DeviceClearance

Product code QQX— Microbiology

BioFire COVID-19 Test 2

Classification name
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Device class
Class 2
Regulation
21 CFR 866.3981
Advisory panel
Microbiology
Total cleared
11
First cleared
Most recent

FDA classification definition

“A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid in the diagnosis of COVID-19 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 QQX under 21 CFR 866.3981, via openFDA

Market context for product code QQX

FDA has cleared 11 devices under product code QQX between 2021 and 2025, filed by 7 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 QQX

Recent clearances under product code QQX

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