Data / Medical devices / Electrode, Ion Specific, Urea Nitrogen
Electrode, Ion Specific, Urea Nitrogen (CDS): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Electrode, Ion Specific, Urea Nitrogen (product code CDS, Class 2, 21 CFR 862.1770). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on January 17, 2018, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CDS
- Device class
- 2
- Regulation
- 862.1770
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Canada | 3 |
| Hungary | 1 |
| Switzerland | 1 |
Makers of Electrode, Ion Specific, Urea Nitrogen
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 |
|---|---|---|---|---|---|---|---|---|
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | Manufacturer | 1 | January 30, 2004 | 0 | 0 | 0 | api.fda.gov |
| Epocal, Inc. | Ottawa Ontario, Canada | Manufacturer, Specification developer | 1 | January 17, 2018 | 0 | 0 | 0 | api.fda.gov |
| Abbott Point Of Care Canada Limited | Ottawa Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Point Of Care Inc. | Princeton, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diamond Diagnostics Inc. | Budapest, Hungary | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epocal Inc | Ottawa Ontario, Canada | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Waltham, MA, United States | Manufacturer, Manufacturer for export, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer, Manufacturer for export, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Opti Medical Systems Inc. | Roswell, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 17, 2018. 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.