Founded in March 2005, New York City-based US Diagnostics, Inc. develops, manufactures and distributes blood glucose monitoring systems for home and clinical use. Its meters have been provided to more than one million people with diabetes, with the company pairing capillary whole-blood measurement technology and plasma-equivalent results with a three-year meter warranty. US Diagnostics also maintains shipping warehouses in New Jersey and Florida to serve customers nationwide.
ISO 15197 compliance
Compliance program
LifeScanFor more than 40 years, LifeScan has focused on helping people with diabetes manage their health through glucose-monitoring technology. Its OneTouch brand is used by more than 20 million people worldwide, while the company’s work also includes digital health solutions and hospital systems for diabetes care.MALVERN, PA
American Diagnostic CorporationAmerican Diagnostic Corporation was founded in 1984 by Marc Blitstein and Neal Weingart, who built the company around long-term supplier relationships and substantial U.S. production. Based in Hauppauge, New York, ADC is known for assembling, testing, and packaging more than half of its products domestically while serving healthcare professionals worldwide. Its quality system is certified to ISO 13485:2016 under MDSAP.HAUPPAUGE, NY
Chembio Diagnostic Systems, IncChembio Diagnostic Systems, a Medford, New York subsidiary of Biosynex, develops and manufactures rapid point-of-care diagnostic tests for detecting and monitoring disease. Its proprietary Dual Path Platform (DPP®) technology supports simple tests that can use a small blood sample and deliver results in about 15 minutes, including the FDA-approved, CLIA-waived DPP® HIV-Syphilis test. Chembio serves clients worldwide through offices and partners and also applies its diagnostic platform to veterinary testing.MEDFORD, NY
Tosoh Bioscience, IncEstablished in the United States in 1989, Tosoh Bioscience, Inc. is the American diagnostics subsidiary of Japan’s Tosoh Corporation, based in Grove City, Ohio. It is known across the Americas for supplying clinical laboratories with diagnostic systems, particularly automated immunoassay and HPLC technology, supported by a quality system built around regulatory compliance and continuous improvement.GROVE CITY, OH