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Licensed Device Manufacturer

Licensed Device Manufacturer

Mission

Epitope Diagnostics Inc. (EDI) strives to develop, manufacture, and market the highest quality and most innovated in-vitro diagnostics (IVD) products to the global research, pharmaceutical, and healthcare community. We seek to become a major contributor in resolving the unmet medical needs of the world.

History

Located in America's finest city and one of the biotech hubs of the U.S., Epitope Diagnostics, Inc. was established in 2003. Since then, EDI has developed and launched many innovative ELISA and rapid test kits that meet the needs of healthcare communities worldwide. For instance, EDI launched the world's first commercial test for the determination of alpha-1-HS-glycoprotein, the human fetuin-A ELISA kit. Many clinical studies were performed using this test which led to the publication of more than 20 scientific papers.

In 2004, EDI was accredited by the State of California Department of Health Services, Food and Drug Branch, as a certified and licensed medical device manufacturer. A year later, EDI developed and innovative, odorless, and self-contained rapid test platform specifically for stool sample-based rapid tests. This innovative device has been patented (US 7,780,915), FDA 510(k) cleared, and CLIA-waived since 2005. This platform has gone on to be the basis of all our rapid test kit, including the European CE certified OTC kit, EpiTuub iFOB test.

ISO Certification

EDI is an ISO 13485:2003 certified company. Our certificate can be found here.