DeviceClearance

Product code QMV— Microbiology

BIOFIRE FILMARRAY Tropical Fever Panel

Classification name
Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
Device class
Class 2
Regulation
21 CFR 866.3966
Advisory panel
Microbiology
Total cleared
3
First cleared
Most recent

FDA classification definition

“A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.”

— U.S. Food and Drug Administration, device classification record for product code QMV under 21 CFR 866.3966, via openFDA

Market context for product code QMV

FDA has cleared 3 devices under product code QMV between 2020 and 2024, 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 QMV

Recent clearances under product code QMV

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