REDx™ Control products are intended to evaluate laboratory testing performance, procedures, and workflow with nucleic acid and/or antigen based assays that detect infectious disease pathogens in patient sample. REDx™ Controls are designed to improve the diagnostic quality outcome by early detection of deviations from desired assay performance. All REDx™ Controls are FDA / CE certified for IVD use and are manufactured under ISO 13485 and 21CFR Part 820 standards.
PROCEEDx™ samples are Research Use Only (RUO) products. Designed for use in test systems IQ/OQ/PQ, Verification/Validation and Training. They represent a very cost-effective way of covering the specific needs of Original Equipment Manufacturers (OEM), research labs, universities and training/teaching centers. Those institutions need to perform routine device or equipment performance, validation and verification and training of personnel. PROCEEDx™ Samples cover most currently used pathogen test platforms with a number of samples offering a unique duality suitable for both immunological and molecular assays.