QNJ

Mass Spectrometry, Microorganism Identification, Blood Culture

Product code

QNJ

Device name

Mass Spectrometry, Microorganism Identification, Blood Culture

Device class

Class 2

21 CFR

21 CFR 866.3378

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification 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.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-09-26.

1 summaries are archived here for direct download.