Device Dossier
Streptococcus IVDs
Device Dossier for Streptococcus IVDs (CT798 - Streptococcus IVDs, Class 3, sponsor DiaSorin). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: CT798 - Streptococcus IVDs
Intended purpose
IVDs that use chemiluminescence immunoassay (CLIA) technology for the qualitative detection of Streptococcus antigen in urine specimens of patients with suspected pneumonia. IVDs intended as an aid in the diagnosis of pneumococcal pneumonia infection.