Clinical chemistry hormone IVDs - Clinical chemistry hormone IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
01-12-2017
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Available from:
KD & A Pty Ltd
Class:
Class 2
Manufactured by:
SPD Swiss Precision Diagnostics GmbH 47 Route de Saint-Georges, Petit Lancy, Geneva, 1213 Switzerland
Therapeutic area:
CT850 - Clinical chemistry hormone IVDs
Therapeutic indications:
In vitro diagnostic tests for home use. Pregnancy tests intended for the detection of human Chorionic Gonadotrophin (hCG) in urine. Ovulation tests intended for the detection of an increase (surge) in Luteinising Hormone (LH), or in LH and estrogen in urine.
Authorization status:
A
Authorization date:
2013-12-13
