Product code PSL

Device name

25-Oh-Vitamin D Mass Spectrometry Test System

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1840

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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.

Source

FDA openFDA device classification dataset