PRH · Class II · 21 CFR 866.1650

FDA Product Code PRH: Positive Blood Culture Identification And Ast Kit

Fluorescence In Situ Hybridization (fish) Identification And Quantitative, Antimicrobial Susceptibility Testing (ast) Kit Intended For Simultaneous Detection And Identification Of Multiple Microbial Targets.

Leading manufacturers include Accelerate Diagnotics and Accelerate Diagnostics, Inc..

2
Total
1
Cleared
292d
Avg days
2017
Since

FDA 510(k) Cleared Positive Blood Culture Identification And Ast Kit Devices (Product Code PRH)

2 devices
1–2 of 2
Cleared Sep 15, 2020
Accelerate Pheno System, Accelerate PhenoTest BC Kit
K192665
Accelerate Diagnostics, Inc.
Microbiology · 356d
Not Cleared Feb 23, 2017
Accelerate Pheno system, Accelerate Phenotest BC Kit
DEN160032
Accelerate Diagnotics
Microbiology · 227d

About Product Code PRH - Regulatory Context