Helix Elite™ Inactivated Standard

Catalog No. HE0056N

Human Papillomavirus 16 (HPV 16) Cellularity Control (Inactivated Pellet)

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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 CharacteristicsEach pellet contains CaSki cervical epidermoid cells.

Catalog numberHE0056N

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: 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)

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

Croatian-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)

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

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

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

German-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)

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

Japanese-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)

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

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

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

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

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

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

Swedish-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

*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.