ARTG 398125Bacterial infectious disease IVDs
ARTG ID: 398125 · Bio-Rad Laboratories Pty Ltd · Exact Diagnostics LLC · Class IIa · Started October 20, 2022
Good Name: Bio-Rad Laboratories Pty Ltd - Bacterial infectious disease IVDs
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 398125
- Start Date
- October 20, 2022
- Effective Date
- October 20, 2022
- Country
- United States of America
- Address
- 100 South Jones Street Suite 100, Fort Worth, Texas, 76104
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.
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 registered under ARTG number 398125 and 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.