C. diff assay and PCR system, 9/13:78 (AACC)
Quidel Corp. and Life Technologies in March received FDA 510(k) clearances to market the Quidel Molecular Direct C. difficile assay with Life Technologies’ QuantStudio Dx and 7500 Fast Dx Applied Biosystems real-time PCR instruments. The C. difficile assay is part of Quidel’s molecular diagnostic product line, which includes PCR reagent kits for molecular diagnostic laboratories including Life Technologies’ QuantStudio Dx and 7500 Fast Dx. These reagents can be refrigerated instead of frozen, are convenient and ready to use, and provide a