Device Dossier

Clinical chemistry substrate IVDs

Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 2, sponsor Douglass Hanly Moir Pathology (Sonic…

Intended purpose

Test kits and controls used for the analysis of lipoprotein sub fractions in serum or plasma. Lipoprotein cholesterol measurements are used as an aid in evaluation of lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment and clinical evaluation

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