Troponin IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
10-11-2017
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Available from:
Beckman Coulter Australia Pty Ltd
Class:
Class 3
Manufactured by:
Beckman Coulter Inc 250 South Kraemer Boulevard, Brea, CA, 92821 United States Of America
Therapeutic area:
CT1242 - Troponin IVDs
Therapeutic indications:
The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the highly sensitive quantitative determination of cardiac troponin I levels in human serum and plasma using the Access 2 and UniCel DxI Immunoassay System to aid in the diagnosis of myocardial infarction.
Authorization status:
A
Authorization date:
2013-11-19
