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EN Instructions for use
Axon Lab AG
AL0509, AL0510, 50 Täfernstrasse 15, CH-5405 Baden-Dättwil
AL0511, AL0511-B
Axon Biotech GmbH Distributor:
Im Oberfeld 2, DE-94491 Hengersberg
mail@medco.eu, www.medco.eu Axon Lab AG
Version: 03, 05/07/2024 A Company of Axonlab www.axonlab.com
ProbeAX Evolution
In vitro diagnostic
Intended use Storage Abbreviations/Symbols
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
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.
Instructions In vitro diagnostic medical device
· Screw the cap tightly to close the ProbeAX Evolution tube well. Contains sufficient for <n> tests
· The tissue should be completely submerged in the liquid. Quality controls
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Contains sufficient for <n> tests
· The tissue should be completely submerged in the liquid. Quality controls
Manufacturer
· Transport the sample to the laboratory as quickly as possible. Quality control is performed on each batch.
· When preparing the sample, follow internal laboratory procedures for sterile handling of Quality certificates: https://www.axonlab.com/download-center/certificates Temperature limit
microbiological samples. Work under a laminar flow hood to prevent contamination.
Use-by date
· Only use ProbeAX Evolution tubes for homogenisation in combination with the SpinAX
device (ref.AL0500). Additional instructions can be found in the handbook. Disposal Batch code
· Adjust the homogenisation time to the type and size of your sample. For any waste produced, each laboratory is responsible for proper disposal in accordance Consult instructions for use
A homogenisation time of 1 minute is recommended for standard samples, with local requirements.
the recommended sample weight is 500 mg. Do not re-use
· Perform additional microbiological and molecular diagnostic methods promptly in keeping CE marking
with internal laboratory procedures. Reporting information
· The friction surfaces should not touch each other before the homogenisation process. In the event of a serious incident in connection with this product, a report must be submitted
For very small samples, ProbeAX Evolution is used exclusively as a transport vessel. to the manufacturer and to the responsible authority of the Member State in which the user is
located. Version Summary of the change
02 Dec. 2023
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02 Dec. 2023
Inclusion of «Weight of the sample is 500
Package contents
mg» in the test procedure section
50 tubes, each containing 5 ml 0.85% NaCl solution Additional information «Room temperature» replaced by «+4°C
The ProbeAX Evolution may only be used in combination with the SpinAX homogenisation to +25°C» replaced under Storage and
Basic composition in % shelf life
device (ref. AL0500). This device is not included.
Sodium chloride 0.85
03 July 2024
Inclusion of the references AL0509, AL0511
and AL0511-B in REF and package contents
Insertion of the change history
Available versions Adaptation of the version number,
date and document number
· AL0509 ProbeAX Evolution single packed – without NaCl
· AL0510 ProbeAX Evolution single packed – with NaCl
· AL0511 ProbeAX Evolution double packed – with NaCl
· AL0511-B ProbeAX Evolution d
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date and document number
· AL0509 ProbeAX Evolution single packed – without NaCl
· AL0510 ProbeAX Evolution single packed – with NaCl
· AL0511 ProbeAX Evolution double packed – with NaCl
· AL0511-B ProbeAX Evolution double packed blister – with NaCl
WARNING
For professional use only
Do not use if you observe signs of microbial contamination, discoloration, cracks or other
evidence of product degradation.
072024 C 05060007
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) info_f@axonlab.ch
www.axonlab.com Luxembourg info@axonlab.lu