Kurin, Inc. announces peer-reviewed publication on Kurin® efficacy from Central Texas Veterans Health Care System

Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, announced today that the Central Texas VA Health Care System in Temple, TX, published their findings comparing results of two devices: Kurin and Steripath® (Magnolia Medical Technologies, Inc.) in the online edition of the Journal of Emergency Nursing. This is the first peer-reviewed publication comparing Kurin, a passive low-volume device with flash technology to Steripath, a mechanical diversion device using a much larger volume of blood. The study concludes that both products “drastically reduced [blood culture contamination rates], irrespective of the volume of initial diversion.” During the study, use of the Kurin collection sets resulted in a blood culture contamination rate of just 0.3%. 

“Congratulations to the authors from the Central Texas VA for publishing these important results,” said Bob Rogers, Inventor and CEO of Kurin. “The authors note that their results corroborate the peer-reviewed study from Hartford Hospital that showed Kurin reduced their blood culture contamination rate to below 0.5%, further strengthening the clinical foundation of Kurin.”

Kurin is the first device to allow for the passive sidelining of the initial flow of blood, providing clinicians a seamless path to compliance. Outcomes are driven by compliance and compliance is a function of how simple technology is integrated into practice, which can be particularly challenging in the busy Emergency Department. Kurin was also designed to use a remarkably low volume of blood, a significant improvement over other options, sidelining just 0.15 mls to achieve these clinical results.

“Although it is not stated in the clinical publication, after the study concluded, the facility allowed the nurses to decide which product to use and we are pleased they chose Kurin and in fact, have now been using Kurin for almost three years,” said Mr. Rogers. “Our goal is to significantly improve patient outcomes while saving hospitals significant dollars and, given the importance of the Department of Veterans Affairs to our country, there is no group we are more pleased to assist than our veterans and those providing their care.”

About Kurin, Inc.

Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Kurin, Inc. honored by MD Tech Review in annual listing of top Infection Control solutions

The New Standard for Blood Culture Collection

Sepsis, is a life-threatening condition caused when the body’s response to an infection goes out of balance, which triggers changes that damage other organs. This deadly infection affects almost 1.7 million people a year in the U.S. and kills nearly 270,000 people. To date, blood cultures remain the gold standard for determining if a patient has sepsis. An early and accurate diagnosis of sepsis is essential to ensure better treatment for such patients.

However, contaminated blood cultures, also known as a false-positive blood culture result, lead to over one million misdiagnoses every year. Patients who are misidentified with sepsis might be treated for a bloodstream infection that they don’t have. This leads to more extended stays in hospitals and continued exposure to tests, drugs, and potentially to severe hospital-acquired conditions, all while the actual reason for admission remains unaddressed.

Helping address this pressing issue is Kurin, a certified Minority Business Enterprise (MBE) focused on the design, development, manufacture, marketing, and sale of products that can help healthcare providers reduce contaminated blood cultures. “Traditional blood culture collection methods provide skin microbes a direct line to the culture bottle. The Kurin blood culture collection set is a replacement for traditional collection sets, introducing technology to sideline skin contaminants while preserving the standard blood culture collection technique for clinicians,” says Bob Rogers, Founder, CEO and Chairman of the Board at Kurin.

A Challenge that Continues to Grow

To better illustrate the critical issue that Kurin strives to address, Rogers explains, “In the infection prevention (IP) world, there are several challenges revolving around sepsis, cultures, and the use of antibiotics.” Too often, these false-positive blood cultures are treated as infections, and some of them must be reported to the Centers for Disease Control and Prevention (CDC), even though the hospital eventually realizes they are not a true infection. Another major problem confronting those in IP is the presence of C. diff, a deadly infection, where antibiotic use is the largest contributor to the disease. As such, eliminating the use of antibiotics wherever possible is essential. There is also increasing concern over superbugs, bacteria that become resistant to antibiotics. Hospitals have antibiotic stewardship programs to reduce the use of antibiotics, and those who are placed on antibiotics because of an incorrect blood culture test would be a straightforward subset of patients to address.

For a long time, hospitals have used a three percent contamination rate as the standard performance benchmark, based on a 2005 Q Probe survey. However, currently, hospitals are using cutting-edge technologies to drive that contamination rate well below one percent. In fact, some recent researchers claim that it’s high time to use a one percent benchmark. For this, it is essential to understand what is often causing these contaminations. A major reason turns out to be the microbes on our skin.

Approximately 20 percent of microbes reside in the dermis layer, and when a needle penetrates the skin, some of these microbes are collected by the needle and can enter the blood culture bottle. Even scrubbing with an alcohol pad does not necessarily prevent sub-surface skin bacteria from getting into the sample. As a result, the analysis will show the presence of bacteria, which a hospital might conclude came from the patient’s bloodstream and, thus, diagnose them as having sepsis.

A straight forward method to prevent any possibility of contaminating the culture sample is to use empty vacuum tubes that are often called waste tubes or diversion tubes. The idea is simple—draw off a few milliliters (mls) of blood and throw the tube away. Keeping aside the fact that this process would require wasting a lot more blood than is needed, data shows that the contamination rates decline with the use of diversion technology.

In essence, it works!

However, the challenge here would be to convince people to actually comply with this practice. Most hospitals report their highest contamination rates are coming from the Emergency Department (ED) and the ED is an incredibly busy, high-stress place where immediate decisions and action can literally mean life and death. What might seem easy in one situation, like using an empty tube, has proven very difficult to maintain as a steady practice in a fast-paced ED. Once compliance to this practice drops, contamination rates will revert to their original level, which is what often happens with waste tubes. In addition to waste tubes, a device specifically intended for diversion has been on the market for years to address this problem. Obstacles to compliance of using this device include the large size of the device, which impacts both storage and disposal, the volume of blood used (1.5-2 mls), and the fact it takes a specific action by the person drawing the blood. This extra step, while not complicated, takes extra time and requires a newly-learned action, and just like with using a waste tube, these obstacles can impact compliance in a busy environment.

An Evolution Beyond Diversion

Being a leading figure in the medical devices space for the last 35 years, recognized for his pioneering contribution to the Luer-activated valve industry, Rogers knew well that to develop a solution to a problem, it is important to understand the drivers of the problem and ignore the confines of what others have said or done. Such wisdom can only come from a person who has done this before. For Rogers, his experience developing the Curos disinfecting cap—a disposable passive disinfection device, which was acquired by 3M Corporation in 2015—came in handy. In his words, “As important as developing a solution to the problem, in this case contaminated blood cultures, the invention has to take into account how the product will be used.”

Looking at the hectic environment where blood cultures are taken, the device has to fit, which means above all else, it must be simple. To truly impact clinical outcomes, the product must be easy to use and not just be something that works. And it is this evolution beyond diversion products that has helped Kurin be so successful.

When asked how he came up with the idea for this leap in technology, Rogers says, “When looking at a video of a blood culture test procedure, something didn’t happen that I was expecting to see. I thought I would see a flash of blood and when I realized why this did not occur, specifically that the blood culture set (also known as a butterfly set)is a sealed tube, blood flow/flash was prevented because air could not enter or exit. In my mind, this created an opportunity to simply address the skin/surface contaminant problem. In effect, I simply created a device with a hole in it to allow air to escape and designed the channels so the initial flash of blood flows into a side channel. This allowed for a technology that was small and it meant a nurse did not have to do anything differently.”

Kurin was designed to be extremely simple. It is integrated into a commonly used butterfly set, so those people drawing cultures are not learning anything new. Instead of a mechanical device where an action is taken to collect the blood, this device uses the patient’s blood pressure to fill a side channel with the initial blood and contaminants that are often in that skin plug. When a vacuum source, like a blood culture bottle, is attached, the blood from the vein then flows through an adjoining channel into the blood culture bottle. The Kurin Lock is incredibly small and only uses an extraordinarily small amount of blood, approximately 0.15 mls, to improve blood culture collection. Kurin has all of the advantages of the diversion products, but without the disadvantages that make compliance so challenging. Simple indeed!

The patented and FDA 510(k) cleared Kurin device transforms a regular blood culture collection set into a powerful yet simple way to put skin contaminants on the sideline. Each Kurin® collection set features industry-leading butterfly needles and is compatible with all major blood culture bottles. The integrated Kurin Lock® enables clinicians to automatically discard the initial flash of blood, which may contain skin microbes, with no change in collection practice.

A Robust Yet Simple Solution for Blood Culture Collection

Kurin has been helping hospitals around the country significantly reduce their contaminated blood cultures and generating Clinical Data to prove it. As an example, Hartford Hospital in CT published a peer-reviewed study where they reduced their contaminations from 1.7% to an amazing 0.44%, which is a 74% reduction.

Several other hospitals have presented similar data, meaning untold thousands of patients around the country have been spared the clinical problems of Contaminated blood cultures, and hospitals have saved tens of millions of dollars, just in the last year. The company has seen a significant increase in demand in the last few months—even during the pandemic.

For Rogers, the success of Kurin is yet another golden feather in the cap and he aims to up the ante in the next 12-18 months. “We continue to build a larger team and are expanding our manufacturing capabilities to support our growth. We believe that if we are not making a difference in saving lives and helping hospitals reduce costs, then we have no reason to be in business. We love what we do, and we are extremely driven to work on significant problems. Our goal with Kurin is simple—to help hospitals improve clinical outcomes and help their financial bottom line,” concludes Rogers.

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About Kurin, Inc.

Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Kurin, Inc. Named to Inc.’s Inaugural Best in Business List in the Prosperous and Thriving Category

Kurin, Inc. has been named to Inc.’s inaugural Best in Business list in the Prosperous and Thriving category. Inc. created the Best in Business Awards to honor companies that have gone above and beyond to make a positive difference.

The list, which can be found in the Winter issue of Inc. (on newsstands December 29, 2020), recognizes small- and medium-size privately held American businesses that have had a superlative impact on their communities, their industries, the environment, or society as a whole.

“We are honored to be recognized by Inc.,” said Bob Rogers, CEO of Kurin. “Our organization is focused on making a difference by helping hospitals improve their clinical outcomes and stem their financial losses from blood culture contaminations. It is rewarding to see our efforts recognized by others. The pandemic has created new challenges but strong demand for Kurin blood culture collection sets remains, and indeed has increased our rapid growth as hospitals understand, more than ever before, that accurate testing is critical to optimal patient health.”

Kurin’s revolutionary approach to the contaminated blood culture problem is an elegantly simple and intuitive design that requires no additional user steps. Kurin is a passive device that sidelines potential contaminants during blood culture collection—simply better than conventional diversion. Contaminated blood cultures are a significant problem, as roughly one-third of the positive results are wrong, exposing these patients to unnecessary antibiotics, extending hospital stays and impacting larger community health issues, such as antimicrobial resistance and the life-threatening C. diff. infection.

Scott Omelianuk, editor-in-chief of Inc., says, “It’s been an incredibly challenging year for companies. Across industries, businesses have had to make brutally tough decisions and face unprecedented uncertainty. That’s why we knew 2020 called for a new recognition program, something to complement our annual Inc. 5000 list of the fastest-growing private companies in the country. For Best in Business, companies have prioritized tackling today’s problems to lead us to a better future, even if they’ve struggled to stay in the black.” 

Instead of relying on quantitative criteria linked to sales or funding, Inc.’s editors reviewed the companies’ achievements over the past year and noted how they made a positive difference in the world. They then selected honorees in more than 30 different industries–health, software, retail, business services, and more–and in age- and revenue-based categories. The applicant pool was very competitive, with around 2,700 entries and an acceptance rate in the low single digits—a huge success for these honors in their inaugural year.

Honorees for gold, silver, bronze, and general excellence across industries and categories are featured online at inc.com/best-in-business.

About Kurin, Inc.

Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Kurin, Inc. Receives Allowance from United States Patent and Trademark Office of Additional Claims to its Innovative Blood Culture Collection Device.

Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, announced today that the United States Patent Office allowed its patent application and has issued U.S. Patent No. 10,827,964. The Kurin blood culture collection set is a replacement for traditional collection sets, enhanced with technology that sidelines skin contaminants while preserving the standard blood culture collection technique for clinicians.

“We continue to add to our intellectual property portfolio for our unique Kurin product line,” said Bob Rogers, Inventor and Chief Executive Officer. “We have been pleased with the rapid acceptance of Kurin in the marketplace, as hospitals continue to demonstrate interest in addressing the significant financial and clinical problems caused by contaminated blood cultures. This US patent further strengthens our position in the market. The simplicity of Kurin is critical to caregiver compliance and compliance is the key to improving clinical outcomes. With no need for manual manipulation, a Kurin set makes it effortless for clinicians to incorporate new technology into their routine collection process.”

Kurin’s revolutionary approach to the contaminated blood culture problem is elegantly simple, an intuitive design that requires no additional user steps. Kurin passively sidelines potential contaminants during blood culture collection—simply better than conventional diversion. Contaminated blood cultures are a significant problem, as roughly one-third of positive results are wrong, exposing these patients to unnecessary antibiotics, extending hospital stays, and impacting larger community health issues, such as antimicrobial resistance and the life-threatening C. diff. infection.

About Kurin, Inc.

Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Kurin, Inc. Reports Record Revenues

>Kurin Inc., the inventor and manufacturer of the Kurin® blood culture collection sets, announced that third quarter revenues exceeded 150% over the same period in 2019. Kurin also reports that in the third quarter of 2020 sales have surpassed total revenues for 2019.

“Given the unprecedented times in which we find ourselves, we are pleasantly surprised to see a continuance of the strong demand that is fueling our rapid growth,” said Bob Rogers, CEO of Kurin, Inc. “Although the hospital world has changed, we’ve seen many hospitals implement Kurin during the pandemic, as they did not want to wait any longer to address their contaminated blood cultures. We have also seen an increase in the use of Kurin in many facilities underscoring the importance in the efficient use of resources and the fact that accuracy of tests has never been more important.”

Kurin’s revolutionary approach to the contaminated blood culture problem is elegantly simple, an intuitive design that requires no additional user steps. Kurin is a passive device that sidelines potential contaminants during blood culture collection—a method simply better than conventional diversion. Contaminated blood cultures are a significant problem, as roughly one-third of the positive results are wrong, exposing these patients to unnecessary antibiotics, extending hospital stays and impacting larger community health issues, such as antimicrobial resistance and the life-threatening C. diff. infection.

About Kurin, Inc.

Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Kurin, Inc. Receives Supplier Horizon Award from Premier Inc.

Kurin today announced that it is a winner of the Supplier Horizon Award from Premier Inc., a leading healthcare improvement company.

One of nine suppliers to receive the award this year, Kurin was recognized for its support of Premier members through exceptional local customer service and engagement, value creation through clinical excellence and commitment to lower costs.

“We are honored to be recognized by Premier for this Horizon Award,” said Bob Rogers, CEO of Kurin, Inc. “We are pleased that Kurin was acknowledged for the value we are bringing to Premier hospitals and for sharing in their pursuit of clinical excellence. Premier hospitals have reported significant reductions in blood culture contaminations with Kurin and we look forward to continuing to expand our relationship with this great organization.”

Horizon Award winners have a tenure of fewer than three years as a Premier contracted supplier.

“Kurin supports Premier members by offering valuable products and services that help to lower supply chain costs and improve operating efficiencies,” said David A. Hargraves, Senior Vice President, Supply Chain, Premier. “We’re honored to recognize them as a Horizon Award recipient.”

About Premier Inc.

Premier Inc. (NASDAQ: PINC) is a leading healthcare improvement company, uniting an alliance of more than 4,100 U.S. hospitals and health systems and approximately 200,000 other providers and organizations to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and consulting and other services, Premier enables better care and outcomes at a lower cost. Premier plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. Headquartered in Charlotte, N.C., Premier is passionate about transforming American healthcare. Please visit Premier’s news and investor sites on www.premierinc.com; as well as Twitter, Facebook, LinkedIn, YouTube, Instagram and Premier’s blog for more information about the company.

About Kurin, Inc.

Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Kurin, Inc. continues sales growth with record month.

Kurin Inc., announced record monthly sales of the Kurin Lock®, its revolutionary passive discard device that helps hospitals reduce contaminated blood cultures. July brought continued acceleration in Kurin sales and the company noted the importance of blood culture tests during the current pandemic. Although accurate testing is always important for the patient and the financial health of the hospital, optimally diagnosing bloodstream infections in highly vulnerable COVID patients is even more critical.

“Kurin has been instrumental for many hospitals in their efforts to provide excellent healthcare, especially in these trying times,” said Bob Rogers, CEO of Kurin. “We started this business to make a difference in healthcare and it is rewarding to see the belief that so many hospitals have in Kurin, as evidenced by our record sales.”

Kurin also addressed a recent court decision in one of Kurin’s false advertising suits against Magnolia Medical. In dismissing Kurin’s legal claims, the Court found that certain statements made by Magnolia regarding the efficacy of its Steripath product were “literally false,” and determined that various other Magnolia product claims are “puffery,” which the Court defined as “exaggerated advertising, blustering, and boasting.”

“While we are disappointed in the recent ruling and believe that the Court did not properly consider certain issues and evidence, Kurin initiated this lawsuit to address Magnolia’s use of false and misleading statements regarding both the efficacy and FDA status of its products.  As a result of the litigation, Magnolia has recently corrected their years of past misbehavior of selling without the necessary FDA clearances by seeking and finally receiving the FDA’s 510(k) clearance to market their Steripath products, modified its advertising, and provided important context for many of its product claims. In this respect, Kurin’s primary objective of establishing a more level playing field has been largely achieved. We believe there is a responsibility in the medical industry to maintain a high standard of integrity and feel the Court’s opinion, in fact, supports the merits of our false advertising lawsuit,” said Mr. Rogers.

“The more important lawsuit between our two companies is the patent lawsuit that is in process, and we remain very confident in prevailing in that matter,” said Mr. Rogers. “In the meantime, our focus remains on helping hospitals and we are pleased that hospitals continue to select Kurin over Steripath when directly competing. Dozens of hospitals that had used Steripath are now using Kurin, opting for a simpler, smaller, user-friendly, and more cost-effective solution to their contaminated blood culture problem.”

Kurin offers an initial specimen discard technology that automatically and passively sidelines potential contaminants during blood culture collection. When skin microbes enter into blood culture samples, false positive test results may misinform physicians and lead to unnecessary medical treatment and risk for patients and significant costs for the hospital.

About Kurin, Inc.

Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Kurin, Inc. Announces Agreement with Intalere for Kurin Lock to impact contaminated blood cultures

Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, announced today that it has been awarded a contract by Intalere for the Kurin product line. Effective July 1, 2020 the new three-year agreement allows Intalere members to take advantage of special pricing and terms.

“An agreement with Intalere is another important accomplishment for Kurin,” said Bob Rogers, Inventor and CEO of Kurin. “Hospitals are under increasing pressure to quickly and accurately diagnose their patients. Intalere emphasizes best practices and patient outcomes and we share patient safety values by providing innovative solutions designed to address a common source of contaminated blood cultures and in doing so, reducing overall healthcare costs.”

Kurin’s revolutionary and disruptive approach automatically and passively corrals potential contaminants during blood culture collection. Contaminated blood cultures are a significant problem, as approximately one-third of the positive results are wrong, exposing these patients to unnecessary antibiotics, extending hospital stays, and impacting larger community health issues, such as antimicrobial resistance and the life-threatening C. diff. infection. Contaminated blood cultures also create a financial burden to hospitals by prolonging hospital stays.

About Kurin, Inc.

Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Kurin, Inc. Announces Agreement with Vizient for Kurin Lock to help reduce contaminated blood cultures

Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, announced today that it has been awarded a contract for the Kurin Lock®, a blood culture optimization device designed to reduce contamination rates. Effective April 1, 2020, the new agreement offers Vizient members negotiated pricing and terms.

“We are pleased to have this agreement with Vizient,” said Bob Rogers, Inventor and CEO of Kurin. “Several Vizient member hospitals have already benefitted from sustained results in reducing their blood culture contamination rates with Kurin and formalizing this agreement will help additional hospitals add Kurin to their important work in protecting patients from harm. By providing this innovative solution at contracted pricing, Vizient and Kurin are helping to reduce overall healthcare costs.”

Kurin’s revolutionary and disruptive approach automatically and passively corrals potential contaminants during blood culture collection. Contaminated blood cultures are a significant problem, as roughly one-third of the positive results are wrong, exposing these patients to unnecessary antibiotics, extending hospital stays and impacting larger community health issues, such as antimicrobial resistance and the life-threatening C. diff. infection. Contaminated blood cultures also create a financial burden to hospitals by prolonging hospital stays.

Vizient is the largest member-driven performance improvement company in the country. Vizient’s diverse membership and customer base includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and nonacute health care providers.

About Kurin, Inc.

Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Kurin, Inc. receives FDA 510k clearance for its push-button needle

Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, has received 510(k) clearance (k191832) for its novel push-button needle.

“The FDA clearance of our push-button needle is another important step in the continued growth of our company,” said Bob Rogers, CEO of Kurin. “Development of our proprietary needle provides us vertical integration and also allows us to offer superior options to our customers. We are experiencing exponential growth and milestones like this one position Kurin well for our rapid expansion plans,” said Mr. Rogers.

Kurin developed initial specimen discard technology that automatically and passively sidelines potential contaminants during blood culture collection. When skin microbes enter into blood culture samples, false positive test results may misinform physicians and lead to unnecessary medical treatment and risk for patients, as well as significant costs for the hospital. Kurin’s patented automatic blood discard product is the only FDA 510(k) cleared blood culture product in its class.

About Kurin, Inc.

Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.