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143 anleitung NaCl AL0604 0.85 1S A5 EN 202208 FINAL

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EN Package insert AL0604 100 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 NaCl 0.85%-solution for Kirby-Bauer Method Intended use Disposal The NaCl 0.85% solution for Kirby-Bauer is a ready-to- For any waste produced, each laboratory is responsible use solution for the agar diffusion test. It is an in vitro for proper disposal in accordance with legal diagnostics product. requirements. Be sure to inactivate any infectious material prior to disposal, for example by autoclaving The ready-to-use test tubes containing 2 ml of the for 30 min. at 134°C. 0.85% NaCl solution can be used directly to prepare the inoculum of the desired test organism for the agar Reporting information diffusion method. A report must be submitted to the responsible authority of the Member State in which the user is located and Contents to the manufacturer in the event of a serious incident in 100 Tubes NaCl 0.85% à 2 ml connection with this product. Composition in % Literature Sodium Chloride 0.85  EUCAST Disk Diffusion Method for Antimicrobial Susceptibility Testing – Version 7.0 (Januar 2019), Warning www.eucast.org The ready-to-use NaCl solution is intended for  Performance Standards for Antimicrobial Susceptibility professional, single use only. Do not use if evidence of Tests; 11th ed., M02-A11; Vol. 32 No.1, Clinical and microbial contamination, discoloration, ruptures, or other Laboratory Standards Institute signs of deterioration; ensure proper product disposal. Abbreviations/Symbols Storage Symbol Signification The NaCl 0.85% solution for Kirby-Bauer method is stored at 15°C to 30°C. Do not freeze. Do not use Catalogue number after the expiration date specified on the package. After In vitro diagnostic medical device opening the shipping package, unopened tubes can be

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Kirby-Bauer method is stored at 15°C to 30°C. Do not freeze. Do not use Catalogue number after the expiration date specified on the package. After In vitro diagnostic medical device opening the shipping package, unopened tubes can be Contains sufficient for <n> tests used up until the expiry date if storage conditions have been met. Manufacturer Batch code Quality control Quality controls are carried out for every lot. Do not re-use CE marking Change history: Adapted to IVDR specifications 062022 C 06040007 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