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PrimeraDx's ICEPlex C. difficile Assay Kit Gets FDA Clearance

The ICEPlex c. difficile Assay Kit and the ICEPlex System from PrimeraDx have received FDA 510(k) clearance. The ICEPlex c. difficile Assay Kit is a molecular diagnostic test for the detection of Clostridium difficile in human stool samples.

The ICEPlex System is a quantitative multiplex PCR system with the unique ability to amplify and quantify multiple nucleic acid species of different types in a single reaction, starting from fresh, frozen or formalin-fixed paraffin-embedded samples. This makes it ideal for high-multiplex assays involving panels of such diverse analytes as mRNAs, microRNAs and genomic loci, and thus for the next generation of in vitro molecular diagnostics.


     
Tags: Clostridium difficile

Date Published: December 16, 2013 » company contact details
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