Search Results

ORAcollect®•Dx is intended for the collection of saliva samples for diagnostic testing of human DNA. Saliva samples may be collected by a healthcare professional or non-healthcare professional, such as a lay user. Saliva samples collected using ORAcollect®•Dx are stabilized and isolated for use in downstream diagnostic testing applications. Saliva samples collected using ORAcollect®•Dx can be transported and/or stored at ambient conditions.

ORAcollect® Dx family of collection devices offers reliable collection, transportation and longterm ambient temperature storage of human DNA from saliva. ORAcollect® • Dx devices are a minimally invasive alternative for collecting high quality and quantity DNA for use with prescription and over-the-counter (direct-to-consumer) diagnostic testing applications. ORAcollect® • Dx consists of a collection tube containing a stabilizing liquid and a double ended cap with an integrated sponge used to collect a saliva sample. Using provided instructions for use, saliva collection can take place in a laboratory setting, physician's office, at home, 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. 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. ORAcollect-Dx device pre-collection shelf life is 24 months at room temperature (15°C to 25°C) from the date of manufacture. Post collection, ORAcollect·Dx samples are stable at room temperature for up to 60 days. ORAcollect-Dx device and sample integrity are preserved during typical ambient transport and storage conditions. ORAcollect®●Dx saliva collection devices are suitable for use with prescription and over-the-counter (direct-to-consumer) downstream diagnostic testing applications, systems or platforms. Test or assay manufacturers must validate the use of ORAcollect®●Dx for their specific indications for use. Using DNA obtained from an ORAcollect®•Dx sample, laboratory testing is performed on genotyping systems or platforms in a CLIA (Clinical Laboratory Improvement Amendments) certified laboratory.

The AncestryDNA Saliva Collection Kit is intended for use in the noninvasive collection of saliva samples for in vitro diagnostic testing of human DNA. Saliva may be collected by spitting directly into the AncestryDNA Saliva Collection Kit by a lay user. Saliva samples collected using the AncestryDNA Saliva Collection Kit are stabilized and isolated for use with over-the-counter AncestryDNA Genetic Health Risk Tests. Saliva samples collected using the AncestryDNA Saliva Collection Kit can be transported and/or stored long term at ambient conditions.

The AncestryDNA Saliva Collection Kit consists of: saliva collection tube, funnel, cap, blister pack, collection bag with absorbent pad, return mailer, and Instructions for Use. The collection device consists of the saliva collection tube, funnel, and cap. The cap contains DNA stabilization solution. Saliva is delivered directly by spitting into the collection tube via the funnel. Once the user has provided the saliva sample, s/he removes the funnel from the saliva collection tube and affixes the cap. Affixing the cap by screwing on releases the stabilization solution. The user is then instructed to shake the tube for at least five seconds to mix the saliva sample with the stabilization solution. After collecting the saliva sample, the user places the closed saliva collection tube in the collection bag. The collection bag with the enclosed saliva collection tube is shipped to a designated Ancestry Genomics location for testing via the pre-addressed postage paid return mailer.

Oragene®•Dx is intended for use in the non-invasive collection of saliva samples for in vitro diagnostic testing of human DNA. Saliva may be collected by spitting directly into the Oragene®•Dx container or may be transferred into the Oragene® Dx container using a sponge. Saliva samples may be collected by a healthcare professional or non-healthcare professional, such as a lay user. Saliva samples collected using Oragene®•Dx are stabilized and isolated for use in downstream diagnostic testing applications. Saliva samples collected using Oragene®•Dx can be transported and/or stored long term at ambient conditions

Oragene®●Dx family of collection devices offers reliable collection, transportation and long-term ambient temperature storage of human DNA from saliva. Oragene®●Dx devices are a noninvasive alternative for collecting high quality and quantity DNA for use with prescription and over-thecounter (direct-to-consumer) diagnostic testing applications. Oragene®●Dx devices consist of a collection tube with a funnel lid attached (containing a stabilizing liquid). Saliva is delivered directly by spitting into the collection tube or may be transferred into the Oragene®●Dx container using a sponge. 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. Oragene®●Dx saliva collection devices are suitable for use with prescription and over-the-counter (direct-to-consumer) downstream diagnostic testing applications, systems or platforms. Test or assay manufacturers must validate the use of Oragene®●Dx for their specific indications for use. Using DNA obtained from an Oragene®●Dx sample, laboratory testing is performed on genotyping systems or platforms in a CLIA (Clinical Laboratory Improvement Amendments) certified laboratory. The resulting genetic information may be used to generate a personalized health report related to detected mutations and may be used by medical and health practitioners as an aid in patient management.

ORAcollect Dx is intended for use in the non-invasive collection of saliva samples. Human DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva sample sultured using ORAcollect+Dx are stabilized and can be transported and/or stored long term at anbient can adions.

The ORAcollect-Dx family of collection devices offers reliable collection, transportation and long-term ambient temperature storage of human DNA from saliva. ORAcollect-Dx is a non-invasive alternative for collecting high quality and quantity human DNA and is suitable for use in molecular diagnostic applications. ORAcollect-Dx consists of a collection tube containing a stabilizing liquid and a double ended cap with an integrated sponge used to collect a saliva sample. After receiving instruction from a professional, saliva collection can take place in a laboratory setting, physician's office, at home, or in the field. Untrained (naïve) or professional users can carry out saliva collection. Using the provided instructions for use, the integrated sponge on the device to collect a saliva sample from the mouth. After saliva is collected, the cap is removed from the tube, inverted to place the sponge into the collection tube with the stabilizing liquid, and re-capped with the sponge remaining inside the tube. 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. ORAcollect-Dx device pre-collection shelf life is 24 months at room temperature (15°C to 25°C) from the date of manufacture. Post collection, ORAcollect·Dx samples are stable at room temperature for up to 60 days. ORAcollect · Dx device and sample integrity are preserved during typical ambient transport and storage conditions.

Oragene Dx devices are intended for use in the non-invasive collection of saliva samples. Human DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva may be collected by spitting directly into the Oragene Dx container or may be transferred into the Oragene Dx container using a sponge. Saliva samples collected using Oragene Dx are stabilized and can be transported and/or stored long term at ambient conditions.

The Oragene-Dx family of products offers reliable collection, transportation and long-term room temperature storage of human DNA from saliva. Oragene Dx is a non-invasive alternative for collecting high quality and quantity DNA for use in molecular diagnostic applications. Oragene-Dx is a device family available in multiple device formats or models. Oragene-Dx device formats OGD-510, OGD-600, OGD-610 and OGD-675, have the same collection principle and intended use as the FDA cleared Oragene-Dx formats (k110701). All Oragene-Dx formats consist of a collection tube, a DNA stabilizing liquid and optional sponges for assisted collection. In addition, Oragene·Dx device formats are made from the same physical and chemical materials. Oragene Dx formats differ in the amount of DNA stabilizing liquid in the tube and in the difference in the amount of saliva to be collected. The ratio of final sample to stabilizing liquid volume remains the same. Saliva collection can take place at home, in a laboratory setting, physician's office, or in the field by untrained (naïve) or professional users. Saliva samples are collected into the device directly by spitting or by using the provided sponges. After saliva is collected, the stabilizing liquid is mixed with the sample. Upon contacting saliva cells, the stabilizing liquid lyses cellular and nuclear membranes to release and stabilize nucleic acids (DNA). Oragene-Dx 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 device pre-collection shelf life is 24 months at room temperature from the date of manufacture. Post collection, Oragene Dx samples are stable at room temperature for up to 12 months. Oragene Dx device performance and sample integrity are maintained during typical ambient transport and storage conditions.

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.

Oragene-Dx is intended for use in the non-invasive collection of saliva samples. DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva may be collected by spitting directly into the Oragene-Dx container or may be transferred into the Oragene·Dx container using a sponge. Saliva samples collected using Oragene·Dx are stabilized and can be transported and/or stored long term at ambient conditions.

The Oragene·Dx family of products offers reliable collection, transportation and long-term room temperature storage of human DNA from saliva. Oragene Dx is a non-invasive alternative for collecting high quality and quantity DNA for use in molecular diagnostic applications. All formats consist of a collection tube, stabilizing liquid and optional sponges for assisted collection. After saliva is collected, the stabilizing liquid is mixed with the sample. Saliva can be delivered directly by spitting or using provided sponges to transfer saliva into the device.