Summary for ARTG Entry:
Vela Diagnostics Australia Pty Ltd - Cytomegalovirus (Human herpesvirus 5) IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Vela Diagnostics Australia Pty Ltd
Level 9 Avaya House 123 Epping Road,NORTH RYDE, NSW, 2113
ARTG Start Date
Medical Device Class 3
- 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.
Vela Operations Singapore Pte Ltd
2-4/5/6 The Kendall 50 Science Park Road
Science Park II, , 117406
1. Cytomegalovirus (Human herpesvirus 5) IVDs
CT748 Cytomegalovirus (Human herpesvirus 5) IVDs
For in vitro diagnostic use in the detection and quantitation of Cytomegalovirus (Human herpesvirus 5).
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:24:44 AEDT
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