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Tag Archives: iCubate

FDA clears iCubate iC-GN Assay

July 18, 2019—The U.S. Food and Drug Administration has cleared iCubate’s iC-GN Assay for the detection and identification of Gram-negative bacteria that are associated with bloodstream infection and subsequent sepsis.  

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FDA clears iCubate platform, 11/17

November 2017—Molecular diagnostic device company iCubate has earned FDA clearance for its iCubate platform, the iC-System, and its first clinical assay, the iC-GPC Assay, used for the rapid detection of pathogenic bacteria associated with bloodstream infection.

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