C. difficile QC Set (Live Culture)

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C. difficile QC Set (Live Culture) includes:

One KWIK-STIK™ unit of Clostridioides difficile derived from ATCC® 9689™* and one KWIK-STIK™ unit of Clostridioides difficile derived from ATCC® 700057™*

General Information

Documentation

Product FormatQC Sets and Panels: KWIK-STIK™

Strain CharacteristicsEach set contains a positive and negative control

C. difficile ATCC® 9689™* is tcdA positive, tcdB positive
C. difficile ATCC® 700057™* is tcdA negative, tcdB negative; nontoxigenic.

ATCC® 700057™* formerly Clostridium difficile
ATCC® 9689™* formerly Clostridium difficile

Catalog number8171

Permits and RestrictionsExport Restrictions May Apply

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: LYFO DISK and KWIK-STIK”.

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Documentation

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Catalog No. 8171 Name Change Letter

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Documentation

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Instructions for Use

Illustrated Instructions

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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.