Device Category Dossier

CT847 - Clinical chemistry vitamin and mineral IVDs

Device Category Dossier for CT847 - Clinical chemistry vitamin and mineral IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

In vitro diagnostic devices intended for the qualitative and/or quantitative determination of vitamins and minerals in clinical specimens operate through various analytical methodologies including chromatographic immunoassay and high-performance liquid chromatography. These devices are used for professional laboratory assessment of vitamin and mineral status in patients requiring nutritional monitoring or screening for micronutrient deficiencies.