115 results
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22ms
·
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
DASH® SARS-CoV-2 & Flu A/B Test
FDA 510(k)
FDA Class 2
·Microbiology
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
FDA 510(k)
FDA Class 2
·Microbiology
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
FDA 510(k)
FDA Class 2
·Microbiology
Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
FDA 510(k)
FDA Class 2
·Microbiology
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
FDA 510(k)
FDA Class 2
·Microbiology
BioFire COVID-19 Test 2
FDA 510(k)
FDA Class 2
·Microbiology
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
FDA 510(k)
FDA Class 2
·Microbiology
BioFire COVID-19 Test 2
FDA 510(k)
FDA Class 2
·Microbiology
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa COVID-19 Direct
FDA 510(k)
FDA Class 2
·Microbiology
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
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
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
FDA 510(k)
FDA Class 2
·Microbiology
FilmArray Respiratory Panel 2 plus (RP2plus)
FDA 510(k)
FDA Class 2
·Pathology
Cue COVID-19 Molecular Test
FDA 510(k)
FDA Class 2
·Microbiology
Cue COVID-19 Molecular Test
FDA 510(k)
FDA Class 2
·Microbiology
cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
FDA 510(k)
FDA Class 2
·Microbiology
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
FDA 510(k)
FDA Class 2
·Microbiology
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
FDA 510(k)
FDA Class 2
·Microbiology