SEKURE

diagnostic substances, preparations, and materials, namely, diagnostic reagents for medical use, diagnostic calibrators for medical use that are used to calibrate the performance of a reagent used on an assay device for determining the amount of analyte in a biological sample, and diagnostic controls for monitoring the performance of diagnostic reagents and calibrators on an assay device for medical use; kits comprised of diagnostic reagents for medical use, kits comprised of diagnostic calibrators for medical use that are used to calibrate the performance of a reagent used on an assay device for determining the amount of analyte in a biological sample, and kits comprised of diagnostic controls for monitoring the performance of diagnostic reagents and calibrators on an assay device for medical use; all the foregoing for in vitro diagnostic testing for medical, clinical chemistry, immunoassay, blood coagulation and hematological testing purposes