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 Respiratory Panel 2.1 (RP2.1)

K-Number: K263054 · 2026-09-22

ApplicantBiofire Diagnostics
Decision Date2026-09-22
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOFIRE Respiratory Panel 2.1 (RP2.1) is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics. It received FDA 510(k) clearance on 2026-09-22 under 510(k) number K263054. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFIRE Respiratory Panel 2.1 (RP2.1)?

BIOFIRE Respiratory Panel 2.1 (RP2.1) is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is Biofire Diagnostics. The 510(k) number is K263054.

When did BIOFIRE Respiratory Panel 2.1 (RP2.1) receive FDA 510(k) clearance?

BIOFIRE Respiratory Panel 2.1 (RP2.1) received FDA 510(k) clearance on 2026-09-22, under 510(k) number K263054.

Who is the listed applicant for BIOFIRE Respiratory Panel 2.1 (RP2.1)?

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

What is the FDA product code for BIOFIRE Respiratory Panel 2.1 (RP2.1)?

The FDA product code for BIOFIRE Respiratory Panel 2.1 (RP2.1) is QOF.

Other records listing Biofire Diagnostics 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.

K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniK243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidK243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelK241194BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniK232954BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

View all 22 devices →

Related Devices (Code: QOF)

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.

K261336Xpert Respiratory PanelCepheidK261837FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLC

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.

↑