Spectral Diagnostics Inc.

Company Description

Spectral possesses a breadth of experience in both the clinical diagnostic setting and the laboratory environment. Spectral Diagnostics Inc. competitive advantage is built upon the ability to identify a clinical need and provide rapid and reliable solutions. Spectrals product development cycle includes R & D activities, clinical investigation and validation studies led by an experienced in-house team of protein chemists, molecular biologists, immunologists and clinical scientists. Products The xxxxx Activity Assay is the first FDA approved diagnostic test in the field of sepsis. xxxxx is an important biomarker for the rapid identification of patients at risk for sepsis. With the ability to provide this unique diagnostic information within an hour, Spectral continues to expand its International customer base, supported by its Toronto, Canada manufacturing facility. The RAPID 1 West Nile Virus Test is another of Spectral innovative products designed to meet the continually changing needs in the world of healthcare. With its flu-like symptoms, the West Nile Virus is a rapidly growing healthcare concern, reaching epidemic proportions in some locations. Armed with this unique and rapid assay, physicians can quickly obtain diagnostic information regarding exposure to this potentially deadly virus. Spectral continues its history of developing high quality, high performance polyclonal and monoclonal antibodies, and recombinant proteins. These proprietary reagents are sought after by highly reputable and specialized research groups and commercial organizations worldwide. Commitment to Quality Spectral has a strong commitment to quality and following The Medical Device Regulations under CMDCAS as mandated by Health Canada, Spectral Diagnostics has received and continues to operate its development and manufacturing facility under cGMP (US 21 CFR Part 820), IS0-9001: 2000 and CAN/CSA ISO-13485-2003 certifications.