Device Dossier
Clinical chemistry trace element IVDs
Device Dossier for Clinical chemistry trace element IVDs (CT1237 - Clinical chemistry trace element IVDs, Class 2, sponsor Emergo). ARTG record, intended…
- GMDN category: CT1237 - Clinical chemistry trace element IVDs
Intended purpose
The UTAK Control is for use as a quality control material for monitoring the accuracy and precision of procedures that measure the levels of trace elements (metals) in serum, urine and whole blood. It is intended for use on a continuous basis so that the deviations of reagents and analytical instrumentation can be detected on a statistical basis.