Getting ready for IVDR

At OGT, we committed early to the In Vitro Diagnostic Regulation (IVDR) and have been working diligently over the last few years to meet the conformity requirements in a timely and compliant manner.
We’re delighted that this hard work has led to the successful IVDR certification of our first CytoCell® fluorescence in situ hybridisation (FISH) probes that play a critical role in the management of patients with haematological cancers and prenatal conditions.
This important milestone places OGT as the first manufacturer of FISH probes to obtain the new IVDR certification, demonstrating our commitment to provide innovative, class-leading products under this substantially more stringent regulation. Switching to IVDR-certified FISH probes means you can be confident that your laboratory is using safe, reliable and effective tools for diagnosing patients.
Further product launches will follow over the coming months as we pursue additional certifications for our CytoCell FISH probes.
Visit www.ogt.com/ivdr for more information.