Nanogen, Inc. Submits 510(K) for Cystic Fibrosis Genetic Assay and NanoChip(R) 400 System

SAN DIEGO--(BUSINESS WIRE)--Nanogen, Inc. (Nasdaq:NGEN), developer of advanced diagnostic products, announced today that it has submitted the 510(K) to FDA for its Cystic Fibrosis Kit and NanoChip® 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.

Back to news