Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Genesis Biotech Pty Ltd - Clinical Chemistry IVDs
ARTG entry for
Medical Device Included - IVD (Export Only) Class 1
Genesis Biotech Pty Ltd
PO Box 4449,Forest Lake, QLD, 4078
ARTG Start Date
Medical Device Class 1
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Taidoc Technology Corporation
3F & 5F no 127 Wugong 2nd Road Wugu
, Taipei County,
Taiwan (Province of China)
1. Clinical Chemistry IVDs
CT287 Clinical Chemistry IVDs
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.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 07:34:53 AEDT
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