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EN Instruction for use
AL0301 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 SAF
Sample tubes for detection of parasites
In vitro diagnostic use
Intended use Unfilled StorAX SAF. Reagent
Transport tube with SAF solution for the detection of Write the variable data onto the label on the tube.
parasites (protozoa and worm eggs) in stool. Use the spoon to place the freshly obtained stool sample Product/Symbol Hazard- and Precautionary-statements
into the SAF transport medium. A spoon-sized sample is
Package contents sufficient (5 gr. approximately). On suspicion of infestation StorAX SAF Hazard-statements:
25 tubes with spoon, and 7.5 ml SAF solution (orange by intestinal parasites, it is necessary to take at least Danger! H315 Causes skin irritation.
screw cap). 3 stool samples on three days in order to isolate eggs H319 Causes serious eye irritation.
and encysted forms. H317 May cause an allergic skin reaction.
H341 Suspected of causing genetic defects.
Principle Screw on the lid tighlty.
H350 May cause cancer.
StorAX SAF is used to preserve parasites in stool during
sample transport. Transporting the stool samples with StorAX SAF Precautionary-statements:
The stool samples can be transported at 15°C-30
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s in stool during
sample transport. Transporting the stool samples with StorAX SAF Precautionary-statements:
The stool samples can be transported at 15°C-30°C. P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
Storage Laboratory processing should occur within 48 hours. P280: Wear protective gloves/protective clothing/eye protection/face protection.
The StorAX SAF tubes are stored at 15°C-30°C. Do not P303+P361+P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower.
freeze. Do not use the product after the expiration date Quality control P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing.
specified on the package. Once the packaging has been Quality controls are carried out of every lot.
P308+P313: IF exposed or concerned: Get medical advice/attention.
opened, test tubes can be used up to the expiry date if P405: Store locked up.
stored properly. Disposal
All laboratories are responsible for disposal of waste
Warnings and Precautions in accordance with the legal requirements.
For professional, single use only. Do not use if evidence Composition Abbreviations/Symbols
of microbial contamination, discoloration, ruptures, Reporting information
or other signs of deterioration; ensure proper disposal of A report must be submitted to the responsible authority Basic composition % Symbol Meaning
affected test tubes. of the Member State in which the user is located and Sodium acetate 1.5 Catalogue number
to the manufacturer in the event of a serious incident in
Obtaining stool samples connection with this product. Acetic acid 2.0 In vitro diagnostic medical device
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event of a serious incident in
Obtaining stool samples connection with this product. Acetic acid 2.0 In vitro diagnostic medical device
Contains sufficient for <n> tests
Formaldehyde 1.5
References
1 2 NCCLS Publication: Quality Assurance Standards pH 4.1 - 4.5
Manufacturer
for Commercially Prepared Microbiological Temperature limit
Culture Media Volume 24:19, 2004 Use-by date
MiQ 04/2013; Qualitätsstandards in der
mikrobiologisch-infektiologischen Diagnostik; Batch code
Parasitosen; K. Janitschke et al.; 2. Auflage; Consult instructions for use
Urban & Fischer
Do not re-use
CE marking
Change history: Adapted to IVDR specifications
3 4
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Change history: Adapted to IVDR specifications
3 4
062022 C 03010007
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