Australia TGA ARTG record

Viral infectious disease IVDs

Australia TGA ARTG Registered Device · Bio-Rad Laboratories Pty Ltd · Exact Diagnostics LLC · Class IIa · Started December 21, 2022

Good Name: Bio-Rad Laboratories Pty Ltd - Viral infectious disease IVDs

Device classification

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

Registration information

Start Date: December 21, 2022
Effective Date: December 21, 2022

Sponsor

Name: Bio-Rad Laboratories Pty Ltd

Manufacturer

Name: Exact Diagnostics LLC
Country: United States of America
Address: 100 South Jones Street Suite 100, Fort Worth, Texas, 76104

Intended purpose

IVD unassayed controls intended to be used with specific molecular assays to monitor the performance of that given assay. Routine use of these controls allows laboratories to evaluate daily of their molecular assays and proficiency.

About this record

Access comprehensive regulatory information for Viral infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Bio-Rad Laboratories Pty Ltd, manufactured by Exact Diagnostics LLC in United States of America. The device registration started on December 21, 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.