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SCIEX announces the first FDA-cleared Vitamin D assay kit for mass spectrometry

SCIEX Diagnostics, the in vitro diagnostics division of SCIEX has announced today the first and only FDA-cleared (via the de novo pathway) LC-MS based Vitamin D assay kit. The Vitamin D 200M Assay, for use with the SCIEX Topaz System. The Topaz System is an integrated LC-MS platform controlled by ClearCore MD, the new software designed specifically for use in clinical labs. While individually quantitating D2 and D3 isomers, the Topaz System running the Vitamin D 200M Assay Kit, also automatically differentiates between D3 epimers, providing the specificity to deliver highly accurate diagnostic results in a single analysis.

The Vitamin D 200M Assay for the Topaz System is intended for in vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D) through the measurement of 25-hydroxyvitamin D3 (25-OH-D3) and 25-hydroxyvitamin D2 (25-OH-D2) in human serum using LC-MS/MS technology by a trained laboratory professional in a clinical laboratory.

Currently, the SCIEX Vitamin D 200M Assay Kit is only available in the United States.

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