Invivoscribe 2019 | 77 Gel & Capillary CE-IVD Assays 76 LeukoStrat Assay kits are in vitro diagnostic 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 standardized Instructions For Use (IFUs) with interpretation guidelines describing the use of the kit’s 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 market 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 LeukoStrat® FLT3 Mutation Assay - Gel (CE-marked) 78 LeukoStrat® FLT3 Mutation Assay 2.0 - ABI Fluorescence (CE-marked) 80 LeukoStrat® CDx FLT3 Mutation Assay (CE-marked) 82 LeukoStrat® CDx FLT3 Mutation Assay - Japan 84 Warranty and Liability Invivoscribe, 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 purchaser’s 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. NOTICE: The products in the section that follows are in vitro diagnostic products and are not available for sale or use within North America. These products require nucleic acid amplification methods such as Polymerase Chain Reaction (PCR). No license under these patents to use amplification processes or enzymes is conveyed expressly or by implication to the purchaser by the purchase of these products. LeukoStrat® is a registered trademark of Invivoscribe® . *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 section. Gel and Capillary Assays and Assays Gel & Capillary CE-IVD Assays