Device Category Dossier

CT787 - Legionella IVDs

Device Category Dossier for CT787 - Legionella IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Legionella in-vitro diagnostic devices use chemiluminescence immunoassay or immunofluorescence technology to qualitatively detect Legionella pneumophila and Legionella longbeachae antigens in human urine. These devices aid in the diagnosis of Legionella infection and are designed to test specimens from patients with symptoms of pneumonia.