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REDx™ Controls 

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.

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PROCEEDx™ Kits

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.

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ONBOARDx™ Kits

ONBOARDx™ Kits are assemblies of PROCEEDx™ Research Use Only (RUO) products and designed as all-encompassing Verification/Validation kit for instrument, kit or assay qualification. They are helpful tools for verifying performance of new test systems and training lab personnel. These non-infectious samples are perfect surrogates for hazardous patient samples to confirm positive and negative detection of specific analytes. ONBOARDx™ Kits are available in liquid form for refrigerated storage or at ambient temperature on Copan FLOQSwabs® and there are several versions containing a range of respiratory samples.

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