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History & Organization

History

2023
  • - Expansion of business area with Molecular diagnosis

2022
  • - Expansion of the 2nd factory in Suwon (MDT Production Plant)
    - Listed on EU Common list of COVID-19 antigen tests
      agreed by EU Health Security Committee
    - Establish US entity

2021
  • - Expansion of the 1st factory in Suwon
      (RDT Production Plant / Monthly Capacity : 100 Mil tests)
    - Acquired COVID-19 Ag Home Test Kit approval from Korea MFDS (1st and official)
    - COVID-19 Ag for professional and home use is formally registered globally.
    - Awarded with $100 million Export Tower in 2021 (Export reached $100 million in 2020)
    - Acquired COVID-19 Ag Home Test Saliva Export Certification
    - Global presence of over 50 countries around the world

2020
  • - ISO 13485 : 2016 Certification
    - Applied WHO PQ for 3 ERPD approved Malaria RDT
    - Acquired KFDA/CE for 3 COVID-19 RDTs

2019
  • - Acquired certification for 3 types of Malaria (GF ERPD)

2017
  • - ISO 13485:2012 Certification

2015
  • - KGMP Certification (by KFDA)

2013
  • - Launched 20 types of IVD products for Human

2011
  • - ISO 13485 Certification 

2009
  • - Launched BIOCREDIT Influenza A&B Antigen

2008
  • - Launched 10 Veterinary IVD products

2007
  • - ISO 9001 Certification

2006
  • - Development of Black Gold Particle Technology

2003
  • - Established Rapigen R&D Center

2002
  • - Establishment of Rapigen Co.,LTD

Organizational chart