Product code PRH

Device name

Positive Blood Culture Identification And Ast Kit

Medical specialty

Microbiology

Device class

2

Regulation number

866.1650

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

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

Source

FDA openFDA device classification dataset