Severe acute respiratory syndrome-associated coronavirus IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
23-10-2020
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Available from:
DiaSorin Australia Pty Ltd
Class:
Class 3
Manufactured by:
DiaSorin Molecular LLC 11331 Valley View Street, Cypress, CA, 90630 United States Of America
Therapeutic area:
CT772 - Severe acute respiratory syndrome-associated coronavirus IVDs
Therapeutic indications:
IVDs intended for the in vitro qualitative detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viral RNA.
Authorization status:
A
Authorization date:
2020-08-04
