Device Dossier
Lancet, manual, allergy testing
Device Dossier for Lancet, manual, allergy testing (Lancet, manual, allergy testing, Class IIa, sponsor Ferrer Pharma Company). ARTG record, intended…
- GMDN category: Lancet, manual, allergy testing
Intended purpose
A small sterile plastic device with sharp cutting pin(s) at the distal end used for breaching the epidermis to facilitate the diagnosis of allergic reactions in skin allergy testing. The tip penetrates only the most superficial layers of the skin, which does not cause breeding. The device is in the presentation of single or multiple (8 or 10 feet) format which contains a range of pins/tips: 1, 5,8,10 and 12.