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About us

 

Quality Assurance


The Quality Policy of Biokit is based on providing customer satisfaction, improving patient's health and compliance with International Standards and Regulations.

All reagents developed and manufactured by Biokit must satisfy stringent quality requirements and fully meet the particular needs of different markets.

The processes at Biokit from development through production and release of product follow G.M.P. (Good Manufacturing Practices), to guarantee Full Quality Assurance System for the manufacturing of the final product. This ensures proper functionality and reproducibility of the products we manufacture.

Biokit's Quality System has been certified to ISO 13485:2003.

Biokit's Quality System is periodically audited and assessed by the regulatory agencies of the different countries where the products are distributed: USA, European Union (CE Mark), and Health Institutions from other worldwide countries.





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