510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN200043Unknown

FilmArray Global Fever Panel

BioFire Defense, LLC, Salt Lake City UT / Direct, Unknown
FDA source (opens on fda.gov)

DEN200043 is the FDA 510(k) clearance record for FilmArray Global Fever Panel, a class II device, cleared for Biofire Defense, LLC on under FDA product code QMV (Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness). FDA's definition for product code QMV reads: "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...". FDA records list 10 510(k) clearances for Biofire Defense, LLC, from to . As of , FDA records show no recalls naming DEN200043.

Clearance record

Decision date
Received
(147 days to decision)
Product code
QMV Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
Regulation
21 CFR 866.3966
Device class
Class II
Review panel
Microbiology
Applicant
Biofire Defense, LLC 79 W 4500 S, Salt Lake City UT
Third party review
No

Clearances, product code QMV

Trailing 12 months

FDA records hold no clearances under product code QMV in the trailing twelve months.

FDA records show no clearances under product code QMV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QMV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260