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NEW YORK (360Dx) – AESKU.Group said today that has received 510(k) clearance from the US Food and Drug Administration for its AESKUSLIDES nDNA for use with the company's Helios automated IFA system.

The assay is for diagnosing lupus and is the second immunofluorescence assay cleared by the FDA for the Helios platform, following the clearance of the ANA Hep-2 assay in 2016, AESKU.Group said.

Grifols, the group's exclusive distribution partner in the US, will help make the kit available to US clinical labs, AESKU Vice President Bruno Larida said in a statement.

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