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iC-GN Assay

The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC-GN Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli.

Details

Device typeMultiple bloodstream bacteria nucleic acid IVD, kit, nucleic acid technique (NAT): A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple bacterial species associated with bloodstream infection in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT).

FDA categoryGram-Negative Bacteria And Associated Resistance Markers

Device IDB769ICCAAQA00000

AvailabilityPrescription

Single useYes

MRI safetyLabeling does not contain MRI Safety Information

Contact

Phone855-256-3330

Emailsupport@icubate.com

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