Solution reagent kit AltoStar®

diagnosticfor CMV

In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® CMV PCR Kit 1.5 has received a new product number and Global Trade Item Number (GTIN). The new product number reflects the desired change in regulatory status. All other product characteristics as well as the product performance remain unchanged. The kit is chemically identical to its already existing counterpart and contains the same kit components. Key features Detection and quantification of cytomegalovirus (CMV) specific DNA CE-IVD marked in vitro diagnostic test Analytical sensitivity reported in IU/ml Intended use The AltoStar® CMV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of cytomegalovirus (CMV) specific DNA in human plasma, whole blood and urine. It is intended to be used as an aid for diagnosis of CMV infection and for monitoring of the CMV load in individuals with CMV infection.