BEUDAMED
    16 results · 50ms · Sources: EU EUDAMED, US FDA

    CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2)

    FDA registration
    CENTERS FOR DISEASE CONTROL AND PREVENTION·1 product·🇺🇸 United States

    CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Influenza A And Influenza B Multiplex Nucleic Acid Assay

    FDA classification
    FDA Class 2 ·Influenza A And Influenza B Multiplex Nucleic Acid Assay

    Synergy Health AST, LLC

    FDA registration
    Synergy Health AST, LLC·1 product·🇺🇸 United States

    VITEK 2 AST-Gram Negative Omadacycline

    FDA registration
    bioMerieux, Inc.·1 product·🇺🇸 United States

    VITEK 2 AST-Gram Negative Omadacycline

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

    Isomedix Operations Inc.

    FDA registration
    Isomedix Operations Inc.·1 product·🇺🇸 United States

    Dexcom G6 Continuous Glucose Monitoring System

    FDA registration
    Sterigenics Radiation Technologies, LLC·1 product·🇺🇸 United States

    Isomedix Operations, Inc

    FDA registration
    Isomedix Operations, Inc·1 product·🇺🇸 United States

    3MP Color LCD Monitors C310S, C316S; 3MP Monochrome LCD Monitors G310S, G316S; 6MP Color LCD Monitor C616W.

    FDA registration
    Shenzhen Beacon Display Technology Co., Ltd.·1 product·🇨🇳 China

    Medicom Asia-Pacific Holdings Limited. Taiwan Branch

    FDA registration
    Medicom Asia-Pacific Holdings Limited. Taiwan Branch·2 products·🇹🇼 Taiwan

    AISight Dx

    FDA registration
    PATHAI·1 product·🇺🇸 United States

    VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Dexcom G6 Continuous Glucose Monitoring (CGM) System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Integrated Continuous Glucose Monitoring System, Factory Calibrated

    FDA classification
    FDA Class 2 ·Integrated Continuous Glucose Monitoring System, Factory Calibrated

    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

    FDA classification
    FDA Class 2 ·System, Test, Automated, Antimicrobial Susceptibility, Short Incubation