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 

  • Dr. Reddy’s Laboratories announces its intent to appeal court decision in preliminary injunction hearing for Buprenorphine and Naloxone Sublingual Film
  • U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
  • NINLARO® (ixazomib)维持治疗3期试验达到主要终点,显示多发性骨髓瘤移植后患者的无进展生存延长有统计学意义
  • 維持療法としてのニンラーロ(イキサゾミブ)を検討する第3相試験は主要評価項目を達成し、移植後の多発性骨髄腫患者で無増悪生存期間の統計的に有意な改善を実証
  • EUSA Pharma:NICE核准靶向癌症免疫治疗药物QARZIBA®▼ (dinutuximab beta)用于治疗高危神经母细胞瘤患儿