498 results · 41ms · Sources: EU EUDAMED, US FDA

Sofia 2 SARS Antigen+ FIA

FDA registration
Ortho-Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

Sofia 2

FDA UDI
QUIDEL CORPORATION·30014613339755·Sofia 2 SARS Ag + FIA

ID NOW COVID-19 2.0

FDA UDI
Alere Scarborough, Inc.·00811877011354·A rapid, automated, molecular test for the qual...

ID NOW COVID-19 2.0 Control Swab Kit

FDA UDI
Alere Scarborough, Inc.·00811877011361·Control Swabs intended for use only with the ID...

ID NOW COVID-19 2.0

FDA 510(k)
FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

FDA 510(k)
FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)
FDA Class 2 ·Microbiology

BinaxNOW COVID-19 Ag Card

FDA 510(k)
FDA Class 2 ·Microbiology

BD Veritor System for SARS-CoV-2

FDA 510(k)
FDA Class 2 ·Microbiology

SCoV-2 Ag Detect Rapid Test

FDA 510(k)
FDA Class 2 ·Microbiology

Healgen Rapid COVID-19 Antigen Test

FDA 510(k)
FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 v2 nucleic acid test

FDA 510(k)
FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)
FDA Class 2 ·Microbiology

Nano-Check™ COVID-19 Antigen Test

FDA 510(k)
FDA Class 2 ·Microbiology

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

FDA classification
FDA Class 2 ·Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA classification
FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

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.