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QC Sets and Panels: Helix Elite™
Catalog No. 8206

Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel (Inactivated Pellet)

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Details

Details


Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel (Inactivated Pellet) contains six individually packaged inactivated microorganism pellets of each control listed below (18 vials total):

Positive Control 1 (six vials per kit): Mycobacterium bovis (MTB) (BCG)

Positive Control 2 (six vials per kit): Mycobacterium tuberculosis (MTB/RIF) surrogate (rpoB: L511P, H526Y, S531L)

Positive Control 3 (six vials per kit): Mycobacterium tuberculosis (MTB/RIF) surrogate (rpoB: D516V, S522L)
General Information
Documentation

General Information

Biosafety Level1
Product FormatQC Sets and Panels: Helix Elite™
Strain CharacteristicsNote: Not compatible with Xpert® MTB/RIF Ultra Assay

Pellets are stable at room-temperature

For in vitro diagnostic use

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.
Test MethodMicrobial Identification, Molecular Testing
Catalog number8206
Permits and RestrictionsExport Restrictions May Apply
TaxonomyBacteria
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 “8206 & 8238 Rifampicin-Resistant M. tuberculosis Positive and Negative Control"

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Documentation

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