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QC Sets and Panels: Helix Elite™
Catalog No. 8208

Vaginal Verification Panel

In Stock

Details

Details

The Vaginal Verification Panel includes two boxes containing 20 individually packaged inactivated microorganism pellets of each pool listed below (120 vials total):

Pool 1 (20 vials per kit)
Lactobacillus crispatus

Pool 2 (20 vials per kit)
Gardnerella vaginalis 

Pool 3 (20 vials per kit)
Atopobium vaginae  
BVAB2 surrogate
Candida albicans 
Gardnerella vaginalis 

Pool 4 (20 vials per kit)
Atopobium vaginae 
BVAB2 surrogate
Gardnerella vaginalis 
Trichomonas vaginalis 

Pool 5 (20 vials per kit)
Atopobium vaginae  
Candida glabrata 
Gardnerella vaginalis 
Lactobacillus crispatus 

Pool 6 (20 vials per kit)
Atopobium vaginae 
Candida krusei  
Gardnerella vaginalis
Lactobacillus crispatus 
General Information
Documentation

General Information

Biosafety Level1
Product FormatQC Sets and Panels: Helix Elite™
Strain CharacteristicsPellets are stable at room-temperature

For in vitro diagnostic use

Minimum Hydration Volume: 1.5 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 number8208
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: 8208 & 8209 Vaginal Verification and Control Panel"

Documents related to this item:

Documentation

Documents related to this item:

French-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Finnish-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Dutch-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
English-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Greek-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Hungarian-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Lithuanian-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Italian-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Japanese-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Korean-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Norwegian-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Polish-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Portuguese BR-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Romanian-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Spanish EU-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Spanish LA-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Swedish-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Turkish-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
German-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Chinese-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Croatian-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
Danish-IVDR Instructions for Use: 8208 & 8209 Vaginal Verification and Control Panel
English-IVDR Instructions for Use: 8248 Gastrointestinal Control Panel
English-IVDR Instructions for Use: 8267 GI Verification Panel
English-IVDR Instructions for Use: HE0082HF GI Hydration Fluid
English-IVDR Instructions for Use: 8257 Comprehensive Human Papillomavirus (HPV) Control Panel
SPAN.LA-IVDR Instructions for Use: 8257 Comprehensive Human Papillomavirus (HPV) Control Panel
POR.LA-IVDR Instructions for Use: 8257 Comprehensive Human Papillomavirus (HPV) Control Panel
Portuguese LA-IVDR Instructions for Use: 8248 Gastrointestinal Control Panel
Spanish.LA -IVDR Instructions for Use: 8248 Gastrointestinal Control Panel
Portuguese.LA-IVDR Instructions for Use: 8267 GI Verification Panel
Spanish.LA-IVDR Instructions for Use: 8267 GI Verification Panel
Portuguese.LA-IVDR Instructions for Use: HE0082HF GI Hydration Fluid
Spanish.LA-IVDR Instructions for Use: HE0082HF GI Hydration Fluid
English-IVDR Instructions for Use: 8269 Rapid Influenza A/B Control Panel
QC Set and Panels: Technical Information

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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