BEUDAMED
    32 results · 45ms · Sources: EU EUDAMED, US FDA

    OraQuick Ebola Rapid Antigen Test

    FDA registration
    ORASURE TECHNOLOGIES INC.·1 product·🇺🇸 United States

    OraQuick Ebola Rapid Antigen Test

    FDA registration
    ORASURE TECHNOLOGIES, INC.·1 product·🇺🇸 United States

    OraQuick Ebola Rapid Antigen Test

    FDA registration
    ORASURE TECHNOLOGIES, INC.·1 product·🇺🇸 United States

    OraQuick Ebola Rapid Antigen Test

    FDA registration
    ORASURE TECHNOLOGIES, INC.·1 product·🇺🇸 United States

    OraQuick Ebola Rapid Antigen Test

    FDA UDI
    Orasure Technologies, Inc.·00608337001426·

    OraQuick Ebola Rapid Antigen Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

    FDA classification
    FDA Class 2 ·Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

    BioFire FilmArray Pneumonia plus Panel

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

    MERS-CoV PCR

    FDA registration
    MONOCENT INC.·1 product·🇺🇸 United States

    BIOFIRE FILMARRAY Pneumonia Panel plus

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

    FilmArray® Pneumonia Panel plus (Pneumoplus)

    FDA UDI
    BIOFIRE DIAGNOSTICS, LLC·00815381020321·IVD reagent kit containing 6 tests

    FilmArray® Pneumonia Panel plus (Pneumoplus)

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

    BIOFIRE FILMARRAY Pneumonia Panel

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

    BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel

    FDA registration
    BioFire Defense, LLC·3 products·🇺🇸 United States

    T2 Biothreat Panel

    FDA registration
    T2 BIOSYSTEMS, INC.·3 products·🇺🇸 United States

    FilmArray Respiratory Panel 2 plus (RP2plus)

    FDA 510(k)
    FDA Class 2 ·Pathology

    BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel

    FDA 510(k)
    FDA Class 2 ·Immunology

    T2 Biothreat Panel

    FDA 510(k)
    FDA Class 2 ·Immunology

    FilmArray Pneumonia Panel plus

    FDA 510(k)
    FDA Class 2 ·Pathology

    BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

    FDA 510(k)
    FDA Class 2 ·Pathology