About us - XEMА

XEMA LLC

XEMA LLC is a research and production company whose main activity is developing and producing a wide range of products for clinical diagnostics.

The company’s product range includes about 200 products for in vitro diagnostics. These are primarily ELISA test kits, real-time PCR kits, tests for rapid diagnostics, and nucleic acid extraction kits.

XEMA’s products are intended for the diagnosis of infectious diseases, diabetes, hormonal disorders, reproductive system disorders in men and women, determination of tumor markers and other human pathologies, as well as for the diagnosis of allergies.

Product

Our clients are public and private medical and reference laboratories, research and blood transfusion centers, medical offices, and other healthcare facilities.

Continuous development of research and development activities ensures the production of key components, namely recombinant and monoclonal proteins, synthetic oligonucleotides, and plasmids.

A wide range of diagnostic products and a full production cycle allow us to comprehensively meet the individual needs of each client.

Some history

From the beginning to the present day: the company's development

2008 - 2012 development of R&D activities

Research and development activities primarily focus on the study, production, and purification of recombinant proteins and antibodies. As a result, a number of monoclonal and polyclonal antibodies and recombinant proteins have been obtained, which are used in the production of kits for the diagnosis of infectious diseases, and detection of biomarkers of cancer and hormonal disorders.

2012 - 2016 production of tests for food products, in particular for assessing the antibiotic content and determining the physical and chemical properties of the products under study

Serial production of test kits for measuring the content of antibiotics in food, agricultural products, and food raw materials by enzyme-linked immunosorbent assay, including aflatoxin, zearalenone, streptomycin, tetracycline, furazolidone, etc. A food safety and quality control laboratory was set up and accredited at the company.

2016 - 2020 launch of the production of kits for Enzyme Immunoassay

Development, implementation, and certification of a quality management system under the requirements of DSTU ISO 13285:2005. Placing on the Ukrainian market and serial production of Enzyme Immunoassay kits for in vitro diagnosis of infectious and oncological diseases, as well as hormonal disorders.

From 2020 - launching the production of real-time PCR kits and rapid tests

Recertification of the quality management system under the international standard ISO 13485:2016. Placing on the Ukrainian market and mass production of molecular genetic and immunochromatographic reagent kits. Registration of EIA kits in the European database EUDAMED with the right to apply CE marking.

Certification and conformity assessment

The quality management system implemented and certified at the company under ISO 13485 ensures that the products meet the requirements of the Technical Regulation on Medical Devices for In Vitro Diagnostics of Ukraine and Directive 98/79/EC of the European Parliament and of the Council on Medical Devices for In Vitro Diagnostics.

XEMA LLC annually participates in the external quality control programs of LABQUALITY (Finland) and demonstrates the high quality of its products.

Certificates