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Bacterial infectious disease IVDs

Access comprehensive regulatory information for Bacterial infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by National Serology Reference Laboratory, manufactured by DiaMex GmbH in Germany. The device registration started on August 13, 2018.

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
Class IIa
Bacterial infectious disease IVDs
Australia TGA ARTG Registered Device
Good Name: National Serology Reference Laboratory - Bacterial infectious disease IVDs
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Intended Purpose

Non assay-specific infectious disease quality control material intended for use with IVDs that detect bacterial DNA/RNA, antigens or antibodies to bacterial infectious organisms in human plasma, serum samples or other samples of human origin

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
August 13, 2018
Effective Date
August 13, 2018
Manufacturer
Country
Germany
Address
Siemenstrasse 38, Heidelberg, 69123