BIOFIRE FILMARRAY Tropical Fever Panel
K-Number: K243463 · 2024-12-05
Device Summary
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. The listed applicant is Biofire Diagnostics, LLC (Biomerieux). The 510(k) number is K243463.
When did BIOFIRE FILMARRAY Tropical Fever Panel receive FDA 510(k) clearance?
BIOFIRE FILMARRAY Tropical Fever Panel received FDA 510(k) clearance on 2024-12-05, under 510(k) number K243463.
Who is the listed applicant for BIOFIRE FILMARRAY Tropical Fever Panel?
The FDA 510(k) record lists Biofire Diagnostics, LLC (Biomerieux) as the applicant. This does not by itself establish the device manufacturer.
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 records listing Biofire Diagnostics, LLC (Biomerieux) as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: QMV)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.