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October 9, 2012
12:35 EDTDGX, MMMQuest Diagnostics unit, 3M say FDA gives clearance for Simplexa test
Focus Diagnostics, a business of Quest Diagnostics (DGX), and 3M (MMM) announced that the U.S. Food and Drug Administration has provided 510(k) clearance and CLIA moderate-complexity categorization to the Simplexa Flu A/B & RSV Direct test on the 3M Integrated Cycler. The new test aids in the qualitative detection and differentiation of RNA of influenza A and B viruses and respiratory syncytial virus, common causes of respiratory illness. The Simplexa Flu A/B & RSV Direct is now available in the United States. It was CE marked for distribution in Europe in 2011.
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