You are here
Home » News room » News & public notices » Behind the news » Coronavirus (COVID-19): Information on medicines and medical devices » Legal supply of COVID-19 diagnostic tests
COVID-19 test kits included in the ARTG for legal supply in Australia
6 May 2022
The TGA has approved the following tests for inclusion in the Australian Register of Therapeutic Goods (ARTG).
Please note:
- Conditions have been imposed on the supply of COVID-19 rapid antigen point-of-care tests, COVID-19 rapid antigen self-tests (home use tests) and COVID-19 serology point-of-care tests. Further information can be found at: Legal supply of COVID-19 test kits.
- For guidance on understanding the key considerations for establishing COVID-19 rapid antigen point-of-care testing in your workplace, see COVID-19 Rapid Antigen Point-of-Care Tests – Guidance for implementation and checklist for businesses.
- The Peter Doherty Institute for Infection and Immunity (the Doherty Institute) has been engaged by the Department of Health to assist with the post-market validation of new COVID-19 rapid antibody tests to inform their best use.
- The TGA is undertaking a post-market review on the ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2 for all COVID tests in the ARTG.
- COVID-19 tests suspended from the ARTG are published on the TGA website – Medical devices and IVDs: Suspension from the ARTG.
For more information please contact us at COVIDtests@tga.gov.au or 1800 141 144.
Only the approved Sponsor (i.e. importer) listed in the table below, or a person acting on their behalf (i.e. the person has a distribution arrangement with the sponsor), can supply the device.
Please refer to the instructions for use for each test to determine intended specimen types.
COVID-19 test kits included on the ARTG for legal supply in Australia
Displaying 1 - 202 of 202
Manufacturer: Abbott Diagnostics Scarborough Inc also d/b/a Alere Scarborough Inc (United States Of America)
Name of test: ID NOW COVID-19
Australian sponsor: Abbott Rapid Diagnostics Pty Ltd
Date approved for supply: 7 Oct 2020
ARTG number: 345457
Intended use environment:
Point-of-care test
Type of test:
Nucleic Acid Test
Manufacturer: Abbott Ireland Diagnostic Division (Ireland)
Name of test: SARS-CoV-2 IgG II Quant Kit
Australian sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Date approved for supply: 11 Feb 2021
ARTG number: 340315
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Abbott Ireland Diagnostic Division (Ireland)
Name of test: SARS-CoV-2 IgM Kit
Australian sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Date approved for supply: 17 Sep 2020
ARTG number: 340315
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Abbott Ireland Diagnostic Division (Ireland)
Name of test: SARS-CoV-2 IgG Kit
Australian sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Date approved for supply: 28 Jul 2020
ARTG number: 340315
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Abbott Molecular Inc (United States Of America)
Name of test: Alinity m Resp-4-Plex AMP kit
Australian sponsor: Abbott Australasia Pty Ltd Molecular Division
Date approved for supply: 1 Apr 2022
ARTG number: 386639
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Abbott Molecular Inc (United States Of America)
Name of test: Alinity m SARS-CoV-2 AMP Kit
Australian sponsor: Abbott Australasia Pty Ltd Molecular Division
Date approved for supply: 27 Aug 2020
ARTG number: 335074
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Abbott Molecular Inc (United States Of America)
Name of test: Abbott RealTime SARS-CoV-2
Australian sponsor: Abbott Australasia Pty Ltd Molecular Division
Date approved for supply: 17 Apr 2020
ARTG number: 335074
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Abbott Rapid Diagnostics Jena GmbH (Germany)
Name of test: Panbio COVID-19 Antigen Self-Test
Australian sponsor: Abbott Rapid Diagnostics Pty Ltd
Date approved for supply: 26 Oct 2021
ARTG number: 345192
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Abbott Rapid Diagnostics Jena GmbH (Germany)
Name of test: Panbio™ COVID-19 Ag Rapid Test Device (Nasal)
Australian sponsor: Abbott Rapid Diagnostics Pty Ltd
Date approved for supply: 2 Mar 2021
ARTG number: 345192
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Abbott Rapid Diagnostics Jena GmbH (Germany)
Name of test: Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal)
Australian sponsor: Abbott Rapid Diagnostics Pty Ltd
Date approved for supply: 30 Sep 2020
ARTG number: 345192
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Access Bio Inc (United States Of America)
Name of test: CareStart COVID-19 Antigen Home Test
Australian sponsor: Pantonic Pty Ltd
Date approved for supply: 21 Oct 2021
ARTG number: 342512
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Access Bio Inc (United States Of America)
Name of test: Atomo Covid-19 Antigen Test
Australian sponsor: Atomo Diagnostics Limited
Date approved for supply: 26 Oct 2020
ARTG number: 346587
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Access Bio Inc (United States Of America)
Name of test: CareStart™ COVID-19 Antigen
Australian sponsor: Pantonic Health Pty Ltd
Date approved for supply: 15 Sep 2020
ARTG number: 342512
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Access Bio Inc (United States Of America)
Name of test: CareStart™ COVID-19 MDx RT-PCR
Australian sponsor: Pantonic Health Pty Ltd
Date approved for supply: 27 Aug 2020
ARTG number: 342512
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Acon Biotech (Hangzhou) Co Ltd (China)
Name of test: Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) - Nasal swab
Australian sponsor: Orvato Healthcare Pty Ltd
Date approved for supply: 8 Jan 2022
ARTG number: 382250
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Acon Biotech (Hangzhou) Co Ltd (China)
Name of test: Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)
Australian sponsor: AusDiagnostics Pty Ltd
Date approved for supply: 6 Jan 2022
ARTG number: 382031
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: AMT Pte Ltd (Singapore)
Name of test: RESOLUTE 2.0
Australian sponsor: Accelagen Pty Ltd
Date approved for supply: 3 Jun 2021
ARTG number: 368051
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Arista Biotech Pte Ltd (Singapore)
Name of test: ARISTA™ COVID-19 Antigen Rapid Test
Australian sponsor: Health Vision Australasia Pty Ltd
Date approved for supply: 5 Jul 2021
ARTG number: 370592
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Assure Tech (Hangzhou) Co Ltd (China)
Name of test: Ecotest COVID-19 Antigen Nasal Test Self Test
Australian sponsor: Emergence Technology Pty Ltd
Date approved for supply: 5 May 2022
ARTG number: 372335
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Assure Tech (Hangzhou) Co Ltd (China)
Name of test: Ecotest COVID-19 Antigen Nasal Test Kit
Australian sponsor: Emergence Technology Pty Ltd
Date approved for supply: 22 Oct 2021
ARTG number: 372335
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Assure Tech (Hangzhou) Co Ltd (China)
Name of test: Ecotest COVID-19 Antigen Saliva Test kit (COV-S35Pen)
Australian sponsor: Emergence Technology Pty Ltd
Date approved for supply: 22 Oct 2021
ARTG number: 372335
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Assure Tech (Hangzhou) Co Ltd (China)
Name of test: Ecotest COVID-19 Antigen Saliva Test Kit
Australian sponsor: Emergence Technology Pty Ltd
Date approved for supply: 6 Aug 2021
ARTG number: 372335
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Assure Tech (Hangzhou) Co Ltd (China)
Name of test: COVID-19 Antigen Rapid Test Device
Australian sponsor: Emergence Technology Pty Ltd
Date approved for supply: 27 Oct 2020
ARTG number: 346643
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Atomo Diagnostics Limited (Australia)
Name of test: AtomoRapid™ COVID-19 IgM/IgG Antibody Test
Australian sponsor: Atomo Diagnostics Limited
Date approved for supply: 12 Aug 2020
ARTG number: 341411
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: AusDiagnostics Pty Ltd (Australia)
Name of test: AusDiagnostics respiratory virus panel (including SARS-CoV-2) test
Australian sponsor: AusDiagnostics Pty Ltd
Date approved for supply: 19 Mar 2020
ARTG number: 236377
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Beckman Coulter Inc (United States Of America)
Name of test: Access SARS-CoV-2 IgG Antibody Test
Australian sponsor: Beckman Coulter Australia Pty Ltd
Date approved for supply: 24 Jul 2020
ARTG number: 340128
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Becton Dickinson and Company (United States Of America)
Name of test: BD Veritor™ System for Rapid Detection of SARS-CoV-2
Australian sponsor: Becton Dickinson Pty Ltd
Date approved for supply: 22 Sep 2020
ARTG number: 344030
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Becton Dickinson and Company (United States Of America)
Name of test: BD SARS-CoV-2 Reagents for BD MAX™ System
Australian sponsor: Becton Dickinson Pty Ltd
Date approved for supply: 17 Apr 2020
ARTG number: 334514
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Beijing Wantai Biologicalpharmacy Enterprise Co Ltd (China)
Name of test: Wantai SARS-CoV-2 Ag Rapid Test (Colloidal Gold)
Australian sponsor: Suretest (formerly Life Clinic Australia Pty Ltd)
Date approved for supply: 30 Jul 2021
ARTG number: 345191
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Beijing Wantai Biologicalpharmacy Enterprise Co Ltd (China)
Name of test: Wantai SARS-CoV-2 Ab ELISA
Australian sponsor: Suretest (formerly Life Clinic Australia Pty Ltd)
Date approved for supply: 30 Sep 2020
ARTG number: 345191
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Beijing Wantai Biologicalpharmacy Enterprise Co Ltd (China)
Name of test: Wantai SARS-CoV-2 Ab Rapid Test kit
Australian sponsor: Suretest (formerly Life Clinic Australia Pty Ltd)
Date approved for supply: 27 Mar 2020
ARTG number: 333149
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: BGI Europe A/S (Denmark)
Name of test: Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 (2 gene)
Australian sponsor: BGI Health (AU) Company Pty Ltd
Date approved for supply: 7 Apr 2021
ARTG number: 334043
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: BGI Europe A/S (Denmark)
Name of test: Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2
Australian sponsor: BGI Health (AU) Company Pty Ltd
Date approved for supply: 10 Apr 2020
ARTG number: 334043
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Bio-Rad (France)
Name of test: Platelia SARS-CoV-2 Total Ab
Australian sponsor: Bio-Rad Laboratories Pty Ltd
Date approved for supply: 23 Jun 2020
ARTG number: 338229
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: BioCore Co Ltd (Korea - Republic of)
Name of test: Bio-Core 2019-nCoV Real Time PCR Kit
Australian sponsor: Joy Surgical Pty Ltd
Date approved for supply: 21 Jul 2020
ARTG number: 339846
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: BioFire Diagnostics LLC
Name of test: BioFire Respiratory Panel 2.1 plus (RP2.1plus)
Australian sponsor: Biomerieux Australia Pty Ltd
Date approved for supply: 27 Jul 2020
ARTG number: 224167
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: BIOHIT HealthCare (Hefei) Co Ltd (China)
Name of test: Hough COVID-19 Home Test
Australian sponsor: Hough Pharma Pty Ltd
Date approved for supply: 18 Oct 2021
ARTG number: 345031
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: BIOHIT HealthCare (Hefei) Co Ltd (China)
Name of test: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Method)
Australian sponsor: Hough Pharma Pty Ltd
Date approved for supply: 30 Sep 2021
ARTG number: 345031
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: BIOHIT HealthCare (Hefei) Co Ltd (China)
Name of test: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Method)
Australian sponsor: Hough Pharma Pty Ltd
Date approved for supply: 29 Sep 2021
ARTG number: 345031
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: BIOHIT HealthCare (Hefei) Co Ltd (China)
Name of test: SARS-CoV-2 Antigen Rapid Test Kit (updated 6 January 2021)
Australian sponsor: Hough Pharma Pty Ltd
Date approved for supply: 19 Oct 2020
ARTG number: 345031
Intended use environment:
Laboratory/Point-of-care test
Type of test:
Antigen Test
Manufacturer: BIOHIT HealthCare (Hefei) Co Ltd (China)
Name of test: SARS-CoV-2 Antigen Quantitative Assay Kit (Enzyme-linked Immunoassay)
Australian sponsor: Hough Pharma Pty Ltd
Date approved for supply: 29 Sep 2020
ARTG number: 345031
Intended use environment:
Laboratory
Type of test:
Antigen Test
Manufacturer: Biomerieux SA (France)
Name of test: SARS-COV-2 R-GENE®
Australian sponsor: Biomerieux Australia Pty Ltd
Date approved for supply: 3 Aug 2020
ARTG number: 340774
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Biomerieux SA (France)
Name of test: VIDAS® SARS-COV-2 IgM
Australian sponsor: Biomerieux Australia Pty Ltd
Date approved for supply: 3 Aug 2020
ARTG number: 340774
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Biomerieux SA (France)
Name of test: VIDAS® SARS-COV-2 IgG
Australian sponsor: Biomerieux Australia Pty Ltd
Date approved for supply: 3 Aug 2020
ARTG number: 340774
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: BioNote Inc (Korea - Republic of)
Name of test: NowCheck COVID-19 Antigen Test
Australian sponsor: Life Bioscience Pty Ltd
Date approved for supply: 11 Sep 2020
ARTG number: 343293
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: BTNX Inc (Canada)
Name of test: Rapid Response™ COVID-19 Antigen Rapid Test Device
Australian sponsor: SureScreen Australia Pty Limited
Date approved for supply: 16 Jun 2021
ARTG number: 347092
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: BTNX Inc (Canada)
Name of test: Surescreen Diagnostics COVID-19 Antigen Rapid Test Cassette
Australian sponsor: SureScreen Australia Pty Limited
Date approved for supply: 3 Nov 2020
ARTG number: 347092
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Cellex Inc (United States Of America)
Name of test: Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test kit
Australian sponsor: Medicision Pty Ltd
Date approved for supply: 31 Mar 2020
ARTG number: 333303
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: Cepheid (USA)
Name of test: Xpert® Xpress SARS-CoV-2/Flu/RSV
Australian sponsor: Cepheid Holdings Pty Ltd
Date approved for supply: 17 Feb 2021
ARTG number: 231513
Intended use environment:
Laboratory/Point-of-care test
Type of test:
Nucleic Acid Test
Manufacturer: Cepheid (USA)
Name of test: Xpert® Xpress SARS-CoV-2
Australian sponsor: Cepheid Holdings Pty Ltd
Date approved for supply: 22 Mar 2020
ARTG number: 332620
Intended use environment:
Laboratory/Point-of-care test
Type of test:
Nucleic Acid Test
Manufacturer: CerTest Biotec SL (Spain)
Name of test: VIASURE SARS-CoV-2 Real Time PCR Detection Kit
Australian sponsor: Abacus dx Pty Ltd
Date approved for supply: 31 Mar 2020
ARTG number: 333161
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Chaozhou Hybribio Biochemistry Ltd (China)
Name of test: COVID-19 Real-Time PCR kit (HBRT-COVID-19)
Australian sponsor: Rachael Flood
Date approved for supply: 12 Mar 2021
ARTG number: 356659
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Co-Diagnostics Inc (United States Of America)
Name of test: Logix Smart™ Coronavirus Disease 2019 (COVID-19) Kit
Australian sponsor: Gene Target Solutions Pty Ltd
Date approved for supply: 4 Aug 2020
ARTG number: 340779
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: CTK Biotech Inc (United States Of America)
Name of test: Aridia COVID-19 Real-Time PCR Test
Australian sponsor: MD Solutions Australasia Pty Ltd
Date approved for supply: 24 Apr 2020
ARTG number: 335082
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: CTK Biotech Inc (USA)
Name of test: OnSite COVID-19 Ag Self Test
Australian sponsor: MD Solutions Australasia Pty Ltd
Date approved for supply: 3 Nov 2021
ARTG number: 332961
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: CTK Biotech Inc (USA)
Name of test: OnSite® COVID-19 Ag Point of care test / Aria® COVID-19 Ag Rapid Test
Australian sponsor: MD Solutions Australasia Pty Ltd
Date approved for supply: 15 Jan 2021
ARTG number: 332961
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: CTK Biotech Inc (USA)
Name of test: OnSite COVID-19 IgG/IgM Rapid Test / Aria COVID-19 IgG/IgM Rapid Test (updated 16 Sep 2020)
Australian sponsor: MD Solutions Australasia Pty Ltd
Date approved for supply: 19 Mar 2020
ARTG number: 332961
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: DiaSorin Molecular LLC (United States Of America)
Name of test: Simplexa™ COVID-19 Direct
Australian sponsor: DiaSorin Australia Pty Ltd
Date approved for supply: 4 Aug 2020
ARTG number: 340804
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: DiaSorin SpA (Italy)
Name of test: LIAISON® SARS-CoV-2 S1/S2 IgG
Australian sponsor: DiaSorin Australia Pty Ltd
Date approved for supply: 31 Jul 2020
ARTG number: 340612
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: DiaSorin SpA (Italy)
Name of test: LIAISON® SARS-CoV-2 IgM
Australian sponsor: DiaSorin Australia Pty Ltd
Date approved for supply: 31 Jul 2020
ARTG number: 340612
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Diesse Diagnostica Senese SPA (Italy)
Name of test: Chorus SARS-CoV-2 IgA
Australian sponsor: R-Biopharm Pty Ltd
Date approved for supply: 30 Mar 2021
ARTG number: 358290
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Diesse Diagnostica Senese SPA (Italy)
Name of test: Chorus SARS-CoV-2 IgG
Australian sponsor: R-Biopharm Pty Ltd
Date approved for supply: 30 Mar 2021
ARTG number: 358290
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Diesse Diagnostica Senese SPA (Italy)
Name of test: Chorus SARS-CoV-2 IgM
Australian sponsor: R-Biopharm Pty Ltd
Date approved for supply: 30 Mar 2021
ARTG number: 358290
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Diesse Diagnostica Senese SPA (Italy)
Name of test: Enzywell SARS-CoV-2 IgA
Australian sponsor: R-Biopharm Pty Ltd
Date approved for supply: 30 Mar 2021
ARTG number: 358290
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Diesse Diagnostica Senese SPA (Italy)
Name of test: Enzywell SARS-CoV-2 IgG
Australian sponsor: R-Biopharm Pty Ltd
Date approved for supply: 30 Mar 2021
ARTG number: 358290
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Diesse Diagnostica Senese SPA (Italy)
Name of test: Enzywell SARS-CoV-2 IgM
Australian sponsor: R-Biopharm Pty Ltd
Date approved for supply: 30 Mar 2021
ARTG number: 358290
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)
Name of test: Anti-SARS-CoV-2 QuantiVac ELISA (IgG)
Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd
Date approved for supply: 23 Dec 2020
ARTG number: 336561
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)
Name of test: Anti-SARS-CoV-2 NCP ELISA (IgG)
Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd
Date approved for supply: 5 Aug 2020
ARTG number: 336561
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)
Name of test: Anti-SARS-CoV-2 NCP ELISA (IgM)
Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd
Date approved for supply: 5 Aug 2020
ARTG number: 336561
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)
Name of test: Anti-SARS-CoV-2 ELISA (IgA)
Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd
Date approved for supply: 18 May 2020
ARTG number: 336561
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)
Name of test: Anti-SARS-CoV-2 ELISA (IgG)
Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd
Date approved for supply: 18 May 2020
ARTG number: 336561
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)
Name of test: EURORealTime SARS-CoV-2
Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd
Date approved for supply: 18 May 2020
ARTG number: 336561
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: GenBody Inc (Korea - Republic of)
Name of test: Covid-19 Ag Home Test
Australian sponsor: Nature's Family Australia Pty Ltd
Date approved for supply: 11 Feb 2022
ARTG number: 383887
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: GenBody Inc (Korea - Republic of)
Name of test: GenBody COVID-19 Ag
Australian sponsor: Nature's Family Australia Pty Ltd
Date approved for supply: 27 Nov 2020
ARTG number: 349933
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Genetic Signatures Ltd (Australia)
Name of test: EasyScreen™ SARS-CoV-2 Detection Kit
Australian sponsor: Genetic Signatures Ltd
Date approved for supply: 13 Apr 2020
ARTG number: 334502
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Guangzhou Decheng Biotechnology Co Ltd (China)
Name of test: 2019-nCoV Ag Rapid Test Kit (Immunochromatography for self-testing)
Australian sponsor: Big Start Pty Ltd
Date approved for supply: 12 Apr 2022
ARTG number: 387020
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Guangzhou Decheng Biotechnology Co Ltd (China)
Name of test: V-Chek COVID-19 Antigen Saliva Test
Australian sponsor: Cole Workwear PL
Date approved for supply: 17 Nov 2021
ARTG number: 374065
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Guangzhou Decheng Biotechnology Co Ltd (China)
Name of test: 2019-nCoV Ag Saliva Rapid Test Card
Australian sponsor: Cole Workwear PL
Date approved for supply: 2 Sep 2021
ARTG number: 374065
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Guangzhou Wondfo Biotech Co Ltd (China)
Name of test: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
Australian sponsor: Australia Biotech Pty Ltd
Date approved for supply: 16 Mar 2022
ARTG number: 385653
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Guangzhou Wondfo Biotech Co Ltd (China)
Name of test: 2019-nCoV Antigen Test (Lateral Flow Method)
Australian sponsor: Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Date approved for supply: 5 Oct 2021
ARTG number: 375754
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Guangzhou Wondfo Biotech Co Ltd (China)
Name of test: SARS-CoV-2 Antibody Test (Lateral Flow Method)
Australian sponsor: Allsafe Medical Pty Ltd
Date approved for supply: 17 Apr 2020
ARTG number: 334542
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: Guangzhou Wondfo Biotech Co Ltd (China)
Name of test: SARS-CoV-2 Antibody Test (Lateral Flow Method)
Australian sponsor: Tayler Dental Consulting Pty Ltd
Date approved for supply: 9 Apr 2020
ARTG number: 333902
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: HA TECH PTY LTD (Australia)
Name of test: RT-PCR IVD MEDICAL DEVICE FOR 2019 NOVEL CORONAVIRUS (SARS-COV-2) NUCLEIC ACID DETECTION
Australian sponsor: HA TECH PTY LTD
Date approved for supply: 14 Dec 2020
ARTG number: 351643
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd
Name of test: JusChek COVID-19 Antigen Rapid Test ICOV-802 (Oral Fluid)
Australian sponsor: Compliance Management Solutions
Date approved for supply: 17 Feb 2022
ARTG number: 374574
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd
Name of test: JusChek SARS-CoV-2 Antigen Rapid Test INCP-502-N
Australian sponsor: Compliance Management Solutions
Date approved for supply: 17 Feb 2022
ARTG number: 374574
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd
Name of test: JusChek COVID-19 Antigen Rapid Test (Oral Fluid) ICOV-802H
Australian sponsor: Compliance Management Solutions
Date approved for supply: 31 Dec 2021
ARTG number: 374574
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd
Name of test: JusChek SARS-CoV-2 Antigen Rapid Test (Nasal Swab) INCP-502H Self Test
Australian sponsor: Compliance Management Solutions
Date approved for supply: 31 Dec 2021
ARTG number: 374574
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Name of test: Beright COVID-19 Antigen Rapid Test ICOV-802 (Oral Fluid)
Australian sponsor: Compliance Management Solutions
Date approved for supply: 17 Feb 2022
ARTG number: 374574
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Name of test: Beright SARS-CoV-2 Antigen Rapid Te st INCP-502-N
Australian sponsor: Compliance Management Solutions
Date approved for supply: 17 Feb 2022
ARTG number: 374574
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Name of test: GSD NovaGen SARS CoV-2 Ag Rapid Test (Nasal swab) Self-testing
Australian sponsor: Eurofins Technologies Australia Pty Ltd
Date approved for supply: 19 Jan 2022
ARTG number: 374693
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Name of test: All Test COVID-19 Antigen Rapid Test (Oral Fluid) Self-Test (ICOV-802H)
Australian sponsor: AM Diagnostics
Date approved for supply: 13 Oct 2021
ARTG number: 376310
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Name of test: All Test SARS-CoV-2 Antigen Rapid Test (Nasal Swab) Self-Test (INCP-502H)
Australian sponsor: AM Diagnostics
Date approved for supply: 13 Oct 2021
ARTG number: 376310
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Name of test: All Test COVID-19 Antigen Rapid Test (Oral fluid) (ICOV-802)
Australian sponsor: AM Diagnostics
Date approved for supply: 13 Oct 2021
ARTG number: 376310
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Name of test: All Test COVID-19 Antigen Rapid Test (Swab) (ICOV-502)
Australian sponsor: AM Diagnostics
Date approved for supply: 13 Oct 2021
ARTG number: 376310
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Name of test: My Covid Test Antigen Rapid Test (Oral Fluid) Self-Test (ICOV-802H)
Australian sponsor: AM Diagnostics
Date approved for supply: 13 Oct 2021
ARTG number: 376310
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Name of test: GSD NovaGen SARS CoV-2 Rapid Test
Australian sponsor: Eurofins Technologies Australia Pty Ltd
Date approved for supply: 15 Sep 2021
ARTG number: 374693
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Name of test: All Test COVID-19 Antigen Rapid Test ICOV-802 (Oral Fluid)
Australian sponsor: Compliance Management Solutions
Date approved for supply: 13 Sep 2021
ARTG number: 374574
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Name of test: All Test SARS-CoV-2 Antigen Rapid Test INCP-502- N
Australian sponsor: Compliance Management Solutions
Date approved for supply: 13 Sep 2021
ARTG number: 374574
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Name of test: 2019-n-CoV IgG/IgM Rapid Test Cassette
Australian sponsor: AM Diagnostics
Date approved for supply: 23 Mar 2020
ARTG number: 333342
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: Hangzhou Biotest Biotech Co Ltd (China)
Name of test: RightSign COVID-19 Antigen Rapid Test Cassette (Nasal Swab)
Australian sponsor: Medsupply Australia Pty Ltd
Date approved for supply: 15 Oct 2021
ARTG number: 333344
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Biotest Biotech Co Ltd (China)
Name of test: COVID-19 IgG/IgM Rapid Test Cassette
Australian sponsor: Medsupply Australia Pty Ltd
Date approved for supply: 4 Apr 2020
ARTG number: 333344
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: Hangzhou Biotest Biotech No Ltd (China)
Name of test: COVID-19 Antigen Rapid Test Cassette
Australian sponsor: Medsupply Australia Pty Ltd
Date approved for supply: 31 Aug 2021
ARTG number: 333344
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Clongene Biotech Co Ltd
Name of test: Clungene Covid-19 Antigen Rapid Test for self-testing
Australian sponsor: APAC Security Pty Ltd
Date approved for supply: 7 Jan 2022
ARTG number: 333341
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Clongene Biotech Co Ltd
Name of test: Clungene Covid-19 Antigen Rapid Test
Australian sponsor: APAC Security Pty Ltd
Date approved for supply: 7 Jan 2022
ARTG number: 333341
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Clongene Biotech Co Ltd (China)
Name of test: COVID-19 IgG/IgM Rapid Test Cassette
Australian sponsor: APAC Security Pty Ltd
Date approved for supply: 26 Mar 2020
ARTG number: 333341
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: Hangzhou Laihe Biotech Co Ltd (China)
Name of test: LYHER Novel Coronavirus (Covid-19) Antigen Test Kit (colloidal Gold) Self-Test
Australian sponsor: 2San Pty Ltd
Date approved for supply: 28 Oct 2021
ARTG number: 374507
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Laihe Biotech Co Ltd (China)
Name of test: LYHER Novel Coronavirus (Covid-19) Antigen Test Kit (Colloidal Gold)
Australian sponsor: 2San Pty Ltd
Date approved for supply: 10 Sep 2021
ARTG number: 374507
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Realy Tech Co Ltd (China)
Name of test: Novel Coronavirus (SARS-COV-2) Antigen Rapid test cassette (swab)
Australian sponsor: Doncaster Australia Pty Ltd
Date approved for supply: 25 Feb 2022
ARTG number: 382615
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Realy Tech Co Ltd (China)
Name of test: Novel coronavirus (SARS-Cov-2) Antigen Rapid tests device (nasal swab)
Australian sponsor: Dexcon Pty Ltd
Date approved for supply: 24 Feb 2022
ARTG number: 384660
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Realy Tech Co Ltd (China)
Name of test: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)
Australian sponsor: Solasta Life Pty Ltd
Date approved for supply: 23 Feb 2022
ARTG number: 334501
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Realy Tech Co Ltd (China)
Name of test: Sonictec Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)
Australian sponsor: Sonictec Pty Ltd
Date approved for supply: 22 Feb 2022
ARTG number: 384537
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Realy Tech Co Ltd (China)
Name of test: Novel Coronavirus (SARS-COV-2) Antigen Rapid test cassette (swab)
Australian sponsor: Doncaster Australia Pty Ltd
Date approved for supply: 14 Jan 2022
ARTG number: 382615
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Realy Tech Co Ltd (China)
Name of test: Novel Coronavirus (SARS-CoV-2) Antigen rapid test
Australian sponsor: Solasta Life Pty Ltd
Date approved for supply: 30 Jul 2021
ARTG number: 334501
Intended use environment:
Laboratory/Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Realy Tech Co Ltd (China)
Name of test: 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device
Australian sponsor: Solasta Life Pty Ltd
Date approved for supply: 16 Apr 2020
ARTG number: 334501
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: Hangzhou Sejoy Electronics & Instruments Co Ltd (China)
Name of test: SARS-CoV-2 Antigen Saliva Lolly Test
Australian sponsor: Alpha-Medics Australia Pty Ltd
Date approved for supply: 4 Apr 2022
ARTG number: 386690
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Testsea Biotechnology Co Ltd (China)
Name of test: Nuex Medical COVID-19 Antigen Test Cassette
Australian sponsor: Nuex Medical Melbourne
Date approved for supply: 25 Mar 2022
ARTG number: 386305
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Testsea Biotechnology Co Ltd (China)
Name of test: SecurePlus COVID-19 Antigen Test Cassette
Australian sponsor: Plus Medical Pty Ltd
Date approved for supply: 15 Mar 2022
ARTG number: 385550
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Testsea Biotechnology Co Ltd (China)
Name of test: Testsealabs Rapid test kit COVID-19 Antigen Test Cassette
Australian sponsor: Jamach Pty Ltd
Date approved for supply: 10 Mar 2022
ARTG number: 385429
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Testsea Biotechnology Co Ltd (China)
Name of test: Jamach COVID-19 Antigen Test Cassette
Australian sponsor: Jamach Pty Ltd
Date approved for supply: 10 Mar 2022
ARTG number: 385429
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Testsea Biotechnology Co Ltd (China)
Name of test: Medriva COVID-19 Rapid Antigen Test
Australian sponsor: ProcureNet APAC Pty Ltd
Date approved for supply: 10 Feb 2022
ARTG number: 383819
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Testsea Biotechnology Co Ltd (China)
Name of test: Cellife Covid-19 Antigen Test Cassette for self-testing
Australian sponsor: Australia Health Products Central Pty Ltd
Date approved for supply: 12 Jan 2022
ARTG number: 375418
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Testsea Biotechnology Co Ltd (China)
Name of test: TESTSEALABS COVID-19 Antigen Test Cassette
Australian sponsor: Pharma Soul Pty Ltd
Date approved for supply: 18 Nov 2021
ARTG number: 373151
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Hangzhou Testsea Biotechnology Co Ltd (China)
Name of test: Cellife Covid-19 Antigen Test Cassette
Australian sponsor: Australia Health Products Central Pty Ltd
Date approved for supply: 28 Sep 2021
ARTG number: 375418
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Hangzhou Testsea Biotechnology Co Ltd (China)
Name of test: Testsea SARS-CoV-2 Antigen Test Kit
Australian sponsor: Pharma Soul Pty Ltd
Date approved for supply: 19 Aug 2021
ARTG number: 373151
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Healgen Scientific Limited Liability Company (United States Of America)
Name of test: COVID-19 IgG/IgM Rapid Test Cassette
Australian sponsor: Southwind International Pty Ltd
Date approved for supply: 29 Apr 2020
ARTG number: 335351
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: Hologic Inc (United States Of America)
Name of test: Aptima SARS-CoV-2/Flu Assay
Australian sponsor: Hologic (Australia & New Zealand) Pty Ltd
Date approved for supply: 13 Apr 2022
ARTG number: 296043
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Hologic Inc (United States Of America)
Name of test: Aptima® SARS-CoV-2 Assay
Australian sponsor: Hologic (Australia & New Zealand) Pty Ltd
Date approved for supply: 29 Jun 2020
ARTG number: 338553
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Hologic Inc (USA)
Name of test: Panther Fusion® SARS-CoV-2 Assay (Panther Fusion® System)
Australian sponsor: Hologic (Australia & New Zealand) Pty Ltd
Date approved for supply: 20 Mar 2020
ARTG number: 332641
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Innovation Scientific Pty Ltd (Australia)
Name of test: InnoScreen COVID-19 Antigen Rapid Test Device (Self Test)
Australian sponsor: Innovation Scientific Pty Ltd
Date approved for supply: 28 Oct 2021
ARTG number: 336146
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Innovation Scientific Pty Ltd (Australia)
Name of test: InnoScreen COVID-19 Antigen Rapid Test Device
Australian sponsor: Innovation Scientific Pty Ltd
Date approved for supply: 19 Oct 2020
ARTG number: 336146
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Innovation Scientific Pty Ltd (Australia)
Name of test: InnoScreen™ COVID-19 IgG/IgM Rapid Test
Australian sponsor: Innovation Scientific Pty Ltd
Date approved for supply: 11 May 2020
ARTG number: 336146
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)
Name of test: 2019 nCoV Ag Test (Latex Chromatography Assay) – Self- test
Australian sponsor: BGI Health (AU) Company Pty Ltd
Date approved for supply: 27 Apr 2022
ARTG number: 387550
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)
Name of test: 2019 nCoV Ag Test (Latex Chromatography Assay) – POCT
Australian sponsor: BGI Health (AU) Company Pty Ltd
Date approved for supply: 27 Apr 2022
ARTG number: 387550
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: iXensor Co Ltd (Taiwan)
Name of test: PixoTest® COVID-19 AG Test Kit
Australian sponsor: Pharma Soul Pty Ltd
Date approved for supply: 14 Sep 2021
ARTG number: 374627
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Jiangsu Bioperfectus Technologies Co Ltd (China)
Name of test: COVID-19 Coronavirus Real Time PCR Kit
Australian sponsor: Sonictec
Date approved for supply: 5 Apr 2020
ARTG number: 335828
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Jiangsu Medomics Medical Technology Co Ltd (China)
Name of test: Gardian T3 COVID-19-SARS-CoV-2 Antigen Saliva Self Test
Australian sponsor: Gardian Technologies Pty Ltd
Date approved for supply: 22 Feb 2022
ARTG number: 384538
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Jiangsu Medomics medical technology Co Ltd (China)
Name of test: SARS-CoV-2 antigen Test Kit (LFIA)
Australian sponsor: Jeninno Solutions Pty Ltd
Date approved for supply: 13 Dec 2021
ARTG number: 380739
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Jiangsu Well Biotech Co Ltd (China)
Name of test: Orawell COVID-19 Ag Rapid Saliva Test Device (Self-test)
Australian sponsor: LRY Group of Companies Pty Ltd
Date approved for supply: 8 Mar 2022
ARTG number: 385275
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Jiangsu Well Biotech Co Ltd (China)
Name of test: Orawell COVID-19 Ag Rapid saliva test device (Self-test)
Australian sponsor: Well Biotech Pty Ltd
Date approved for supply: 29 Oct 2021
ARTG number: 377136
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Labnovation Technologies Inc (China)
Name of test: SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography)
Australian sponsor: VITRYL AUS PTY LTD
Date approved for supply: 5 May 2022
ARTG number: 388031
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Life Technologies Corporation (USA)
Name of test: TaqPath COVID-19 Combo Kit
Australian sponsor: Life Technologies Australia Pty Ltd
Date approved for supply: 24 Mar 2020
ARTG number: 332640
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Maccura Biotechnology Co Ltd (China)
Name of test: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Assay Kit
Australian sponsor: Talbot Medical Pty Ltd
Date approved for supply: 9 Mar 2022
ARTG number: 385370
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Meril Diagnostics Pvt Ltd (India)
Name of test: COVIFIND COVID-19 Antigen Self-Test
Australian sponsor: Safe Interact Pty Ltd
Date approved for supply: 22 Apr 2022
ARTG number: 387390
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: MP Biomedicals Asia Pacific Pte Ltd (Singapore)
Name of test: Rapid SARS-COV-2 Antigen Test Card Self-test
Australian sponsor: MP Biomedicals Australasia Pty Ltd
Date approved for supply: 30 Dec 2021
ARTG number: 373711
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: MP Biomedicals Asia Pacific Pte Ltd (Singapore)
Name of test: Rapid SARS-CoV-2 Antigen Test Card
Australian sponsor: MP Biomedicals Australasia Pty Ltd
Date approved for supply: 27 Aug 2021
ARTG number: 373711
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: NeuMoDx Molecular Inc (United States Of America)
Name of test: NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Strip
Australian sponsor: Qiagen Pty Ltd
Date approved for supply: 18 Feb 2022
ARTG number: 368479
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: NeuMoDx Molecular Inc (United States Of America)
Name of test: NeuMoDx™ SARS-CoV-2 Assay
Australian sponsor: Qiagen Pty Ltd
Date approved for supply: 10 Sep 2020
ARTG number: 343260
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: NTBIO Diagnostics Inc (Canada)
Name of test: NTBIO One Step Rapid Test - COVID-19 IgG/IgM Antibody Test
Australian sponsor: Healtheguru Pty Ltd
Date approved for supply: 26 May 2020
ARTG number: 337071
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: Ortho-Clinical Diagnostics (United Kingdom)
Name of test: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen
Australian sponsor: Ortho-Clinical Diagnostics Australia Pty Ltd
Date approved for supply: 9 Mar 2021
ARTG number: 346588
Intended use environment:
Laboratory
Type of test:
Antigen Test
Manufacturer: Ortho-Clinical Diagnostics (United Kingdom)
Name of test: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG
Australian sponsor: Ortho-Clinical Diagnostics Australia Pty Ltd
Date approved for supply: 26 Oct 2020
ARTG number: 346588
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Ortho-Clinical Diagnostics (United Kingdom)
Name of test: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total
Australian sponsor: Ortho-Clinical Diagnostics Australia Pty Ltd
Date approved for supply: 18 Jun 2020
ARTG number: 338079
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: OSANG Healthcare Co Ltd (Korea - Republic of)
Name of test: GeneFinder™ COVID-19 Plus RealAmp Kit
Australian sponsor: Elitechgroup Australia Pty Ltd
Date approved for supply: 24 Jul 2020
ARTG number: 340047
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: PCL Inc (Korea - Republic of)
Name of test: PCL COVID19 Rapid FIA
Australian sponsor: Haemokinesis Pty Ltd
Date approved for supply: 30 Jul 2021
ARTG number: 335597
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: PCL Inc (Korea - Republic of)
Name of test: PCL COVID19 IgG/IgM Rapid Gold
Australian sponsor: Haemokinesis Pty Ltd
Date approved for supply: 1 May 2020
ARTG number: 335597
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: Philosys Co Ltd (Korea - Republic of)
Name of test: Gmate COVID-19 Ag Saliva
Australian sponsor: MD Solutions Australasia Pty Ltd
Date approved for supply: 10 Feb 2022
ARTG number: 383823
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Primer Design Limited (United Kingdom)
Name of test: genesig® Real-Time PCR Coronavirus COVID-19
Australian sponsor: Pacific Laboratory Products Pty Ltd
Date approved for supply: 10 Sep 2020
ARTG number: 343259
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Qiagen GmbH
Name of test: QIAstat-Dx® Respiratory SARS-CoV-2 Panel
Australian sponsor: Qiagen Pty Ltd
Date approved for supply: 8 May 2020
ARTG number: 322230
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Qingdao Hightop Biotech Co Ltd (China)
Name of test: SARS-CoV-2 Antigen Rapid Test
Australian sponsor: Alpha-Medics Australia Pty Ltd
Date approved for supply: 4 Mar 2022
ARTG number: 385179
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Quidel Corporation (United States Of America)
Name of test: Sofia® SARS Antigen FIA
Australian sponsor: Point Of Care Diagnostics Australia Pty Ltd
Date approved for supply: 26 Aug 2020
ARTG number: 342390
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: RapiGEN Inc (Korea - Republic of)
Name of test: BIOCREDIT COVID-19 Ag
Australian sponsor: Haemokinesis Pty Ltd
Date approved for supply: 12 May 2021
ARTG number: 365551
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Roche Diagnostics GmbH (Germany)
Name of test: Elecsys SARS-CoV-2 Antigen assay
Australian sponsor: Roche Diagnostics Australia Pty Limited
Date approved for supply: 30 Aug 2021
ARTG number: 336661
Intended use environment:
Laboratory
Type of test:
Antigen Test
Manufacturer: Roche Diagnostics GmbH (Germany)
Name of test: Elecsys Anti-SARS-CoV-2 S
Australian sponsor: Roche Diagnostics Australia Pty Limited
Date approved for supply: 23 Mar 2021
ARTG number: 336661
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Roche Diagnostics GmbH (Germany)
Name of test: Elecsys Anti-SARS-CoV-2
Australian sponsor: Roche Diagnostics Australia Pty Limited
Date approved for supply: 20 May 2020
ARTG number: 336661
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Roche Molecular Systems Inc (USA)
Name of test: cobas® SARS-CoV-2 & Influenza A/B
Australian sponsor: Roche Diagnostics Australia Pty Limited
Date approved for supply: 11 Dec 2020
ARTG number: 299690
Intended use environment:
Point-of-care test
Type of test:
Nucleic Acid Test
Manufacturer: Roche Molecular Systems Inc (USA)
Name of test: cobas® SARS-CoV-2
Australian sponsor: Roche Diagnostics Australia Pty Limited
Date approved for supply: 20 Mar 2020
ARTG number: 332509
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Sansure Biotech Inc (China)
Name of test: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Australian sponsor: Allsafe Medical Pty Ltd
Date approved for supply: 29 Jun 2020
ARTG number: 338589
Intended use environment:
Point-of-care test
Type of test:
Nucleic Acid Test
Manufacturer: SD Biosensor Inc (Korea - Republic of)
Name of test: SARS-CoV-2 Antigen Self Test Nasal
Australian sponsor: Roche Diagnostics Australia Pty Limited
Date approved for supply: 15 Oct 2021
ARTG number: 352250
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: SD Biosensor Inc (Korea - Republic of)
Name of test: SARS-CoV-2 Rapid Antigen Test Nasal
Australian sponsor: Roche Diagnostics Australia Pty Limited
Date approved for supply: 4 Aug 2021
ARTG number: 352250
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: SD Biosensor Inc (Korea - Republic of)
Name of test: SARS-CoV-2 Rapid Antigen Test
Australian sponsor: Roche Diagnostics Australia Pty Limited
Date approved for supply: 24 Dec 2020
ARTG number: 352250
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: SD Biosensor Inc (Korea - Republic of)
Name of test: STANDARD™ Q COVID-19 Ag Test
Australian sponsor: Biocelect Pty Ltd
Date approved for supply: 1 Oct 2020
ARTG number: 345219
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: Seegene Inc (Korea - Republic of)
Name of test: Allplex SARS-CoV-2 Fast PCR Assay
Australian sponsor: Integrated Sciences Pty Ltd
Date approved for supply: 12 Apr 2022
ARTG number: 333060
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Seegene Inc (Korea - Republic of)
Name of test: Allplex RV Master Assay
Australian sponsor: Integrated Sciences Pty Ltd
Date approved for supply: 22 Mar 2022
ARTG number: 239512
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Seegene Inc (Korea - Republic of)
Name of test: Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay
Australian sponsor: Integrated Sciences Pty Ltd
Date approved for supply: 18 Dec 2020
ARTG number: 239512
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Seegene Inc (Korea - Republic of)
Name of test: Allplex™ SARS-CoV-2 Assay
Australian sponsor: Integrated Sciences Pty Ltd
Date approved for supply: 17 Jun 2020
ARTG number: 333060
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Seegene Inc (Korea - Republic of)
Name of test: Allplex™ 2019-nCoV Assay
Australian sponsor: Integrated Sciences Pty Ltd
Date approved for supply: 27 Mar 2020
ARTG number: 333060
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Shanghai ZJ Bio-Tech Co Ltd (China)
Name of test: Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 Genes)
Australian sponsor: Pocratis Medical Pty Ltd
Date approved for supply: 22 Sep 2020
ARTG number: 344090
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Shanghai ZJ Bio-Tech Co Ltd (China)
Name of test: Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 genes)
Australian sponsor: Icon International Pty Ltd t/a Icon Medipharm
Date approved for supply: 22 Mar 2020
ARTG number: 332963
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)
Name of test: Dimension Vista® SARS-CoV-2 IgG Assay (CV2G)
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 19 Mar 2021
ARTG number: 340530
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)
Name of test: Dimension EXL SARS-CoV-2 IgG Assay (CV2G)
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 19 Mar 2021
ARTG number: 340530
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)
Name of test: Atellica® IM SARS-CoV-2 IgG (sCOVG) assay
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 29 Jan 2021
ARTG number: 337497
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)
Name of test: ADVIA Centaur® SARS-CoV-2 IgG (sCOVG) assay
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 29 Jan 2021
ARTG number: 337497
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)
Name of test: Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 30 Jul 2020
ARTG number: 340530
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)
Name of test: Dimension Vista® SARS-CoV-2 Total antibody assay (COV2T)
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 30 Jul 2020
ARTG number: 340530
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)
Name of test: ADVIA Centaur® SARS-CoV-2 IgG assay
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 28 Jul 2020
ARTG number: 337497
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)
Name of test: Atellica® IM SARS-CoV-2 IgG assay
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 28 Jul 2020
ARTG number: 337497
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)
Name of test: ADVIA Centaur® SARS-CoV-2 Total (COV2T) assay
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 5 Jun 2020
ARTG number: 337497
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)
Name of test: Atellica® IM SARS-CoV-2 Total (COV2T) assay
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 5 Jun 2020
ARTG number: 337497
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: SpeeDx Pty Ltd (Australia)
Name of test: PlexPCR® SARS-CoV-2
Australian sponsor: SpeeDx Pty Ltd
Date approved for supply: 12 Aug 2021
ARTG number: 372688
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: SureScreen Diagnostics Ltd (United Kingdom)
Name of test: SureScreen SARS-CoV-2 Antigen Rapid test Cassette (Nasal Swab) (Gold)
Australian sponsor: SureScreen Australia Pty Limited
Date approved for supply: 29 Apr 2022
ARTG number: 387662
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: SureScreen Diagnostics Ltd (United Kingdom)
Name of test: SureScreen Diagnostics SARS-CoV-2 Antigen Rapid Test Cassette (Nasal Swab) Gold) with RhinoSwab Junior
Australian sponsor: SureScreen Australia Pty Limited
Date approved for supply: 29 Apr 2022
ARTG number: 387662
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: Suzhou Sym-Bio Lifescience Co Ltd (China)
Name of test: PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel
Australian sponsor: PerkinElmer
Date approved for supply: 26 Nov 2020
ARTG number: 349811
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Suzhou Sym-Bio Lifescience Co Ltd (China)
Name of test: PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay
Australian sponsor: PerkinElmer
Date approved for supply: 3 Jun 2020
ARTG number: 337365
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd (China)
Name of test: Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)
Australian sponsor: Emergence Technology Pty Ltd
Date approved for supply: 2 Nov 2020
ARTG number: 346951
Intended use environment:
Laboratory/Point-of-care test
Type of test:
Nucleic Acid Test
Manufacturer: Vela Operations Singapore Pte Ltd (Singapore)
Name of test: ViroKey™ SARS-CoV-2 RT-PCR Test v2.0
Australian sponsor: Vela Diagnostics Australia Pty Ltd
Date approved for supply: 26 Aug 2020
ARTG number: 342337
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: VivaChek Biotech (Hangzhou) Co Ltd (China)
Name of test: VivaDiag Pro SARS-CoV-2 Ag Rapid Test
Australian sponsor: Stonestar Wholesale Pty Ltd
Date approved for supply: 25 Feb 2022
ARTG number: 348890
Intended use environment:
Self-test
Type of test:
Antigen Test
Manufacturer: VivaChek Biotech (Hangzhou) Co Ltd (China)
Name of test: VivaDiag™ SARS-CoV-2 Ag Rapid Test
Australian sponsor: Stonestar Wholesale Pty Ltd
Date approved for supply: 18 Nov 2020
ARTG number: 348890
Intended use environment:
Point-of-care test
Type of test:
Antigen Test
Manufacturer: VivaChek Biotech (Hangzhou) Co Ltd (China)
Name of test: VivaDiag™ COVID-19 IgM/IgG Rapid Test
Australian sponsor: Stonestar Wholesale Pty Ltd
Date approved for supply: 6 Apr 2020
ARTG number: 333909
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: Wallac Oy (Finland)
Name of test: GSP®/DELFIA® Anti-SARS-CoV-2 IgG kit
Australian sponsor: PerkinElmer
Date approved for supply: 2 Nov 2020
ARTG number: 342770
Intended use environment:
Laboratory
Type of test:
Immunoassay
Manufacturer: Wallac Oy (Finland)
Name of test: SARS-CoV-2 RT-qPCR Reagent Kit
Australian sponsor: PerkinElmer
Date approved for supply: 1 Sep 2020
ARTG number: 342770
Intended use environment:
Laboratory
Type of test:
Nucleic Acid Test
Manufacturer: Xiamen Biotime Biotechnology Co Ltd (China)
Name of test: BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test
Australian sponsor: Cartex Hoya Pty Ltd
Date approved for supply: 9 Nov 2020
ARTG number: 347730
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: Zhejiang Orient Gene Biotech Co Ltd (China)
Name of test: COVID-19 IgG/IgM Rapid Test Cassette
Australian sponsor: Onsite Diagnostics Pty Ltd
Date approved for supply: 14 Apr 2020
ARTG number: 334505
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
Manufacturer: Zhongshan Chuangyi Biochemical Engineering Co Ltd (China)
Name of test: COVID-19 IgG/IgM Rapid Test Kit
Australian sponsor: LJCJ Pty Ltd
Date approved for supply: 7 Sep 2020
ARTG number: 343116
Intended use environment:
Point-of-care test
Type of test:
Lateral Flow IgG/IgM
- Category:Medical devices/IVDs
- Tags:medical devices, COVID-19 tests, rapid antigen testing, businesses
- URL:https://www.tga.gov.au/node/904122