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COMAPANY

A Leading Molecular Diagnostics Company with Unrivaled Competitiveness

History

Get an overview of the journey and growth of BioSewoom Co.,Ltd.

2024

  • Certified for Real-Q HLA-B*51 Kit
  • Certified for Real-Q HLA-B*27 Kit
  • Certified for Real-Q ApoE 112/158 Kit

2021

  • Product approval for Real-Q Direct SARS-CoV-2 Detection Kit
  • Product approval for Real-Q SARS-CoV2/FluA/FluB Detection Kit

2020

  • Real-Q 2019-nCoV Detection kit CE Certification
  • Real-Q 2019-nCoV Detection kit EUA by MFDS
  • Real-Q RV Ⅱ Detection kit manufacturing Approval by MFDA
  • Official approval for Real-Q 2019-nCoV Detection Kit

2019

  • Real-Q Pneumonia Detection Kit manufacturing Approval by MFDA

2017

  • Real-Q RNF213 R4810K Kit manufacturing Approval by MFDA

2015

  • Factor II, Factor V, MTHFR, MPL, EBV New Medical Technology Certification

2013

  • GMP Certification
  • IVD for class 2,6 products Manufacturing Approval by MFDA

2012

  • IVD for class 3, 63 products Manufacturing Approval by MFDA
  • HLA Typing for hight resolution Program development for diagnostic analysis

2011

  • Real-Q BRAF V600E New Medical Technology Certification HCV PCR SBT New Medical Technology Certification

2010

  • HLA DR SBT Kit, HCV Genotyping Kit Released

2009

  • WHO Collaboratory study HBV Genotyping PANEL

2008

  • Real-Q HBV QT PCR Kit CE0123 ISO 13485:2003

2007

  • Patent registration for HBV-specific gene quantification kit (KIPO)

2006

  • Patent registration for composition for extracting viral nucleic acid(KIPO)

2003

  • Company name change to BioSewoom INC.

2001

  • Mycorbacterium.Tuberculosis PCR diagnostic kit Approval by KFDA first in KOREA
  • ISO 19001

2000

  • Manufacturing Facility Approval
  • Established Company Biotechnology Institute

1999

  • License for Manufacturing Medicines (Minister of Food and Drug Safety)

1997

  • Establishes SLAM INC.
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