InDevR Gains Market Clearance for Influenza A+B Assay

(from FDA Device News) 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.

Read the related guidance here.