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Bacterial infectious disease IVDs - ARTG 408221

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 registered under ARTG number 408221 and sponsored by VITRYL AUS PTY LTD, manufactured by Qingdao Hightop Biotech Co Ltd in China. The device registration started on April 28, 2023.

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 408221
Class IIa
Bacterial infectious disease IVDs
ARTG ID: 408221
Good Name: VITRYL AUS PTY LTD - Bacterial infectious disease IVDs
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DJ Fang

DJ Fang

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Intended Purpose

The H. pylori antibody rapid test is a rapid chromatographic immunoassay for the qualitative detection of HP IgG antibody in serum plasma/whole blood, as an indicator of potential current infection or of previous infection with H. pylori. The test is intended for used by health care professionals.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
408221
Start Date
April 28, 2023
Effective Date
April 28, 2023
Manufacturer
Country
China
Address
No 369 Hedong Road Hi-tech Industrial Development Zone, Qingdao City, Shandong Province, 266112