DeviceClearance

Product code QVR— Immunology

BioFire Global Fever Special Pathogens Panel +1 more

Classification name
Multiplex Nucleic Acid Detection System For Biothreat Agents
Device class
Class 2
Regulation
21 CFR 866.4000
Advisory panel
Immunology
Total cleared
3
First cleared
Most recent

FDA classification definition

“A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens”

— U.S. Food and Drug Administration, device classification record for product code QVR under 21 CFR 866.4000, via openFDA

Market context for product code QVR

FDA has cleared 3 devices under product code QVR between 2023 and 2026, filed by 3 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 QVR

Recent clearances under product code QVR

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