578 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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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
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