www.fdanews.com/articles/183112-icubate-blood-infection-assay-gets-fda-clearance
iCubate Blood Infection Assay Gets FDA Clearance
August 15, 2017
The FDA has cleared iCubate’s iC-System and blood infection assay, the company announced last week.
The iC-System derives from technology developed by the company to detect several pathogens at once and identify potentially pathogenic bacteria or resistance markers. It is the firm’s first approved assay.
The system and assay provide test results as much as 48 hours earlier than conventional means, which can take between two and four days.