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Quidel Corp Receive FDA Clearance For Clostridium Difficile Assay And Quantstudio DX And 7500 Fast DX Real-Time PCR Instruments


Monday, 18 Mar 2013 08:00am EDT 

Quidel Corp announced that they received 510(k) clearances from the United States Food and Drug Administration (FDA) to market the Quidel Molecular Direct C. difficile Assay with Life Technologies' QuantStudio Dx and 7500 Fast Dx Applied Biosystems Real-Time PCR Instruments. Clostridium difficile bacterial infections are life-threatening, especially for the elderly, immunocompromised populations, and for patients on a prolonged antibiotic regimen. C. difficile infection (CDI) is frequently associated with antibiotic therapy and extended hospital stays. This Quidel Molecular Direct C. difficile Assay is part of Quidel's expanding line of molecular diagnostics products. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories, including Life Technologies' QuantStudio Dx and 7500 Fast Dx. These reagents provide attractive features that include refrigerated storage instead of freezing, convenient ready-to-use reagents, a short time to result, and other benefits that favorably enhance the molecular workflow. The current 510(k) clearance represents another milestone in the extension of Life Technologies' move into the diagnostics arena. In September 2012, Life Technologies launched Pervenio Lung RS, a lab-developed test distinguishing high-risk from low-risk early stage lung cancer patients. In February 2013, the company received 510(k) clearance for its 3500 Dx Genetic Analyzers and SeCore(R) HLA typing kits. 

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19 Dec 2014