Chembio Diagnostics Inc was formed in 1985. The Company with its subsidiaries develops, manufactures and markets diagnostic tests that detect infectious diseases. The Company's main products presently commercially available are four rapid tests for the detection of HIV antibodies in whole blood, serum and plasma samples, all of which Employ lateral flow technology, and two of which were approved by the FDA in 2006. The Company's products are sold to medical laboratories and hospitals, governmental and public health entities, non-governmental organizations, medical professionals and retail establishments both domestically and internationally. The Company's products are sold under its STAT PAK, SURE CHECK or DPP registered trademarks. The Company's HIV tests are qualitative (reactive/non-reactive) tests. Many of its competitors are substantially larger and have greater financial, research, manufacturing and marketing resources. The manufacturing and marketing of the Company's existing and proposed diagnostic products are regulated by the United States Food and Drug Administration ('FDA'), United States Department of Agriculture ('USDA'), certain state and local agencies, and/or comparable regulatory bodies in other countries.