Inborn/inherited genetic disorder IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
12-11-2017
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Available from:
Abacus dx Pty Ltd
Class:
Class 3
Manufactured by:
Asuragen Inc 2150 Woodward Street, Austin, Texas, 78744-1840 United States Of America
Therapeutic area:
CT903 - Inborn/inherited genetic disorder IVDs
Therapeutic indications:
IVDs used as an aid in the screening of carriers for, and diagnosis of, inherited genetic disorders which includes but is not limited to sex-linked disorders and autosomal recessive/dominant disorders.
Authorization status:
A
Authorization date:
2012-10-09
