Kurin, Inc., the inventor and manufacturer of 510(k)-cleared Kurin blood culture collection sets, has received its CE Mark that allows product distribution into the European Economic Area (EEA) and European Union (EU) Candidate Member States (i.e. Iceland and Turkey).
"We are pleased to receive the CE Mark, the clearance needed for medical products to be marketed in this important region," said Bob Rogers, CEO of Kurin. "The family of Kurin products was developed to help hospitals improve their blood culture samples and we look forward to helping hospitals in the EEA and EU Candidate States in their efforts to lower their contamination rates."
Kurin developed initial specimen diversion technology that automatically and passively diverts 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.
Kurin's patented automatic blood diversion product is the only FDA 510k-cleared blood culture diversion product in the US and now holds that same distinction for the European market.
About Kurin, Inc.
Kurin, Inc., 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. Kurin, manufactured in San Diego, CA, has received FDA 510(k) market clearance. For more information about Kurin, visit the website at www.kurin.com.