EPITOPE DIAGNOSTICS, INC.

Epitope Diagnostics Inc. is an ISO 13485:2016 certified and FDA-registered medical device manufacturer specializing in niche immunoassays for clinical diagnostics and research communities. Headquartered in San Diego, California, the company manufactures chemiluminescence immunoassay kits, automated ELISA kits, lateral flow rapid test kits (EPITUUB® US patented), and specialty antibodies. Product portfolios span tumor markers and cancer research, gastrointestinal disease diagnostics, infectious disease testing, cardiovascular disease markers, calcium and bone metabolism assays, endocrinology and diabetes testing, autoimmune disease panels, and anemia diagnostics. The company serves both USA and international markets through separate product catalogs and maintains automation and analyzer platforms alongside traditional immunoassay methodologies. All products are designed for professional laboratory use in clinical and research settings. The company maintains full regulatory compliance with FDA licensing and ISO quality management systems certification valid through June 2026.