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Oragene®●Dx OGD-500.001 is intended for use in the non-invasive collection of saliva samples. DNA from the saliva sample is isolated, stabilized, and suitable for over-the-counter use with FDA cleared, approved, or legally marketed exempt DNA carrier screening genotyping tests. Saliva samples collected using Oragene®Dx OGD-500.001 are stabilized and can be transported and/or stored long term at ambient conditions.

Oragene Dx family of collection devices offers reliable collection, transportation and longterm ambient temperature storage of human DNA from saliva. Oragene Dx OGD-500.001 is a noninvasive alternative for collecting high quality and quantity DNA and is suitable for use in over-thecounter molecular genotyping applications. Oragene-Dx OGD-500.001 consists of a collection tube with a funnel lid attached (containing a stabilizing liquid). Saliva is delivered directly by spitting into the collection tube. Saliva collection can take place at home, in a laboratory setting, physician's office, or in the field. Untrained (naïve) or professional users can carry out saliva collection. After saliva is collected, the stabilizing liquid is mixed with the sample. A small cap is provided to close the tube for transport and storage (funnel with lid is removed and discarded). Upon contacting saliva cells, the stabilizing liquid lyses cellular and nuclear membranes to release and stabilize nucleic acids (DNA). Samples can be immediately processed, transported or stored for future use. Samples can be shipped at ambient temperature to the laboratory for processing. Oragene-Dx samples are stable at room temperature for up to 12 months. Device and sample integrity are preserved during typical ambient transport and storage conditions.