Severe acute respiratory syndrome-associated coronavirus IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
17-01-2022
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Available from:
Pale Blue Medical Trading Pty Ltd
Class:
Class 3
Manufactured by:
Jiangsu Medomics Medical Technology Co Ltd F3 Building C No 3-1 Xinjinhu Road, Jiangbei new area, Nanjing Jiangsu, 210030 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 from symptomatic individuals at the point of care by trained health professionals (anterior nasal, nasopharyngeal and throat samples) and for self-testing by lay persons (nasal swab).
Authorization status:
A
Authorization date:
2021-12-13
