Pure Global

Multiple-viruses IVDs - ARTG 455706

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
ARTG 455706
Class IIb
Multiple-viruses IVDs
ARTG ID: 455706
Good Name: BIO TOP Pty Ltd - Multiple-viruses IVDs
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

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
Manufacturer
Country
China
Address
Room 201 Building 1 No 37-3 Futang Road Tangqi Town Linping District, Hangzhou City, Zhejiang Province