b"LeukoStrat Assay kits are in vitrodiagnostic products.* These assay kits are intended for PCR-based detection of FLT3 activating mutations in patients with acute myelogenous leukemia (AML) using gel or capillary electrophoresis methods.These tests include Instructions For Use (IFUs) with interpretation guidelines describing the use of the kits' master mixes and controls. Master mixes are composed of a buffered magnesium chloride solution, deoxynucleotides, and primers targeting the gene segments of interest. These assay master mixes are complete other than Taq DNA polymerase.In the Japan marketed IVD product, Tag DNA Polymerase and EcoRV Enzyme are further included in the LeukoStrat Assay Kit.These assays are available in regular (33 reactions) and in MegaKit formats (330 reactions), with exception of the LeukoStrat CDx FLT3 Mutation Assay, which is only available in regular format.For more information, please visit www.invivoscribe.com*NOTICE: LeukoStrat Assays are in vitro diagnostic products and are not available for sale or use within North America. For more information regarding the research use only reagents, please see the Gel & Capillary Research Use Only Assays section.Invivoscribe 2020|81"