Cytek Biosciences, Inc. operates as a cell analysis solutions company advancing the next generation of research and clinical tools with the company’s novel technical approach of leveraging the full spectrum of fluorescence signatures from multiple lasers to distinguish fluorescent tags on single cells (Full Spectrum Profiling or FSP technology).
The company's FSP platform includes instruments, accessories, reagents, software, and services to provide a comprehensive and integrated suite of solut...
Cytek Biosciences, Inc. operates as a cell analysis solutions company advancing the next generation of research and clinical tools with the company’s novel technical approach of leveraging the full spectrum of fluorescence signatures from multiple lasers to distinguish fluorescent tags on single cells (Full Spectrum Profiling or FSP technology).
The company's FSP platform includes instruments, accessories, reagents, software, and services to provide a comprehensive and integrated suite of solutions for its customers. The company's customer base includes academic and government institutions, pharmaceutical and biotechnology companies, clinical research organizations and clinical laboratories focused on cell analysis. Approximately 40% of the company's revenue came from sales to academic and government-owned institutions and 60% of the company's revenue came from sales to pharmaceutical and biotechnology companies, distributors and CROs in the year ended December 31, 2024.
Full Spectrum Profiling (FSP) Technology
The company's patented FSP technology optimizes sensitivity and accuracy through its unique optical and electronic designs that utilize an innovative method of light detection and distribution to a specifically selected number and type of detectors. This patented optics design enables researchers to effectively collect the full range of light emissions in an extremely compact space, resulting in higher resolution and enabling the development of highly complex assays with more than 50 different colors (individual fluorochromes), supporting more than 50 biomarkers within just a single tube.
The company's FSP cell analyzers, the Cytek Aurora and Northern Lights systems, deliver high-resolution, high-content and high-sensitivity cell analysis and address the inherent limitations of other technologies by providing a higher level of multiplexing with exquisite sensitivity, more flexibility and increased efficiency. Additionally, the company's Cytek Aurora cell sorter ('Aurora CS' system) leverages the company's FSP technology to further broaden the company's potential applications across cell analysis by enabling the same number of parameters with the same sensitivity as the Cytek Aurora cell analyzer system. Each system is supported by the company's highly intuitive, proprietary embedded SpectroFlo software, the company's reagents, and the company's service offerings to provide a comprehensive, end-to-end platform of solutions for the company's customers.
Since the company's first U.S. commercial launch in mid-2017 through December 31, 2024, the company has sold and deployed its instruments to customers around the world, including pharmaceutical companies, biopharma companies, academic research centers, and clinical research organizations ('CROs'). The company's solutions have enabled researchers to make significant scientific advances in key areas of medical discovery (such as oncology, immunology and infectious diseases) in addition to empowering improved downstream cell analysis with complementary cell analysis technologies (such as next-generation sequencing ('NGS')). Further, there has been a meaningful acceleration in the rate of publications generated to showcase the company's technology, with more than 2,300 peer-reviewed articles published, including many prominent journals, across a wide range of applications, including oncology, infectious diseases, immunology, immunotherapy and immuno-oncology.
The company's FSP platform was purpose-built to advance the next generation of cell analysis by delivering deep insights, high throughputs, and ease of use.
Flow Cytometry and Imaging (FCI) Business
On February 28, 2023, the company completed the acquisition of certain assets (the 'FCI Acquisition') relating to the flow cytometry and imaging business of Luminex Corporation ('Luminex'), including relating to the business of manufacturing, marketing, selling, servicing and maintaining Amnis- and Guava-branded instruments, and flow cytometry reagent products and services (the 'FCI Business'). The acquired FCI Business includes conventional flow and image-based flow cytometry instrumentation and related products and services (the 'FCI Products'), which provide insights into all facets of cellular phenotypes and morphology.
Amnis instruments and applications are important tools in the investigation of cell morphology, intracellular translocation, and cell-cell interaction in a variety of research areas, including immunology, neurobiology, stem cell research, and cell biology. The addition of Guava flow cytometers expands the company's core instrument offerings, adding cost-effective, entry-level, and personal instrument options with microcapillary-based fluidics for cell analysis. The Guava microcapillary-based flow cytometers are mainly adopted by entry to mid-range flow cytometry users who are looking for easy-to-use and cost-effective solutions for applications, such as cell counting, cell biology, and lower-plex immunophenotyping. The FCI Acquisition supports the company's plan to develop new products and capabilities with flow cytometry and imaging technology, expand its reach and offerings into customer segments previously underserved, and increase the efficiency of its operations.
Strategy
The company's strategy includes the following core elements: accelerating the adoption of the company's solutions; continuing to innovate and offer the company's customers best-in-class solutions; investing in integrated workflow solutions to drive pull-through from the company's consumables and services; and driving clinical research application development.
Products
The company is a leading cell analysis solutions provider that develops compact, cost-effective instruments with high multiplexing capability, and the company offers a wide range of services to support scientists and clinicians. The company's products are used in the world's most renowned pharmaceutical and CROs, as well as premier academic and research institutions.
Cytek Aurora and Northern Lights Systems
The company's Cytek Aurora and Cytek Northern Lights systems were commercially launched in June 2017 and October 2018, respectively. Both instruments are highly flexible, intuitive, and ultra-sensitive full spectrum flow cytometers, utilizing state-of-the-art optics and low-noise electronics to provide excellent sensitivity and resolution, allowing researchers to resolve rare cell populations that were previously challenging to resolve. The optics and electronics designs, combined with flat-top beam profiles and a unique vacuum fluidics system, translate to outstanding performance from low to high sample flow rate, analyzing up to 35,000 events per second with certain configurations. Additionally, the company's optical design and unmixing algorithm make the instrument amenable to a wide array of applications and fluorochrome options, all without needing to reconfigure the instrument hardware as would otherwise be required on a conventional flow cytometer. The company's Cytek Aurora and Northern Lights systems are used in the study of infectious diseases, immunology, immunotherapy, immuno-oncology, oncology, inflammation, and drug discovery.
The Cytek Aurora system is available with three to five lasers and can detect more than 50 biomarkers in one sample tube. The Northern Lights system is available with one to three lasers and can detect more than 24 biomarkers in one sample tube. Both instruments are upgradeable based on the desired number of lasers, which drives greater or less access to biomarkers. In addition, both instruments incorporate the company's SpectroFlo software, which offers an intuitive workflow from quality control to sample acquisition to data analysis, with technology- enabling tools that simplify running applications.
The Northern Lights-CLC system was registered in the European Union in compliance with Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (the IVDR) in November 2023. This registration enables the Northern Lights-CLC system to be marketed for clinical use in the European Union and in other countries around the world that accept the Certification of Free Sale issued from an EU Competent Authority. The Northern Lights-CLC system is also registered as a Class II In Vitro Diagnostic Medical Device in China.
Cytek Aurora CS System
The company's Aurora CS system was commercially launched in June 2021 and is the first highly flexible, intuitive and ultra-sensitive cell sorter that leverages the detection and sensitivity capabilities of the company's FSP technology to isolate living cell populations from lower to higher complexity panels beyond 40 biomarkers. The company's FSP technology enables the processing of a tremendous amount of highly complex information to provide real-time unmixing and sorting capabilities at the field-programmable gate array level. The implications are significant in terms of flexibility and user experience, including experiment workflow transportability and assay reproducibility, enabling a 50-biomarker assay to be run in both the Cytek Aurora and the Aurora CS systems, with similar results. With the company's technology, users can first identify cell populations and then isolate the live cells for downstream studies, such as single-cell RNA sequencing, proteomics, and cell biology.
Enhanced Small Particle (ESP) Detection Option
In May 2024, the company launched its Enhanced Small Particle (ESP) Detection Option for its Cytek Aurora and Northern Lights systems to identify and analyze a variety of small particles, including extracellular vesicles, (EVs), small bacteria, viruses, viral particles, and nanoparticles. Typically, flow cytometers have been unable to detect particles smaller than 500 nm, limiting their use to the study of cells and larger particles. The ESP Detection Option expands the capabilities of small particle research on the company's Cytek Aurora and Northern Lights systems by enabling high-resolution detection of label-free or fluorescent-tagged particles down to 70 nm, providing researchers the ability to characterize and determine the full emission spectra of small particles. In November 2024, the ESP Detection Option was launched for the Cytek Aurora CS system, positioning this instrument as the first commercially available cell sorter with the ability to analyze and sort EVs based on fluorescent-tagged markers or autofluorescence with high resolution, efficiency, and sensitivity.
Cytek Amnis ImageStream Imaging Flow Cytometer
The Cytek Amnis ImageStream imaging flow cytometer includes multiple configurations to fit specific research needs and combines speed, sensitivity, and phenotyping abilities of flow cytometry with high resolution images and functional insights of microscopy. This unique combination enables a broad range of applications that would be impossible using either technique alone.
The ImageStreamX Mk II system is a benchtop, multispectral, imaging flow cytometer designed for the rapid acquisition of millions of cells with up to 12 channels of cellular imagery. It collects large numbers of digital images, performs spectral compensation and provides high quality images of every cell in your sample. Combined with the company's advanced AI-assisted image analysis software where each object is quantified for hundreds of parameters using not only fluorescence intensity but the spatial location of that fluoresced as well, the ImageStream system provides an unprecedented level of cellular information.
Cytek Guava Muse Cell Analyzer
The Cytek Guava Muse cell analyzer is a compact, easy-to-use benchtop device with a user-friendly touchscreen interface and intuitive cell analysis software. The Muse system delivers high-performance cell analysis using microcapillary technology and miniaturized optics. Laser-based fluorescence detection of each cell event can evaluate up to three cellular parameters, providing more quantitative results than non-flow cytometry-based imaging systems.
Cytek Guava easyCyte Flow Cytometer
The Cytek Guava easyCyte flow cytometer is a highly dynamic benchtop system with great sensitivity and optional high-throughput capabilities driven by intuitive software. The flexible configuration of the instrument allows for up to three lasers and 14 parameter measurements. Innovative microcapillary technology provides for direct absolute counting with industry-leading precision.
Cytek Orion Reagent Cocktail Preparation System
The Cytek Orion reagent cocktail preparation system enables researchers to fully automate the preparation of antibody cocktails for flow cytometry. With the ability to concoct cocktails comprising up to 60 individual antibodies, hands-on time is saved, allowing for increased efficiency and accuracy in the lab. The Cytek Orion reagent cocktail preparation system features robust, reliable cocktail preparation that eliminates potential user errors and pipetting mistakes; fast cocktail preparation that saves precious time in the lab; a robotic interface that allows for a decrease in repetitive motion from pipetting multi-color panels; and cooling and light protection to keep reagents stable.
Automated Micro-Sampling System and Automated Sample Loader System
The company's Automated Micro-Sampling ('AMS') system and Automated Sample Loader ('ASL') system were commercially launched in 2018 and 2021, respectively. The AMS and ASL systems are automated loaders designed to integrate seamlessly into the Cytek Aurora and Northern Lights systems, increasing sample throughput and adding automation capabilities to the company's FSP systems. The systems offer preset settings for ease of use, but also allow researchers to customize and fine-tune the systems for their unique experimental requirements. Both systems allow acquisition from standard 96-well plates, enabling automated sample acquisition without user intervention. The ASL adds additional compatibility with 96 deep-well plates, 38 well plates and 40-tube racks. Both systems have three throughput modes (high-throughput, default, low carryover) to meet changing customer priorities.
Reagents and Kits
The company launched the company's cFluor reagent products to provide additional options for researchers and clinical laboratories when choosing which biomarkers to run together in a panel, particularly since the company's Cytek Aurora, Northern Lights and Aurora CS systems allow for more fluorochromes to be run together than was previously commercially available. The company's cFluor reagents are fluorochrome conjugated antibodies used to identify cells of interest for analysis on the company's instruments. The company's technology was able to inform its fluorochrome development through the identification of areas within the spectrum for which there were no available fluorochrome options.
The company offers and continues to develop additional cFluor immunoprofiling kits, which include cFluor conjugated antibody reagents and tools necessary to simplify the workflow from sample preparation to data analysis. For example, the company's 14-color immunoprofiling kit distinguishes different subsets of human T, B, and natural killer, (NK), cells and monocytes, while its 25-color immunoprofiling assay provides a turnkey solution for identifying major human immune subpopulations for T, B, NK cells and monocytes, as well as dendritic cells and basophils. The Cytek 13-color human B cell monitoring kit offers a turnkey solution for identifying and enumerating B cell subsets in human whole blood and peripheral blood mononuclear cells. In 2023, the company introduced a single-tube 20-color panel for identifying and characterizing normal and aberrant cells and evaluating MRD in acute myeloid leukemia samples, and its pan leukocyte kit is designed to help researchers fully enumerate the complete set of major leukocyte subsets for drug discovery and development. In 2024, the company released the Cytek 24-color mouse immunoprofiling panel for identifying and characterizing more than 20 mouse immune cell lineages, including T, B, and NK cells, dendritic cells, monocytes, and granulocyte populations, as well as cellular subpopulations. This research use only, such as (RUO), products are optimized for use with the company's FSP systems and help improve operational efficiency for its customers.
The company's single-color reagents are registered as Class 1 with the China National Medical Products Administration, (the NMPA), and in the European Union under the IVDD. The company's 6-color reagent cocktails that identify and determine the percentages and absolute counts of T, B, and NK cells in peripheral blood are registered as Class 3 with the NMPA. The company expects these reagent and application solutions to be a significant driver of its future reagent revenue and pull-through as its installed base of instruments grows.
To help accelerate the company's overarching goal to become a comprehensive solutions provider to the company's customers, the company acquired the reagents business of Tonbo Biotechnologies Corporation in November 2021 (the 'Tonbo Acquisition') and offers reagents under the Tonbo brand. Additionally, the company also offers Amnis and Guava-branded reagents and kits.
Software
The company's proprietary SpectroFlo software is integrated into its systems and is unique in that it offers intuitive workflows for handling full spectrum flow cytometry data, from quality control to data analysis. The software was developed specifically for the company's Cytek Aurora and Northern Lights systems to streamline instrument setup, automated quality control, data analysis, and data management. With the ability to import a previously designed experiment template, either from a collaborator or from an experiment designed in Cytek Cloud, users are able to quickly set up their experiments, and there is no need to re-enter the panel design, acquisition criteria, reagent information, or data analysis worksheets, fluorochrome names, cell markers, reagent lots, or acquisition criteria. With the company's SpectroFlo software, users can conveniently and efficiently collect both raw and unmixed FCS 3.1 files, which can be used to live unmix samples and extract autofluorescence that would otherwise negatively impact data resolution.
Built on the same intuitive SpectroFlo software workflows and user interface, the company provides its SpectroFlo CS software with its Aurora CS systems and its SpectroPrep software with its Cytek Orion reagent cocktail preparation system. The SpectroFlo CS software enables the acquisition and analysis of cell populations with the same high-level resolution provided by the company's Cytek Aurora system, with the added ability to sort live cells of interest. The SpectroPrep software is wizard-based and guides users to automate their cocktail preparation.
For Guava Muse and easyCyte systems, the company utilizes InCyte software that has an intuitive, easy-to-use interface that enables users to focus on data at the sample or experimental level. The software simplifies the setup and analysis of plots, and automated compensation makes it easy to perform complex, multi-color assays. InCyte software includes heat-mapping features to rapidly evaluate data on the multi-plate or parameter analysis. The software allows for easy integration for 21 CFR Part 11 environments, as well as direct integration with robotic arms and liquid handlers through the GuavaLink programs.
For ImageStream systems, the company’s IDEAS software packages, along with machine learning and Amnis AI software, combine image analysis, statistical rigor, and visual confirmation in an easy-to-use software suite that works seamlessly with data sets generated on the ImageStream system. The Image Gallery allows users to see every image of every cell or perform a virtual cell sort to inspect and validate cells within a specific population. Every dot in every scatter plot is linked to the corresponding cell imagery. Machine learning modules add the power of computer learning and the ability to create experiment-specific super features tailored to maximize the separation of critical populations using the thousands of features in an IDEAS analysis. The Amnis AI analysis software package takes advantage of deep learning using convolutional neural networks to greatly simplify analysis and accurately identify even the most subtle of cell differences.
Customer Support Tools
The company strives to continually innovate by developing new quantitative tools, which are integrated into its software or available to its customers on its website, to enable users to independently create high-color panels for use with its systems, support efficient workflow solutions, and provide an intuitive user experience. The company launched Cytek Cloud, a digital ecosystem that supports full spectrum flow cytometry research from panel design to data acquisition, seamlessly integrating with its SpectroFlo software. Cytek Cloud features three integrated online tools, including Full Spectrum Viewer, Panel Builder, and Experiment Builder, to streamline experiment workflow on the company's Cytek Aurora, Northern Lights, and Aurora CS systems.
As fluorochrome, (color), selection is a key component of assay development and optimization, the company's Full Spectrum Viewer is a unique tool capable of displaying the full emission spectrum of a fluorochrome, (emission at different wavelengths post-excitation with multiple lasers). The company's FSP technology provides an in-depth understanding of the fluorescence emission characteristics of nearly every color available in the market, and the company’s Full Spectrum Viewer provides users with comprehensive information regarding the emission characteristics of the fluorochromes to optimize fluorochrome selection for assay development. As a complementary tool to the company’s Full Spectrum Viewer, the company's Similarity and Complexity indices provide unique metrics for assessing fluorochrome compatibility within a panel. The Similarity index compares the emission spectrum of two dyes, identifying whether the dyes have unique characteristics or if the dyes are identical, which determines whether they can be used together to analyze a sample in a flow cytometry assay. The Complexity index is a metric that predicts how well a panel of colors will work in combination to minimize loss of resolution and sensitivity.
The company's Panel Builder tool combines all the features of the Full Spectrum Viewer with additional tools for panel design and collaboration in a simple and organized interface. Users can quickly visualize, compare, and optimize their fluorochrome selections with a suite of spectral panel design tools in real-time, allowing them to build their panels faster. To simplify panel design further, the company expanded the capabilities of Panel Builder with the addition of its SpectroPanel tool, a proprietary new intelligent algorithm which suggests optimized panels in minutes, reducing the panel design time from days and weeks. Optimized for the company's FSP technology, the SpectroPanel tool automates the assignment of fluorochromes to markers, removing the labor-intensive manual process. It also enables researchers to design panels with ease, taking into account antigen density, marker expression, reagent availability, and reagent preferences. Users can access cFluor and Tonbo reagents within the platform, via built-in Cytek and partner catalogs. In addition, users can jumpstart their panel design process with a built-in repository of pre-designed panels, such as the Cytek reagent kits and optimized multicolor immunofluorescence panels. Users can also easily manage and share their panels between colleagues to enable faster collaboration.
The company's Experiment Builder tool allows users to set up their experiments in advance to make efficient use of their time on the instrument. In addition, users can auto-populate fluorochromes and marker names and seamlessly transfer panels from Panel Builder to Experiment Builder with a single click, removing redundancies and simplifying the workflow.
DxP Athena System
The company's DxP Athena conventional flow cytometry system commercially launched in 2016 and is available for sale only in China. It is certified for clinical use by China NMPA. The DxP Athena system incorporates technology with efficient photomultiplier tubes to enable high sensitivity and high resolution and the company's proprietary QbSure software to ensure optimal daily instrument performance. The system is available in multiple configurations with one to three lasers and up to 13 fluorescence detection channels. The automated monthly clean bleach cycle minimizes downtime, streamlines maintenance and encourages compliance.
Sales and Marketing
The company distributes its products through its direct sales force and support organizations located in North America, Europe, China and several other countries in the Asia-Pacific region, and through distributors or sales agents in several countries in Europe, Latin America, the Middle East and the Asia-Pacific region. The company's sales and marketing efforts are targeted at academic and governmental institutions, CROs, pharmaceutical and biotechnology companies and clinical laboratories focused on single-cell analysis.
The company's sales process often involves interactions and demonstrations with multiple people within an organization. Some potential customers conduct in-depth evaluations of the system, including running experiments on the company's system and competing systems. In addition, in many countries outside of North America, sales to academic or governmental institutions require participation in a tender process involving preparation of extensive documentation and a lengthy review process. As a result of these factors and the budget cycles of the company's customers, the sales cycle on the company's instrument, the time from initial contact with a customer to the company's receipt of a purchase order, can be six months or longer.
Competition
The company’s direct competitors include Agilent Technologies, Beckman Coulter (Danaher Corporation), Becton, Dickinson and Company, Bio-Rad Laboratories, Standard BioTools, Miltenyi Biotec, Sony Biotechnology (Sony Corporation) and Thermo Fisher Scientific.
Intellectual Property
The company has developed its own portfolio of issued patents and patent applications directed at its core and system-level technology, including claims directed to methods and apparatus of flow cytometers and cell sorters with excitation, fluidics, emission, mechanical, magnetic, electronics, bio-safety, and temperature control technology in configurations of its Cytek Aurora, Aurora CS, Northern Lights, and Northern Lights-CLC systems.
The company also owns a number of issued patents related to the Amnis and Guava families of flow cytometer products from the FCI Acquisition. The company generally seeks patent protection in the United States, Japan, China, the United Kingdom, and selected countries of the European Union, such as France and Germany.
Including rights acquired in connection with the FCI Acquisition, as of December 31, 2024, the company owns 35 issued U.S. utility patents, ten issued Japan utility patents, seven issued European utility patents, three issued China utility patents, one Canada utility patent, one India utility patent, two Australian utility patents, and three Singapore utility patents. The company has 70 pending utility patent applications, including 45 utility patent applications in the United States, three international utility patent applications, nine utility patent applications in the European Union, nine utility patent applications in China, and four utility patent applications in Japan. Assuming all maintenance fees are paid, the U.S. issued patents are expected to naturally expire between the years 2025 and 2038. Patents covering intellectual property relating to design-specific technologies invented by the company's researchers in Shanghai and Wuxi, China, are filed in China and owned by the company's China subsidiaries, respectively. As of December 31, 2024, the Shanghai subsidiary owns 12 issued utility patents and eight issued invention patents and has two pending invention patent applications, while the Wuxi subsidiary owns 42 issued patents and has five pending invention patent applications.
Key Agreements, Licenses and Collaborations
Biotium, Inc. Supply and License Agreement
On September 1, 2020, the company entered into a Supply and License Agreement with Biotium, Inc. ('Biotium') pursuant to which Biotium agreed to supply, and the company obtained a worldwide, non-exclusive license to market and resell to the company's customers and distributors, certain Biotium products to conjugate proteins and/or antibodies and to use such conjugates as a component in the company's cFluor reagent products, for research and analyte specific reagents (as defined by 21 CFR 864.4020) use only (the 'Field of Use') (the 'Biotium Agreement').
Becton, Dickinson and Company Settlement, License and Equity Issuance Agreement
On February 13, 2018, Becton, Dickinson and Company (BD) filed a lawsuit against the company alleging trade secret misappropriation and copyright infringement. On October 6, 2020, the company entered into a Settlement, License and Equity Issuance Agreement with BD pursuant to which the company and BD agreed to a mutual release of all claims against each other as of the date thereof (the BD Agreement). As part of the settlement, BD granted the company a non-exclusive, irrevocable, perpetual, worldwide, and non-transferrable license to certain BD patents and covenanted that it would not enforce, or permit or encourage the enforcement of BD patents against the company or its affiliates in connection with the development, manufacture, use, importation, offer for sale or sale of the company’s then-current instruments.
Coherent NA, Inc. Supply Agreement
On August 25, 2021, the company and Cytek (Wuxi) Biosciences Co., Ltd, the company's Wuxi, China subsidiary, entered into a Supply Agreement (the 'Coherent Agreement') with Coherent NA, Inc. ('Coherent') pursuant to which Coherent agreed to sell and supply to the company, on a non-exclusive basis, laser products manufactured by Coherent. The company provides Coherent with rolling forecasts of the company's anticipated orders, which are non-binding.
Trademarks
‘Cytek,’ ‘Cytek Aurora,’ ‘Northern Lights,’ ‘NL-CLC,’ ‘Cytek Orion,’ ‘Amnis,’ ‘Guava,’ ‘ImageStream,’ ‘Muse,’ ‘easyCyte,’ ‘Tonbo,’ ‘cFluor,’ ‘SpectroFlo,’ ‘SpectroPanel,’ ‘SpectroPrep,’ ‘InCyte,’ ‘GuavaLink,’ ‘IDEAS,’ ‘Similarity,’ ‘Complexity,’ ‘FSP,’ ‘Full Spectrum Profiling,’ ‘ESP,’ ‘Enhanced Small Particle’ and ‘DxP Athena’ are trademarks of the company.
Research and Development
The company’s research and development expenses were $39.4 million for the year ended December 31, 2024.
Government Regulation and Product Approval
To obtain 510(k) clearance, the company must submit a pre-market notification to the FDA demonstrating that the proposed device is substantially equivalent to a previously-cleared 510(k) device, a device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of PMA applications, or is a device that has been reclassified from Class III to either Class II or I.
To the extent that the company's products have already been certified under the existing regulatory framework, the IVDR allows the company to market them provided that the requirements of the transitional provisions are fulfilled.
The company's business activities are subject to healthcare regulation and enforcement by the federal government and the states and foreign governments in which the company conducts its business. These laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims and physician sunshine laws and regulations.
History
The company was founded in 1992. The company was incorporated in 2014. The company was formerly known as Cytoville, Inc. and changed its name to Cytek Biosciences, Inc. in August 2015.
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