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QC Sets and Panels: Helix Elite™
Catalog No. 8249

Bacterial vaginosis (BV) Control Panel

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Details

Details

The Bacterial vaginosis (BV) Control Panel contains six inactivated pre-pooled positive control pellets and 6 inactivated negative control pellets comprised of the organisms listed below (12 vials/pellets total). 

Positive Control (six vials/pellets):
Atopobium vaginae
Gardnerella vaginalis

Negative Control (six vials/pellets):
Lactobacillus crispatus
General Information
Documentation

General Information

Biosafety Level1
Product FormatQC Sets and Panels: Helix Elite™
Test MethodMolecular Testing
Catalog number8249
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 “8249 Bacterial Vaginosis Control Panel"

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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.