NeuMoDx Molecular, Inc. CONFIDENTIAL P/N 40600196_Rev B
March 2019
Pg. 2 of 4 For Ex-US Distribution Only
NeuMoDx™ Reagents and Consumables Required But Not Provided
Other Equipment and Materials Required But Not Provided
NeuMoDx™ 288 Molecular System [REF 500100] or NeuMoDx™ 96 Molecular System [REF 500200]
WARNINGS & PRECAUTIONS
•
The NeuMoDx HCV External Controls are for in vitro diagnostic use only with the NeuMoDx HCV Quant Test Strip as implemented on
the NeuMoDx System.
•
Do not use the NeuMoDx HCV External Controls after the listed expiration date.
•
Do not use the NeuMoDx HCV External Controls if the packaging is damaged or the kit is not frozen upon arrival.
•
Because the NeuMoDx HCV positive controls contain intact HCV positive material, all components of the NeuMoDx HCV External
Controls should be treated as potentially biohazardous.
•
Always handle specimens as if they are infectious and in accordance with safe laboratory procedures such as those described in
Biosafety in Microbiological and Biomedical Laboratories
1
and in CLSI Document M29-A3.
2
•
Do not pipette by mouth. Do not smoke, drink, or eat in areas where specimens or reagents are being handled.
• Dispose of unused reagents and waste in accordance with country, federal, provincial, state and local regulations.
•
Clean, powder-free, nitrile gloves should be worn when handling all NeuMoDx reagents and consumables.
•
Wash hands thoroughly after performing the test.
•
Safety Data Sheets (SDS) are provided for each reagent.
PRODUCT STORAGE, HANDLING & STABILITY
• The NeuMoDx HCV External Controls are shipped with dry ice to maintain a frozen state; do not use if kit contents are not frozen upon
receipt.
• It is recommended that the NeuMoDx HCV External Controls be stored at ≤ -80°C to ensure stability.
• Control vials are intended for single use only. Thawed external controls may be stored at 4°C for no longer than 24 hours.
• Refreezing after a first thaw is not recommended.
• Discard any unused material after use as biohazard waste.
• Discard any controls that appear cloudy or contain large precipitates after thawing.
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