Le Lézard
Classified in: Health, Covid-19 virus
Subject: FDA

Zymo Research Receives 510(k) Clearance for its Collection/Transport Device for COVID-19


IRVINE, Calif., March 11, 2021 /CNW/ -- Zymo Research announced today the U.S. Food and Drug Administration (FDA) has cleared its DNA/RNA Shieldtm Collection Tube as a Class II medical device. The FDA's 510(k) clearance allows the product to be used as an In-vitro Diagnostic (IVD) device for COVID-19 testing.

Specifically granted for COVID-19 testing, the DNA/RNA Shieldtm Collection device is the first FDA-cleared technology that inactivates the virus and preserves the SARS-CoV-2 RNA. The SARS-CoV-2 virus is effectively inactivated, which allows the sample to be safely handled, transported, and stored. This provides for the safety of frontline healthcare and laboratory workers. The viral RNA is stabilized at ambient temperature for prolonged periods for robust analysis via downstream RT-PCR.

"DNA/RNA Shield had a proven track record in various infectious disease applications prior to the current pandemic, facilitating its rapid adoption and deployment in the early stages of the COVID outbreak," said Dr. Marc Van Eden, Vice President of Business Development at Zymo Research. "The 510(k) is the result of the FDA's active collaboration with Zymo Research in bringing this technology to the forefront of current testing and future surveillance efforts."

The product consists of a tube filled with Zymo Research's proprietary DNA/RNA Shieldtm transport medium. The transport medium ensures the stability of the SARS-CoV-2 RNA during sample transportation and storage for up to 28 days at ambient temperatures. The DNA/RNA Shieldtm transport medium may be kitted with a swab, sputum collection kit, or as a tube alone.

The technology is compatible with upper and lower respiratory human specimens suspected of containing SARS-CoV-2. Specimens collected and stored in a DNA/RNA Shieldtm Collection Tube are suitable for use with appropriate molecular diagnostic tests.

For more information visit Zymo Research's website or contact them via email at [email protected].

About Zymo Research Corp.

Zymo Research is a privately owned company that has been serving the scientific and diagnostics community with state-of-the-art molecular biology tools since 1994. "The Beauty of Science is to Make Things Simple" is their motto, which is reflected in all of their products, from epigenetics to DNA/RNA purification technologies. Historically recognized as the leader in epigenetics, Zymo Research is breaking boundaries with novel solutions for sample collection, microbiomic measurements, diagnostic devices, and NGS technologies that are high quality and simple to use. Follow Zymo Research on Facebook, LinkedIn, Twitter, and Instagram.

For more information about Zymo Research's COVID-19 products, check out the following links:

 

SOURCE Zymo Research Corp.


These press releases may also interest you

at 17:20
Adicet Bio, Inc. , a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced it granted an inducement award on March 28, 2024. One individual was...

at 17:15
Paladin Labs Inc., a subsidiary of Endo International plc , today announced Health Canada's approval of WAKIX® (pitolisant hydrochloride tablets) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in pediatric patients aged 6 years...

at 17:05
Sirona Biochem Corp. ("Sirona") announces the voting results from its Annual General Meeting of Shareholders (the "Meeting"), held in Vancouver, British Columbia on March 28, 2024. The total number of shares represented by shareholders present in...

at 17:00
The Doctors Company, the nation's largest physician-owned medical malpractice insurer, announced today that it has approved a 2024 premium dividend of approximately $14.7 million, bringing the total of declared dividends to date to $470 million....

at 17:00
Northern Virginia Oral, Maxillofacial & Implant Surgery ("NOVA OMS") has learned of a data security incident that may have impacted data belonging to certain patients and guarantors. On October 5, 2023, NOVA OMS became aware of unusual activity on...

at 17:00
The Journey Venture Studio announced today a strategic collaboration with Valleywise Health, a comprehensive healthcare system with locations throughout the Phoenix metro area. In pursuit of fostering innovation, this collaboration is set to...



News published on and distributed by: