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Bacterial infectious disease IVDs

Access comprehensive regulatory information for Bacterial 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 October 20, 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.

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Class IIa
Class IIa
Bacterial infectious disease IVDs
Australia TGA ARTG Registered Device
Good Name: Bio-Rad Laboratories Pty Ltd - Bacterial infectious disease IVDs
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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.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
October 20, 2022
Effective Date
October 20, 2022
Manufacturer
Country
United States of America
Address
100 South Jones Street Suite 100, Fort Worth, Texas, 76104