QBX

Direct Blood Bacterial Nucleic Acid Detection System

Product code

QBX

Device name

Direct Blood Bacterial Nucleic Acid Detection System

Device class

Class 2

21 CFR

21 CFR 866.3960

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

Amplification, detection and identification of microbial pathogens directly from whole blood specimens

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: 2024-02-08.

1 summaries are archived here for direct download.