409 results
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45ms
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Sources: EU EUDAMED, US FDA
BioFire Joint Infection (JI) Panel
FDA registration
BioFire Diagnostics, LLC·1 product·🇺🇸 United States
BioFire® Joint Infection (JI) Panel
FDA UDI
BIOFIRE DIAGNOSTICS, LLC·00815381020192·IVD reagent kit containing 30 kits.
BioFire Joint Infection (JI) Panel
FDA 510(k)
FDA Class 2
·Microbiology
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
FDA classification
FDA Class 2
·Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
FDA UDI
BIOFIRE DIAGNOSTICS, LLC·00815381020765·IVD reagent kit containing 30 tests.
BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel
FDA UDI
BIOFIRE DIAGNOSTICS, LLC·00815381020659·IVD reagent kit containing 30 tests.
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