Multiple-viruses IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
19-04-2022
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Available from:
Abbott Australasia Pty Ltd Molecular Division
Class:
Class 3
Manufactured by:
Abbott Molecular Inc 1300 East Touhy Avenue, Des Plaines, Illinois, 60018 United States Of America
Therapeutic area:
CT702 - Multiple-viruses IVDs
Therapeutic indications:
The Abbott Resp-4-Plex assay is a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection.
Authorization status:
A
Authorization date:
2022-04-01
