Australia TGA ARTG record

Clinical chemistry autoimmune IVDs

Australia TGA ARTG Registered Device · Bio-Strategy Pty Ltd · AliveDx Suisse SA · Class IIa · Started February 12, 2024

Good Name: Bio-Strategy Pty Ltd - Clinical chemistry autoimmune IVDs

Device classification

Risk Class: Class IIa
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: February 12, 2024
Effective Date: February 12, 2024

Sponsor

Name: Bio-Strategy Pty Ltd

Manufacturer

Name: AliveDx Suisse SA
Country: Switzerland
Address: Business Park Terre Bonne Route de Crassier 13, Eysins, 1262

Intended purpose

The MosaiQ AIplex CTD is composed of single use immunoassay microarrays to be used in conjunction with the automated MosaiQ 125 instrument and the associated MosaiQ reagents. It is intended for the in vitro simultaneous qualitative detection of antibodies directed to native dsDNA and to Extractable Nuclear Antigens (ENAs: TRIM21 (SS-A52), SS-A 60, SS-B, Sm, Sm/RNP, U1RNP, Scl-70, Jo-1, CENP B, Ribosomal P Protein) in human serum

About this record

Access comprehensive regulatory information for Clinical chemistry autoimmune IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Bio-Strategy Pty Ltd, manufactured by AliveDx Suisse SA in Switzerland. The device registration started on February 12, 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.