Acquired genetic alteration IVDs

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Saadav alates:

Sysmex Australia Pty Ltd

Klass:

Class 3

Valmistatud:

Cytocell Ltd 418 Cambridge Science Park Milton Road, Oxford Gene Technology, Cambridge, CB4 0PZ United Kingdom

Terapeutiline ala:

CT929 - Acquired genetic alteration IVDs

Näidustused:

IVDs that are intended to be used in genetic testing to provide information about acquired genetic alterations, which may include chromosomal alterations, mutations and/or alterations in gene expression, and which may be used to characterise haematological or solid tumour malignancies and/or provide prognostic information. These products are intended for use as an adjunct to classic cytogenetics and not as independent tests or assays.

Volitamisolek:

A

Loa andmise kuupäev:

2014-07-21