AM Diagnostics Pty Ltd

01/08/2022

27/01/2022

Warning to consumers please ensure that you are buying the real registered product not non compliant one

30/11/2021

AM Diagnostics would like announce that the All Test Nasal and Oral fluid antigen tests will detect the new Omicron(B.1.1.529) Variant of Covid-19

SARS-CoV-2 Antigen Rapid Test (COVID-19 Antigen Rapid Test) is designated to detect nucleocapsid protein (NP) of SARS-CoV-2 virus. Epitope of capture antibody and detection antibody was not in the mutation area. Thus, above mentioned spike protein mutation SARS-CoV-2 and nucleocapsid protein mutation SARS-CoV-2 of Alpha(B.1.1.7), Beta(B.1.351), Gamma(P.1), Delta(B.1.617.2), Lambda(C.37), Zeta(P.2), Kappa(B.1.617.1), Eta(B.1.525), Iota(B.1.526),
Epsilon(B.1.427), Theta(P.3) and Omicron(B.1.1.529) is not affecting virus performance of All Test SARS-CoV-2 Antigen Rapid Test (COVID-19 Antigen Rapid Test).

With the All Test COVID 19 Antigen Test rated as Very high sensitivity, along with detecting the Omicron Variant ,this demonstrates how market leading the All Test Antigen Self Tests are, in the fight against this Virus

https://www.tga.gov.au/covid-19-rapid-antigen-self-tests-are-approved-australia

Acceptable sensitivity - clinical sensitivity greater than 80% PPA
High sensitivity - clinical sensitivity greater than 90% PPA
Very high sensitivity - clinical sensitivity greater than 95% PPA

A list of self-tests that are approved in Australia

05/11/2021

Pallets and pallets of retail orders thank you team for being so amazing

13/10/2021

AM Diagnostics is pleased to announce that our My Covid Test Covid-19 Antigen Rapid Test ( Oral Fluid) has been included in the Australian Register of Therapeutic Goods (ARTG) from Today. You can find out more information by visiting www.amdiagnostics.com.au or www.Mycovidtest.com.au
Pre orders are now open, however due to government restrictions no Tests will be allowed to be shipped until the 1st November 2021

https://www.tga.gov.au/covid-19-test-kits-included-artg-legal-supply-australia

13/10/2021

AM Diagnostics is please to announce that our All Test SARS-CoV-19 Antigen Rapid Test ( Nasal Swab ) has been included in the Australian Register of Therapeutic Goods (ARTG) From Today and that you can find out more information by visiting www.amdiagnostics.com.au or www.Mycovidtest.com.au Pre orders are now open however due to government restrictions no Tests will be allowed to be shipped until the 1st November 2021

https://www.tga.gov.au/covid-19-test-kits-included-artg-legal-supply-australia

13/10/2021

AM Diagnostics is please to announce that our All Test Covid-19 Antigen Rapid Test ( Oral Fluid) has been included in the Australian Register of Therapeutic Goods (ARTG) From Today and that you can find out more information by visiting www.amdiagnostics.com.au or www.Mycovidtest.com.au Pre orders are now open however due to government restrictions no Tests will be allowed to be shipped until the 1st November 2021

30/06/2021

AM Diagnostics is please to update that our two new ISO 7 dry rooms are now completed and fully NATA approved with this our new manufacturing equipment starting to arrive, AM Diagnostics will start the batch runs to bring our medical device manufacturing back to Australia

31/08/2020

Welcome to the new home of AM Diagnostics

04/04/2020

23/03/2020

23/03/2020

We officially got our TGA approval for our COVID-19 test for professional use only!!
This is a 10 minute blood test. We are currently working tirelessly to get them out ASAP!!

22/03/2020

New COVID-19 Rapid Test now available here in Australia for the Public Health Network.

RESULTS IN 10 MINUTES

For further information please visit our web site www.amdiagnostics.com.au/covid

On 20th March 2020 the Therapeutic Goods Administration made an announcement that follows

Exemption allows for immediate supply of COVID-19 tests

The Australian regulatory framework for medical devices allows National Association of Testing Authorities (NATA) accredited laboratories to develop and use their own laboratory developed tests (referred to as 'in-house' IVDs), without requiring those tests to be included in the Australian Register for Therapeutic Goods (ARTG). This has enabled Australian laboratories to immediately develop COVID-19 tests based on internationally available COVID-19 genomic information and to commence testing.

To support a rapid COVID-19 response, tests used to test for COVID-19 (COVID-19 tests) will be exempt from particular requirements of the Therapeutic Goods Act 1989. This emergency exemption allows commercial suppliers of COVID-19 tests to immediately supply their tests to laboratories within the Australian Public Health Laboratory Network (PHLN). Because the PHLN is well integrated in state and territory public health systems, this will help facilitate reporting, recording and tracing of the spread of COVID-19 infections.

Please note the exemption does not allow for general supply of rapid tests, including serological rapid tests intended for use at the point of care, other than to the laboratories specified in the exemption.

https://www.tga.gov.au/media-release/supplying-covid-19-tests

Due to this AM Diagnostics is please to announce that immediately we now have these test available for the PHLN network across Australia

Information for sponsors regarding the supply of COVID-19 tests

17/12/2015

AM Diagnostics is please to announce that our fertility range of tests have now been approved by TGA and now ready for market

28/11/2014

New Synthetic Cannabis Tests are now available in Urine and Saliva

11/06/2014

Safety and Action