Established 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.
ISO 13485
Registration
ISO 9001
Registration
ISO 13485 – Tosoh Europe N.V. (EMEA)
ISO 9001 – Tosoh Europe N.V. (EMEA)
ISO 9001 – Tosoh Corporation (JP) Bioscience Division
ISO 13485 – Tosoh Corporation (JP) Bioscience Division
ISO 14001 – Tosoh Corporation (JP) Nanyo Complex
MDSAP Certification – Tosoh Corporation (JP)
Compliance program
FDA 510(k) Clearance
Registration
NGSP Certification
IFCC Traceability Certification
US Diagnostics, IncFounded 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.NEW YORK, NY
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
Tosoh USA, IncEstablished in New York in 1964 as Tosoh Corporation’s first U.S. representative office, Tosoh USA now operates from Grove City as the corporation’s North American sales, marketing, and business-development center. The company markets chemical products made by Tosoh Corporation and its affiliates, including materials such as silica glass, organic chemicals, and specialty polymers that support a wide range of everyday goods. Its portfolio also includes advanced zirconia materials, with Tosoh’s parent corporation described as having the world’s largest zirconia powder production capacity.GROVE CITY, OH
Enzo Life Sciences, IncEstablished in 1976, Enzo Life Sciences develops and manufactures labeling and detection technologies that support life-science research, drug discovery, biopharmaceutical development, and diagnostics. From its Long Island headquarters campus, the company combines in-house U.S. manufacturing with more than 45 years of experience and has produced over 20,000 life-science products. Enzo also provides custom and GMP manufacturing through facilities certified to ISO 9001 and ISO 13485.FARMINGDALE, NY