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Bacterial infectious disease IVDs

ARTG ID: 401146 · Thermo Fisher Scientific Australia Pty Ltd · Life Technologies Corporation · Class IIa · Started December 15, 2022

Good Name: Thermo Fisher Scientific Australia Pty Ltd - Bacterial infectious disease IVDs

Device classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
401146
Start Date
December 15, 2022
Effective Date
December 15, 2022
Sponsor
Manufacturer
Country
United States of America
Address
6055 Sunol Boulevard, Pleasonton, California, 94566
Intended purpose

IVD consisting of assays and controls for a real time polymerase chain reaction (PCR) intended to be used in testing for the qualitative detection and differentiation of one or a number of bacterial pathogens.

About this record

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 401146 and sponsored by Thermo Fisher Scientific Australia Pty Ltd, manufactured by Life Technologies Corporation in United States of America. The device registration started on December 15, 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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