8/19/2009 1:50:53 PM
CAMBRIDGE, MA—August 19, 2009— IntelligentMDx has produced an assay solution for influenza that can distinguish seasonal from novel strains including H1N1 as well as antiviral resistance. This will be available for use during this upcoming flu season meeting the needs of the clinician and the clinical laboratory. Our proprietary solution has been designed and developed to be compliant with FDA, ISO 13485 and IVDD regulations and guidances.
IntelligentMDx’s mission is to commercialize test solutions under FDA quality system regulations for use in clinical reference labs. To guarantee quality for customers and partners we are compliant with FDA QSR and ISO 13485:2003 guidelines. IntelligentMDx test solutions are designed to be clinically impactful, competitively differentiated, and platform-agnostic test solutions.
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