Pure Global

PreciControl HBeAg quant - Hepatitis B virus e-antigen IVD, control - ARTG 440890

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 registered under ARTG number 440890 and 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class III
ARTG 440890
Class III
PreciControl HBeAg quant - Hepatitis B virus e-antigen IVD, control
ARTG ID: 440890
Good Name: Roche Diagnostics Australia Pty Limited - PreciControl HBeAg quant - Hepatitis B virus e-antigen IVD, control
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

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

Device Classification
Risk Class
Class III
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
440890
Start Date
February 13, 2024
Effective Date
February 13, 2024
Manufacturer
Country
Germany
Address
Sandhofer Strasse 116, Mannheim, D-68305