![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » InDevR Gains Market Clearance for Influenza A+B Assay
InDevR Gains Market Clearance for Influenza A+B Assay
![ClearanceStamp_Gray.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Gray.gif?t=1576043982&width=430)
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.
Upcoming Events
-
11Jul
-
18Jul
-
21Oct