Applied BioCode Achieves ISO 13485:2003 Certification

Applied BioCode, a publicly traded medical diagnostic company, has received ISO 13485:2003 certification 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 its business processes as well as its product quality environments.
 
“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.
 
Applied BioCode 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. The company’s 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.

* Currently in clinical trials. Not yet cleared by the U.S. Food and Drug Administration.