Haematology calibrator/control IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
05-11-2017
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Available from:
Abacus dx Pty Ltd
Class:
Class 2
Manufactured by:
R & D Systems Inc 614 Mckinley Place, NE MINNEAPOLIS, Minnesota, 55413 United States Of America
Therapeutic area:
CT879 - Haematology calibrator/control IVDs
Therapeutic indications:
FETALtrol is an assayed, stabilized 3 level control set designed to validate and monitor the quality of procedures of Fetal Maternal Haemorrhage (FMH) testing. FETALtrol is compatible as a control for both manual (Kleihauer Bettke Methods) and flow cytometry methods
Authorization status:
A
Authorization date:
2015-12-11
