Leading the Way in In-Vitro Diagnostics

Delivering Quality and Innovation to the Global Healthcare Community

Our three methodologies / platforms


Chemiluminescence Platform


(Automated ELISA Platform)

Rapid Test

EPITUUB® US Patented

Featured Products

Epitope Diagnostics Inc., is an ISO13485:2016 certified and US FDA registered/licensed medical device manufacturer that focuses on niche immunoassays for the global clinical diagnostics and research communities. We specialize in chemiluminescence immunoassay kits, ELISA kits, lateral flow rapid test kits, and special antibodies.​​​​​​​

ISO 13485:2016 Certification

ISO 13485:2016 CertifiedISO 13485:2016 Certified
EDI is an ISO 13485:2016 certified company. Our certificate can be downloaded here. Updated 05/26/2023