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Obtained Australian TGA approval for Allplex™ stx1/2/2a/2d Typing
Seegene has received approval from Australia’s Therapeutic Goods Administration for Allplex™ stx1/2/2a/2d Typing. Therapeutic goods must be entered in the Australian Register of Therapeutic Goods before they can be supplied in the country.
Oct 28, 2022｜ Allplex™ stx1/2/2a/2d Typing
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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
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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
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Obtained approval of MFDS for Allplex™ H. pylori&ClaR Assay
Allplex™ H.pylori & ClaR 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 H.pylori and the most frequent point mutations (A2142G and A2143G) responsible for clarithromycin resistance within the H.pylori 23S rRNA gene.
Dec 27, 2019｜ Allplex™ H. pylori & ClaR Assay
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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™ H. pylori & ClariR Assay
Seegene has received CE-IVD mark under European Union on?In Vitro?Diagnostics Medical Devices for Allplex™ H. pylori & ClariR Assay. This assays is a Multiplex Real-time PCR assay that detects and identifies H. pylori and the most frequent point mutations (A2142G, A2143G and A2142C) responsible for clarithromycin resistance within the H. pylori 23S rRNA gene.
Feb 20, 2019｜ Allplex™ H. pylori & ClariR Assay
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Obtained CE-IVD marking for Allplex™ GI-Helminth(I) Assay
Seegene has received CE-IVD mark under European Union on?In Vitro?Diagnostics Medical Devices for Allplex™ GI-Helminth(I) Assay. This assays?allows detection of 1 protozoa and 8 helminths which are highly pathogenic parasites. 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.
Jan 31, 2019｜ Allplex™ GI-Helminth(I) Assay
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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