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Obtained CE-IVD marking for Allplex™ SARS-CoV-2 fast PCR Assay
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ SARS-CoV-2 fast PCR Assay. Allplex™ SARS-CoV-2 fast PCR Assay is a multiplex real-time PCR assay that detects of 3 types of SARS-CoV-2 gene(E gene, RdRP gene and N gene) in a single tube. This assay also used an endogenous gene as Internal Control(IC) to monitor the whole process including sampling steps.
Dec 29, 2021｜ Allplex™ SARS-CoV-2 fast PCR Assay
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Launched Novaplex™ SARS-CoV-2 Variants VII Assay
Seegene has launched Novaplex™ SARS-CoV-2 Variants VII Assay. Novaplex™ SARS-CoV-2 Variants VII Assay is a multiplex real-time PCR assay that detects and identifies a total of five analytes including three key Omicron S-gene mutations (E484A, N501Y, HV69/70 deletion) and RdRP gene in a single tube.
Dec 20, 2021｜ Novaplex™ SARS-CoV-2 Variants VII Assay
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Obtained CE-IVD marking for Allplex™ RV Master Assay
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ SARS-CoV-2 RV Master Assay. Allplex™ SARS-CoV-2 RV Master Assay is a multiplex real-time PCR assay that detects and identifies various major respiratory viruses (Flu A, Flu B, RSV, MPV, AdV, HRV and PIV), including SARS-CoV-2.
Nov 19, 2021｜ Allplex™ RV Master 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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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