IVD Clinical Performance Studies
No. 1 in Korea for In Vitro Diagnostic (IVD) Medical Device Clinical Trials. Through a strategic alliance with U2Labs, U2XLab provides comprehensive services including clinical performance studies for in vitro diagnostic medical devices. Clinical performance studies for IVD medical devices are evaluations conducted by analyzing specimens to verify device performance and confirm results related to clinical, physiological, and pathological conditions.
Clinical Performance Study Experience
72
Number of Clinical Performance Studies Conducted
36
Number of IVD Medical Device Companies
Key Advantages of U2Labs
01A designated institution for clinical performance studies
02QCRC-certified qualifications and experienced study personnel
03Systematic process management from IRB submission through study completion
04Extensive rare sample resources and residual sample availability
05Pre-study protocol review and customized study scheduling
06Fast and accurate results based on statistical analysis
Major Clients
