Haemoximetry and blood gas IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
20-10-2017
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Available from:
Werfen Australia Pty Ltd
Class:
Class 2
Manufactured by:
Instrumentation Laboratory 180 Hartwell Road, Bedford, MA, 01730-2443 United States Of America
Therapeutic area:
CT806 - Haemoximetry and blood gas IVDs
Therapeutic indications:
IVDs that are intended to be used for the qualitative and/or quantitative determination of blood gas analytes, calculated blood gas parameters and haemoglobin complexes using gas permeable membranes and co-oximetery, in a clinical specimen.
Authorization status:
A
Authorization date:
2013-05-29
