Red and white cell metabolic enzyme and haemolysis 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:
Mindray Medical Australia Pty Ltd
Class:
Class 2
Manufactured by:
Shenzhen Mindray Bio Medical Electronics Co Ltd Mindray Building Keji 12th Road South Hi-Tech Industrial Park, Nanshan District, Shenzhen Guangdong, 518057 China
Therapeutic area:
CT881 - Red and white cell metabolic enzyme and haemolysis IVDs
Therapeutic indications:
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for quantitative determination of G6PD in human erythrocytes on photometric systems.
Authorization status:
A
Authorization date:
2013-11-21
