Interpretive software IVDs

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Avaliku hindamisaruande Avaliku hindamisaruande (PAR)
03-11-2017

Saadav alates:

Roche Diagnostics Australia Pty Limited

Klass:

Class 3

Valmistatud:

Roche Sequencing Solutions Inc 2821 Scott Boulevard, Santa Clara, California, 95050 United States Of America

Terapeutiline ala:

CT910 - Interpretive software IVDs

Näidustused:

An interpretative software algorithm intended to be applied to a clinical result or set of results obtained through testing in order to identify and/or formulate additional clinical information which may then be used to guide patient management.

Volitamisolek:

A

Loa andmise kuupäev:

2017-06-06

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