Device Dossier
Legionella IVDs
Device Dossier for Legionella IVDs (CT787 - Legionella IVDs, Class 3, sponsor Ortho-Clinical Diagnostics). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT787 - Legionella IVDs
Intended purpose
The Sofia Legionella FIA employs immunofluorescence for qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. It is designed to test specimens from patients with symptoms of pneumonia. Test results are to be used as an aid in diagnosis of Legionella pneumophila serogroup 1 infection and in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures.