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Multiple-viruses IVDs - ARTG 404854

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 404854 and sponsored by APAC Security Pty Ltd, manufactured by Hangzhou Clongene Biotech Co Ltd in China. The device registration started on February 14, 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 404854
Class IIb
Multiple-viruses IVDs
ARTG ID: 404854
Good Name: APAC Security Pty Ltd - Multiple-viruses IVDs
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Intended Purpose

Intended to detect Influenza A/B and the novel coronavirus SARS-CoV-2 from symptomatic individuals for self-testing by lay persons (nasal swab).

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
404854
Start Date
February 14, 2023
Effective Date
September 11, 2024
Manufacturer
Country
China
Address
No 1 Yichuang Road Yuhang Sub district, Yuhang District, Hangzhou, 311121