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www.fdanews.com/articles/137938-chembio-initiates-pre-ide-studies-for-home-use-of-sure-check-rapid-hiv-test

Chembio Initiates Pre-IDE Studies for Home Use of Sure Check Rapid HIV Test

June 27, 2011
Chembio Diagnostics Inc., which develops, manufactures, markets and licenses point-of-care diagnostic tests, has initiated studies required for submission of an Investigational Device Exemption (IDE) to the Food and Drug Administration for its Sure Check rapid HIV Test as the first step toward over-the-counter (OTC) product approval.
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