Interpretive software IVDs

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Kauptu það núna

Opinber matsskýrsla Opinber matsskýrsla (PAR)
03-11-2017

Fáanlegur frá:

Roche Diagnostics Australia Pty Limited

Tegund:

Class 3

Framleitt af:

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

Lækningarsvæði:

CT910 - Interpretive software IVDs

Ábendingar:

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.

Leyfisstaða:

A

Leyfisdagur:

2017-06-06

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