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Obtained CE-IVD marking for Allplex™ MG & AziR Assay
Seegene has received CE-IVD mark under European Union on?In Vitro?Diagnostics Medical Devices for Allplex™ MG & AziR Assay. This assays?is a multiplex real-time PCR assay that detects and identifies?Mycoplasma genitalium?(MG) and 6 mutations causing azithromycin resistance. Azithromycin is generally prescribed for 1st-line treatment of MG. Based on Seegene’s proprietary DPO™ & MuDT™ Technology, this assay enables to check MG infection and azithromycin resistance in a single test and reports multiple Ct?values of each pathogen in a single tube.
Oct 29, 2018｜ Allplex™ MG & AziR Assay
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Obtained CE-IVD marking for assays that detects MTB and Multi-Drug Resistance and Extensively Drug Resistance
Seegene has received CE-IVD mark under European Union on?In Vitro?Diagnostics Medical Devices for Allplex™ MTB/MDR/XDRe Detection, Allplex™ MTB/MDRe Detection, Allplex™ MTB/XDRe Detection. Based on Seegene's proprietary DPO™ and TOCE™ technology, these assays are multiplex real-time PCR assay that detects and identifies?Mycobacterium tuberculosis (MTB) and 25 mutations associated with Multi-Drug Resistance (MDR) and 13 mutations associated with Extensively Drug Resistance (XDR). These assays enable to deliver MTB and Drug-resistant TB result in one day, which helps effective management of tuberculosis.
Oct 29, 2018｜ Allplex™ MTB/MDR/XDRe Detection , Allplex™ MTB/MDRe Detection , Allplex™ MTB/XDRe Detection
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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
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Obtained CE-IVD marking for Allplex™ Bacterial Vaginosis Assay
Allplex™ Bacterial Vaginosis Assay simultaneously detects 7 bacteria (G. vaginalis, A. vaginae, Megasphaera type 1, BV-associated bacteria 2, Mobiluncus spp., B. fragilis, Lactobacillus spp.) associated with vaginosis. It provides quantitative information of 3 major bacteria (G. vaginalis, A. vaginae, Lactobacillus spp.). Based on Seegene’s proprietary MuDT™ technology, this assay makes it possible to report individual Ct value of multiple bacteria in a single channel. The CE-IVD mark will allow more opportunities for Seegene to market and sell within the European Union.
Dec 15, 2016｜ Allplex™ Bacterial Vaginosis Assay
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Obtained approval of MFDS for Allplex™ Respiratory Panel3
Allplex™ Respiratory Panel 3 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 Bocavirus, Rhinovirus and three Coronaviruses (NL63, 229E, OC43) which cause respiratory infections in a single tube.
Nov 24, 2016｜ Allplex™ Respiratory Panel 3