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Clinical chemistry autoimmune IVDs - ARTG 197247

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 IIa is registered under ARTG number 197247 and sponsored by Southern Cross Diagnostics Pty Ltd, manufactured by Orgentec Diagnostika GmbH in Germany. The device registration started on May 07, 2012.

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 IIa
ARTG 197247
Class IIa
Clinical chemistry autoimmune IVDs
ARTG ID: 197247
Good Name: Southern Cross Diagnostics Pty Ltd - Clinical chemistry autoimmune IVDs
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Intended Purpose

IVDs that are intended to be used for the qualitative and/or quantitative determination of autoimmune markers in a clinical specimen.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
197247
Start Date
May 07, 2012
Effective Date
May 07, 2012
Manufacturer
Country
Germany
Address
Carl-Zeiss-Strasse 49-51, Mainz, 55129