Severe acute respiratory syndrome-associated coronavirus IVDs

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Saadav alates:

Pale Blue Medical Trading Pty Ltd

Klass:

Class 3

Valmistatud:

Jiangsu Medomics Medical Technology Co Ltd F3 Building C No 3-1 Xinjinhu Road, Jiangbei new area, Nanjing Jiangsu, 210030 China

Terapeutiline ala:

CT772 - Severe acute respiratory syndrome-associated coronavirus IVDs

Näidustused:

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).

Volitamisolek:

A

Loa andmise kuupäev:

2021-12-13