Pure Global

Influenza virus IVDs - ARTG 462123

Access comprehensive regulatory information for Influenza virus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 462123 and sponsored by Aceso Diagnostics Pty Ltd, manufactured by Hangzhou Alltest Biotech Co Ltd in China. The device registration started on September 10, 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 IIb
ARTG 462123
Class IIb
Influenza virus IVDs
ARTG ID: 462123
Good Name: Aceso Diagnostics Pty Ltd - Influenza virus IVDs
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The Influenza A+B Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of influenza A and B antigens in human nasal swab and nasopharyngeal swab specimens. For near-patient and laboratory professional in vitro diagnostic use only.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
462123
Start Date
September 10, 2024
Effective Date
September 10, 2024
Manufacturer
Country
China
Address
550# Yinhai Street Hangzhou Economic & Technological Development Area, Hangzhou, 310018