ARTG 483771

Streptococcus IVDs

ARTG ID: 483771 · Aceso Diagnostics Pty Ltd · Hangzhou Alltest Biotech Co Ltd · Class IIb · Started March 24, 2025

Good Name: Aceso Diagnostics Pty Ltd - Streptococcus IVDs

Device classification

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

Registration information

ARTG ID: 483771
Start Date: March 24, 2025
Effective Date: March 24, 2025

Sponsor

Name: Aceso Diagnostics Pty Ltd

Manufacturer

Name: Hangzhou Alltest Biotech Co Ltd
Country: China
Address: 550# Yinhai Street Hangzhou Economic & Technological Development Area, Hangzhou, 310018

Intended purpose

The Strep A Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigens in throat swab specimens. For near-patient and laboratory professional in vitro diagnostic use only.

About this record

Access comprehensive regulatory information for Streptococcus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 483771 and sponsored by Aceso Diagnostics Pty Ltd, manufactured by Hangzhou Alltest Biotech Co Ltd in China. The device registration started on March 24, 2025.

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.