Australia TGA ARTG record

Multiple-viruses IVDs

Australia TGA ARTG Registered Device · BIO TOP Pty Ltd · Hangzhou Fanttest Biotech Co Ltd · Class IIb · Started January 15, 2024

Good Name: BIO TOP Pty Ltd - Multiple-viruses IVDs

Device classification

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

Registration information

Start Date: January 15, 2024
Effective Date: January 16, 2024

Sponsor

Name: BIO TOP Pty Ltd

Manufacturer

Name: Hangzhou Fanttest Biotech Co Ltd
Country: China
Address: Room 201 Building 1 No 37-3 Futang Road Tangqi Town Linping District, Hangzhou City, Zhejiang Province

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).

About this record

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 sponsored by BIO TOP Pty Ltd, manufactured by Hangzhou Fanttest Biotech Co Ltd in China. The device registration started on January 15, 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.