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QC Sets and Panels: Helix Elite™
Catalog No. 8184

Enteric Pathogens Control Panel (Inactivated Pellet)

Kit

In Stock

Details

Details

Enteric Pathogens Control Panel (Inactivated Pellet) includes two pools: one positive pool and one negative pool. Kits contain five vials of each pool (ten vials total) and feature color coordinated labels for easy pool identification. 

Pool 7
C. jejuni 
E. coli (STEC)
Rotavirus SA11
Norovirus GII.4 surrogate
S. sonnei 
S. Typhimurium
V. parahaemolyticus 
Y. enterocolitica 

Pool 8
C. difficile (NAP1/027) 


General Information
Documentation

General Information

Biosafety Level1
Product FormatQC Sets and Panels: Helix Elite™
Strain CharacteristicsMinimum Hydration Volume: 0.3 ml

Clostridioides difficile (NAP1/027) formerly known as Clostridium difficile

This item contains surrogate material designed around a specific gene sequence or sequences and does not contain whole genomic material. It is strongly advised to contact technical support to ensure compatibility with gene targets of your chosen assay.
Catalog number8184
Permits and RestrictionsExport License Required
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 “8184 Enteric Pathogens Control Panel (Inactivated Pellet)"

Documents related to this item:

Documentation

Documents related to this item:

Hungarian- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Italian- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Greek- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Japanese- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Korean- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Lithuanian- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Norwegian- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Portuguese LA- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Polish- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Romanian- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Spanish EU- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Spanish LA- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Swedish- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Turkish- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Danish- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Croatian- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Dutch- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
English- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
French- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Finnish- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
German- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
Chinese- IVDR Instructions for Use: 8184 Enteric Pathogens Control Panel (Inactivated Pellet)
QC Set and Panels: Technical Information
Catalog No. 8184 Name Change Letter

Documents related to this product format:

Documentation

Documents related to this product format:

Instructions for Use
Safety Data Sheets
Illustrated Instructions
Technical Publications
Promotional Literature
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