Fibrosis

Nanogen Submits 510(K) for Cystic Fibrosis Genetic Assay and NanoChip 400 System

Published in Medical Letter on the CDC and FDA, May 6th, 2007

Nanogen, Inc. (Nasdaq:NGEN), developer of advanced diagnostic products, announced that it has submitted the 510(K) to FDA for its Cystic Fibrosis Kit and NanoChip(R) 400 microarray system. The Cystic Fibrosis Kit is intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children.

"The premarket notification of the NanoChip(R) system and the Cystic Fibrosis assay to the FDA is an important milestone for Nanogen," said Howard C. Birndorf, Nanogen's chairman and CEO. "This submission not only meets the commitment we made to the FDA, but also receiving 510(K) clearance...

Want to see the full article?

Purchase this article for only $3.00

We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.

Welcome to NewsRx!

Learn more about a six-week, no-risk free trial of Medical Letter on the CDC and FDA

Source: Medical Letter on the CDC and FDA (2007-05-06)

NewsRx is Social

Top Medical Newsletters

Awards

Best Health/Healthcare Content, 2012
Best Health/Healthcare Content, 2011
Best e-Business Site, 2010
Best e-Business Site, 2009
Best e-Business Site, 2008
Best e-Business Site, 2007
Best e-Business Site, 2006
Best Healthcare Content, 2005
Best Overall Internet Site, 2005
Best Interactive Site, 2005

Facts & Stats

NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.

Google 2010 PageRank: #2 Among Top Health News and Media Publications
Google 2010 PageRank: #2 Among Top Science Publications in Biology/Physiology
Google 2010 PageRank: #2 Among Top News and Media for the Business of Pharmaceuticals
Amazon's Alexa 2010 PageRank: #2 News and Media Site for the Pharmaceutical Industry