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FDA clears automated IFA system

Aug. 18, 2016—Aesku Group has received 510(k) clearance from the Food and Drug Administration for its new Helios Automated IFA System with Aeskuslides ANA HEp-2-Gamma Assay. The Helios platform employs automated immunofluorescence technology to process and analyze patient samples. The Helios is an automated system for immunofluorescence processing with image capturing with an integrated fluorescence microscope and software. Results must ...

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