b'IdentiClone Assay kits are CE-markedin vitro diagnostic products.* Gel and CapillaryAssays These kits are intended for PCR-based detection of clonal gene rearrangements B-Cell AssaysT-Cell Assaysand translocations in patients with suspected lymphoproliferations, using gel or 62/ IdentiClone IGH + IGK 70/ IdentiClone TCRB capillary electrophoresis methods.B-Cell Clonality Assays Gene Clonality Assays The Invivoscribe CE-marked IdentiClone Assays represent a simple approach to PCR-based clonality testing. 64/ IdentiClone IGH Gene 72/ IdentiClone T-Cell Receptor GamaThese standardized assays were carefully optimized testing positive and negative control samples using Clonality AssaysGene Rearrangement Assay 2.0 multiplex master mixes. Assay development was followed by extensive validation including the testing of more 66/ IdentiClone IGK Gene 74/ IdentiClone TCRD than 400 clinical samples using Revised European/American Lymphoma (REAL) Classification. Testing was Clonality Assays Gene Clonality Assays performed at more than thirty prominent independent testing centers throughout Europe in a collaborative study known as the BIOMED-2 Concerted Action. 1These PCR-based tests include standardized Instructions 68/ IdentiClone IGL Gene For Use (IFUs) with interpretation guidelines describing the use of the kits master mixes and controls. A single Clonality Assays thermal cycler program and similar detection methods are used within each IdentiClone kit to improve consistency, reduce human error, and facilitate cross-training.Translocation AssaysFor more information, please visit www.invivoscribe.com76/ IdentiClone BCL1/J H Translocation Assays78/ IdentiClone BCL2/J H Translocation Assays 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.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, United States Patent 10280462, 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.1. JJM van Dongen et al., (2003) Leukemia 17:2257-2317.Identiclone is a registered trademark of Invivoscribe. DISCLAIMER: 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. Invivoscribe 2021|61'