25-Oh-Vitamin D Mass Spectrometry Test System

What Is This Device?

A 25-OH-Vitamin D Mass Spectrometry test system is intended to for vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D)using mass spectrometry.

How Is PSL Classified?

25-Oh-Vitamin D Mass Spectrometry Test System is FDA product code PSL, Class 2, 21 CFR 862.1840.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.