Mega menu

Home
Product regulation
Product regulation

Understand your obligations and access industry Guidance and other information about the products we regulate.
Safety and shortages
Safety and shortages

Access information about product recalls, shortages and other alerts, and learn how we manage safety.
Resources and guidance
Resources and guidance

Get information to help you understand our work, regulations and industry obligations.
Business services
Business services

Access our systems to submit applications, manage forms, make payments and communicate securely.

Roche Diagnostics Australia Pty Limited

Regulatory activities for this sponsor.

- LinkedIn
- (Twitter)
- Facebook
- Email

Loading...

Type

ARTG (194)
Cancellation by sponsor (50)
COVID-19 test kit (5)

Date

2026 (5)
2025 (11)
2024 (27)
2023 (23)
2022 (16)
2021 (8)
2020 (21)
2019 (11)
2018 (38)
2017 (19)
2016 (4)
2015 (5)
2014 (7)
2013 (11)
2012 (15)
2011 (10)
2010 (18)

Search

Sponsor content

249 result(s) found, displaying 11 to 20

Roche Diagnostics Australia Pty Limited - Clinical chemistry-specific protein IVDs (491226)

10 June 2025

ARTG

Australian Register of Therapeutic Goods (ARTG) information for Roche Diagnostics Australia Pty Limited - Clinical chemistry-specific protein IVDs.
Roche Diagnostics Australia Pty Limited - VENTANA CLDN18 (43-14A) RxDx Assay - Immunohistology cell marker IVDs (484807)

31 March 2025

ARTG

Australian Register of Therapeutic Goods (ARTG) information for Roche Diagnostics Australia Pty Limited - VENTANA CLDN18 (43-14A) RxDx Assay - Immunohistology cell marker IVDs.
Roche Diagnostics Australia Pty Limited - General laboratoryware IVDs Cancelled under Section 41GL(d) of the Act

17 June 2025

Cancellation by sponsor

Requested by Roche Diagnostics Australia Pty Limited
Roche Diagnostics Australia Pty Limited - Immunohistology cell marker IVDs Cancelled under Section 41GL(d) of the Act

17 June 2025

Cancellation by sponsor

Requested by Roche Diagnostics Australia Pty Limited
Roche Diagnostics Australia Pty Limited - cobas® NHP Negative Control Kit. - PCR/NAT negative control IVD Cancelled under Section 41GL(d) of the Act

17 June 2025

Cancellation by sponsor

Requested by Roche Diagnostics Australia Pty Limited
Roche Diagnostics Australia Pty Limited - Dried blood spot collection kit (474588)

23 December 2024

ARTG

Australian Register of Therapeutic Goods (ARTG) information for Roche Diagnostics Australia Pty Limited - Dried blood spot collection kit.
Roche Diagnostics Australia Pty Limited - cobas® MPX. - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Cancelled under Section 41GL(d) of the Act

24 February 2025

Cancellation by sponsor

Requested by Roche Diagnostics Australia Pty Limited
Roche Diagnostics Australia Pty Limited - Software IVDs (447765)

6 May 2024

ARTG

Australian Register of Therapeutic Goods (ARTG) information for Roche Diagnostics Australia Pty Limited - Software IVDs.
Roche Diagnostics Australia Pty Limited - Software IVDs (447766)

6 May 2024

ARTG

Australian Register of Therapeutic Goods (ARTG) information for Roche Diagnostics Australia Pty Limited - Software IVDs.
Roche Diagnostics Australia Pty Limited - Software IVDs (447632)

2 May 2024

ARTG

Australian Register of Therapeutic Goods (ARTG) information for Roche Diagnostics Australia Pty Limited - Software IVDs.

Pages

First page
Previous page
Page 1
Current page 2
Page 3
Page 4
Page 5
Page 6
Page 7
Page 8
Page 9
…
Next page
Last page

Using our website

Accessibility
Privacy
Security
Disclaimer
Copyright
Freedom of information
Acronyms and glossary terms

Quick links

Search our databases
Report a problem or side effect
TGA Business Services
Special Access Scheme
Authorised Prescriber
Office of Drug Control
State and territory contacts

Connect with us

Email subscriptions
Contact us
Facebook
(formerly Twitter)
Youtube
Instagram
LinkedIn

Help us improve

We are always looking for ways to improve our website.

Provide feedback

The Department of Health, Disability and Ageing acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.