DeviceClearance

Product code QWB— Microbiology

Cue COVID-19 Molecular Test

Classification name
Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
Device class
Class 2
Regulation
21 CFR 866.3984
Advisory panel
Microbiology
Total cleared
3
First cleared
Most recent

FDA classification definition

“An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.”

— U.S. Food and Drug Administration, device classification record for product code QWB under 21 CFR 866.3984, via openFDA

Market context for product code QWB

FDA has cleared 3 devices under product code QWB between 2023 and 2026, 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 QWB

Recent clearances under product code QWB

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