Device Category Dossier

CT798 - Streptococcus IVDs

Device Category Dossier for CT798 - Streptococcus IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Streptococcus in vitro diagnostic devices employ rapid chromatographic immunoassay technology to qualitatively detect Streptococcus antigens in clinical specimens such as throat swabs or urine . These devices are used to aid in the diagnosis of Group A Streptococcal infections, particularly pharyngitis, in patients presenting with relevant clinical signs and symptoms .