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EN Instructions for use
Axon Lab AG
AL0512, AL0513, 50 Täfernstrasse 15, CH-5405 Baden-Dättwil
AL0513-B
Axon Biotech GmbH Distributor:
Im Oberfeld 2, DE-94491 Hengersberg
info@axonbiotech.de, www.axonbiotech.de Axon Lab AG
Version: 01/08/2025 a company of Axonlab www.axonlab.com
ProbeAX Evolution (sterile)
In vitro diagnostic
Intended use Storage Abbreviations/Symbols
Sterile sample tubes for homogenising biopsies, tissue, cartilage and bone. Store tubes at +4°C to +25°C. Do not use the product beyond the use-by date indicated Symbol Signification
Suitable for microbiological diagnostics on the package. Once the packaging has been opened, unopened tubes may be used until the
Catalogue number
expiry date, provided storage conditions are met.
In vitro diagnostic medical device
Instructions Contains sufficient for <n> tests
· Screw the cap tightly to close the ProbeAX Evolution tube well. Quality controls
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Contains sufficient for <n> tests
· Screw the cap tightly to close the ProbeAX Evolution tube well. Quality controls
Manufacturer
· The tissue should be completely submerged in the liquid. Quality control is performed on each batch.
· Transport the sample to the laboratory as quickly as possible. Quality certificates: https://www.axonlab.com/download-center/certificates Temperature limit
· When preparing the sample, follow internal laboratory procedures for sterile handling
Use-by date
of microbiological samples. Work under a laminar flow hood to prevent contamination.
· Only use ProbeAX Evolution tubes for homogenisation in combination with the SpinAX Disposal Batch code
device (ref.AL0500). Additional instructions can be found in the handbook. For any waste produced, each laboratory is responsible for proper disposal in accordance Consult instructions for use
· Adjust the homogenisation time to the type and size of your sample. A homogenisation with local requirements.
time of 1 minute is recommended for standard samples, the recommended sample weight Do not re-use
is 500 mg. Do not use if package is damaged and consult
· Perform additional microbiological and molecular diagnostic methods promptly in keeping Reporting information instructions for use
with internal laboratory procedures. In the event of a serious incident in connection with this product, a report must be submitted Sterilized using irradiation
· The friction surfaces should not touch each other before the homogenisation process. to the manufacturer and to the responsible authority of the Member State in which the user is Unique device identifier
For very small samples, ProbeAX Evolution is used exclusively as a transport vessel. located.
This product complies with the requirements
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This product complies with the requirements
of Regulation (EU) 2017/746 on in vitro diagnostic
medical devices
Package contents Additional information
50 tubes, each containing 5 ml 0.85% NaCl solution The ProbeAX Evolution may only be used in combination with the SpinAX homogenisation
device (ref. AL0500). This device is not included.
Basic composition in %
Sodium chloride 0.85
Erhältliche Versionen:
· AL0512 ProbeAX Evolution single packed
· AL0513 ProbeAX Evolution double packed
· AL0513-B ProbeAX Evolution double packed blister
WARNING
For professional use only
Do not use if you observe signs of microbial contamination, discoloration, cracks,
damage to the packaging and/or bag/blister or other
evidence of product degradation.
082025 A 05120007
Headquarters Axon Lab AG Affiliates
Täfernstrasse 15 Austria info@axonlab.at Netherlands info@axonlab.nl
CH-5405 Baden-Dättwil Belgium info@axonlab.be Poland info@axonlab.pl
Croatia info@axonlab.hr Slovenia info@axonlab.si
Czech Republic info@axonlab.cz Switzerland (de) info@axonlab.ch
Germany info@axonlab.de Switzerland (fr
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epublic info@axonlab.cz Switzerland (de) info@axonlab.ch
Germany info@axonlab.de Switzerland (fr) info_f@axonlab.ch
www.axonlab.com Luxembourg info@axonlab.lu