Summary for ARTG Entry:
Diagnostic Solutions Pty Ltd - Multiple human leukocyte antigen (HLA) antibodies IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Diagnostic Solutions Pty Ltd
PO Box 248,FAIRFIELD, VIC, 3078
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.
Immucor GTI Diagnostics Inc
20925 Crossroads Circle
Waukesha, WI, 53186
United States Of America
1. Multiple human leukocyte antigen (HLA) antibodies IVDs
CT1038 Multiple human leukocyte antigen (HLA) antibodies IVDs
Immucor Transplant IVD kits and reagents are IVDs intended to provide tissue typing information about
antibodies directed against human leukocyte antigens (HLA) from multiple loci.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:43:34 AEDT
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