Skip to main content
A Singapore Government Agency Website

HSA Expedites Approval of COVID-19 Diagnostic Tests in Singapore via Provisional Authorisation

The Health Sciences Authority (HSA) is committed to ensuring the rapid availability of diagnostic tests for COVID-19 in Singapore. Since 29 January 2020, HSA has been closely providing regulatory and scientific advice to research institutions as well as local and multi-national companies to ensure the timely availability of good quality performing test kits that are critical during this period of need.

See Table below for more information on the diagnostic tests that we have approved to date via provisional authorisation.

Provisional authorisation

To address the urgent need for timely detection of COVID-19 infection, HSA has set up a provisional authorisation process for tests intended for the detection and/or diagnosis of COVID-19 infection. This has helped expand the number and variety of diagnostic tests available in Singapore.

This provisional authorisation is based on a risk-calibrated review process that considers the design aspects of the test (e.g. primers and probe design, target sequence in the viral RNA) and the supporting validation data122 KB (e.g. Limit of detection, cross reactivity, inclusivity). Periodic reports on specific data on the safety and/or performance of these tests will be required to be submitted to HSA post authorisation to assure the continued performance of these devices. If any safety or performance issues are observed, HSA will require relevant follow up actions at the manufacturer’s end. 

This provisional authorisation has been implemented as an interim measure in response to the current public health need for timely detection of COVID-19 infections. If an applicant wishes to supply this test in the long  term, it must be registered with HSA. You can find more information on product registration here.

If you have any questions regarding this provisional authorisation process, please contact us here.

How to submit an application for Provisional Authorisation to HSA:

Email hsa_md_info@hsa.gov.sg with the subject ‘Provisional Authorisation’ with the following information:

  • A brief description of your test (test design, target biomarker, device technology, description of key functional elements, specifications, composition, accessories)
  • Intended purpose of your test
  • Information for Users (IFU) for the test
  • Summary of analytical validation (e.g. Limit of Detection, inclusivity, cross-reactivity, precision, interfering substances, Hook effect) and clinical data collected for your test where available
  • Summary of any planned or ongoing validation including clinical studies

HSA will get in touch with the applicant within 3 working days.

 

The Table below lists the COVID-19 tests that have received provisional authorisation to date. It will be updated as more tests gets approved: 

No.

Applicant

Name of test

For more information

1

Diagnostics Development Hub (DxD)

 

FORTITUDE KIT 2.0E
2

Veredus Laboratories Pte Ltd

 

VereCoV™ Detection Kit
3

AITbiotech Pte Ltd

 

abTES™ COVID-19 qPCR I Kit
4

DSO National Laboratories

Real-Time PCR Assay for the Detection of SARS-CoV-2 Virus
5

Roche Diagnostics Asia Pacific Pte Ltd

Cobas® SARS-CoV-2

 Roche_Provisional Authorisation for Covid-19 tests_17042020448 KB
6

JN Medsys Pte Ltd

ProTect™ COVID-19 RT-qPCR Kit
7

Life Technologies Holdings Pte Ltd

TaqPath™ COVID-19 Combo Kit
8

Everest Links Pte Ltd

VivaDiag™ SARS-CoV-2 IgM/IgG Rapid Test
9  Biolidics Limited              

Nanjing Vazyme 2019-nCoV IgG/IgM Detection Kit

also marketed as

Biolidics 2019-nCoV IgG/IgM Detection Kit

 Biolidics Limited451 KB
10 Biowalker Pte Ltd Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)
 Biowalker Pte Ltd453 KB
11 SPD Scientific Pte Ltd  Cepheid® Xpert® Xpress SARS-CoV-2  SPD_Cepheid® Xpert® Xpress SARS-CoV-2_Provisional Authorisation for Covid-19 tests_14102020100 KB
12 MiRXES Pte Ltd MiRXES FORTITUDE KIT 2.0
 MiRXES_Provisional Authorisation for Covid-19 tests_17042020439 KB
13 Acumen Research Laboratories
 Acu-Corona™ 2.0  Acumen Research Laboratories Pte Ltd442 KB
14 Credo Diagnostics Biomedical Pte Ltd
 VitaPCR™ SARS-CoV-2 Assay
 Credo Diagnostics Biomedical Pte Ltd443 KB
15 Abbott Laboratories (Singapore) Pte Ltd
 Abbott RealTime SARS-CoV-2 assay
 Abbott Laboratories (Singapore) Pte Ltd445 KB
16 All Eights (Singapore) Pte Ltd
 Seegene AllplexTM 2019-nCoV Assay
 All Eights (Singapore) Pte Ltd444 KB
17 SkyQuest Pte Ltd
 Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method)
 SkyQuest_Wondfo_Provisional Authorisation for Covid-19 tests_17072020135 KB
18 Camtech Diagnostics Pte Ltd
 Camtech COVID-19 IgM/IgG
 Camtech Diagnostics Pte Ltd442 KB
19 Acumen Research Laboratories Pte Ltd
 Acu-Corona 3.0
 Acumen Research Laboratories Pte Ltd - Acu-Corona 3.0444 KB
20 Vela Operations Singapore Pte Ltd
 ViroKey SARS-CoV-2 RT-PCR Test  Vela_Provisional Authorisation for Covid-19 tests_17042020441 KB
21 PerkinElmer Singapore Pte Ltd               PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay
 PerkinElmer_Provisional Authorisation for Covid-19 tests_24042020438 KB
22 BioWalker Pte Ltd
 BioWalker SARS-CoV-2 Assay
 Biowalker_Provisional Authorisation for Covid-19 tests_24042020438 KB
23 Medicell Pharmaceutical (S) Pte Ltd
 Sansure Biotech Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit
 Medicell_Provisional Authorisation for Covid-19 tests_24042020448 KB
24  Grit Overseas Pte Ltd  DiagnoSure COVID-19 IgG/ IgM Rapid Test Cassette
 Grit_Provisional Authorisation for Covid-19 tests_24042020445 KB
25 BGI Health (SG) Company Pte Ltd
 Real-time fluorescent RT-PCR kit for detecting 2019-nCoV
 BGI_Provisional Authorisation for Covid-19 tests_12052020457 KB
26 Veredus Laboratories Pte Ltd
 Shanghai LiangRun LionRun Diagnostic Kit for Antibody IgM-IgG of Novel Coronavirus COVID-19  Veredus_Provisional Authorisation for Covid-19 tests_05052020454 KB
27 Bioforge Solutions Pte Ltd
 INNOVITA 2019-nCoV Ab Test (Colloidal Gold)
 Bioforge_INNOVITA_Provisional Authorisation for Covid-19 tests_05052020451 KB
28 Bioforge Solutions Pte Ltd
 Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method)
 Bioforge_Wondfo_Provisional Authorisation for Covid-19 tests_05052020447 KB
29 Diagnostics Development Hub (DxD)
 Fortitude™ Kit 2.1
 DXD_Provisional Authorisation for Covid-19 tests_05052020444 KB
30 Abbott Laboratories (S) Pte Ltd
 Abbott SARS-CoV-2 IgG – ARCHITECT assay
 Abbott_Provisional Authorisation for Covid-19 tests_05052020444 KB
31 Genomax Technologies Pte Ltd
 Allplex 2019-nCoV Assay
 Genomax_Provisional Authorisation for Covid-19 tests_05052020446 KB
32 BioWalker Pte Ltd
 BioWalker SARS-CoV-2 Assay 2.0
 Biowalker_Provisional Authorisation for Covid-19 tests_05052020441 KB
33 Tanglin Cardiology Pte Ltd
 Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit
 Tanglin_Provisional Authorisation for Covid-19 tests_05052020451 KB
34  Roche Diagnostics Asia Pacific Pte Ltd
 Roche Elecsys Anti-SARS-CoV-2
 Roche_Provisional Authorisation for Covid-19 tests_05052020443 KB
35  Becton Dickinson Holding Ptd Ltd
 BD SARS-CoV-2 Reagents for BD MAX™ System
 Becton Dickinson_Provisional Authorisation for Covid-19 tests__06052020450 KB
36 Biomed Diagnostics Pte Ltd
 Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit  Biomed_Provisional Authorisation for Covid-19 tests_06052020455 KB
37 Ortho Clinical Diagnostics
 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack
 Ortho Clinical Diagnostics_Provisional Authorisation for Covid-19 tests_15052020455 KB
38 MP Biomedicals Asia Pacific Pte Ltd
 MP Diagnostics ASSURE® SARS-CoV-2 IgG/IgM Rapid Test
 MP Biomedicals_Provisional Authorisation for Covid-19 tests_09072020134 KB
39 Biomed Diagnostics Pte Ltd
 INNOVITA 2019-nCoV Ab Test (Colloidal Gold)
 Biomed_Innovita_Provisional Authorisation for Covid-19 tests_12052020450 KB
40 Biomed Diagnostics Pte Ltd
 Luminex NxTAG® CoV Extended Panel Assay
 Biomed_Luminex_Provisional Authorisation for Covid-19 tests_12052020443 KB
41 Genscript Biotech (Singapore) Pte Ltd
 cPassTM SARS-CoV-2 Neutralization Antibody Detection Kit
 Genscript_cPass_Provisional Authorisation for Covid-19 tests_18082020132 KB
42 MiRXES Pte Ltd
 MiRXES Fortitude Kit 2.1
 MiRXES_Fortitude 2.1_Provisional Authorisation for Covid-19 tests_12052020440 KB
43 Trans Sahara Corporation Pte Ltd
 Xiamen Boson Rapid 2019-nCOV IgG/IgM Combo Test Card
 Trans Sahara_Provisional Authorisation for Covid-19 tests_15052020448 KB
44 BioMérieux Singapore Pte Ltd
 BioFire® Respiratory Panel 2.1 (RP2.1)
 BioMérieux_Provisional Authorisation for Covid-19 tests_15052020442 KB
45 SPD Scientific Pte Ltd
 GeneFinder™ COVID-19 Plus RealAmp Kit
 SPD_GeneFinder_Provisional Authorisation for Covid-19 tests_15052020449 KB
46 All Eights (Singapore) Pte Ltd
 EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit
 All Eights_EDI IgG_Provisional Authorisation for Covid-19 tests_19052020446 KB
47 All Eights (Singapore) Pte Ltd
 EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit
 All Eights_EDI IgM_Provisional Authorisation for Covid-19 tests_19052020445 KB
48 SDT Molecular Pte Ltd
 altona Diagnostics RealStar™ SARS-CoV-2 RT-PCR Kit 1.0
 SDT_Provisional Authorisation for Covid-19 tests_19052020445 KB
49 Healthgroup Medical Pte Ltd
 HealthGroup Medical V-CODE Sars-CoV-2 (COVID-19) IgG/IgM Rapid Test
 Healthgroup_Provisional Authorisation for Covid-19 tests_19052020446 KB
50 AMT Pte Ltd
 AMT RESOLUTE 1.0
 AMT_Provisional Authorisation for Covid-19 tests_22052020433 KB
51 I-Test Pte Ltd
 i-Test COVID -19 IgM/IgG Antibody Rapid Test (Colloidal Gold)
 I-Test_Provisional Authorisation for Covid-19 tests_22052020442 KB
52 Ying Assets Management Pte Ltd
 INNOVITA 2019-nCoV Ab Test (Colloidal Gold)
 Ying Assets_Provisional Authorisation for Covid-19 tests_22052020443 KB
53 Abbott Laboratories (S) Pte Ltd
 ABBOTT Alinity i SARS-CoV-2 IgG
 Abbott_Alinity_Provisional Authorisation for Covid-19 tests_28052020127 KB
54 Novena Global Healthcare Pte Ltd
 Fosun Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
 Novena_Fosun_Provisional Authorisation for Covid-19 tests_28052020131 KB
55 COBS Pte Ltd
 BIOSYNEX COVID-19 BSS
 COBS_BIOSYNEX_Provisional Authorisation for Covid-19 tests_28052020127 KB
56 Siemens Healthcare Pte Ltd
 FTD™ SARS-CoV-2
 Siemens_FTD_Provisional Authorisation for Covid-19 tests_28052020131 KB
57 Qiagen Singapore Pte. Ltd 
 QIAstat-Dx® Respiratory SARS-CoV-2 Panel
 Qiagen_QIAstat_Provisional Authorisation for Covid-19 tests_02062020137 KB
58 Euroimmun (South East Asia) Pte. Ltd.
 EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG)
 Euroimmun_Anti-SARS IgG_Provisional Authorisation for Covid-19 tests_02062020127 KB
59 SPD Scientific Pte Ltd
 2019-nCoV IgG/IgM Rapid Test
 SPD Scientific_2019-nCoV_Provisional Authorisation for Covid-19 tests_02062020133 KB
60 Trident Pharm Pte Ltd
 SARS-CoV-2 Antibody Test Strip
 Trident_SARS-CoV-2_Provisional Authorisation for Covid-19 tests_02062020124 KB
61 Sinch Medical Pte Ltd
 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device
 Sinch_2019-nCov_Provisional Authorisation for Covid-19 tests_02062020133 KB
62 Euroimmun (South East Asia) Pte. Ltd.
 EUROIMMUN Anti-SARS-CoV-2 ELISA (IgA)
 Euroimmun_Anti-SARS IgA_Provisional Authorisation for Covid-19 tests_02062020126 KB
63 Transmedic Pte Ltd
 Genrui Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold)
 Transmedic_Genrui_Provisional Authorisation for Covid-19 tests_12062020132 KB
64 Siemens Healthcare Pte Ltd
 Siemens Atellica® IM SARS-CoV-2 Total (COV2T)
 Siemens_Atellica_Provisional Authorisation for Covid-19 tests_02062020129 KB
65 Siemens Healthcare Pte Ltd
 Siemens ADVIA Centaur® SARS-CoV-2 Total (COV2T)
 Siemens_ADVIA_Provisional Authorisation for Covid-19 tests_02062020129 KB
66 Xentific Labs Pte Ltd
 Standard Q COVID-19 Ag Test
 Xentific_Standard Q_Provisional Authorisation for Covid-19 tests_08062020135 KB
67 Veredus Laboratories Pte Ltd
 VereRT™ COVID-19 PCR Kit
 Veredus_VereRT™_Provisional Authorisation for Covid-19 tests_23092020101 KB
68 Ortho Clinical Diagnostics
 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
 Ortho Clinical_VITROS_Provisional Authorisation for Covid-19 tests_08062020143 KB
69 Alcotech Pte Ltd
 2019-nCoV IgG/IgM Rapid Test Cassette
 Alcotech_2019-nCoV_Provisional Authorisation for Covid-19 tests_08062020131 KB
70 Unison Collaborative Pte Ltd
 RightSign COVID-19 IgG/IgM Rapid Test Cassette
 Unison_RightSign_Provisional Authorisation for Covid-19 tests_12062020131 KB
71 XIN Pte Ltd
 Fosun Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
 Xin_Fosun_Provisional Authorisation for Covid-19 tests_19062020130 KB
72 Credo Diagnostics Biomedical Pte Ltd
 VitaPCR™ SARS-CoV-2 Gen 2 Assay  Credo_VitaPCR_Provisional Authorisation for Covid-19 tests_19062020132 KB
73  Biomed Diagnostics Pte Ltd
 Luminex ARIES® SARS-CoV-2 Assay
 Biomed_Luminex Aries_Provisional Authorisation for Covid-19 tests_19062020132 KB
74 TODOS MEDICAL SINGAPORE Pte Ltd
 Kaira 2019-nCoV Detection Kit
 TODOS_Kaira_Provisional Authorisation for Covid-19 tests_25062020129 KB
75 Bio-Rad Laboratories (Singapore) Pte Ltd
 Biorad Platelia SARS-CoV-2 Total Ab
 Biorad_Platelia_Provisional Authorisation for Covid-19 tests_25062020128 KB 
76 All Eights (Singapore) Pte Ltd
 Hologic Aptima® SARS-CoV-2 assay
 All Eights_Hologic_Provisional Authorisation for Covid-19 tests_25062020128 KB
77 Beckman Coulter Singapore Pte Ltd
 ACCESS SARS-CoV-2 IgG
 Beckman Coulter_Access_Provisional Authorisation for Covid-19 tests_03072020128 KB
78 Accelerate Technologies Pte Ltd (DxD Hub)
 Accelerate Technologies Resolute 2.0 assay
 Accelerate Technologies_Resolute_Provisional Authorisation for Covid-19 tests_25062020133 KB
79 ZMC Technologies (Singapore) Pte Ltd

 

Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Test Kit (Colloidal Gold)

 ZMC_nCoV_Provisional Authorisation for Covid-19 tests updated_09072020136 KB
80 Unison Collaborative Pte Ltd
 Panbio™ COVID-19 IgG/IgM Rapid Test Device
 Unison_Panbio_Provisional Authorisation for Covid-19 tests_25062020137 KB
81 All Eights (Singapore) Pte Ltd
 genesig® Real-Time PCR COVID-19 (Swab Use)
 All Eights_genesig_Provisional Authorisation for Covid-19 tests_27082020103 KB
82 Andaman Medical Pte Ltd
 Seegene Allplex™ SARS-CoV-2 Assay
 Andaman_Seegene_Provisional Authorisation for Covid-19 tests_25062020128 KB
83 RAS Pharma and Biochem Pte Ltd
 RAS Rapid Test - 2019-nCov IgG/IgM Rapid Test
 RAS Pharma_RAS Rapid_Provisional Authorisation for Covid-19 tests_25062020133 KB
84 Cell ID Pte Ltd
 Smart COVID-19 IgM-IgG Rapid Diagnostic Test
 Cell ID_Smart_Provisional Authorisation for Covid-19 tests_03072020132 KB
85 DSO National Laboratories
 RESOLUTE 1.0 LITE
 DSO_Resolute 1.0 LITE_Provisional Authorisation for Covid-19 tests_03072020129 KB
86 Restalyst Pte Ltd
 RAPIT COVID-19 IgM/IgG Test Kit
 Restalyst_Rapit_Provisional Authorisation for Covid-19 tests_03072020131 KB
87 EMERGO by UL 
 AccuraDTect SARS-CoV-2 RT-qPCR Kit
 Emergo_AccuraDTect_Provisional Authorisation for Covid-19 tests_03072020128 KB
88 Vela Operations Singapore Pte Ltd
 ViroKey™ SARS-CoV-2 RT-PCR Test v2.0
 Vela_ViroKey_Provisional Authorisation for Covid-19 tests_03072020130 KB
89 Biotrilance Pte Ltd
 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
 Biotrilance_Novel_Provisional Authorisation for Covid-19 tests_09072020134 KB
90 Genomax Technologies Pte Ltd
 Hangzhou Lysun 2019-nCoV IgG/IgM Rapid Test Device
 Genomax_Hangzhou Lysun_Provisional Authorisation for Covid-19 tests_09072020133 KB
91 JN Medsys Pte Ltd
 ProTect COVID-19 RT-qPCR Kit 2.0
 JN Medsys_ProTect_Provisional Authorisation for Covid-19 tests_09072020129 KB
92 AMT Pte Ltd
 AMT Resolute 2.0 assay
 AMT_Resolute 2.0_Provisional Authorisation for Covid-19 tests_09072020125 KB
93 Alcotech Pte Ltd
 FaStep COVID-19 Antigen Rapid Test Device (Nasopharyngeal/ Oropharyngeal Swab)
 Alcotech_FaStep_Provisional Authorisation for Covid-19 tests_09072020132 KB
94 Siemens Healthcare Pte Ltd
 Siemens Atellica® IM SARS-CoV-2 IgG (COV2G)
 Siemens_Atellica_Provisional Authorisation for Covid-19 tests_17072020132 KB
95 Siemens Healthcare Pte Ltd
 Siemens ADVIA Centaur® SARS-CoV-2 IgG (COV2G)
 Siemens_ADVIA Centaur_Provisional Authorisation for Covid-19 tests_17072020132 KB
96 Hi-Beau Group
 SAVANT™ New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography)
 Hi-Beau Group_SAVANT_Provisional Authorisation for Covid-19 tests_17072020138 KB
97 Becton Dickinson Holding Ptd.Ltd
 BD Veritor™ System for Rapid Detection of SARS-CoV-2
 BD_Veritor_Provisional Authorisation for Covid-19 tests_28072020135 KB
98 SPD Scientific Pte Ltd
 Standard Q COVID-19 Ag Test
 SPD Scientific_Standard Q_Provisional Authorisation for Covid-19 tests_28072020135 KB
99 An Xin Home Care
 genesig® Real-Time PCR Coronavirus COVID-19
 An Xin_genesig_Provisional Authorisation for Covid-19 tests_28072020128 KB
100 Life Technologies Holdings Pte Ltd
 TaqPath™ COVID 19 CE IVD RT PCR Kit
 Life Technologies_TaqPath_Provisional Authorisation for Covid-19 tests_28072020136 KB
101 BioMérieux Singapore Pte Ltd
 BioFire® Respiratory Panel 2.1 plus (RP2.1plus)
 BioMérieux_BioFire_Provisional Authorisation for Covid-19 tests_28072020131 KB
102 All Eights (Singapore) Pte Ltd
 StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit
 All Eights_StrongStep_Provisional Authorisation for Covid-19 tests_28072020132 KB
103 Thermo Scientific Microbiology Pte Ltd
 Standard Q COVID-19 Ag Test
 Thermo Scientific_Standard Q_Provisional Authorisation for Covid-19 tests_06082020137 KB
104 EUROIMMUN (SOUTH EAST ASIA) PTE. LTD.
 EUROIMMUN Anti-SARS-CoV-2 NCP ELISA (IgG)
 EUROIMMUN_NCP_Provisional Authorisation for Covid-19 tests_06082020133 KB
105 Quantum Technologies Global Pte Ltd
 Sofia SARS Antigen FIA
 Quantum_Sofia_Provisional Authorisation for Covid-19 tests_06082020134 KB
106 i-DNA Biotechnology Pte Ltd
 Maccura SARS-CoV-2 Fluorescent PCR
 i-DNA_Maccura_Provisional Authorisation for Covid-19 tests_06082020130 KB
107 Cheung Yong Sam Investment Private Limited
 COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit
 Cheung Yong Sam_Covid-19_Provisional Authorisation for Covid-19 tests_06082020133 KB
108 Restalyst Pte Ltd
 Restalyst COVID19N-REAAD™ Anti-SARS-CoV-2 Nucleocapsid Protein IgG ELISA
 Restalyst_COVID19N_Provisional Authorisation for Covid-19 tests_18082020139 KB
109 Restalyst Pte Ltd
 genesig® Real-Time PCR COVID-19 (Swab Use)
 Restalyst_genesig_Provisional Authorisation for Covid-19 tests_18082020130 KB
110 Gaia Science Pte Ltd
 genesig® Real-Time PCR COVID-19 (Swab Use)
 Gaia_genesig_Provisional Authorisation for Covid-19 tests_18082020131 KB
111 Veredus Laboratories Pte Ltd
 VereRT™ ZeroPrep™ COVID-19 PCR Kit
 Veredus_VereRT™ ZeroPrep™_Provisional Authorisation for Covid-19 tests_02102020103 KB
112 Link Trust Laboratories Pte Ltd
 DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection kit
 Linktrust_DiaPlexQ_Provisional Authorisation for Covid-19 tests_18082020137 KB
113 Nova Diagnostics Pte Ltd
 MAGLUMI 2019-nCoV IgG (CLIA)
 Nova Diagnostics_MAGLUMI IgG_Provisional Authorisation for Covid-19 tests_2108202099 KB
114 Nova Diagnostics Pte Ltd
 MAGLUMI 2019-nCoV IgM (CLIA)
 Nova Diagnostics_MAGLUMI IgM_Provisional Authorisation for Covid-19 tests_2108202099 KB
115 Alcotech Pte Ltd
 FaStep COVID-19 IgG/IgM Rapid Test Device
 Alcotech_FaStep_Provisional Authorisation for Covid-19 tests_01092020103 KB
116 Jian Yuan Holdings Pte Ltd
 COVID-19 Antigen Rapid Test Kit
 Jian Yuan_COVID-19 Antigen_Provisional Authorisation for Covid-19 tests_01092020102 KB
117  Camtech Diagnostics Pte Ltd
 Camtech COVID-19 Antigen Rapid Test
 Camtech_COVID-19 Antigen_Provisional Authorisation for Covid-19 tests_01092020102 KB
118 Abbott Laboratories (S) Pte Ltd
 Abbott ARCHITECT SARS-CoV-2 IgM
 Abbott_ARCHITECT SARS-CoV-2 IgM_Provisional Authorisation for Covid-19 tests_08092020101 KB
119 Illumina Singapore Pte Ltd
 Illumina COVIDSeq Test
 Illumina_COVIDSeq Test_Provisional Authorisation for Covid-19 tests_18102020102 KB
120 INEX Innovate Pte Ltd
 GenoAmp Real-Time RT-PCR SARS-CoV-2
 INEX_GenoAmp_Provisional Authorisation for Covid-19 tests_08092020101 KB
121 Unison Collaborative Pte Ltd
 GenBody COVID-19 Ag
 Unison_GenBody COVID-19 Ag_Provisional Authorisation for Covid-19 tests_08092020102 KB
122 AGSG
 COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit
 AGSG_COVID-19 (SARS-CoV-2)_Provisional Authorisation for Covid-19 tests_08092020101 KB
123 Abbott Laboratories (S) Pte Ltd
 ABBOTT Alinity i SARS-CoV-2 IgM Abbott_Alinity i SARS-CoV-2 IgM_Provisional Authorisation for Covid-19 tests_08092020101 KB
124 BioAcumen Global Pte Ltd
 BioA SARS-CoV-2 Real-Time RT-PCR Kit v1.0
 BioAcumen_BioA_Provisional Authorisation for Covid-19 tests_17092020103 KB
125 Cellbae Pte Ltd
 TEPAT 1.0 SARS-CoV-2 Multiplex RT-PCR Kit
 Cellbae_TEPAT_Provisional Authorisation for Covid-19 tests_17092020102 KB
126 Abbott Laboratories (S) Pte Ltd
 Abbott Alinity m SARS-CoV-2 AMP Kit
 Abbott_Alinity m_Provisional Authorisation for Covid-19 tests_17092020103 KB 
127 QuikPath Pte Ltd
 QuikPath SARS-CoV-2 Isothermal RT- PCR Kit
 QuikPath_SARS-CoV-2 Isothermal _Provisional Authorisation for Covid-19 tests_17092020101 KB
128 Tigermed Asia Pacific Private Limited
 GenBody COVID-19 Ag
 Tigermed_GenBody_Provisional Authorisation for Covid-19 tests_23092020102 KB
129 Acumen Research Laboratories Pte Ltd
 Satugen Solo
 Acumen_Satugen Solo_Provisional Authorisation for Covid-19 tests_23092020100 KB
130 Acumen Research Laboratories Pte Ltd
 Acu-Corona Solo
 Acumen_Acu-Corona Solo_Provisional Authorisation for Covid-19 tests_23092020100 KB
131 All Eights (Singapore) Pte Ltd
 ESPLINE® SARS-CoV-2
 All Eights_ESPLINE®_Provisional Authorisation for Covid-19 tests_02102020101 KB
132 Biorodi Company Pte Ltd
 Xiamen Zeesan SARS-CoV-2 Test Kit (Real-time PCR)
 Biorodi_Xiamen Zeesan_Provisional Authorisation for Covid-19 tests_02102020101 KB
133 Anomalous Materials Pte Ltd
 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit
 Anomalous_Triplex RT-qPCR_Provisional Authorisation for Covid-19 tests_14102020101 KB
134 Veredus Laboratories Pte Ltd
 VereCoV™ OneMix Detection Kit
 Veredus_VereCoV™ OneMix_Provisional Authorisation for Covid-19 tests_14102020101 KB
135 Genome Institute of Singapore
 3S SARS-CoV-2 RT-PCR Kit
 GIS_3S SARS-CoV-2 RT-PCR_Provisional Authorisation for Covid-19 tests_14102020103 KB
136 bioMérieux Singapore Pte Ltd
 VIDAS® SARS-COV-2 IgG
 bioMérieux_VIDAS® IgG_Provisional Authorisation for Covid-19 tests_14102020103 KB
137 bioMérieux Singapore Pte Ltd
 VIDAS® SARS-COV-2 IgM
 bioMérieux_VIDAS® IgM_Provisional Authorisation for Covid-19 tests_14102020103 KB
138 All Eights (Singapore) Pte Ltd
 Ansh Labs SARS-CoV2 IgM ELISA (μ-Capture)
 All Eights_Ansh Labs SARS-CoV2 IgM ELISA (μ-Capture)_Provisional Authorisation for Covid-19 tests_14102020141 KB
139 All Eights (Singapore) Pte Ltd
 Ansh Labs SARS-CoV2 IgG ELISA
 All Eights_Ansh Labs SARS-CoV2 IgG ELISA_Provisional Authorisation for Covid-19 tests_14102020101 KB
140 Roche Diagnostics Asia Pacific Pte Ltd
 Roche Elecsys Anti-SARS-CoV-2 S
 Roche_Elecsys Anti-SARS-CoV-2 S_Provisional Authorisation for Covid-19 tests_14102020102 KB
141 Unison Collaborative Pte Ltd
 Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal)
 Unison_Panbio_Provisional Authorisation for Covid-19 tests_18102020104 KB 
142 Biomed Diagnostics Pte Ltd
 BIOCREDIT COVID-19 Ag
 Biomed_BIOCREDIT_Provisional Authorisation for Covid-19 tests_18102020102 KB
Consumer, Healthcare professional, Industry member, Medical devices

Regulatory Updates

Singapore Quality Class Star