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QC Sets and Panels: Helix Elite™
Catalog No. 8203

Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)

Kit

In Stock

Details

Details


Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab) contains six positive control swabs and six negative control swabs.

The positive control consists of Enterococcus faecium (vanA)

The negative control consists of Enterococcus faecalis (vanB)

General Information
Documentation

General Information

Biosafety Level1
Product FormatQC Sets and Panels: Helix Elite™
Strain CharacteristicsThe positive control is vanA-type glycopeptide resistance and Vancomycin resistant

Minimum Hydration Volume: 1.7 ml
Test MethodMicrobial Identification, Molecular Testing
Catalog number8203
Permits and RestrictionsExport Restrictions May Apply
Antibiotic/Drug Resistant StrainsVancomycin-Resistant enterococci (VRE)
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 “8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)"

Documents related to this item:

Documentation

Documents related to this item:

Danish - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Romanian - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Hungarian - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Portuguese LA - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Spanish EU - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Swedish - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Italian - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Greek - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Dutch - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Chinese - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Croatian - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
French - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Polish - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Turkish - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Norwegian - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Lithuanian - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Korean - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Japanese - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
German - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Finnish - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Spanish LA - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
English - IVDR Instructions for Use: 8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
Catalog No. 8203 Name Change Letter
QC Set and Panels: Technical Information
English-Instructions for Use: Helix Elite CE Marked Inactivated Swab Panels

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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