CE IVDR certification for our HLA PCR products

We are delighted to announce that most kits in our HLA-Ready Gene and HLA-FluoGene product ranges, including the HLA part of the FluoGene software, are now officially certified in accordance with European Regulation 2017/746 (IVDR). Furthermore, under EU Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), disease-associated kits such as HLA-FluoGene B27/B27 Q and HLA-Ready Gene B27/Coealiac Disease/B57 remain certified.

This confirms that the high quality standards we have always applied in the development and manufacture of our products are now also formally recognized. This certification underscores our commitment to safety, reliability, and excellence in diagnostics—for the benefit of our customers and patients.

We are proud that our products now meet the stringent requirements of the IVDR and look forward to continuing to deliver top quality in HLA diagnostics.

Note: For USA and CANADA: Products are not FDA cleared devices and are for Research Use Only (RUO). Not for use in diagnostic procedures. Please select RUO designated documents.