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 Aceso Diagnostics).…
- GMDN category: CT847 - Clinical chemistry vitamin and mineral IVDs
Intended purpose
The Vitamin D Rapid Test Cassette is a rapid chromatographic immunoassay for the semi-quantitative detection of 25-hydroxyvitamin D (25 (OH) D) in human fingerstick Whole blood. This assay provides a preliminary diagnostic test result and can be used to screen for Vitamin D deficiency. For self-testing in vitro diagnostic use.