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Multiple-viruses IVDs - ARTG 399270

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 399270 and sponsored by Nationwide Asset Management Consolidated Pty Ltd, manufactured by Getein Biotech Inc in China. The device registration started on November 11, 2022.

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 399270
Class IIb
Multiple-viruses IVDs
ARTG ID: 399270
Good Name: Nationwide Asset Management Consolidated 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 at the point of care by trained health professionals (nasal swab) and for self-testing by lay persons (nasal swab).

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
399270
Start Date
November 11, 2022
Effective Date
September 11, 2024
Manufacturer
Country
China
Address
No 9 Bofu Road Luhe District, Nanjing, Jiangsu, 211505