IVD Kit Manufacturing Service

GENERI BIOTECH s.r.o.

Hradec Králové - Pražské Předměstí, Czech Republic

GENERI BIOTECH s.r.o. is a Czech biotechnological company focused on research and development, manufacturing and selling of own proprietary products: the CE IVD kits based on molecular genetic methods, Life Sciences products and Oligonucleotides. In addition, GENERI BIOTECH s.r.o. also run testing facilities for both public and GLP/GMP tests, typically for CROs in the field of drug development. GENERI BIOTECH s.r.o. was established in 1995, originally as a facility for production of oligonucleotides. The synthesis of oligonucleotides has long been the basis of the company's activities. Since 2010, however, in addition to oligo synthesis, we have also focused on the development and production of our own IVD kits and products for Life Science. Since then, our IVD portfolio has been growing steadily, covering not only hematological diagnostics, but also pharmacogenetics, genetics, microbiology and oncology, within the market segment of laboratory diagnostics in human medicine. The production at GB is certified according to IVDR Regulation (EU) 2017/746 of the European Parliament and of the Council ( in vitro diagnostics), EN ISO 13485:2016 ( in vitro diagnostics) and EN ISO 9001:2016 (oligonucleotides and life science products).