Product Manual

MedSchenker® Saliva Collection Kit, February 23, 2021, SCK-KIT-001-Q121
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MedSchenker® Saliva Collection Kit in Pouch
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Product Insert & How-to-Use Guide
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INTENDED USE
MedSchenker® Saliva Collection Kit in pouch is a ready-for-use Kit intended for saliva collection for clinical procedure and testing. Product
should be used as directed.
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SUMMARY AND PRINCIPLES
One of the routine procedures in the diagnosis of infections involves the collection of Saliva samples. This can be accomplished using the
MedSchenker® Saliva Collection Kit. MedSchenker® Saliva Collection Kit products are used to collect, store and transport both saliva DNA &
RNA samples. They are made from polypropylene and packed into a medical grade paper pouch.
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The MedSchenker® Saliva Collection Kit consists of
1. Funnel
2. Tube
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PRECAUTIONS
1. Carefully follow the instructions for use.
2. Product cannot be reused.
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KIT STORAGE
Store the MedSchenker® Saliva Collection Kit device at 2-30°C (59-77°F). If the product is stored at a different temperature, it would not
maintain the stated specifications.
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SAMPLE/SPECIMEN FOR STORAGE/TRANSPORT
If the samples are not tested within 60 minutes of collection, refrigerate the sample at 4°C (39°F) for no longer than 24hrs.
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PRODUCT DETERIORATION
The MedSchenker® Saliva Collection Kit should not be used if (1) there is evidence of damage or contamination to the product, (2) the
expiration date has passed, (3) the package is open or damaged, or (4) there are other signs of deterioration.
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DIRECTIONS FOR USE, SPECIMEN COLLECTION
NOTE: Sterile gloves, protective clothing and eyewear should be worn when collecting and handling Saliva samples
1.Open the peel pouch and extract the Saliva Collection Kit.
2.Collect the appropriate amount of sample for the desired test in the tube with the help of the funnel.
3.Do not forget to cap the saliva tube tightly.
Specimens collected for clinical investigations should be collected and handled following published manuals and guidelines. Specific
requirements for the shipment and handling of specimens should be in full compliance with state and federal regulations. Shipping of specimens
within medical institutions should comply with internal guidelines of the institution.
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LIMITATIONS
1. In the laboratory, wear protective gloves and other protection commensurate with universal precautions when handling Saliva samples.
Observe Biosafety recommendations when handling or analyzing patient samples.
2. Condition, timing and volume of specimen collected for clinical investigation are significant variables in obtaining reliable results. Follow
recommended guidelines for specimen collection.
3. The MedSchenker® Saliva Collection Kit must be used by skilled personnel only.