BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
FDA 510(k) K261475 · Biofire Defense, LLC
510(k) numberK261475
Submission
- Device name
- BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
- Applicant
- Biofire Defense, LLC
Salt Lake City, UT, US - Received
- May 5, 2026
- Decision date
- July 17, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PMN – Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3920
- Specialty
- Microbiology
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
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More from Maine Molecular Quality Controls, Inc.
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| K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control KitPRD · Traditional | 03/12/2025SE |
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| K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelQMV · Traditional | 10/20/2022SE |
| K221460 | BioFire COVID-19 Test 2QQX · Special | 07/25/2022SE |
| K211079 | BioFire COVID-19 Test 2QQX · Traditional | 11/01/2021SE |
| K202382 | FilmArray Global Fever Panel External Control KitPMN · Traditional | 11/20/2020SE |
| K170883 | FilmArray NGDS Warrior PanelPRD · Traditional | 06/22/2017SE |
Questions and answers
When was BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit cleared by the FDA?
BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit (K261475) received a 510(k) decision of Substantially Equivalent on July 17, 2026, 73 days after the submission was received.
What is the product code of K261475?
The FDA product code is PMN – Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays, a Class II (moderate risk) device regulated under 21 CFR 866.3920.