Device Dossier
Clinical chemistry substrate IVDs
Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 3, sponsor Ascensia Diabetes Care). ARTG record,…
- GMDN category: CT833 - Clinical chemistry substrate IVDs
Intended purpose
For qualitative and semi-quantitative testing of clinical chemistry substrates in urine and quantitative testing of clinical chemistry substrates in capillary, venous or arterial whole blood samples. Suitable for self-testing by patients and for use by healthcare professionals. The meter is for use with whole capillary blood from fingertips, palm or forearm and sends blood glucose results to compatible systems. The test strips can be used with capillary, venous, and arterial whole blood samples