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Allplex™ 2019-nCoV Assay: U.S. FDA-Emergency Use Authorization
Seegene has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Allplex™ 2019-nCoV Assay, which detects the SARS-CoV-2 virus.Allplex™ 2019-nCoV Assay is a multiplex Real-time PCR assay to simultaneously detect three target genes of SARS-CoV-2, the virus causing COVID-19, in a single tube. The assay is designed to detect RdRP and N genes specific for SARS-CoV-2, and E gene for all of Sarbecovirus including SARS-CoV-2. The Allplex™ 2019-nCoV Assay can be run on Seegene's automated system, which enables high throughput testing of COVID-19.
Apr 22, 2020｜ Allplex™ 2019-nCoV assay (USA Only)
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Allplex™ 2019-nCoV Assay : Authorized by Health Canada under Emergency Use Authorization (Currently exporting to 52 countries)
Seegene's Allplex™ 2019-nCoV Assay has received emergency use authorization from Health Canada.Allplex™ 2019-nCoV Assay has been officially approved by Peru, Malaysia, the Philippines, Ecuador, Colombia, Thailand and Australia since the CE-IVD in Europe, and has also received emergency approval from India, Singapore, Kazakhstan and Canadian health authorities.Currently, Seegens's COVID-19 test kit is exporting to 52 countries under official and/or emergency use authorization.
Apr 10, 2020｜ Allplex™ 2019-nCoV assay
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Obtained CE-IVD marking for Allplex™ SARS-CoV-2 Assay
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ SARS-CoV-2 Assay. This assay is a multiplex Real-time PCR assay that detects and identifies the new coronavirus named as COVID-19 using four target genes, RdRP, S and N genes specific for SARS-CoV-2, and E gene. Allplex SARS-CoV-2 assay realizes increase of throughput using test in one tube and automation system.
Apr 03, 2020｜ Allplex™ SARS-CoV-2 Assay
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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
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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)
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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
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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
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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