Severe acute respiratory syndrome-associated coronavirus IVDs

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Avaliku hindamisaruande Avaliku hindamisaruande (PAR)
19-04-2022

Saadav alates:

MD Solutions Australasia Pty Ltd

Klass:

Class 3

Valmistatud:

Philosys Co Ltd 28-5 Gwangwol-gil Okgu-Eup, Gunsan-si, Jeollabuk-do, 54172 Korea - Republic of

Terapeutiline ala:

CT772 - Severe acute respiratory syndrome-associated coronavirus IVDs

Näidustused:

Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, for self-testing by lay persons (saliva).

Volitamisolek:

A

Loa andmise kuupäev:

2022-02-10