Xpert Xpress CoV-2/Flu/RSV plus

FDA 510(k)

FDA Class 2 ·Microbiology

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Xpress CoV-2/Flu/RSV plus

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire Respiratory Panel 2.1 (RP2.1)

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa COVID-19 & Flu A/B Direct

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE SPOTFIRE Respiratory (R) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m Resp-4-Plex

FDA 510(k)

FDA Class 2 ·Microbiology

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay

FDA 510(k)

FDA Class 2 ·Microbiology

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)

FDA 510(k)

FDA Class 2 ·Microbiology

QIAstat-Dx Respiratory Panel Mini

FDA 510(k)

FDA Class 2 ·Microbiology

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON PLEX Respiratory Flex Assay

FDA 510(k)

FDA Class 2 ·Microbiology

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System

FDA 510(k)

FDA Class 2 ·Microbiology

Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

FDA 510(k)

FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE SPOTFIRE R Panel Mini

FDA registration

BioFire Diagnostics, LLC·4 products·🇺🇸 United States

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

FDA UDI

BIOFIRE DIAGNOSTICS, LLC·00815381020765·IVD reagent kit containing 30 tests.

SPOTFIRE R/ST Panel Mini

FDA registration

BioFire Diagnostics, LLC·5 products·🇺🇸 United States

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification

FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel

FDA UDI

BIOFIRE DIAGNOSTICS, LLC·00815381020659·IVD reagent kit containing 30 tests.