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History & Organization

History

2021
  • - Suwon factory expansion capable of producing 100 Mil tests per month

    - 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

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

2002
  • Establishment of Rapigen Co.,LTD

Organizational chart