Device Dossier

Clinical chemistry enzyme IVDs

Device Dossier for Clinical chemistry enzyme IVDs (CT827 - Clinical chemistry enzyme IVDs, Class 2, sponsor Randox). ARTG record, intended purpose, GMDN…

Intended purpose

Randox Laboratories Ltd produce a range of kits, calibrators, controls and test reagents intended to be used for the qualitative and/or quantitative determination of Clinical Chemistry Enzymes in a clinical specimen.

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