Home » 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.
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