Skip to the page

Data / Medical devices / Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (CDM): 42 FDA-registered makers in 10 countries

42 establishments in 10 countries are registered with the FDA to make Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (product code CDM, Class 1, 21 CFR 862.1785). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on December 5, 2006, and lists 1 recall event (0 Class I). 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.

Product code
CDM
Device class
1
Regulation
862.1785
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States18
China11
Japan3
South Korea3
Germany2
Ireland1
Poland1
Switzerland1
United Kingdom1
Argentina1

Makers of Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Acon Laboratories, Inc.San Diego, CA, United StatesManufacturer, Specification developer1August 11, 2006000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler1August 11, 2006000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer0000api.fda.gov
Acon Biotech (hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer0000api.fda.gov
ARKRAY Factory, Inc.Koka-shi Shiga, JapanManufacturer0000api.fda.gov
Arkray, Inc.Kamigyo-ku Kyoto, JapanSpecification developer0000api.fda.gov
Ave Science & Technology Co., LtdChangsha Hunan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Miami, FL, United StatesSpecification developer0000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandContract manufacturer0000api.fda.gov
Changchun Merydi Bio-Tech Co., Ltd.changchun Jilin, ChinaManufacturer0000api.fda.gov
Changchun Wancheng Bio-Electron Co., Ltd.Changchun Jilin, ChinaManufacturer0000api.fda.gov
Chungdo Pharm. Co., Ltd.Chuncheon-si Gangwon, South KoreaContract manufacturer, Manufacturer0000api.fda.gov
Changchun LYZ Technology Co.,LTDChangchun City Jilin, ChinaExporter to the US, Manufacturer0000api.fda.gov
Chong Qing Teco Huayi Pharm. Co.Shapingba Dist., Chongqing, ChinaManufacturer0000api.fda.gov
Dfi Co., Ltd.Gimhae Jeonnam, South KoreaManufacturer0000api.fda.gov
Dirui Industrial Co., Ltd.CHANGCHUN Jilin, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Jilin Hongyi Bio-Tech Co., Ltd.Changchun Jilin, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kimball Electronics Poland Sp.z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Macherey-Nagel GMBH & Co., KG.DUEREN North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Nihon Seimitsu Sokki Co., Ltd.SHIBUKAWA Gunma, JapanManufacturer, Specification developer0000api.fda.gov
Ricca Chemical Company LLCPocomoke City, MD, United StatesManufacturer0000api.fda.gov
Ricca Chemical Company LLCArlington, TX, United StatesManufacturer0000api.fda.gov
Ricca Chemical Company LLCBatesville, IN, United StatesManufacturer0000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing LtdSUDBURY Suffolk, United KingdomManufacturer0000api.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
Teco DiagnosticsAnaheim, CA, United StatesManufacturer0000api.fda.gov
URIT Medical Electronic Co., Ltd.Guilin Guangxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Wiener Laboratorios S.A.I.C.ROSARIO Santa Fe, ArgentinaManufacturer0000api.fda.gov
Weihai Kangzheng Medical Equipments Technology Co.,Ltdweihai Shandong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yd DiagnosticsYongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov

Updated December 5, 2006. 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.