Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor Pale Blue Medical Trading). ARTG record, intended purpose, GMDN…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
The SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA) is an in vitro diagnostic device that utilizes immunochromatography. It is designed for the rapid qualitative detection of antigens from SARS-CoV-2, Influenza A, Influenza B, Adenovirus (ADV), and Respiratory Syncytial Virus (RSV) in anterior nasal swabs from individuals suspected of these viral infections. This test kit aids in the clinical diagnosis of these infections and is intended for self-testing.