Multiple-viruses IVDs - ARTG 473906
Access comprehensive regulatory information for Multiple-viruses IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 473906 and sponsored by BIO TOP Pty Ltd, manufactured by Hangzhou Fanttest Biotech Co Ltd in China. The device registration started on December 19, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The COVID-19/RSV/ADV/Flu A&B Antigen Combo Rapid Test Kit is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2, respiratory syncytial, Adenovirus, influenza A and influenza B viral nucleoprotein antigens in nasal swabs from subjects. The symptoms of respiratory viral infection due to SARSCoV-2, respiratory syncytial, Adenovirus, influenza can be similar. The test is intended as an aid in diagnosis of symptomatic individual meeting respiratory infection for SARS-CoV-2 (within the first 7 days of the onset of symptoms) and influenza A/B, Adenovirus or Respiratory syncytial virus (RSV) (within the first 4 days of the onset of symptoms).