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Data / Medical devices / System, Test, Blood Glucose, Over The Counter / United States

FDA-registered makers of System, Test, Blood Glucose, Over The Counter in the United States: 42 establishments

42 establishments in the United States are registered with the FDA to make System, Test, Blood Glucose, Over The Counter (product code NBW). 30 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 3, 2026.

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Device
System, Test, Blood Glucose, Over The Counter
Product code
NBW
Country
United States

Makers of System, Test, Blood Glucose, Over The Counter in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ascensia Diabetes Care US Inc.Parsippany, NJ, United StatesSpecification developer16August 27, 2026000api.fda.gov
Ascensia Diabetes Care US Inc.Valhalla, NY, United StatesComplaint file establishment, Specification developer16August 27, 2026010api.fda.gov
Abbott Diabetes Care Inc.Alameda, CA, United StatesComplaint file establishment, Manufacturer, Specification developer11September 27, 20170133api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesContract manufacturer, Manufacturer, Specification developer9October 10, 2025000api.fda.gov
Bionostics, Inc.Devens, MA, United StatesContract manufacturer, Manufacturer8September 24, 2014000api.fda.gov
RR Donnelley-Supply Chain SolutionsPlover, WI, United StatesContract manufacturer, Repackager or relabeler8September 27, 2017000api.fda.gov
Trividia Health, Inc.Fort Lauderdale, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer8July 23, 2026061api.fda.gov
Roche Diabetes Care, Inc.Indianapolis, IN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer7May 6, 2022050api.fda.gov
Nova Biomedical Corporation Diabetes ProductsBillerica, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export6June 23, 2016000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer6June 23, 2016000api.fda.gov
Polymer Technology SystemsWhitestown, IN, United StatesManufacturer6February 26, 2022050api.fda.gov
AgamatrixDerry, NH, United StatesComplaint file establishment, Manufacturer, Specification developer5June 6, 2024000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer, Specification developer5June 23, 2016011api.fda.gov
Metene LimitedCity of Industry, CA, United StatesSpecification developer4May 8, 2019000api.fda.gov
LifeScan U.S. LLCMalvern, PA, United StatesSpecification developer3October 5, 2007000api.fda.gov
Osang LLCS Pasadena, CA, United StatesComplaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer3October 16, 2020000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer, Repackager or relabeler3April 21, 2017000api.fda.gov
Fondcircle Inc.Newport Beach, CA, United StatesSpecification developer2March 20, 2020000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Remanufacturer, Repackager or relabeler2June 21, 2013000api.fda.gov
IMPILO, Inc.Philadelphia, PA, United StatesContract manufacturer, Repackager or relabeler2March 20, 2020000api.fda.gov
Optum Distribution Center, LLCMarietta, GA, United StatesManufacturer2December 23, 2021000api.fda.gov
AnriwellRiverside, CA, United StatesRepackager or relabeler, Specification developer1March 20, 2020000api.fda.gov
Care Living Diagnostics IncSouth Setauket, NY, United StatesSpecification developer1December 9, 2005000api.fda.gov
Mediusa Inc.Los Angeles, CA, United StatesRemanufacturer, Repackager or relabeler1November 10, 2016000api.fda.gov
Mio Labs Inc.Franklin D Roosevelt, NY, United StatesManufacturer1June 28, 2023000api.fda.gov
Rasimo Systems LLCRaleigh, NC, United StatesSpecification developer1November 10, 2016000api.fda.gov
Rosie Connectivity Solutions, Inc.Savannah, GA, United StatesRemanufacturer, Repackager or relabeler, Specification developer1June 28, 2010000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer1November 10, 2016000api.fda.gov
Teladoc Health, Inc. - LewisvilleLewisville, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1January 30, 2025000api.fda.gov
Telcare, LLCLinwood, PA, United StatesComplaint file establishment, Manufacturer, Specification developer1July 28, 2011010api.fda.gov
ALOM Technologies CorporationIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
BiometerPlus USA, Inc.Fremont, CA, United StatesManufacturer0000api.fda.gov
Conductive Technologies, Inc.York, PA, United StatesContract manufacturer0000api.fda.gov
East West WisconsinWhitewater, WI, United StatesContract manufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Flextronics America, LLCAustin, TX, United StatesContract manufacturer0000api.fda.gov
Flextronics International USABuffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
GL Diabetes CorporationSan Diego, CA, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
IMPILO - PHL KubachPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Impilo PhoenixPhoenix, AZ, United StatesContract manufacturer0000api.fda.gov
Insulet CorporationActon, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov

Updated November 3, 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.