Seegene obtained CE IVDR marking for its Allplex MDRO Assay, a multiplex real-time PCR test for detecting multidrug-resistant organisms and associated resistance genes linked to healthcare-associated infections. With the certification, the company launched the kit in Europe. The assay is designed for rapid first-line screening ahead of culture results, supporting earlier infection prevention and control decisions in hospital settings. Seegene also stated it is developing the Allplex MRSA assay as part of its broader antimicrobial resistance testing expansion strategy. For diagnostic developers, IVDR clearance remains a key gating item for scaling sales in the EU and for integrating molecular workflows into routine clinical microbiology.