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Clinical chemistry autoimmune IVDs - ARTG 475935

Access comprehensive regulatory information for Clinical chemistry autoimmune IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 475935 and sponsored by Siemens Healthcare Pty Ltd, manufactured by Siemens Healthcare Diagnostics Inc in United States of America. The device registration started on January 16, 2025.

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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Class IIb
ARTG 475935
Class IIb
Clinical chemistry autoimmune IVDs
ARTG ID: 475935
Good Name: Siemens Healthcare Pty Ltd - Clinical chemistry autoimmune IVDs
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Intended Purpose

In vitro diagnostic use in the quantitative measurement of autoimmune biomarkers in a clinical specimen.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
475935
Start Date
January 16, 2025
Effective Date
January 16, 2025
Manufacturer
Country
United States of America
Address
511 Benedict Avenue, Tarrytown, NY, 10591