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 software is a reader control and data reduction software for analyzing data generated from
microplates using a Tecan absorbance, fluorescence, luminescence and/or AlphaScreen/ AlphaLISA
microplate reader. The software is intended for professional use for endpoint, kinetic, multilabel,
fluorescence lifetime, and spectral scanning assays. It cannot be used for agglutination assays. Together
with a Tecan Sunrise or Infinite F50 reader, the software is also intended for in-vitro diagnostic use.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:28:46 AEDT
This is not an ARTG Certificate document.
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