FDA Clears Quidel C. difficile Assay for Life Tech's QuantStudio Dx and 7500 Fast Dx PCR Instruments | GenomeWeb

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared the Quidel Molecular Direct C. difficile Assay with Life Technologies' QuantStudio Dx and 7500 Fast Dx Applied Biosystems Real-Time PCR Instruments to be marketed in the US, the companies jointly announced today.

The assay kit includes an extraction-free, three-step sample preparation process requiring no heat step, timed step, or centrifugation. The fast and easy direct-to-amplification procedure allows for results in less than 70 minutes, Quidel and Life Tech said.

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