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Produktneuigkeiten Hier finden Sie die neuesten Produktinformationen

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
Allplex™ 2019-nCoV Assay: U.S. FDA-Emergency Use Authorization

Seegene has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Allplex™ 2019-nCoV Assay, which detects the SARS-CoV-2 virus.Allplex™ 2019-nCoV Assay is a multiplex Real-time PCR assay to simultaneously detect three target genes of SARS-CoV-2, the virus causing COVID-19, in a single tube. The assay is designed to detect RdRP and N genes specific for SARS-CoV-2, and E gene for all of Sarbecovirus including SARS-CoV-2. The Allplex™ 2019-nCoV Assay can be run on Seegene's automated system, which enables high throughput testing of COVID-19.

Apr 22, 2020｜ Allplex™ 2019-nCoV assay (USA Only)
Allplex™ 2019-nCoV Assay : Authorized by Health Canada under Emergency Use Authorization (Currently exporting to 52 countries)

Seegene's Allplex™ 2019-nCoV Assay has received emergency use authorization from Health Canada.Allplex™ 2019-nCoV Assay has been officially approved by Peru, Malaysia, the Philippines, Ecuador, Colombia, Thailand and Australia since the CE-IVD in Europe, and has also received emergency approval from India, Singapore, Kazakhstan and Canadian health authorities.Currently, Seegens's COVID-19 test kit is exporting to 52 countries under official and/or emergency use authorization.

Apr 10, 2020｜ Allplex™ 2019-nCoV assay
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
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)
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
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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Produktneuigkeiten Hier finden Sie die neuesten Produktinformationen

Obtained approval of MFDS for Allplex™ RV Essential Assay

Obtained approval of MFDS for Allplex™ GI-Bacteria (II) Assay

Allplex™ 2019-nCoV Assay: U.S. FDA-Emergency Use Authorization

Allplex™ 2019-nCoV Assay : Authorized by Health Canada under Emergency Use Authorization (Currently exporting to 52 countries)

Obtained CE-IVD marking for Allplex™ 2019-nCoV Assay

Obtained CE-IVD marking for Allplex™ STI Essential Assay Q(MH,UU)

Obtained CE-IVD marking for Allplex™ GI-EB Screening Assay

Obtained CE-IVD marking for Allplex™ Meningitis Panel Assays