ARTG 408221Bacterial infectious disease IVDs
ARTG ID: 408221 · 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
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 408221
- Start Date
- April 28, 2023
- Effective Date
- April 28, 2023
- Country
- China
- Address
- No 369 Hedong Road Hi-tech Industrial Development Zone, Qingdao City, Shandong Province, 266112
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.
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.