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Accelerate Pheno™ System

The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC, Analysis PC(s), touchscreen monitor and Accelerate Pheno system software for use with Accelerate PhenoTest™ kits. It is designed to perform identification (ID) and quantitation of bacterial and yeast cells in less than 90 minutes and antimicrobial susceptibility testing (AST) on average in less than 7 hours directly from patient samples.Identification uses fluorescence in situ hybridization (FISH) and susceptibility testing uses microscopic observation of individual, live, growing bacterial cells in near real time (approximately every 10 minutes) in the presence of antimicrobial agents.

Details

Device typeMultiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry: 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 types of microorgansims associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate, using a nucleic acid amplification/mass spectrometry method.

FDA categoryPositive Blood Culture Identification And Ast Kit

Device ID00862011000321

Single useYes

MRI safetyLabeling does not contain MRI Safety Information

Contact

No contact is listed for this device.

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