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www.fdanews.com/articles/203423-inova-gets-510k-clearance-for-aptiva-lab-system-celiac-disease-assay
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Inova Gets 510(k) Clearance for Aptiva Lab System, Celiac Disease Assay

July 2, 2021

San Diego, Calif.-based Inova Diagnostics has received FDA 510(k) clearance for its Aptiva system for clinical laboratories and its Aptiva Celiac Disease IgA assay.

The Aptiva system, which can process multiple analytes from a patient sample at one time, has also earned CE mark certification in Europe.

Inova’s celiac disease assay is the only one currently available for the Aptiva system, but assays for seven other autoimmune diseases are on the way, the company said.

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