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  • Obtained CE-IVD marking for Allplex™ 2019-nCoV Assay

    Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ 2019-nCoV Assay.          This assay is a multiplex Real-time PCR assay that detects and identifies the new coronavirus named as COVID-19 using three target genes,  E gene, RdRP gene and N gene. Allplex 2019-nCoV assay realizes increase of throughput using test in one tube and automation system.

    Feb 13, 2020｜ Allplex™ 2019-nCoV assay

  • Obtained CE-IVD marking for Allplex™ STI Essential Assay Q(MH,UU)

    Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ STI Essential Assay Q(MH,UU). This assays?is a multiplex real-time PCR assay to simultaneously detect 7 pathogens causing sexually transmitted infections. Based on Seegene’s proprietary MuDT™ Technology, this assay reports multiple Ct value or quantitative result of each pathogen in a single channel. The quantitative result of Mycoplasma hominis and Ureaplasma urealyticum helps effective management of STIs.

    May 30, 2019｜ Allplex™ STI Essential Assay Q(MH,UU)

  • Obtained CE-IVD marking for Allplex™ GI-EB Screening Assay

    Seegene has received CE-IVD mark under European Union on?In Vitro?Diagnostics Medical Devices for Allplex™ GI-EB Screening Assay. This assays?allows detection of 7 key bacteria associated with gastroenteritis. Based on Seegene’s proprietary MuDT™ technology, this assay reports multiple Ct values of each pathogen in a single channel using real-time PCR instruments.

    Feb 20, 2019｜ Allplex™ GI-EB Screening Assay

  • Obtained CE-IVD marking for Allplex™ H. pylori & ClariR Assay

    Seegene has received CE-IVD mark under European Union on?In Vitro?Diagnostics Medical Devices for Allplex™ H. pylori & ClariR Assay. This assays is a Multiplex Real-time PCR assay that detects and identifies H. pylori and the most frequent point mutations (A2142G, A2143G and A2142C) responsible for clarithromycin resistance within the H. pylori 23S rRNA gene.

    Feb 20, 2019｜ Allplex™ H. pylori & ClariR Assay

  • Obtained CE-IVD marking and MFDS approval for Allplex™ PneumoBacter Assay

    Seegene has received CE-IVD mark under European Union on?In Vitro?Diagnostics Medical Devices, and received approval from Korean Ministry of Food and Drug Safety (MFDS) for Allplex™ PneumoBacter Assay. This assays?is a Multiplex Real-time PCR assay that detects and identifies 7 major respiratory bacteria associated with pneumonia. Based on Seegene's proprietary MuDT™ technology, this assay reports multiple Ct values of each pathogen in a single channel.

    Feb 20, 2019｜ Allplex™ PneumoBacter Assay

  • Obtained CE-IVD marking for Allplex™ GI-Helminth(I) Assay

    Seegene has received CE-IVD mark under European Union on?In Vitro?Diagnostics Medical Devices for Allplex™ GI-Helminth(I) Assay. This assays?allows detection of 1 protozoa and 8 helminths which are highly pathogenic parasites. Based on Seegene’s proprietary MuDT™ technology, this assay reports multiple Ct values of each pathogen in a single channel using real-time PCR instruments.

    Jan 31, 2019｜ Allplex™ GI-Helminth(I) Assay

  • Obtained CE-IVD marking for Allplex™ Vaginitis Screening Assay

    Seegene has received CE-IVD mark under European Union on?In Vitro?Diagnostics Medical Devices for Allplex™ Vaginitis Screening Assay. This assay is a Multiplex Real-time PCR assay that detects and identifies major pathogens related vaginitis simultaneously. Based on Seegene’s proprietary MuDT™ Technology, this assay reports multiple Ct values of each pathogen in a single channel. And it provides automated interpretation of BV using Seegene Viewer based on quantification information of major targets.

    Jan 25, 2019｜ Allplex™ Vaginitis Screening Assay

  • Obtained CE-IVD marking for Allplex™ GI-Virus plus Assay

    Seegene has received CE-IVD mark under European Union on?In Vitro?Diagnostics Medical Devices for Allplex™ GI-Virus plus Assay. This assay is a one-step real-time RT-PCR assay to detect simultaneously Norovirus GI, Norovirus GII, Rotavirus, Astrovirus, Sapovirus and wide range of human Adenovirus in a single tube. Based on Seegene's proprietary DPO™ and MuDT™ technology, it allows reporting of each Ct value for multiple pathogens in a single channel.

    Oct 29, 2018｜ Allplex™ GI-Virus plus Assay

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