Maria needs to work hard to be able to sell some of these test kits, as you can see the TGA list below, since 25 March, there are 28 more companies have been approved to distribute test kits in Australia, 18 of them are the same kind of test kits eg. Lateral Flow IgG/IgM, further more, these companies are very very big do compare with us.
Name of Test Type of Test Australian Sponsor** Manufacturer country Date Approved for Supply 1 SARS-CoV-2 Antibody Test (Lateral Flow Method) Lateral Flow IgG/IgM ALLSAFE MEDICAL PTY LTD Guangzhou Wondfo Biotech Co Ltd (China) Denmark 17-Apr-20 2 Abbott RealTime SARS-CoV-2 Nucleic Acid Test Abbott Australasia Pty Ltd Molecular Division Abbott Molecular Inc (United States Of America) USA 17-Apr-20 3 BD SARS-CoV-2 Reagents for BD MAX™ System Nucleic Acid Test Becton Dickinson Pty Ltd Becton Dickinson and Company (United States Of America) USA 17-Apr-20 4 2019-nCov Ab Test (Colloidal Gold) Lateral Flow IgG/IgM Laser Corporation Holdings Pty Limited Innovita (Tangshan) Biological Technology Co Ltd (China) China 16-Apr-20 5 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device Lateral Flow IgG/IgM Solasta Life Pty Ltd Hangzhou Realy Tech Co Ltd (China) China 16-Apr-20 6 PowerChekTM 2019-nCoV Real-time PCR Kit Nucleic Acid Test World Systems Corporation Pty Ltd Kogene Biotech Co Ltd (Korea - Republic of) Korea 16-Apr-20 7 COVID-19 IgG/IgM Rapid Test Cassette Lateral Flow IgG/IgM Onsite Diagnostics Pty Ltd Zhejiang Orient Gene Biotech Co Ltd (China) China 14-Apr-20 8 EasyScreen™ SARS-CoV-2 Detection Kit Nucleic Acid Test Genetic Signatures Ltd Genetic Signatures Ltd (Australia) Australia 13-Apr-20 9 2019-nCoV Ab Test (Colloidal Gold) Lateral Flow IgG/IgM TrendBio Pty Ltd Innovita (Tangshan) Biological Technology Co Ltd (China) China 11-Apr-20 10 Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 Nucleic Acid Test BGI Health (AU) Company Pty Ltd BGI Europe A/S (Denmark) Denmark 10-Apr-20 11 SARS-CoV-2 Antibody Test (Lateral Flow Method) Lateral Flow IgG/IgM Tayler Dental Consulting Pty Ltd Guangzhou Wondfo Biotech Co Ltd (China) China 9-Apr-20 12 2019-nCoV Ab Test (Colloidal Gold) Lateral Flow IgG/IgM Endo X Innovita (Tangshan) Biological Technology Co Ltd (China) China 8-Apr-20 13 SARS-CoV-2 IgM/lgG Antibody Rapid Test Lateral Flow IgG/IgM CK Surgitech Pty Ltd Qingdao Hightop Biotech Co Ltd (China) China 7-Apr-20 14 COVID-19 IgG/IgM Rapid Test Cassette Lateral Flow IgG/IgM Zenpharm Pty Ltd Hangzhou Clongene Biotech Co Ltd (China) China 6-Apr-20 15 Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) Lateral Flow IgG/IgM Complementary Medicines Group Pty Ltd Hangzhou Laihe Biotech Co Ltd (China) China 6-Apr-20 16 VivaDiag™ COVID-19 IgM/IgG Rapid Test Lateral Flow IgG/IgM Stonestar Wholesale Pty Ltd VivaChek Biotech (Hangzhou) Co Ltd (China) China 6-Apr-20 17 2019-nCoV Ab Test (Colloidal Gold) Lateral Flow IgG/IgM Aurora Future Education Group Innovita (Tangshan) Biological Technology Co Ltd (China) China 4-Apr-20 18 COVID-19 IgG/IgM Rapid Test Cassette Lateral Flow IgG/IgM Ausliance Group Pty Ltd Hangzhou Clongene Biotech Co Ltd (China) China 4-Apr-20 19 COVID-19 IgG/IgM Rapid Test Cassette Lateral Flow IgG/IgM Medsupply Australia Pty Ltd Hangzhou Biotest Biotech Co Ltd (China) China 4-Apr-20 20 COVID-19 IgG/IgM Rapid Test Cassette Lateral Flow IgG/IgM Amandla China Pty Limited Zhejiang Orient Gene Biotech Co Ltd (China) China 1-Apr-20 21 Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test kit Lateral Flow IgG/IgM Medicision Pty Ltd Cellex Inc (United States Of America) USA 31-Mar-20 22 SARS-CoV-2 IgM/IgG Antibody Rapid Test Lateral Flow IgG/IgM Envon Pty Ltd Qingdao Hightop Biotech Co Ltd (China) China 31-Mar-20 23 VIASURE SARS-CoV-2 Real Time PCR Detection Kit Nucleic Acid Test Abacus dx Pty Ltd CerTest Biotec SL (Spain) Spain 31-Mar-20 24 Wantai SARS-CoV-2 Ab Rapid Test kit Lateral Flow IgG/IgM Life Clinic Australia Pty Ltd Beijing Wantai Biologicalpharmacy Enterprise Co Ltd (China) China 27-Mar-20 25 Allplex™ 2019-nCoV Assay Nucleic Acid Test Integrated Sciences Pty Ltd Seegene Inc (Korea - Republic of) Korea 27-Mar-20 26 COVID-19 IgG/IgM Rapid Test Cassette Lateral Flow IgG/IgM APAC Security Pty Ltd Hangzhou Clongene Biotech Co Ltd (China) China 26-Mar-20 27 VivaDiag™ COVID-19 IgM/IgG Rapid Test Lateral Flow IgG/IgM Device Technologies Australia Pty Ltd VivaChek Biotech (Hangzhou) Co Ltd (China) China 26-Mar-20 28 SARS-CoV-2 Antibody Test (Lateral Flow Method) Lateral Flow IgG/IgM Advangen International Pty Ltd Guangzhou Wondfo Biotech Co Ltd (China) China 25-Mar-20 29 TaqPath COVID-19 Combo Kit Nucleic Acid Test Life Technologies Australia Pty Ltd Life Technologies Corporation (USA) USA 24-Mar-20 30 2019-n-CoV IgG/IgM Rapid Test Cassette Lateral Flow IgG/IgM AM Diagnostics - DC Hangzhou Alltest Biotech Co Ltd (China) China 23-Mar-20 31 Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 genes) Nucleic Acid Test Icon International Pty Ltd t/a Icon Medipharm Shanghai ZJ Bio-Tech Co Ltd (China) China 22-Mar-20 32 Xpert® Xpress SARS-CoV-2 Nucleic Acid Test Cepheid Holdings Pty Ltd Cepheid (USA) USA 22-Mar-20 33 VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit Nucleic Acid Test Becton Dickinson Pty Ltd CerTest Biotec SL (Spain) Spain 21-Mar-20 34 VivaDiag™ COVID-19 IgM/IgG Rapid Test Lateral Flow IgG/IgM Endo X Pty Ltd VivaCheck Biotech (Hangzhou) Co Ltd (China) China 20-Mar-20 35 cobas® SARS-CoV-2 Nucleic Acid Test Roche Diagnostics Australia Pty Limited Roche Molecular Systems Inc (USA) USA 20-Mar-20 36 Panther Fusion® SARS-CoV-2 Assay (Panther Fusion® System) Nucleic Acid Test Hologic (Australia & New Zealand) Pty Ltd Hologic Inc (USA) USA 20-Mar-20 37 OnSite COVID-19 IgG/IgM Rapid Test Lateral Flow IgG/IgM MD Solutions Australasia Pty Ltd CTK Biotech Inc (USA) USA 19-Mar-20 38 AusDiagnostics respiratory virus panel (including SARS-CoV-2) test Nucleic Acid Test AusDiagnostics Pty Ltd AusDiagnostics Pty Ltd (Australia) Australia 19-Mar-20
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