BioCentury
ARTICLE | Clinical News

Impact Dx Factor V Leiden and Factor II Genotyping Test regulatory update

June 23, 2014 7:00 AM UTC

Sequenom said FDA granted 510(k) clearance to the Impact Dx Factor V Leiden and Factor II Genotyping Test for use as an aid in diagnosing patients with suspected thrombophilia and to its Impact Dx System. The Impact Dx Factor V Leiden and Factor II Genotyping Test runs on the Impact Dx System, which detects multiple analytes in a DNA sample utilizing matrix-assisted desorption ionization time-of-flight (MALDI-TOF) mass spectrometry. ...