Australia TGA ARTG record

Viral infectious disease IVDs

Australia TGA ARTG Registered Device · Bio-Rad Laboratories Pty Ltd · Exact Diagnostics LLC · Class IIa · Started November 07, 2023

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: November 07, 2023
Effective Date: November 07, 2023

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. These controls are used to monitor the presence/absence of one or a number of viruses. Routine use of these controls allows laboratories to evaluate their molecular assays and operator 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 November 07, 2023.

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.