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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


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Description

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

Specifications

Saliva Collection Device
COVID-19 Testing: Emergency Use Authorized
8 Extractions/Kit, 200 Kits/Cs.
Room temperature
FDA EUA Authorized, CE Marked, Health Canada Interim Order Authorization
Saliva funnel attached to collection tube, screw cap, packaging clamshell and IFU
Non-sterile
250 μL/Extraction
Safety and Handling

Safety and Handling

ShelfLife : 24 months

SDS
Documents

Documents

Product Certifications
Promotions

Promotions

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