510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243463Substantially Equivalent

BIOFIRE FILMARRAY Tropical Fever Panel

Biofire Diagnostics, LLC (Biomerieux), Salt Lake City UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243463 is the FDA 510(k) clearance record for BIOFIRE FILMARRAY Tropical Fever Panel, a class II device, cleared for Biofire Diagnostics, LLC (Biomerieux) 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 2 510(k) clearances for Biofire Diagnostics, LLC (Biomerieux), from to . As of , FDA records show no recalls naming K243463.

Clearance record

Decision date
Received
(27 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 Diagnostics, LLC (Biomerieux) 515 Colorow Dr., Salt Lake City UT
510(k) summary
Summary PDF
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