Haematology full blood count IVDs

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Mindray Medical Australia Pty Ltd

Klasse:

Class 2

Fremstillet af:

Shenzhen Mindray Bio Medical Electronics Co Ltd Mindray Building Keji 12th Road South Hi-Tech Industrial Park, Nanshan District, Shenzhen Guangdong, 518057 China

Terapeutisk område:

CT878 - Haematology full blood count IVDs

Terapeutiske indikationer:

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters[also known as complete blood count(CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.

Autorisation status:

A

Autorisation dato:

2013-11-21