Infectious disease IVDs
Access comprehensive regulatory information for Infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Biomerieux Australia Pty Ltd, manufactured by Biomerieux SA in France. The device registration started on March 15, 2022.
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.
VIDAS® SARS-COV-2 IgG II (9COG) is an automated semi‑quantitative assay for use on the VIDAS® family of instruments, for the detection of immunoglobulin G (IgG) specific for the SARS‑CoV‑2 receptor-binding domain (RBD) of the spike protein in human serum or plasma (lithium heparin) using the ELFA (Enzyme Linked Fluorescent Assay) technique. This assay is intended for use as an aid to determine if individuals have developed a humoral immune response to SARS‑CoV‑2, either after exposure to the virus or following vaccination.