Epstein-Barr virus (Human herpesvirus 4) IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
19-10-2022
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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:
CT747 - Epstein-Barr virus (Human herpesvirus 4) IVDs
Therapeutic indications:
The Abbott EBV assay is an in vitro polymerase chain reaction (PCR) assay to quantitate Epstein-Barr Virus (EBV) DNA in human EDTA plasma. The assay is intended for use as an aid in the diagnosis and management of EBV in transplant patients and other immunocompromised patients.
Authorization status:
A
Authorization date:
2022-05-25
