b'LeukoStrat Assay Kits are in vitro diagnostic products intended for PCR-based detection of FLT3 activating mutations (ITD, TKD) in patients with acute myelogenous leukemia (AML) using gel or capillary electrophoresis methods.All tests include PCR master mixes and controls for ITD and TKD detection, along with Instructions For Use (IFUs). 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. Gel detection kits contain a 3rd master mix to ensure high quality DNA inputs are used preventing false negative test results.The LeukoStrat CDx FLT3 Mutation Assays provide a complete solution with software automated PDF reports including mutant identification, mutant to wild type signal ratios, and clinical interpretation. Additional reagents of Taq DNA Polymerase (US, JP), EcoRV Enzyme (US, JP), and NEBuffer 3.1 (US) are included in IVD kits.DISCLAIMER: LeukoStrat Assays are in vitro diagnostic products. CE-IVD products are not available for sale or use within North America. IVD products are available for sale or use where registered. Refer to product page for respective detail. For more information regarding the research use only reagents, please see the Gel & Capillary Research Use Only Assays section.Invivoscribe 2021|83'