Clinical Chemistry IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
02-11-2017
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Available from:
Genesis Biotech Pty Ltd
Class:
Class 1
Manufactured by:
Taidoc Technology Corporation 3F & 5F no 127 Wugong 2nd Road Wugu Township, Taipei County Taiwan
Therapeutic area:
CT287 - Clinical Chemistry IVDs
Therapeutic indications:
Pregnancy Test for the qualitative determination of human chorionic gonadotropin (hCG) in urine. They are intended for use as an aid in the early detection of pregnancy for self-testing. Ovulation Test for the qualitative determination of luteinising hormone (LH) in urine. They are intended for use as an aid in the early detection of ovulation for self-testing.
Authorization status:
A
Authorization date:
2017-08-14
