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

FDA-registered makers of Glucose Dehydrogenase, Glucose in the United States: 17 establishments

17 establishments in the United States are registered with the FDA to make Glucose Dehydrogenase, Glucose (product code LFR). 9 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Glucose Dehydrogenase, Glucose
Product code
LFR
Country
United States

Makers of Glucose Dehydrogenase, Glucose in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ascensia Diabetes Care US Inc.Parsippany, NJ, United StatesSpecification developer3July 26, 2012000api.fda.gov
Ascensia Diabetes Care US Inc.Valhalla, NY, United StatesComplaint file establishment, Specification developer3July 26, 2012000api.fda.gov
Abbott Diabetes Care Inc.Alameda, CA, United StatesComplaint file establishment, Specification developer2September 17, 2015020api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer, Specification developer2April 4, 2013000api.fda.gov
Nova Biomedical Corporation Diabetes ProductsBillerica, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export2April 4, 2013000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export2April 4, 2013000api.fda.gov
Bionostics, Inc.Devens, MA, United StatesContract manufacturer, Manufacturer1April 27, 2005000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer1April 21, 1986000api.fda.gov
RR Donnelley-Supply Chain SolutionsPlover, WI, United StatesContract manufacturer, Repackager or relabeler1July 26, 2012000api.fda.gov
GL Diabetes CorporationSan Diego, CA, United StatesContract manufacturer0000api.fda.gov
Mediusa Inc.Los Angeles, CA, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Osang LLCS Pasadena, CA, United StatesComplaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Rasimo Systems LLCRaleigh, NC, United StatesSpecification developer0000api.fda.gov
Roche Diabetes Care, Inc.Indianapolis, IN, United StatesManufacturer, Manufacturer for export, Repackager or relabeler, Specification developer0020api.fda.gov
Rosie Connectivity Solutions, Inc.Savannah, GA, United StatesRemanufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer0000api.fda.gov
Trividia Health, Inc.Fort Lauderdale, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.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.