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Medical Devices / Submissions and Approvals

InDevR Gains Market Clearance for Influenza A+B Assay

May 13, 2019
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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.

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