History

2018

  • AOAC/ Microvalvalidation for Salmonella detection including rapid extraction method
  • Succesful reaccreditation according to DIN 17025:2005
  • Succesful recertification according to DIN EN ISO 9001:2015

2017

  • Succesful recertification according to DIN EN ISO 13485
  • certified VLOG lab (GMO free labeling)
  • Servicelab move to new and from production seperated laboratories in house 80
  • First 510(k) Premarket Notification (PMN) for Norovirus genogroup detection kit
  • Start of product sales for personalized medicine.
  • rebuilding and expansion for planed FDA approval regarding special detection kits for clinic parameters and Norovirus

2016

  • Development of detection kits in the field of personalized medicine.
  • Award “Innovative through Research” by the German Stifterverband

2013

  • ISO 13485 certification – development, production and distribution of molecular biological test systems for clinical diagnostics
  • Development of the first 5plex real-time applications for clinical diagnostics
  • Pull-out of Dr. Kuhn from the operative business
  • 30 employees

2011

  • R-Biopharm acquire GmbH-shares
  • First external product validation of AOAC/Microval

2010

  • Start of product sales for clinical diagnostics
  • Development of the first 4plex real-time applications

2008

  • Start of product development for clinical applications

2003

  • ISO 17025 accreditation (competence of testing and calibration laboratories)
  • Reorientation towards real-time PCR products with hydrolysis probes (TaqMan)

2001

  • ISO 9001 certification (quality management system)
  • Distribution via R-Biopharm

1999

  • Opening of the laboratory and beginning of development work for applications in the fields of GMO, animal species and allergens

1998

  • Founding of CONGEN Biotechnologie GmbH by Dr. M. Kuhn and Dr. S. Mergemeier
  • 3 employees