HAYWARD, Calif.–(BUSINESS WIRE)–Mawi DNA Technologies (Mawi), a leader in biological specimen collection technologies, announces that the company has received CE Marking and UK MHRA approval for its iSWAB non-invasive collection device portfolio. This approval includes Mawi’s HemaSure-OMICS Whole Blood Collection Tubes for gDNA, cDNA and RNA from the same sample and the NextSWAB 100% injection molded swab.
The internationally recognized CE certification means that Mawi products comply with EU and UK medical device directives. With CE marking and UK MHRA approval, Mawi is able to market its full range of products in the UK, European Union and all countries recognizing this molecular diagnostic testing standard.
“The CE Mark and UK MHRA approvals are significant milestones for Mawi,” said Dr. Bassam El-Fahmawi, CEO of Mawi DNA Technologies. “This allows us to expand the utility and access of our innovative biological sample collection technologies from research use only to the molecular in vitro diagnostics market in Europe. “Furthermore, it opens opportunities for collaboration and partnership with European companies and organizations to integrate our products into high-value regulated market segments such as molecular diagnostic testing, clinical trials and infectious disease surveillance. .”
“Receiving CE Marking and the UK MHRA is a great achievement for our business,” said Hanzel Lawas, QMS and Chief Operating Officer at Mawi. “With our recent ISO 9001/13485 certification, it reaffirms our compliance with IVD Medical Device guidelines and our commitment to providing high quality products that meet our customers’ expectations and regulatory requirements.”
About Mawi DNA Technologies
Mawi DNA Technologies, founded in 2013, has developed and commercialized iSWAB technology, an innovative biological sample collection system. Mawi’s mission is to maintain sample integrity from anywhere in the world at room temperature, enabling true sample diversity in any geographic area or population segment. At Mawi, The Future of Biosampling is Here™. For more information, visit http://www.mawidna.com.