Device Dossier

Multiple-viruses IVDs

Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 2, sponsor Pale Blue Medical Trading). ARTG record, intended purpose, GMDN…

Intended purpose

ADV/RSV Antigen Combo Rapid Test Kit (LFIA) is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative detect Adenovirus (ADV), Respiratory syncytial virus (RSV) antigen in anterior nasal swab from individuals suspected of ADV, RSV. It can be used for detecting ADV, RSV infection rapidly, which is often used as an auxiliary method in the clinical diagnosis, but not as the only basis. The test kit is designed for use as self-testing.

TGA Public Summary