ARTG 433772Multiple-viruses IVDs
ARTG ID: 433772 · BIO TOP Pty Ltd · Hangzhou Fanttest Biotech Co Ltd · Class IIb · Started January 15, 2024
Good Name: BIO TOP Pty Ltd - Multiple-viruses IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 433772
- Start Date
- January 15, 2024
- Effective Date
- September 11, 2024
- Name
- BIO TOP Pty Ltd
- Country
- China
- Address
- Room 201 Building 1 No 37-3 Futang Road Tangqi Town Linping District, Hangzhou City, Zhejiang Province
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).
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 433772 and 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.