902 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
FDA 510(k)
FDA Class 2
·Microbiology
FilmArray Pneumonia Panel plus
FDA 510(k)
FDA Class 2
·Pathology
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
FDA 510(k)
FDA Class 2
·Pathology
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
FilmArray Pneumonia Panel plus
FDA 510(k)
FDA Class 2
·Pathology
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
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
2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase
FDA classification
FDA Class 2
·2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
FDA classification
FDA Class 2
·Alpha-1-Lipoprotein, Antigen, Antiserum, Control