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Troponin IVDs

Access comprehensive regulatory information for Troponin IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Siemens Healthcare Pty Ltd, manufactured by Sero AS in Norway. The device registration started on December 13, 2021.

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
Troponin IVDs
Australia TGA ARTG Registered Device
Good Name: Siemens Healthcare Pty Ltd - Troponin IVDs
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Intended Purpose

The QC material is intended to be used as a quality control material for the Siemens Atellica VTLi system for cardiac Troponin I.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
December 13, 2021
Effective Date
December 13, 2021
Manufacturer
Country
Norway
Address
Stasjonsveien 44, Billingstad, N-1396