Cellex

Biotechnology company Cellex Incorporated was founded in 2002. Develops technologies, tools and medical products for testing, sampling, etc. Manufactures everything necessary for medical diagnostics for the last 25 years.

Cellex’s main facilities are located in North Carolina. The main research staff is stationed there. Cellex supports the GMP production site in Suzhou, China, which is ISO 13485 certified and complies with the US FDA QSR (Quality System Regulations).

The research complex is equipped with the most modern laboratory premises. The general laboratory space is divided into special zones for work on molecular biology, immunology and immunochemistry, microbiology, cell culture and development of the production process. It also has a separate microbiology lab designed for work that requires BSL-2.

Cellex manufactures the world’s only FDA-certified rapid tests for coronavirus. (Department of Sanitary Supervision of Food and Drug Quality)
The tests are performed in accordance with the requirements of the provisions of the EU Council Directive IVDD 98/79 EC on in vitro diagnostic medical devices.
They are certified: DIN EN ISO 13485: 2016, meet the requirements of the US QSR (Quality System Rules).