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).…

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.

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