Pharmacogenetic IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
09-02-2020
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Available from:
Southern Cross Diagnostics Pty Ltd
Class:
Class 3
Manufactured by:
Delta Diagnostics UK Ltd t/a Elucigene Diagnostics Citylabs Nelson Street, Manchester, M13 9NQ United Kingdom
Therapeutic area:
CT918 - Pharmacogenetic IVDs
Therapeutic indications:
For the simultaneous in vitro qualitative detection of gene mutations in DNA to aid in the diagnosis of pharmacogenetic related toxicity in patients referred for drug therapy.
Authorization status:
A
Authorization date:
2020-02-06
