Invivoscribe 2019 | 53 Gel & Capillary CE-IVD Assays 52 IdentiClone Assay kits are CE-marked in vitro diagnostic products*. These kits are intended for PCR-based detection of clonal gene rearrangements and translocations in patients with suspected lymphoproliferations, using gel or capillary electrophoresis methods. These PCR-based tests include standardized 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 multiple primers that target the gene segments of interest. Multiple primers are necessary to ensure a comprehensive testing approach that reliably identifies clonal rearrangements. These assay master mixes are complete with the exception of Taq DNA polymerase, which is not provided. A single thermocycler program and similar detection methods are used within each IdentiClone kit to improve consistency, reduce human error, and facilitate cross-training. These assays are available in regular (33 reactions) and in MegaKit formats (330 reactions). For more information, please visit www.invivoscribe.com B-Cell Assays IdentiClone IGH + IGK B-Cell Clonality Assays 54 IdentiClone IGH Gene Clonality Assays 56 IdentiClone IGK Gene Clonality Assays 58 IdentiClone IGL Gene Clonality Assays 60 T-Cell Assays IdentiClone TCRB + TCRG T-Cell Clonality Assays 62 IdentiClone TCRB Gene Clonality Assays 64 IdentiClone T-Cell Receptor Gamma Gene Rearrangement Assay 2.0 66 IdentiClone TCRG Gene Clonality Assays 68 IdentiClone TCRD Gene Clonality Assays 70 Translocation Assays IdentiClone BCL1/JH Translocation Assay 72 IdentiClone BCL2/JH Translocation Assay 74 *NOTICE: IdentiClone 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. Gel and Capillary Assays 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. Many of these products are covered by one or more of the following: European Patent Number 1549764, European Patent Number 2418287, European Patent Number 2460889, Japanese Patent Number 4708029, United States Patent 8859748, and related pending and future applications. All of these patents and applications are licensed exclusively to Invivoscribe® . Additional patents licensed to Invivoscribe covering some of these products apply elsewhere. 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. Identiclone™ is a registered trademark of Invivoscribe® .