November-2017 New Company Office and Production Site
We are glad to inform you that AusDiagnostics has moved to a more spacious and well designed site. We sure it will help us to deliver better quality and service for our products.
October-2017 CRE panel has been released for IVD in Australia and Europe Union
A panel detecting a broad range of Carbapenem-resistance genes of Enterobacteriaceae passed through extensive validation studies and was released for IVD use.
September-2017 The new version of processor is ready
Customers of the new MARK3 processor will benefit from an embedded computer, simpler service and further design improvements.
May-2017 CSF Products IVD listed
The main products intended for pathogen detection in CSF are now listed as IVD in Australia and EU. See more in the advisory notice.
January-2017 New round of ASEP Programme in Australia and NZ
AusDiagnostics is about to start the next 2017 round of sample exchange programme (ASEP) for its Australian and New Zealand customers. See more details in the letter attached.
December-2016 New sections on the website: Regulatory & Careers
We have added a 'Regulatory' section with the list of advisory notices and relevant regulatory documents. The new 'Career' section has a list of current vacancies and a job application form.
November-2016 ISO 13485 Certified & 98/79/EC IVDD Certified
We are proud to announce that AusDiagnostics Pty Ltd was certified in accordance with standard ISO13485:2012 Medical Devices - Quality Management System and Directive 98/79/EC on In Vitro Diagnostic Medical Devices.
August-2016 Parechovirus assay and Faecal Bacteria and Parasites product were listed as IVD
See more in product change notification letters for Parechovirus assay and Faecal Bacteria and Parasite panel.
August-2016 Company launches new IFUs and Product Labels
More intuitive, detailed and harmonised with international requirements instructions for use (IFU) and products labels were implemented. See more.
May-2016 CSF testing in less than 2 hours, New Legionella Assays in panels and advanced new software features
Read more in our latest Company Newsletter Feb-May 2016.
March-2016 New AusDiagnostics Website launched!
New diagnostics platforms, updated product information, more detailed descriptions along with modern design and convenient navigation. Welcome to our new website! Your feedback is very welcome. Learn here how to place an order on the new website.
March-2016 Updated Herpes, Adenovirus, Enterovirus Panel released
With updated thermocycling conditions and chemistry, a new version of HAE panel delivers more sensitivity for enterovirus detection.
March-2016 AusDiagnostics participated in Molecular Microbiology Meeting 2016
We have launched the Ultra-Plex processor, which is capable of performing up to 48 samples per run.
2015 DNA test identifies sheep worm species
Australian veterinary specialists have valued our sheep worm assay, praising its speed, robustness, and additional information for the vet. See more.
ISO 13485 & 98/79/EC IVDD Certified