DeviceClearance

Product code QBX— Microbiology

T2Bacteria Panel

Classification name
Direct Blood Bacterial Nucleic Acid Detection System
Device class
Class 2
Regulation
21 CFR 866.3960
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QBX under 21 CFR 866.3960, via openFDA

Market context for product code QBX

FDA has cleared 2 devices under product code QBX between 2018 and 2024, filed by 1 applicant company. 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 QBX

Recent clearances under product code QBX

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