Device Dossier
Clinical chemistry substrate IVDs
Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 3, sponsor Nova Biomedical). ARTG record, intended…
- GMDN category: CT833 - Clinical chemistry substrate IVDs
Intended purpose
Intended for the quantitative determination of clinical chemistry substrates in a clinical specimen (arterial, venous and capillary blood). The StatStrip Glucose test strips can be used for measurement of Patient whole blood glucose, including use with Critically ill Patients (e.g. ED, ICU, NICU). The StatStrip Lactate test strips can be used for the measurement of Patient whole blood lactate, including Foetal Scalp/Capillary Lactate testing.