1,254 results · 44ms · 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