Quality and Regulatory

To comply with In Vitro Diagnostic Device Regulation (98/79 CE) and to continually improve the effectiveness of the Quality Management System (QMS), the company implements a Quality Management Program following several ISO standards recognized and linked to international regulations  ISO 13485, US cGMP 21 CFR part 820 and ISO 9001.

iDTECT™ Blood is the first and only CE-IVD metagenomic test for blood stream infections.