BIOFIRE FILMARRAY Tropical Fever Panel
K-Number: K243463 · 2024-12-05
Decision Date2024-12-05
Product CodeQMV
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
BIOFIRE FILMARRAY Tropical Fever Panel is a medical device manufactured by Biofire Diagnostics, LLC (Biomerieux). It received FDA 510(k) clearance on 2024-12-05 under approval number K243463. The device is classified under product code QMV. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BIOFIRE FILMARRAY Tropical Fever Panel?
BIOFIRE FILMARRAY Tropical Fever Panel is a medical device that received FDA 510(k) clearance on 2024-12-05. It is manufactured by Biofire Diagnostics, LLC (Biomerieux). The 510(k) number is K243463.
When was BIOFIRE FILMARRAY Tropical Fever Panel approved by the FDA?
BIOFIRE FILMARRAY Tropical Fever Panel received FDA 510(k) clearance on 2024-12-05, under approval number K243463.
What company makes BIOFIRE FILMARRAY Tropical Fever Panel?
BIOFIRE FILMARRAY Tropical Fever Panel is manufactured by Biofire Diagnostics, LLC (Biomerieux).
What is the FDA product code for BIOFIRE FILMARRAY Tropical Fever Panel?
The FDA product code for BIOFIRE FILMARRAY Tropical Fever Panel is QMV.
Other Devices by Biofire Diagnostics, LLC (Biomerieux)
Related Devices (Code: QMV)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.