医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

Applied BioCode Achieves a Significant Milestone with ISO 13485:2003 Certification

2017年05月30日 PM08:07
このエントリーをはてなブックマークに追加


 

SANTA FE SPRINGS, Calif.

Applied BioCode, a publicly traded medical diagnostic company is proud to announce it has received ISO 13485:2003 certification (FM 661595) from the British Standards Institution (BSI) Group for the design, development, manufacture and distribution of in-vitro diagnostic reagents and in-vitro medical devices used in molecular and protein detection.

ISO 13485:2003 is the world’s most widely recognized quality management standard for the medical industry and helps organizations to meet the quality expectations and needs of their customers. As part of the ISO 13485:2003 certification process, Applied BioCode engaged in a rigorous audit of our business processes as well as our product quality environments. By achieving this level of certification we continue to demonstrate our ability and desire to effectively and efficiently provide a quality management system while continuously improving our products and services as well as our internal processes.

“This certification demonstrates Applied BioCode’s continued commitment to the highest level of quality management and design controls to ensure delivery of safe and effective products to our customers. Our customers can be assured that the products we deliver are of the highest quality standards,” said Winston Ho, Ph.D., President of Applied BioCode.

About Applied BioCode

Applied BioCode is a publicly traded medical diagnostic company that develops, manufactures, and markets Barcoded Magnetic Beads (BMBs) and detection systems to facilitate development of highly multiplexed nucleic acids or protein detection assays. The BMB technology offers up to 4,096 unique digital barcodes for multiplex analysis with unmatched decoding accuracy. Our easy-to-use BioCode systems employ steady state detection without requiring flow cytometers that are prone to channel blockage or sample cross contamination. The system is well suited for clinical diagnostic applications* such as detection of infectious pathogens, drug resistance markers, cancer markers and mutation analysis, as well as specific applications for the life science research and agricultural testing markets. For more information, please visit the company’s website at www.apbiocode.com

*Currently in Clinical Trials. Not yet cleared by U.S. FDA.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170530005299/en/

CONTACT

Applied BioCode
Dr. Winston Z. Ho
President
+1 (562)
801-0050

Related Posts Plugin for WordPress, Blogger...

同じカテゴリーの記事 

  • 印尼生命科学与技术学院在NCRM NICHE 2021上赢得第16届Fujio Cup Quiz大赛;印度Rajalakshmi工程学院获得亚军
  • 辉凌将在ACG 2021上展示基于微生物群的在研活体生物治疗药物RBX2660用于治疗艰难梭菌反复感染和IBD患者的获奖真实临床转归分析
  • ShouTi Secures $100 Million Series B Financing to Accelerate Development of Life-Changing Medicines Fueled by Advanced Computational, Structure-Based Drug Design Platform
  • 硕迪B轮成功融资1亿美元,利用先进的计算和结构药物设计平台加速开发改变患者命运的药物
  • CANbridge Pharmaceuticals CAN103 Investigational New Drug Application Approved in China for Treatment of Gaucher Disease