FDA Product Code PRE: Rt-qpcr Assay For Mrna Transcript Immune Biomarkers
A Quantitative Gene Expression Assay Using Reverse Transcription Polymerase Chain Reaction To Quantify The Relative Expression Levels Of Host Response Genes Isolated From Whole Blood.
Leading manufacturers include Immunexpress, Inc. and Inflammatix, Inc..
FDA 510(k) Cleared Rt-qpcr Assay For Mrna Transcript Immune Biomarkers Devices (Product Code PRE)
About Product Code PRE - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PRE since 2017, with 4 receiving FDA clearance (average review time: 199 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
FDA review times for PRE submissions have been consistent, averaging 213 days recently vs 195 days historically.
PRE devices are reviewed by the Microbiology panel. Browse all Microbiology devices →