Clinical chemistry substrate IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
11-10-2017
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Available from:
Roche Diagnostics Australia Pty Limited
Class:
Class 2
Manufactured by:
Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany
Therapeutic area:
CT833 - Clinical chemistry substrate IVDs
Therapeutic indications:
Products used for the qualitative/quantitative determination of clinical chemistry substrates in biological samples, including use at the point of care setting as well as for patient self-testing.
Authorization status:
A
Authorization date:
2012-10-12
