Device Dossier
Home blood collection kit
Device Dossier for Home blood collection kit (Capillary blood collection set, home-use, Class IIa, sponsor RN Labs). ARTG record, intended purpose, GMDN…
- GMDN category: Capillary blood collection set, home-use
- Sponsor: RN Labs
Intended purpose
Home blood collection kit for the collection and transport of a capillary blood sample for laboratory testing or screening purposes. A collection of sterile devices and materials intended to be used by a layperson to collect and mail the sample to a clinical laboratory for diagnostic testing or screening purposes.