Cytek Biosciences, Inc. (Nasdaq: CTKB), a leading cell analysis
solutions company, today announced that it has received EN ISO
13485:2016 Quality Management System (QMS) certification. The
certification applies to Cytek’s headquarters and manufacturing
operations in Fremont, California for the design, development,
manufacturing, distribution, installation and service of flow
cytometers, reagents and accessories. The company’s manufacturing
facilities in Wuxi, China are also EN ISO 13485:2016 certified.
ISO 13485 is the global standard
established by the international standards organization to ensure
that medical devices meet the proper regulatory compliance laws to
keep professionals and customers in clinics, hospitals and other
medical settings safe.
“At Cytek, we have long held a ‘quality first’
mindset – we are constantly striving for higher quality in all that
we do, from conception through manufacturing,” said Chris Williams,
chief operating officer for Cytek Biosciences. “Having an ISO
13485 certified QMS is a terrific achievement, and bolsters
our plans to focus on the translational and clinical
markets. This certification sends a strong signal to customers
in these segments that we are committed to serving them, and we
plan to take every step necessary to responsibly do so in the
future.”
Recognized as a pioneer in spectral flow
cytometry, Cytek’s patented Full Spectrum Profiling™ (FSP™)
technology empowers scientists, allowing them to go even further
with their research – all with greater ease and shorter time to
results compared to conventional flow cytometry.
Cytek’s EN ISO 13485:2016 certification follows
extensive analysis and audit of its QMS by TÜV Rheinland®, an
independent certification body. Cytek plans to pursue
certifications for increasingly stringent standards and
regulations, targeting additional geographies to seek authorization
to sell its cell analysis solutions for clinical use in countries
worldwide. Currently, Cytek solutions are approved for clinical and
diagnostic use in China and the European Union, with EN ISO
13485:2016 certification representing a first step to achieve
Cytek’s goal of entering the U.S. clinical market.
Please visit www.cytekbio.com for more
information.
About Cytek Biosciences,
Inc.
Cytek Biosciences (Nasdaq: CTKB) is a leading
cell analysis solutions company advancing the next generation of
cell analysis tools by delivering high-resolution, high-content and
high-sensitivity cell analysis utilizing its patented Full Spectrum
Profiling™ (FSP™) technology. Cytek’s novel approach harnesses the
power of information within the entire spectrum of a fluorescent
signal to achieve a higher level of multiplexing with precision and
sensitivity. Cytek’s FSP platform includes its core instruments,
the Cytek Aurora™ and Northern Lights™ systems; its cell sorter,
the Cytek Aurora™ CS; the flow cytometer and imaging products under
the Amnis® and Guava® brands; and reagents, software and services
to provide a comprehensive and integrated suite of solutions for
its customers. Cytek is headquartered in Fremont, California with
offices and distribution channels across the globe. More
information about the company and its products is available at
www.cytekbio.com.
Cytek’s products are for research use only and
not for use in diagnostic procedures (other than Cytek’s Northern
Lights-CLC system and certain reagents, which are available for
clinical use in China and the European Union).
Cytek, Full Spectrum Profiling, FSP, Cytek
Aurora, Northern Lights, Amnis and Guava are trademarks of Cytek
Biosciences, Inc.
In addition to filings with the Securities and
Exchange Commission (SEC), press releases, public conference calls
and webcasts, Cytek uses its website (www.cytekbio.com), LinkedIn
page and X (formerly Twitter) account as channels of
distribution of information about its company, products, planned
financial and other announcements, attendance at upcoming investor
and industry conferences and other matters. Such information may be
deemed material information and Cytek may use these channels to
comply with its disclosure obligations under Regulation FD.
Therefore, investors should monitor Cytek’s website, LinkedIn page,
and X account in addition to following its SEC filings, news
releases, public conference calls and webcasts.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 as
contained in Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended,
which are subject to the “safe harbor” created by those sections.
All statements, other than statements of historical facts, may be
forward-looking statements. Forward-looking statements generally
can be identified by the use of forward-looking terminology such as
“may,” “might," "will,” “should,” “expect,” “plan,” “anticipate,”
“could,” “intend,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “potential” or “continue” or the negatives
of these terms or variations of them or similar terminology, but
the absence of these words does not mean that a statement is not
forward-looking. These forward-looking statements include
statements regarding Cytek’s business and product plans in the
translational and clinical markets; Cytek’s goals and plans to take
all necessary steps to achieve higher quality standards; Cytek
plans to pursue certifications for increasingly stringent standards
and regulations, targeting additional geographies to seek
authorization to sell its cell analysis solutions for clinical use
in countries worldwide; and Cytek’s goal of entering the U.S.
clinical market. These statements are based on management’s current
expectations, forecasts, beliefs, assumptions and information
currently available to management. These statements also deal with
future events and involve known and unknown risks, uncertainties
and other factors that may cause actual results, performance or
achievements to be materially different from the information
expressed or implied by these forward-looking statements. Factors
that could cause actual results to differ materially include risks
and uncertainties such as those relating to Cytek’s ability to
manage the growth and complexity of its organization and maintain
and further improve its quality management system; Cytek’s ability
to manage relationships with key customers and suppliers; Cytek’s
ability to retain key employees; Cytek’s ability to continue to
stay in compliance with its material contractual obligations,
applicable laws and regulations; global economic and market
conditions; and Cytek’s dependence on certain sole and single
source suppliers. You should refer to the section entitled “Risk
Factors” set forth in Cytek’s Quarterly Report on Form 10-Q filed
with the SEC on August 8, 2023 and other filings Cytek Biosciences
makes with the SEC from time to time for a discussion of important
factors that may cause actual results to differ materially from
those expressed or implied by Cytek’s forward-looking statements.
Although Cytek believes that the expectations reflected in the
forward-looking statements are reasonable, it cannot provide any
assurance that these expectations will prove to be correct nor can
it guarantee that the future results, levels of activity,
performance and events and circumstances reflected in the
forward-looking statements will be achieved or occur. The
forward-looking statements in this press release are based on
information available to Cytek as of the date hereof, and Cytek
disclaims any obligation to update any forward-looking statements
provided to reflect any change in its expectations or any change in
events, conditions, or circumstances on which any such statement is
based, except as required by law. These forward-looking statements
should not be relied upon as representing Cytek’s views as of any
date subsequent to the date of this press release.
Media Contact:Stephanie
OlsenLages & Associates(949) 453-8080stephanie@lages.com
Investor Contact:Paul
GoodsonHead of Investor RelationsCytek
Biosciencespgoodson@cytekbio.com
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