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28 September 2015

Alkor Bio Group have transferred the European production of TORCH infections diagnostic kits

In September 2015, Alkor Bio Group have announced successful transfer of technologies from Europe.These are nine diagnostic kits designed by RADIM, Italy, for diagnostic of TORCH-infections: Toxoplasmosis, Rubella, Cytomegalovirus. The kits are intended for diagnostic different diseases steps: Toxoplasma IgG, Toxoplasma IgG Avidity, Toxoplasma IgM, Rubella IgG, Rubella IgG Avidity, Rubella IgM, Cytomegalovirus IgG, Cytomegalovirus IgG Avidity, Cytomegalovirus IgM. 

To notify the transfer, the external audit was fulfilled by Lloyd`s Register, Great Britain. During the audit the conformity to requirements of European Directive 98/79/EC on medical devices for in vitro diagnostic was assessed for all nine kits. The Noyfied Body have checked Alkor Bio`s quality management system, technical documentation, clinical evaluation results, infrastructure and personnel. As the kits for TORCH-infections diagnostic are included into the List B of the Annex II of European Directive 98/79/EC, Paul Erlich Institute, Germany has also participated in this audit as independent expert. This institute is the basic European expert center for medical device for in vitro diagnostic. During the audit no nonconformities have been detected. 

Previously all nine assessed kits were registered by Russian Ministry of Health. 

So Alkor Bio Group starts production of the kits for TORCH infections diagnostic for marketing both in Russia and in Europe. These kits will be sold under RADIM trade mark. 

In addition, Alkor Bio Group have transferred production of kits for herpes diagnostic of RADIM TM. As a result, and  taking into accountr the kits for Toxoplasmosis and Herpes diagnostic designed by Alkor Bio before, now Alkor Bio Group produces the full range of the kits for diagnostic of the main TORCH pathogens.