SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--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.