Our Products
Our product range consists of over 80 quality diagnostic test kits. The majority of our kits are quantitative, and include up to six calibration standards. The reagents are ready to use and colour coded to ensure accurate reagent dispensing. Several products have 510(k) approval by the US Food and Drug Administration.
Quality Assurance and Regulatory Compliance
Quality assurance is the cornerstone of the Company’s success. Our quality management system was one of the first in the industry to obtain ISO9001:2000 and ISO 13485:2003 certification and all aspects of product design and manufacture are carried out in accordance with these standards.
Where possible, our diagnostic assays are subject to ongoing evaluation in national and international external quality assessment schemes. The performances of our assays are, without exception, rated as excellent/good by UK Neqas. Our products have performed consistently well in head-to-head comparisons with kits produced by other manufacturers, as revealed by evaluations conducted by the Medicines and Healthcare Products Regulatory Agency (MHRA). For example, Genesis Diagnostics’ Tissue Tranglutaminase IgA ELISA was identified as having the highest clinical sensitivity and greatest accuracy in a recent MHRA evaluation. All products for sale in the EEC are CE marked in compliance with Directive 98/79EC and products sold into the Canadian Market are ISO 13485:2003 CMDCAS approved.
Certificates
