Thermo Fisher Scientific Announces 510(k) Clearance of ImmunoCAP Tryptase Assay
Published: Mar 02, 2012
PORTAGE, Mich.--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its immunodiagnostics business has received 510(k) clearance of the Thermo Scientific ImmunoCAP Tryptase Assay for use on its Thermo Scientific Phadia Laboratory Systems line of automated laboratory instruments. ImmunoCAP Tryptase is the first commercially available assay in the U.S. for mast cell tryptase to be available on Clinical Laboratory Improvement Amendments (CLIA) Moderate Complexity fully automated laboratory instruments. ImmunoCAP Tryptase is now cleared for use with the Phadia® 100, Phadia 250, and Phadia 1000 instruments.