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History 1 페이지

History 1 페이지

2022
06
  • CE/IVDR certification (Class A in accordance with the rules set out in IVDR (Regulation (EU) 2017/746) Annex III: alphaPrepTM Viral DNA/RNA Extraction Kit, alphaPrepTM  Nucleic Acids Extraction Kit, alphaPrepTM  Total DRex Kit, alphaPrepTM  QS DRex Kit, alphaPrepTM  E-QS DRex Kit)
2021
11
  • FDA registration (alphaPrepTM Nucleic Acids Extraction Kit, alphaPrepTM Total DRex Kit, alphaPrepTM QS DRex Kit, alphaPrepTM E-QS DRex Kit)
  • CE/IVDD certification (alphaPrepTM Nucleic Acids Extraction Kit, alphaPrepTM  Total DRex Kit, alphaPrepTM  QS DRex Kit, alphaPrepTM  E-QS DRex Kit)
03
  • Expansion of Headquarters and Production facilities
2020
04
  • FDA registration (alphaPrepTM Viral DNA/RNA Extraction Kit)
  • CE/IVDD certification (alphaPrepTM Viral DNA/RNA Extraction Kit)
  • ISO13485:2016 certification (Design & Development, Manufacture and Sales of In-Vitro Diagnostic Reagent)
2016
11

  • Registration of IVD with the Ministry of Food and Drug Safety: alphaPrepTM NAX extraction reagent series (Magnetic beads method) for automatic nucleic acid extractor. 

06
  • Relocation of headquarters to Sangdaewon-dong, Jungwon-gu, Seongnam-si, Gyeonggi-do
2013
11
  • Registration of medical devices and approval for manufacturing medical devices by the Ministry of Food and Drug Safety. Registration of IVD with the Ministry of Food and Drug Safety: alphaPrepTM NAX extraction reagents : 8 items, 16 types
  • Registration of trademark for ALPHαGENE, alphaPrepTM, alphaAmpTM
07
  • Certification of R&D center (Korea Industrial Technology Promotion Association)
2012
06
  • Certification of venture business (Korea Technology Finance Corporation)
05
  • Establishment of ALPHAGENE CO., Ltd.
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알파젠

Address : B-109, Ssangyong IT Twin Towers, 531 Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do

Main phone : +82-31-741-6002 | FAX : +82-31-741-6003

Mail : info@alpha-gene.com, sales@alpha-gene.com

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