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COVID-19 test kits included in the ARTG for legal supply in Australia
17 September 2021
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 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 tests to inform their best use.
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.
*Note: Some point-of-care tests are not intended for use with finger-prick (finger-stick) specimens. 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 - 136 of 136
Point-of-care test*
Nucleic Acid Test
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
Laboratory
Immunoassay
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Point-of-care 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
Point-of-care 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
Point-of-care 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
Laboratory
Nucleic Acid 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
Point-of-care 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
Laboratory
Nucleic Acid Test
Manufacturer: AMT Pte Ltd (Singapore)
Name of test: RESOLUTE 2.0
Australian sponsor: Accelagen Pty Ltd
Date approved for supply: 3 Jun 2021
Point-of-care test*
Antigen 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
Point-of-care 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
Point-of-care 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
Point-of-care test*
Lateral Flow IgG/IgM
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
Laboratory
Nucleic Acid Test
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
Laboratory
Immunoassay
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
Laboratory
Nucleic Acid 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
Point-of-care test*
Antigen Test
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
Point-of-care test*
Lateral Flow IgG/IgM
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
Point-of-care test*
Antigen 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
Laboratory
Immunoassay
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
Laboratory
Nucleic Acid Test
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
Laboratory
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
Laboratory
Immunoassay
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
Laboratory
Nucleic Acid Test
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
Laboratory
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
Point-of-care test*
Lateral Flow IgG/IgM
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 2020
Laboratory
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
Laboratory/Point-of-care test*
Antigen Test
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
Laboratory
Nucleic Acid 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
Laboratory
Immunoassay
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
Laboratory
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
Point-of-care test*
Antigen Test
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
Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: BTNX Inc (Canada)
Name of test: COVID-19 IgG/IgM Rapid Test
Australian sponsor: SureScreen Australia Pty Limited
Date approved for supply: 2 Jul 2021
Point-of-care 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
Point-of-care test*
Lateral Flow IgG/IgM
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
Laboratory/Point-of-care test*
Nucleic Acid Test
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
Laboratory/Point-of-care 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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Point-of-care test*
Lateral Flow IgG/IgM
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
Point-of-care 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
Laboratory
Nucleic Acid Test
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
Laboratory
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
Laboratory
Immunoassay
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Point-of-care test*
Antigen Test
Manufacturer: Empowered Diagnostics LLC (United States Of America)
Name of test: CovClear COVID-19 Antigen Test
Australian sponsor: Medi-Stats ANZ Pty Ltd
Date approved for supply: 2 Sep 2021
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
Nucleic Acid Test
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
Point-of-care 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
Laboratory
Nucleic Acid 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
Point-of-care 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
Point-of-care 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: Allsafe Medical Pty Ltd
Date approved for supply: 17 Apr 2020
Point-of-care 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
Laboratory
Nucleic Acid Test
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
Point-of-care test*
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd
Name of test: COVID-19 Antigen Rapid Test (Oral Fluid) ICOV-802
Australian sponsor: Compliance Management Solutions
Date approved for supply: 13 Sep 2021
Point-of-care test*
Antigen Test
Manufacturer: Hangzhou Alltest Biotech Co Ltd
Name of test: SARS-CoV-2 Antigen Rapid Test INCP-502-N
Australian sponsor: Compliance Management Solutions
Date approved for supply: 13 Sep 2021
Point-of-care 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
Point-of-care test*
Lateral Flow IgG/IgM
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
Point-of-care test*
Lateral Flow IgG/IgM
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
Point-of-care test*
Antigen Test
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
Point-of-care test*
Lateral Flow IgG/IgM
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
Point-of-care 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
Laboratory/Point-of-care 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
Point-of-care test*
Lateral Flow IgG/IgM
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
Point-of-care 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
Point-of-care test*
Lateral Flow IgG/IgM
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
Laboratory
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
Laboratory
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
Point-of-care test*
Lateral Flow IgG/IgM
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
Point-of-care 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
Point-of-care 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
Laboratory
Nucleic Acid 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 May 2020
Laboratory
Nucleic Acid 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
Point-of-care 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
Laboratory
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
Point-of-care test*
Lateral Flow IgG/IgM
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: 27 May 2020
Laboratory
Immunoassay
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
Laboratory
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: 19 Jun 2020
Laboratory
Antigen Test
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
Laboratory
Nucleic Acid Test
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
Point-of-care test*
Antigen 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
Point-of-care test*
Lateral Flow IgG/IgM
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
Laboratory
Nucleic Acid 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
Laboratory
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
Point-of-care 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
Point-of-care 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
Laboratory
Immunoassay
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
Laboratory
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
Laboratory
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
Laboratory
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
Point-of-care test*
Nucleic Acid Test
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
Point-of-care 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
Point-of-care 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
Point-of-care 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: 30 Sep 2020
Point-of-care 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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
Immunoassay
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
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
Laboratory
Nucleic Acid Test
Manufacturer: SpeeDx Pty Ltd (Australia)
Name of test: PlexPCR® SARS-CoV-2
Australian sponsor: SpeeDx Pty Ltd
Date approved for supply: 12 Aug 2021
Laboratory
Nucleic Acid 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
Laboratory
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: 2 Jun 2020
Laboratory/Point-of-care 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
Laboratory
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
Point-of-care test*
Lateral Flow IgG/IgM
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
Point-of-care 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
Laboratory
Immunoassay
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
Laboratory
Nucleic Acid Test
Manufacturer: Wallac Oy (Finland)
Name of test: SARS-CoV-2 RT-qPCR Reagent Kit
Australian sponsor: PerkinElmer
Date approved for supply: 1 Sep 2020
Point-of-care test*
Lateral Flow IgG/IgM
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
Point-of-care 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
Point-of-care 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
- Category:Medical devices/IVDs
- Tags:medical devices, COVID-19 tests, rapid antigen testing, businesses
- URL:https://www.tga.gov.au/node/904122