Epitope Diagnostics Inc产品代理
Epitope Diagnostics Inc产品代理
历史
Epitope Diagnostics, Inc. 位于美国最好的城市和美国的生物技术中心之一，成立于 2003 年。 从那时起，EDI 开发并推出了许多创新的 ELISA 和快速检测试剂盒，以满足全球医疗保健社区的需求。例如，EDI 推出了世界上第一个测定 alpha-1-HS-糖蛋白的商业化测试，即人胎球蛋白-A ELISA 试剂盒。使用该测试进行了许多临床研究，导致发表了 20 多篇科学论文。
2004 年，EDI 获得加利福尼亚州卫生服务部食品和药品分部的认可，成为经过认证和许可的医疗器械制造商。一年后，EDI 开发并创新、无味且自成一体的快速检测平台，专门用于基于粪便样本的快速检测。自 2005 年以来，该创新设备已获得专利（US 7,780,915）、FDA 510(k) 批准和 CLIA 豁免。该平台已成为我们所有快速测试套件的基础，包括欧洲 CE 认证的 OTC 套件 EpiTuub iFOB 测试。
ISO认证
EDI 是一家通过 ISO 13485:2016 认证的公司。我们的证书可以在这里找到。
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 13485:2016 certified company. Our certificate can be found here.
