FDAnews Device Daily Bulletin

CHEMBIO RECEIVES FDA APPROVAL FOR ITS RAPID HIV TESTS; COMPANY EXPECTS NEW MARKET OPPORTUNITIES AND REVENUE GROWTH

May 31, 2006
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Chembio Diagnostics, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its SURE CHECK HIV 1/2 and HIV 1/2 STAT-PAK rapid test Pre-Market Applications (PMAs). The approved PMAs allow Chembio to market its rapid HIV tests to clinical laboratories and hospitals in the United States. FDA approval also allows Chembio to further expand its international marketing efforts into countries that require regulatory approval in the manufacturer's country of domicile.
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