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QC Sets and Panels: Helix Elite™
Catalog No. 8236

Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet)

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Details

Details

Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet) contains 6 pellets of Positive Control 1, 6 pellets of Positive Control 2, and 12 negative control pellets (24 vials/pellets total). The negative control pellets are blank and do not contain microorganisms.

Positive Control 1
  • Campylobacter jejuni
  • Clostridioides (Clostridium) difficile
  • Plesiomonas shigelloides
  • Yersinia enterocolitica
  • Escherichia coli (STEC)
  • Escherichia coli (EAEC) surrogate
  • Escherichia coli (O157)
  • Shigella sonnei
  • Cryptosporidium parvum
  • Adenovirus
  • Sapovirus surrogate

Positive Control 2 (six vials per kit): 
  • Salmonella typhimurium
  • Vibrio cholerae
  • Escherichia coli (EPEC)
  • Escherichia coli (ETEC)
  • Cyclospora cayetanensis surrogate
  • Entamoeba histolytica surrogate
  • Giardia lamblia
  • Astrovirus surrogate
  • Norovirus GI surrogate
  • Norovirus GII surrogate
  • Rotavirus A

Negative Control (twelve vials/pellets): Blank pellets
General Information
Documentation

General Information

Biosafety Level1
Product FormatQC Sets and Panels: Helix Elite™
Strain CharacteristicsFor in vitro diagnostic use

Minimum Hydration Volume: 0.2 ml

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 number8236
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 “8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)"

Documents related to this item:

Documentation

Documents related to this item:

Chinese - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Portuguese LA - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Croatian - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Japanese - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
French - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Hungarian - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Spanish EU - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Finnish - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
German - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Swedish - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Greek - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Turkish - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Polish - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Italian - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Romanian - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Lithuanian - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
English - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Spanish LA - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Danish - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Korean - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Norwegian - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)
Dutch - Instructions for Use: 8236 Gastrointestinal_22 Targets_Control Panel (Inactivated Pellet)

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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