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  • Obtained CE-IVD marking for Allplex™ SARS-CoV-2 fast MDx Assay

    Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for  Allplex™ SARS-CoV-2 fast MDx Assay.This new assay is optimized for the ‘living with COVID-19’ era, where mass, swift and cost-efficient testing is vital. The test can deliver results within 30 minutes, the fastest among diagnostics assays developed by Seegene, while matching the accuracy of RT-PCR tests.

    Feb 25, 2022 Allplex™ SARS-CoV-2 fast MDx PCR Assay

  • 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

  • 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

  • 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

  • Obtained CE-IVD marking for Allplex™ SARS-CoV-2 Variants II Assay

    Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ SARS-CoV-2 Variants II Assay. Allplex™ SARS-CoV-2 Variants II Assay is a multiplex real-time PCR assay that simultaneously detects and identifies four notable mutation sites in S gene in a single tube.

    Jun 30, 2021 Allplex™ SARS-CoV-2 Variants II Assay

  • Obtained CE-IVD marking for Allplex™ SARS-CoV-2 Master Assay

    Seegene’ Allplex™ SARS-CoV-2 Master Assay has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices. Allplex™ SARS-CoV-2 Master Assay is a multiplex real-time PCR assay that full screening for five notable S gene mutations (HV69/70 deletion, Y144 deletion, E484K, N501Y, and P681H) in one signal, in addition to four target genes of SARS-CoV-2 all in a single tube. 

    Mar 26, 2021 Allplex™ SARS-CoV-2 Master Assay

  • Obtained CE-IVD marking for Allplex™ SARS-CoV-2 Variants I Assay

    Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ SARS-CoV-2 Variants I Assay. Allplex™ SARS-CoV-2 Variants I Assay is a multiplex real-time PCR assay that simultaneously detects and identifies three notable mutation sites in S gene including HV69/70 deletion, E484K and N501Y and highly conserved region in RdRP gene in a single tube.

    Mar 26, 2021 Allplex™ SARS-CoV-2 Variants I Assay

  • Obtained approval of MFDS for Allplex™ SARS-CoV-2/Flu A/Flu B/RSV Assay

    Allplex™ SARS-CoV-2/Flu A/Flu B/RSV Assay has received approval from Korean Ministry of Food and Drug Safety (MFDS). This assay is a multiplex real-time PCR assay for primary screening of N, RdRP, and S genes for SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) A/B in a single tube. This assay also includes dual internal controls (exogenous and endogenous internal controls), which allows verification of whole test process as well as sample collection.

    Jan 26, 2021 Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay