407 results
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49ms
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Sources: EU EUDAMED, US FDA
FilmArray ME Panel for use on FilmArray Torch
FDA registration
BioFire Diagnostics, LLC·1 product·🇺🇸 United States
MENINGITIS ENCEPHALITIS MULTIPLEX PCR
FDA registration
MONOCENT INC.·1 product·🇺🇸 United States
QIAstat-Dx Meningitis-Encephalitis (ME) Panel
FDA registration
STAT-Dx Life, S.L.·1 product·🇪🇸 Spain
Simplexa VZV Positive Control Pack
FDA registration
DiaSorin Molecular LLC·1 product·🇺🇸 United States
QIAstat-Dx Meningitis-Encephalitis (ME) Panel
FDA registration
QIAGEN, GMBH·1 product·🇩🇪 Germany
Simplexa™ VZV Positive Control Pack
FDA UDI
DIASORIN MOLECULAR LLC·20816101025781·
FilmArray® Meningitis/Encephalitis (ME) Panel
FDA UDI
BIOFIRE DIAGNOSTICS, LLC·00815381020130·IVD reagent kit containing 6 tests.
Simplexa™ VZV Direct
FDA UDI
DIASORIN MOLECULAR LLC·20816101025774·
FilmArray Meningitis/Encephalitis(ME) Panel
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa VZV Direct, Simplexa VZV Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
QIAstat-Dx Meningitis/Encephalitis (ME) Panel
FDA 510(k)
FDA Class 2
·Microbiology
FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
FDA 510(k)
FDA Class 2
·Microbiology
FilmArray Meningitis/Encephalitis (ME) Panel
FDA registration
BioFire Diagnostics, LLC·3 products·🇺🇸 United States
FilmArray® Meningitis/Encephalitis (ME) Panel
FDA UDI
BIOFIRE DIAGNOSTICS, LLC·00815381020123·IVD reagent kit containing 30 tests.
Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
FDA classification
FDA Class 2
·Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
Aptima HCV Quant Dx Calibrator Kit
FDA registration
Hologic, Inc.·1 product·🇺🇸 United States
cobas NHP Negative Control Kit in cassettes
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States
HCV Rapid Test Dipstick
FDA registration
ACRO BIOTECH Inc.·1 product·🇺🇸 United States
cobas NHP Negative Control Kit in cassettes
FDA registration
ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany
KIT CAP/CTM HIV-1 v2 QUAL CE-IVD
FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States