400 results
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53ms
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Sources: EU EUDAMED, US FDA
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
FDA 510(k)
FDA Class 2
·Microbiology
Elecsys Anti-SARS-CoV-2
FDA 510(k)
FDA Class 2
·Microbiology
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
FDA 510(k)
FDA Class 2
·Microbiology
Sars-Cov-2 Serology Test
FDA classification
FDA Class 2
·Sars-Cov-2 Serology Test
Microbiology
FDA registration
Diamond Diagnostics Inc.·7 products·🇭🇺 Hungary
Microbiology
FDA registration
DIAMOND DIAGNOSTICS Inc·7 products·🇺🇸 United States
FilmArray Respiratory Panel (RP) For Use With FilmArray Torch
FDA registration
BioFire Diagnostics, LLC·7 products·🇺🇸 United States
BioCode Respiratory Pathogen Panel
FDA registration
Applied BioCode, Inc.·10 products·🇺🇸 United States
Lyra RSV+hMPV Assay
FDA registration
Ortho-Clinical Diagnostics, Inc.·2 products·🇺🇸 United States
Verigene System
FDA registration
Luminex Corporation·7 products·🇺🇸 United States
Verigene System
FDA registration
Luminex Corporation·7 products·🇺🇸 United States
ePlex Respiratory Pathogen (RP) Panel
FDA registration
GENMARK DIAGNOSTICS, INC.·10 products·🇺🇸 United States
ePlex® Respiratory Pathogen (RP) Panel
FDA registration
HOCHUEN MEDICAL SDN. BHD.·10 products·🇲🇾 Malaysia
BIOFIRE SPOTFIRE Module
FDA registration
BioFire Diagnostics, LLC·10 products·🇺🇸 United States
ePlex® Respiratory Pathogen (RP) Panel
FDA registration
Hochuen Medical Technology Co.,Ltd.·10 products·🇨🇳 China
LIAISON PLEX Respiratory Flex Assay
FDA registration
Luminex Corporation·10 products·🇺🇸 United States
NXTAG Respiratory Pathogen Panel
FDA registration
LUMINEX MOLECULAR DIAGNOSTICS, INC.·9 products·🇨🇦 Canada
ABBOTT MOLECULAR, INC.
FDA registration
ABBOTT MOLECULAR, INC.·1 product·🇺🇸 United States
QMI / Nucleic acid amplification test for the quantitation of BK virus (BK) DNA
FDA registration
MONOCENT INC.·1 product·🇺🇸 United States
cobas® EBV/BKV Control Kit
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States