407 results · 49ms · 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