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 and CapillaryAssays and Assays gel or capillary electrophoresis methods.82/ FLT3 Mutation Assay86/ LeukoStrat CDx FLT3 Mutation All tests include PCR master mixes and controls for ITD and TKD detection, along with Instructions For Use Gel Detection Assay (IVD) - USA (IFUs). Master mixes are composed of a buffered magnesium chloride solution, deoxynucleotides, and 84/ FLT3 Mutation Assay 2.0 88/ LeukoStrat CDx FLT3 Mutation primers targeting the gene segments of interest. These assay master mixes are complete other than Taq DNA ABI Fluorescence DetectionAssay (CE-IVD)polymerase. Gel detection kits contain a 3rd master mix to ensure high quality DNA inputs are used preventing false negative test results.90/ LeukoStrat CDx FLT3 Mutation The LeukoStrat CDx FLT3 Mutation Assays provide a complete solution with software automated PDF reports Assay - AUSincluding mutant identification, mutant to wild type signal ratios, and clinical interpretation. Additional reagents 92/ LeukoStrat CDx FLT3 Mutation of Taq DNA Polymerase (US, JP), EcoRV Enzyme (US, JP), and NEBuffer 3.1 (US) are included in IVD kits.Assay - Japan WARRANTY AND LIABILITYInvivoscribe, Inc. (Invivoscribe) is committed to providing the highest quality products. Invivoscribe warrants that the products meet or exceed the performance standards described in the Instructions For Use, as to products with such an insert. If a product is covered by product specifications and does not perform as specified, our policy is to replace the product or credit the full purchase price. No other warranties of any kind, expressed or implied, are provided by Invivoscribe. Invivoscribe liability shall not exceed the purchase price of the product. Invivoscribe shall have no liability for direct, indirect, consequential or incidental damages arising from the use, results of use, or inability to use its products; product efficacy under purchaser controlled conditions in purchasers laboratory must be established and continually monitored through purchaser defined and controlled processes including but not limited to testing of positive, negative, and blank controls every time a sample is tested. Ordering, acceptance, and use of product constitutes purchaser acceptance of sole responsibility for assuring product efficacy and purchaser agreement to the limitation of liability set forth in this paragraph.Use of this product may require nucleic acid amplification methods such as Polymerase Chain Reaction (PCR). Any necessary license to practice amplification methods or to use reagents, amplification enzymes or equipment covered by third party patents is the responsibility of the user and no such license is granted by Invivoscribe, Inc., expressly or by implication. 2020 Invivoscribe, Inc. All rights reserved. The trademarks mentioned herein are the property of Invivoscribe, Inc. and/or its affiliates, or (as to the trademarks of others used herein) their respective owners. DISCLAIMER: LeukoStrat Assays are in vitro diagnostic products. CE-IVD products are not available for sale or use within North America. DISCLAIMER: The products in the section that follows 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|81'