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Organism identification and antimicrobial susceptibility testing IVDs - ARTG 452226

Access comprehensive regulatory information for Organism identification and antimicrobial susceptibility testing IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 452226 and sponsored by Beckman Coulter Australia Pty Ltd, manufactured by Beckman Coulter Inc in United States of America. The device registration started on June 14, 2024.

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 IIb
ARTG 452226
Class IIb
Organism identification and antimicrobial susceptibility testing IVDs
ARTG ID: 452226
Good Name: Beckman Coulter Australia Pty Ltd - Organism identification and antimicrobial susceptibility testing IVDs
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Intended Purpose

In vitro diagnostic medical devices intended for quantitative and qualitative determination of antimicrobial agent susceptibility and/or qualitative identification of infectious agents.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
452226
Start Date
June 14, 2024
Effective Date
June 14, 2024
Manufacturer
Country
United States of America
Address
250 South Kraemer Boulevard, Brea, CA, 92821