Australia TGA ARTG record

Bacterial infectious disease IVDs

Australia TGA ARTG Registered Device · VITRYL AUS PTY LTD · Qingdao Hightop Biotech Co Ltd · Class IIa · Started April 28, 2023

Good Name: VITRYL AUS PTY LTD - Bacterial infectious disease IVDs

Device classification

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

Registration information

Start Date: April 28, 2023
Effective Date: April 28, 2023

Sponsor

Name: VITRYL AUS PTY LTD

Manufacturer

Name: Qingdao Hightop Biotech Co Ltd
Country: China
Address: No 369 Hedong Road Hi-tech Industrial Development Zone, Qingdao City, Shandong Province, 266112

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.

About this record

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 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.