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Medical Devices / Submissions and Approvals

Akonni’s Molecular Testing Platform Cleared

June 10, 2019

Akonni Biosystems has earned the FDA’s 510(k) clearance for its TruDiagnosis system, which includes its TruDx Imagers, TruArray Assays and TruTip Kits for extracting nucleic acid.

The molecular diagnostic device automates complex laboratory processes and performs multiplex analyses of clinical samples — taking just 15 minutes for immunoassays and one to three hours for nucleic acid-based tests.

The platform includes software that is used for analyzing and reporting data and has the flexibility to “handle any protein or nucleic acid-based assay,” the devicemaker said.

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