InDevR Gains Market Clearance for Influenza A+B Assay

The FDA granted InDevR 510(k) clearance for its FluChip-8G influenza diagnostic test, an assay that can identify multiple non-seasonal viruses.

The in vitro diagnostic test qualitatively detects and distinguishes between several influenza A viruses and the genetic lineage of influenza B viruses.

The single multiplexed assay can both characterize a variety of viruses as non-seasonal and characterize seasonal viruses in one day.