FDAnews
www.fdanews.com/articles/67199-dade-behring-receives-fda-clearance-for-use-of-its-advanced-d-dimer-assay

DADE BEHRING RECEIVES FDA CLEARANCE FOR USE OF ITS ADVANCED D-DIMER ASSAY

January 5, 2005

Dade Behring has received clearance from the FDA for the use of its Advanced D-Dimer assay as an aid in the diagnosis of venous thromboembolism -- deep vein thrombosis or pulmonary embolism. The clearance included performance data with a defined cutoff value for the Dade Behring BCS System and Sysmex CA-1500 System. The assay is also for use on Dade Behring's BCT System, and Sysmex CA-7000 and CA-560 Systems.

Yahoo News (http://biz.yahoo.com/bw/050104/45557_1.html)