Women's Health Weekly
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Diagnostics
U.S. FDA grants 510(k) clearance for OTC pregnancy test
August 4th, 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 +/- Midstream OTC Pregnancy Test. This simple one step midstream test, available for OTC use, provides accurate, easy to read results in just 3 minutes. The Acon +/- Midstream Pregnancy Test qualitatively detects hCG (human chorionic gonadotropin) in a urine sample with a designated cutoff hCG concentration of 25 mIU/mL, a concentration that has been standardized to the World Health Organization Fourth International Standard for Chorionic Gonadotropin. A "+" sign in the test window indicates a...
Source: Women's Health Weekly (2005-08-04)
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