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143 anleitung StorAX Cary-Blair ref AL0302 1S A4q EN 202208 FINAL

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EN Instruction for use AL0302 25 Axon Biotech GmbH Distributor: Im Oberfeld 2, DE-94491 Hengersberg mail@medco.eu, www.medco.eu Axon Lab AG Version: 03, 13/06/2022 A Company of Axonlab www.axonlab.com StorAX Cary-Blair Sample tubes for fecal cultures For in vitro diagnostic use Intended use Transporting stool samples with StorAX Cary-Blair Transport tubes with Cary-Blair solution for stool sampels. The stool samples can be transported at 15°C-30°C. Laboratory processing should occur within 48 hours. Package contents Quality control 25 transport tubes with spoon and 7.5 ml Cary-Blair solution Quality controls are carried out of every lot. Principle Disposal StorAX Cary-Blair is designed to preserve pathogenic intestinal bacteria in stool samples during transport. All laboratories are responsible for disposal of waste in accordance with the legal requirements. Composition Reporting information Basic composition in % A report must be submitted to the responsible authority of the Member State in which the user is located and to the manufacturer in the event of a serious incident in connection with this product. Disodium phosphate 0.1 Sodium chloride 0.5 References 1. Cary and Blair: J. Bacteriol. 88:96, 1964 Sodium thioglycolate 0.15 2. NCCLS Publ

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1. Cary and Blair: J. Bacteriol. 88:96, 1964 Sodium thioglycolate 0.15 2. NCCLS Publication: Quality Assurance Standards for Commercially Prepared pH 8.4 Microbiological Culture Media Volume 24:19, 2004 Storage The StorAX Cary-Blair tubes are stored at 15°C-30°C. Do not freeze. Do not use the product after the expiration date Abbreviations/Symbols specified on the package. Once the packaging has been opened, test tubes can be used up to the expiry date if stored Symbol Signification properly. Catalogue number Warnings and Precautions In vitro diagnostic medical device For professional, single use only. Do not use if evidence of microbial contamination, discoloration, ruptures, Contains sufficient for <n> tests or other signs of deterioration; ensure proper disposal of affected test tubes. Manufacturer Obtaining stool samples Temperature limit 1 2 3 4 Use-by date Batch code Consult instructions for use Do not re-use CE marking Change history: Adapted to IVDR specifications  Unfilled StorAX Cary-Blair.  Write the variable data onto the label on the tube.  Use the spoon to place the freshly obtained stool sample into the Cary-Blair transport medium. A spoon-sized sample is sufficient (5 gr. approximately).

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R specifications  Unfilled StorAX Cary-Blair.  Write the variable data onto the label on the tube.  Use the spoon to place the freshly obtained stool sample into the Cary-Blair transport medium. A spoon-sized sample is sufficient (5 gr. approximately). 062022 C 03020007  Screw on the lid tighlty. Headquarters Axon Lab AG Affiliates Täfernstrasse 15 Austria info@axonlab.at Luxembourg info@axonlab.lu CH-5405 Baden-Dättwil Belgium info@axonlab.be Netherlands info@axonlab.nl Croatia info@axonlab.hr Slovenia info@axonlab.si Czech Republic info@axonlab.cz Switzerland (de) info@axonlab.ch www.axonlab.com Germany info@axonlab.de Switzerland (fr) info_f@axonlab.ch