SCIEX Gains FDA Clearance for Vitamin D Assay Kit for Mass Spectrometry
SCIEX has received FDA clearance via the de novo pathway for its LC-MS based vitamin D assay kit, the Vitamin D 200M assay for the Topaz system.
The assay is intended for in vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D in human serum using liquid chromatography–mass spectrometry.
The assay is for use in conjunction with other clinical or laboratory data to assist clinicians in making individual patient management decisions. — Cynthia Jessup