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RNA guidance

This article was originally published in The Gray Sheet

Executive Summary

A Class II special controls guidance document was issued Aug. 25 for RNA pre-analytical systems for collection, stabilization and purification of ribonucleic acid used in molecular diagnostic testing. A same-day Federal Register notice reclassified the previously Class III devices into Class II. The Becton Dickinson-Qiagen joint venture PreAnalytiX received de novo 510(k) clearance in April for its PAXgene blood RNA system after submitting a reclassification petition...
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