BEUDAMED
    97 results · 115ms · Sources: EU EUDAMED, US FDA

    FilmArray® 2.0 Instrument

    FDA UDI
    BIOFIRE DIAGNOSTICS, LLC·00815381020048·Refurbished IVD Instrument (FilmArray® 2.0 Inst...

    FilmArray® Respiratory Panel 2 plus (RP2plus)

    FDA UDI
    BIOFIRE DIAGNOSTICS, LLC·00815381020307·IVD reagent kit containing 6 tests

    BIOFIRE ® SPOTFIRE ® Module

    FDA UDI
    BIOFIRE DIAGNOSTICS, LLC·00815381020369·IVD Instrument (SPOTFIRE ® Module).

    FilmArray® Respiratory Panel 2 (RP2)

    FDA UDI
    BIOFIRE DIAGNOSTICS, LLC·00815381020154·IVD reagent kit containing 30 tests

    FilmArray® Pneumonia Panel plus (Pneumoplus)

    FDA UDI
    BIOFIRE DIAGNOSTICS, LLC·00815381020314·IVD reagent kit containing 30 tests

    FilmArray® Meningitis/Encephalitis (ME) Panel

    FDA UDI
    BIOFIRE DIAGNOSTICS, LLC·00815381020123·IVD reagent kit containing 30 tests.

    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FilmArray Respiratory Panel 2 plus (RP2plus)

    FDA 510(k)
    FDA Class 2 ·Pathology

    BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FilmArray 2.0 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FilmArray Meningitis/Encephalitis(ME) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FilmArray Respiratory Panel 2 (RP2)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FilmArray Blood Culture Identification (BCID) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BioFire Respiratory Panel 2.1 (RP2.1)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0

    FDA 510(k)
    FDA Class 2 ·Microbiology