BIOFIRE FILMARRAY Pneumonia Panel

FDA registration

BioFire Diagnostics, LLC·1 product·🇺🇸 United States

BioFire Pneumo Panel

FDA registration

BioFire Diagnostics, LLC·1 product·🇺🇸 United States

AspID

FDA registration

INTEGRATED DNA TECHNOLOGIES, INC.·1 product·🇺🇸 United States

Unyvero L4 Lysator

FDA registration

Zollner Elektronik AG, Plant Zandt 2·1 product·🇩🇪 Germany

Unyvero

FDA UDI

Curetis GmbH·04260364750041·Kit of 12 Unyvero M1 Master Mix Tubes, to be us...

FilmArray® Pneumonia Panel (Pneumo)

FDA UDI

BIOFIRE DIAGNOSTICS, LLC·00815381020178·IVD reagent kit containing 30 tests

Unyvero

FDA UDI

Curetis GmbH·04260364750027·User interface and instrument to control Unyver...

FilmArray® Pneumonia Panel (Pneumo)

FDA UDI

BIOFIRE DIAGNOSTICS, LLC·00815381020185·IVD reagent kit containing 6 tests

Unyvero

FDA UDI

Curetis GmbH·04260364750003·Instrument to process 2 Unyvero Cartridges

Unyvero

FDA UDI

Curetis GmbH·04260364750034·Kit of 12 disposable Unyvero LRT Cartridges, in...

Unyvero

FDA UDI

Curetis GmbH·04260364750010·Instrument to pre-process up to 4 samples for U...

Unyvero

FDA UDI

Curetis GmbH·04260364750058·Kit of 12 disposable Unyvero LRT BAL Cartridges...

BIOFIRE FILMARRAY Pneumonia Panel

FDA registration

BioFire Diagnostics, LLC·2 products·🇺🇸 United States

Curetis Unyvero LRT Application

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Pneumonia Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Unyvero LRT BAL Application

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Pneumonia Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Respiratory Panel

FDA classification

FDA Class 2 ·Respiratory Panel

Lower Respiratory Microbial Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Lower Respiratory Microbial Nucleic Acid Detection System

Anti-Brucella abortus ELISA (IgG)

FDA registration

EUROIMMUN US INC.·1 product·🇺🇸 United States