5,127 results · 54ms · Sources: EU EUDAMED, US FDA

illumigene Mycoplasma DNA Amplification Assay

FDA 510(k)
FDA Class 2 ·Microbiology

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10

FDA 510(k)
FDA Class 2 ·Microbiology

ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT

FDA 510(k)
FDA Class 2 ·Microbiology

Alethia™ Mycoplasma Direct External Control Kit

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733102103·The Alethia Mycoplasma Direct External Control ...

Alethia™ Mycoplasma Direct

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733102189·The Alethia Mycoplasma Direct DNA amplification...

illumigene Mycoplasma

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733101175·"The illumigene Mycoplasma DNA amplification as...

illumigene Mycoplasma External Control Kit

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733101144·The illumigene Mycoplasma External Control Kit ...

illumigene Mycoplasma Direct External Control Kit

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733101281·The illumigene Mycoplasma Direct External Contr...

illumigene Mycoplasma Direct

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733101274·The illumigene Mycoplasma Direct DNA amplificat...

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

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.

NXTAG Respiratory Pathogen Panel

FDA registration
LUMINEX MOLECULAR DIAGNOSTICS, INC.·9 products·🇨🇦 Canada

Mycoplasma Pneumoniae Dna Assay System

FDA classification
FDA Class 2 ·Mycoplasma Pneumoniae Dna Assay System

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

BioCode Respiratory Pathogen Panel

FDA registration
Applied BioCode, Inc.·10 products·🇺🇸 United States

BIOFIRE SPOTFIRE Module

FDA registration
BioFire Diagnostics, LLC·10 products·🇺🇸 United States