BEUDAMED
    2,207 results · 46ms · Sources: EU EUDAMED, US FDA

    cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BioFire COVID-19 Test 2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BioFire COVID-19 Test 2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Aptima SARS-CoV-2 Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Simplexa COVID-19 Direct

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    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

    ID NOW Influenza A & B 2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Xpert Xpress Strep A

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LIAT STREP A ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Solana Strep Complete Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Solana GAS Assay, Solana instrument

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,

    FDA 510(k)
    FDA Class 2 ·Microbiology

    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 Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING

    FDA 510(k)
    FDA Class 2 ·Microbiology