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NEW YORK (360Dx) – Sciex said today that it has received de novo US Food and Drug Administration clearance for its mass spec-based Vitamin D assay kit.

The test, which will be offered through the company's Sciex Diagnostics division, is the only FDA-cleared LC-MS-based Vitamin D assay kit currently on the market, Sciex said.

Called the Vitamin D 200M Assay, the kit is meant to be run exclusively on the Sciex Topaz System, an integrated LC-MS platform running Sciex's ClearCore MD clinical software.

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