Data / Medical devices / Electrode, Ion-Specific, Chloride
Electrode, Ion-Specific, Chloride (CGZ): 69 FDA-registered makers in 15 countries
69 establishments in 15 countries are registered with the FDA to make Electrode, Ion-Specific, Chloride (product code CGZ, Class 2, 21 CFR 862.1170). 10 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 38 510(k) clearances under this code, the latest on October 30, 2018, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CGZ
- Device class
- 2
- Regulation
- 862.1170
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 32 |
| Japan | 8 |
| Germany | 6 |
| Canada | 4 |
| China | 3 |
| United Kingdom | 3 |
| Italy | 2 |
| France | 2 |
| Switzerland | 2 |
| Poland | 2 |
| Mexico | 1 |
| Hungary | 1 |
| Denmark | 1 |
| Ireland | 1 |
| Netherlands | 1 |
Makers of Electrode, Ion-Specific, Chloride
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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Laboratories | Irving, TX, United States | Manufacturer, Specification developer | 2 | October 24, 2017 | 0 | 0 | 0 | api.fda.gov |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 2 | May 15, 2000 | 0 | 0 | 0 | api.fda.gov |
| Nova Biomedical Corporation | Waltham, MA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer | 2 | November 6, 1992 | 0 | 0 | 0 | api.fda.gov |
| Phoenix Diagnostics, Inc. | Natick, MA, United States | Manufacturer | 2 | February 4, 2002 | 0 | 0 | 0 | api.fda.gov |
| ELITechGroup Inc | Logan, UT, United States | Contract manufacturer, Manufacturer | 1 | May 24, 1988 | 0 | 0 | 0 | api.fda.gov |
| Infrared Laboratory Systems dba SYNERMED | Westfield, IN, United States | Manufacturer | 1 | March 3, 1997 | 0 | 0 | 0 | api.fda.gov |
| Opti Medical Systems Inc. | Roswell, GA, United States | Manufacturer | 1 | September 29, 2005 | 0 | 2 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | October 30, 2018 | 0 | 2 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 1 | October 30, 2018 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | May 15, 2000 | 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 | |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Awareness Technology, Inc. | Palm City, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Automation Solutions GmbH | Hamburg, Germany | Manufacturer | 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 | 0 | 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 K. K. | Sunto-Gun Shizuoka, Japan | Specification developer | 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 | |
| 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 | |
| Carolina Liquid Chemistries | Brea, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | 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 | |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epocal, Inc. | Ottawa Ontario, Canada | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ever Pharma Jena | Jena Thuringia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epocal Inc | Ottawa Ontario, Canada | Manufacturer, Specification developer | 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 | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumentation Laboratory Co. | Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jeol Ltd. | Musashimurayama Tokyo, Japan | Manufacturer | 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 | |
| Nypro Inc. (Chicago) | Gurnee, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiometer Medical Aps | BROENSHOEJ Hovedstaden, Denmark | Complaint file establishment, 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 | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 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 | 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 | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Manufacturing Ltd | SUDBURY Suffolk, United Kingdom | Manufacturer, Specification developer | 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 | |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 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 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Manufacturing Ltd. | SWORDS Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tessy Plastics Corp. | Elbridge, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VitalScientific | SEES Normandie, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VitalScientific B.V. | SPANKEREN Gelderland, Netherlands | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 30, 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.