Severe acute respiratory syndrome-associated coronavirus IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
19-04-2022
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Available from:
ProcureNet APAC Pty Ltd
Class:
Class 3
Manufactured by:
Hangzhou Testsea Biotechnology Co Ltd 3rd Floor Building 6 North No 8-2 Keji Avenue Yuhang District, Hangzhou, Zhejiang Province, 311121 China
Therapeutic area:
CT772 - Severe acute respiratory syndrome-associated coronavirus IVDs
Therapeutic indications:
Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, for self-testing by lay persons (anterior nasal swabs).
Authorization status:
A
Authorization date:
2022-02-10
