Severe acute respiratory syndrome-associated coronavirus IVDs

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Prenos Javno poročilo o oceni (PAR)
19-04-2022

Dostopno od:

MD Solutions Australasia Pty Ltd

Razred:

Class 3

Izdeluje:

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

Terapevtsko območje:

CT772 - Severe acute respiratory syndrome-associated coronavirus IVDs

Terapevtske indikacije:

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

Status dovoljenje:

A

Datum dovoljenje:

2022-02-10

Opozorila o iskanju, povezana s tem izdelkom