Australia TGA ARTG record

PreciControl HBeAg quant - Hepatitis B virus e-antigen IVD, control

Australia TGA ARTG Registered Device · Roche Diagnostics Australia Pty Limited · Roche Diagnostics GmbH · Class III · Started February 13, 2024

Good Name: Roche Diagnostics Australia Pty Limited - PreciControl HBeAg quant - Hepatitis B virus e-antigen IVD, control

Device classification

Risk Class: Class III
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: February 13, 2024
Effective Date: February 13, 2024

Sponsor

Name: Roche Diagnostics Australia Pty Limited

Manufacturer

Name: Roche Diagnostics GmbH
Country: Germany
Address: Sandhofer Strasse 116, Mannheim, D-68305

Intended purpose

PreciControl HBeAg quant is used for quality control of the Elecsys HBeAg quant immunoassay on cobas e immunoassay analysers.

About this record

Access comprehensive regulatory information for PreciControl HBeAg quant - Hepatitis B virus e-antigen IVD, control in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Roche Diagnostics GmbH in Germany. The device registration started on February 13, 2024.

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.