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Akonni

BioMérieux, Ortho Clinical Diagnostics, iCubate, Others Receive FDA Clearances in June

Included in the 510(k) clearances was one for AMS Diagnostics' Liasys 600 Electrolyte Measurement System for measuring sodium, chloride, and potassium in human serum.

Akonni Biosystems Developing Multi-Target Infectious Diseases Tests for Newly Cleared TruDx System
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The Frederick, Maryland-based firm has received regulatory clearance for a multiplexed array-based assay after more than 15 years in development.

Akonni Bio Obtains FDA 510(k) Clearance for TruDiagnosis MDx System, PGx Test

Akonni has received clearance for a molecular diagnostic instrument and a saliva-based pharmacogenomics test for warfarin metabolism.

Akonni Wins $3M NIH Contract to Develop TB Sample Prep Device

The device can process high-volume sputum samples for PCR-based Mycobacterium tuberculosis detection at smear-negative, culture-positive levels.

Akonni Biosystems Submits Multiplex Diagnostics System to FDA

Upon clearance of the platform, the company will commercialize the TruDiagnosis, an IVD system for genotyping multiple genes in a DNA sample, this year.