DeviceClearance

Product code PRH— Microbiology

Accelerate Pheno System, Accelerate PhenoTest BC Kit

Classification name
Positive Blood Culture Identification And Ast Kit
Device class
Class 2
Regulation
21 CFR 866.1650
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PRH under 21 CFR 866.1650, via openFDA

Market context for product code PRH

FDA has cleared 2 devices under product code PRH between 2017 and 2020, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PRH

Recent clearances under product code PRH

Data sourced from openFDA. This site is unofficial and independent of the FDA.