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143 anleitung NaCl AL0603 0.45 1S A5 EN 202208 FINAL

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EN Package insert AL0603 100 Axon Biotech GmbH Distributor: Im Oberfeld 2, DE-94491 Hengersberg mail@medco.eu, www.medco.eu Axon Lab AG Version: 02, 13/06/2022 A Company of Axonlab www.axonlab.com NaCl 0.45%-solution for ID/AST Intended use Disposal The NaCl 0.45% solution for ID/AST is a ready-to-use For any waste produced, each laboratory is responsible solution that can be used for working with the Vitek® for proper disposal in accordance with legal System, among other applications. It is an in vitro requirements. Be sure to inactivate any infectious diagnostics product. material prior to disposal, for example by autoclaving for 30 min. at 134°C. The ready-to-use tubes with 3 ml NaCl-solution can be used directly for the inoculum preparation of the Vitek®. The turbitity is adjusted according Reporting information to the Vitek® card inoculation. 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 0.45% à 3 ml connection with this product. Composition in % Literature Sodium Chloride 0.45 Encyclopedia of Rapid Microbiological Methods, Volume II; Edited by: Michael Miller Microbial Identification Using Warning the bioMérieux VITEK® 2 System by David H. Pincus The ready-to-use NaCl solution is intended for professional, single use only. Do not use if evidence of Abbreviations/Symbols microbial contamination, discoloration, ruptures, or other signs of deterioration; ensure proper product disposal. Symbol Signification Catalogue number Storage In vitro diagnostic medical device The NaCl 0.45% solution for ID/AST is stored at 15°C to 30°C. Do not freeze. Do not use after the Contains sufficient for <n> tests expiration date specified on the package. After opening Manufacturer the shi

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nostic medical device The NaCl 0.45% solution for ID/AST is stored at 15°C to 30°C. Do not freeze. Do not use after the Contains sufficient for <n> tests expiration date specified on the package. After opening Manufacturer the shipping package, unopened tubes can be used up Batch code until the expiry date if storage conditions have been met. Do not re-use Quality control CE marking Quality controls are carried out for every lot. Change history: Adapted to IVDR specifications 062022 C 06030007 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