1,254 results
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44ms
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Sources: EU EUDAMED, US FDA
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
FDA 510(k)
FDA Class 2
·Microbiology
illumigene Pertussis DNA Amplification Assay
FDA 510(k)
FDA Class 2
·Microbiology
Bordetella Direct Test
FDA UDI
GREAT BASIN SCIENTIFIC, INC.·B178GBBORD100·Bordetella Direct Test Cartridge
Verigene System
FDA registration
Luminex Corporation·7 products·🇺🇸 United States
Microbiology
FDA registration
Diamond Diagnostics Inc.·7 products·🇭🇺 Hungary
Verigene System
FDA registration
Luminex Corporation·7 products·🇺🇸 United States
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
Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
FDA UDI
LUMINEX CORPORATION·00840487101612·The Verigene® Respiratory Pathogens Flex Nuclei...
Respiratory Pathogens Flex (RP Flex) Amplification Tray
FDA UDI
LUMINEX CORPORATION·00840487101711·The Verigene® Respiratory Pathogens Flex Nuclei...
Respiratory Pathogens Flex (RP Flex) Amplification Tray
FDA UDI
NANOSPHERE, INC.·00857573006324·The Verigene® Respiratory Pathogens Flex Nucl...
Respiratory Pathogens Flex (RP Flex) Extraction Tray
FDA UDI
LUMINEX CORPORATION·00840487101667·The Verigene® Respiratory Pathogens Flex Nuclei...
Respiratory Pathogens Flex (RP Flex) Extraction Tray
FDA UDI
NANOSPHERE, INC.·00857573006263·The Verigene® Respiratory Pathogens Flex Nucl...
Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
FDA UDI
NANOSPHERE, INC.·00857573006164·The Verigene® Respiratory Pathogens Flex Nucl...
FilmArray® Respiratory Panel (RP)
FDA UDI
BIOFIRE DIAGNOSTICS, LLC·00815381020079·IVD reagent kit containing 6 tests.
FilmArray® Respiratory Panel (RP)
FDA UDI
BIOFIRE DIAGNOSTICS, LLC·00815381020062·IVD reagent kit containing 30 tests.
Bordetella Pertussis Dna Assay System
FDA classification
FDA Class 2
·Bordetella Pertussis Dna Assay System