![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » SCIEX Gains FDA Clearance for Vitamin D Assay Kit for Mass Spectrometry
SCIEX Gains FDA Clearance for Vitamin D Assay Kit for Mass Spectrometry
![](https://www.fdanews.com/ext/resources/test/Drug-Images4/BlueTestTubeandBlueGlove.gif?t=1480612563&width=430)
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
Upcoming Events
-
21Oct