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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™ Meningitis Panel Assays
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ Meningitis Panel-V1, Allplex™ Meningitis-V2 Assay, Allplex™ Meningitis-B Assay. These assays are the multiplex one-step Real-time RT-PCR assay that detect and identifie 18 meningitis causative pathogens including 12 viruses and 6 bacteria. Based on Seegene’s proprietary MuDT™ technology, it allows reporting of each Ct value for multiple pathogens in a single channel without the melt curve analysis.
May 09, 2018｜ Allplex™ Meningitis Panel Assays
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Obtained approval of MFDS for Allplex™ GI- Bacteria(I) Assay
Allplex™ GI-Bacteria(I) Assay has received approval from Korean Ministry of Food and Drug Safety (MFDS). This assay is a Real-time PCR assay to detect simultaneously Campylobacter spp., Clostridium difficile toxin B, Salmonella spp., EIEC*/Shigella spp., Vibrio spp., Yersinia enterocolitica and Aeromonas spp. which cause gastrointestinal disease in a single tube. * EIEC : Enteroinvasive E. coli
May 22, 2017｜ Allplex™ GI-Bacteria(I) Assay
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Obtained CE-IVD marking for Anyplex™ MTB/NTMe Real-time Detection
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Anyplex™ MTB/NTMe Real-time Detection. This assay is a Real-time PCR assay to detect simultaneously Mycobacterium tuberculosis dissociated from non-tuberculosis mycobacteria and include whole process control for assay validity.
May 12, 2017｜ Anyplex™ MTB/NTMe Real-time Detection
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Obtained approval of MFDS for Allplex™ GI-Virus Assay
Allplex™ GI-Virus Assay has received approval from Korean Ministry of Food and Drug Safety (MFDS). This assay is a One-step real-time RT-PCR assay to detect simultaneously Norovirus GI, Norovirus GII, Rotavirus, Adenovirus, Astrovirus and Sapovirus which cause gastrointestinal disease in a single tube.
Apr 26, 2017｜ Allplex™ GI-Virus Assay
