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  • Obtención de marcado CE-IVD para Allplex™ SARS-CoV-2 fast PCR Assay

    Seegene ha recibido la marca CE-IVD de la Unión Europea en dispositivos médicos de diagnostico in vitro para Allplex™ SARS-CoV-2 fast PCR Assay. Allplex™ SARS-CoV-2 fast PCR Assay es un ensayo de PCR multiplex en tiempo real que detecta los 3 genes de SARS-CoV-2 (gen E, gen RdRP y gen N) en un solo tubo. En este ensayo se usa un control endógeno como Control Interno (IC) para validar todo el proceso incluyendo la parte de recoleccion de muestras.

    Dec 29, 2021 Allplex™ SARS-CoV-2 fast PCR Assay

  • Lanzamiento de Novaplex™ SARS-CoV-2 Variants VII Assay

    Seegene ha lanzado Novaplex™ SARS-CoV-2 Variants VII Assay. Novaplex™ SARS-CoV-2 Variants VII Assay es un ensayo de PCR multiplex en tiempo real que detecta e identifica un total de 5 analitos, incluyendo las 3 mutaciones clave del gen S de Omicron (E484A, N501Y, HV69/70 deletion) y el gen RdRP en un solo tubo.

    Dec 20, 2021 Novaplex™ SARS-CoV-2 Variants VII Assay

  • Obtención del marcado CE-IVD para Allplex™ RV Master Assay

    Seegene ha recibido la marca CE-IVD de la Unión Europea en dispositivos médicos de diagnostico in vitro para Allplex™ SARS-CoV-2 RV Master Assay. Allplex™ SARS-CoV-2 RV Master Assay es un ensayo de PCR multiplex en tiempo real que detecta e identifica varios virus respiratorios importantes (Influenza A, Influenza B, RSV ,MPV, AdV, HRV y PIV), incluyendo el SARS-CoV-2.

    Nov 19, 2021 Allplex™ RV Master Assay

  • Obtuvo la aprobación de MFDS para Allplex™ RV Essential Assay

    Allplex™ RV Essential Assay ha recibido la aprobación del Ministerio de Seguridad de Alimentos y Medicamentos de Corea (MFDS). Este es un ensayo de RT-PCR en tiempo real de un solo paso para la detección simultanea de influenza A, influenza B, virus sincitial respiratorio (RSV), metapneumovirus, virus de parainfluenza, adenovirus, rinovirus humano. Además, en este ensayo esta aplicada la tecnología MuDT™ patentada de Seegene para proporcionar el valor de Ct individual de los virus infectados en un solo canal.

    Nov 30, 2020 Allplex™ RV Essential 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™ 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

  • 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