Interpretive software IVDs

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
03-11-2017

Dostopno od:

Roche Diagnostics Australia Pty Limited

Razred:

Class 3

Izdeluje:

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

Terapevtsko območje:

CT910 - Interpretive software IVDs

Terapevtske indikacije:

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.

Status dovoljenje:

A

Datum dovoljenje:

2017-06-06

Opozorila o iskanju, povezana s tem izdelkom