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Seegene has received approval from Australia’s Therapeutic Goods Administration for Allplex™ SARS-CoV-2 fast PCR Assay. Therapeutic goods must be entered in the Australian Register of Therapeutic Goods before they can be supplied in the country.
Apr 12, 2022| Allplex™ SARS-CoV-2 fast PCR Assay
Allplex™ RV Master Assay has received approval from Australia’s Therapeutic Goods Administration and achieved the European CE-IVD marking.Therapeutic goods must be entered in the Australian Register of Therapeutic Goods before they can be supplied in the country. The CE-IVD marking is a legal requirement for marketing medical devices in the European Union.
Apr 01, 2022| Allplex™ RV Master Assay
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ SARS-CoV-2 fast MDx Assay.This new assay is optimized for the ‘living with COVID-19’ era, where mass, swift and cost-efficient testing is vital. The test can deliver results within 30 minutes, the fastest among diagnostics assays developed by Seegene, while matching the accuracy of RT-PCR tests.
Feb 25, 2022| Allplex™ SARS-CoV-2 fast MDx PCR Assay
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ SARS-CoV-2 fast PCR Assay. Allplex™ SARS-CoV-2 fast PCR Assay is a multiplex real-time PCR assay that detects of 3 types of SARS-CoV-2 gene(E gene, RdRP gene and N gene) in a single tube. This assay also used an endogenous gene as Internal Control(IC) to monitor the whole process including sampling steps.
Dec 29, 2021| Allplex™ SARS-CoV-2 fast PCR Assay
Seegene has launched Novaplex™ SARS-CoV-2 Variants VII Assay. Novaplex™ SARS-CoV-2 Variants VII Assay is a multiplex real-time PCR assay that detects and identifies a total of five analytes including three key Omicron S-gene mutations (E484A, N501Y, HV69/70 deletion) and RdRP gene in a single tube.
Dec 20, 2021| Novaplex™ SARS-CoV-2 Variants VII Assay
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ SARS-CoV-2 RV Master Assay. Allplex™ SARS-CoV-2 RV Master Assay is a multiplex real-time PCR assay that detects and identifies various major respiratory viruses (Flu A, Flu B, RSV, MPV, AdV, HRV and PIV), including SARS-CoV-2.
Nov 19, 2021| Allplex™ RV Master Assay
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ SARS-CoV-2 Variants II Assay. Allplex™ SARS-CoV-2 Variants II Assay is a multiplex real-time PCR assay that simultaneously detects and identifies four notable mutation sites in S gene in a single tube.
Jun 30, 2021| Allplex™ SARS-CoV-2 Variants II Assay
Seegene’ Allplex™ SARS-CoV-2 Master Assay has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices. Allplex™ SARS-CoV-2 Master Assay is a multiplex real-time PCR assay that full screening for five notable S gene mutations (HV69/70 deletion, Y144 deletion, E484K, N501Y, and P681H) in one signal, in addition to four target genes of SARS-CoV-2 all in a single tube.
Mar 26, 2021| Allplex™ SARS-CoV-2 Master Assay