ARTG 376103Infectious disease IVDs
ARTG ID: 376103 · Acusal Pty Ltd · Anhui Deepblue Medical Technology Co Ltd · Class I · Started October 11, 2021
Good Name: Acusal Pty Ltd - Infectious disease IVDs
- Risk Class
- Class I
- Product Type
- IVD
- ARTG Category
- IVD-Export
- ARTG ID
- 376103
- Start Date
- October 11, 2021
- Effective Date
- October 11, 2021
- Name
- Acusal Pty Ltd
- Country
- China
- Address
- 4th Floor D-1 Zone Pearl Industrial Park 106 Innovation Avenue, High-Tech Development Zone, Hefei, Anhui, 230088
This is a self-test device for the in vitro qualitative detection of the antigen of SARS-CoV-2 in human saliva specimen. The novel coronaviruses belong to the Beta genus. COVID-19 is an acute respiratory infectious disease. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. This product is suitable for users over 10 years old. Users under 10 years old are advised to complete the self-test under the guidance and assistance of appropriate family members. However, please do not make a medical relevance decision without consulting with your doctor.
Access comprehensive regulatory information for Infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 376103 and sponsored by Acusal Pty Ltd, manufactured by Anhui Deepblue Medical Technology Co Ltd in China. The device registration started on October 11, 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.