SAN DIEGO, Nov. 1 /PRNewswire-FirstCall/ -- Nanogen, Inc. , developer of advanced diagnostic products, announced today that the quality management system of its point-of-care division successfully meets the requirements of the International Organization for Standardization (ISO) certification 13485: 2003. The certification signifies that as a medical device manufacturer, Nanogen’s point-of-care division has quality management processes in place that have been assessed for their ability to meet customer and regulatory requirements. In addition, Nanogen demonstrated during the ISO review process that its quality management system complies with Canadian Medical Device Regulations.
The ISO requirements focus on design and process control, customer and regulatory requirements, and continual improvement of the quality management system, which are critical for ensuring high-quality, safe and effective medical devices. Securing ISO registration is a prerequisite for Nanogen’s point-of-care division to register its congestive heart failure product with Health Canada’s Therapeutic Products Directorate. Nanogen’s quality management system is also designed to conform to the U.S. Food and Drug Administration’s Center for Devices and Radiological Health’s Quality System Regulations.
The audit for Nanogen’s ISO certification was completed by QMI, an independent Standards Council of Canada accredited registrar.
About Nanogen, Inc.
Nanogen’s advanced technologies provide researchers, clinicians and physicians worldwide with improved methods and tests to predict, diagnose and ultimately help treat disease. The company’s products include real-time PCR reagents, the NanoChip(R) electronic microarray platform for molecular diagnostic applications, and a line of rapid point-of-care diagnostic tests. Nanogen’s ten years of pioneering research involving nanotechnology holds the promise of miniaturization and continues to be supported for its potential for diagnostic and biowarfare applications. For additional information please visit Nanogen’s website at www.nanogen.com.
Forward-Looking Statement
This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements, including whether products under development can be successfully developed and commercialized, whether patents owned or licensed by Nanogen will be developed into products, whether the patents owned by Nanogen offer any protection against competitors with competing technologies, whether results reported by our customers or partners can be identically replicated, and other risks and uncertainties discussed under the caption “Factors That May Affect Results” and elsewhere in Nanogen’s Form 10-K or Form 10-Q most recently filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Nanogen disclaims any intent or obligation to update these forward-looking statements.
Nanogen, Inc.
CONTACT: Robert Saltmarsh, Chief Financial Officer of Nanogen, Inc.,+1-858-410-4600, rsaltmarsh@nanogen.com; or Pam Lord, Media & InvestorRelations of Atkins + Associates, +1-858-527-3494, plord@irpr.com, forNanogen, Inc.
Web site: http://www.nanogen.com/
