The ImuPro tests and antigens are manufactured by the German company R-Biopharm AG, Darmstadt under strict quality management ISO 9001 and ISO 13485 systems, accredited by the DQS according to the international standards ISO 9001 and EN 46001 (medical devices). In 2003, the company gained ISO 13485 quality management certification. All reagents used in the test are IVD-CE approved. Plus: ImuPro tests are processed in more than 20 laboratories worldwide, each run by specialists in this field – this enables us to conduct inter-laboratory trials on a yearly basis to ensure the consistency and quality of each and every step of this test.
Does the ImuPro test have any certification?
Friday, February 8, 2019