Acquired genetic alteration IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
04-11-2017
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Available from:
Elitechgroup Australia Pty Ltd
Class:
Class 3
Manufactured by:
ELITechGroup SpA Corso Svizzera 185, Torino, 10149 Italy
Therapeutic area:
CT929 - Acquired genetic alteration IVDs
Therapeutic indications:
In vitro diagnostic test kits intended for the detection and/or monitoring for minimal residual disease follow-up of leukemia patients based on the quantification of oncogene transcripts using nucleic acids extracted from human samples.
Authorization status:
A
Authorization date:
2016-08-02
