Do You Know What it Takes to CE Mark an HLA Typing Product?

16/03/2020

Abstract presentation by Omixon’s Senior Technical Lead Assay R&D, Dr. Gergely Tölgyesi, from the latest 14th East-West Immunogenetics Conference (Budapest, Hungary). Abstract: European transplantation laboratories require the use of CE-marked HLA typing products for diagnostic purposes. The CE mark (“Conformité Européenne”, French for European conformity) is a symbol that...

Omixon Announces Holotype HLA v2 Products are CE Certified

18/04/2018

Omixon has announced that it has received CE Certificate for the v2 protocol of its world leading Holotype HLA Typing Kit. It certifies that all v2 products comply with IVD Directive 98/79/EC to commercialize the new version products as IVD in Europe. Holotype HLA Configurations deliver improved amplification robustness,...

Holotype HLA Now CE-IVD in Europe

06/04/2016

Omixon announce today that Holotype HLA™ has been approved as a CE Marked IVD for sale in Europe, and will be available from April 2016 to all European customers as IVD, while remains RUO in the USA. Holotype HLA is the most globally recognized Next Generation Sequencing (NGS) Assay...