ARTG 455706

Multiple-viruses IVDs

ARTG ID: 455706 · BIO TOP Pty Ltd · Hangzhou Fanttest Biotech Co Ltd · Class IIb · Started July 19, 2024

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

Device classification

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

Registration information

ARTG ID: 455706
Start Date: July 19, 2024
Effective Date: November 07, 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

Lateral flow immunoassay for the qualitative detection of SARS-CoV-2, respiratory syncytial (RSV), influenza A and influenza B viral nucleoprotein antigens in nasal swabs as an aid in diagnosis of symptomatic individuals. Intended for use at the point of care by trained health professionals and for self-testing by lay persons.

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 registered under ARTG number 455706 and sponsored by BIO TOP Pty Ltd, manufactured by Hangzhou Fanttest Biotech Co Ltd in China. The device registration started on July 19, 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.