Inactive

The Government procured the required clinical and development services to obtain U.S. Food and Drug Administration (FDA) Section 510(k) clearance of Luminex Corporation’s combined ARIES ® Flu A/B/RSV ... The Government procured the required clinical and development services to obtain U.S. Food and Drug Administration (FDA) Section 510(k) clearance of Luminex Corporation’s combined ARIES ® Flu A/B/RSV + Coronavirus (SARS-CoV-2 test using simplified acquisition procedures. FDA 510(k) clearance will allow Luminex to commercially market their combined SARS-CoV-2, influenza A, influenza B, and Respiratory syncytial virus (RSV) diagnostic test that operate on the proprietary ARIES® platform.