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Severe acute respiratory syndrome-associated coronavirus IVDs - ARTG 374065

Access comprehensive regulatory information for Severe acute respiratory syndrome-associated coronavirus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 374065 and sponsored by Cole Supplies Pty Ltd, manufactured by Guangzhou Decheng Biotechnology Co Ltd in China. The device registration started on September 02, 2021.

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 374065
Class IIb
Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 374065
Good Name: Cole Supplies Pty Ltd- Severe acute respiratory syndrome-associated coronavirus IVDs
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DJ Fang

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Intended Purpose

Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 from symptomatic individuals at the point of care by trained health professionals (saliva samples) and for self-testing by lay persons (saliva samples)

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
374065
Start Date
September 02, 2021
Effective Date
September 11, 2024
Manufacturer
Country
China
Address
Room 405 Room 218 Room 212 and Room 107 Building 2 No 68 Nanxiang 1st Road, Science City, Huangpu District Guangzhou, Guangdong, 510663