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Multiple-viruses IVDs - ARTG 414738

Access comprehensive regulatory information for Multiple-viruses IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 414738 and sponsored by Australia Health Products Central Pty Ltd, manufactured by Hangzhou Fanttest Biotech Co Ltd in China. The device registration started on July 27, 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 IIb
ARTG 414738
Class IIb
Multiple-viruses IVDs
ARTG ID: 414738
Good Name: Australia Health Products Central Pty Ltd - Multiple-viruses IVDs
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Intended Purpose

Intended to detect influenza A/B and the novel coronavirus SARS-CoV-2 by lateral flow immunoassay from symptomatic individuals for self-testing by lay person (nasal swab).

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
414738
Start Date
July 27, 2023
Effective Date
September 11, 2024
Manufacturer
Country
China
Address
Room 201 Building 1 No 37-3 Futang Road Tangqi Town Linping District, Hangzhou City, Zhejiang Province