Summary for ARTG Entry:
Becton Dickinson Pty Ltd - Instrument/analyser IVDs
ARTG entry for
Medical Device Included - IVD (Export Only) Class 1
Becton Dickinson Pty Ltd
Locked Bag 3200,NORTH RYDE, NSW, 2113
ARTG Start Date
Medical Device Class 1
- 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.
Becton Dickinson and Company
2350 Qume Drive
San Jose, California, 95131
United States Of America
1. Instrument/analyser IVDs
CT943 Instrument/analyser IVDs
The BD FACSPresto Near-Patient CD4 Counter is an automated system for in vitro diagnostic use in
performing the direct enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and
hemoglobin concentration in human whole blood.
No Specific Conditions included on Record
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Produced at 09.11.2017 at 11:08:04 AEDT
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