ACCELERATE DIAGNOSTICS, INC. 10104018 Accelerate PhenoTest BC kit

The Accelerate PhenoTest® BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification (ID/AST configuration) and quantitative, antimicrobial susceptibility testing (AST) methods (ID/AST and AST configurations) and is intended for use with the Accelerate Pheno® system. The Accelerate PhenoTest® BC kit is capable of simultaneous detection and identification of multiple microbial targets (ID/AST configuration) followed by susceptibility testing of the appropriate detected bacterial organisms (ID/AST and AST configuration). The Accelerate PhenoTest® BC kit is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results.