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Instrument/analyser IVDs - ARTG 224128

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 224128 and sponsored by Biomerieux Australia Pty Ltd, manufactured by BioFire Diagnostics LLC in United States of America. The device registration started on June 04, 2014.

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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TGA ARTG Official Data
Class I
ARTG 224128
Class I
Instrument/analyser IVDs
ARTG ID: 224128
Good Name: Biomerieux Australia Pty Ltd - Instrument/analyser IVDs
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Intended Purpose

Instruments to be used for the purposes of processing, examining and/or providing information about a clinical specimen.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
224128
Start Date
June 04, 2014
Effective Date
September 09, 2024
Manufacturer
Country
United States of America
Address
515 Colorow Dr, Salt Lake City, Utah, 84108