DeviceClearance

Product code QOF— Microbiology

Xpert Xpress CoV-2/Flu/RSV plus

Classification name
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Device class
Class 2
Regulation
21 CFR 866.3981
Advisory panel
Microbiology
Total cleared
33
First cleared
Most recent

FDA classification definition

“A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.”

— U.S. Food and Drug Administration, device classification record for product code QOF under 21 CFR 866.3981, via openFDA

Market context for product code QOF

FDA has cleared 33 devices under product code QOF between 2021 and 2026, filed by 17 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 QOF

Recent clearances under product code QOF

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