PRH — Positive Blood Culture Identification And Ast Kit Class II

FDA Device Classification

Classification Details

Product Code: PRH
Device Class: Class II
Regulation Number: 866.1650
Submission Type
Review Panel: MI
Medical Specialty: Microbiology
Implant: No

Definition

Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K192665	accelerate diagnostics	Accelerate Pheno System, Accelerate PhenoTest BC Kit	September 15, 2020
DEN160032	accelerate diagnotics	Accelerate Pheno system, Accelerate Phenotest BC Kit	February 23, 2017