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  • Obtained CE-IVDD marking for Allplex™ stx1/2/2a/2d Typing

    Seegene has received CE-IVD mark under European Union on In Vitro Diagnostic for Allplex™ stx1/2/2a/2d Typing. Allplex™ stx1/2/2a/2d Typing provides screening and genotyping test not only for stx1 and stx2, but also the most potent types, stx2a and stx2d.

    May 20, 2022 Allplex™ stx1/2/2a/2d Typing

  • Obtained CE-IVDD marking for Allplex™ HPV HR Detection

    Seegene has received CE-IVD mark under European Union on In Vitro Diagnostic for Allplex™ HPV HR Detection. Allplex™ HPV HR Detection is a multiplex real-time PCR assay that enables simultaneous amplification and detection of target nucleic acids of 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) as well as Internal Control (IC).

    May 20, 2022 Allplex™ HPV HR Detection

  • Obtained CE-IVDD marking for Allplex™ HPV 28 Detection

    Seegene has received CE-IVD mark under European Union on In Vitro Diagnostic for Allplex™ HPV28 Detection. Allplex™ HPV28 Detection is a multiplex real-time PCR assay that enables simultaneous amplification and detection of target nucleic acids of 19 high-risk HPV types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73, 82) and 9 low-risk HPV types (6, 11, 40, 42, 43, 44, 54, 61, 70) as well as Internal Control (IC)

    May 20, 2022 Allplex™ HPV28 Detection

  • 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 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

  • 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