Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Instrument/analyser IVDs
ARTG entry for
Medical Device Included - IVD Class 1
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
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.
Tecan Austria GmbH
, Grodig, A-5082
1. Instrument/analyser IVDs
CT943 Instrument/analyser IVDs
The instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density)
of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples
from the human body to obtain information on physiological and pathological states. For applications in
human medicine, only the Magellan Tracker software is intended for the use with the instrument. Software
and instrument have been validated for measurement and for the evaluation of qualitative and quantitative
Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and
instrument specifications; they are therefore intended for professional use in in-vitro diagnostics.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 05:00:29 AEDT
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