Data / Medical devices / Electrode, Ion Specific, Sodium
Electrode, Ion Specific, Sodium (JGS): 72 FDA-registered makers in 15 countries
72 establishments in 15 countries are registered with the FDA to make Electrode, Ion Specific, Sodium (product code JGS, Class 2, 21 CFR 862.1665). 33 of them have a 510(k) clearance or PMA approval on file and 8 have a recall event. The FDA has issued 162 510(k) clearances under this code, the latest on May 1, 2026, and lists 34 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JGS
- Device class
- 2
- Regulation
- 862.1665
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 34 |
| Japan | 8 |
| Germany | 6 |
| Canada | 4 |
| China | 3 |
| United Kingdom | 3 |
| Ireland | 2 |
| France | 2 |
| Italy | 2 |
| Switzerland | 2 |
| Poland | 2 |
| Hungary | 1 |
| Denmark | 1 |
| Netherlands | 1 |
| Mexico | 1 |
Makers of Electrode, Ion Specific, Sodium
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 |
|---|---|---|---|---|---|---|---|---|
| Nova Biomedical Corporation | Waltham, MA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer | 9 | July 19, 2019 | 0 | 1 | 0 | api.fda.gov |
| Abbott Point Of Care Canada Limited | Ottawa Ontario, Canada | Manufacturer | 6 | October 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 5 | February 2, 2001 | 0 | 0 | 0 | api.fda.gov |
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | Manufacturer | 4 | August 22, 2012 | 0 | 0 | 0 | api.fda.gov |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer, Manufacturer for export, Remanufacturer | 4 | July 19, 2019 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 4 | July 25, 2023 | 0 | 15 | 0 | api.fda.gov |
| Abbott Point Of Care Inc. | Princeton, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | October 27, 2023 | 0 | 4 | 0 | api.fda.gov |
| Diamond Diagnostics Inc. | Budapest, Hungary | Contract manufacturer, Exporter to the US | 3 | December 16, 2016 | 0 | 0 | 0 | api.fda.gov |
| Carolina Liquid Chemistries | Brea, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | December 27, 2004 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 2 | July 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Manufacturing Ltd. | SWORDS Dublin(County), Ireland | Manufacturer | 2 | March 9, 2017 | 0 | 0 | 0 | api.fda.gov |
| Abaxis, Inc. | Union City, CA, United States | Manufacturer | 1 | October 25, 1999 | 0 | 0 | 0 | api.fda.gov |
| Awareness Technology, Inc. | Palm City, FL, United States | Manufacturer | 1 | February 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| Abbott Automation Solutions GmbH | Hamburg, Germany | Manufacturer | 1 | March 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Contract manufacturer, Manufacturer | 1 | July 21, 1992 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter K. K. | Sunto-Gun Shizuoka, Japan | Specification developer | 1 | December 16, 2016 | 0 | 0 | 0 | api.fda.gov |
| Epocal, Inc. | Ottawa Ontario, Canada | Manufacturer, Specification developer | 1 | September 27, 2006 | 0 | 0 | 0 | api.fda.gov |
| Epocal Inc | Ottawa Ontario, Canada | Manufacturer, Specification developer | 1 | September 27, 2006 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Bedford, MA, United States | Manufacturer | 1 | February 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer, Repackager or relabeler | 1 | December 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Infrared Laboratory Systems dba SYNERMED | Westfield, IN, United States | Manufacturer | 1 | June 20, 1995 | 0 | 0 | 0 | api.fda.gov |
| Jeol Ltd. | Musashimurayama Tokyo, Japan | Manufacturer | 1 | May 21, 1999 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | June 30, 2008 | 0 | 2 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 1 | June 30, 2008 | 0 | 2 | 0 | api.fda.gov |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Specification developer | 1 | December 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| Radiometer Medical Aps | BROENSHOEJ Hovedstaden, Denmark | Complaint file establishment, Manufacturer | 1 | May 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | October 24, 1996 | 0 | 0 | 0 | api.fda.gov |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 1 | April 6, 2010 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | June 9, 2016 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Manufacturing Ltd | SUDBURY Suffolk, United Kingdom | Manufacturer, Specification developer | 1 | May 28, 1987 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 1 | June 9, 2016 | 0 | 0 | 0 | api.fda.gov |
| VitalScientific | SEES Normandie, France | Manufacturer | 1 | March 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| VitalScientific B.V. | SPANKEREN Gelderland, Netherlands | Contract manufacturer, Manufacturer | 1 | March 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Laboratories de Mexico | Cuautitlan Izcalli Mexico, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer, Specification developer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bionostics, Inc. | Devens, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BIOTECNICA INSTRUMENTS, Srl | ROME Roma, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Mishima K.K. | SUNTO-GUN Shizuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Hebron, KY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biolis Medical Corp. | Hino Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canon Inc. | OTAWARA-SHI Tochigi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cliniqa Corporation | San Marcos, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Currier Plastics | Auburn, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ELITechGroup Inc | Logan, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ever Pharma Jena | Jena Thuringia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Furuno Electric Co., Ltd. | NISHINOMIYA-CITY Hyogo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hitachi High-Tech Corp., Naka Division | Hitachinaka-shi Ibaraki, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horiba Abx SAS | MONTPELLIER Herault, France | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horiba Ltd. | Kyoto, Japan | Contract manufacturer, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inpeco S.P.A. | Val della Torre Torino, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inpeco SA | Novazzano Ticino, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Inc. (Chicago) | Gurnee, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Opti Medical Systems Inc. | Roswell, GA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Phoenix Diagnostics, Inc. | Natick, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories Limited | ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiometer Minneapolis | New Brighton, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiometer Solutions Sp. z o.o. | Stargard Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiometer Sp. z o.o | Stargard Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanzay Corporation - | Miami Gardens, FL, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sekisui Diagnostics P.E.I. Inc. | CHARLOTTETOWN Prince Edward Island, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siegfried Hameln GmbH | Hameln Lower Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tessy Plastics Corp. | Elbridge, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 1, 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.