498 results
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41ms
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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.