Device Dossier
Legionella IVDs
Device Dossier for Legionella IVDs (CT787 - Legionella IVDs, Class 3, sponsor DiaSorin). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: CT787 - Legionella IVDs
Intended purpose
IVDs that use chemiluminescence immunoassay (CLIA) technology and are intended for the qualitative detection of Legionella pneumophila and Legionella longbeachae antigens in human urine. IVDs intended as an aid in the diagnosis of Legionella infection.