Zymo Research Receives 510(k) Clearance for its Collection/Transport Device for COVID-19
PR88459
IRVINE, Calif., March 11, 2021 /PRNewswire=KYODO JBN/ --
-- The first 510(k)-cleared transport medium for COVID-19 testing
Zymo Research announced today the U.S. Food and Drug Administration (FDA) has
cleared its DNA/RNA Shield(TM)(
) 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.
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Specifically granted for COVID-19 testing, the DNA/RNA Shield(TM) 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
Shield(TM) 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 Shield(TM) 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
Shield(TM) 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 covid19requests@zymoresearch.com.
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:
-- Zymo Research Releases Free Software to Streamline COVID-19 Test Reporting(
)
-- Zymo Research Obtains CE IVD Mark for its Quick SARS-CoV-2 Multiplex Kit(
)
-- Zymo Research Obtains Emergency Use Authorization from FDA for Their Quick
SARS-CoV-2 rRT-PCR Kit
-- Zymo Research Receives CE IVD Mark for its Quick-DNA/RNA(TM) Viral MagBead
Kit (
)
-- Zymo Research Launches COVID-19 Sequencing Service for the Detection and
Surveillance of Emerging SARS-CoV-2 Variants(
)
-- Zymo Research Offers Community-Wide SARS-CoV-2 Detection and Variant
Tracking with the Environ(TM) COVID-19 Wastewater Testing Service (
)
SOURCE: Zymo Research Corp.
CONTACT: Marketing Department, Zymo Research Corp., +1 949.679.1190,
marketing@zymoresearch.com
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