishawaka, IN, United StatesManufacturer0000api.fda.gov
Sysmex America, Inc.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
Sysmex America, Inc. - Vernon HillsVernon Hills, IL, United StatesContract manufacturer0000api.fda.gov
VWR Chemicals, LLCSolon, OH, 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.