Summary for ARTG Entry:
Biospecifix Pty Ltd - Haemoglobin IVDs
ARTG entry for
Medical Device Included - IVD Class 2
Biospecifix Pty Ltd
79 Peter Street,BOX HILL NORTH, VIC, 3129
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.
IQ Products BV
, DL Groningen, 9727
1. Haemoglobin IVDs
CT880 Haemoglobin IVDs
IQ Products manufactures a kit called the Fetal Cell Count Kit which is used to measure HbF levels. It is a
class 2 IVD GMND Code CT880 - IVD that are intended to for quantitative determination of Haemoglobin
and the various subtypes of Haemoglobin in a clinical specimen
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:54:14 AEDT
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