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Accelerate PhenoTest BC AST QC test
The Accelerate PhenoTest™ BC AST QC test is intended to serve as an external quality control to monitor the accuracy of the antimicrobial susceptibility test (AST) calls made by the Accelerate PhenoTest™ BC kit. This quality control test is run in conjunction with the Accelerate PhenoTest™ BC kit.
Details
Device typeMultiple-type bloodstream pathogen nucleic acid IVD, control: A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorganisms associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate.
FDA categoryPositive Blood Culture Identification And Ast Kit
Device ID10862011000342
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information