Equitest Сертифікати – Equitest


Ekvitestlab LLC is registered in the single electronic database of the International Accreditation Forum (IAF) - a recognized international association of accreditation bodies and other organizations interested in assessing conformity in the field of management systems, products, processes, services, personnel, validation, and verification, as well as other conformity assessment programs.

The certificate of conformity with the requirements of the ISO 13485:2016 standard of the company is recognized as an accredited member of the IAF MLA Accreditation Authority, which allows all market participants to verify its validity at any time online, as well as the fact that the quality management system of Ekvitestlab LLC » developed, implemented and operates in accordance with the requirements of the international standard ISO 13485:2016 "Medical products. Quality management systems. Requirements for regulation". Participation in this international program ensures the confidence of buyers in the reliability of the manufacturer and contributes to the achievement of common goals in world trade.

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"EQUI" brand ELISA kits for the diagnosis of COVID-19, parasitic infections, gastrointestinal infections, as well as hepatitis A have successfully passed registration in the EU and received Certificates of compliance with Directive 98/79/EC of the Council of the European Union and the European Parliament on medical devices for in vitro diagnostics and marked with the "CE" mark of compliance with EU safety requirements.

The products of Ekvitestlab LLC meet the requirements of the national legislation in the field of circulation of medical devices, established by the "Technical Regulation on medical devices for in vitro diagnostics" approved by the Resolution of the CMU of October 2, 2013 No. 754.