Product code QNJ

Device name

Mass Spectrometry, Microorganism Identification, Blood Culture

Medical specialty

Microbiology

Device class

2

Regulation number

866.3378

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry.

Source

FDA openFDA device classification dataset