Zymo Research Receives 510(k) Clearance for Self-Collection and Delivery of Saliva

Newswise – IRVINE, CA., November 15, 2023 /PRNewswire/ — Zymo Research today announced that the US Food and Drug Administration (FDA) has cleared its DNA/RNA Shield™ SafeCollect™ Saliva Collection Kit As a Class II medical device for storage and stabilization of microbial nucleic acids. FDA 510(k) clearance allows the product to be used as an in-vitro diagnostic (IVD) device for saliva collection and transport.

Specifically designed for COVID-19 testing, the SafeCollect™ Saliva Collection Kit uses DNA/RNA Shield™ – The first FDA-cleared inactivating vehicle (ITM) to demonstrate inactivation and retention of SARS-CoV-2 RNA virus. The properties of ITM simplify sample handling, transport, and storage, and also maintain the integrity of viral RNA at ambient temperature for extended periods of time, ensuring stable analysis by RT-PCR.

“Non-invasive saliva collection is vital to the field of molecular diagnostics, unlocking a wealth of genetic and biomolecular information easily and conveniently, paving the way for innovative advances in personalized healthcare and disease detection,” said Dr. Stanislav Forman, Sample Prep's CTO. at Zymo Research. “This 510(k) clearance underscores the FDA's initiative to bring enabling technologies to the molecular diagnostics space.”

The product features a convenient funnel with an innovative safety seal designed to prevent accidental spillage or user impact. DNA/RNA Shield™ Preservative reagent in a tube. The technology is compatible with human saliva suspected of containing SARS-CoV-2. Collected and stored samples are suitable for use with appropriate molecular diagnostic tests.

For more information visit www.zymoresearch.com or contact [email protected].

About Zymo Research Corp.

Zymo Research is a privately held company serving the scientific and diagnostic community with state-of-the-art molecular biology tools since 1994. “The beauty of science is the simplification of things” is their motto, which is reflected in everything. Their products range from epigenetics to DNA/RNA purification technologies. Historically recognized as a leader in epigenetics, Zymo Research is pushing boundaries with new sample collection solutions, microbiome measurements, diagnostic devices and NGS technologies and services that are high quality and easy to use.

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