Helix Elite™ Inactivated Standard

Catalog No. HE0034N

Inactivated Chlamydia pneumoniae

Product may require manufacture or assembly. Product to be shipped within 6 weeks. For exact shipment date, please contact Customer Service at info@microbiologics.com.

1 kit

Details

Inactivated Helix Elite Molecular Standards are specially designed, full process controls for use in molecular testing. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.

General Information

Documentation

General Information

Biosafety Level1

Product FormatHelix Elite™ Inactivated Standard

Strain CharacteristicsThis strain of Chlamydia pneumoniae is sourced from Microbix Biosystems

For in vitro diagnostic use

Test MethodMolecular Testing

Catalog numberHE0034N

Permits and RestrictionsExport Restrictions May Apply

TaxonomyBacteria

Industry TypeClinical

DisclaimerAs 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: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet).”

Documents related to this item:

Documentation

Documents related to this item:

Chinese - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Croatian - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Danish - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Dutch - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

English - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Finnish - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

French - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

German - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Greek - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Hungarian - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Italian - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Japanese - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Korean - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Lithuanian - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Norwegian - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Portuguese (Latin America) - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Romanian - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Spanish (Europe) - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Spanish (Latin America) - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Swedish- IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

Turkish - IVDR Instructions for Use: Inactivated Helix Elite™ Molecular Standards (Inactivated Pellet)

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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