Summary for ARTG Entry:
Radiometer Pacific Pty Ltd - Haemoglobin IVDs
ARTG entry for
Medical Device Included - IVD Class 2
Radiometer Pacific Pty Ltd
PO Box 5134,MOUNT WAVERLEY, VIC, 3149
ARTG Start Date
Medical Device Class 2
- 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.
, Angelholm, 26271
1. Haemoglobin IVDs
CT880 Haemoglobin IVDs
HemoCue Haemoglobin Microcuvettes are to be used in conjunction with the specified HemoCue
Analyser. The two combined are an IVD intended for the quantitative determination of haemoglobin in a
No Specific Conditions included on Record
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Produced at 09.11.2017 at 08:53:34 AEDT
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