Device Dossier
Clinical chemistry substrate IVDs
Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 2, sponsor PM Separations). ARTG record, intended…
- GMDN category: CT833 - Clinical chemistry substrate IVDs
Intended purpose
The ClinSpot® Complete Kits are intended for the semi-quantitative determination of amino acids and acylcarnitines for neonatal screening. The determination is performed with LC-MS/MS from dried blood spot specimen.