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Home › Business, Policy & Funding › Regulatory News & FDA Approvals › Akonni Biosystems Submits Multiplex Diagnostics System to FDA

Akonni Biosystems Submits Multiplex Diagnostics System to FDA

Jan 04, 2019

NEW YORK (GenomeWeb) – Akonni Biosystems announced today it has submitted a molecular diagnostics system to the US Food and Drug Administration for 510(k) clearance. The system can perform multiplex testing using on-slide PCR and microarray technologies.

The system, called TruDiagnosis, consists of the TruDx imager, TruArray consumable test kit, and TruSpot software. The firm did not disclose whether a specific diagnostic assay was submitted along with the TruDiagnosis system.

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