We have approved the following COVID-19 self-tests (home use tests) for supply in Australia from 1 November 2021.
Some, but not all manufacturers of approved rapid antigen tests (RATs) have extended the shelf-life of their products. We will update the table below as we receive further information on the extended shelf-life from the sponsor.
This information is provided for health services and distributors of these tests to verify whether we have accepted a shelf-life extension for that RAT, so they can contact their supplier to clarify the expiry date for their stock of RATs.
This information is not intended for users or the general public to determine the expiry date of their RAT. The list does not specify the expiry date for individual batches of RATs from that manufacturer.
Users are advised to not use a RAT after its expiry date (or use by date). You should contact the customer support number on the 'Instructions For Use' if you are unsure about using the test or its expiry date.
It is important to follow the instructions for the specific test you do. Instructions for each test are provided in the below table.
COVID-19 rapid antigen self-tests (for home use) provides more information on:
- where to buy rapid antigen self-tests, what to look for and how to use them correctly
- what to do if you are travelling overseas with a COVID-19 self-test
- reporting a problem or issue with a COVID-19 self-test
- how you can legally supply and advertise COVID-19 self-tests in Australia.
COVID-19 nucleic acid amplification self-tests (for home use) are also approved for supply in Australia. Nucleic acid amplification (NAA) tests detect the genetic material from the SARS-CoV-2 virus, rather than the spike protein detected by rapid antigen tests during active infection.
Our performance requirements for COVID-19 self-tests are internationally aligned with technical specifications published by the World Health Organisation (WHO) and the European Commission.
For rapid antigen tests, this includes a clinical sensitivity of at least 80% (for specimens collected within 7 days of symptom onset) and a clinical specificity of at least 98%.
COVID-19 self-tests (home use) approved by TGA
*Clicking on the name of the test will link to the instructions on how to use it.
Easy Read factsheets on how to do a rapid test have been published by the Department of Health:
PDF instructions on how to use the test are provided as a supplementary resource for the visually read tests listed below and do not meet disability access requirements.
| Name of self-test* and how to use the test | Sample type used | Australian sponsor (supplier) | Manufacturer | ARTG | Date approved | Shelf life |
|---|---|---|---|---|---|---|
|
(Combination Rapid antigen self-test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 524286 | 11 March 2026 | 24 Months |
|
CorePharma 5in1-IFU-1.0
[PDF, 511.8 KB]
(Combination Rapid antigen test) | Nasal swab | BIO TOP Pty Ltd | Hangzhou Clongene Biotech Co Ltd (China) | 473906 | 27 March 2026 | 24 months |
|
COVID-19 Antigen Rapid Test 524589
[PDF, 620.66 KB]
(Rapid antigen test) | Nasal swab | TLC Healthcare | Hangzhou Fanttest Biotech Co Ltd (China) | 524589 | 19 March 2026 | 24 Months |
|
Diagfest - COVID-19/RSV/ADV/Flu A&B Antigen Combo Rapid Test Kit
[PDF, 509.78 KB]
(Combination Rapid antigen self-test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 524286 | 11 March 2026 | 24 Months |
|
Fanttest - COVID-19/RSV/ADV/Flu A&B Antigen Combo Rapid Test Kit
[PDF, 510.62 KB]
(Combination Rapid antigen self-test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 524286 | 11 March 2026 | 24 Months |
|
Flu A/B+COVID-19/HMPV+RSV/Adeno Antigen Combo Test Cassette
[PDF, 8.49 MB]
(Combination Rapid antigen self-test) | Nasal swab | Sonictec Pty Ltd | Hangzhou Testsea Biotechnology Co Ltd (China) | 525693 | 17 April 2026 | 24 Months |
|
InnoScreen Flu A/B, RSV & COVID-19 Antigen Combo Test Device
[PDF, 1.39 MB]
(Combination Rapid antigen self-test) | Nasal swab | Innovation Scientific Pty Ltd | Innovation Scientific Pty Ltd (Australia) | 524723 | 20 March 2026 | 24 Months |
|
JusChek - COVID-19/FLU A+B/RSV/Adenovirus Antigen Rapid Test
[PDF, 401.86 KB]
(Combination Rapid antigen Self-test) | Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 524057 | 2 March 2026 | 21 Months |
|
MyTest - COVID-19/FLU A+B/RSV/Adenovirus Antigen Rapid Test
[PDF, 493.8 KB]
(Combination Rapid antigen Self-test) | Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 524057 | 2 March 2026 | 21 Months |
|
OWN Covid-19 Antigen RAT Self-testing
[PDF, 4.17 MB]
(Rapid antigen test) | Nasal swab | 2San Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China) | 525761 | 20 April 2026 | 24 Months |
|
(Combination Rapid antigen self-test) | Nasal swab | Touch Biotechnology Pty Ltd | Vitrosens Biotechnology Inc (Turkey) | 408459 | 2 April 2026 | 24 Months |
|
(Combination Rapid antigen self-test) | Touch Biotechnology Pty Ltd | Vitrosens Biotechnology Inc (Turkey) | 408459 | 2 April 2026 | 24 Months | Touch Biotechnology Pty Ltd |
2San 5 in 1 Self-Test SARS-CoV-2/FluA/FluB/ADV/RSV Antigen Combo Rapid Test Kit (Combination Rapid antigen Self test) | Nasal swab | 2San Pty Ltd | Jiangsu Medomics Medical Technology Co Ltd (China) | 525026 | 27 March 2026 | 36 Months |
AHPC - COVID-19/RSV/ADV/Flu A&B Antigen Combo Rapid Test Kit (Combination Rapid antigen self-test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 524286 | 11 March 2026 | 24 Months |
ALLTEST - COVID-19/FLU A+B/RSV/Adenovirus Antigen Rapid Test (Combination Rapid antigen Self-test) | Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 524057 | 2 March 2026 | 21 Months |
Beright - COVID-19/FLU A+B/RSV/Adenovirus Antigen Rapid Test (Combination Rapid antigen Self-test) | Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 524057 | 2 March 2026 | 21 Months |
Cellife - COVID-19/RSV/ADV/Flu A&B Antigen Combo Rapid Test Kit (Combination Rapid antigen self-test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 524286 | 11 March 2026 | 24 Months |
2SAN Covid-19 Antigen RAT Self-testing (Rapid antigen test) | Nasal swab | 2San Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China) | 525761 | 20 April 2026 | 24 Months |
2019 nCoV Ag Test (Latex Chromatography Assay) - Self-test (pdf 1.3Mb) (Rapid antigen test) | Nasal swab | BGI Health (AU) Company Pty Ltd | Innovita (Tangshan) Biological Technology Co Ltd (China) | 387550 | 27 April 2022 | 18 months |
2SAN COVID-19, Influenza A/B & RSV Antigen Nasal (Combination rapid antigen self-test) | Nasal swab | 2San Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China) | 462767 | 16 July 2025 | 36 months |
COVID-19/Influenza (A+B)/RSV Antigen Combo Rapid Test Kit (Colloidal gold method) (Combination rapid antigen self-test) | Nasal swab | Chem-Pack Supplies Australasia Pty Ltd | Nanjing Synthgene Medical Technology Co Ltd | 509865 | 22 August 2025 | 24 months |
Touchbio RSV, ADV, FLU A/B & COVID-19 Rapid Antigen Combo Test (Combination rapid antigen self-test) | Nasal swab | Sonictec Pty Ltd | Hangzhou Realy Tech Co Ltd (China) | 408073 | 14 August 2025 | 24 months |
RSV, ADV, FLU A/B & COVID-19 Rapid Antigen Combo Test : For self-testing (pdf, 515KB) (Combination rapid antigen self-test) | Nasal swab | Doncaster Australia Pty Ltd | Hangzhou Realy Tech Co Ltd (China) | 402448 | 10 April 2025 | 24 months |
WeTest Bio SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) (pdf, 2.47MB) (Combination rapid antigen self-test) | Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 443914 | 20 March 2025 | 24 months |
2019-nCoV Ag Rapid Test Kit (Immunochromatography for self-testing) (pdf,1.18Mb) (Rapid antigen test) | Nasal swab | Big Start Pty Ltd | Guangzhou Decheng Biotechnology Co Ltd (China) | 387020 | 12 April 2022 | 24 months |
2SAN COVID-19 & Influenza A/B Antigen Nasal Test Kit for Self-testing (pdf 14.1MB) (Combination rapid antigen self-test) | Nasal swab | 2San Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China) | 462767 | 25 September 2024 | 24 months |
2SAN COVID-19 Antigen Nasal Test Kit for Self-Testing (pdf 13.21MB) (Rapid antigen test) | Nasal swab | 2San Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China)
| 462948 | 26 September 2024 | 24 months |
All Test COVID-19 Antigen Rapid Test (Oral Fluid) Self-Test (ICOV-802H) (pdf,366kb) (Rapid antigen test) | Oral fluid | AM Diagnostics | Hangzhou Alltest Biotech Co Ltd (China) | 376310 | 13 October 2021 | 24 months (extended) |
All Test SARS-CoV-2 Antigen Rapid Test (Nasal Swab) Self-Test (INCP-502H) (pdf,649kb) (Rapid antigen test) | Nasal swab | AM Diagnostics | Hangzhou Alltest Biotech Co Ltd (China) | 376310 | 13 October 2021 | 24 months (extended) |
Alltest SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test ISIR-N535H (pdf,554kb) (Combination rapid antigen self test) | Nasal swab | Aceso Diagnostics Pty Ltd | Hangzhou Alltest Biotech Co Ltd (China) | 513625 | 29 September 2025 | 12 months |
AHPC COVID-19/Influenza A&B Antigen Test Kit (Combination rapid antigen self-test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 414738 | 06 December 2024 | 24 months |
AHPC COVID-19 / RSV / Influenza A&B Antigen Test Kit (Combination rapid antigen self-test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 427686 | 22 November 2024 | 24 months |
AHPC SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (Combination rapid antigen self-test) | Nasal swab | Cellife Health Products Pty Ltd | Jiangsu Medomics Medical Technology Co Ltd (China) | 521139 | 02 December 2025 | 36 months |
Beright SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) (pdf,248kb) (Combination rapid antigen self-test) | Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 443914 | 18 March 2024 | 24 months |
Beright SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test ISIR-N535H (pdf,759kb) (Combination rapid antigen self-test) | Nasal swab | Aceso Diagnostics Pty Ltd | Hangzhou Alltest Biotech Co Ltd (China) | 513625 | 29 September 2025 | 12 months |
Biopen COVID-19 Antigen Nasal Test Kit for Self-Testing (pdf,354kb) (Rapid antigen test) | Nasal swab | Emergence Technology Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China) | 372335 | 5 May 2022 | 30 months (extended) |
Biopen COVID-19 Oral Test Kit for Self-testing (pdf,361kb) (Rapid antigen test) | Saliva | Emergence Technology Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China) | 372335 | 22 October 2021 | 33 months (extended) |
EASY TEST SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) (Combination rapid antigen self-test) | Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China | 443914 | 23 July 2024 | 24 months |
Cellife Covid-19 Antigen Test Cassette for self-testing (pdf,784Kb) (Rapid antigen test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Testsea Biotechnology Co Ltd (China) | 375418 | 12 January 2022 | 24 months (extended) |
Cellife Diagfest Covid -19/Influenza A & B Antigen Test Kit(pdf,1324Kb) (Combination rapid antigen self-test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 414738 | 28 July 2023 | 24 months (extended) |
Cellife COVID-19/Influenza A&B Antigen Test Kit (Combination rapid antigen self-test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 414738 | 6 December 2024 | 24 months |
Cellife Diagfest - COVID-19/RSV/Influenza A&B Antigen Test Kit(pdf,561Kb) (Combination self-test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 427686 | 10 November 2023 | 24 months (extended) |
Celllife COVID-19/RSV/Influenza A&B Antigen Test Kit (Combination self‐test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 427686 | 22 November 2024 | 24 months |
Cellife SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (Combination rapid antigen self-test) | Nasal swab | Cellife Health Products Pty Ltd | Jiangsu Medomics Medical Technology Co Ltd (China) | 521139 | 2 December 2025 | 36 months |
Cellife COVID-19 Antigen Rapid Test (Oral Fluid) ICOV-802H (Rapid antigen test) | Oral fluid | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 374574 | 19 December 2025 | 12 months |
Chemists Own PROCHECK COVID-19/RSV/Influenza A&B Antigen Test kit: Self testing (pdf,1.16mb) (Combination self‐test) | Nasal swab | BIO TOP Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 455706 | 11 March 2025 | 24 months |
CLUNGENE COVID-19 Antigen Rapid Test (For (Rapid antigen test) | Nasal swab | Fortun8 International Trading Co Pty Limited | Hangzhou Clongene Biotech Co Ltd (China) | 396675 | 29 September 2022 | 24 months (extended) |
Clungene Covid-19 Antigen Rapid Test for self-testing (pdf,481kb) (Rapid antigen test) | Nasal swab | APAC Security Pty Ltd | Hangzhou Clongene Biotech Co Ltd (China) | 333341 | 7 January 2022 | 24 months (extended) |
CLUNGENE COVID-19/Influenza A+B Antigen Combo Rapid Test (For Self-testing) (pdf,492kb) (Combination rapid antigen self-test) | Nasal swab | APAC Security Pty Ltd | Hangzhou Clongene Biotech Co Ltd (China) | 404854 | 14 February 2023 | 18 months |
CorePharma SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) (Combination rapid antigen self-test) | Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 443914 | 23 July 2024 | 24 months |
CorePharma COVID-19/RSV/Influenza A&B Antigen Test Kit (Combination rapid antigen self-test) | Nasal swab | BIO TOP Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 455706 | 5 November 2024 | 24 months |
CLUNGENE COVID-19 Antigen Rapid Test (For Self-testing) (Rapid antigen test) | Nasal swab | Powersource Group Pty Ltd | Hangzhou Clongene Biotech Co Ltd (China) | 461547 | 30 August 2024 | 24 months |
COVID-19 Antigen Rapid Test (For Self-testing) (pdf,543kb) (Rapid antigen test) | Nasal swab | Shield Right Pty Ltd | Hangzhou Clongene Biotech Co Ltd (China) | 459346 | 13 August 2024 | 24 months |
COVID-19 Antigen Rapid Test (For Self-testing) (Rapid antigen test) | Nasal swab | Starshine Media Pty Ltd | Hangzhou Clongene Biotech Co Ltd (China) | 519525 | 12 November 2025 | 24 months |
COVID-19 & Influenza A/B Antigen Nasal Test Kit (Biolink Ecotest) (pdf,1.7MB) | Nasal swab | Emergence Technology Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China) | 407849 | 6 December 2023 | 24 months |
Covid-19 Ag Home Test (pdf,10.4Mb) (Rapid antigen test) | Nasal swab | Nature's Family Australia Pty Ltd | GenBody Inc (Korea - Republic of) | 383887 | 11 February 2022 | 12 months |
COVIFIND COVID-19 Antigen Self-Test (Rapid antigen test) (pdf 2.7Mb) (Rapid antigen test) | Nasal swab | Safe Interact Pty Ltd | Meril Diagnostics Pvt Ltd (India) | 387390 | 22 April 2023 | 24 months (extended) |
CoviFind, COVID-19 Antigen Self-Test (pdf,2.4Mb) (Rapid antigen test) | Nasal swab | KSJ Pharmatech | Meril Diagnostics Pvt Ltd (India) | 403510 | 25 January 2023 | 9 months |
COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette (For Self- testing) (Combination rapid antigen self-test) | Nasal swab | AusPharma Medical Devices | Hangzhou Heo Technology Co Ltd (China) | 404883 | 15 February 2023 | 24 months |
COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette (For Self- testing) with RHINOSWAB (Combination rapid antigen self-test) | Nasal swab | AusPharma Medical Devices | Hangzhou Heo Technology Co Ltd (China) | 44883 | 6 May 2025 | 24 months |
COVID-19, Influenza A/B & RSV Antigen Nasal Test Kit for Self-testing (Biolink Biopen)
Combination rapid antigen self-test) | Nasal swab | Emergence Technology Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China) | 430031 | 19 July 2024 | 12 months |
Diagfest Covid -19/Influenza A & B Antigen Test Kit (pdf,1314Kb) (Combination rapid antigen self-test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 414738 | 27 July 2023 | 24 months (extended) |
Diagfest - COVID-19/ RSV/ lnfluenza A&B Antigen Test Kit (pdf,549Kb) (Combination self‐test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 427686 | 10 November 2023 | 24 months (extended) |
Diagfest - COVID-19/Influenza A&B Antigen Test Kit (pdf,573kb) (Combination self‐test) | Nasal | BIO TOP Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 433772 | 15 January 2024 | 24 months |
Diagfest – COVID-19/RSV/Influenza A&B Antigen Test Kit (Combination self‐test) | Nasal swab | BIO TOP Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 455706 | 19 July 2024 | 24 months |
Diagfest – COVID-19/RSV/ADV/Flu A&B Antigen Combo Rapid Test Kit (pdf,507.56kb) (Combination self‐test) | Nasal swab | BIO TOP Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 473906 | 23 December 2024 | 24 months |
Diaghome - COVID-19/Influenza A&B Antigen Test Kit (pdf,536kb) (Combination self‐test) | Nasal | BIO TOP Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 433772 | 15 January 2024 | 24 months |
Diaghome – COVID-19/RSV/Influenza A&B Antigen Test Kit (Combination self‐test) | Nasal swab | BIO TOP Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 455706 | 19 July 2024 | 24 months |
Diaghome – COVID-19/RSV/ADV/Flu A&B Antigen Combo Rapid Test Kit (pdf,512kb) (Combination self‐test) | Nasal swab | BIO TOP Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 473906 | 23 December 2024 | 24 months |
EasyNAT COVID-19 RNA Test for Self-Testing (pdf,4.45Mb) (Nucleic acid test) | Nasal swab | Australia Health Products Central Pty Ltd | Ustar Biotechnologies (Hangzhou) Ltd (China) | 390609 | 17 June 2022 | 6 months |
Fanttest - COVID-19/Influenza A&B Antigen Test Kit (pdf,532kb) (Combination self‐test) | Nasal | BIO TOP Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 433772 | 15 January 2024 | 24 months |
Fanttest – COVID-19/RSV/Influenza A&B Antigen Test Kit (Combination self‐test) | Nasal swab | BIO TOP Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 455706 | 19 July 2024 | 24 months |
Fanttest – COVID-19/RSV/ADV/Flu A&B Antigen Combo Rapid Test Kit (Combination self‐test) | Nasal swab | BIO TOP Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 455706 | 23 December 2024 | 24 months |
Fanttest Covid -19/Influenza A & B Antigen Test Kit(pdf,1324Kb) (Combination rapid antigen self-test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 414738 | 27 July 2023 | 24 months (extended) |
Fanttest Covid-19/RSV/Influenza A & B Antigen Test Kit(pdf,547Kb) (Combination self test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 427686 | 10 November 2023 | 24 months (extended) |
Fanttest: Covid-19/Influenza A&B Antigen Test Kit (Combination self‐tests) | Nasal swab | Sonictec Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 395590 | 7 September 2022 | 24 months (extended) |
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (pdf,422KB) (Rapid antigen test) | Nasal swab | AusDiagnostics Pty Ltd | Acon Biotech (Hangzhou) Co Ltd (China) | 382031 | 6 January 2022 | 24 months (extended) |
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (pdf,975kb) (Rapid antigen test) | Nasal swab | Compliance Management Solutions | Acon Biotech (Hangzhou) Co Ltd (China) | 382250 | 8 January 2022 | 12 months |
GENEDIAN COVID-19 Antigen Test Cassette - Self Testing (pdf,334kb) (Rapid antigen test) | Nasal swab | Nationwide Asset Management Consolidated Pty Ltd | Hangzhou Testsea Biotechnology Co Ltd (China) | 399643 | 18 November 2022 | 24 months |
Gmate COVID-19 Ag Saliva (pdf,2.38Mb) (Rapid antigen test) | Saliva | MD Solutions Australasia Pty Ltd | Philosys Co Ltd (Korea - Republic of) | 383823 | 10 February 2022 | 24 months |
GSD NovaGen SARS CoV-2 Ag Rapid Test (Nasal swab) Self-testing (pdf,297kb) (Rapid antigen test) | Nasal swab | Eurofins Technologies Australia Pty Ltd | Hangzhou Alltest Biotech Co Ltd (China) | 374693 | 19 January 2022 | 6 months |
Healgen Rapid Check COVID-19/Flu A&B Antigen Test (Rapid antigen test) | Nasal swab | Compliance Management Solutions | Healgen Scientific Limited Liability Company (USA) | 514905 | 8 October 2025 | 24 months |
Hough COVID-19 Home Test (pdf,3.48Mb) (Rapid antigen test) | Nasal swab | Hough Pharma Pty Ltd | BIOHIT HealthCare (Hefei) Co Ltd (China) | 345031 | 18 October 2021 | 21 months (extended) |
Influenza A/B/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) (PDF, 16.41 MB) (Combination rapid antigen self-test) | Nasal swab | Epic Medical & Health Pty Ltd | Hoyotek Biomedical Co Ltd (China) | 452965 | 20 June 2024 | 24 months |
Influenza A/B/Corona Virus (COVID-19)/RSV Antigen Rapid Test kit (Colloidal Gold) (Combination rapid antigen self-test) | Nasal swab | Epic Medical & Health Pty Ltd | Hoyotek Biomedical Co Ltd (China) | 452965 | 15 December 2025 | 24 months |
InnoScreen COVID-19 Antigen Rapid Test Device (Self Test) (pdf,613kb) (Rapid antigen test) | Nasal swab | Innovation Scientific Pty Ltd | Innovation Scientific Pty Ltd (Australia) | 336146 | 28 October 2021 | 24 months (extended) |
JusChek COVID-19 Antigen Rapid Test (Oral Fluid) ICOV-802H Self Test (pdf,177kb) (Rapid antigen test) | Oral fluid | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 374574 | 31 December 2021 | 12 months |
JusChek SARS-CoV-2 Antigen Rapid Test (Nasal Swab) INCP-502H Self Test (pdf,166kb) (Rapid antigen test) | Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 374574 | 31 December 2021 | 12 months |
JusChek SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) (pdf,253kb) (Combination rapid antigen self-test) | Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 443914 | 18 March 2024 | 24 months |
LUCA NK COVID-19 Ag Nasal LLB Self-Test (pdf, 19mb) (Rapid antigen test) | Nasal swab | Involution Healthcare Pty Ltd | LUCA AICell Inc (Korea - Republic of) | 412730 | 22 February 2024 | 36 months (extended) |
LYHER Novel Coronavirus (Covid-19) Antigen Test Kit (colloidal Gold) Self-Test (pdf,6.85mb) (Rapid antigen test) | Nasal swab | 2San Pty Ltd | Hangzhou Laihe Biotech Co Ltd (China) | 374507 | 27 October 2021 | 24 months (extended) |
Medriva COVID-19 Rapid Antigen Test (pdf,258kb) (Rapid antigen test) | Nasal swab | ProcureNet APAC Pty Ltd | Hangzhou Testsea Biotechnology Co Ltd (China) | 383819 | 10 February 2022 | 15 months |
Medriva COVID-19 Rapid Antigen Self-Test (pdf,278kb) (Rapid antigen test) | Nasal swab | ProcureNet APAC Pty Ltd | Hangzhou Sejoy Electronics & Instruments Co Ltd (China) | 403271
| 24 January 2023 | 18 months |
My Covid Test Antigen Rapid Test (Oral Fluid) (ICOV-802H) Self-Test (pdf,366kb) (Rapid antigen test) | Oral fluid | AM Diagnostics | Hangzhou Alltest Biotech Co Ltd (China) | 376310 | 13 October 2021 | 24 months (extended) |
Novel Coronavirus (SARS-COV-2) Antigen Rapid test cassette (swab) (pdf,431kb) (Rapid antigen test) | Nasal swab | Doncaster Australia Pty Ltd | Hangzhou Realy Tech Co Ltd (China) | 382615 | 25 February 2022 | 24 months (extended) |
Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) (pdf,482kb) (Rapid antigen test) | Nasal swab | Auscan Medbio Pty Limited | Hangzhou Realy Tech Co Ltd (China) | 334501 | 23 February 2022 | 12 months |
Novel coronavirus (SARS-Cov-2) Antigen Rapid tests device (nasal swab) (pdf,443kb) (Rapid antigen test) | Nasal swab | Dexcon Pty Ltd | Hangzhou Realy Tech Co Ltd (China) | 384660 | 24 February 2022 | 24 months (extended) |
Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) (pdf,535kb) (Rapid antigen test) | Nasal swab | Rapant Pty Ltd | Hangzhou Realy Tech Co Ltd (China) | 395414 | 02 September 2022 | 20 months |
OnSite COVID-19 Ag Self Test (pdf,2.22Mb) (Rapid antigen test) | Nasal swab | MD Solutions Australasia Pty Ltd | CTK Biotech Inc (USA) | 332961 | 3 November 2021 | 18.5 months |
Orawell COVID-19 Ag Rapid Saliva Test Device (Self-test) (pdf,273kb) (Rapid antigen test) | Saliva | LRY Group of Companies Pty Ltd | Jiangsu Well Biotech Co Ltd (China) | 385275 | 8 March 2022 | 6 months |
OWN COVID-19 & Influenza A/B Antigen Nasal Test Kit for Self-testing (pdf 9.75MB) (Combination rapid antigen self-test) | Nasal swab | 2San Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China)
| 462767 | 25 September 2024 | 24 months |
OWN COVID-19 Antigen Nasal Test Kit for Self-Testing (pdf 10.11MB)
(Rapid antigen test) | Nasal swab | 2San Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China)
| 462948 | 26 September 2024 | 24 months |
Panbio COVID-19 Antigen Self-Test (pdf,886kb) (Rapid antigen test) | Nasal swab | Abbott Rapid Diagnostics Pty Ltd | Abbott Rapid Diagnostics Jena GmbH (Germany) | 345192 | 26 October 2021 | 24 months (extended) |
Pure LIVING COVID-19 Antigen Rapid Test (Oral Fluid) ICOV-802H (pdf 170KB) (Rapid antigen test) | Oral fluid | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 374574 | 17 September 2024 | 12 months |
Pure LIVING SARS-CoV-2 Antigen Rapid Test (Nasal Swab) INCP-502H (pdf 161KB) (Rapid antigen test) | Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 374574 | 17 September 2024 | 12 months |
Pure Living COVID-19/RSV/Influenza A&B Antigen Test Kit (pdf 563.56KB)
(Combination Rapid antigen self test) | Nasal swab | BIO TOP Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 455706 | 22 October 2024 | 24 months |
Rapid SARS-COV-2 Antigen Test Card Self-test (with pre -filled buffer)(pdf,1.97Mb) (Rapid antigen test) | Nasal swab | MP Biomedicals Australasia Pty Ltd | MP Biomedicals Asia Pacific Pte Ltd (Singapore) | 373711 | 16 August 2022 | 18 months |
Rapid SARS-CoV-2 and Flu A+B Antigen Test Card (Nasal Swab) (pdf,68KB) (Combination rapid antigen self-test) | Nasal swab | MP Biomedicals Australasia Pty Ltd | MP Biomedicals Asia Pacific Pte Ltd (Singapore) | 443903 | 18 March 2023 | 24 months |
Realy SARS-Cov-2 & Influenza A/B Combo Rapid Test Cassette (swab) – Self-testing (pdf,407kb) (Combination rapid antigen self-test) | Nasal swab | Doncaster Australia Pty Ltd | Hangzhou Realy Tech Co Ltd (China) | 402448 | 18 January 2023 | 24 months |
Realy SARS-Cov-2 & Influenza A/B Combo Rapid Test Cassette (swab) – For Self-testing use (pdf,449kb) (Combination rapid antigen self-test) | Nasal swab | Auscan Medbio Pty Limited | Hangzhou Realy Tech Co Ltd (China) | 402449 | 18 January 2023 | 24 months |
(Combination rapid antigen self-test) | Nasal swab | HA TECH PTY LTD | HA TECH PTY LTD (Australia) | 406813 | 18 January 2024 | 15 months (extended) |
RightSign COVID-19 Antigen Rapid Test Cassette (Nasal Swab) (pdf,1.06Mb) (Rapid antigen test) | Nasal swab | Medsupply Australia Pty Ltd | Hangzhou Biotest Biotech Co Ltd (China) | 333344 | 15 October 2021 | 24 months |
Salixium COVID-19 Rapid Antigen Test (Saliva/Nasal Swab Samples) (pdf, 1.19Mb) (Rapid antigen test) | Saliva/Nasal Swab | Avantua Pharmaceuticals Pty Limited | Reszon Diagnostics International Sdn Bhd (Malaysia) | 418208 | 15 August 2023 | 27 months |
SARS-CoV-2/FluA/FluB+ADV /RSV Antigen Combo Rapid Test Kit (LFIA) (pdf,6.7MB) (Combination rapid antigen self-test) | Nasal swab | Pale Blue Medical Trading Pty Ltd | Jiangsu Medomics Medical Technology Co Ltd (China) | 510725 | 29 August 2025 | 24 months |
SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) (pdf,3.1Mb) (Rapid antigen test) | Nasal swab | Vendart Diagnostics Pty Ltd | Shenzhen Watmind Medical Co Ltd (China) | 401373 | 20 December 2022 | 20 months |
SARS-CoV-2 Ag Self-test Kit (Nasal Swab)(pdf,1038Kb) (Rapid antigen test) | Nasal swab | Share Info Pty Ltd | Shenzhen Watmind Medical Co Ltd (China) | 414814 | 28 July 2023 | 20 months |
SARS-COV-2 Antigen Home Test (Oral Fluid) (pdf,655kb) (Rapid antigen test) | Saliva | Plus Daily Ltd | Acro Biotech Inc (United States of America) | 401127 | 15 December 2022 | 21 months |
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (pdf,1.16Mb) (Rapid antigen test) | Nasal swab | iJoysBio Pty Ltd | JOYSBIO (Tianjin) Biotechnology Co Ltd (China) | 409052 | 16 May 2023 | 24 months |
SARS-CoV-2 Antigen Test Kit (Colloidal Gold) (Rapid antigen test) (pdf 296kb) (Rapid antigen test) | Nasal swab | ALMITAS GROUP INTERNATIONAL PTY LTD | Genrui Biotech Inc (China) | 407574 | 13 April 2023 | 20 months |
SARS-CoV-2 Antigen Test Kit (LFIA) (pdf,2.19Mb) (Rapid antigen test) | Nasal swab | Pale Blue Medical Trading Pty Ltd | Jiangsu Medomics Medical Technology Co Ltd (China) | 380739 | 23 June 2022 | 24 months |
SARS-CoV-2/Influenza A/B Antigen Rapid Self-Test Kit (pdf,4Mb) (Combination rapid antigen self-test) | Nasal swab | Nationwide Asset Management Consolidated Pty Ltd | Getein Biotech Inc (China) | 399270 | 11 November 2022 | 24 months |
SARS-CoV-2 & Influenza A/B Combo Rapid Antigen Test Kit (RAT-03) (pdf,2.71Mb) (Combination rapid antigen self-test) | Nasal swab | HA TECH PTY LTD | HA TECH PTY LTD (Australia) | 406813 | 24 March 2023 | 18 months (extended) |
SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) (pdf,467kb) (Combination rapid antigen self-test) | Nasal swab | KnG Healthcare Pty Ltd | Jiangsu Medomics Medical Technology Co Ltd (China) | 407923 | 20 April 2023 | 20 months |
SARS-CoV-2/FluA/FluB+ ADV/RSV Antigen Combo Rapid Test Kit (LFIA) (Combination rapid antigen self-test) | Nasal swab | Pale Blue Medical Trading Pty Ltd
| Jiangsu Medomics Medical Technology Co Ltd | 520868 | 26 November 2025 | 36 months |
| SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) (pdf,6.8MB) (Combination rapid antigen self-test) | Nasal swab | Pale Blue Medical Trading Pty Ltd | Jiangsu Medomics Medical Technology Co Ltd | 408222 | 8 December 2023 | 24 months (extended) |
SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) (pdf,1.9Mb) (Combination rapid antigen self-test) | Nasal swab | Broad Oaks Holding Pty Ltd | Jiangsu Medomics Medical Technology Co Ltd (China) | 421051 | 04 September 2023 | 24 months |
SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA): Self Testing (pdf,1.9Mb) (Combination rapid antigen self-test) | Nasal swab | Pale Blue Medical Trading Pty Ltd | Jiangsu Medomics Medical Technology Co Ltd (China) | 408222 | 28 April 2023 | 25 months |
(Rapid antigen test) | Nasal swab | BOSTON MED PTY LTD | Nanjing Synthgene Medical Technology Co Ltd (China) | 405810 | 6 March 2023 | 18 months |
SARS-COV-2 RAPID ANTIGEN TEST KIT RAT-01 (SELF-TEST) (pdf,4.6Mb) (Rapid antigen test) | Nasal swab | HA TECH PTY LTD | HA TECH PTY LTD (Australia)
| 399559 | 16 November 2022 | 36 months (extended) |
SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) – Self-test (pdf,447kb) (Rapid antigen test) | Nasal swab | BGI Health (AU) Company Pty Ltd | BGI Europe A/S (Denmark) | 334043 | 20 June 2022 | 12 months |
SecurePlus COVID-19(SARS-CoV-2) Antigen Test Kit (Rapid antigen test) | Nasal swab | Plus Medical Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 515645 | 15 October 2025 | 25 months |
SecurePlus COVID-19 Antigen Test Cassette (pdf,522kb) (Rapid antigen test) | Nasal swab | Plus Medical Pty Ltd | Hangzhou Testsea Biotechnology Co Ltd (China) | 385550 | 15 March 2022 | 24 months |
Shield Right - SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) (Rapid antigen test) | Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 443914 | 22 December 2025 | 24 months |
SGTi-flex COVID-19 Ag (pdf,1MB) (Rapid antigen test) | Nasal swab | Involution Healthcare Pty Ltd | Sugentech Inc (Korea - Republic of) | 412813 | 06 July 2023 | 24 months |
Sonictec Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (pdf,879kb) (Rapid antigen test) | Nasal swab | Sonictec Pty Ltd | Hangzhou Realy Tech Co Ltd (China) | 384537 | 22 February 2022 | 24 months (extended) |
Sonictec SARS-Cov-2＆Influenza A/B Combo Rapid Test Cassette (swab) (pdf,535kb) (Combination rapid antigen self-test) | Nasal swab | Sonictec Pty Ltd | Hangzhou Realy Tech Co Ltd (China) | 408073 | 26 April 2023 | 20 months |
Sonictec RSV, Influenza A/B & Covid-19 Rapid Antigen Combo Test (Nasal) (Combination rapid antigen self-test) | Nasal swab | Sonictec Pty Ltd | Hangzhou Realy Tech Co Ltd (China) | 408073 | 04 July 2024 | 24 months |
Sonictec RSV, ADV, FLU A/B & COVID-19 Rapid Antigen Combo Test (pdf, 10mb) (Combination rapid antigen self-test) | Nasal swab | Sonictec Pty Ltd | Hangzhou Realy Tech Co Ltd (China) | 408073 | 18 March 2025 | 24 months |
SureScreen SARS-CoV-2 Antigen Rapid test Cassette (Nasal Swab) (Gold) (pdf 1.1Mb) (Rapid antigen test) | Nasal swab | SureScreen Australia Pty Limited | SureScreen Diagnostics Ltd (United Kingdom) | 387662 | 17 April 2023 | 6 months |
Synthgene COVID-19 Antigen Rapid Test Kit (pdf,1.01Mb) (Rapid antigen test) | Nasal swab | Tilemall Pty Ltd | Nanjing Synthgene Medical Technology Co Ltd (China) | 406154 | 14 March 2023 | 18 months |
TESTSEALABS COVID-19 Antigen Test Cassette (pdf,9.04Mb) (Rapid antigen test) | Nasal swab | Pharma Soul Holdings Pty Ltd | Hangzhou Testsea Biotechnology Co Ltd (China) | 373151 | 18 November 2021 | 24 months |
TouchBio COVID-19 Rapid Antigen Test Kit (for self-testing) (pdf 4.58MB) (Rapid antigen test) | Nasal swab | Touch Biotechnology Pty Ltd | Vitrosens Biyoteknoloji LTD STI (Turkey) | 462691 | 24 September 2024 | 24 months |
TouchBio SARS-CoV-2 & FLU A/B Antigen Combo Test (nasal) (pdf,6.72Mb) (Combination rapid antigen self-test) | Nasal swab | Touch Biotechnology Pty Ltd | Vitrosens Biyoteknoloji LTD STI (Turkey) | 395591 | 07 September 2022 | 24 months (extended) |
TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) For Self-Testing (Combination rapid antigen Self test) | Nasal swab | Touch Biotechnology Pty Ltd | Vitrosens Biyoteknoloji LTD STI (Turkey) | 408459 | 04 May 2023 | 24 months |
TouchBio COVID-19 Antigen Rapid Test (Oral Fluid) ICOV-802H (Rapid antigen test) | Oral fluid | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 374574 | 19 December 2025 | 12 months |
TouchBio SARS-CoV-2 Antigen Rapid Test (Nasal Swab) INCP-502H (Rapid antigen test) | Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 374574 | 19 December 2025 | 12 months |
V-Chek COVID-19 Antigen Saliva Test (pdf,591kb) (Rapid antigen test) | Saliva | Cole Workwear PL | Guangzhou Decheng Biotechnology Co Ltd (China) | 374065 | 17 November 2021 | 15 months |
VivaDiag Pro SARS-CoV-2 Ag Rapid Test (pdf,404kb) (Rapid antigen test) | Nasal swab | Stonestar Wholesale Pty Ltd | VivaChek Biotech (Hangzhou) Co Ltd (China) | 348890 | 25 February 2022 | 24 months (extended) |
VivaDiag SARS-CoV-2/Flu A/Flu B Ag Rapid (Anterior nasal Swab) Self Testing (pdf, 592) (Combination rapid antigen self-test) | Nasal Swab | Stonestar Wholesale Pty Ltd | VivaChek Biotech | 417487 | 11 August 2023 | 24 months |
Wellwisse COVID-19 ANTIGEN TEST CASSETTE (pdf,2.95Mb) (Rapid antigen test) | Nasal swab | Wellwisse Pharmaceuticals Pty Ltd | Hangzhou Testsea Biotechnology Co Ltd (China) | 409956 | 2 June 2023 | 24 months |
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (pdf,1.98Mb) (Rapid antigen test) | Nasal swab | Australia Biotech Pty Ltd | Guangzhou Wondfo Biotech Co Ltd (China) | 385653 | 15 March 2022 | 15 months |