Australia TGA ARTG record

Infectious disease IVDs

Australia TGA ARTG Registered Device · Biomerieux Australia Pty Ltd · Biomerieux SA · Class I · Started March 15, 2022

Good Name: Biomerieux Australia Pty Ltd - Infectious disease IVDs

Device classification

Risk Class: Class I
Product Type: IVD
ARTG Category: IVD-Export

Registration information

Start Date: March 15, 2022
Effective Date: March 15, 2022

Sponsor

Name: Biomerieux Australia Pty Ltd

Manufacturer

Name: Biomerieux SA
Country: France
Address: 376 Chemin de l'Orme, Marcy, L Etoile, 69280

Intended purpose

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.

About this record

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.