Invivoscribe 2019 | 125 Analyte Specific Reagents 124 Analyte Specific Reagents Invivoscribe Analyte Specific Reagents (ASRs) target B- and T-cell antigen receptor loci, as well as IGH-BCL2, BCR-ABL1, and PML-RARA chromosome translocations. The ASRs are available as a single tube containing a volume of 1500 μL. To ensure the highest quality and reliability of reagents ASRs are manufactured under cGMP and ISO 13485 standards. The analytical and performance characteristics of the ASRs have not been established. Per the current US FDA regulations, ASRs may only be sold to in vitro diagnostic manufacturers, CLIA accredited high complexity laboratories, VHA regulated clinical laboratories, and laboratories not intending to use ASRs as a part of a diagnostic test. ASRs are not available for sale or use outside of the USA. IGH (Immunoglobulin Heavy Chain Gene Locus) Description Catalog # IGH Framework 1 - 6FAM A-101-0061 IGH Framework 2 - Unlabeled A-101-0070 IGH Framework 2 - 6FAM A-101-0091 IGH Framework 3 - Unlabeled A-101-0080 IGH Framework 3 - HEX A-101-0081 IGH FR1 - Unlabeled A-101-0010 IGH FR1 - 6FAM A-101-0011 IGH FR2 - Unlabeled A-101-0020 IGH FR2 - 6FAM A-101-0101 IGH FR3 - Unlabeled A-101-0030 IGH FR3 - HEX A-101-0031 IGH DH1 - 6 - HEX A-101-0041 IGH DH7 - 6FAM A-101-0051 IGK (Immunoglobulin Kappa Light Chain Gene Locus) Description Catalog # IGK V - J - Unlabeled A-102-0010 IGK V - J - 6FAM A-102-0011 IGK V - Kde - Unlabeled A-102-0020 IGK V - Kde - 6FAM A-102-0021 TRB (T-Cell Receptor Beta Chain Gene Locus) Description Catalog # TCRB V - J1 + 2 - Unlabeled A-205-0010 TCRB V - J1 + 2 - 6FAM & HEX A-205-0011 TCRB V - J2 - Unlabeled A-205-0020 TCRB V - J2 - 6FAM A-205-0021 TCRB D - J1 + 2 - Unlabeled A-205-0030 TCRB D - J1 + 2 - 6FAM & HEX A-205-0031 TRG (T-Cell Receptor Gamma Chain Gene Locus) Description Catalog # TCRG V(2-5,8-11) J 1 + 2+P - 6FAM A-207-0091 TCRG V(1-8,9) J - 6FAM A-207-0071 TCRG V(1-8) J - HEX A-207-0021 TCRG V(1-8,10) J - Unlabeled A-207-0030 TCRG V(1-8,10) J - 6FAM & HEX A-207-0031 TCRG V(9,11) J - Unlabeled A-207-0040 TCRG V(9,11) J - 6FAM & HEX A-207-0041 BCR-ABL1 t(9;22) Description Catalog # BCR/ABL e1.1-a3.1 - Unlabeled A-310-0020 BCR/ABL b2.1-a3.1 - Unlabeled A-310-0030 BCR/ABL, e1.2-a2.2 - HEX A-310-0051 BCR/ABL, e1.2-a3.2 - HEX A-310-0061 BCR/ABL, b2.2-a2.2 - 6FAM A-310-0071 BCR/ABL, b2.2-a3.2 - 6FAM A-310-0081 BCR/ABL, b3.2-a3.2 - 6FAM A-310-0101 IGH-BCL2 t(14;18) Description Catalog # BCL2/JH Mbr - Unlabeled A-309-0050 BCL2/JH 3’Mbr - Unlabeled A-309-0060 BCL2/JH mcr - Unlabeled A-309-0070 PML-RARA t(15;17) Description Catalog # PML/RARa, MYL2-RARa - Unlabeled A-311-0020 PML/RARa, MYL1-RARa - Unlabeled A-311-0030 PML/RARa, PML3-RARa - Unlabeled A-311-0040 IGL (Immunoglobulin Lambda Light Chain Gene Locus) Description Catalog # IGL V - J - 6FAM A-103-0011 FLT3 (FMS-like Tyrosine Kinase 3) Description Catalog # FLT3 ITD Master Mix - Unlabeled Please contact Invivoscribe FLT3 TKD Master Mix - Unlabeled Please contact Invivoscribe TRD (T-Cell Receptor Delta Chain Gene Locus) Description Catalog # TCRD V - D - J - 6FAM & HEX A-206-0011 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 Patents 6846630, 8178292 and 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. Analyte Specific Reagents