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Data / Medical devices / Glucose Oxidase, Glucose / United States

FDA-registered makers of Glucose Oxidase, Glucose in the United States: 47 establishments

47 establishments in the United States are registered with the FDA to make Glucose Oxidase, Glucose (product code CGA). 29 have a 510(k) clearance or PMA approval on file and 12 have a recall event. FDA data exported November 2, 2026.

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Device
Glucose Oxidase, Glucose
Product code
CGA
Country
United States

Makers of Glucose Oxidase, Glucose in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Abbott Point Of Care Inc.Princeton, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer6September 11, 2023050api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer6October 18, 2022040api.fda.gov
Instrumentation Laboratory Co.Bedford, MA, United StatesManufacturer5January 27, 2023020api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer, Repackager or relabeler4April 24, 2012000api.fda.gov
Bionostics, Inc.Devens, MA, United StatesContract manufacturer, Manufacturer3August 21, 2012000api.fda.gov
Nova Biomedical Corporation Diabetes ProductsBillerica, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export3July 11, 2007000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer3July 11, 2007000api.fda.gov
Polymer Technology SystemsWhitestown, IN, United StatesManufacturer3December 22, 2016030api.fda.gov
BiometerPlus USA, Inc.Fremont, CA, United StatesManufacturer2August 9, 2005000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesManufacturer2April 21, 1997010api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer, Repackager or relabeler2January 27, 2023000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer2June 24, 2016000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer, Remanufacturer2October 18, 2022000api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesManufacturer1September 20, 2023040api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer, Specification developer1April 27, 2011010api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer1January 14, 1986000api.fda.gov
Chematics, Inc.North Webster, IN, United StatesContract manufacturer, Manufacturer1July 23, 1996000api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesManufacturer1January 30, 2004000api.fda.gov
LifeScan U.S. LLCMalvern, PA, United StatesSpecification developer1May 20, 2005000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer1August 30, 2007000api.fda.gov
Mediusa Inc.Los Angeles, CA, United StatesRemanufacturer, Repackager or relabeler1August 21, 2012000api.fda.gov
Opti Medical Systems Inc.Roswell, GA, United StatesManufacturer1December 16, 1999010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1April 3, 2019040api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer1April 3, 2019010api.fda.gov
Radiometer MinneapolisNew Brighton, MN, United StatesManufacturer1December 7, 2015000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer, Repackager or relabeler, Specification developer1August 16, 1983000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer1September 29, 2004000api.fda.gov
Teladoc Health, Inc. - LewisvilleLewisville, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1September 8, 2014000api.fda.gov
Ysi IncorporatedYellow Spgs, OH, United StatesComplaint file establishment, Manufacturer1September 30, 2024000api.fda.gov
Abaxis, Inc.Union City, CA, United StatesManufacturer0000api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
AgamatrixDerry, NH, United StatesManufacturer, Specification developer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Care Living Diagnostics IncSouth Setauket, NY, United StatesSpecification developer0000api.fda.gov
Conductive Technologies, Inc.York, PA, United StatesContract manufacturer0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer for export0000api.fda.gov
East West WisconsinWhitewater, WI, United StatesContract manufacturer0000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
GL Diabetes CorporationSan Diego, CA, United StatesManufacturer for export0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medtronic MinimedNorthridge, CA, United StatesManufacturer for export0000api.fda.gov
Metene LimitedCity of Industry, CA, United StatesSpecification developer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Osang LLCS Pasadena, CA, United StatesContract manufacturer0000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer0010api.fda.gov
Telcare, LLCLinwood, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov

Updated November 2, 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.