Quidel
This article was originally published in The Gray Sheet
Executive Summary
Files 510(k) with FDA for a rapid, single-step point-of-care diagnostic test for detection of influenza A and B. Quidel developed the test with Glaxo Group Ltd., a subsidiary of Glaxo Wellcome PLC, under a March 1996 agreement. Glaxo currently has a new drug application pending at FDA for its Relenza (zanamivir) influenza A and B treatment