CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test

FDA 510(k)

FDA Class 2 ·Microbiology

Flowflex COVID-19 Antigen Home Test

FDA 510(k)

FDA Class 2 ·Microbiology

CareSuperb™ COVID-19 Antigen Home Test

FDA 510(k)

FDA Class 2 ·Microbiology

BinaxNOW™ COVID-19 Antigen Self Test; BinaxNOW™ COVID-19 Ag Card

FDA 510(k)

FDA Class 2 ·Microbiology

QuickVue COVID-19 Test

FDA 510(k)

FDA Class 2 ·Microbiology

Cue COVID-19 Molecular Test

FDA 510(k)

FDA Class 2 ·Microbiology

Cue COVID-19 Molecular Test

FDA 510(k)

FDA Class 2 ·Microbiology

OHC COVID-19 Antigen Self Test

FDA 510(k)

FDA Class 2 ·Microbiology

iHealth COVID-19 Antigen Rapid Test

FDA 510(k)

FDA Class 2 ·Microbiology

Flowflex® Plus COVID-19 Home Test

FDA 510(k)

FDA Class 2 ·Microbiology

Over-The-Counter Covid-19 Antigen Test

FDA classification

FDA Class 2 ·Over-The-Counter Covid-19 Antigen Test

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification

FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

BIOFIRE SPOTFIRE R Panel Mini

FDA registration

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

BIOFIRE SPOTFIRE Module

FDA registration

BioFire Diagnostics, LLC·10 products·🇺🇸 United States

LIAISON PLEX Respiratory Flex Assay

FDA registration

Luminex Corporation·10 products·🇺🇸 United States

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

FDA UDI

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

BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel

FDA UDI

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

Microbiology

FDA registration

Diamond Diagnostics Inc.·7 products·🇭🇺 Hungary

Microbiology

FDA registration

DIAMOND DIAGNOSTICS Inc·7 products·🇺🇸 United States

FilmArray Respiratory Panel (RP) For Use With FilmArray Torch

FDA registration

BioFire Diagnostics, LLC·7 products·🇺🇸 United States