History

(주)시선바이오머티리얼스
  • 2021

    2021 연혁
    12

    Epi-TOP mMGMT Detection Kit Food and Drug Administration Manufacturing License

    11

    Intellectual Property Management Certification

    09

    Designated as a high-tech company (Minister of Science and Technology Information and Communication)

    07

    SSu ApoE Ministry of Food and Drug Safety Manufacturing Certification (IVD CLASS 2)

    07

    Check high-tech products (PNA probe-based diagnostic biomarker amplification and diagnostic technology, Ministry of Trade, Industry and Energy)

    06

    AQ-TOP COVID-19 Rapid Detection Kit Plus
    (Korea Halal Certification)

    05

    Certificate of Inno-Biz

    04

    U-TOP SARS-CoV-2 & Flu A/B Food and Drug Administration Manufacturing License

  • 2020

    2020 연혁
    12

    Korean National brand K certification

    11

    Molecular diagnosis product for rapid diagnosis of COVID-19 is approved by the US FDA-EUA

    10

    Molecular diagnostic product for precise diagnosis of COVID-19 approved by the Korean Food and Drug Administration

    10

    Received a citation from the Minister of Food and Drug Safety at the 13th Medical Device Industry Awards

    07

    COVID-19 emergency molecular diagnostic product approved by the Korean Food and Drug Administration

    04

    US FDA-EUA approval for molecular diagnosis product for precise diagnosis of COVID-19

  • 2019

    2019 연혁
    09

    Epi-TOP DNA methylation diagnosis original technology patent registration

    05

    Patio (high sensitivity chromosomal abnormality syndrome) detection original technology patent registration

    04

    Launched prenatal inspection service (Mom's seasun)

    04

    U-TOP (MSI) detection original technology patent registration

  • 2018

    2018 연혁
    09

    Selected as a bio industry core technology development project (MOTIE)

    08

    Obtained ISO9001 Certification

    07

    Subsidiary company "SEASUN THERAPEUTICS"

  • 2017

    2017 연혁
    09

    CE Marked (MSI Detection Kit)

    08

    Acquired a license for manufacturing medical device by Ministry Of Food and Drug Safety (MSI Detection Kit, In vitro diagnostic medical device Grade 3)

    03

    Selected for the Interconnection Technology Development Project for Commercialization (MOTIE)

    02

    Selected for the Local Major Industry Promotion(R&D) Technology Development Project (MOTIE)

  • 2016

    2016 연혁
    10

    Medical device quality management system (ISO13485)

    09

    Medical device manufacturing and quality control standards (GMP)

    01

    HL Genotyping Kit, Manufacturing permit

  • 2015

    2015 연혁
    07

    Selected as a private-public joint investment technology development project by MSS

    03

    Approval of medical device manufacturing business license

    01

    Genetic Testing Agency Certification

  • 2014

    2014 연혁
    08

    Venture Business Certification

  • 2013

    2013 연혁
    11

    Established R&D Institute

  • 2012

    2012 연혁
    03

    Established SEASUN BIOMATERIALS Inc.

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