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.
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- Product code
- CDM
- Device class
- 1
- Regulation
- 862.1785
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 18 |
| China | 11 |
| Japan | 3 |
| South Korea | 3 |
| Germany | 2 |
| Ireland | 1 |
| Poland | 1 |
| Switzerland | 1 |
| United Kingdom | 1 |
| Argentina | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Acon Laboratories, Inc. | San Diego, CA, United States | Manufacturer, Specification developer | 1 | August 11, 2006 | 0 | 0 | 0 | api.fda.gov |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 1 | August 11, 2006 | 0 | 0 | 0 | api.fda.gov |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acon Biotech (hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARKRAY Factory, Inc. | Koka-shi Shiga, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arkray, Inc. | Kamigyo-ku Kyoto, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ave Science & Technology Co., Ltd | Changsha Hunan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Chaska, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changchun Merydi Bio-Tech Co., Ltd. | changchun Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changchun Wancheng Bio-Electron Co., Ltd. | Changchun Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chungdo Pharm. Co., Ltd. | Chuncheon-si Gangwon, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changchun LYZ Technology Co.,LTD | Changchun City Jilin, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist., Chongqing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dfi Co., Ltd. | Gimhae Jeonnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dirui Industrial Co., Ltd. | CHANGCHUN Jilin, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jilin Hongyi Bio-Tech Co., Ltd. | Changchun Jilin, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Electronics Poland Sp.z o.o | Tarnowo Podgorne Wielkopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Macherey-Nagel GMBH & Co., KG. | DUEREN North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Seimitsu Sokki Co., Ltd. | SHIBUKAWA Gunma, Japan | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ricca Chemical Company LLC | Pocomoke City, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ricca Chemical Company LLC | Arlington, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ricca Chemical Company LLC | Batesville, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Manufacturing Ltd | SUDBURY Suffolk, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics, Inc. | Mishawaka, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex America, Inc. | Buffalo Grove, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex America, Inc. - Vernon Hills | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| URIT Medical Electronic Co., Ltd. | Guilin Guangxi, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wiener Laboratorios S.A.I.C. | ROSARIO Santa Fe, Argentina | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Kangzheng Medical Equipments Technology Co.,Ltd | weihai Shandong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yd Diagnostics | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.