QZX

Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing

Product code

QZX

Device name

Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing

Device class

Class 2

21 CFR

21 CFR 866.1650

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.

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

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

Last three years. Most recent: 2025-03-28.

3 summaries are archived here for direct download.