DeviceClearance

Product code QZX— Microbiology

PBC Separator with Selux AST System

Classification name
Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
Device class
Class 2
Regulation
21 CFR 866.1650
Advisory panel
Microbiology
Total cleared
3
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QZX under 21 CFR 866.1650, via openFDA

Market context for product code QZX

FDA has cleared 3 devices under product code QZX between 2024 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QZX

Recent clearances under product code QZX

Data sourced from openFDA. This site is unofficial and independent of the FDA.