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Multiple infectious organism IVDs - ARTG 286043

Access comprehensive regulatory information for Multiple infectious organism IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 286043 and sponsored by National Serology Reference Laboratory, manufactured by DiaMex GmbH in Germany. The device registration started on February 22, 2017.

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 286043
Class IIa
Multiple infectious organism IVDs
ARTG ID: 286043
Good Name: National Serology Reference Laboratory - Multiple infectious organism IVDs
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Intended Purpose

Non assay-specific infectious disease quality control material intended for use with IVDs that detect antigens or antibodies for multiple infectious organisms in human plasma or serum samples.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
286043
Start Date
February 22, 2017
Effective Date
June 29, 2020
Manufacturer
Country
Germany
Address
Siemenstrasse 38, Heidelberg, 69123