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QC Sets and Panels: Helix Elite™
Catalog No. 8246

Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab)

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Details

Details

Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab) can be used to monitor the extraction, amplification and detection of Influenza A, Influenza B, Respiratory Syncytial Virus, and SARS-CoV-2 Virus molecular applications. Routine use of external quality controls monitor day to day performance of molecular testing procedures.

Each kit contains six positive and six negative, inactivated control swabs (12 swabs/kit).

Positive Control (six swabs):
Influenza A (H3N2) Virus
Influenza A (H1N1) Virus
Influenza B Virus 
Respiratory Syncytial Virus 
SARS-CoV-2 Virus
Human lung epithelial cells

Negative Control (six swabs)
Coxsackievirus B1
Human lung epithelial cells
General Information
Documentation

General Information

Biosafety Level1
Product FormatQC Sets and Panels: Helix Elite™
Test MethodMolecular Testing
Catalog number8246
Permits and RestrictionsExport Restrictions May Apply
Industry TypeClinical
DisclaimerHelix Elite QC Panels and Molecular Standards are FDA Class I exempt unassayed, in vitro diagnostic external controls, and are intended for professional laboratory use only. Results with diagnostic instruments may vary.

As Microbiologics transitions to the EU In Vitro Diagnostic Regulation (IVDR), there will be a period of time that we will be shipping existing inventory labeled under the IVDD and new product labeled under the IVDR. These products are identical but are labeled slightly differently due to the changes in EU regulation. It is important to obtain the correct IFU for your product. For products that are labeled as CE Marked under the IVDR, the CE Mark symbol on the actual product labeling DOES include a four digit number beside it. Please use the IFU labeled “IVDR Instructions for Use: 8246 Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab)"

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Documentation

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*The ATCC Licensed Derivative Emblem, the ATCC Licensed Derivative word mark and the ATCC catalog marks are trademarks of ATCC. Microbiologics, Inc. is licensed to use these trademarks and to sell products derived from ATCC® cultures. Look for the ATCC Licensed Derivative © Emblem for products derived from ATCC© cultures.