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Obtained approval of MFDS for Allplex™ SARS-CoV-2 Assay
Allplex™ SARS-CoV-2 Assay has received approval from Korean Ministry of Food and Drug Safety (MFDS). Allplex™ SARS-CoV-2 Assay is a multiplex real-time PCR assay to detect 4 target genes of SARS-CoV-2, a virus causing COVID-19 in a single tube. The assay enables a combination test with Allplex™ RV Essential Assay, to provide more insights for diagnosis of not only SARS-CoV-2 but also other major viruses causing respiratory infections.
Dec 07, 2020｜ Allplex™ SARS-CoV-2 Assay
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Obtained approval of MFDS for Allplex™ RV Essential Assay
Allplex™ RV Essential Assay has received approval from Korean Ministry of Food and Drug Safety (MFDS). This assay is a One-step real-time RT-PCR assay for simultaneous detection of Influenza A, Influenza B, Respiratory syncytial virus (RSV), Metapneumovirus, Parainfluenza virus, Adenovirus, Human rhinovirus. Moreover, this assay is applied with Seegene’s proprietary MuDT™ Technology to provide individual Ct value of infected viruses in a single channel.
Nov 30, 2020｜ Allplex™ RV Essential Assay
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Obtained approval of MFDS for Allplex™ GI-Bacteria (II) Assay
Allplex™ GI-Bacteria(II) Assay has received approval from Korean Ministry of Food and Drug Safety (MFDS). This assay is a multiplex real-time PCR assay for detection of stx1/stx2 (Shiga toxin genes), eaeA for enteropathogenic Escherichia coli (EPEC), lt/st for enterotoxigenic E. coli (ETEC), E. coli O157, aggR for enteroaggregative E. coli (EAEC) and hypervirulent Clostridium difficile.
Oct 19, 2020｜ Allplex™ GI-Bacteria(II) Assay
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Obtained CE-IVD marking for Allplex™ SARS-CoV-2/Flu A/Flu B/RSV Assay
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ SARS-CoV-2/Flu A/Flu B/RSV Assay. Allplex™ SARS-CoV-2/Flu A/Flu B/RSV Assay is a multiplex real-time PCR assay that detects and differentiates N, RdRP and S genes for SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) A/B in a single tube. The assay also includes dual internal controls (exogenous and endogenous internal controls) run in the same reaction, which allow verification of the whole test process as well as sampling.
Sep 15, 2020｜ Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay
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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. Allplex™ SARS-CoV-2 Assay is a multiplex real-time PCR assay to detect 4 target genes of SARS-CoV-2, a virus causing COVID-19 in a single tube. The assay is designed to detect RdRP, S and N genes specific for SARS-CoV-2, and E gene for all of Sarbecovirus including SARS-CoV-2.
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