Summary for ARTG Entry:
Bio-Rad Laboratories Pty Ltd - Immunohaematology sensitised cell-typing 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 sensitised cell-typing IVDs
CT888 Immunohaematology sensitised cell-typing IVDs
Immunoglobulins capable of binding to substances on the surface of sensitised red blood cells that are
intended to be used in immunohaematological testing to provide information about the nature of red blood
cell sensitisation, including immunoglobulin heavy chain class or complement protein type
No Specific Conditions included on Record
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