PRH

Positive Blood Culture Identification And Ast Kit

Product code

PRH

Device name

Positive Blood Culture Identification And Ast Kit

Device class

Class 2

21 CFR

21 CFR 866.1650

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).