Device Dossier

Lancet, manual, allergy testing

Device Dossier for Lancet, manual, allergy testing (Lancet, manual, allergy testing, Class IIa, sponsor Stallergenes). ARTG record, intended purpose,…

Intended purpose

A small single use device with a sharp triangular cutting edge at the distal end used for breaching the epidermis to facilitate the diagnosis of allergic reactions in skin allergy testing performed by an allergist or other healthcare professional. The tip penetrates only the most superficial layers of the skin allowing a small volume of the allergen extract to enter the skin and diffuse into the skin layers below.

TGA Public Summary