Company Profile About Us SentinelDiagnostics is an Italian company founded in 1983. For over thirty years Sentinel has been committed to the development of innovative IVD devices in the bid to make clinical diagnosis ever more reliable. In 2006 Sentinel moved to new high-tech premises covering a total area of about 10.000m2 . The company is ISO 9001:2008, EN ISO 13485:2012, ISO 13485:2003 CMDCAS, BS OHSAS 18001:2007 and ISO 14001:2004certified. Sentinel is compliant with the European Directives (98/79/CE), 21C CFR 820 "Code of Federal Regulations" FDA (U.S. Food and Drug Administration), SOR-98-282 (Canadian Medical Devices Regulations). Sentinel's commitment to comply with IVD regulations has facilitated and supported successful partnerships in the industry as well as the distribution of Sentinel's products in over 70 countries worldwide. The company's main areas of activity are: Clinical Chemistry, Immunoturbidimetry Calibrators andControls, Fully automated systems for Clinical and Immunochemistry, FaecalImmunochemical Testing (FIT) and Molecular Diagnostics. The new Molecular Biology department initiated in 2008 has its own Production clean rooms (ISO 7) as well as R&D laboratory.