www.fdanews.com/articles/186267-automated-vasculitis-test-cleared-by-fda
Automated Vasculitis Test Cleared by FDA
April 4, 2018
The FDA granted 510(k) clearance for Aesku’s automated vasculitis test, the Helios automated immunofluorescence assay system.
The sample-in/sample-out platform processes and analyzes patient samples in a single run and uses an integrated design and pattern recognition software.
The automated assay can be used to distinguish between adeno-associated viruses and infection.