Severe acute respiratory syndrome-associated coronavirus IVDs

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

ProcureNet APAC Pty Ltd

Class:

Class 3

Manufactured by:

Hangzhou Sejoy Electronics & Instruments Co Ltd Area C Building 2 No 365 Wuzhou Road Yuhang Economic Development Zone, Hangzhou City, Zhejiang, 311100 China

Therapeutic area:

CT772 - Severe acute respiratory syndrome-associated coronavirus IVDs

Therapeutic indications:

The Medriva COVID-19 Rapid Antigen Self-test is a single-use test kit which uses a self-collected nasal swab specimen and is intended to detect SARS-CoV-2 that causes COVID-19. SARS-CoV-2 antigen testing is typically used in the acute phase of infection, with samples tested within the first 7 days of symptom onset when the antigen is generally detectable in the upper respiratory tract. The Medriva Self-test is intended to be used by lay users as a self-test in the home and workplace (in offices, airports, schools, for sporting events, etc.).

Authorization status:

A

Authorization date:

2023-01-24