Summary for ARTG Entry:
Bio-Rad Laboratories Pty Ltd - Immunohaematology calibrator/control IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Bio-Rad Laboratories Pty Ltd
PO Box 752,GLADESVILLE, NSW, 1675
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.
Pra Rond 23
Cressier, FR, 1785
1. Immunohaematology calibrator/control IVDs
CT890 Immunohaematology calibrator/control IVDs
IVDs that are intended to be used as quality controls in testing to provide information of reference and/or
verify the perfomance of immunohaematological tests.
No Specific Conditions included on Record
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