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QC Sets and Panels: Helix Elite™
Catalog No. 8219

Group A Streptococcus (GAS) Control Panel

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Details

Details


Group A Streptococcus (GAS) Control Panel includes 6 positive control swabs and 6 negative control swabs.

Positive Control (6 swabs)
Streptococcus pyogenes 

Negative Control (6 swabs)
Streptococcus dysgalactiae 
General Information
Documentation

General Information

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

Minimum Hydration Volume: 1.0 ml
Test MethodMolecular Testing
Catalog number8219
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 “8219 Group A Streptococcus (GAS) Control Panel"

Documents related to this item:

Documentation

Documents related to this item:

Dutch -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Croatian -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
English -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Danish -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Finnish- IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Greek -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
French -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Hungarian -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
German -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Italian -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Japanese -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Korean -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Lithuanian -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Norwegian -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Polish -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Portuguese LA -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Romanian -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Spanish EU -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Spanish LA -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Swedish -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Turkish -IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
Chinese- IVDR Instructions for Use: 8219 Group A Streptococcus (GAS) Control Panel
QC Set and Panels: Technical Information
English-Instructions for Use: Helix Elite CE Marked Inactivated Swab Panels
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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