DNA Genotek™ OMNIgene™•ORAL OME-505 (For IVD, Rx and For Use Under Emergency Use Authorization)

A non-invasive, saliva self-collection and stabilization device for use in validated assays for the detection of the SARS-CoV-2 RNA virus (the coronavirus that causes COVID-19). DNA Genotek kits are used in laboratory-based tests for back-to-work and back-to-school programs, population screening applications, and laboratory testing.

Supplier:  DNA Genotek™ OME505

Catalog No. 23-410-000

Description

• FDA EUA authorized device for self or assisted collection of saliva for use in the detection of SARS-CoV-2 RNA
• Stabilization of SARS-CoV-2 RNA for at least 3 days at room temperature, eliminating the need for freezer storage and cold-chain transport  
• Maintains sample integrity throughout temperature fluctuations encountered during real-life shipping and handling conditions (e.g., -20°C to +50°C)
• Safe for home collection with >99% inactivation of SARS-CoV-2 in collected and stabilized samples
• Improves donor compliance and maximizes successful sample collections with intuitive and validated instructions
• Bar coded for full sample traceability (128C format)
• Buffer solution does not include guanidine
• Compatible with commercially available extraction kits including Thermo Fisher, Zymo, and Omega Biotek
• Compatible with laboratory automation

Specifications

• Type: Saliva Collection Device
• For Use With (Application): COVID-19 Testing: Emergency Use Authorized
• Quantity: 8 Extractions/Kit, 200 Kits/Cs.
• Storage Requirements: Room temperature

• Certifications/Compliance: FDA EUA Authorized, CE Marked, Health Canada Interim Order Authorization
• Includes: Saliva funnel attached to collection tube, screw cap, packaging clamshell and IFU
• Sterility: Non-sterile
• Volume (Metric): 250 μL/Extraction

Safety and Handling

ShelfLife : 24 months