Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit

K-Number: K261475 · 2026-07-17

ApplicantBiofire Defense, LLC
Decision Date2026-07-17
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Defense, LLC. It received FDA 510(k) clearance on 2026-07-17 under 510(k) number K261475. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit?

BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit is a medical device that received FDA 510(k) clearance on 2026-07-17. The listed applicant is Biofire Defense, LLC. The 510(k) number is K261475.

When did BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit receive FDA 510(k) clearance?

BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit received FDA 510(k) clearance on 2026-07-17, under 510(k) number K261475.

Who is the listed applicant for BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit?

The FDA 510(k) record lists Biofire Defense, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit?

The FDA product code for BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit is PMN.

Other records listing Biofire Defense, LLC 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.

K243822BioFire Warrior Panel; BioFire Warrior Panel Control KitK213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens PanelK220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelK221460BioFire COVID-19 Test 2K211079BioFire COVID-19 Test 2K202382FilmArray Global Fever Panel External Control Kit

View all 8 devices →

Related Devices (Code: PMN)

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.

K260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc.K260041MDx-Chex for BCPStreck, LLCK254166MDx-Chex for BCNStreckK254167MDx-Chex for BCYStreck, LLCK251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc.K241289SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc.

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.

↑