Trinity Biotech PLC was incorporated as a public limited company, registered in Ireland in January 1992. The Company commenced operations in 1992 and, in October 1992, completed an initial public offering of its securities in the US. The Company develops, acquires, manufactures and markets medical diagnostic products for the clinical laboratory and point-of-care (POC) segments of the diagnostic market. These products are used to detect autoimmune, infectious and sexually transmitted diseases, diabetes and disorders of the blood, liver and intestine. It is also a provider of raw materials to the life sciences industry. The Company markets its portfolio of almost 850 products to customers in approximately 100 countries around the world through its own sales force and a network of international distributors and strategic partners. The primary market for Trinity Biotech's tests remains the USA. The Company develops, acquires, manufactures and markets clinical in-vitro diagnostic products. It supplies the clinical laboratory segment of the in-vitro diagnostic market. It also sells raw materials to the life sciences industry. Its Point-of-Care product is Unigold (tm), which tests for the presence of HIV antibodies. It sells its product through its own direct sales-force in four countries: the United States, Germany, France and the United Kingdom. Its competitors are Abbott Diagnostics, Alere Inc., Arkray, Bio-Rad, Diasorin Inc., Euroimmun, Johnson & Johnson, OraSure Technologies Inc., Phadia, Roche Diagnostics, Siemens (from the combined acquisitions of Bayer, Dade-Behring and DPC), Thermo Fisher, Tosoh and Werfen. The preclinical and clinical testing, manufacture, labelling, distribution, and promotion of Trinity Biotech's products are subject to extensive and rigorous government regulation in the United States and in other countries in which its products are sought to be marketed.