Severe acute respiratory syndrome-associated coronavirus IVDs
Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
Avaliku hindamisaruande
(PAR)
23-10-2020
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Saada päring.
Saada päring.
Saadav alates:
Pantonic Pty Ltd
Klass:
Class 3
Valmistatud:
Access Bio Inc 65 Clyde Road, Somerset, NJ, 08873 United States Of America
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 (nasopharyngeal and nasal swabs) and for self-testing by lay persons (nasal swabs). This ARTG entry also includes IVD medical devices of the kind supplied for accredited laboratory use.
Volitamisolek:
A
Loa andmise kuupäev:
2020-08-27
