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Reticulocyte Enumeration Reagents For Coulter® Epics® Xl™ Flow

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reticONE™ Reagent Kit 7547059 - 100 tests PN 7504320-D 3. These reagents must be used as a set as supplied in the kit. 4. Do not use reagents beyond the expiration date printed on the kit label. 5. Protect reagents from light during storage or incubation. 6. Incubation times or temperatures other than those specified may give erroneous results. 7. Use Good Laboratory Practices (GLP) when handling these reagents. STORAGE CONDITIONS AND STABILITY Unopened reagent vials are stable to the expiration date on the kit label when stored at 2-8°C. Opened vials are stable for 90 days when stored at 2-8°C. Return reagents to 2-8°C immediately after use. Do not freeze. Minimize exposure to light. EVIDENCE OF DETERIORATION RETICULOCYTE ENUMERATION REAGENTS FOR COULTER® EPICS® XL™ FLOW CYTOMETRY SYSTEMS Any change in the physical appearance of the reagents* or any major variation in values obtained for control samples may indicate deterioration and the reagents should not be used. For In Vitro Diagnostic Use * Normal Appearance of Reagents INTENDED USE Retic-STAT reagent = clear, yellow liquid Retic-CAL biological calibrator = red, viscous liquid The reticONE Reagent Kit is for use with the reticONE SYSTEM for COULTER EPICS XL Flow Cytometry Systems. The reticONE SYSTEM combines a biological calibrator, a dye, and software to enumerate reticulocyte percentage and absolute count in whole blood using XL Flow Cytometry Systems with SYSTEM II™ Software. The system is intended “For In Vitro Diagnostic Use”. Refer to the reticONE System Guide (PN 4237292) for instructions on how to use this kit. REAGENTS CONTAINED IN KIT REAGENT PREPARATION No preparation is necessary. Reagents are used directly from the vials with no dilution or centrifugation necessary. Refer to the reticONE SYSTEM Guide (PN 4237292) for instructions on how to use these reagents. PRODUCT AVAILABILITY reticONE Reagent Kit PN 7547059 - 100 tests reticONE Reagent Kit, PN 7547059 - 100 tests Retic-STAT™ Reagent (1 x 100 mL) Retic-CAL™ Biological Calibrator (1 x 0.2 mL) For additional information, or if damaged product is received, call Beckman Coulter Customer Service at 800-526-7694 (USA or Canada) or contact your local Beckman Coulter Representative. REAGENT CONTENTS TRADEMARKS Retic-STAT Reagent contains Acridine orange dye, which stains cellular DNA and RNA. The dye excites at 488 nm and emits at 500-550 nm (DNA) and 630-700 nm (RNA). Retic-CAL Biological Calibrator contains treated, stabilized human erythrocytes in an isotonic, bacteriostatic medium. STATEMENTS OF WARNINGS WARNING - POTENTIALLY BIOHAZARDOUS MATERIAL. Each donor unit used in preparation of this material was tested by an FDA approved method for the presence of the antibodies to Human Immunodeficiency Virus (HIV-1 and HIV-2) and Hepatitis C Virus (HCV) as well as for hepatitis B virus surface antigen and found to be negative (were not repeatedly reactive). Because no test method can offer complete assurance that hepatitis B virus, Human Immunodeficiency Virus (HIV-1 and HIV-2), or other infectious agents are absent, this specimen/ reagent should be handled at Biosafety Level 2, as recommended for any potentially infectious human serum or blood specimen in the Centers for Disease Control/National Institutes of Health manual "Biosafety in Microbiological and Biomedical Laboratories," 1988. The Beckman Coulter logo, COULTER, EPICS, Retic-CAL, reticONE, Retic-STAT, SYSTEM II, and XL are trademarks of Beckman Coulter, Inc. The reticONE Reagent Kit is protected under patent 5639666. Beckman Coulter, Inc. 4300 N. Harbor Blvd. Fullerton, CA 92835 www.beckmancoulter.com Printed in USA Made in USA © 2005 Beckman Coulter, Inc. All Rights Reserved 1. Specimens, samples, and all material coming into contact with them, should be handled as if capable of transmitting infection and disposed of with proper precautions. 2. Never pipet by mouth and avoid contact with skin and mucous membranes. 1 of 1