DeviceClearance

Product code QBH— Microbiology

Curetis Unyvero LRT Application

Classification name
Lower Respiratory Microbial Nucleic Acid Detection System
Device class
Class 2
Regulation
21 CFR 866.3985
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification definition

“Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.”

— U.S. Food and Drug Administration, device classification record for product code QBH under 21 CFR 866.3985, via openFDA

Market context for product code QBH

FDA has cleared 2 devices under product code QBH between 2018 and 2019, 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 QBH

Recent clearances under product code QBH

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