Published in AIDS Weekly, August 16th, 2004
This is the initial step toward a Premarket Approval (PMA) application to the U.S. Food & Drug Administration. The clinical trials will be conducted at approved sites throughout the United States, in accordance with an Investigational Device Exemption (IDE), granted by the FDA to the company. Chembio Diagnostics, Inc., expects that the trials will be completed during the...
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