0 |
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 |