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Acon Laboratories, Inc.
U.S. FDA grants 510(k) clearance for infectious mononucleosis rapid tests
August 10th, 2005
Acon Laboratories, Inc., of San Diego, California, announced that the U.S. Food and Drug Administration (FDA) cleared the company's 510(k) submission for its Infectious Mononucleosis Rapid Tests, available in both strip and device formats. Infectious mononucleosis, sometimes referred to as the "kissing disease," is caused by the Epstein-Barr virus, a member of the herpesvirus family. Transmitted by saliva, it begins with flu-like symptoms and may progress into swollen lymph glands, sore throat, and spleen enlargement. A ruptured spleen is a potentially serious complication of infectious mononucleosis. Early and rapid detection is the first step...
Source: Biotech Week (2005-08-10)
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