Device Dossier
Phlebotomy kit
Device Dossier for Phlebotomy kit (Class IIa, sponsor Masdiag). ARTG record, intended purpose, GMDN category — compiled by arcimedes.
Intended purpose
The Masdiag Dried Blood Spot (DBS) Collection Kit is a procedure pack intended for use by healthcare professionals or self-collection by individuals to obtain capillary blood samples via fingerstick for subsequent laboratory analysis. The kit contains a sterile safety lancet for skin puncture, a CE-marked DBS collection card for sample deposition, alcohol swabs for skin preparation, a bandage, gauze, a desiccant pack and a biohazard return mailer. The collected dried blood spots are intended to be transported to an accredited clinical pathology laboratory for quantitative analysis of analytes such as fatty acid profiles, vitamin D, HbA1c and other biomarkers. The kit is not intended to provide a diagnostic result at the point of collection; it is a sample collection device only.