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Interpretive software IVDs

Access comprehensive regulatory information for Interpretive software IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Beckman Coulter Australia Pty Ltd, manufactured by Beckman Coulter Inc in United States of America. The device registration started on June 06, 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
Class IIb
Interpretive software IVDs
Australia TGA ARTG Registered Device
Good Name: Beckman Coulter Australia Pty Ltd - Interpretive software IVDs
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Intended Purpose

In vitro diagnostic software devices intended for microbial identification and antimicrobial agent susceptibility testing

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
June 06, 2024
Effective Date
June 06, 2024
Manufacturer
Country
United States of America
Address
250 South Kraemer Boulevard, Brea, CA, 92821