Device Dossier

Clinical chemistry vitamin and mineral IVDs

Device Dossier for Clinical chemistry vitamin and mineral IVDs (CT847 - Clinical chemistry vitamin and mineral IVDs, Class 2, sponsor Emergo). ARTG…

Intended purpose

The Waters MassTrak Vitamin D kit is for the quantitative determination of 25-hydroxyvitamin D3, 25-hydroxyvitamin D2, which in combination provide the total 25-hydroxyvitamin D in human plasma and serum using an automated liquid handling system and Waters ACQUITY UPLC I-Class/Xevo TQD IVD System. Results are to be used as an aid in the assessment of vitamin D sufficiency.

TGA Public Summary