QC Sets and Panels: Helix Elite™

Catalog No. 8229

Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

In Stock

Details

Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab) contains six positive control swabs (pre-pooled) and six negative control swabs.

Positive Control (six swabs):

Chlamydia trachomatis
Neisseria gonorrhoeae

Negative Control (six swabs): Human cells

General Information

Documentation

General Information

Biosafety Level1

Product FormatQC Sets and Panels: Helix Elite™

Strain CharacteristicsChlamydia trachomatis is sourced from Microbix Biosystems

Catalog number8229

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 “IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG)
Control Panel (Inactivated Swab)"

Documents related to this item:

Documentation

Documents related to this item:

Chinese - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Danish - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Dutch - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Finnish - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

French - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

English - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

German - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Greek - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Hungarian - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Japanese - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Italian - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Korean - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Norwegian - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Polish - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Portuguese (Latin America)- IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Romanian - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Spanish (Europe) - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Spanish (Latin America) - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Swedish - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Turkish - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

Lithuanian - IVDR Instructions for Use: 8229 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)

English Helix Elite (Inactivated Swab) - Chlamydia and CMV Instructions for Use

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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